AU2021221549A1

AU2021221549A1 - A medical packaging

Info

Publication number: AU2021221549A1
Application number: AU2021221549A
Authority: AU
Inventors: Jay Dimitri; Mark Dimitri
Original assignee: Garrde Pty Ltd
Current assignee: Garrde Pty Ltd
Priority date: 2020-10-27
Filing date: 2021-08-24
Publication date: 2022-05-12

Abstract

A MEDICAL PACKAGING ABSTRACT A single-use only sterile package 11 with frangible connections 25, used to enclose a single use medical device 40. By activating the frangible connection 25 and removing a small section of the package being a first end portion 21, the enclosed device can be exposed for its function without any direct touching of the device, and the device is held and used through the remainder of the packaging of the second portion 22 which remains around the device 40 at all times, without any direct touching of the device by the user. As the device is not touched directly by the user, this minimizes contamination of the device, therefore minimizing the transmission of microorganisms to the patient in the healthcare setting, and to the individual in the external location, in a fast, simple, reliable and straight-forward manner. 1/7 11 41 22 .' 42 40 25 FIGURE 1

Description

1/7

11

41

22 .'

42

40 25

FIGURE 1

A MEDICAL PACKAGING

[001]Field of the Invention

[002]The present invention relates to medical packaging and in particular to medical packaging that holds a sterile single-use medical device.

[003]The invention has been developed primarily for use in/with a medical packaging that holds a sterile single-use medical device and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use.

[004]Background of the Invention

[005]Healthcare associated infections are one of the most common, significant and preventable patient safety issues in the world today. Currently each year in Australia alone, over 180,000 patients suffer from healthcare associated infections caused by the transmission of microorganisms. This prolongs patient hospital stays and consumes in excess of 2 million hospital bed days per year.

[006]Healthcare associated infections lead to increased use of antimicrobial drugs, primarily antibiotics. Microorganisms continue to adapt to the antimicrobial medications used in the healthcare environment, accelerating the development of antimicrobial resistance, resulting in non-treatable microorganisms that can present devastating risks to patients.

[007]10% of healthcare associated infections are caused by the airborne transmission of microorganisms. In addition to contact and droplet transmission, even COVID-19 has also shown indoor airborne transmission. Currently there are no techniques available to deal with the contamination of single-use medical devices by airborne transmission. Even devices prepared using full surgical aseptic method are susceptible to airborne spread of microorganisms.

[008]90% of healthcare associated infections are caused by contact transmission. There are approximately 3 million bacteria per square centimetre of skin, and there is no evidence showing hospital gloves reduce the incidence of cross-infection. Contrary to popular belief, gloves are worn to protect the user, not the patient, from hazardous substances such as bodily fluids.

[009]Bacteria are always present on the skin of the hands and classed as either transient or resident bacteria. Transient organisms are not usually present on the hand. These organisms are acquired by contact with infectious patients or contaminated surfaces. Hence, healthcare settings are considered high-risk sites for cross-infection. Resident bacteria are deeply ingrained into the skin of the hand and cannot even be completely removed by thorough handwashing. The two main types are Staphylococcus Aureus and Staphylococcus Epidermidis, both of these can cause serious and potentially fatal infections.

[0010] To combat increasing rates of healthcare associated infections, aseptic non touch technique is evidence-based recommended procedure. The main principles of aseptic non-touch technique are:

1) Wash hands thoroughly

2) Never contaminate key parts of the single-use medical device

3) Only expose key parts of the single-use medical device for the shortest possible time

4) Touch non-key parts of the device with confidence

where key part means the part of a device which comes into direct contact with the patient's skin, or an injection port and therefore must remain sterile.

[0011] The success and effectiveness of aseptic non-touch technique currently depends on a number of significant variables, including adherence to handwashing and aseptic non-touch technique procedures, the competency and discipline of healthcare practitioners and the availability of resources and infrastructure.

[0012] Even despite current measures to achieve aseptic non-touch technique, healthcare associated infections continue to rise in incidence and prevalence around the world.

[0013] Many countries have not even been able to adopt aseptic non-touch technique in healthcare settings due to numerous factors including deficient infrastructure, deficient training, compliance systems and sanitation, patient overcrowding and healthcare understaffing, as well as general attitudes of non-compliance by healthcare providers towards basic infection control procedures.

[0014] Note, long and complex procedures do exist which can be implemented to maintain the sterility of a single-use medical device once the device is removed from its sterile packaging. These procedures involve opening and maintaining a sterile field, collectively referred to as the surgical aseptic method. This method is resource and time intensive and complex and are not considered appropriate for everyday procedures. They are appropriate for surgical operations and complex invasive procedures. Mastering surgical aseptic method requires years of professional training and experience. The method is resource heavy, requires pre-planning and preparation, can be highly wasteful and carries a high risk of failure.

[0015] It can be seen that known prior art methods and apparatuses of medical packaging that hold a sterile single-use medical device has the problems of:

a) A single-use medical device being unpackaged and the package being discarded to allow the device to be used and therefore the single-use medical device is directly touched, placed directly on surfaces, and exposed to contact, droplet and airborne microorganisms that can void the sterile nature of the single-use medical device.

b) Not allowing versatility in use of single-use medical devices while retaining a sterile environment.

c) Requiring training, experience and secondary procedures to retain location and single-use medical devices in sterile conditions according to multiple protocols.

d) Losing advantage of sterile single-use medical packaging.

e) Lack of ease of use of single-use medical equipment in a sterile manner.

f) No protection of a single-use medical device from airborne transmission of microorganisms as the device is completely exposed in order to be used.

g) Need to minimize the contact, droplet and airborne transmission of microorganisms to patients during the use of single-use medical devices in healthcare settings.

h) If hand-washing is not available, a single-use medical device fully exposed is easily contaminated posing substantial risk of cross-infection.

i) No protection of a single-use medical device from contamination during use if there are visible solid or liquid contaminants.

j) Obligatory loss of sterility when a single-use medical device is used in the absence of a surgical aseptic method.

[0016] It can be seen that a localized sterile environment is needed when use of single use sterile equipment is not in a controllable environment. This can be in private residence or in the field or in external locations where resources are not available. It is therefore important that a system is needed for other than the perfect location such as a hospital.

[0017] The present invention seeks to provide medical packaging that holds a sterile single-use medical device which will overcome or substantially ameliorate at least one or more of the deficiencies of the prior art, or to at least provide an alternative.

[0018] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

[0019] Summary of the Invention

[0020] According to a first aspect of the present invention, there is provided a medical packaging that holds a sterile single-use medical device in a medical packaging that has at least two parts with at least one frangible connection therebetween.

[0021] The medical packaging can hold a sterile single-use medical device. It includes a body forming an enclosing volume with at least one first end portion and at least one second portion that can be an end portion or central portion and together is able to hold the single-use medical device therein in a sterile condition, with the at least one first end portion sized and shaped for substantially covering an operative part of the single-use medical device, and the at least one second portion sized and shaped for substantially covering a controlling part of the single-use medical device.

[0022] There can be at least one openable element on at least part of the at least one first end portion wherein the openable element on at least part of the at least one first end portion is able to be substantially displaced into an open state at time of use to allow operative part of the single-use medical device to be used while the controlling part remains substantially within the second portion.

[0023] It can be seen that the invention of medical packaging provides the benefit of achieving a single-use only sterile sealed packaging, used to enclose a single-use medical device, enabling the user to hold and use the enclosed device without directly touching it, and thereby minimizing contamination of the device from microorganisms via contact, droplet and airborne transmission. In particular the controlling part of the single use medical device can be held due to the flexibility and texture of the at least one second portion allowing the user to have full control of the single-use medical device without touching the device to fully remove it from the packaging. This would then usually result in placing the device on a surface. However, in this non-sterile location such placement increases risk of contamination. By this novel packaging the operative part of the device has been released and is maintained in a sterile localized area for application to the patient and the device is not touched by the user but fully controllable by being held by the user while still substantially within the sterile packaging.

[0024] Therefore, the system is fully transportable for a location other than the perfect location of a hospital.

[0025] According to a second aspect of the present invention, there is provided a medical packaging that holds a sterile single-use medical device wherein the medical packaging has at least one first end portion which corresponds in shape to an operative part of the single-use medical device.

[0026] According to a further aspect of the present invention, the medical packaging can hold a sterile single-use medical device and the medical packaging has at least one second portion which corresponds in shape to a controlling part of the single-use medical device.

[0027] It can be seen that the invention of medical packaging provides the benefit of allowing the single-use medical device to be used while remaining substantially within the sterile packaging. However, as the device has movable parts it is important that one or other or both of the first end portions and second portions have movable or shaped parts which allow the movement of the operative parts or controlling parts or both of the single use medical device while remaining substantially within the sterile medical packaging. However again by this novel packaging the operative part of the device has not been released until just before use and thereby is maintained in a sterile localized area for application to the patient and the single-use medical device is not touched by the user but fully controllable by being held by the user while still substantially within the sterile packaging.

[0028] According to a third aspect of the present invention, there is provided a medical packaging that holds a sterile single-use medical device and has at least one part which transforms in a corresponding manner to the change of shape of an operative part of the single-use medical device. With such medical packaging able to transform to accommodate the single-use medical device which operatively changes dimensions in its use then the single-use medical device can still stay substantially within the packaging and be fully operative. By this novel packaging the operative part of the device has been released and is maintained in a sterile localized area for application to the patient and the device is not touched by the user but fully controllable by being held by the user while still substantially within the sterile packaging.

[0029] The invention allows for packaging and use of shaped movable single-use medical devices. The packaging allows for holding in a sterile condition and usage of single-use medical devices that require operative parts to move relative to each other to form an operative end or require controlling parts to move relative to each other to form a controlling end or a combination thereof. The shaped movable packaging can hold such single-use medical device and allow them to be operatively moved while still substantially in the packaging.

[0030] The invention can further provide for packaging and operative use in sterile conditions of change of shape or other transformations of single-use medical devices while still remaining substantially in the packaging by use of an intermediate second portion which can be an expandable concertina portion that allows for retaining a sterile outer protection over a range of lengths of the single-use medical device such as in the form of a syringe.

[0031] The invention also provides for packaging and operative use in sterile conditions of multi ended operative single-use medical devices that have a packaging with a plurality of first end portions connected to a second portion that extends and connects therebetween and forms a second central portion. In this way there is selective use of one or more operative parts while still being held by the controlling part that remains in the central second portion and thereby ensures contactless use.

[0032] In one form the invention provides a medical packaging including single-use only sterile sealed package with openable elements, used to enclose a single-use medical device. By activating an openable element and removing a small section of the package, the enclosed device can be exposed for its function without any direct touching of the device, and the device is held and used through the remainder of the packaging which remains around the device at all times, without any direct touching of the device by the user.

[0033] In another form the invention provides a medical packaging that holds a sterile single-use medical device comprising a body forming an enclosing volume with at least one first end portion and at least one second portion able to hold the single-use medical device therein in a sterile condition wherein the at least one first end portion is sized and shaped for substantially covering an operative part of the single-use medical device. The at least one second portion is sized and shaped for substantially covering a controlling part of the single-use medical device; and at least one openable element on at least part of the at least one first end portion wherein the openable element on at least part of the at least one first end portion is able to be displaced into an open state at time of use to allow the at least one operative part of the single-use medical device to be usable and controlled by the at least one controlling part while the at least one controlling part remains substantially within the at least one second portion.

[0034] As the device is not touched directly by the user, this minimizes contamination of the device, therefore minimizing the transmission of microorganisms to the patient in the healthcare setting, and to the individual in the external location, in a fast, simple, reliable and straight-forward manner; wherein the medical packaging can provide improvements including any one or more of the following:

i. improvements in structure and packaging of single-use medical devices in a sterile manner;

ii. Improvements in minimising the transmission of microorganisms to patients during the use of single-use medical devices in healthcare settings;

iii. Improvements in using of single-use medical devices in a sterile manner;

iv. Reducing need for secondary protocols due to eliminating of voiding actions which break sterile conditions;

v. Ability to retain a localized sterile location;

vi. Ability to use the single-use medical device while substantially within the sterile packaging; vii. Ability to use the sterile single-use medical device without directly touching it to remove it from the packaging; viii. Ability to use the sterile single-use medical device such as a syringe without placing it on a non-sterile surface in order to be usable in other than the perfect location of a hospital while maintaining sterile effectiveness; ix. Ability to use the single-use medical device without directly touching it or exposing it to contact transmission of microorganisms; x. Ability to use the single-use medical device in a sterile fashion without requiring substantial training or experience; xi. Retains advantage of sterile single-use medical packaging; xii. Protection of substantial portion of the single-use medical device from droplet and airborne transmission of microorganisms during use; xiii. Protection of substantial portion of the single-use medical device from contamination by visible solid or liquid contaminants during use; xiv. Ability to use the single-use medical device in the absence of surgical aseptic method without loss of sterility.

[0035] It can be seen that the present invention of medical packaging provides the benefit of a physical barrier substantially covering a sterile single-use medical device during its use, protecting against contact, droplet and airborne transmission of microorganisms.

[0036] It can be seen that the present invention of medical packaging that holds a sterile single-use medical device does not intend to replace the surgical aseptic method, but provides the benefit of an easier and more effective way to achieve the aseptic non touch technique principles, minimising contamination of the device by microorganisms in every day procedures and raising the standard of cleanliness achievable in those procedures.

[0037] It can be seen that the invention of medical packaging that holds a sterile single use medical device provides the benefit of easier working conditions for users and safer treatment conditions for patients that need sterile single-use medical devices.

[0038] Other aspects of the invention are also disclosed.

[0039] Brief Description of the Drawings

[0040] Notwithstanding any other forms which can fall within the scope of the present invention, preferred embodiments of various different forms of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Fig. 1 is a diagrammatic view of a medical packaging that holds a sterile single-use medical device in accordance with a general preferred embodiment of the present invention having a first end portion and a second end portion intermediate with a frangible connection therebetween; Fig. 2 is a medical packaging that holds a sterile single-use medical device in accordance with another preferred embodiment of the present invention having a shaped fixed package; Fig. 3 is a medical packaging that holds a sterile single-use medical device in accordance with another preferred embodiment of the present invention having two first end portions and an intermediate central second portion therebetween; Figs. 4 and 5 are a medical packaging that holds a sterile single-use medical device in accordance with another preferred embodiment of the present invention having a shaped movable package; Fig. 6 is a medical packaging that holds a sterile single-use medical device in accordance with another preferred embodiment of the present invention having a transformable shaped package; and Fig. 7 is an illustrative embodiment of a method of providing a usable sterile single-use medical device in a continuing sterile manner in accordance with an embodiment of the invention.

[0041] Description of Preferred Embodiments

[0042] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0043] Referring to the drawings there is shown a medical packaging 11, 12, 13, 14, 15, 16 that holds a sterile single-use medical device 40, 50, 60, 70 such as scissors, ring forceps, thumb forceps, scalpel, suture blades, cotton buds, medication cups, syringe, clamps, hypodermic needles, and cannulas. Other single use medical devices could have packaging in accordance with other embodiments of the present invention.

[0044] As shown conceptually in Fig. 1 and in embodiments in Figs 2 to 6, the invention provides a single-use only sterile package 11 with frangible connections 25, used to enclose a single-use medical device 40. By activating the frangible connection 25 and removing a small section of the package being a first end portion 21, the enclosed device can be exposed for its function without any direct touching of the device, and the device is held and used through the remainder of the packaging of the second portion 22 which remains around the device 40 at all times, without any direct touching of the device by the user. As the device is not touched directly by the user, this minimizes contamination of the device, therefore minimizing the transmission of microorganisms to the patient in the healthcare setting, and to the individual in the external location, in a fast, simple, reliable and straight-forward manner.

[0045] Further the device 40 has an operative part 41 which is the part that is to come into contact with the patient and therefore needs to be revealed. However, the operative end of the single-use medical device 40 only needs to be revealed at the time, when it is actually to be used to contact the patient. The single use medical device 40 has a controlling portion 42 which can be at the other end of the single-use medical device and therefore be a second end portion 42 for the user to control the use of the operative part 41. However, this controlling portion can be at a central location and therefore be a controlling central portion 43.

[0046] The packaging allows the single-use medical device 40 to remain enclosed in the sterile packaging until just before use and therefore provides a sterile environment around the operative part 41 even at the time of use since the device has not needed to be taken out of the packaging but can be held while still substantially the operative part has a minimal time in open environment and generally its sterile environment lingers.

[0047] Therefore, the packaging provides the results by one or more of:

a) Holding of controlling part 42, 43 while still in packaging 11, 12, 13, 14, 15, 16

b) Ease of removal of second portion 22, 23

c) No need to remove single-use medical device from packaging and therefore touch single-use medical device or place it down on a surface to be ready for use d) Ability to only reveal operative part at the last moment e) Ability to control operation while still substantially in the packaging.

[0048] However, there are various forms of the invention shown in Figs 2 to 6, with novelty over each other including:

a) Shaped fixed packaging 11, 12, 13 such as in Figs 1, 2, 3 for holding a fixed shaped single-use fixed medical device 40 that can be operatively used while still substantially in the packaging

b) Shaped Movable packaging 14, 15 such as in Figs 4, 5 for holding a movable shaped single-use medical device 50, 60 that can be operatively moved while still substantially in the packaging

c) Transformable Shaped Packaging 16 such as in Fig 6 for holding a transformable shaped single-use medical device 70 that can be operatively moved while still substantially in the transformed packaging

d) Packaging for single ended operative parts, such as in Figs 1, 2, 4, 5 and 6, or multiple operative ends such as in Fig 3

e) Combinations of one or more of the above.

[0049] Shaped Fixed Packaging

[0050] Referring to Figs 1, 2, 3 there are shown various preferred forms of a single use only sterile sealed package 11, 12, 13, used to enclose a single-use medical device 40.

[0051] In particular in Fig. 1 there is a general conceptual one form of a medical packaging 22 showing the benefit of the lingering localized area of sterile location around the operative part 41 of the single-use medical device 40.

[0052] Referring to Fig 2 there is shown an example 12 in which a single-use medical device 40 of a scalpel which is sealed in a shaped package 26. The scalpel has an operative part 41 at one end, used for incisions, and a controlling part 42 at the other end, for holding and operating the operative part. The medical packaging 26 has at least one frangible connection 25 between the two parts 21, 22 and closer to the operative part, which is generally smaller than the controlling part, and is the only part contacting the patient. By activating the frangible connection 25 and removing a small first end portion 21 of the packaging 26, the operative part 41 of the enclosed device 40 can be exposed for its operative function without any direct touching of the device. Further the controlling part 42 of the device is held and used through the second portion 22 formed by the remainder of the packaging 26 and which remains around the device at all times, without any direct touching of the device by the user.

[0053] The packaging can be constructed to include a backing board to which is attached an enveloping clear plastic dome creating a sealed volume in which the single use medical device is held in a sterile form. It will be understood that changes in the size and shape of the package, and the size and placement of the frangible connections can be made based on the size and shape of the single-use medical device enclosed.

[0054] Referring to Fig. 3 this packaging can be a medical packaging that has two first end portions 41 covering one each of two operative parts 41 at each opposing end of the single-use medical device and an intermediate central second portion 23 therebetween covering the central controlling part 43.

[0055] The packaging 26 provides a choice of which of two first end portions 21 to detach at the respective frangible connection 25 from the central section portion 23 to selectively reveal one end of single-use medical device that has two selective operative parts 41. Alternatively, each end can be removed so as to reveal the two operative parts of the single-use medical device such as double ended cotton buds so that the device is held in the central portion with the surrounding packaging 23.

[0056] In this form activating the frangible connection 25 and removing a small first end portion 21 of the package at each end simultaneously or sequentially provides the operative parts of the enclosed device to be exposed for its operative function without any direct touching of the device. Further the controlling part of the device is held and used through the remainder controlling part portion 23 of the packaging which remains around the device at all times, without any direct touching of the device by the user.

[0057] In each version, each frangible connection until used, provides protection for the enclosed single-use medical device, equal to the remainder of the package; produces an opening of predetermined size and shape, and is not subject to tearing beyond the predetermined limits; and is sufficiently anchored to resist accidental, premature tearing during handling of the package.

[0058] When the invention is used, as the enclosed single-use medical device is not directly touched by the user at any time, the invention provides the benefit of an easier and more effective way to achieve the aseptic non- touch technique principles, minimizing contamination of the device by microorganisms in every day procedures via contact, droplet and airborne transmission. By using the invention, the aseptic non- touch technique principles can be upheld with reduced need for assistant staff, reduced risk of human error, reduced overall equipment resource burden and reduced waste burden when compared to existing methods.

[0059] Using the invention enables the aseptic non-touch technique principles to be achievable by individuals who are not trained or experienced. The invention allows aseptic non-touch technique principles to be upheld irrespective of the environment, raising the level of cleanliness achievable in locations external to hospital such as homecare settings.

[0060] The invention substantially changes the use of the sterile sealed single-use medical device package, as the package is no longer removed and discarded, but rather, remains around the enclosed single-use medical device at all times, acting as a physical barrier, preventing the contamination of the device by microorganisms from contact, droplet and airborne transmission.

[0061] Shaped Movable Packaging

[0062] The invention provides embodiments of shaped movable packaging 14, 15 such as in Figs 4 and 5 for holding a movable shaped single-use medical device 50, 60. In these embodiments the packaging allows for holding in a sterile condition and usage of single use medical devices that require operative parts to move relative to each other to form an operative end or require controlling parts to move relative to each other to form a controlling end or a combination thereof. The shaped movable packaging 14, 15 can hold such single use medical device 50, 60 and allow them to be operatively moved while still substantially in the packaging.

[0063] Referring to Fig 4 there is a medical packaging 14 that holds a sterile single-use medical device 50 of thumb forceps. The packaging has an enclosing body 27 forming an enclosing volume with a plurality of first end portions 21 at one end connecting to a second end portion 22 at opposing end and able to hold the single-use medical device 50 therein in a sterile condition.

[0064] The first end portion 21 in this case is sized and shaped for substantially following the shape and covering a plurality of operative parts 51 of the single-use medical device. The operative part 21 is formed of finger sections 51 covering each extension of the thumb forceps 50. The second end portion 22 is sized and shaped for substantially covering a controlling part 52 of the single-use medical device being the gripping elements further down the thumb forceps extensions closer to the connecting pivot end structure. The second end portion includes an enclosure covering the outer extremities of the controlling part. However the shaping of the detachable first end portions 21 around the fingers of the operative parts 51 and the joined controlling part 22 and the shaping and material allows for the packaging 27 to be movable to allow the plurality of operative parts 51 of thumb forceps extensions to be moved towards each other and operatively function due to their change in relative positions while the controlling part 52 remains in the second end portion 22.

[0065] There is an openable element 25 between the first end portions 21 and the second portion 22 wherein the openable element is able to be displaced into an open state at the time of use to allow the operative parts 51 of the single-use medical device 50 to be used while the second end 52 remains substantially within the second end portion 22.

[0066] Referring to Fig. 5 there is a medical packaging 15 that holds a sterile single use medical device of scissors 60. The packaging has an enclosing body 28 forming an enclosing volume with a single first end portion 21 and a plurality of second end portions 22 able to hold the single-use medical device therein in a sterile condition.

[0067] In this embodiment the single first end portion 21 is an outer body enclosure covering the plurality of operative ends 61 that move relative to each other so as to be functional. Due to the length of the operating part to a central pivot 64, a single first end portion 21 is used rather than the plurality of first end portions used for the packaging of the thumb forceps of Fig. 4. The controlling part of the scissors 60 are a plurality of controlling parts 62 that are moved relative to each other around the central pivot 64 to create the functional operation. The packaging 28 includes a plurality of second end portions 22 that can move relative to each other.

[0068] The single first end portion 21 extends to an opening frangible line 25 below the central pivot 64 of the scissors. The plurality of second end portions 22 in this case are sized and shaped for substantially following the shape and covering a controlling part 62 being the finger grips of the single-use medical device 60. Therefore, the second portions 22 are formed of shaped bifurcated finger holding sections covering each extension of the finger holding portions 62 of the scissors 60.

[0069] The shaping of the bifurcated finger sections of the second portions 22 and the joined first end portion 21 and the material of the packaging 28 allows for the packaging of the controlling parts 62 to be movable to allow the finger sections 62 of the scissors 60 to be moved towards each other and effect a similar action of the two cutting blades of the scissors forming the operative parts 61 on the other side of the pivot 64 while the controlling part remains in the second end portions 22.

[0070] There is an openable element 25 on at least part of the first end portion 21 wherein the openable element on at least part of the first end portion is able to be displaced into an open state at time of use to allow operative part 61 of the single-use medical device 60 to be used while the second end 62 remains substantially within the second end portion 22.

[0071] Transformable Shaped Packaging

[0072] Referring to Fig 6 there is shown a medical packaging 16 that holds a sterile single-use medical device in the form of a syringe 70 for dispensing of the contents of the syringe upon plunging the controlling part 72 of the plunger into the central cylindrical body 73 and expelling through the operative part 71.

[0073] The medical packaging 16 has four parts, being a first end portion 21, connecting to a central second portion 23 connecting to a transformable intermediate second portion 30 and to a second end portion 22. There is at least one frangible connection 25 between the first end portion 21 and the central second portion 23.

[0074] By activating the frangible connection 25 and removing the smaller first end portion 21 of the package 29, the operative part 71 of the enclosed device 70 can be exposed for its operative function, such as connecting to a cannula, without any direct touching of the device. Further the controlling part 72 of the device is held and used through the remainder of the packaging 29, formed by the central second portion 23, the transformable intermediate second portion 30 and the second end portion 22, which remains around the device at all times, without any direct touching of the device by the user.

[0075] It can be seen therefore that the single-use medical device of the syringe is a transformable shaped body as the plunger fits within the central cylindrical body 73 and therefore changes its length and shape. The packaging 16 is formed by an enclosing material that has a body 29 forming an enclosing volume with a first end portion 21 and a second end portion 22 and a transformable intermediate part 30 so as to be able to hold the single-use medical device therein in a sterile condition whether that device is in an extended or contracted form. In particular the syringe could come prepackaged with medicine or other contents included within the central cylindrical body.

[0076] The packaging can have at least one openable element 31 at an end allowing the syringe to be placed in a filled and ready to use condition but also with a second openable on at least part of the first end portion 21 so that the second openable element on the first end portion is able to be displaced into an open state at time of use to allow operative part of the single-use medical device to be used while the second end remains substantially within the second end portion 22.

[0077] The invention allows for the small end opening 31 in the first end portion for a sterile needle, in its sterile packaging, to be attached to the single-use sterile syringe while still enclosed in the package. As the attaching part of the needle is sterile, the sterility of the syringe is maintained. Once attached, the small end opening 31 can be closed around the needle, protecting the sterility of the enclosed syringe. This allows medicine or other contents to be drawn into the barrel while the syringe remains totally within the packaging in its sterile environment. As the syringe remains completely covered by the sterile package, it can be placed on a non-sterile surface for transport to the patient's location without compromising its sterility. When ready for administration, the second openable element on the first end portion 25 of the package is able to be displaced into an open state to allow the operative part of the syringe to be used in contact with the patient or the patient's intravenous port.

[0078] In this packaging 16, thefirstend portion 21 is sized and shaped for substantially covering an operative part of the single-use medical device, and the central second portion 23 connecting to a transformable intermediate second portion 30 and to a second end portion 22 sized and shaped for substantially covering a controlling part 72, 73 of the single use medical device. However, the intermediate second portion 30 can be an expandable concertina portion that allows for retaining a sterile outer protection over a range of lengths of the single-use medical device in the form of a syringe 70.

[0079] Packaging for single ended operative parts or multiple ended operative parts

[0080] As shown in Figs 1, 2, 4, 5 and 6 the single-use medical device 40, 50, 60, 70 has one end of the device with an operative end 41. That operative end could be fixed 40 with single operative part 41, 71 or be movable 50, 60, and work due to relative motion of plurality of operative parts 51, 61.

[0081] However as shown in Fig. 3 the single-use medical device 40 can include a plurality of operative parts 41 at each end of a central controlling part 43. This requires a packaging 26 with a plurality of first end portions 21 connected to a second portion that extends and connects therebetween and forms a second central portion 23. Such packaging allows for selective use of one or more ends of a single-use medical device. This can be so that one end can be used selectively after the other end such as in the case of a cotton bud, or it could be so that the single-use medical device has different sizes or different uses so that the user can select the appropriate end and use that end. An example can be a tongue depressor that has one end sized for a larger person or adult while the other end is sized for a smaller person or child.

[0082] Combination

[0083] It can be seen that the invention includes various forms of fixed, shaped, movable and transformable packaging parts together with a thickness flexibility and transparency of the packaging such that the single-use medical device can be used and fully controlled by the user by holding the controllable part of the device while still substantially within the second portion 21.

[0084] For example on the shaped movable packaging where either or both of the operative part and controlling part can be enclosing and movable relative to each other there can also be This can be in the form of a concertina gusset between finger joints of the packaging so as to provide a transformation of shape of the packaging and relative movement of either or both of the operative and controlling parts of the single-use medical device while remaining substantially within the second end portion which is held by the user.

[0085] Referring to Fig. 7 there is shown that the invention also provides a method of providing a usable sterile single-use medical device in a continuing sterile manner including the steps of:

a) Providing a sterile single-use medical device in a flexible packaging body forming an enclosing volume with at least one first end portion and at least one second portion able to hold the single-use medical device therein in a sterile condition wherein the at least one first end portion sized and shaped for substantially covering an operative part of the single-use medical device, and the at least one second portion sized and shaped for substantially covering a controlling part of the single use medical device

b) Providing at least one openable element on at least part of each of the at least one first end portion of the body

c) Holding the at least one second portion with the controlling part of the single-use medical device still within the at least one second portion

d) Opening the at least one openable element of the at least one first end portion of the packaging by removing breaking or opening at least part of the at least one first end portion to reveal the at least one operative part of the single-use medical device without directly touching the device and

e) Using the revealed operative part of the single-use medical device by manipulating a controlling part of the single-use medical device with the controlling part of the single-use medical device still within the at least one second portion.

[0086] The at least one part which corresponds in shape to an operative part of the single-use medical device.

[0087] The at least one part which transforms in a corresponding manner to change of shape of an operative part of the single-use medical device

[0088] It can be seen that the invention in various forms allows a single-use only sterile sealed package used to enclose a single-use medical device. An operative part of the enclosed device can be exposed for its function while the controlling part of the device is held and manipulated by the user through the remainder of the packaging which remains around the device at all times. Therefore, the device can be used without being directly touched by the user. This minimizes contamination of the device by microorganisms via contact, droplet and airborne transmission in a fast, simple, reliable and straight-forward manner.

[0089] Interpretation

Embodiments:

[0090] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but can. Furthermore, the particular features, structures or characteristics can be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0091] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[0092] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

Different Instances of Objects

[0093] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

Specific Details

[0094] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention can be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Terminology

[0095] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "forward", "rearward", "radially", "peripherally", "upwardly", "downwardly", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

Comprising and Including

[0096] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[0097] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

Scope of Invention

[0098] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications can be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that can be used. Functionality can be added or deleted from the block diagrams and operations can be interchanged among functional blocks. Steps can be added or deleted to methods described within the scope of the present invention.

[0099] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention can be embodied in many other forms.

[00100] Industrial Applicability

[00101] It is apparent from the above, that the arrangements described are applicable to the single-use medical packaging that holds a sterile single-use medical device industries.

Claims

Claims The claims defining the invention are as follows:

1. A medical packaging that holds a sterile single-use medical device comprising:

a body forming an enclosing volume with at least one first end portion and at least one second portion able to hold the single-use medical device therein in a sterile condition wherein:

i. the at least one first end portion is sized and shaped for substantially covering an operative part of the single-use medical device; ii. the at least one second portion is sized and shaped for substantially covering a controlling part of the single-use medical device; and iii. at least one openable element on at least part of the at least one first end portion wherein the at least one openable element on at least part of the at least one first end portion is able to be displaced into an open state at time of use to allow the at least one operative part of the single-use medical device to be usable and controlled by the at least one controlling part while the at least one controlling part remains substantially within the at least one second portion.

2. A medical packaging according to claim 1 wherein the body forming the enclosing volume has one first end portion and one second portion which forms a second end portion connecting to the first end portion wherein the packaging is able to enclose a single-use medical device having a single operative part and a single controlling part.

3. A medical packaging according to claim 1 wherein the body forming an enclosing volume has a plurality of first end portions wherein the packaging is able to enclose a single-use medical device having a plurality of operative parts.

4. A medical packaging according to claim 1 wherein the body forming an enclosing volume has a plurality of second portions formed by second end portions wherein the packaging is able to enclose a single-use medical device having a plurality of controlling parts.

5. A medical packaging according to claim 3 wherein the body forming an enclosing volume has a plurality of second portions formed by second end portions wherein the packaging is able to enclose a single-use medical device having a plurality of controlling parts.

6. A medical packaging according to claim 1 wherein the body forming an enclosing volume has a plurality of first end portions and one second portion which forms a central second portion connecting to each of the first end portions wherein the packaging is able to enclose a single-use medical device having an operative part at each end and a single central controlling part.

7. A medical packaging according to any one of the preceding claims wherein the body is substantially flexible to allow the user to hold and operate the enclosed sterile single-use medical device without touching the device still in a substantially enclosed position in the packaging body.

8. A medical packaging according to any one of the preceding claims wherein the at least one openable element on the at least one first end portion of the body is at least one frangible connection extending on at least part of the body between the at least one first end portion and the at least one second portion wherein the at least one first end portion is openable with the user holding the at least one second portion with the at least one controlling part of the single-use medical device therein.

9. A medical packaging according to any one of the preceding claims including a plurality of openable elements with one on at least part of the at least one first end portion of the body and another on at least part of the body between the at least one first end portion and the at least one second portion.

1.A medical packaging according to any one of the preceding claims wherein the at least one openable element on at least part of the at least one first end portion of the body is at least a frangible connection circumscribing the entire body between the at least one first end portion and the at least one second portion.

11.A medical packaging according to any one of the preceding claims wherein the openable element is a frangible connection of one or more of:

a. a tear line

b. a break line

c. a breaking ribbon

12.A medical packaging openable element wherein the packaging can hold a predefined one of a plurality of single-use medical devices.

13.A medical packaging according to claim 12 wherein the plurality of single-use medical devices includes a single-use medical device from the category of fixed single-use medical devices in which there is a fixed operative part and an opposing fixed controlling part and wherein the packaging provides a fixed shape volume enclosing the fixed single-use medical device.

14.A medical packaging according to claim 12 wherein the plurality of single-use medical devices includes a single-use medical device from the category of single use medical devices in which there is a plurality of movable operative parts and an opposing movable plurality of controlling parts and wherein the packaging provides at least one first end portion for enclosing the plurality of movable operative parts and at least one second portions for enclosing the plurality of movable controlling parts and the packaging is sized, shaped and formed of material to allow operative movable use of controlling parts and the operative parts of the single-use medical device while the controlling parts are substantially within the packaging.

15.A medical packaging according to claim 12 wherein the plurality of single-use medical devices includes a single-use medical device from the category of single use medical devices in which there are multiple operative ends that are separately usable and the packaging includes a plurality of first end portions connected to a second portion that extends and connects therebetween and forms a central second portion and an openable element between each first end portions and the central second portion allowing for selective use of one or more operative parts of the single-use medical device.

16.A medical packaging according to claim 12 wherein the plurality of single-use medical devices includes a single-use medical device from the category of fixed single-use medical devices in which there is an operative part and opposing controlling part and a changing shape therebetween and the packaging includes a first end portion and at least one second portion wherein at least part of one second portion is expandable or otherwise transformable that allows for retaining the single-use medical device in a sterile outer protection over a range of lengths or other transformations of the single-use medical device.

17.A medical packaging according to claim 12 wherein the plurality of single-use medical devices includes a single-use medical device selected from:

a. Scissors;

b. Ring Forceps;

c. Thumb Forceps;

d. Scalpels;

e. Suture Blades;

f. Medication cups;

g. Cotton buds;

h. Syringes;

i. Clamps;

j. Hypodermic needles; and

k. Cannulas.

18.A medical packaging according to any one of the preceding claims wherein the at least one second portion includes a shape corresponding to the shape of a controlling part of the single-use medical device.

19.A medical packaging according to any one of the preceding claims wherein the at least one first end portion includes a shape corresponding to the shape of an operative part of the single-use medical device.

20.A medical packaging according to claim 18 wherein the second portion is a plurality of jointed second end portions which include finger location shape to allow the user to use fingers on controlling parts of the single-use medical device while the at least one controlling parts of the single-use medical device remains in the second end portions.

21.A medical packaging according to claim 19 wherein at least one part of the at least one first end portion transforms in a corresponding manner to the change of shape of an operative part of the single-use medical device.

22.A medical packaging according to claim 18 wherein at least one part of the at least one second portion transforms in a corresponding manner to the change of shape of a controlling part of the single-use medical device.

23.A medical packaging according to claim 18 wherein the at least one second portion, which is sized and shaped for substantially covering a controlling part of the single-use medical device, is changeable or relatively moveable to allow controllable usage of the operative part by the controlling part, while retaining coverage over substantially all of the controlling part of the single-use medical device.

24.A medical packaging according to claim 23 wherein the changeable is one or more of:

a. Flexible

b. Deformable

c. Expandible

d. Malleable

e. Compressible

25.A method of using a sterile single-use medical device in a continuing sterile manner including the steps of:

a. Providing a sterile single-use medical device in a flexible packaging body forming an enclosing volume with at least one first end portion and at least one second portion able to hold the single-use medical device therein in a sterile condition wherein the at least one first end portion sized and shaped for substantially covering an operative part of the single-use medical device, and the at least one second portion sized and shaped for substantially covering a controlling part of the single-use medical device; b. Providing at least one openable element on at least part of each of the at least one first end portion of the body; c. Holding the at least one second portion with the controlling part of the single-use medical device still within the at least one second portion; d. Opening the at least one openable element of the at least one first end portion of the packaging by removing breaking or opening at least part of the at least one first end portion to reveal the at least one operative part of the single-use medical device without directly touching the device; and e. Using the revealed operative part of the single-use medical device by manipulating a controlling part of the single-use medical device with the controlling part of the single-use medical device still within the at least one second portion.

26.A method of medical packaging according to claim 25 wherein at least one part which corresponds in shape to an operative part of the single-use medical device.

27.A method according to claim 25 wherein at least one part which transforms in a corresponding manner to change of shape of an operative part of the single-use medical device.

28.A method of medical packaging according to claim 25 wherein at least one part which corresponds in shape to a controlling part of the single-use medical device.

29.A method according to claim 25 wherein at least one part which transforms in a corresponding manner to change of shape of a controlling part of the single-use medical device.