WO2020070186A1

WO2020070186A1 - A device for thermal ablation

Info

Publication number: WO2020070186A1
Application number: PCT/EP2019/076694
Authority: WO
Inventors: Jacob Kollerup Jensen
Original assignee: Lina Medical International Operations Ag
Priority date: 2018-10-02
Filing date: 2019-10-02
Publication date: 2020-04-09
Also published as: EP3860485A1

Abstract

A device for thermal ablation of an endometrium, the device comprising a catheter extending from a proximal end to a distal end, a balloon attached to the distal end and forming a cavity. The device further comprises a reservoir containing a substance, and a displacement structure for displacing substances between the reservoir and the cavity. To reduce ingress of gas or water into the cavity, the device is in a packaging forming a first surface and a second surface, the first surface and second surface being located opposing each other at a distance on opposite sides of the balloon thereby forming a space enclosing the balloon and fixing a shape of the balloon during storage. The fixing of the shape prevents a natural reshaping of the balloon and ingress of gas or water is reduced or prevented.

Description

A DEVICE FOR THERMAL ABLATION

FIELD OF THE INVENTION

The invention relates to a device for thermal ablation. The device comprises a catheter extending from a proximal end to a distal end, a balloon configured for a collapsed state and an expanded state and being attached to the distal end, the balloon forming a cavity, a reservoir containing a substance, and a displacement structure which can be activated to communicate the substance between the reservoir and the cavity to thereby shift between the collapsed state and the expanded state.

DESCRIPTION OF RELATED ART

Application of thermal energy is known for treating body tissues. Particularly, it is well known to effect necrosis of the endometrium e.g . by use of an expandable balloon or bladder which is filled with an inflation medium at an elevated temperature, typically about 80-90° Celsius.

In a collapsed state, the balloon is inserted into uterus of the subject and a hot inflation medium is displaced into the balloon which thereby expands. Close contact between the hot outer surface of the balloon and the tissue lining for which necrosis is desired is typically maintained for 8-15 minutes after which the inflation medium is drained from the balloon.

The collapsed balloon can finally be removed from the subject.

In some devices, the inflation medium is heated to a temperature above the boiling point for water. In such devices, content of water in the balloon or in the inflation medium begins to boil and water vapour expands the balloon. The boiling may therefore cause an undesired early, fast, or large degree of inflation. Accordingly, content of water may have a negative impact on the usability and particularly the controllability of the device due to formation of water vapour during heating. Unfortunately, the balloon is typically made of a thin membrane of a polymeric material and may, to a certain extent, be permeable to gas and water vapour. Prolonged storage or assembly routines in humid environment may therefore cause ingress of water into the cavity and may thus affect the quality of the device. SUMMARY OF THE INVENTION

It is an object of embodiments of the invention to improve the existing methods and devices for conducting thermal ablation and particularly to provide a simpler and more reliable device with better control over the inflation.

It is a further object to increase the safety during thermal ablation procedures, to increase the stability of devices during storage, and/or to simplify manufacturing.

According to a first aspect, the invention provides a product comprising a device and a packaging .

The device comprises a catheter extending from a proximal end to a distal end, and a balloon forming a cavity and configured for a collapsed state and an expanded state. The balloon is attached to the distal end, and the device comprises a reservoir containing a substance and a displacement structure which can be activated to communicate the substance between the reservoir and the cavity to thereby shift between the collapsed and the expanded state.

The device is contained in an encapsulated space in the packaging, wherein the product further comprises a first surface and a second surface in the encapsulated space, the first surface and the second surface opposing each other on opposite sides of the balloon thereby holding the balloon in a fixed shape in the encapsulated space.

During storage, balloons will normally seek back to an original shape. During this process of reshaping, air from the ambient space may diffuse into the cavity of the balloon and thus accumulate water vapour in the cavity.

Since the balloon of the present disclosure is maintained in a fixed shape, it is prevented from returning to its original shape and consequently, ingress of air from the ambient space is reduced. Accordingly, accumulation of water and contaminants in the cavity is reduced or at least postponed and that allows an increased storage time, improved safety, and better control of the expansion of the balloon.

The liquid is added to the cavity, and the first surface and second surface spread the liquid in the cavity by squeezing the balloon from opposite sides. Accordingly, a large part or the entire inner surface of the balloon may, continuously, be in contact with the liquid during storage in the packaging. The continuous wetting of the inner surface may further reduce or completely prevent diffusion of air and thus accumulation of water vapour in the cavity. The liquid which could be added to the cavity may particularly be the substance which is contained in the reservoir. The liquid could e.g. be glycerol or another liquid having a boiling point above the boiling point of water.

Particularly, it may be desired to preserve a curved shape of the balloon, and for that reason, at least one of the first surface and second surface may have a concave shape, meaning that it curves inwardly and forms a shallow bowl shape corresponding essentially to the shape of a spoon, and the other one of the first and second surface may have a convex shape, meaning that it curves outwardly, e.g. with a shape matching the concave shape of the other surface, i.e. they curve in the same direction. By the term "at least one of" is herein meant one of them, the other one of them, or both of them, i.e. in this instance, at least one of the first surface and second surface is herein meant, one of the surfaces, the other one of the surfaces, or both of the surfaces.

Particularly, the term "shallow bowl shape" may define that the first and second surfaces forms a curve extending from a circumferential edge towards a curved bottom. The curve could be concave or convex, and it may follow the shape of a sphere or have any other shape forming a bowl. Particularly, the circumference of the edge may be at least 2-3 even at least four times the height formed by the shortest distance between the curved bottom and a plane in which the circumferential edge is located.

Particularly, the convex shape of one of the first and second surfaces may enter into the space formed by the concavity of the other surface. In one such embodiment, one of the first and second surfaces forms a bowl shape with a wall extending in a curved shape from a bottom of the bowl to the circumferential edge of the bowl. In this embodiment, the other one of the first and second surfaces forms a top point located in a cross section which is between the bottom of the bowl and the circumferential edge of the bowl shape.

The balloon is formed by a membrane having a thickness, t. In one embodiment, the first surface and second surface are made to enclose the balloon very narrowly, for that purpose, the distance between the first surface and the second surface could be at least 2 times the thickness, t, of the membrane, such as 2,5 times t, or 3 times t or 4 times t.

In one embodiment the distance between the first surface and the second surface is at most 30 times the thickness of the membrane, i.e. the distance may e.g. be in the range of 2-30 times the thickness. Particularly, the first and second surface may compress the balloon and thereby smooth out the membrane.

The thickness, t, could e.g. be in the range of 0.1-0.3 mm, such as 0.2 mm and the distance between the first and second surfaces could be in the range of 0.2-9 mm such as at least 0.4 mm and at most 18 mm. Due to the distance, the balloon may be held in a fixed shape without being squeezed between the first and second surfaces.

The catheter has a transverse dimension, i .e. a dimension perpendicular to the longitudinal direction between the proximal end and the distal end. At least one of the first surface and second surface may form a recess, and the catheter may extend in the recess. By at least one of the first surface and second surface is herein meant, one of them, the other one of them, or both of them . The recess may particularly extend narrowly around the catheter such that the catheter is prevented from moving radially in the recess. The recess may e.g . have a size in a cross section perpendicular to the axial direction of the catheter which is not more than 1,5 or not more than 2 times, or not more than 3 times the size of the catheter in the same cross section.

To provide a uniform stretching, smoothening, or compression of the balloon, and thus to provide a completely fixed shape, or to provide a uniform spreading of liquid in the cavity if liquid is added to the cavity, the first surface may be parallel to the second surface thereby creating a uniform distance between the surfaces. By the specification of the first and second surfaces being parallel is herein meant that the surfaces have matching shapes such that in cross sections perpendicular through the surfaces, the surfaces define parallel lines, and particularly parallel and curved lines.

The first surface may form part of a first packaging insert component and the second surface may form part of a second packaging insert component. The two packaging insert components may be removable from each other to thereby enable complete opening of the space and easy insertion and removal of the balloon from the space.

The first surface and second surface could be formed as separate components which are movable within the packaging . This may increase the flexibility during manufacturing and allow the balloon to be supported in fixed shape and/or liquid to be spread in the cavity already before the final packaging takes place by arranging the balloon between the separate components and subsequently arranging the balloon and the separate components as one part in the packaging . The separate components may e.g. be assembled on opposite sides of the balloon, e.g. by use of an adhesive, e.g . by use of adhesive tape etc.

The insert component may particularly form both the first surface and the second surface. In this embodiment, the insert component may be configured to be moved from a closed state to an open state thereby moving the first surface away from the second surface and allowing removal of the balloon from the insert component. For this purpose, the first and second surfaces may be joined e.g. by a hinge structure. The device includes a stop member which is slidable along the catheter. The stop member is applied for preventing a too deep insertion of the catheter and balloon into the cervix and uterus.

The stop member may be configured to engage the insert component in a way which prevents movement to the open state unless it has been moved. I.e. to prevent opening in one position of the stop member relative to the insert component and to allow movement to the open state in another position of the stop member relative to the insert component. The stop member may e.g. engage projecting prongs provided on each of the first and second surfaces such that the engagement has the effect that the insert component can not be opened unless the stop member is moved until the prongs disengage the stop member, e.g . downwards along the catheter. The engagement between the stop member and the insert component has the effect that the user is forced to move the stop member and thereby becomes aware about its existence and ability to be adjusted according to the depth of the uterus and cervix.

Alternatively, at least one of the first surface and second surface may form part of an outer packaging of the packaging. By at least one of the first surface and second surface is herein meant, one of them, the other one of them or both of them .

The substance may be a liquid substance, e.g . containing glycerol or completely being constituted by glycerol .

The balloon may particularly be a thin membrane, e.g. of a polymeric material and it may to a certain extend be permeable by gas or water.

The reservoir may particularly be less permeable to gas or water compared to the balloon. It may particularly have a larger wall thickness and/or a more rigid structure.

The liquid is contained in a cavity, and it may e.g. be in very small amounts since it is typically not used for the thermal ablation procedure as such, but only for preventing ingress of gas or water through the barrier of the balloon during storage of the device.

The catheter may contain one or more conduits which fluidly connects the cavity and the reservoir.

The cavity may be sealed from the reservoir. The sealing may prevent the substance in the reservoir from entering the cavity before it is intended to expand the balloon. The sealing could be established by a removable closure structure between the reservoir and the cavity, e.g. located between the at least one conduit of the catheter and the reservoir, or located between the at least one conduit of the catheter and the cavity. The closure structure may be configured to burst, melt, or otherwise destruct and thereby open a passage from the reservoir to the cavity. The sealing thus further facilitates that the balloon can remain in a fixed shape during storage. The closure structure could e.g. be constituted by a melt plug which melts upon heating of the substance, e.g. a melt plug which melts at a temperature above 100 degrees. It could also be in the form of a burst plug which bursts at a specific pressure e.g. applied by the displacement structure. The removable sealing may particularly form a gas barrier with a seal characteristic against diffusion of gas or water being superior to the first barrier characteristics.

The displacement structure may e.g. be a pump, e.g . an electrically driven pump, e.g . a syringe pump, which, upon activation, displaces the substance from the reservoir into the cavity.

Additionally, the device may comprise heating means configured to heat the substance, e.g. in the reservoir, such that the temperature is raised, e.g. to above 100 degrees, e.g . prior to the displacement of the substance into the cavity.

The balloon forms a first gas barrier with a first barrier characteristic against diffusion of gas or water into the cavity, and the reservoir forms a second gas barrier with a second barrier characteristic against diffusion of gas or water into the reservoir. The second barrier characteristic may particularly be superior to the first barrier characteristic to thereby protect the substance against gas or water. I.e. herein, the barrier characteristics specify how well the barrier prevents intrusion of gas or water through the barrier, and superior means that it is better suited for preventing the intrusion .

The second gas barrier may e.g . be obtained by a wall of a polymeric material with a wall thickness higher than that of the balloon or by a metallisation layer on the wall of the reservoir. The barrier characteristic may e.g . be expressed by a duration in which the device can be stored with essentially no gas or water ingress into the reservoir. The duration may e.g. be more than 6 month, more than one year, more than 2 years, or even more than 3 years. By essentially no gas or water ingress may e.g . be meant that the weight of the substance in the reservoir including the gas or water ingress is in the range of 100,001-101 percent of the initial weight of the substance in the reservoir. I.e., the gas or water constitutes less than 1 percent of the weight of the substance without the water.

In a second aspect, the invention provides a method of preventing ingress of gas or water into a device for thermal ablation, the device comprising a catheter extending from a proximal end to a distal end, a balloon configured for a collapsed state and an expanded state and being attached to the distal end, the balloon forming a cavity, a reservoir containing a substance, and a displacement structure which can be activated to communicate the substance between the cavity and the reservoir to thereby shift between the collapsed and the expanded state, the method comprising holding the balloon in a fixed shape until use.

According to this method, the shape of the balloon is fixed during storage, and since the shape does not change, ingress of gas or water is reduced or eliminated .

The method may further comprise the step of compressing the balloon during storage.

The method may further comprise the step of adding liquid to the cavity and compressing the balloon to spread the liquid in the cavity.

The compression could be effected by a first surface and a second surface, the first surface and second surface being arranged to oppose each other at a distance on opposite sides of the balloon thereby forming a space enclosing the balloon and thereby spreading the liquid in the cavity.

Alternatively, or additionally, the compression could be effected by applying a pressure in the cavity which is lower than the pressure in an ambient space outside the cavity to thereby collapse the balloon and spread the liquid in the cavity.

Alternatively, the pressure in the balloon could be increased relative to the pressure in the surrounding space around the balloon to thereby prevent ingress of gas or water into the cavity.

In another alternative, the shape of the balloon is fixed by applying a higher pressure in the packaging outside the balloon than inside the balloon such that the balloon is compressed by the pressure.

In a third aspect, the invention provides a method of packing a device, the device comprising a catheter extending from a proximal end to a distal end, a balloon forming a cavity and configured for a collapsed state and an expanded state, the balloon being attached to the distal end, the device further comprising a reservoir containing a substance, and a

displacement structure which can be activated to communicate the substance between the reservoir and the cavity to thereby shift between the collapsed and the expanded state, the method comprising : providing a packaging defining an encapsulated space for the device providing, in the encapsulated space, a first surface and a second surface and arranging the surfaces such that they oppose each other at a distance on opposite sides of the balloon to thereby define a space enclosing the balloon and hold the balloon in a fixed shape.

Particularly, the first surface and a second surface could be arranged such that they oppose each other at a distance on opposite sides of the balloon before the surfaces and the device are placed as one unit in the encapsulated space.

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. 1 and 2 are perspective views of a device according to the invention;

Figs. 3 and 4 illustrate the device, in a cross section;

Fig . 5 illustrates a perspective view of a part of the packaging and device of the invention;

Fig . 6 illustrates a side view of the packaging and device according to the invention,

Fig . 7 illustrates an embodiment, where the first and second surfaces form part of first and second packaging insert components being separate components which are movable within an outer packaging,

Fig . 8 illustrates a side view of the embodiment of Fig. 7, and

Figs. 9-11 illustrate an alternative embodiment of the first and second surfaces being integrated in a single insert component having two parts joined in a hinge.

DETAILED DESCRIPTION OF AN EMBODIMENT

Further scope of applicability of the present invention will become apparent from the following detailed description and specific examples. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

Figs. 1 and 2 illustrate a product for thermal ablation. The product includes a device 1 for effecting necrosis of the endometrium . The device comprises a liquid contained in a cavity which is constituted by an expandable balloon 2 which is connected by an elongated catheter 3 to a reservoir inside the casing 4. The casing 4 houses a displacement structure which can be operated to displace a substance contained in the reservoir via the catheter 3 into the cavity where it is mixed with the liquid contained in the cavity.

An operation interface is provided at the proximal end, on the outer surface of the housing. The operation interface allows the user to initiate, monitor, and terminate the treatment.

The balloon is made from silicone, latex, or similar soft and elastic material and has a wall thickness in the range of 0.1-0.3 mm. The shape of the balloon matches the shape of the uterus such that contact can be established between the outer surface of the balloon and the endometrium substantially throughout the uterus upon inflation of the balloon.

The device is illustrated in a cross sectional view in Fig. 3. The casing houses the reservoir 5 which forms a syringe-like displacement structure, a control system 6, and a battery 7.

The casing may further comprise different structures, e.g. being used for draining the cavity of the balloon when the treatment is ended. Such structures may e.g. include a body 8 of a liquid absorbing material into which the substance can be drained. The casing may also comprise a user interface 9 (Cf. Fig. 4) including buttons 10 for controlling operation of the device and a display 11 for monitoring the temperature and/or the duration of the treatment.

The reservoir is constituted by a syringe-like structure including a piston 12 movable in a cylinder 13 by an electrical motor 14 - in this case a DC motor.

The control system 6 may particularly provide a fully automatic system managing the entire treatment, i.e. the heating of the fluid, the expansion of the bladder, the duration in which the bladder is expanded and the collapsing of the bladder once the treatment is finished.

When the device is delivered to the customer, the balloon 2 is in the collapsed state, the control system 6 is switched off, and the entire device is packed in sterile condition in a packaging. The packaging is typically a vacuum formed blister package of a thermo-plastic material, e.g. a transparent material. The packaging comprises an upper shell and a lower shell. The upper and lower shells form a shape suitable for fixing the position of the device in an encapsulated space in the packaging. The device is typically assembled, but the battery 7 could be removed and packed separately to thereby enable sterilisation of the battery in a separate process. The balloon and catheter have to be in liquid sealing connection, and they would typically be assembled from manufacturing and be delivered to the customer in the packaging in assembled condition. Fig. 5 illustrates an exploded view of the distal part of the device including the distal part of the catheter and the balloon. The device is in a packaging of which only the distal part is visible.

The packaging 15 includes a first packaging insert component 16 which forms the first surface 17 and a second packaging insert component 18, which forms the second surface 19. In the embodiment of Fig. 5, the first packaging insert component forms the entire upper shell of the packaging and the second packaging insert component forms the entire lower shell. The first and second packaging insert components thereby form the encapsulated space and the first and second surfaces.

The first surface 17 and the second surface 19 becomes located on opposite sides of the balloon 2 when the first and second packaging insert components 16, 18 are assembled and the surfaces therefore hold the balloon 2 in a fixed shape.

Fig. 6 illustrates the packaging from Fig. 5 in a side-view. In this view, the insert component 16, 17 are moved away from each other for illustration purpose. Flowever, it is illustrated that the balloon 2, by the first and second surfaces 17, 19 are maintained in a fixed shape, and any liquid in the balloon is squeezed out. The balloon is maintained in the illustrated shape and prevented from expanding.

The device forms a stop member 20 located in the transition between the catheter 3 and the balloon 2. The stop member can seal against cervix during the treatment. In the packaging, the stop member is located against the surface 21. The device thereby becomes further fixed in the encapsulated space.

Even though the insert components 16, 17 illustrated in the foregoing drawings could be components which are inserted in an outer packaging, they could also form the outer packaging and thereby define the encapsulated space and constitute the packaging as such.

Figs. 7 and 8 illustrate an alternative embodiment of the product in which the first packaging insert component 22 and the second packaging insert component 23 are separate

components which do not form the encapsulated space. In this embodiment, the

encapsulated space is formed by an outer packaging, e.g. constituted by an upper and lower shell of a blister package, or an outer packaging formed by a bag which contains the device and the separate first and second packaging insert components 22, 23.

Prior to arranging the device in the encapsulated space, the first and second packaging insert components 22, 23 are positioned on opposite sides of the balloon 2 to thereby preserve the shape of the balloon 2. The first and second packaging insert components 22, 23 could be assembled by tape, by the strap 24 connectable to the strap 25.

During manufacturing, the first and second packaging insert components 22, 23 could be arranged on opposite sides of the balloon long before the device is packed in the

encapsulated space. After purchase, the device may be removed from the encapsulated space while the shape of the balloon is preserved between the first and second packaging insert components which could be removed just prior to the use of the device.

The balloon could be made of silicone, latex or similar soft and elastic material. The packaging, or at least the first surface and the second surface which hold the balloon could be made from a more rigid and dimensionally stable material, e.g. a polymer material, e.g. Polyetylentereftalat (PET) or amorphous Polyetylentereftalat (APET). The first surface 17 and the second surface 19 could be made from the same material as the other parts of the packaging or from a harder or more rigid material than the rest of the packaging.

In one embodiment, the first surface 17 and the second surface 19 and/or the first and second packaging insert components 22, 23 are made from dimensionally stable plastic, steel, or composite material such that the first and second surfaces keep their intended shape while the rest of the packaging is made from soft pliable material, e.g. forming a soft plastic bag forming the encapsulated space.

Figs. 9 and 10 illustrate an embodiment of the product, wherein the packaging comprises an insert component 26 arranged within the encapsulated space. In this embodiment, both the first surface 27 and the second surface 28 are formed by the same insert component 26. The insert component forms a hinge zone 29 where the second surface 28 can pivot relative to the first surface 27. Fig. 9 illustrates the insert component in a closed state where the first surface and second surface oppose each other on opposite sides of the balloon thereby holding the balloon in a fixed shape in the encapsulated space. Fig. 10 illustrates the insert component in an open state where the user can remove the device from the first and second surfaces.

The stop member 20 comprises indentations configured to engage the projecting prongs 30 which engagement has the effect that the insert component can not be opened unless the stop member is moved downwards along the catheter in the direction indicated by the arrow 31. c.f. also Fig. 11. Accordingly, when the insert component 26 has been opened, the user must have become aware of the ability of the stop member 20 to slide along the catheter.

In one embodiment, the insert component encapsulates all parts of the device.

Claims

1. A product for thermal ablation of an endometrium, the product comprising a device (1) and a packaging (15), the device (1) comprising a catheter (3) extending from a proximal end to a distal end, a balloon (2) forming a cavity and configured for a collapsed state and an expanded state, the balloon being attached to the distal end, the device further comprising a reservoir (5) containing a substance, and a displacement structure (12, 13, 14) which can be activated to communicate the substance between the reservoir and the cavity to thereby shift between the collapsed and the expanded state, the device being contained in an

encapsulated space in the packaging (15), wherein the product further comprises a first surface (17) and a second surface (19) in the encapsulated space, the first surface and second surface opposing each other at a distance and being on opposite sides of the balloon thereby holding the balloon in a fixed shape in the encapsulated space, wherein the cavity contains a liquid and wherein the first surface and second surface are configured to spread the liquid in the cavity.

2. The product according to claim 1, wherein the packaging comprises an outer packaging defining the encapsulated space, and at least one insert component (22, 23) arranged within the encapsulated space, and wherein at least one of the first surface (17) and the second surface (19) are formed by the insert component (22, 23).

3. The product according to claim 2, wherein the insert component can be moved from a closed state to an open state thereby moving the first surface away from the second surface and allowing removal of the balloon from the insert component.

4. The product according to claim 3, wherein the device includes a stop member slidable along the catheter and configured to engage the insert component in a way preventing movement to the open state in one position of the stop member relative to the insert component and allowing movement to the open state in another position of the stop member relative to the insert component.

5. The product according to any of the preceding claims, wherein the balloon is made from a membrane having a thickness, t, and wherein the distance between the first surface and the second surface is larger than 2 times the thickness t to thereby provide a space between the balloon and at least one of the first surface and the second surface.

6. The product according to any of the preceding claims, wherein the balloon is made from a membrane having a thickness, t, and wherein the distance between the first surface and the second surface is at most 30 times the thickness t.

7. The product according to any of the preceding claims, wherein the catheter has a transverse dimension exceeding the distance, and wherein at least one of the first surface and second surface forms a recess and the catheter extends in the recess.

8. The product according to any of the preceding claims, wherein the first surface is parallel to the second surface.

9. The product according to claim 1, wherein the packaging comprises an outer packaging defining the encapsulated space, and wherein at least one of the first surface (17) and the second surface (19) forms part of the outer packaging .

10. A method of preventing ingress of gas or water into a device for thermal ablation, the device comprising a catheter (3) extending from a proximal end to a distal end, a balloon (2) configured for a collapsed state and an expanded state and being attached to the distal end, the balloon forming a cavity, a reservoir (5) containing a substance, and a displacement structure (12, 13, 14) which can be activated to communicate the substance between the cavity and the reservoir to thereby shift between the collapsed and the expanded state, the method comprising holding the balloon in a fixed shape until use.

11. A method according to claim 10, further comprising compressing the balloon during storage.

12. A method according to claim 10 or 11, further comprising adding liquid to the cavity and compressing the balloon to spread the liquid in the cavity.

13. The method of claim 12, wherein the compression is effected by a first surface and a second surface, the first surface and second surface being arranged to oppose each other at a distance on opposite sides of the balloon thereby forming a space enclosing the balloon.

14. The method of claim 12, wherein the compression is effected by applying a pressure in the cavity which is lower than pressure in an ambient space outside the cavity to thereby collapse the balloon.

15. The method according to any of claims 10-14, wherein the balloon is held in fixed shape by partial inflation of the balloon within the packaging .

16. The method according to any of claims 10- 15, wherein the balloon is held in the fixed shape by applying a higher pressure in the packaging outside the balloon than inside the balloon such that the balloon is compressed by the pressure.

17. A method of packing a device (1), the device comprising a catheter (3) extending from a proximal end to a distal end, a balloon (2) forming a cavity and configured for a collapsed state and an expanded state, the balloon being attached to the distal end, the device further comprising a reservoir (5) containing a substance, and a displacement structure (12, 13, 14) which can be activated to communicate the substance between the reservoir and the cavity to thereby shift between the collapsed and the expanded state, the method comprising : - providing a packaging defining an encapsulated space for the device, providing, in the encapsulated space, a first surface and a second surface and arranging the first surface and the second surface such that they oppose each other at a distance on opposite sides of the balloon to thereby define a space enclosing the balloon and holding the balloon in a fixed shape.

18. The method according to claim 17, wherein the first surface and the second surface are arranged such that they oppose each other at a distance on opposite sides of the balloon before the first surface, the second surface, and the device are joined and placed in the encapsulated space as one unit.