Valved container for dispensing radioactive microparticles

Abstract

The present disclosure provides a valve that includes a valve body formed from polyphenylsulfone (PPSU) or polyether ether ketone (PEEK), and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU. The disclosure also provides a container that includes a receptacle configured to hold radioactive microparticles, and a valve. The receptacle includes a sealable inlet configured to accept a dose of the microparticles, and an outlet for the microparticles. The valve is in fluid communication with the outlet of the receptacle. The valve may be a 3-way valve and / or may have a valve body formed from PPSU or PEEK, and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU.

Description

VALVED CONTAINER FOR DISPENSING RADIOACTIVE MICROPARTICLESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of United States Provisional Patent Appln No. 63 / 568,262 filed March 21, 2024, which is hereby incorporated by reference.TECHNICAL FIELD

[0002] The present application relates to valves suitable for autoclave and gamma sterilization.BACKGROUND

[0003] The following paragraphs are not an admission that anything discussed in them is prior art or part of the knowledge of persons skilled in the art.

[0004] Medical devices, and in particular devices that enter an already aseptic part of the body, are sterilized to remove, kill, or deactivate microorganisms and other biological agents in order to reduce or eliminate the possibility that a patient will be infected by a microorganism or biological agent. Medical devices are typically sterilized using steam sterilization. Ethylene oxide gas, vaporized hydrogen peroxide, peracetic acid immersion, and ozone are alternative chemical methods used to sterilize medical devices. Sterilization using electromagnetic radiation (such as ultraviolet light, X-rays and gamma rays), or irradiation by subatomic particles (such as by electron beams) are still other methods used to sterilize medical devices.INTRODUCTION

[0005] The following introduction is intended to introduce the reader to this specification but not to define any invention. One or more inventions may reside in a combination or sub-combination of the apparatus elements or method steps described below or in other parts of this document. The inventors do not waive or disclaim their rights to any invention or inventions disclosed in this specification merely by not describing such other invention or inventions in the claims.

[0006] Gamma radiation is very penetrating, and is commonly used for sterilization of disposable medical equipment. Sterilization by irradiation with gamma rays may affect material properties.

[0007] Steam sterilization, also known as moist heat sterilization, uses heated saturated steam under pressure to inactivate or kill microorganisms via denaturation of macromolecules, primarily proteins. Typical steam sterilization cycles are between 3 and 30 minutes at 121-134 °C (250-273 °F) at 100 kPa (15 psi).

[0008] Valves and / or containers that are capable of being exposed to steam sterilization and gamma ray sterilization without deforming may be desired.

[0009] In one aspect, the present disclosure provides a valve. The valve includes a valve body formed from polyphenylsulfone (PPSU) or polyether ether ketone (PEEK), and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU. The valve may be a 3-way valve.

[0010] In another aspect, the present disclosure provides a container that includes a receptacle configured to hold radioactive microparticles. The receptacle includes: a sealable inlet configured to accept a dose of the microparticles, and an outlet for the microparticles. The container also includes a valve in fluid communication with the outlet of the receptacle. The valve may include a valve body formed from PPSU or PEEK, and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU, and / or the valve may be a 3-way valve.

[0011] The container may also include a fluid flow path having a fluid inlet and a fluid outlet, where the valve is downstream of the fluid inlet and upstream of the fluid outlet. The fluid inlet of the container may be fluidly connectable to a linking fluid outlet of a microparticle delivery device, and the fluid outlet of the container may be fluidly connectable to a linking fluid inlet of the delivery device. In such a manner, the container fluid flow path fluidly links the fluid outlet of the microparticle delivery device to the fluid inlet of the microparticle delivery device.

[0012] The delivery device may include an intake fluid inlet fluidly connectable to a source of injectable medium; a delivery fluid outlet; a fluid mixer fluidly coupling the intake fluid inlet to the delivery fluid outlet; a displacement-medium flow path that fluidly couples the intake fluid inlet to the fluid mixer via the linking fluid outlet, thefluid flow path of the container, and the linking fluid inlet; and a transport-medium flow path distinct from the displacement-medium flow path. The displacementmedium flow path includes a receptacle for holding the microparticles. The transportmedium flow path fluidly couples the delivery fluid inlet to the fluid mixer.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0013] To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the figure number in which that element is first introduced.

[0014] FIG. 1 illustrates an exemplary valve according to the present disclosure.

[0015] FIG. 2A illustrates an exemplary container according to the present disclosure.

[0016] FIG. 2B illustrates an aspect of the subject matter in accordance with one embodiment.

[0017] FIG. 3 illustrates a cutaway side view of the container illustrated in FIG. 2 A, and illustrates additional components.

[0018] FIG. 4 illustrates a cutaway side view of the container illustrated in FIG. 2 A in combination with an exemplary delivery device.DETAILED DESCRIPTION

[0019] In one aspect, the present disclosure provides a valve. The valve includes a valve body formed from polyphenylsulfone (PPSU) or polyether ether ketone (PEEK), and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU. In some examples, one of the valve body and the diverter may be formed from PPSU and the other may be formed from PEEK. In particular examples, the diverter may be formed from PEEK. In other particular examples, the diverter may be formed from PPSU. In other examples, both the valve body and the diverter may be formed from PEEK. The valve may lack lubrication between the valve and the diverter. The valve may include silicone O-rings on the diverter.

[0020] The valve may be a 3-way valve, such as a T-pattern valve. In a T-pattern valve, the diverter defines a T-shaped fluid passageway and the valve body definesfluid passageways with three ports that are fluidly connectable to the T-shaped fluid passageway.

[0021] In another aspect, the present disclosure provides a container that includes a receptacle configured to hold radioactive microparticles. The receptacle includes: a sealable inlet configured to accept a dose of the microparticles, and an outlet for the microparticles. The container also includes a valve in fluid communication with the outlet of the receptacle. The valve may include a valve body formed from PPSU or PEEK, and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU, and / or the valve may be a 3-way valve, such as a T- pattem valve. In some examples, one of the valve body and the diverter may be formed from PPSU and the other may be formed from PEEK. In particular examples, the diverter may be formed from PEEK. In other particular examples, the diverter may be formed from PPSU. In other examples, both the valve body and the diverter may be formed from PEEK.

[0022] The 3 -way valve, for example the T-pattern valve, may include a valve body formed from PPSU or PEEK, and a diverter formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU. As noted above, one of the valve body and the diverter may be formed from PPSU and the other may be formed from PEEK. In particular examples, the diverter may be formed from PEEK. In other particular examples, the diverter may be formed from PPSU. Alternatively, both the valve body and the diverter may be formed from PEEK.

[0023] The receptacle and the valve body may be of unitary construction. In the context of the present disclosure, “unitary” construction should be understood to refer to two or more components of the device being part of a single, undivided unit, such as being made as a single piece during manufacturing.

[0024] The receptacle may further include a conical portion to funnel the microparticles towards the outlet when the container is in a delivery orientation.

[0025] The container may also include a fluid flow path having a fluid inlet and a fluid outlet, where the valve is downstream of the fluid inlet and upstream of the fluid outlet. The fluid inlet of the container may be fluidly connectable to a linking fluid outlet of a microparticle delivery device, and the fluid outlet of the container may befluidly connectable to a linking fluid inlet of the delivery device. In such a manner, the container fluid flow path fluidly links the fluid outlet of the microparticle delivery device to the fluid inlet of the microparticle delivery device.

[0026] The delivery device may include one or more intake fluid inlets fluidly connectable to one or more sources of injectable medium; a delivery fluid outlet; a fluid mixer fluidly coupling the one or more intake fluid inlets to the delivery fluid outlet; a displacement-medium flow path that fluidly couples one of the one or more intake fluid inlets to the fluid mixer via the linking fluid outlet, the fluid flow path of the container, and the linking fluid inlet; and a transport-medium flow path distinct from the displacement-medium flow path. The displacement-medium flow path includes a receptacle for holding the microparticles. The transport-medium flow path fluidly couples one of the one or more intake fluid inlets to the fluid mixer. The device may include a single intake fluid inlet and a fluid splitter to divide the injectable medium between the displacement-medium flow path and the transportmedium flow path.

[0027] The 3 -way valve may lack lubrication between the valve and the diverter. The 3 -way valve may include silicone O-rings on the diverter.

[0028] The receptacle may be formed from an autoclavable material, preferably PPSU or PEEK.

[0029] The receptacle may hold radioactive microparticles. When the receptacle holds radioactive microparticles, the container may be housed within a beta shield.

[0030] FIG. 1 illustrates an exemplary valve according to the present disclosure. Valve 100 includes a valve body 102 and a diverter 104. The valve body 102 is formed from PPSU or PEEK. The diverter 104 is formed from PPSU or PEEK. The valve body 102 and the diverter 104 are not both PPSU. The valve 100 is a T-pattern valve with ports 106a, 106b, and 106c. One arm of the fluid passageway 108 is visible in the diverter. The diverter is illustrated with silicone O-rings 110.

[0031] FIG. 2A illustrates a cutaway side view of an exemplary container according to the present disclosure. The container 200 includes a receptacle 202 configured to hold radioactive microparticles (not shown). The receptacle 202 includes a sealable inlet 204 through with the microparticles may be added. The receptacle 202 alsoincludes a receptacle outlet 206 for the microparticles, and a conical portion 208. The receptacle outlet 206 is in fluid communication with the exemplary valve 100 illustrated in FIG. 1 via port 106b. The valve 100 is illustrated in a closed position where the receptacle 202 is not in fluid communication with the fluid passageway 108 in the 3-way valve.

[0032] FIG. 2B illustrates another cutaway side view of the container of FIG. 2A, more clearly showing valve body 102, diverter 104, and O-rings 110.

[0033] FIG. 3 illustrates a cutaway side view of the container 200 of FIG. 2A in combination with a beta shield 302 and fluidly connected to a delivery device (not shown). The sealable inlet 204 of the container 200 is illustrated as being sealed by a septum 304. The container 200 includes fluid inlet 306 and fluid outlet 308, which lead to ports 106a and 106c, respectively. Fluid inlet 306 is fluidly connected to linking fluid outlet 310 of the delivery device, and fluid outlet 308 is fluidly connected to linking fluid inlet 312 of the delivery device. FIG. 3 shows arrows illustrating the flow path of an injectable medium travelling from the delivery device, through linking fluid outlet 310, into fluid inlet 306, through port 106a and diverter 104. As illustrated, diverter 104 is positioned to close off port 106b and divert the injectable medium through port 106c and out fluid outlet 308. The injectable medium travels through linking fluid inlet 312 and into the delivery device. It should be understood that diverter 104 could alternatively be positioned to divert the injectable medium through port 106b and into the receptacle 202. It should also be understood that diverter 104 could be positioned to allow microparticles (not shown) housed in the receptacle 202 to fall through the diverter 104 and into the delivery device.

[0034] FIG. 4 illustrates container 200 of FIG. 2A in combination with beta shield 302 and fluidly connected to delivery device 402 via fluid inlet 306 and fluid outlet 308. The delivery device 402 includes the linking fluid outlet 310 and linking fluid inlet 312 illustrated in FIG. 3. The delivery device 402 also includes one or more intake fluid inlets (not shown), a delivery fluid outlet 404, and a fluid mixer 406. A displacement-medium flow path 408 includes a receptacle 410 for holding the microparticles. The displacement-medium flow path 408 fluidly couples one of the one or more intake fluid inlets with the fluid mixer 406 via the container 200 and thereceptacle 410. A transport-medium flow path 412 fluidly couples one of the one or more intake fluid inlets with the fluid mixer 406.

[0035] Examples

[0036] Valves were made from various combinations of materials, as outlined in Table 1, having properties that were expected to render them capable of being exposed to steam sterilization and gamma ray sterilization without deforming.

[0037] Polycarbonate (PC) has a typical coefficient of thermal linear thermal expansion (CoE) 23-55 °C of 3.8x10'5in. / in. / °F and a heat deflection temperature (HDT) at 1.8 MPa / 264 psi of 133 °C. Poly vinylidene fluoride (PVDF), has a typical coefficient of thermal linear thermal expansion 23-55 °C of 6.6xl0'5in. / in. / °F and a heat deflection temperature at 1.8 MPa / 264 psi of 110 °C. Cyclic olefin polymers (COP) has a typical coefficient of thermal linear thermal expansion 23-55 °C of 3.8x10'5in. / in. / °F and a typical heat deflection temperature at 1.8 MPa / 264 psi of 112 °C. Polysulfone (PSU) has a typical coefficient of thermal linear thermal expansion 23-55 °C of 3.1xl0'5in. / in. / °F and a heat deflection temperature at 1.8 MPa / 264 psi of 174 °C. Poly etherimide has a typical coefficient of thermal linear thermal expansion 23-55 °C of 3.1xl0'5in. / in. / °F and a heat deflection temperature at 1.8 MPa / 264 psi of 201 °C. Polyphenylsulfone (PPSU) has a typical coefficient of thermal linear thermal expansion 23-55 °C of 2.7xl0'5in. / in. / °F and a heat deflection temperature at 1.8 MPa / 264 psi of 207 °C. Polyether ether ketone (PEEK) has a typical coefficient of thermal linear thermal expansion 23-55 °C of 2.6xl0'5in. / in. / °F and a heat deflection temperature at 1.8 MPa / 264 psi of 250 °C.

[0038] Copolyester elastomer (COPE), high temperature nylon, Polymethylmethacrylate (PMMA) and polyoxymethylene (POM), while commonly used in valve applications, were not considered due to their low resistance to autoclave conditions and / or gamma irradiation.

[0039] The valves were exposed to autoclave sterilization and gamma sterilization. Subsequently the material combinations were assessed for leak resistance vial pressure testing as well as movement / torque testing to assess the viability of the combination to function as a rotational valve. The authors of the present disclosure surprisingly found that only the combination of (a) PPSU or PEEK as the valve body,and (b) PPSU or PEEK as the diverter, wherein the valve body and the diverter are not both PPSU, provided an acceptable valve. This was surprising as there were several material combinations which, based on their thermally resistant material properties (i.e. high HDT) outlined above, were expected to be suitable. Additionally, several combinations of materials were expected to be suitable when considering the coefficient of thermal expansion as the diverter material should be selected to expand at an equal or lower rate than the housing material to reduce the possibility of failure. However, as outlined in Table 1, all other material combinations when subjected to testing post-gamma sterilization and autoclave sterilization proved to be unsuitable candidates. The likely suitability of the PEEK and PPSU combination derives from the similar CoE of the PEEK coupled with the high strength of the PPSU at high temperatures. This reduces the likelihood that the two materials would separate in the event of plastic deformation of the PPSU.

[0040] Table 1

[0041] In the preceding description, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the examples. However, it will be apparent to one skilled in the art that these specific details are not required. Accordingly, what has been described is merely illustrative of the application of the described examples and numerous modifications and variations are possible in light of the above teachings.

[0042] Since the above description provides examples, it will be appreciated that modifications and variations can be effected to the particular examples by those ofskill in the art. Accordingly, the scope of the claims should not be limited by the particular examples set forth herein, but should be construed in a manner consistent with the specification as a whole.

Claims

CLAIMSWhat is claimed is:

1. A container comprising: a receptacle configured to hold radioactive microparticles, the receptacle comprising: a sealable inlet configured to accept a dose of the microparticles, and an outlet for the microparticles, a valve comprising a valve body and a diverter, the valve in fluid communication with the outlet of the receptacle, wherein: the valve is a 3-way valve, and / or the valve body is formed from polyphenylsulfone (PPSU) or polyether ether ketone (PEEK) and the diverter is formed from PPSU or PEEK, wherein the valve body and the diverter are not both PPSU.

2. The container of claim 1 wherein one of the valve body and the diverter is formed from PPSU and the other is formed from PEEK.

3. The container of claim 1 wherein both the valve body and the diverter are formed from PEEK.

4. The container of claim 1 or 2, wherein the diverter is formed from PEEK.

5. The container or claim 1 or 2, wherein the diverter is formed from PPSU.

6. The container of any one of claims 1 to 5, wherein the valve is a T-pattern valve.

7. The container of any one of claims 1 to 6, further comprising a fluid flow path comprising a fluid inlet and a fluid outlet, wherein the valve is downstream of the fluid inlet and of the linking fluid outlet.

8. The container of claim 7, wherein the fluid inlet is fluidly connectable to a linking fluid outlet of a microparticle delivery device, andthe fluid outlet is fluidly connectable to a linking fluid inlet of the delivery device.

9. The container of claim 8, wherein the delivery device further comprises an intake fluid inlet fluidly connectable to a source of injectable medium; a delivery fluid outlet; a fluid mixer fluidly coupling the intake fluid inlet to the delivery fluid outlet; a displacement-medium flow path that fluidly couples the intake fluid inlet to the fluid mixer via the linking fluid outlet, the fluid flow path of the container, and the linking fluid outlet, wherein the displacement-medium flow path comprises a receptacle for holding the microparticles; and a transport-medium flow path distinct from the displacement-medium flow path, wherein the transport-medium flow path fluidly couples the intake fluid inlet to the fluid mixer.

10. The container of any one of claims 1 to 9, wherein the receptacle and the valve body are of unitary construction.

11. The container of any one of claims 1 to 10, wherein the receptacle further comprises a conical portion to funnel the microparticles towards the outlet when the container is in a delivery orientation.

12. The container of any one of claims 1 to 11, wherein the valve lacks lubrication between the valve body and the diverter.

13. The container of any one of claims 1 to 12, wherein the valve comprises silicone O-rings on the diverter.

14. The container of any one of claims 1 to 13, wherein the receptacle is formed from an autoclavable material, preferably PPSU or PEEK.

15. The container of any one of claims 1 to 14, wherein the receptacle holds radioactive microparticles, and the container is housed within a beta shield.

16. A valve comprising: a valve body formed from polyphenylsulfone (PPSU) or poly ether ether ketone (PEEK), and a diverter formed from PPSU or PEEK. wherein the valve body and the diverter are not both PPSU.

17. The valve of claim 16 wherein one of the valve body and the diverter is formed from PPSU and the other is formed from PEEK.

18. The valve of claim 16 wherein both the valve body and the diverter are formed from PEEK.

19. The valve of claim 16 or 17, wherein the diverter is formed from PEEK.

20. The valve of claim 16 or 17, wherein the diverter is formed from PPSU.

21. The valve of any one of claims 16 to 20, wherein the valve lacks lubrication between the valve and the diverter.

22. The valve of any one of claims 16 to 21, wherein the valve comprises silicone O-rings on the diverter.

23. The valve of any one of claims 16 to 22, wherein the valve is a 3-way valve.

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