WO2008142636A2

WO2008142636A2 - Wearable drug delivery device

Info

Publication number: WO2008142636A2
Application number: PCT/IB2008/051969
Authority: WO
Inventors: Giovanni Nisato; Jan-Eric J. M. Rubingh
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2007-05-22
Filing date: 2008-05-20
Publication date: 2008-11-27
Also published as: WO2008142636A3

Abstract

Drug delivery through the skin of a patient has become a standard way for the administration of drugs, which cannot be formulated in the form of pills for oral application. However, a hypodermic needle applied to a skin always damages the skin bearing a risk for an infection. Therefore usage of a high-speed jet pump (102) for transdermal, needle-less drug delivery is suggested which is wearable by a patient for long-term treatment. In order to enable an easy refilling of the system even for the medical laymen it is suggested to arrange the system such that the reservoir (82) forms a cartridge (80) which might easily be exchanged while the pump system might remain fixed to a patient.

Description

WEARABLE DRUG DELIVERY DEVICE

FIELD OF THE INVENTION

The invention relates to the field of wearable drug delivery devices.

BACKGROUND OF THE INVENTION While oral delivery is the most common standard for drug delivery, many drugs cannot easily be formulated in a format suitable for oral administration. For example, treatment of diabetes, genetic disorders, and novel cancer treatments are based on (polypeptides, which are destroyed in the gastro -intestinal tract. For these drugs, the preferred way of administration is usually an injection, and appropriate formulations need to be developed or matched to optimize the therapeutic effects, which can be highly dependent on the patient and can additionally be time-dependent. Furthermore, compliance is considered a major issue for the effective treatment of diseases. Therefore, there is a need for an alternative administration of drugs, which provides an application of the right amount of drugs at the right time without requiring any action by the patient. US 4,734,092 discloses a device for infusing a drug into an ambulatory patient, the drug being contained in a transparent spiral conduit which is embedded in a disposable flexible casting conformingly adhered to the patient's body, includes a reusable micro-pump module, which is detachably mounted in a collar on the casting and forces oxygen into the conduit under pressure to expel the drug into a semi-pivoting cannula inserted into the patient's body. A colored oil drop between the oxygen and the drug in the conduit provides a visual indication of drug quantity, while a filter of hydrophobic and hydrophilic membranes keeps the oxygen and oil substantially out of the cannula. A test button sounds an alarm when the device is ready for use and a pressure sensitive switch automatically sounds an alarm and shuts off the pump if the drug becomes completely discharged from the conduit or if the drug delivery system becomes occluded and an interlock switch completes the circuit between the pump and a power source when the reusable module and disposable casting are joined.

The usage of a cannula or needle requires the penetration of the patient's skin by the needle in order to administer the drug through the skin barrier. However, any entering of the cannula to the patient's skin restricts the mobility and comfort of the patient and furthermore enhances the risk for an infection.

SUMMARY OF THE INVENTION It would be advantageous to provide a wearable drug delivery device, which would not require a cannula for the application of the drug into the patient's body.

It would also be desirable to provide a wearable drug delivery device enhancing the mobility and comfort of the patient.

Furthermore it is desirable to provide a wearable drug delivery device according to an embodiment of the present invention does not require any surgical intervention for implantation of the device prior to the usage of the device.

It would also be desirable to provide a wearable drug delivery device operable when oriented in different directions, e.g. when the patient is standing up, lying down and having different orientations. It would further be advantageous to provide a wearable drug delivery system enabling a refilling of a reservoir by a medical layman.

To better address one or more of these concerns, in a first aspect of the invention a cartridge for a wearable micro-jet drug delivery system is provided comprising a tubular reservoir having an outlet end and a second end, a first connector being connected to the outlet end of the tubular reservoir, wherein the first connector is connectable to a highspeed jet pump from which a drug may be ejected into a patient's body, and a second connector being connected to the second end of the tubular reservoir.

In an embodiment the tubular reservoir of the cartridge is spirally arranged, wherein the second connector is connected to a venting valve and wherein the venting valve is arranged in the center of the spiral. By locating the venting valve in the center of the spiral a pump system may be connected to the cartridge having the pump mounted such that is located close to the center of the spiral as well.

In a further embodiment the first connector at the outlet end of the tubular reservoir comprises a fluid outlet septum sealing the outlet end of the reservoir. The septum may be connected to a pump system by inserting a cannula or needle into the septum allowing a fluid to be pumped out of the reservoir.

Preferably in an embodiment the second connector at the second end of the tubular reservoir comprises an air inlet septum sealing the second end of the reservoir. When connecting the cartridge to a pump system the air inlet septum may be penetrated by a cannula or needle connecting the reservoir to a venting valve being part of the pump system. In terms of the present application a septum is a foil or membrane working as a seal or for any fluid, e.g. the drug or air, inside the reservoir, which can be penetrated by a cannula or needle and which will be sealing up again after retracting the cannula or needle.

In an embodiment the cartridge may be connected to a pump system comprising a high-speed jet pump for transdermal, needle-less drug delivery, wherein the high-speed jet pump is in communication with a first connector being connectable to a cartridge. In summary usage of a high-speed jet pump for transdermal, needle-less drug delivery is suggested which is wearable by a patient for long-term treatment. In order to enable an easy refilling of the system even for the medical laymen it is suggested to arrange the system such that the reservoir forms part of a cartridge which might easily be exchanged while the pump system might remain fixed to a patient. When compared to needle-based drug delivery devices such as a syringe, the wearable drug delivery device according to an embodiment of the present invention does not require insertion of a needle or cannula into the patient.

Transdermal drug delivery, i.e. drug delivery directly through the skin, can be used for controlled and/or continuous delivery of drugs. Skin is an essential organ ensuring both protection from external pathogens and preventing water loss. In both cases, the barrier properties of skin, which are the result of millions of years of biological evolution, are essential to our survival. The top layer of the skin is the stratum corneum), the main layer ensuring barrier properties of the skin, which essentially consists of dead cells (corneocyts) surrounded by lipid bilayers. Due to their respective composition and structures, the stratum corneum is mostly hydrophobic and impermeable while the lower layers, epidermis and dermis, are mostly hydrophilic. As a consequence, molecules with low molecular weight of less than 5 kilo Dalton (kDa) and with a lipophilic character tend to permeate the skin rather than large, hydrophilic molecules.

A high-speed jet pump for transdermal, needle-less micro-jet drug delivery in the terms of the present invention is a high-speed jet pump as disclosed in European patent application no. 06 119 215, the disclosure of which is incorporated herein in its full entirety by reference.

According to an embodiment of the invention, the high-speed jet pump comprises a casing with a fluid chamber, a membrane forming a wall of the fluid chamber, the fluid chamber further comprising at least one exit orifice and the membrane being piezo- electrically actuable for fluid ejection from the fluid chamber through the exit orifice, wherein a speed of the fluid ejection is adjustable by controlling the piezo-electric actuation of the membrane. Particularly in an embodiment of the present invention, the high-speed jet pump is an electrically driven needless injection device based on piezo-electric actuation.

It is an advantage of a high-speed jet pump according to an embodiment of the present invention, that it allows the delivery of small amounts of the drug per injection.

It will be appreciated by a person skilled in the art, that the speed of the fluid ejection in an embodiment may advantageously be set to any desired value, for example depending on how deep into the patient's skin the fluid shall be delivered. The speed of the fluid ejection may as well be reduced below values at which the human skin is ruptured which advantageously allow ingestible or implantable devices.

In a further embodiment, the speed of the fluid ejection is adjustable to a highspeed regime, and at least one dispensing regime, advantageously the high-speed jet pump according to an embodiment can be used both to pierce the epidermis, for example for transdermal drug delivery and to deliver controlled amounts of drug. The fluid ejection speed in the high-speed regime is thus preferably at least sufficient for injecting the fluid through at least an outer layer of the skin of a patient. The top layer of the skin is the stratum corneum (sc), the main layer ensuring barrier properties of the skin. The fluid to be ejected is accelerated to an ejection speed high enough to disrupt the stratum corneum, to penetrate and diffuse in the epidermis and dermis, accessing peripheral blood vessels.

In an embodiment of the present invention, the fluid ejection speed in the high-speed regime is controllable, particularly between 60 m/s and 200 m/s. Therefore the high-speed jet pump provides a broad range for utilization. The fluid ejection speed of 60 m/s is a typical speed for damage of soft tissue of biological nature such as bacterial films. A preferable fluid ejection speed by application in an embodiment according to the present invention in the high-speed regime for needle-less drug injection is about 20 m/s to 150 m/s.

As the high-speed jet pump is used to eject the liquid drug through the patient's skin without puncturing the skin by a needle, it is essential that in the system consisting of the venting valve, the high-speed jet pump and the tubular reservoir being in fluid communication with each other, the jet pump is located as close as possible to the patient's skin, i.e. at the first of the tubular reservoir facing to the patient, from which the drug is expelled. In comparison in the above reference US 4,734,092 the cannula or needle is connected to a first end of the spiral conduit, while the pump is connected to a second end of the conduit. When in operation the pump presses air into the first second end of the conduit, and therefore it expels the drug from the first end into the cannula and into the patient's body. According to the disclosure of the above reference the casting or reservoir and the pump module can be provided as separate detachable units. However due to the mounting of the pump at the second end opposite to the outlet end of the reservoir exchanging the casting always requires to dismount the whole device comprising the casting and the pump from the patient's body before dismantling the casting and the pump for an exchange of the casting.

A tubular reservoir in the terms of the present invention is a reservoir whose dimension in a first direction is at least twice as large as its dimension in the second direction.

The tubular reservoir according to an embodiment of the present invention at each filling level of the drug in the tubular reservoir has a minimal surface, i.e. the surface of the liquid level in the tube. Only the surface of the liquid in the tube forms the working surface for the external pressure.

In an embodiment of the invention the diameter and maximum radius of the tubular reservoir are adjusted to the properties drug solution to be injected so that the fluid is constrained in the tubular reservoir by capillary action. The parameters of interest are the surface tension γof the fluid, the contact angle θ with the reservoir walls, the density p of the solution, the diameter of the reservoir, the maximum outer radius of the spiral manifold l_max.

It is preferable that in an embodiment the internal diameter of the reservoir be

2γ cosθ less than d_max , defined as: d = — . This condition insures that the fluid does not leak

out of the open nozzle or outlet orifice of the jet injector. Furthermore, the tubular reservoir in an embodiment enables the usage of capillary forces keeping the fluid entirely between the filling level and an outlet orifice of the jet pump avoiding gas, e.g. air, to be pumped into the patient's body.

In an embodiment of the present invention, the medical grade tubing material should not interact chemically with the drug solution and should be sterilized prior to use. Tubing materials for the tubular reservoir include, but are not restricted to: polycarbonates, high-density polyethylene, nylon, retains, polypropylene, polyethylene, cyclic polyolefins, and the materials can be coated with inorganic compounds (e.g. silicon oxide) to reduce the contact angle θ for aqueous solutions. The tubing material in an embodiment can be transparent to allow for optical inspection, a fluid level monitoring and to detect the presence of air bubbles in the tubular reservoir.

The tubing inner diameter in an embodiment ranges from 0,4 mm to 2 mm. In an embodiment, the volumes available for the fluid storage are in the range from 1 to 5 ml. The overall volume of the reservoir in an embodiment is smaller than 10 ml. Preferably, the construction of the tubular reservoir is flexible such that it can occupy the volume of a casing in an optimum manner.

In an embodiment of a present invention, the venting valve is located adjacent to the jet pump when the cartridge and the pump are connected to form the wearable drug delivery device. "Adjacent" herein means that the venting valve is located close to the nozzle or outlet orifice of the high-speed jet pump, in order to reduce the possible hydrostatic pressure differences between the venting valve and the outlet orifice of the jet pump as much as possible. This way, the differences in hydrostatic pressure between the venting valve and the micro-jet pump can be minimized. In a further embodiment, the distance between the jet pump and the venting valve is smaller than 2 cm and preferably smaller or equal to 1 cm, when the cartridge and the pump are connected to form the wearable drug delivery device.

Desirably, there is an embodiment of the invention in which the tubular reservoir is spirally arranged. A spiral arrangement as understood in terms of the present invention requires that at least part of the tubular reservoir forms a spiral such that when being pressed through the tubular reservoir, the liquid drug moves inward or outward on a spiral track. This construction can minimize the differences in hydrostatic pressure between the reservoir and the jet pump and enables the application of the drug in every different physical orientation of the patient and thus of the wearable drug delivery device according to an embodiment of the present invention.

In an embodiment of the present invention, the spiral formed by the tubular reservoir is arranged essentially in a plane and the venting valve and the jet pump are arranged on an axis perpendicular to the plane, when the cartridge and the pump are connected. Furthermore, an embodiment of the invention may be advantageous in which the jet pump and the venting valve are arranged in the center of the spirally arranged tubular reservoir, when the cartridge and the pump are connected. In an embodiment, the venting valve comprises a semi-permeable membrane fastened at the second end of the tubular reservoir, wherein the membrane works as a sealing for any liquids and is permeable for gas, i.e. air.

In a further embodiment of the present invention, the tubular reservoir comprises a filling system enabling a refilling of the reservoir while being attached to the patient's body.

In an embodiment, the reservoir may then be refilled through the filling system using a standard syringe with a hypodermic needle. Therefore in an embodiment, the filling system comprises a septum forming one of its outer walls, in which the hypodermic needle of the syringe may be inserted.

In order to avoid the injection of air through the filling system into the tubular reservoir, the filling system in an embodiment may comprise an electrical or optical system enabling the detection of gas bubbles in the liquid drug being injected into the filling system.

Alternatively, in an embodiment of the wearable drug delivery device refilling may be achieved through the outlet orifice or nozzle of the jet pump.

In an embodiment the connector being in communication with the high-speed jet pump comprises a cannula for penetration of a fluid outlet septum of a cartridge, enabling a fluid coupling to a cartridge filled with a drug to be administered.

In an embodiment the pump system preferably comprises a venting valve and a connector in communication with the venting valve to connect the venting valve to a cartridge. This construction enables to integrate all sophisticated parts of the wearable drug delivery device in the pump system while the cartridge may be a disposable element. When dismantling the cartridge from the pump system all sophisticated and working elements may thus remain attached to the patient. In a preferred embodiment the connector in communication with the venting valve comprises a needle to penetrate an air inlet septum of a cartridge in order to establish a communication between the second end of the cartridge and the venting valve.

In an arrangement comprising a septum at the outlet end of the reservoir and a needle at the inlet conduit of the jet pump, the cartridge can be connected to a pump mounted to a patient without spilling any of the valuable drug stored inside the reservoir. Furthermore the cartridge containing the reservoir can be dismounted from the pump even when still partly filled without spilling any of the drug.

In terms of the present invention, a wearable drug delivery device is a device which is arranged such that it can be carried by a patient in an operable condition on a long- term basis. Therefore, in a further embodiment the high-speed jet pump comprises mounting means for mounting the drug delivery device to a patient. Such mounting means could be self-adherent surfaces, bandages or strips to strap the device to the patient but are not restricted to such. Thus the pump may remain attached to a patient while exchanging the cartridge with the reservoir.

For an easy connection between the pump and the cartridge each in an embodiment may comprise a mount. A mount according to an embodiment of the invention may be bayonet coupling or any other sort of form fit or press fit connection.

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 diagrammatically shows a first embodiment of a wearable drug delivery device according to the present invention. Figure 2 diagrammatically shows a further embodiment of a wearable drug delivery device according to the present invention.

Figure 3 shows a schematic cross-sectional view of a high-speed piezo jet pump being part of the device shown in figures 1 and 2.

Figure 4 shows a cross-sectional view of the venting valve being part of the device shown in figures 1 and 2.

Figure 5 shows a top view on a cartridge according to an embodiment of the invention.

Figure 6 shows a cross sectional view of the cartridge of figure 5. Figure 7 schematically shows a cross sectional view of a cartridge and a pump system.

Figure 8 schematically shows a cross sectional view of a cartridge and an alternative embodiment of the pump system.

DETAILED DESCRIPTION OF EMBODIMENTS Figure 1 schematically shows the components of a wearable drug delivery system according to a first embodiment comprising a tubular reservoir 1, a high-speed jet pump 2 as well as a venting valve 3. The three components 1, 2, 3 are in fluid communication with each other, i.e. a liquid drug may flow or may be pumped from the venting valve 3 via the tubular reservoir 1 to the jet pump 2. The tubular reservoir 1 comprises a first end 4 and a second end 5. The first end 4 of the tubular reservoir 1 is considered the end from which a dug is ejected through the pump 2 into a patient's body. The jet pump 2 is connected to the first end 4 of a tubular reservoir 1. In contrast, the venting valve 3 is connected to the second end 5 of the tubular reservoir 1. Denoted by reference number 7 is a connector pair mounted to the pump 2 on the one hand and to the cartridge 9 formed by the tubular reservoir 1 on the other hand. A further connector pair 8 connects the venting valve 3 to the second end of the reservoir 1 on the cartridge 9. The venting valve 3 and the pump 2 form a pump system denoted by 10. The cartridge 9 and the pump 10 may be separated by dismantling the connector pairs 7 and 8. In figure 2, a further alternative embodiment of a wearable drug delivery device according to the present invention is schematically drawn. If compared to figure 1 , the device as laid out in figure 2 further comprises a filling system 6 enabling a refilling of the tubular reservoir 1. Denoted by reference number 7 is again a connector pair mounted to the pump 2 on the one hand and to the cartridge formed by the tubular reservoir 1, the filling system 6 and the venting valve 3 on the other hand. The cartridge and the pump 2 may be separated at the location of the connectors 7.

Figure 3 shows an elaborate cross-sectional view of the jet pump 2 as used in the embodiments of figures 1 and 2. In figure 5, the jet pump 2 is schematically depicted in cross-section comprising a casing 30, a piezo-electric transducer 31, mechanically coupled via support structure 32 to the casing 30 at a first site and to a membrane 33 at the other site. The piezo-electric transducer 31, for example a small bulk piezo-electric transducer of multilayer ceramic is driven via powerlines 34, which connect the piezo-electric transducer 31 to a driving unit (not shown). A micro-controller controls the pump, in particular the supply of the piezo-electric transducer 31. The membrane 33 forms a wall of a fluid chamber 35 which comprises an outlet orifice or a nozzle 36 and which is connected to a fluid supply line 37. The fluid supply line 37 leads through the membrane 33 remote from the fluid chamber and runs at least partly between the membrane 33 and in interlayer 38. Fluid is supplied to the device via an intake connection 39 which is located at one side of the device. The intake connection 39 is connected to the first end 4 of the tubular reservoir 1 as shown in figures 3 and 4.

During driving of the piezo-electric transducer 31, the piezo-electric transducer 31 expands and pushes on the flexible membrane 33. This compresses the fluid in the fluid chamber 35, resulting in a pressure built up and as a consequence, a fluid flow out of the exist orifice 36. The exit orifice 36 is formed as a nozzle with a diameter typically ranging from 10 μm to 200 μm and a length between 50 μm and 200 μm. As soon as the driving of the piezo-electric transducer 31 stops, both the piezo-electric transducer 31 and the membrane 33 return to their rest state and fluid will enter the fluid chamber 35 through the fluid supply line 37 by capillary force. In order to generate a high-speed fluid ejection, the high-speed jet pump as used in the embodiments shown is mechanically stiff. If there was too much mechanical deformation of the device during driving of the piezo-electric transducer 31, the pressure in the fluid chamber would be too low to generate a high-speed fluid ejection. Further, the relation between the length and diameter of the fluid supply line 37 and the length and diameter of the nozzle 36 determine the functioning of the employed jet pump.

Figure 4 shows a schematic cross-sectional view of the venting valve 3 as employed in the wearable drug delivery device shown in figures 3 and 4. Figure 6 shows the second end 5 of the tubular reservoir 1 containing the liquid drug 50 and air 53, the venting valve 3 comprising a mount 52 and a semi-permeable membrane 51 sealing the second end 5 of the tubular reservoir 1. The semi-permeable membrane 51 mounted by the mount 52 is permeable for gases like air and provides a solid barrier for a fluid like the drug 50 in the reservoir 1. Therefore, air 53 enclosed in the tubular reservoir 1 can degas through the semipermeable membrane 51 when the reservoir 1 is filled through the filling system 6 with a liquid drug 50. On the other hand, the semi-permeable membrane provides a venting, i.e. a flow of air into the reservoir 1 when the fluid 50 is ejected by the jet pump 2 from the tubular reservoir 1 avoiding the built up of a vacuum in the tubular reservoir counter-acting on the pumping forces of the jet pump 2.

Figure 5 provides a top view on a cartridge 80 according to an embodiment of the present invention. The cartridge is integrally formed as a polymer disk, wherein the polymer is a medical grade polycarbonate. The cartridge 80 comprises a spirally shaped manifold reservoir 81 filled with a liquid drug 82. The cartridge 80 furthermore comprises two alignment notches 85 for a proper alignment with the pump when connecting the cartridge 80 to a pump system.

Further two septa 83, 84 are provided in order to establish a connection between the cartridge 80 and an ejection module. A fluid outlet septum 83 is located at the outlet end 87, wherein an air inlet septum 84 is located in the center of the spirally shaped tubular reservoir 81. The two septa are membranes, which seal the reservoir 81 at its two opposite ends 83, 84. The septa can be punctured or penetrated by a needle or cannula in order to establish a fluid connection with the reservoir. However, when the cannula is retracted the septum 83, 84 seals up again.

Figure 6 shows a side view of the cartridge of Figure 5. It clearly shows that the reservoir 81 is integrated into the disk forming the cartridge 80. The two septa 83, 84 are located underneath the spirally shaped reservoir 81 in order to enable the establishing of a connection to the pump module. The air inlet septum 84 is located such that it extends essentially parallel to the plane in which the spirally shaped reservoir is located. In contrast the fluid outlet septum 83 extends in a plane being essentially perpendicular to the plane of the reservoir 81. This way the fluid outlet septum and the air inlet septum may be penetrated by two different cannulas being perpendicular to each other.

Figure 7 shows a schematic side view of the cartridge 80 and a pump system 100. The pump system 100 comprises a high-speed jet pump 102 and a venting valve 101 as described above.

In Figure 7 the venting valve 101 forming part of the pump system 100 has already been connected to the air inlet septum 84. For connecting to the air inlet septum 84 the venting valve 101 comprises a cannula 114, being sharp enough to penetrate the air inlet septum. The cannula 103 provides a passage for air through the septum 103 into the mount 104 of the valve 101. The mount 104 holds a semi permeable membrane 105 being permeable for air and forming a seal for any liquid contained in the reservoir 81. When the liquid drug is pumped out of the tubular reservoir 81 by the high-speed jet-pump 102 air can flow through the membrane 105, the venting valve 101 and the cannula 103 into the reservoir 81 in order not to create a vacuum at the second end 88 of the tubular reservoir 81.

In Figure 7 the septum 83 located at the outlet end 87 of the reservoir 81 has not yet been punctured by a cannula 106. The cannula 106 forms part of a connector 107 being in fluid communication with the high-speed jet pump 102 via a conduit 108. When the cannula 106 penetrates through the fluid outlet septum 83, the pump 102 can pump the liquid drug from the reservoir 81 and eject it into the patient's body. In order to avoid any back flow from the jet pump 102 into the connector 107 and further into the reservoir 81

Figure 8 shows an alternative embodiment of the pump system 100' being connected to a cartridge 80. The major features of the pump system 100' are identical to the embodiment shown in Figure 7. Similar elements have been denoted by equal reference numbers. However, the system 100' shown in Figure 8 further comprises a filling system with a filling septum 110 and a further one-way fluid valve 112. The filling system 109 is connected via the one-way fluid valve 112 to the conduit 108 between the connector 107 and the jet pump 102. To fill the cartridge a hypodermic needle, e.g. of a syringe, is penetrated through the septum 110 and the syringe is emptied into the reservoir 81. The one way valve 112 avoids any backflow of the liquid drug into the filling system.

From Figures 7 and 8 it becomes clear how the venting valve 101 and the jet pump 102 are located with respect to each other when the wearable drug delivery device is in an operable condition. The venting valve 101 and the jet pump 102 are located in close proximity on a common axis defined by the direction 113 of a beam of liquid ejected from the jet pump 102. This way any pressure differences between the outlet orifice of the jet pump 102 and the air inlet septum 104 of the venting valve 101 are kept to a minimum. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive, the invention is not limited to the disclosed embodiments.

Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that the combination of these measures cannot be used to an advantage. Any reference signs in the claims should not be construed as limiting the scope.

List of reference numerals:

1 Tubular reservoir

2 Jet pump

3 Venting valve

4 First end of the tubular reservoir

5 Second end of the tubular reservoir

6 Filling system

7 Connectors

8 Connectors

9 Cartridge

10 Pump system

30 Casing

31 Piezo-electric transducer

32 Support structure

33 Membrane

34 Powerlines

35 Fluid chamber

36 Nozzle

37 Fluid supply line

38 Interlayer

39 Intake connection

50 Liquid drug

51 Semi-permeable membrane

52 Mount

53 Air

80 Cartridge

81 Reservoir 82 Liquid drug

83 Fluid outlet septum

84 Air inlet septum

85 Alignment notch

86 Air

87 Outlet end

88 Second end

100 Pump system

101 Venting valve

102 High-speed jet pump

103 Cannula

104 Mount

105 Semi-permeable membrane

106 Cannula

107 Connector

108 Conduit

109 Filling system

110 Septum

111 One way valve

112 One way valve

113 Direction of ejected fluid beam

Claims

CLAIMS:

1. A cartridge (80) for a wearable micro-jet drug delivery system comprising a tubular reservoir (1, 81) having an outlet end (4, 87) and a second end (5,

88), a first connector (83) being connected to the outlet end (87) of the tubular reservoir (1, 81), wherein the first connector (83) is connectable to a high-speed jet pump (2,

102) from which a drug may be ejected into a patient's body, and a second connector (84) being connected to the second end (88) of the tubular reservoir (1, 81).

2. A cartridge according to claim 1, characterized in that the tubular reservoir (1, 81) is spirally arranged, wherein the second connector (84) is connected to a venting valve (3,

103) and wherein the venting valve (3, 103) is arranged in the center of the spiral.

3. A cartridge according to claim 1, characterized in that the first connector (83) at the outlet end (87) of the tubular reservoir (1, 81) comprises a fluid outlet septum sealing the outlet end of the reservoir (1, 81).

4. A cartridge according to claim 1, characterized in that the second connector (84) at the second end (5, 88) of the tubular reservoir (1, 80) comprises an air inlet septum sealing the second end (5, 88) of the reservoir.

5. A pump system (100, 100') comprising a high-speed jet pump (2, 102) for transdermal, needle-less drug delivery, wherein the high-speed jet pump (2, 102) is in communication with a connector (107) being connectable to a cartridge (80).

6. A pump system (100, 100') according to claim 5, characterized in that the connector (107) being in communication with the high-speed jet pump (102) comprises a cannula (106) for penetration of a fluid outlet septum (83) of a cartridge (80).

7. A pump system (100, 100') according to claim 5, characterized in that the cannula (106) is spring biased.

8. A pump system (100, 100') according to claim 5, characterized in that it further comprises a venting valve (3, 101) and a connector in communication with the venting valve (3, 101) to connect the venting valve (3, 101) to a cartridge (80).

9. A pump system (100, 100') according to claim 8, characterized in that the connector being in communication with the venting valve (3, 101) comprises a cannula (103) to penetrate an air inlet septum (84) of a cartridge (80).

10. A wearable micro-jet drug delivery system comprising a cartridge (80) according to claim 1 , and a pump system (100, 100') for transdermal, needle-less drug delivery according to claim 5.