IE20090152A1

IE20090152A1 - Medical product manufacture

Info

Publication number: IE20090152A1
Application number: IE20090152A
Authority: IE
Inventors: Michael Mcenroe; Jarlath Henry
Original assignee: Camrah Developments Ltd
Priority date: 2008-12-23
Filing date: 2009-02-26
Publication date: 2010-06-23
Also published as: GB2466523A; GB0903265D0; IES20081024A2; GB2466523B

Abstract

A medical device prepared at a forming station (31) and delivered to a packaging station (42, 50). An upwardly open plastics pouch is formed (45) by drawing a thermoplastics web into a shaped nest. The medical device is loaded in the pouch which is then delivered to sealing station (50). At the sealing station (50) a vacuum is applied to an exterior of the pouch to pull the pouch against an inside face of the nest for centering the medical device in the pouch. A medical grade paper panel is heat sealed to a rim of the pouch to seal the medical device within the pouch thus forming the medical product (1). The medical product (1) is delivered to a packing station (70), inserted in a foil envelope (72) and boxed (64). <Figure 5>

Description

"Medical Product Manufacture" ί This invention relates to the manufacture of medical products. .· ' -Ϊ : -.. -p ; * I '3 -, ... i, V p’i 9 /57 J (Ci1 -w* » tj i The invention particularly relates to the manufacture of medical products of the type comprising a medical device in a sealed pouch. The pouch comprises a thermoformed plastics container sealed by a panel of medical grade paper which is gas permeable to allow sterilisation of the contents of the pouch and thereafter form a bacteriological barrier to protect the pouch contents prior to use. A problem can arise in sealing the paper panel to the plastics container in that if there is any overlap of the medical device and the side edge seal between the container and the paper panel, this compromises the integrity of the sealed pouch and the product must be rejected. Such overlap can easily happen as the medical device is loosely mounted in the pouch. If faulty pouches are found in quality checks, then it is necessary to check the whole batch of pouches produced together, which is very inconvenient, greatly slows down production and adds to the manufacturing cost. in The present invention is directed towards overcoming these problems.

Statements of Invention According to the invention there is provided a process for manufacturing a medical product comprising a medical device in a sealed pouch, the process including: delivering a medical device to a packaging station, at the packaging station, forming a pouch to receive the medical device by leading a web of clear thermoplastics material from a supply reel to a pouch forming station, at the pouch forming station, heating the web and drawing the web into a shaping nest below the web for forming an upwardly open pouch, inserting the medical device into the pouch, IF Ο 90 1 52 delivering the pouch to a sealing station, at the sealing station, applying a vacuum to an exterior of the pouch for evenly 5 pulling the pouch side walls against the inner face of the nest, applying a vacuum to an interior of the pouch for less than 0.5 seconds for evacuating air from the pouch, covering the open top of the pouch with a medical grade paper panel, heat sealing the paper panel to a peripheral rim of the pouch, downstream of the sealing station, applying a vacuum to an exterior of the 15 pouch for drawing out excess air through the paper panel, delivering the sealed pouch to a packing station and packing the pouch in a foil envelope.

In another embodiment the process includes forming the medical device by: inserting a flexible plastics drain catheter into a plastics drain bag, inserting an outer end of the catheter into a gel container, positioning a neck of the gel container at an open neck of the bag, forming an edge seal along the neck edge of the bag and sealing the neck 30 about the gel container, injecting gel into the gel container, and capping an outer end of the gel container. -3Ιΐ ο 9 Ο 1 5 2 In a lurther embodiment the process includes: mounting the drain bag assembly and contents in a cradle with the neck of the bag and a neck portion of the gel container engaging an associated neck support at one end of the cradle, delivering the cradle to a sealing station, engaging the neck support with a complementary sealing head for clamping and heat sealing the neck edge of the drain bag and sealing the neck of the drain bag to the neck of the gel container, whilst clamped, inserting a gel injection needle into the gel container and injecting a preset quantity of gel into the container, releasing the sealing head and removing the bag from the cradle, and delivering the bag to the packaging station.

In one embodiment of the invention the process includes the step of manufacturing the plastics drain bag in a contrasting colour to the plastics pouch.

Detailed Description of the Invention The invention will be more clearly understood by the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which: Fig. 1 is a front elevational view of a medical product according to the invention: Fig. 2 is a side elevational view of the medical product shown in Fig. 1; IE 0 90 1 52. -4Fig. 3 is a rear elevational view of the medical product shown in Fig. 1; Fig. 4 is a front elevational view of a medical device for another medical product; Fig. 5 is a schematic illustration of a process for manufacturing the medical products according to the invention; Fig. 6 is a detail perspective view of apparatus used in the process; Figs. 7 to 12 are detail diagrammatic sectional views showing a pouch forming portion of the process; Fig. 13 is a perspective view of a mould insert used in the process; and Fig. 14 is an underneath plan view of the insert of Fig. 13.

Referring to the drawings and initially to Figs. 1 to 3 thereof, there is illustrated a medical product according to the invention indicated generally by the reference numeral 1. The medical product 1 comprises a medical device 2 contained within a sealed pouch 3. The medical device 2, in this case comprises a plastics drain bag 4. A flexible plastics drain catheter 5 is mounted within the drain bag 4. An outer end 6 of the catheter is housed in and is movable through a plastics gel container 7 which is mounted in a side edge seal 8 of the drain bag 4 at a closed upper end of the drain bag 4. A removable cap 9 covers an opening of the gel container 7 to retain the gel therein. The pouch 3 comprises a thin walled clear thermoplastics pouch container 10 joined by a peripheral rim seal 11 to a medical grade paper panel 12 which retains the medical device 2 within the pouch 3. A flap 14 at one end of the pouch 3 has a hanging hole 15.

Referring now to Fig. 4, there is shown another medical device according to the invention indicated generally by the reference numeral 20. This Is largely similar to the medical device 2 described previously and like parts are assigned the same reference numerals. In this case the drain bag 4 is completely closed by an edge IE 9 9 0 ΐ 5 2 -5seal 22. A hanging opening 24 is formed at one corner of the bag 4.

Referring now to Figs. 5 to 14, the process of the invention will be described. Various components of the medical device 2,20 are prepared and delivered into a clean room 30. The components are delivered to a medical device forming station 31. At the forming station 31, there is provided a rotatable carousel 32 having a first loading station 33, a second loading station 34, a sealing station 35 and an unloading station 36.

At each loading station 33, 34 operatives insert the catheter 5 into the drain bag 4. The outer end 6 of the catheter 5 is inserted into an empty gel container 7. A neck portion 16 of the gel container 7 is positioned at an open neck of the drain bag 4. The drain bag assembly is then mounted in an associated cradle 38 at a loading station 33, 34. A neck of the drain bag 4 and a neck portion of the gel container 7 engage with an associated neck support 39 at one end of the cradle 38. The carousel 32 is rotated to bring the cradle 38 to the sealing station 35.

At the sealing station 35, the neck support 39 is engaged by a complementary sealing head for clamping and heat sealing the neck edge of the drain bag 4 and sealing the neck of the drain bag 4 to the neck of the gel container 7. Whilst clamped, a gel injection needle (not shown) is advanced and inserted into the gel container 7. A preset quantity of gel is injected into the gel container 7, The needle is then retracted and the carousel 32 rotated to bring the medical device to the unloading station 36. At the unloading station 36, the medical device 2 is discharged from the carousel 32 and caps 9 are mounted on the gel containers 7.

The medical devices 2 are then delivered to a pouch forming line 42. At the pouch forming tine 42, a web 43 of clear thermoplastics material is delivered from a supply reel 44 to a pouch forming station 45. At the pouch forming station the web 43 is led over a recessed nest 46 having an insert 47 corresponding to the shape of one or more pouch containers 10. A vacuum port 48 connects to a number of venting channels in the insert 47 for evacuation of air from the nest 46. At the pouch forming station 45 the web 43 is heated and is drawn by vacuum into the nest 46 as shown in Fig. 8 to form the pouch container 10. As shown in Fig. 9, when the vacuum is It 3 90 1 52 •6released the material of the pouch container 10 will tend to retract somewhat moving upwardly away from the insert 47 due to its natural elasticity. A medical device 2 is inserted into the pouch 10 as shown in Fig. 10. It will be appreciated that at this stage an edge portion 49 of the medical device 2 may be overlapping an edge of the pouch container 10 as shown in Fig. 10. The pouch container 10 is delivered to a sealing station 50.

At the sealing station 50 a vacuum is applied to an exterior of the pouch 10 through openings in the insert 47 for evenly pulling the pouch 10 sidewalls against the inner face of the nest 46 and insert 47 as shown in Fig. 11. Thus, the pouch 10 sidewall closely conforms to the inner sidewall of the nest 46. This pulling down action on the pouch 10 tends to drawn in and centre the medical device 2 within the pouch 10 as shown in Fig. 11 thus ensuring that the medical device 2 does not overlap the side edges of the pouch 10.

The insert 47 is shown in more detail in Figs. 13 and 14 and essentially comprises a metal body with curved top edges 60 to provide a smooth transition between side walls of the nest 46 and a top 62 of the insert 47. A number of spaced-apart vent holes 64 pass through the insert 47 body leading to vent channels 65 on an underside of the insert 47 which connect to the vacuum port 48 so the vacuum can be quickly and evenly applied to the pouch container 10.

A vacuum is briefly i.e. for a period of less than about 0.5 seconds applied to an interior of the pouch 10 for evacuating air from the pouch. The open top of the pouch container 10 is then covered by the medical grade paper panel 12 which is delivered over the top of the pouch container 10 from a supply reel 55. The paper panel 12 is then heat sealed to a peripheral rim to form the edge seal 11.

After sealing a vacuum will be applied to an exterior of the pouch 3 to evacuate excess air from within the pouch 3. Pouches 3 are cut away from the web and delivered by a conveyor 58 outside the clean room 30 to a packing station 70. At the packing station 70, each medical product 1 is inserted into a foil envelope and sealed within the foil envelope 72, A number of the foil envelopes 72 are inserted into a box 74, These boxes 74 are then stacked on a pallet 75 for shipping. -7IE Ο 90 152 It will be noted that the drain bag 4 material may be made in a contrasting colour, for example blue to the material of the pouch container 10. This obviously helps the quality checks as it will be readily apparent whether the drain bag 4 overlaps with the side edge seal 11 of the pouch 10.

It will be appreciated that the process of the invention provides for efficient and accurate manufacture of the medical devices and high quality packaging ot the medical devices in the pouches minimising the risk of overlap and interference between the loose medical devices and pouch edge seals.

The invention is not limited to the embodiments hereinbefore described which may be varied in both construction and detail with the scope of the appended claims.

Claims

CLAIMS IE ν 90 ϊ'52

1. A process for manufacturing a medical product comprising a medical device in a seated pouch, the process including: delivering a medical device to a packaging station, at the packaging station, forming a pouch to receive the medical device by leading a web ot clear thermoplastics material from a supply reel to a pouch forming station, at the pouch forming station, heating the web and drawing the web into a shaping nest below the web for forming an upwardly open pouch, inserting the medical device into the pouch, delivering the pouch to a sealing station, at the sealing station, applying a vacuum to an exterior of the pouch for evenly pulling the pouch side walls against the inner face of the nest, applying a vacuum to an interior of the pouch for less than 0.5 seconds for evacuating air from the pouch, covering the open top of the pouch with a medical grade paper panel, heat sealing the paper panel to a peripheral rim of the pouch, downstream of the sealing station, applying a vacuum to an exterior of the pouch for drawing out excess air through the paper panel, delivering the sealed pouch to a packing station and packing the pouch in a foil envelope. -9IE 0 9 0 1 5 2

2. The process as claimed in claim 1 wherein the process includes forming the medical device by; inserting a flexible plastics drain catheter into a plastics drain bag, inserting an outer end of the catheter into a gel container, positioning a neck of the gel container at an open neck of the bag, forming an edge seal along the neck edge of the bag and sealing the neck about the gel container, injecting gel into the gel container, and capping an outer end of the gel container.

3. The process as claimed in claim 2, wherein the process includes: mounting the drain bag assembly and contents in a cradle with the neck of the bag and a neck portion of the gel container engaging an associated neck support at one end of the cradle, delivering the cradle to a sealing station, engaging the neck support with a complementary sealing head for clamping and heat sealing the neck edge of the drain bag and sealing the neck of the drain bag to the neck of the gel container, whilst clamped, inserting a gel Injection needle into the gel container and injecting a preset quantity of gel into the container, releasing the sealing head and removing the bag from the cradle, and delivering the bag to the packaging station. IE 0 9 0 T 5 2 -104. The process as claimed in claim 2 or claim 3 wherein the plastics drain bag has a contrasting colour to the plastics pouch.

4. 5

5. A process for manufacturing a medical product substantially as hereinbefore described with reference to the accompanying drawings.

6. Medical products whenever manufactured according to the process as claimed in any preceding claim