WO2005072623A1

WO2005072623A1 - Haemostatic device

Info

Publication number: WO2005072623A1
Application number: PCT/DK2005/000064
Authority: WO
Inventors: Kristina Devantier; Søren HERN
Original assignee: Ferrosan A/S
Priority date: 2004-01-30
Filing date: 2005-01-28
Publication date: 2005-08-11
Also published as: AR054636A1

Abstract

The present invention relates to a medical device suitable for providing haemostasis through an expansible catheter so as to exert both mechanical pressure and provide haemostasis. The invention allows for surgeons to provide haemostasis in the event of generalised bleeding over a large surface area or localised to tissue areas.

Description

HAEMOSTATIC DEVICE

FIELD OF THE INVENTION A medical device for providing haemostasis through an expansible catheter so as to exert both mechanical pressure and provide chemical haemostasis allows for surgeons to provide ^' haemostasis in the event of generalised bleeding over a large surface area or localised to tissue areas.

BACKGROUND OF THE INVENTION Endo A ^'tene^® Preloaded Applications is microfibrillar collagen (MCH) used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. It is a topical hemostat available in a preloaded endoscopic delivery system designed for use in laparoscopic procedures. It does not provide static mechanical pressure to the site of bleeding.

WO 03/055531 (Ferrosan) discloses the injection of putty-like paste of gelatine in surgical procedures.

EP 0 584 959 (Symbiosis Corporation) discloses an endoscopic haemostatic agent delivery system for incremental and small delivery of a haemostatic agent. The document outlines advantages of collagen paste over Endo-Avitene^®. The system does not provide for static mechanical pressure applied to the site of bleeding.

US 6,368,300 (C.R. Bard) discloses an endoscopic haemostatic agent delivery system. The device addresses problems relating to the delivery of particulate haemostatic agents and does not provide for static mechanical pressure to the site of bleeding.

WO 00/18301 (Biointerventional) discloses a system for use in percutaneous occlusion of puncture sites and tract. It does not provide for static mechanical pressure to the site of bleeding. US 5,443,481 (Lee) teaches the closure of a puncture in a wall of a artery. The document discloses the use of an enlongated catheter into the artery for delivery of a haemostatic agent. The method includes the steps of withdrawing the cardiovascular catheter from the artery while ensuring that the location of the puncture remains identified, and introducing a thrombogenic, hemostatic material so as to contact the wall of the artery at the puncture location, enabling the material to precipitate clot formation and seal the puncture. SUMMARY OF THE INVENTION

There is the need in the art for a device for providing haemostasis through a trocar or endoscope during a surgical procedure. The present inventors have successfully addressed this problem by developing a device practical and suitable for these types of surgeries. A first aspect of the invention relates to a method of providing haemostatis and corresponding medical device comprising : a means for providing static mechanical pressure on a tissue area; and means for delivering an agent to the area.

Further, the inventors have developed a method of providing haemostatis and corresponding medical device comprising: a means for providing static mechanical pressure on a tissue, venal or arterial area; and a means for delivering an agent to the area; wherein the delivering of the agent is by means of an outlet from a hollowed member, said hollowed member having a cross-sectional area wherein the means for providing the static mechanical pressure is suitable for exerting said mechanical pressure over a surface area of at least twice that of the cross-sectional area of the hollow member.

Moreover, the invention is directed to a method of providing haemostatis and corresponding medical device comprising: a means for providing static mechanical pressure on a tissue venal or arterial area, said means being an expansible means so as to provide said pressure on the area; and a means for delivering an agent to the area.

A further aspect of the invention relates to a kit comprising the medical device as defined herein, a haemostatic agent, and a delivery system, such as a syringe and plunger or penlike delivery system as described herein.

DESCRIPTION OF THE INVENTION

The term "mechanical pressure" and "static mechanical pressure" is used interchangeably and intended to differentiate the pressure of the invention from that applied dynamically such as from a constant flow of gas or fluid or from manual pressure di rectly applied using a part of the human anatomy. In general, the term "mechanical pressure" relates to pressure in a constant but variable level applied by a mechanical object.

The term "tissue" is intended to mean all tissue and organs of the human or animal body. The term does not include veins and arteries themselves. The term "venal" and "arterial" area is intended to mean an area defines by the exterior surface of these conduits.

A first aspect of the invention relates to a medical device comprising a means for providing static mechanical pressure on a tissue area; and a means for delivering an agent to the area.

The medical device of the invention is particularly useful for purposes of providing haemostasis, typically during a surgical procedure. According to the present invention, haemostasis is provided by two separate means, acting in concert, either simultaneously or sequentially during the surgical procedure, by providing pressure on the site and by applying a haemostatic agent.

In a suitable embodiment, the invention allows for mechanical pressure to be applied to a tissue area distally removed from the surface of the wound area, such as into the body cavity. Thus, the invention allows for the application of both a haemostatic agent and mechanical pressure to be applied to a tissue area distally removed from the surface. The invention is also applicable to both means of haemostasis to be provided at the surface of the wound area. The invention is also suitable for application of mechanical pressure to a tissue area distally removed from the surface and a haemostatic agent to the surface of the wound area such as, for instance, the mechanical pressure providing some degree of haemostasis, yet nonetheless resulting blood surfacing or bleeding which is then treated with the haemostatic agent.

The invention is directed to provide haemostasis to bleedings that can be conventionally controlled with passive haemostats. The invention is directed to provide haemostasis to bleedings such as capillary bleeding, oozing bleeding, venous and arteriolar bleeding. Suitably, the invention provides haemostasis for minor bleedings that may occur on a larger surface. For illustrative purposes, small bleedings on a liver surface are suitably treated by the present invention. Conversely to US 5,443,481, the present invention is not specifically directed to closing a puncture in a wall of artery which entails strong, pulsating bleeding.

Thus, one aspect of the invention relates to a medical device comprising: a means for providing static mechanical pressure on a tissue, venal or arterial area; and a means for delivering an agent to the area; wherein the delivering of the agent is by means of an outlet from a hollowed member, said hollowed member having a cross-sectional area wherein the means for providing the static mechanical pressure is suitable for exerting said mechanical pressure over a surface area of at least twice that of the cross-sectional area of the hollow member.

A further aspect of the invention is directed to a medical device comprising: a means for providing static mechanical pressure on a tissue venal or arterial area, said means being an expansible means so as to provide said pressure on the area; and a means for delivering an agent to the area.

In a typical embodiment of the medical device, the means for delivering the agent comprises a hollowed member having an agent inlet and outlet. Suitably, the hollow member is defining a channel there between for containing and/or delivering said agent, as shown in Figure 1.

In a preferred embodiment, the means for providing the pressure comprises expansible means provided externally on said hollowed member (or a part thereof) and being expansible so as to provide said pressure on the area. In a typical embodiment, the expansible means comprises a flexible inflatable membrane, such as a balloon-type device. The inflatable membrane may be of any material suitably elastic and impermeable allowing for inflation and is conventionally known in the art.

The inflatable membrane or balloon of the invention is intended for compression directly on the bleeding site and for fitting bleeding cavities, etc. Thus the balloon can change its shape according to the material it is made from, the amount of air or fluid that it is inflated with and the tissue on which it is applied.

In the embodiment wherein the means for providing the static mechanical pressure is an expansible means provided by an inflatable membrane, the volume of the means can be varied according to the size of the bleeding area. Typically, the expansible means provided by an inflatable membrane is expanded to provide the static mechanical pressure over a surface area of at least twice that of the cross-sectional area of the hollow member, such as at least 2.5 times, typically at least 3 times, more typically at least 3.5 times the cross- sectional area of the hollow membrane. The means for providing the static mechanical pressure is typically suitable for exerting said mechanical pressure over a surface a rea of 2-50 times that of the cross-sectional area of the hollow member, such as 2.5-50 times, such as 3-50 times, such as 3.5 -50 times the cross-sectional area of the hollow member.

In one embodiment the diameter of the expanded membrane is suitable for expansion to a diameter of more than lxl cm, such as more than 1.5x1.5 cm, such as more than 2x2 cm. This is not intended to denote any shape or symmetry of the expanded membrane, since the expanded membrane is typically circular in shape with curved sides rather than sharp angles. Alternatively stated, the diameter of the expanded membrane may be from lxlcm to 40x40 cm, preferably from 1.5x1.5 cm to 30x30 cm, more preferably 2x2 cm to 20x20 cm, more typically 2x2cm to lOxlOcm, such as 5x5 cm. Typically, the inflatable membrane is attached to an outer surface of the hollowed member and being in communication with an inlet provided in the end towards the agent inlet of the hollowed member.

5 In a suitable embodiment, the membrane is attached to an outer surface of the hollowed member. In this embodiment the membrane is in communication with an inlet provided in the end towards the agent inlet of the hollowed member thereby and comprising a compressible chamber. In a typical embodiment said compressible chamber is containing a transferable material selected from the group of gas, fluid, gel and foam or a 10 combination thereof to expand the expansible means, said chamber and expansible means together defines a fluid tight volume. In this embodiment said expansible means being adapted to be expanded upon compression of said chamber.

In a acceptable embodiment of the invention, the expansible means comprises a sheathing 15 member adapted to receive and surround at least a part of said hollowed member, the sheathing member comprising a inlet, a flexible inflatable membrane to be expanded, and a channel providing communication between the inlet and the membrane. The hollowed member and sheathing member are typically substantially circular in cross-section.

20 The device of the invention typically comprises a plunger for pressing said agent through the channel and out of said outlet. It may furthermore comprise a plunger for pressing fluid, air or gas into the inflatable membrane. It may furthermore comprise a plunger for compressing the compressible chamber. Typically, the inflatable membrane extends around a part of or the entire circumference of the hollowed member.

25 The membrane may be expanded by gas or liquid. Suitable gases include air, oxygen, nitrogen and helium. Any number of liquids is suitable. In a further embodiment of the invention, the inflatable membrane which provides the mechanical pressure is filled with a gas or liquid at a temperature below body temperature, such as below 30°C, such as below

30 25°C, typically below 20°C, suitably below 15°C, more suitably below 10°C, more typically below 5°C, such as below 0°C. The temperature of the gas or liquid may be in the range of -180°C to +50°C, such as -100 to +50°C, typically -75 to +50°C, more typically -50 to +40°C. Temperatures below body temperature may assist in the haemostatic process. Temperatures below 0°C may also damage cellular structure which may also assist in the

35 haemostatic process.

In a typical embodiment the hollow member has a length of less than 80 cm, preferably less than 60 cm, such as less than 50 cm, such as less than 40 cm. Typically, the hollowed member has a length of more than 5 cm, such as more than 10 cm, 20 cm, 25 cm and 30cm. In another embodiment the hollow member has a length of 5 to 60 cm, preferably 10 to 55 cm, more preferably 20 to 50 cm, most preferably 30 to 45 cm, such as 40 cm. In an embodiment, when intended to be used in a child, the hollowed member's length is suitably dimensioned to 5 to 20 cm, such as 5 to 15 cm, such as 5 to 10 cm. The length of the hollow member may be varied in length depending on its intended use and the age and gender of the patient.

In a suitable embodiment the hollowed member or the sheathing member has an outer diameter of more than 0.5 mm, preferably more than 2.5 mm, 5 mm, 7.5mm and l O mm. In another embodiment the hollowed member or the sheathing member has an outer diameter of less than 20 mm, preferably less than 17.5 mm, 15 mm, 10 mm and 7.5 mm. In an alternative embodiment the sheathing member's length is suitably dimensioned 0.5 to 20 mm, preferably 5 to 15 mm, such as 10 mm.

The hollowed member suitably has an inner diameter of less than 18 mm, preferably less than 14 mm, more preferably less than 10 mm, such as 8 mm. Alternatively stated, the hollowed member may have an inner diameter of 0.5 to 18 mm, preferably 2 to 14 mm, most preferable 6 to 10 mm, such as 8 mm.

The expansible means may be expansible symmetrically or asymmetrically in relation to the longitudinal axis of the hollowed member or sheathing member. The hollowed member may be made of any array of materials such as glass or plastic, polypropylene or polyethylene. The hollow member may be made of any material, which when provid ing an inner diameter of 1-15 mm and an outer diameter of 2-20 mm is substantially rigid but with some degree of flexability along the axis of the hollow member. In a preferred embodiment the hollowed member is substantially rigid.

In a suitable embodiment the sheathing member and membrane is made of rubber or plastic, such as polypropylene based and/or polyethylene based.

In a preferred embodiment the medical device adapted to be used in connection with an endoscope or a laparoscopic procedure. In present embodiment the medical device, or part of the medical device and/or the hollow member is transferred to the site of action through the trocar.

The medical device may comprise an agent, typically a haemostatic agent. The haemostatic may be selected from the group consisting of a passive haemostat, an active haemostat, an antiadhesive agent and a combination thereof. The haemostatic agent may further comprise other agents to assist in its movement through the hollow membra ne, as well as stabilisers, colouring agents, and tackifiers. In one embodiment, the agent comprises a haemostatic agent and a tackifying agent. In a further suitable embodiment, the agent comprises an antiadhesive agent and a tackifying agent. Suitably, the agent may comprise a haemostat and/or an antiadhesive agent.

In one embodiment, the haemostatic agent is an antifibrinolytic agent, wherein the antifibrinolytic agent is selected from the group of consisting of tranexamic acid, a protinin or aminocaproic acid or a combination thereof.

In a suitable embodiment, the haemostatic agent is an active haemostatic agent. Suitable active haemostatic agents many be selected from the group of consisting of fibrin, thrombin, coagulation factors or a combination thereof.

In a typical embodiment, the agent is in powder form. In a more typical embodiment, the agent is a powdered haemostatic agent. In a preferred embodiment the agent comprises a polymer selected from the group consisting of gelatine, collagen, cellulose, chitosa n or a combination thereof, more preferably selected from gelatine or collagen.

In a more typical embodiment, the haemostatic agent is collagen powder or collagen- derived powder. Preferably, said collagen or collagen-derived powder is gelatine. The gelatine may be derived from an animal or are made synthetically, such as recomb inantly. Suitably, the gelatine originates from porcine but may originate from other mamm als. The powder is preferably sterile.

In typical embodiment the agent, more typically the haemostatic agent, is in a mixture with a liquid. The liquid may be water or a physiologically balanced solution, such as a saline solution typically at a pH of 5-8.5, more typically 5.5-8, such as 6-8. In an interesting embodiment, the mixture is a combination of a liquid active haemostatic agent and a powdered passive haemostatic agent. In a suitable embodiment, the mixture is a combination of thrombin and gelatine or thrombin and collagen. In a very common embodiment, the agent is a mixture of gelatine or collagen in saline or water.

In one embodiment, the haemostatic agent is a processed gelatine or collagen-derived powder. Specifically, said agent may be processed in such a manner so as to expand in particular after or upon application by the medical device. The increase in size may commence while in the medical device itself, or upon or after application. The processed agent will influences the structure of the agent, such as the microstructure. The processed agent may allow for a change in the particle size of the flake-like gelatine powder. . The processing of the agent will result in a modification of the flake-like structure of the powder.

In a typical embodiment of a processed gelatine or collagen-derived product, the processed agent increases in particle size, such as the size of a flake-like gelatine powder, upon or after application by the medical device.

The processed agent will result in an improved porosity of the gelatine powder.

The increase in particle size of the agent may create a compression on the application site, thereby promoting haemostatis at the site of bleeding or site of application

In one embodiment, the agent with in the device can be processed such that the agent is compressed while within the medical device and expands upon use by means of decompression upon delivery of the agent. The expansion causes a compression on the application site, thereby promoting haemostatis at the site of bleeding or application site.

In another embodiment, the effect of the processed agent is such that its volume increases after application. The increase of the volume may occur due to absorption of fluids.

In the embodiment wherein the agent is in powder form, typically 95% of the powder is less than 1000 microns in size, preferably such that 90% of the second volume is less than approximately 700 μm. In a further preferred embodiment, 50% volume is less than approximately 350 μm.

In the embodiment wherein the agent is in powder form in a mixture with a liquid, typically 95% of the powder is less than 1000 microns in size, preferably such that 90% of the second volume is less than approximately 700 μm. In a further preferred embodiment, 50% volume is less than approximately 350 μm.

In the embodiment wherein the agent is in powder form, the mean particle size of the powder haemostat is such that the powder possesses sufficient flowability properties. Thus, usually, the mean particle size is in the range of 10-250 μm, such as in the range of 20-250 μm. In a preferred embodiment of the invention, the mean particles size is in the range of 20-200 μm, such as in the range of 30-180 μm, e.g. in the range of 40- 175 μm, more preferably in the range of 50-150 μm, such as in the range of 55-125 μm, e.g. in the range of 60-100 μm or in the range of 70-90 μm. When used herein, the term "mean particle size" is defined with reference to the examples provided herein, i.e. the mean particle size is based on laser diffraction measurements.

The particles preferably have a particle size distribution so that 90% of the particles have a particle size below 200 μm, such as below 190 μm, e.g. below 180 μm, more preferably below 170 μm. In addition, the particle size distribution is preferably so that 90% of the particles have a particle size above 5 μm, such as above 10 μm, e.g. above 15 μm.

The powder may be prepared from a gelatine sponge cut into pieces that fit into a mill and that will be bulk packaged into sterilization bags and placed in an oven (dry heat), for hardening for three hours. The gelatine plates raw material are typically manually fed into a rotor knife mill with a sieve for final grinding. The particle size is preferably such that not more than 5% (w/w) is retained on a 1 mm mesh.

The resulting powder of said preparation is characterised by their flakelike shape. The flakelike shape of said gelatine powder differ that of gelatine powder produced by a simple milling process leaving out the hardening procedure. The flakelike shape of the gelatine powder is essential for the efficiency of the passive haemostate. The flakelike shape of the gelatine powder is essential for the flowability of the gelatine powder.

Furthermore, the agent, preferably gelatine must have a suitable density for the agent to be delivered unproblematically through the hollowed member. When used herein, the term "density" refers to "apparent density" as defined in European Pharmacopoeia.

The agent, preferably gelatine, have an apparent density of 0.05-1.5 g/ml, such as 0.06-1 g/ml, typically from 0.075-1 g/ml. Accordingly, the gelatine or collagen powder preferably has a poured density in the range of 0.05-0.3 g/ml, such as in the range of 0.O6-0.25 g/ml, e.g. in the range of 0.07-0.20 g/ml, more preferably in the range of 0.075-0.15 g/ml. Similarly, the gelatine or collagen powder preferably has a tapped density in the range of 0.075-0.4 g/ml, such as in the range of 0.1-0.3 g/ml, e.g. in the range of 0.125- 0.25 g/ml, more preferably in the range of 0.15-0.25 g/ml.

In an embodiment the agent comprises a powder suspended in water, saline, a solvated active haemostat, a suspended active haemostat or a combination thereof. In a preferred embodiment said haemostat consists of gelatine powder suspended in saline. The suspension must be diluted sufficiently for the mixture to pass the hollowed member unproblematically. On the other hand the mixture must not be diluted too much as this might compromise the haemostatic effect. The degree of dilution must be prepared in such a manner that the flowability of the mixture is suitable unhindered passage through the hollow member. The degree of dilution suitable depends on the flowability and of the particle size of the dried powder.

In one embodiment, wherein the agent is gelatine; said gelatine being gelatine powder having a specific surface area is preferably at least 0.15 m²/g (e.g. 0.15-3.00 m²/g or 0.25-2.00 m²/g) such as at least 0.35 m²/g (e.g. 0.35-3.00 m²/g or 0.35-2.00 m²/g), more preferably at least 0.50 m²/g (e.g. 0.50-3.00 m²/g or 0.50-2.00 m²/g), such as at least 0.75 m²/g (e.g. 0.75-3.00 m²/g or 0.75-2.00 m²/g). In some particular interesting embodiments, the specific surface area is at least 0.90 m²/g (e.g. 0.90-3.00 m²/g or 0.90- 2.00 m²/g), such as at least 1.00 m²/g (e.g. 1.00-3.00 m²/g or 1.00 to 2.00 m²/g). In even further embodiments of the invention, the specific surface area may be at least 1.25 m /g (e.g. 1.25-3.00 m²/g or 1.25-2.00 m²/g), such as at least 1.50 m²/g (e.g. 1.50-3 m²/g or 1.50-2.00 m²/g). The specific surface is conveniently determined by gas adsorption (BET).

The surface area of the powder may have an influence on the efficiency of the gelatine or collagen powder as a haemostatic agent as well as of being an antiadhesive agent. The surface area of the powder has influence on the degree of diluting when preparing the mixture; as is known to the person skilled in the art, the larger the surface area, the higher the ratio of liquid needed.

In a very interesting embodiment, the medical device of the invention further comprising iii) the agent. The agent is typically contained inside the hollow member.

Alternatively, the agent may be comprised in a delivery system. The agent may be delivered through a syringe system or any other suitable delivery device.

A further aspect of the invention is directed to a kit comprising the medical device, the agent, and a delivery system, such as a syringe with plunger. The agent may be comprised within the delivery system or in a separate container. Alternatively, the kit may comprise the medical device and a syringe with plunger.

A further aspect of invention relates a particularly interesting delivery system, said device being in the form of a pen-like device. This pen-like device is a device suitable for pressurised delivery of an agent wherein the delivery is through an outlet of a hollowed member upon compression of a bow engaged with a serrated edge portion of a serrated piston located within the hollowed membrane, so as to propel the piston in the direction of the outlet, said engagement being through an aperture in said hollowed tubular membrane. Compression of the engaged bow propels the piston in the direction of the outlet by a distance defined by the radius of the bow so as to deliver the agent. Release of the compression allows for the bow to return to its curved position of higher potential energy and to re-engage with a second serrated edge portion of the piston, said second serrated edge portion being distally positioned on the piston from the outlet.

As stated, the delivery is made in finite volumes defined by the radius of the bow in concert with the spacing of the serrated edges. The degree of compression can be so as to project the serrated piston by a distance of 1-4 serrations, such as 1, 2, 3, or 4 preferably 1, 2 and 3 serrations, more preferably 1 and 2 serrations. For instance, full compression propels the piston a distance of 2 serrations and slight compression propels the piston by a distance of 1 serration. In order for the bow to return to its position of maximal potential energy, it's resting position, it must re-engaged with a serration distally located on the piston from the outlet.

The hollowed member may be a hollowed tubular member with an inner diameter appropriate and suitable for the agent to be delivered. The agent may be in an array of forms such as in the form of a liquid, solid granules, powder, paste, suspension or emulsion.

In a typical embodiment, the radius of the bow is such that compression of its arch results in the projection of the serrated piston so as to deliver a volu me of 0.05 to 2 mL per full compression, typically 0.075 to 1 mL, more typically 0.1 to 0.5 mL, such as 0.1, 0.2, 0.3, 0.4 and 0.5 mL.

The present inventors have found that the delivery is of a hig h pressure compared to conventional devices, and suitable for delivery of a powdered agent at a pressure of 50- 200 N, such as 75-200 N, typically 100-180 N.

The bow of the pen-like device is typically located along the longitudinal axis of the hollow member so as to render the device easy to hold and use at the same time, such as by compression by the thumb. Figure 2 depicts an illustrative example of the pen-like device.

A further aspect of the invention is directed to a kit comprising the medical device, the agent, and a delivery system, such as the pen-like delivery device. The agent may be comprised within the delivery system or in a separate container. Alternatively, the kit may comprise the medical device and the pen-like delivery device. A further aspect of the invention is directed to a method of providing haemostasis comprising the use of a medical device as defined herein. A further aspect of the invention is directed to a method of providing haemostasis comprising the use of the kit as defined herein.

The invention provides for a method of providing haemostasis comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent, wherein the delivering of the agent is by means of an outlet from a hollowed member, said hollowed member having a cross-sectional area wherein the mechanical pressure is applied over a surface area of at least twice that of the cross-sectional area of the hollowed member.

The invention alternatively provides for method of providing haemostasis comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent, said mechanical pressure applied by an expansible means.

Moreover, the invention further provides for method of providing haemostasis to a tissue comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent.

The invention is further defined by the present Examples in a non-limiting fashion.

EXAMPLES

Example 1 - Product and Preparation Gelatine powder was obtained from milling sheets of Surgifoam^® sponge under a controlled process to produce a product meeting the following specification : 5 The powder is a porcine gelatin based powder, off white in colour.

10% volume is less than approximately 90 μm; 50% volume is less than approximately 350 μm; 10 90% volume is less than approximately 700 μm; as determined by laser diffraction.

The milled product is collected under slight negative pressure to avoid particulate emission in the area and filled into a primary container, such as by using a hopper and scoop filling 15 operation or by using pharmaceutical cGMP standard auger filling equipment.

Example 2 - Test in a porcine model

The haemostatic effect of a preliminary model of the product was tested in a porcine model. An open laparoscopy was performed in euthanized pigs. Once the gall bladder had 20 been removed oozing bleeding from the liver bed could be observed. A gelatin powder was mixed with saline and applied on the bleeding site through a 25 cm long applicator where after mechanical pressure was applied by inflating the balloon. After two minutes the inflated balloon was removed and it was found that the oozing bleedings had stopped.

Claims

1. A medical device comprising: a means for providing static mechanical pressure on a tissue area; and means for delivering an agent to the area.

2. A medical device comprising: a means for providing static mechanical pressure on a tissue, venal or arterial area; a means for delivering an agent to the area; wherein the delivering of the agent is by means of an outlet from a hollowed member, said hollowed member having a cross-sectional area wherein the means for providing the static mechanical pressure is suitable for exerting said mechanical pressure over a surface area of at least twice that of the cross-sectional area of the hollow member.

3. A medical device comprising: a means for providing static mechanical pressure on a tissue venal or arterial area, said means being an expansible means so as to provide said pressure on the area; a means for delivering an agent to the area.

4. A medical device according to any one of claims 1-3, wherein the means for delivering comprises a hollowed member having an agent inlet and outlet and defining a channel there between for containing said agent.

5. A medical device according to cla im 3, wherein the expansible means comprises a flexible inflatable membrane, such as a balloon.

6. A medical device according to cla im 5, wherein the membrane is attached to an outer surface of the hollowed member and being in communication with an inlet provided in the end towards the agent inlet of the hollowed member.

7. A medical device according to claim 5, wherein the membrane is attached to an outer surface of the hollowed member and being in communication with a inlet provided in the end towards the agent inlet of the hollowed member and comprising a compressible chamber containing a transferable material selected from the group of gas, fluid, gel and foam or a combination thereof to expand the expansible means, said chamber and expansible means together defines a fluid tight volume, the expansible means being adapted to be expanded upon compression of said chamber.

8. A medical device according to claim 4 or 5, wherein the expansible means comprises a sheathing member adapted to receive and surround at least a part of said hollowed member, the sheathing member comprising a inlet, a flexible inflatable membrane to be 5 expanded, and a channel providing communication between the inlet and the membrane.

9. A medical device according to any of claims 2-8 comprising a plunger for pressing said agent through the channel and out of said outlet, and/or for pressing fluid into the membrane and/or for compressing the compressible chamber.

10 10. A medical device according to any of claims 5-9, wherein the membrane is expanded by gas or liquid.

11. A medical device according to any of claims 4-10, wherein the flexible membrane 15 extends around a part of or the entire circumference of the hollowed member.

12. A medical device according to any of claims 4-11, wherein the hollowed member and sheathing member is substantially circular in cross-section.

20 13. A medical device according to any of the preceding claims, wherein the length of the device is 5-60 cm.

14. A medical device according to any of claims 2-13, wherein the hollowed member or the sheathing member has an outer diameter of 0.5-20 mm.

25 15. A medical device according to any of claims 2-14, wherein hollowed member has an inner diameter of the is 0.5-18 mm.

16. A medical device according to any of claims 2-15, wherein the expansible means are 30 expansible symmetrical or asymmetrical in relation to the longitudinal axis of the hollowed member or sheathing member.

17. A medical device according to any of claims 2-16, wherein the hollowed member is made of glass or plastic such as polypropylene or polyethylene.

35 18. A medical device according to any of claims 6-14, wherein the sheathing member and membrane is made of rubber or plastic, such as polypropylene or polyethylene.

19. A medical device according to any of claims 4-18, wherein the diameter of the expanded membra ne is 1 cmx l cm - 20 cmx20 cm.

20. A medical device according to any of claims 2-19, wherein the hollowed member is 5 substantially rigid.

21. A medical device according to any one of the preceding claims, wherein the medical device is adapted to be used through a trocar in endoscopic or laparoscopic procedures.

10 22. A medical device according to claim 1, further comprising iii) the agent.

23. A medical device according to any one of the preceding claims, wherein the agent is a haemostatic agent.

15 24. A medical device according to according any one of the preceding claims, wherein the agent selected from the group consisting of a passive haemostat, an active haemostat for instance fibrin, thrombin or coagulation factors, an antifibrinolytic agent for instance tranexamic acid, aprotinin or aminocaproic acid, an antiadhesive agent and a combination thereof.

20 25. A medical device according to according to claim 24, wherein the passive haemostat comprises a polymer selected from the group consisting of gelatine, collagen, cellulose, chitosan or a combination thereof.

25 26. A medical device according to according to claim 23-25 wherein the haemostat is in powder form.

27. A medical device according to any one of the preceding claims, wherein the agent is a haemostatic agent comprising a powder suspended in water, saline, a liquid, an active

30 haemostat or a combination thereof.

28. A medical device according to according to claims 23-28, wherein the haemostatic agent is gelatine.

35 29. A medical device according to claim 22-28, wherein the haemostatic agent is contained inside the hollow member.

30. A method of providing haemostasis comprising the use of a device as defined in any one of claims 1-29.

31. A method of providing haemostasis comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent, wherein the delivering of the agent is by means of an outlet from a hollowed member, said hollowed member having 5 a cross-sectional area wherein the mechanical pressure is applied over a surface area of at least twice that of the cross-sectional area of the hollowed member.

32. A method of providing haemostasis comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent, said mechanical pressure

10 applied by an expansible means.

33. A method of providing haemostasis to a tissue comprising providing mechanical pressure and simultaneously or sequentially delivering a haemostatic agent.

15 34. A kit comprising the medical device as defined in any one of claims 1-29, a haemostatic agent, and a delivery system.

35. A kit according to claim 34, wherein the agent is comprised within the delivery system or in a separate container.

20 36. A kit comprising the medical device as defined in any one of claims 1-29 and a delivery system .