WO2006037337A1

WO2006037337A1 - A medical device comprising a deployment mechanism

Info

Publication number: WO2006037337A1
Application number: PCT/DK2005/000642
Authority: WO
Inventors: Allan TANGHØJ; Robert Snell; Sam Martin; Sinan Kiamil
Original assignee: Coloplast A/S; Ranier Limited
Priority date: 2004-10-05
Filing date: 2005-10-05
Publication date: 2006-04-13

Abstract

The present invention related to a medical device such as a catheter. In particular the present invention relates to a medical device comprising a tip, a drainage section and a braided retention section extending between the drainage section and the tip. More specifically, the invention relates device comprising a movable part comprising a surface portion which is adapted to slide relative to, and in contact with a corresponding surface portion of a stationary part of the device and wherein the stationary part comprises the drainage section and the movable part comprises a deployment member connected to the tip.

Description

A MEDICAL DEVICE COMPRISING A DEPLOYMENT MECHANISM

INTRODUCTION

The present invention relates to a medical device such as a catheter. In particular the present invention relates to a medical device comprising a tip section, a drainage section and a braided retention section extending between the drainage section and the tip section. More specifically, the invention relates to a device comprising a movable part comprising a surface portion which is adapted to slide relative to, and in contact with a corresponding surface portion of a stationary part of the device and wherein the stationary part comprises the drainage section and the movable part comprises a deployment member connected to the tip.

BACKGROUND OF THE INVENTION

Catheters with a braided retention section are known in the art. One such catheter is disclosed in US 5,041,093 wherein a catheter is made from an elongated flexible tubular member with a conduit. The catheter discloses in the reference comprises an axially and radially elastically extensible, woven tube. The woven tube is translatable between three configurations, i.e. a relaxed configuration, an extended configuration and an over-centre configuration. In the over-centre configuration, the woven tube forms a cup-like shape whereby the catheter can be maintained in place inside the body.

Furthermore braided catheters are known from US 6 033 413, US 4 572 186, US 4 154 242, US 2003/144636, US 3 854 483, US 4 921 484, US 6 55S 350, US 5 221 261 and GB-patent applications 0314503 and 0314504.

DESCRIPTION OF THE INVENTION

Accordingly, a first aspect of the present invention relates to a medical device with a proximal end for insertion into a body of a living being and an axial Iy opposite distal end, the device comprising:

- a tip section defining a tip which in a first position forms the proximal end of the device, the tip being operable between the first position and a second position;

- a drainage section forming a conduit extending in an axial direction of the device and forming an outer surface of the device; - a retention section which is braided and which extends between the drainage section and the tip section, and the retention section being operable between a first configuration and a second configuration, the size of the retention section in a direction transverse to an axial direction of the device, being larger when the retention section is in the second configuration than when the retention section is in the first configuration; and

- a deployment member which when the medical device is inserted into a body of a living being, is operable to move the retention section between the first and second configuration;

wherein the device comprises a movable part comprising the deployment member and having a surface portion which is adapted to slide relative to, and in contact with a corresponding surface portion of a stationary part. The stationary part may define the conduit e.g. in combination with the movable part.

The deployment member may form part of or define the movable part. In one embodiment the deployment member may be attached or connected to the remaining part of the movable part. As an example this may be achieved by means of an adhesive, welding, or moulded together.

The drainage section which defines the conduit, may form part of the stationary part.

In the context of the present invention, the tip shall be interpreted as any part of the device which, when the device is in the first configuration, forms a proximal end of the device. Thus, in some embodiments the tip is defined by the most proximal end of a tip section to which the braided retention section is attached, while in other embodiments, the retention section and the deployment member may be attached directly to each other, and thus in this embodiment the proximal end of the retention section and/or the deployment member may constitute the tip, i.e. the foremost part of the device.

The deployment member may be any actuating means, such as a rod, filaments, yarns, tapes, cables, wires, threads, tubes or any combination thereof, suitable for moving the tip in the distal and/or the proximal direction. Thus, the deployment member may be capable of transferring tension forces, e.g. in the case of filaments, yams, tapes, cables, wires and threads. Alternatively, or as a supplement, the deployment member may be capable of transferring compression forces, e.g. in the case of rods, tubes.

The deployment member may extend inside the conduit of the drainage section, and thus, it may be desired that the cross-sectional area of the conduit is big enough to accommodate the deployment member and to provide sufficient drainage capacity. One solution to this problem is to provide a thin and rigid deployment member e.g. in the form of a rod. Another solution to this problem is to provide a drainage section with as thin a sidewall as possible. In some embodiments, the aforementioned solutions are combined.

As will be apparent from the below description, the specific embodiment of the present invention determines whether a specific part of the medical device forms part of the movable part or the stationary part. As an example, a connector may in some embodiments form part of the stationary part, whereas the connector in other embodiments forms part of the movable part. However in relation to any embodiment of the invention, the stationary part always comprises the drainage section and the movable part always comprises the deployment member.

A surface portion (a movable surface portion) of the movable part may be adapted to slide relative to, and in contact with a corresponding surface portion (a stationary surface portion) of a stationary part of the device. By ^λin contact with' is meant that during the essential part of the relative movement between the stationary part and the movable part, at least a part of the two surfaces are in contact with each other. However, for some embodiments the two surfaces may be brought out of contact during a small part of the relative travelled distance e.g. less than 5% of the travelled distance and e.g. in connection with, and in order to locking the deployment member in a locking position.

The retention section may be movable between the first and second configuration upon movement of the tip between the first and the second position. The retention section is in fluid communication with the conduit such that fluid may be drained through the retention section.

Furthermore, the deployment member may in one embodiment extend between a first point located between the retention section and the proximal end of the device, and a second point located between the retention section and the distal end of the device. Accordingly, the retention section may encircle the deployment member and the deployment member may extend out of a proximal and a distal end of the retention section.

The deployment member may form part of an outer surface of the drainage section so as to allow manipulation of said deployment member from said outer surface, e.g. in a distal end.

In one embodiment, the movable part comprises an operator defining an outer gripping surface of the device. As the movable part also comprises the deployment member which is connected to the tip section, movement of the operator causes the tip to move, whereby the configuration of the retention section may be controlled by the operator.

In one embodiment the movable part and the stationary part define a boundary between a fluid flowing in the conduit and the surroundings of the device, i.e. the movable part and the stationary part in combination form part of an outer wall of a flow path. Accordingly, both the movable part and the stationary part may be in direct contact with any fluid passing through the device. It will be appreciated that when the movable part e.g. the deployment member, forms part of an outer surface of the device e.g. by being provided on the outer surface of the drainage section, a seal may preferably be provided between the movable part and the stationary part. The seal may ensure that the movable part and the stationary part are able to move relative to each other without leakage of fluid passing through the device, to the outer surface of the device, such a seal may comprise e.g. a sliding seal between the two parts, or the two parts may be joined via a soft flexible foil, e.g. of a polymeric material or the two parts may be joined by a bellow.

Moreover, the operator may comprise further elements e.g. a connector or a valve. The connector or the valve may form a distal end of the device. When the operator is provided as a connector or a valve the user may move the connector/valve in an axial direction in order to change the position of the tip.

In the present invention, the term connector means an element which is adapted to be connected to another device such as a tube or a bag, so as to form a connection allowing fluid communication between the medical device and the other device, when the connector and the other device are connected.

In another embodiment, the stationary part comprises a connector. In the latter embodiment, a separate operator may be provided which when moved relative to the connector, moves the tip of the device.

A radial dimension of the connector of the stationary part or movable part may increase in a direction towards the distal end of the medical device. One advantage of such an embodiment is that the outer surface may provide a gripping surface while the inner surface may provide a connecting surface which may be connected to another element with a corresponding outer surface.

A first corrugated section may extend between the operator and a connector so as to provide a seal between the operator and the connector. One advantage of such an embodiment is that the contacting surfaces between the movable part and the stationary part need not to provide a seal between said parts as the bellows or corrugated section provides the seal. From, a manufacturing point of view, it may be desirable as tolerances between the movable surface portion and the stationary surface portion are thus less critical.

The first corrugated section may extend away from the operator and in a distal direction of the device. Furthermore, a second corrugated section may extend away from the operator and in a proximal direction of the device. The second corrugated section may provide a seal between the operator and the drainage section. The second corrugated section may provide the same advantages as mentioned under the first corrugated section.

In one embodiment the corrugated section(s) is/are not adapted to lock the deployment member/actuator in a predetermined position. On the contrary the corrugated section

(bellows) is as soft as possible and as flexible as possible whereby the risk of getting skin caught in the bellows is reduced.

In one embodiment, the operator is arranged in relation to the deployment member and/or the tip section such that movement of the operator in a proximal direction causes the deployment member and/or the tip to move in a distal direction and vice versa. This may be achieved by means of a direction changing arrangement e.g. a wheel or a surface, the deployment member or a flexible part of it, cling around. Thus, when the operator is pushed in the proximal direction, the retention section is moved towards the second configuration, and when it is moved in the distal direction the retention section is moved towards the first configuration.

The device may further comprise an indicating means which indicates when the tip is in a predetermined position, when operated between the first and the second position. Such a predetermined position could be a position wherein the tip no longer forms the proximal end of the device or wherein the tip is in the first position.

Furthermore, the device may comprise locking means for locking the tip in a predetermined position, when operated between the first and the second position. This makes it possible to ensure that the device stays in a desired position, e.g. the first position or in a position wherein the retention section is capable of retaining the medical device inside the body. The locking means may be locked and un-locked a plurality of times.

In yet another embodiment, the device forms a catheter.

To facilitate comfortable insertion or to reduce the risk of adherence of body tissue to the surface of the device, at least a part of the device, e.g. the braided portion or the tip-section may define an outer surface, i.e. a surface towards the body tissue when the device is inserted into the body, which surface has a low surface friction characteristic compared to other pa rts of the device. To provide the low friction characteristics, the medical device, e.g. the braided portion thereof may have a hydrophilic surface, e.g. provided by a hydrophilic coating of the surface, e.g. a coating comprising polyvinylpyrolidone.

In one embodiment, namely when a first part of the braided portion is located inside a second part of the braided portion, the low friction surface may in particular be provided on the second part of the braided portion. During retention inside the body, the body tissue is thereby protected by the low friction character of the second part. A hydrophilic coating may further reduce irritation of the body tissue, e.g. the mucosa. If a hydrophilic coating is applied to the braided portion, the coating may incorporate an anti-infective compound or a compou nd which counteracts ingrowth.

In one embodiment, the tip section or at least a part thereof is made from a material which is soluble in water, such as PVA, such that once the catheter is inserted and the tip has been used to ease insertion, the tip section dissolves when it is brought into contact with a body fluid e.g . urine. In the context of the present invention the term soluble in water shall be understood as soluble by any body fluid and not only water. In some embodiments the tip section is only soluble in body fluids under temperatures close to body temperature e.g. between 30 and 45 degrees, such as between 37 and 40 degrees. When the tip section has dissolved, a second drainage passes may emerge. When the medical device is removed it may be pulled in a direction opposite the tip (the distal direction) and thus a smooth tip may not be needed anymore.

In order to further increase the degree of expansion or to form a specific shape of the braided portion in the second configuration, a first part of the braided portion may be located inside a second part of the braided portion when the device is in the second configuration. These fi rst and second parts of the braided portion do not have to be structurally separated, but cou ld form one uniform braided portion, and merely the fold arising by the inverting or rolling of one part of the braided portion into another part of the braided portion defines the transition between the first and second parts of the braided portion. In the first configuration, the braided portion could extend un-folded in the axial direction.

The device could be used for transporting fluids or substances into or out of a body, e.g. for gastro content aspiration. The device could be applied subcutaneously or through insertion of the catheter into a natural or artificial opening in the body, or the medical device could be applied for stent delivery, e.g. for placing a stent within the prostatic urethra, or in general for drai ning fluids from a natural or artificial body lumen, for anal insertion or for insertion into the gastrointestinal region, e.g. with the purpose of fixating a camera or surgical instruments inside the body or in general to establish a passage into the body. Alternatively, the device may be used for urinary drainage, i.e. wherein the catheter is inserted into a natural or artificial urina ry canal e.g. urethra, and into a bladder for draining urine.

In the first configuration, i.e. in an extended state wherein the first and second parts of the braided portion are located in axial extension of each other, the braided portion has a generally cylindrical or ovoid shape facilitating insertion into the body. Depending on how the braiding angle is varied, the shape of the resulting funnel can be controlled, and in the second configuration, the braided portion may be provided to form an ovoid shape of a larger dimension transverse to the axial direction, a funnel shape, a tulip-like shape, a disc-shape, a hemispherical shell, a conical shell, a elliptic parabolic shell or any other cup like shell or any other shapes which support retaining of the device in the body. In particular, axially disposed rim portions of the braided portion may form a larger braiding angle than an intermediate centre portion.

The medical device, especially the retention section, may be designed with "shape-memory" such that it will automatically move towards a predetermined shape i.e. towards a more relaxed state. In a first embodiment the medical device is designed such that the predetermined shape is the first configuration, i.e. the medical device will have a tendency to move towards the first configuration, but may be moved into the second configuration by axial displacement of the first part of the braided portion into a second part of the braided portion. In some embodiments, the first configuration is a configuration wherein the larger dimension of a cross-section of the braided portion is equal or less than the larger dimension of a cross-section of the remaining part of the tube.

In a second embodiment, the medical device is designed such that the predetermined shape is the second configuration, i.e. the medical device will have a tendency to move towards the second configuration, but may be moved into the first configuration by axial displacement of the first part of the braided portion out of the second part of the braided portion. In some embodiments, the second configuration is a configuration wherein the largest dimension of a cross-section of the bra ided portion is larger than the largest dimension of a cross-section of the remaining part of the tube.

In a third embodiment, the medical device is designed such that the predetermined shape when the braided portion is located inside the remaining part of the tube, e.g. the drainage section, coaxially therewith. When the medical device is located in the body, the second part is displaced out of the remaining part of the medical device to form a medical device in the second configuration, i. e. retained in the body. To operate the medical device between the different configurations, a deployment member could be attached to the proximal end, e.g. to a proximal tip of the medical device, and extend to the distal end to facilitate manipulation of the proximal end from outside the body. A Deployment member could e.g. extend inside the lumen. The tip may be shaped as a Nelaton tip or as a Tiemann tip, or the tip co uld have the form of an open ring, e.g. with a smoothly rounded part extending in a forward direction to form a proximal end of the device and th us to facilitate comfortable insertion of the device into the body.

In one embodiment a friction between the contacting surfaces is chosen so as to allow the retention section to be retained in an un- relaxed state. Accordingly, the static frictional force will be larger than the force which the retention section exerts on the moveable part due to its tendency to move towards the relaxed state. One advantage of the latter em bodiment is that the retention section may be positioned in any position, which position is unchanged unless changed by the user.

The retention section may comprise a braided portion with crossed filaments wh ich mutually form a braiding angle. The braiding angle may vary along the length of the retention section e.g. such that the braiding angle in the middle of the retention section is different from the braiding angle in the top and bottom of the retention section.

The wording "braided portion" includes in general a device portion provided with through- going windows, i.e. openings formed from an outer peripheral surface to an inner peripheral surface and often being symmetrically arranged to form a uniform grid of windows. More specifically, the braided portion may comprise cross-braided filaments, i.e. threads which are braided over and under each other. Preferably, the braiding enables the filaments to slide relative to each other. The braided portion could also be constituted by a section of the device with openings forming a mesh-pattern. Irrespective of the type of braiding, the angle, α, which the filaments form with the axial direction, is important for determining the degree of radial expansion and the more precise shape of the retention section which a rises when the first part is displaced into the second part of the braided portion. This is described in further details later.

The braided filaments may be braided over and under each other. Alternatively, the filaments are arranged in two separate layers provided over each other, wherein the filaments of one layer extend in a direction different from the direction of the filaments of the other layer. In each intersection between a filament of one of the layers and a filament of another layer, the filaments of the two layers may be joined by adhesion. In connection with one device there may be used between 20 and 100 filaments, such as between 24 and 48 filaments.

The braiding may be provided in the retention section and/or the drainage section and/or the deployment member. Furthermore the tip of the device may be made of the same braided material as the retention section. In order to provide a homogeneous surface of the tip, the braided material may be shaped by means of a heated tool or a tool for plastically deforming the material in to e.g. a bullet-like shape.

By providing a drainage section comprising a braided material, the strength of the drainage section is reinforced as the braided section and an appropriate matrix material constitutes a composite. Accordingly it is possible to make the wall oF the drainage section thinner. Thus for a given outer diameter of the medical device the cross-sectional flow area may be larger.

In the table below, it is indicated how the use of a braid ed drainage section can increase the cross section of the conduit in a catheter.

Traditional silicone catheter cross Cross sectional area with a braided

Ch size sectional area [mm²] drainage section [mm²]

8 1,3 2,3

10 3,1 4,2

12 3,8 7,1

14 4,9 10,8

16 3,8 14,5

18 8,0 19,6

Moreover the filaments of the drainage section may form an extension of the filaments of the retention section.

At least the drainage section may be at least partially coated with polymeric material. Furthermore the retention section may be at least partially coated with polymeric material, the coating on the retention section being thinner or having the same thickness as the coating on the drainage section.

The filaments could e.g. be made from polyester, polya mide, polyalkane, polyurethane, PET^", PBT, Nylon, PEEK, PE, Glass Fibre, Metal Wire or Acrylic materials or any composition of the mentioned materials. A preferred material would be PET or polyester.

The medical device may include a matrix material, e.g. any medical grade polymer that can be dissolved in a solvent or manufactured as a polymer emulsion. Examples of these are polyurethane, polyurethane dispersions, acrylic, PVC, b lock copolymers (SIS SBS) etc, natural rubber, silicone, neoprene, nitrile or compositions thereof. Polyurethane, acrylic, PVC, block copolymers (SIS SBS) etc, natural rubber, silicone, or EPO or compositions thereof, could be used if the medical device is made by extrusion or injection moulding.

The device may comprise reduction means for reducing the cross sections of at least a part of the first and/or second drainage passages. The reduction means could e.g. be constituted by a filler material disposed between the filaments or by a lining, i.e. e.g. a skirt shaped foil which covers at least a part of the braided portion, e.g. in contact with an inner surface of the braided portion or in contact with an outer surface of the braided portion. The filler and the lining can either substitute each other to prevent ingrowth into the braided portion or the filler may be combined with a lining.

The filler could comprise a matrix material disposed between the filaments or partly coveri ng the filaments. The material could be any medical grade polymer that can be dissolved in a solvent or manufactured as a polymer emulsion. Examples of theses are polyurethane, polyurethane dispersions, acrylic, PVC, block copolymers (SIS SBS) etc, natural rubber, silicone, neoprene, nitrile or compositions thereof. Polyurethane, acrylic, PVC, block copolymers (SIS SBS) etc, natural rubber, silicone, or EPO or compositions thereof, could be used if the medical device is made by extrusion or injection moulding.

The lining could form a skirt or mantle on the surface of the braiding. The lining could be a pre-formed funnel shaped piece of a thin elastically flexible polymeric film, e.g. made from any medical grade polymer that can be dissolved in a solvent or manufactured as a polymer emulsion, e.g polyurethane, polyurethane dispersions, acrylic, PVC, block copolymers (SIS SBS) etc, natural rubber, silicone, neoprene. The lining could also be made from PU, Evoprene or nitrile and possibly with a surface layer of a hydrogel. The thickness of the film could be in the range of 3-1000 μm. such as 20-200 μm., such as 40-80 μm. In one embodiment, a foam material, e.g. a hydrogel, PEG-PU, or Kraton™ can be used with in a thickness of up to 5 mm.

The deployment member may be able to be moved between 10mm and 70mm, such as between 20 and 35mm. The stationary part and the movable part may provide a tight sea I relative to the surroundings or substantially tight for any relative position between said parts. At least a part of the outer surface may be round or oval. In one embodiment at least a part of the stationary part and/or the movable part and/or the corrugated sections may be of a thermoplastic material which is suitable for welding. In one embodiment the outer surfaces are smooth such that they do not define any cutting edges, which potentially could cut the patient or the person inserting the device. DETAILED DESCRIPTION

In the following, the invention will be described in further detail with reference to the drawings in which:

Figs. la-7a and 8a-8c illustrate embodiments of the deployment mechanism of the present invention,

Fig. 7b illustrates a coupling system shown comprising a first coupling part 146 and a second coupling part 148, and

Figs. 9a and 9b illustrate the medical device according to the present invention.

Figs. la-7a and 8a-8c illustrate the distal part of the medical device i.e. the part which in the use situation is positioned outside the body and where the deployment mechanism is operable. In the embodiment the proximal end of the device i.e. the part adapted for insertion in to the body of a living being, is situated in the direction of the arrow 102. The opposite distal end in indicated by reference number 104. In order to provide simple drawings the length of the actuator member is not illustrated in its full length. However, this should not be interpreted as a limiting feature, as the actuator mem ber as described in the rest of the application, is connected to the tip section. As it will be apparent from the claims and the aforementioned description, the movable part and the stationary part comprise different parts and elements of the device depending on the embodiment, e.g. the connector may in some embodiments be a part of the movable part, while it is a part of the stationary part in other embodiments. In the following description it is explained which elements define the movable part and which define the stationary part.

In the embodiment of Figs. Ia and Ib, the stationary part 106 comprises a drainage section 110 and a gripping member 112, while the movable part 108 comprises a connector 114 and an actuator 115 (deployment member), the actuator is attached to the connector 114. A stationary surface portion 116 is adapted to slide relative to, and in contact with a movable surface portion 118. In order to change the retention section between the first and the second configuration, the movable part may be moved in the direction indicated by the arrow 120. On the movable part a first stop surface 122 limits the movement in the proximal direction and a second stop surface 124 limits the movement is the distal direction. In this embodiment the connector is used to operate the medical device. In Fig. Ia the device is shown in a situation wherein the retention section is close to its first configuration. In the embodiment of Figs. 2a and 2b the stationary part 106 comprises the drainage section 110 and a connector 114, while the movable part 108 comprises an operator 126, which is received in a slot 128 in the stationary part. A slot 128 is provided on both sides of the stationary part. The actuator is connected to the operator 126 through the slots 128, via an interconnecting member (not shown). The actuator 115 is connected to the interconnecting member. A first stop surface 122 and the second stop surface 122 limit the axial movement of the operator 126, which is used to move the retention section between the first and the second configuration. The device is shown in a situation wherein the retention section is in the second configuration. In order to reduce or limit leakage a first corrugated section 130 (in Fig. 2a not shown as a corrugated section, but as a straight line) extends between the operator 126 and a connector 114 so as to provide a seal between the ope rator and the connector. Accordingly, the first corrugated section 130 extends in a distal direction of the operator and furthermore a second corrugated section 132 extends in a proximal direction of the operator 126, the second corrugated section providing a seal between the operator and the drainage section 110.

In the embodiment of Figs. 3a and 3b, the stationary part 106 comprises a drainage section 110 and a gripping member 112, while the movable part 108 comprises a connector 114 and an actuator 115, the actuator is attached to the connector. Contrary to the embodiment of Figs. Ia and Ib the movable part 108 is provided on the outer surface of the stationary part 106 i.e. the stationary surface portion 116 which is adapted to slide relative to, and in contact with a movable surface portion 118. On the movable part 108 there is provided an inwardly protruding part 134 which is adapted to engage one of indentations 136,136' in the stationary part, this makes it possible to lock the movable part in a predetermined position.

In the embodiment of Figs. 4a, 4b and 4c, the stationary part 106 comprises a drainage section 110 and a gripping member 112 and a female part 138 (defining a groove) of a locking means, while the movable part 108, comprises a connector 114 and an actuator 115, which is adapted to slide in the groove of the female part 108 of the locking means and which comprises the male part 140 (a protruding part of the actuator) of the locking means. The inner surface of the groove of the female part 138 defines the stationary surface portion 117 and the outer surface of the actuator 115 defines the movable surface portion 118. In order to reduce or limit leakage a first corrugated section 130 extends between the operator and a connector so as to provide a seal between the operator and the connector.

In the embodiment of Figs. 5a and 5b, the stationary part 106 comprises a drainage section 110 and a gripping member 112, while the movable part 108 comprises a connector 114 and an actuator 115 connected thereto. Furthermore, the movable part 108 comprises guiding members 142, which engage the inner surface of the stationary part and thus the stationary surface portion 116 is provided on the inner surface of the drainage section and the gripping member, while the movable surface portion 118 is provided on the outer surface of the guiding members 142.

In the embodiment of Figs. 6a and 6b, the stationary part 106 comprises a drainage section 110 and a gripping member 112', 112", which is divided into a first part 112' and 112", while the movable part comprises a connector 114 and an actuator connected thereto (not visible in the drawing but similar to the actuator mechanism of fig. 5a). Furthermore the movable part 108 comprises guiding members 142, which engage the outer surface of the stationary part and thus the stationary surface portion 116 is provided on the outer surface of the drainage section, while the movable surface portion 118 is provided on the inner surface of the guiding members 142.

In the embodiment of Fig. 7a, the stationary part 106 comprises a drainage section 110 and a connector 114, while the movable part comprises an actuator 115 which is connected to an operator 126 the outer surface of which, is received in and is free to slide in an aperture 144 of a stationary section. The operator and the actuator are connected via the coupling system exemplified in Fig. 7b, which comprises first coupling part 146 and a second coupling part 148. The two parts are adapted to engage each other and could be made in any way known per se. In the embodiment of Fig. 7b, the first coupling part is T-shaped end is adapted to engage a corresponding second coupling part. The parts are disengaged by pushing the T- shaped element as indicated by arrow 150. When the operator has been pulled out of the aperture 144, such that the aperture now engages the actuator, the operator may be disengaged. Afterwards the operator may be reused or a new operator which is provided in the compartment 152, may be used to move retention section from the second configuration to the first configuration. One advantage of using a new operator is that may be sterile contrary to the old operator which may be contaminated by body fluids during insertion of the catheter.

A first alternative to the embodiment of Fig. 7a, is illustrated in Fig. 8a wherein the stationary part 106 comprises a drainage section 110 and a connector 114, while the movable part 108 comprises an actuator 115 and a operator 126. In order to be able to operate the operator under sealed conditions, the actuator extends through a seal 154 which may be made from any suitable material such as a, PP, Polyurethane, silicone, natural rubber, SBS, SEBS, Neoprene, nitrile rubber, butyl rubber, plasticised PVC.

In a second alternative illustrated in Figs. 8b and 8c, the stationary part 106 comprises a drainage section 110 and a connector 114, while the movable part 108 comprises an actuator 115 and an operator 126. The operator 126 may slide as indicated by arrow 156 so as to move the retention section between the first and the second configuration. In order to be able to operate the operator under sealed conditions, the actuator extends through a seal 154 which may be a made from any suitable material such as a, PP, Polyurethane, silicone, natural rubber, SBS, SEBS, Neoprene, nitrile rubber, butyl rubber, plasticised PVC.

Figs. 9a and 9b illustrate a medical device 170 according to the present invention comprising a tip section 172, an retention section 174, a drainage section 110 and connector 114. The tip section 172 defines a tip 200. In Fig. 9a the tip 200 is in the first position and the retention section is in the first configuration, while in Fig. 9b the tip 200 is in the second position and the retention section is in the second configuration.

Claims

1. A medical device with a proximal end for insertion into a body of a living being and an axially opposite distal end, the device comprising:

a tip section defining a tip which in a first position forms the proximal end of the device, the tip being operable between the first position and a second position;

a drainage section forming a conduit extending in an axial direction of the device and forming an outer surface of the device;

a retention section which is braided and which extends between the drainage section and the tip section, the retention section being operable between a first configuration and a second configuration, the size of the retention section in a direction transverse to an axial direction of the device being larger when the retention section is in the second configuration than when the retention section is in the first configuration; and

a deployment member which when the medical device is inserted into a body of a living being, is operable to move the retention section between the first and second configuration;

wherein the device comprises a movable part comprising the deployment member and having a surface portion which is adapted to slide relative to, and in contact with a corresponding surface portion of a stationary part.

2. A device according to claim 1, wherein the retention section is movable between the first and second configuration upon movement of the tip between the first and the second position.

3. A device according to any of the preceding claims, wherein the deployment member extends between a first point located between the retention section and the proximal end of the device, and a second point located between the retention section and the distal end of the device.

4. A device according to any of the preceding claims, wherein the deployment member forms part of an outer surface of the conduit so as to allow manipulation of the deployment member from said outer surface.

5. A device according to any of the preceding claims, wherein the movable part and the stationary part define a boundary between a fluid flowing in the conduit and the surroundings of the device.

6. A device according to any of the preceding claims, wherein the movable part comprises an operator defining an outer gripping surface of the device.

7. A device according to claim 6, wherein the operator comprises a connector.

8. A device according to claim 7, wherein the connector forms the distal end of the device.

9. A device according to claim 6, wherein the stationary part comprises a connector.

10. A device according to claim 9, wherein a first corrugated section extends between the operator and a connector so as to provide a seal between the operator and the connector.

11. A device according to claim 10, wherein the first corrugated section extends in a distal direction of the operator and wherein a second corrugated section extends in a proximal direction of the operator, the second corrugated section providing a seal between the operator and the drainage section.

12. A device according to claim 6, wherein the operator is arranged in relation to the deployment member and/or the tip such that movement of the operator in a proximal direction causes the deployment member and/or the tip to move in a distal direction.

13. A device according to any of the preceding claims, further comprising an indicating means which indicates when the tip is in a predetermined position when operated between the first and the second position.

14. A device according to any of the preceding claims, further comprising a locking means for locking the tip in a predetermined position, when operated between the first and the second position.

15. A device according to any of the preceding claims, wherein the retention section has a relaxed state and an un-relaxed state, and wherein a friction between the contacting surfaces is chosen so as to allow the retention section to be retained in an un-relaxed state.

16. A device according to any of the preceding claims, forming a catheter.