A medical product, and a method of sterilizing a medical product

THE TECHNICAL FIELD OF THE INVENTION

The present invention refers to a medical product according to the preamble of claim 1 , cf. EP-B-28601. The present invention also refers to a medical product according to the preamble of claim 14. Furthermore, the present invention refers to a method of sterilizing a medical product according to the preamble of claim 15.

In the medical field, there are numerous situations where a medical fluid is to be transported from one subsystem to another subsystem during sterile conditions for preventing contamination of the medical fluid or any one of the subsystems. In a first possible application of the present invention, the first subsystem may be a system for supplying infusion liquid to the blood system of a patient. A second application of the present invention may include the transfer of blood products or the transfer of blood from the blood system of an individual to the blood system of another individual, either directly between the individual or via any system for storing blood. Further applications of the present invention may include any supply of other medical fluids into the body of an individual. A common aspect of these applications is that one of the subsystems is a biological system, such as the blood system of an individual. However, the present invention is also applicable to the transport of a medical fluid between two non-biological subsystems, for instance during the manufacture, cleaning, processing or treating of medical fluids.

In the following, the present invention will be described in connection with a further important application of the invention, namely dialysis. However, the invention is not restricted to this application, but may be applied to other fields as defined above.

There are various dialysis therapies used today. One differs between extracorporeal dialysis, such as hemodialysis and intensive care dialysis, and intracorporeal dialysis, such as peritoneal dialysis.

During a dialysis treatment, a medical fluid, i.e. a dialysis liquid, is used. The dialysis liquid may be contained in a container, which is connected directly to the patient in intracorporeal dialysis or to a dialysis apparatus in extracorporeal dialysis, via a so-called connector. Typically, the connector is connected to the container, directly or indirectly via a line. The container may be manufactured in a flexible material, preferably a plastic material. Before use the connector is closed by means of a frangible pin arranged in the flow passage of the connector and preventing a flow of the medical fluid from the container through the connector. Such a container including a frangible pin is disclosed in WO 2005/117802. When the medical fluid is to be used, the connector is connected to the patient or the dialysis apparatus via a line. The frangible pin is then removed by being broken off. A disadvantage of this known connector design is that the connector does not permit closing of the fluid communication once the connector has been opened, e.g. if medical fluid remains after the dialysis treatment has been finished or if the dialysis treatment is interrupted in advance for any reason. Another disadvantage is that the breaking of the frangible pin could be experienced as difficult for certain users, e.g. patients with a poor health condition. A further disadvantage of the prior art solutions is the possibility of obtaining a sterilization of the medical product and the connector in an efficient manner.

EP-B-28601 shows a slide valve and a coupler assembly for medical applications, such as peritoneal dialysis applications and collection of urine. The slide valve comprises a valve housing forming a fluid passage. A cylinder with a piston is arranged transversally to the fluid passage. The piston is movable in the cylinder between a closed position and an open position. Some provisions are made for sterilizing the slide valve.

US-A-4, 431 ,424 discloses a slide valve for medical applications. A disinfectant is supplied to the interior of the valve before the valve is connected to a coupling element.

SUMMARY OF THE INVENTION

The object of the present invention is to remedy the disadvantages mentioned above. A further object is to provide a medical product, which permits

sterilization in an easy and efficient manner. A further object is to provide a method of sterilizing a medical product.

This object is achieved by the medical product initially defined, which is characterized in that the connector comprises at least one small passage permitting, in the closed stable position, an introduction of a sterilizing gas in such a way that the sterilizing gas will contact wall surfaces defining the channel. By means of such a small passage or small passages, the wall surfaces defining the channel in the interior of the connector may, in a convenient manner, be sterilized before use of the medical product, for instance during an autoclaving process.

According to an embodiment of the invention, the at least one small passage comprises a sterilizing groove formed in one of the first part and the second part and extending to an interior at least partly defined by said wall surfaces. Such a groove may be very thin, with a diameter of less than 0,5 mm, to permit introduction of sterilizing gas.

According to an embodiment of the invention, the medical product comprises a cover element attachable to the first connection pipe for protecting an interior of the first connection pipe, wherein the cover element is removable before the first connection pipe is connected to the first connection portion of the first subsystem. Such a cover element may protect the interior of the first connection pipe from dust or other particles in the environment. Advantageously, the at least one small passage may then comprise an aperture extending through the cover element for enabling introduction of the sterilizing gas into an interior of the first connection pipe. Such an aperture may be very thin, with a diameter of less than 0,5 mm, to permit introduction of sterilizing gas but prevent introduction of dust or other particles from the environment.

According to a further embodiment of the invention, the second subsystem comprises a container containing the medical fluid, wherein the container is comprised by the medical product and connected to the second connection pipe of the connector. The container and the connector may be sterilized during a common process, such as an autoclaving process.

According to a further embodiment of the invention, the first part comprises a housing, through which the channel extends and which comprises a cylinder forming an inner chamber extending transversally to and crossing the channel, wherein the second part comprises a piston, which is movable in the inner chamber between the closed stable position closing the channel and the open stable position, in which the channel is open by means of a recess in the piston. Such a valve device can be handled in a convenient manner by a user, such as a patient, by moving the piston of the second part after changing of the state of the blocking member. Advantageously, the at least one small passage may then comprise a sterilizing groove formed in one of an inner wall of the cylinder and an outer surface of the piston and extending to the recess when the piston is in the closed stable position.

According to a further embodiment of the invention, the cylinder has a primary end and a secondary end and the piston may have a primary end and a secondary end, wherein the primary end of the piston protrudes from the primary end of the cylinder in the closed stable position and wherein the secondary end of the piston protrudes from the secondary end of the cylinder in the open stable position. Advantageously, the sterilizing groove of the small passage may extend from the primary end of the cylinder to the recess.

According to a further embodiment of the invention, the piston has a primary end portion, which is provided at the primary end of the piston and which is configured to prevent the primary end of the piston from entering the inner chamber of the cylinder, and a secondary end portion, which is provided at the secondary end of the piston and which is configured to prevent the secondary end of the piston from entering the inner chamber of the cylinder.

According to a further embodiment of the invention, the piston is manufactured in a piston material and the cylinder in a cylinder material, wherein the piston material is softer than the cylinder material. Such a relatively soft material will function as sealing means having a sealing effect and thus contribute to a tight abutment between the inner wall of the cylinder and the outer surface of the piston. In such a way leakage of the medical fluid is prevented. In addition, the piston may be provided with further sealing means in order to provide a tight sealing against an inner wall of the cylinder. Such further sealing means may then comprise at least one ridge extending outwardly from an outer surface of

the piston and around an outer periphery of the piston. Such a ridge, for instance of the above-mentioned relatively soft material, will ensure a tight abutment against the inner wall of the cylinder.

The object is also achieved by the method initially defined, which is characterized by the steps of: providing the medical product with the valve device in the closed stable position; introducing the medical product in a space in a vessel; and introducing sterilizing gas into the space and into to connector to contact wall surfaces defining the channel via at least one small passage. Preferably, the method comprises also the preparing step of filling the container with the medical product.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is now to be explained more closely by the description, by way of example only, of various embodiments and with reference to the drawings attached hereto.

Fig 1 discloses schematically an example of a first medical system. F Fiigg 2 2 discloses schematically an example of a second medical system.

Fig 3 discloses a side view of a connector of a medical product according to a first embodiment of the invention.

Fig 4 discloses a sectional view along the line IV-IV in Fig 3.

Fig 5 discloses a sectional view of a first part of the connector in Fig 4. F Fiigg 6 6 discloses a side view of an end portion of a second part of the connector in Fig 3.

Fig 7 discloses a side view of a piston of a second part of the connector in Fig 3.

Fig 8 discloses a side view of a connector of a medical product according to a second embodiment of the invention.

Fig 9 discloses another side view of the connector in Fig 8.

Fig 10 discloses a top view of the connector in Fig 8 in a closed stable position.

Fig 1 1 discloses a sectional view along the line XI-XI in Fig 10. F Fiigg 1 122 discloses a sectional view through a first part of the connector along the line XII-XII in Fig 10.

Fig 13 discloses a top view of the connector in Fig 8 in an open stable position.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

Fig 1 discloses a medical system which illustrates schematically intracorporeal dialysis care, such as peritoneal dialysis, and comprises a first subsystem 1 having a first connection portion Ia and a second subsystem 2 having a second connection portion 2a. In Fig 1 , the first subsystem 1 comprises a patient p, whereas the second subsystem 2 comprises a container 3 with a medical fluid in the form of a dialysis liquid. The first connection portion Ia of the first subsystem 1 is connected to the second connection portion 2a of the second subsystem 2 via a connector 4 in order to permit transport of the medical fluid from the second subsystem 2, in this example the container 3, to the first subsystem 1 , in this example the patient p. The first connection portion Ia comprises a flexible line with an appropriate connection member adapted to be connected to the connector 4. The second connection portion 2a also comprises a flexible line with an appropriate connection member adapted to be connected to the connector 4. A medical product is constituted by the connector 4 and the second subsystem 2. A medical product may also be constituted by the connector 4 only.

Fig 2 discloses another medical subsystem which illustrates schematically extracorporeal dialysis, such as hemodialysis care or acute renal care dialysis, hemodialysis and differs from the first medical system in that the first system 1 comprises a dialysis apparatus 5 to which a patient p is connected, and that the blood is treated extracorporeally.

The connector 4 will be described more closely below in conjunction with the description of the various embodiments. Generally, the connector 4 comprises a valve device 10, a first connection pipe 11 and a second connection pipe 12.

The first connection pipe 11 is connected to the valve device 10 and configured to be connected to the first connection portion Ia of the first subsystem, in the example disclosed to the line and the connection member of the first connection portion Ia. The second connection pipe 12 is connected to the valve device 10 and is, or configured to be, connected directly to the container 3 or indirectly to the container 3 via the second connection portion 2a of the second subsystem 2,

in the example disclosed to the line and the connection member of the second connection portion 2a.

With reference to Figs. 3 to 7, a first embodiment is to be described. Figs. 3 and 4 discloses the connector 4 with the valve device 10, the first connection pipe

11 and the second connection pipe 12. The valve device 10 comprises a first part 21 and a second part 22. Described in a general manner, the first part 21 and the second part 22 are movable in relation to each other to permit an opening movement from a closed stable position, preventing fluid communication with the first connection pipe 11 and the second connection pipe 12, see Fig. 4, and an open stable position, forming a channel 23, which is defined by inner wall surfaces belonging to the first part 21 and the second part

22, respectively. The channel 23 permits fluid communication between the first connection pipe 11 and the second connection pipe 12.

More specifically, in the first embodiment the first part 21 and the second part 22 are movable in relation to each other along a longitudinal axis x. The first part 21 comprises a housing 25 through which the channel 23 extends, see Fig 5. The housing 25 comprises a cylinder 26 forming an inner chamber 27 which extends along the longitudinal axis x transversally to and crossing the channel

23. The second part 22 comprises a piston 28, which is movable in the inner chamber 27 of the cylinder 26 between the closed stable position closing the channel 23 and the open stable position in which the channel 23 is open by means of a recess 29 in the piston 28, see also Figs 6 and 7. In the first embodiment disclosed, the recess 29 is formed by a groove extending around the periphery of the outer surface of the piston 28. The recess 29 may however also have a different shape, for instance as a cavity or a hole extending through the piston 28.

The cylinder 26 has a primary end 26' and a secondary end 26" . The piston 28 has a primary end 28 ' and a secondary end 28". In the closed stable position shown in Fig. 4, the primary end 28' of the piston 28 protrudes from the primary end 26' of the cylinder 26. In the open stable position, the secondary end 28" of the piston 28 protrudes from the secondary end 26" of the cylinder 26.

Furthermore, the piston 28 has a primary end portion 31 , which is provided at the primary end 28' of the piston 28. The primary end portion 31 comprises a flange preventing the primary end 28' from entering the inner chamber 27 of the cylinder 26. The piston 28 also has a secondary end portion 32, which is provided at the secondary end 28" of the piston 28. The secondary end portion 32 comprises a flange preventing the secondary end 28" of the piston 28 from entering the inner chamber 27 of the cylinder 26.

As can be seen from Fig. 4, the primary end portion 31 is formed by a separate part which is introduced into an inner space of the piston 28 and attached to the piston 28 in the inner space by means of a hook connection 33, see also Figs. 6 and 7. In Figs 6 and 7, the two parts are separated from each other, i.e. before mounting of the valve device 10.

The piston 28, at least the part comprising the secondary end portion 32, is manufactured in a piston material and the cylinder 26 in a cylinder material. The piston material is softer then the cylinder material in order to improve the sealing between the outer surface of the piston 28 and the inner wall of the cylinder 26. As can be seen from especially Figs 6 and 7, the piston 28 is provided with further sealing means in order to provide a tight sealing against an inner wall of the cylinder 26. This further sealing means comprises three ridges 37 extending outwardly from the outer surface of the piston 28 and around an outer periphery of the piston 28. In the first embodiment disclosed, two of the ridges 37 are provided between the recess 29 and the secondary end 28" of the piston 28, and one ridge 37 is provided between the recess 29 and the primary end 28' of the piston 28.

As can be seen in Figs 3 and 4, the connector 4 also comprises a cover element 35, which is attached to the first connection pipe 11 for protecting the interior of the first connection pipe 11. The cover element 35 is attached to the first connection pipe 11 in a removable manner by means of a thread on the outer surface of the first connection pipe 11 and a corresponding thread on the inner surface of the cover element 35. The cover element 35 is removed from the first connection pipe 11 by being unscrewed before the first connection pipe 11 is connected to the first connection portion Ia of the first subsystem 1.

The connector 4 also comprises a blocking member 38. The blocking member 38 is, in a blocking state, configured to prevent the opening movement from the closed stable position to the open stable position. Furthermore, the blocking member 38 is configured to permit changing of the blocking state of the blocking member 38 to a non-blocking state permitting the opening movement from the closed stable position to the open stable position. The blocking member 38 is provided on the valve device 10, and in the first embodiment on the piston 28 at the primary end 28' of the piston 28, and more specifically between the primary end 26' of the cylinder 26 and the primary end portion 31 of the piston 28. In the first embodiment, the blocking member 38 is configured as a removable ring extending around a main part of the periphery of the piston 28 at the primary end 28' . The blocking member 38, e.g. the ring, is attached to the piston 28 via a breakable attachment 39. The breakable attachment 39 may be obtained by one or several thin, weakened connecting strips.

The blocking member 38 is thus configured to permit the changing of the blocking state of the blocking member 38 to the non-blocking state by a user applying a determined force to the blocking member 38. In the first embodiment, this force is applied, as a pulling force, to a flap 40 of the blocking member 38 protruding outwardly from the blocking member 38. The user thus pulls the flap 40 whereby the pulling force applied will break the breakable attachment 39, in an irreversible manner, and remove the blocking member 38 from the piston 28. After this changing of the blocking state of the blocking member 38, the piston 28 may be moved along the longitudinal axis x from the closed stable position, disclosed in Fig. 4, to an open position in which the recess 29 establishes the channel 23 permitting fluid communication from the second connection pipe 12 to the first connection pipe 11 , or possible vice versa.

It is to be noted here, that the first part 21 , comprising the cylinder 26, and the second part 22, comprising the piston 28, are configured to remain in the open stable position when the open stable position has been obtained, i.e. after the opening movement along the longitudinal axis x. However, it is also to be noted that the first part 21 , comprising the cylinder 26, and the second part 22, comprising the piston 28, in the non-blocking state of the blocking member 38, are moveable by a user applying a determined force in order to permit a closing movement from the open stable position back to the closed stable position

disclosed in Fig. 4. After this closing movement, the removed blocking member 38 will serve as an indication to the user or any other person involved, that the connector 4 or the medical product may once have been used. For instance, a part of the medical fluid contained in the container 3 may have been used and the remaining part of the medical fluid may then be intended for waste or for use at a later occasion, preferably within a prescribed time limit. Even if the blocking member 38, e.g. in the form of a ring, for any reason is reattached onto the piston 28, the user may still observe that the medical product has been used thanks to the broken breakable attachment 39.

The connector 4 also comprises a number of small passages 41 , 42, 43 permitting, in the closed stable position, an introduction of a sterilizing gas to an interior of the connector 4 in such a way that the sterilizing gas will contact the inner wall surfaces defining the channel 23. These small passages 41 , 42, 43 thus enable sterilization of the connector 4 before use, i.e. before the blocking state of the blocking member 38 has been changed. Especially, it is to be noted that the connector 4 could be sterilized together with the container 3 and the optional second connection portion 2a, for instance during an autoclaving process. During the autoclaving process, sterilizing gas is thus permitted to enter the interior of the connector 4 through the small passages 41 , 42, 43.

One such small passage 41 comprises a small aperture or slit extending through the cover element 35 for enabling introduction of the sterilizing gas into the interior of the first connection pipe 1 1. Consequently, the inner wall surface of the first connection pipe 11 and a part of the outer surface of the piston 28 will thus be subjected to the sterilizing gas.

Two further small passages 42, 43 comprises a respective sterilizing groove formed in the inner wall surface of the cylinder 26 and extending from the primary end 26' of the cylinder 26 and the secondary end 26" of the cylinder 26, respectively. As can be seen in Fig. 4, the sterilizing groove of the small passage 42 extends between the primary end 26' of the cylinder 26 and the recess 29. Consequently, sterilizing gas can be introduced into the interior of the connector 4, i.e. into the cavity formed by the recess 29 and thus subject all surfaces of this cavity to the sterilizing gas. The sterilizing groove of the small passage 43 is provided for symmetry reasons, see fig. 5, i.e. during manufacturing the piston 28 may be introduced through either of the primary

end 26' or the secondary end 26" of the cylinder 26. It should be noted that instead of providing the sterilizing grooves in the inner wall surface of the cylinder 26, corresponding grooves can be made in the outer surface of the piston 28.

The manufacturing of the medical product, including the container 3 and the connector 4, may be performed by filling the container with a medical fluid via an opening (not shown) that after filling is closed, e.g. by welding. In an alternative embodiment, the container is filled by a medical fluid via an opening that subsequently is closed by the connector 4. The medical product is then sterilized by means of an autoclaving process. During the autoclaving process, the medical product, e.g. including the connector 4 and the container 3, may be introduced in a closed space in a vessel. A sterilizing gas is introduced into the space of the vessel, and into the connector 4 via the small passages 41 , 42, 43. The medical fluid in the container 3 is sterilized in a manner known per se, e.g. by means of heat generated in the space. The so sterilized medical fluid willl ensure sterilization also of the interior of the second connection pipe 12. After the autoclaving process, the medical product is enclosed in an overwrap that among other things ensures maintenance of the sterility of the product.

Figs 8 to 13 disclose a second embodiment, wherein the valve device 10 comprises a first part 21 and a second part 22, which are rotatable in relation to each other with respect to an axis x' of rotation to permit an opening movement from a closed stable position, preventing fluid communication between the first connection pipe 11 and the second connection pipe 12, and an open stable position, see Fig 13, forming a channel 73, which is defined by inner wall surfaces belonging to the first part 21 and the second part 22, respectively. The channel 73 permits fluid communication between the first connection pipe 11 and the second connection pipe 12. The first connection pipe 11 is provided with a thread, see Figs 8 and 9, permitting the removable attachment of a cover element 35 of the kind described in conjunction with the description of the first embodiment. Also in the second embodiment, the first part 21 and the second part 22 are configured to remain in the open stable position when the open stable position has been obtained.

In the second embodiment, the first part 21 comprises a first abutment surface 61 through which the first connection pipe 11 extends via a first aperture 63.

The second part 22 comprises a second abutment surface 62 through which the second connection pipe 12 extends via a second aperture 64. The first and second abutment surfaces 61 , 62 are facing each other at an interface. The abutment surfaces 61, 62 are arranged close to each other so that merely a very thin space remains at the interface between the abutment surfaces 61 , 62. The abutment surfaces 61 , 62 are rotatable in relation to each other around the common axis x' of rotation. The first aperture 63 and the second aperture 64 are eccentric with respect to the axis x' of rotation. Consequently, the first connection pipe 11 and the second connection pipe 12 are at an angle distance from each other in the closed stable position but aligned to form the channel 73 extending straight through the connector 4 in the open stable position in parallel with the axis x' of rotation.

In the second embodiment disclosed, the first part 21 comprises a projecting member 65 and the second part 22 a projecting member 66. The projecting members 65 and 66 both have a wing-like shape and are configured to be engaged by a user as gripping members for performing the opening and closing movement of the valve device 10. As can be seen from Figs 8 - 11 , in which the valve device 10 is in the closed stable position, the projecting members 65, 66 are at an angle distance from each other with respect to the axis x' of rotation.

In the open stable position, see Fig 13, the projecting members 65, 66 are aligned seen in the direction of the axis x' of rotation.

In the second embodiment disclosed, the second part 22 comprises sealing means extending through the second abutment surface 62 around the second aperture 64. The sealing means comprises a groove 67 and a seal element 67a provided in the groove 67. It is to be noted that the sealing means could also be provided in the first part 21 to extend through the first abutment surface 61 around the first aperture 63.

In the second embodiment disclosed, a blocking member 68 is attached to the first part 21 to cooperate with the projecting member 66 of the second part 22 in such a way that the opening movement is prevented as long as the blocking member 68 is in the blocking state. Also in the second embodiment, the blocking member 68 is configured to permit the changing of the blocking state of the blocking member 68 to the non-blocking state by a user applying a determined force to the blocking member 68. The blocking member 68 is

configured to permit the application of the force directly to the blocking member 68 itself. Moreover, the blocking member 68 is configured in such way that the changing of the blocking state of the blocking member 68 to the non- blocking state is performed by removing the blocking member 68 from the first part 21 , wherein the blocking member 68 is attached to the first part 21 via a breakable attachment 69. In the non-blocking state, the first part 21 and the second part 22 are movable by a user applying a determined force in order to permit a closing movement from the open stable position, disclosed in Fig 13, back to the closed stable position.

In the second embodiment, the first part 21 has a circumferential flange 70 extending around the first abutment surface 61 and forming a receiving cavity for the second part 22, see Fig 11. The receiving cavity will determine the space in which the second part may be rotated. Furthermore, the relative rotation of the second part 22 and the first part 21 is controlled by a pin 71 protruding from the second abutment surface 62 into a curved groove 72 through the first abutment surface 61. The ends of the groove 72 determine the open stable position and the closed stable position, respectively.

In the second embodiment disclosed, the blocking member 68 is attached to the flange 70 of the first part 21. It is to be noted that the blocking member 68 of the second embodiment also could be attached at another position of the first part 21 or to the second part 22.

Also the connector 4 of the second embodiment comprises at least one small passage 41 through the cover element 35, see Fig 12, permitting, in the closed stable position, an introduction of a sterilizing gas to an interior of the connector 4 in such a way that the sterilizing gas will contact the inner wall surfaces defining the channel 73. The small passage 41 enables sterilization of the connector 4 before use, i.e. before the blocking state of the blocking member 68 has been changed. Also in the second embodiment, the connector 4 could be sterilized together with the container 3 containing the medical fluid and the optional second connection portion 2a, for instance during an autoclaving process. The small passage 41 may extend through the cover element 35 as described in conjunction with the description of the first embodiment. Consequently, the inner wall surface of the first connection pipe

11 and a part of the second abutment surface 62 will thus be subjected to the sterilizing gas.

The invention is not limited to the embodiments disclosed but may be varied and modified within the scope of the following claims.