CA2096688A1 - Package for an active medical device - Google Patents
Package for an active medical deviceInfo
- Publication number
- CA2096688A1 CA2096688A1 CA002096688A CA2096688A CA2096688A1 CA 2096688 A1 CA2096688 A1 CA 2096688A1 CA 002096688 A CA002096688 A CA 002096688A CA 2096688 A CA2096688 A CA 2096688A CA 2096688 A1 CA2096688 A1 CA 2096688A1
- Authority
- CA
- Canada
- Prior art keywords
- package
- recess
- medical device
- wall
- active medical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
- A61B50/33—Trays
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S439/00—Electrical connectors
- Y10S439/912—Electrical connectors with testing means
Abstract
ABSTRACT
A package 10 for an active medical device 11 comprising a film member 15 having a pocket 16 which defines a recess 13 shaped to receive the active medical device; a flange 17 about the recess 13 and a wall 18 with an opening 20 for providing access to the outside of the pocket 16; and a lid 12 covering the recess 13 to maintain a sterile field therein. Also disclosed is a method for assembling the package 10 and a method of testing the active medical device 11 while maintaining It in a sterile field within the package.
A package 10 for an active medical device 11 comprising a film member 15 having a pocket 16 which defines a recess 13 shaped to receive the active medical device; a flange 17 about the recess 13 and a wall 18 with an opening 20 for providing access to the outside of the pocket 16; and a lid 12 covering the recess 13 to maintain a sterile field therein. Also disclosed is a method for assembling the package 10 and a method of testing the active medical device 11 while maintaining It in a sterile field within the package.
Description
2~3~688 PACKAGE FOi~ AN ACTIVE MEDICAL DEVICE
This invention relates to a package for an active medical device and to a methodof assembly and testing thereof. More particularly, the invention is concerned with a structure that contains the active medicai device and allows testing without compromising the sterile environment provided by the package.
Disposable medical devices generally are distributed In groups of like size and type which are typically carried in an over carton in a number, for example a dozen or more, of individually packaged, Identlcal devlces. A package can be removed from the over carton and opened to obtain a single dlsposable device. Individual packaglng malntains a sterile environment for each disposable medicai device. Consequentiy, the package for each should be inexpensive, easy to open without contamination of the product and structurally adequate to protect the sterility of the product prior to use.
Commonly used packaging for disposable medical devices includes two components; a flat top or cover with printed product information as, for example, product size, type, name of manufacturer, instructions and the like. The top or cover Is usually a thin sheet of extrusion coated paper having a polyethylene layer and a heat sealable lacquer layer. The paper Is called Tyvek paper and the polyethylene Is added for tear resistance.
The other or second component of a typical package is a drawn semi rigid pocket which has a recess for receiving the product and a flange for supporting the top or cover. The pocket preferably is thermally formed from a semi-rigid polymer sheet, for example polystyrene, whlch is heated and drawn such that the depth of the recess is no more than one and one-half times the width. Products which are wider than they are deep have to be packed sideways, or the package has to be drawn less than required for efficient use of the drawn polymer material. Typicaily, the flange is the thickest part of the formed pocket in that it Is not drawn and the corners of the recess are the thinnest area because they are stretched the most. A ratio of flange thickness to corner thickness of slx to one is about the maximum amount of tninning that can be accompllshed with an economical starting thickness for the polymer sheet. The flange protects the device and provides support during opening.
The cover and flange are heat sealed to securely enclose the product within the recess of the pocket, but a portion along an edge is usually left unsealed in order to provide an area where the top can be peeled from the flange. In particular, the unsealed portion of the edge of the top can be fanned away from the edge of the flange and then grasped and peeled away from the heat sealed areas about the rest 2~Qi~8~
of the flange. . The product remalning within the recess is supported thereby during peeling. Afler removal of the top or cover, the product can be accessed without having vlolated the sterlle field of the product, but the use of gloved hands is r~ecessary to malntain sterility~ Since the product and package are typically sterilized after assembly but before use, the package has to maintain a sterile environment until the described opening procedure is performed.
Active medical device may include optical fibres or fibre optic chemical sensorsused in vivo as probes; such devices are sensitive to changes in gas or ion concentrations. U.S. Patent No. 4,200,110 discloses a fiber optic probe with an ion permeable membrane enclosure about the dlstal ends of a pair of optical fibres.
Change In colour of a pH sensitive dye Is detected. U.S. Patent Re 31,87g discloses a method for measuring concentration of an analyte in a sample that changes the colour and/or the intensity of light emitted from a fluorescent indicator attached to an optical fibre. U.S. Patent No. 5,047,208 discloses an optical sensor for blood gas measurement comprising a pH sensitive absorption dye between the end of an opticai fibre and a mirror. The mirror is located by a tube which carries a mirror spaced from and coaxlally aligned with the fibre.so the dye is located in the space. These and other patents are typical of the prior art disclosures of microscopic constructions use for in vlvo blood analysls.
Blood gas sensors are typicaily packaged in a vessel filled with solution and then sealed In a sterility protecting package as described. The solution maintains the chemlcals of the sensor fresh and ready to be used.. Optical and electrical slgnals may be~transmitted and returned through miniature wave-guldes or conductors which pass through a lumen of the blood sensor catheter during use In vivo. The ability to access 25 those miniature conductors before delivery to verify that the sensors are viable and may be used reliably is important to the manner in whlch active medical devices are handled in their distribution and ultimate application.
In accordance wlth the present invention there is provided a package for an active medical device having conductors between the dista! and proximal ends thereof 30 comprising: a film member having a pocket formed therein to define a recess shaped to recelve the active medical devlce and havlng a flange In a plane about the recess;
a wall of the recess formed as part of the pocket, the wail having at least a flat portion generally perpendicular to the plane of the flange; an opening in the flat portion for .- , .; ..
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This invention relates to a package for an active medical device and to a methodof assembly and testing thereof. More particularly, the invention is concerned with a structure that contains the active medicai device and allows testing without compromising the sterile environment provided by the package.
Disposable medical devices generally are distributed In groups of like size and type which are typically carried in an over carton in a number, for example a dozen or more, of individually packaged, Identlcal devlces. A package can be removed from the over carton and opened to obtain a single dlsposable device. Individual packaglng malntains a sterile environment for each disposable medicai device. Consequentiy, the package for each should be inexpensive, easy to open without contamination of the product and structurally adequate to protect the sterility of the product prior to use.
Commonly used packaging for disposable medical devices includes two components; a flat top or cover with printed product information as, for example, product size, type, name of manufacturer, instructions and the like. The top or cover Is usually a thin sheet of extrusion coated paper having a polyethylene layer and a heat sealable lacquer layer. The paper Is called Tyvek paper and the polyethylene Is added for tear resistance.
The other or second component of a typical package is a drawn semi rigid pocket which has a recess for receiving the product and a flange for supporting the top or cover. The pocket preferably is thermally formed from a semi-rigid polymer sheet, for example polystyrene, whlch is heated and drawn such that the depth of the recess is no more than one and one-half times the width. Products which are wider than they are deep have to be packed sideways, or the package has to be drawn less than required for efficient use of the drawn polymer material. Typicaily, the flange is the thickest part of the formed pocket in that it Is not drawn and the corners of the recess are the thinnest area because they are stretched the most. A ratio of flange thickness to corner thickness of slx to one is about the maximum amount of tninning that can be accompllshed with an economical starting thickness for the polymer sheet. The flange protects the device and provides support during opening.
The cover and flange are heat sealed to securely enclose the product within the recess of the pocket, but a portion along an edge is usually left unsealed in order to provide an area where the top can be peeled from the flange. In particular, the unsealed portion of the edge of the top can be fanned away from the edge of the flange and then grasped and peeled away from the heat sealed areas about the rest 2~Qi~8~
of the flange. . The product remalning within the recess is supported thereby during peeling. Afler removal of the top or cover, the product can be accessed without having vlolated the sterlle field of the product, but the use of gloved hands is r~ecessary to malntain sterility~ Since the product and package are typically sterilized after assembly but before use, the package has to maintain a sterile environment until the described opening procedure is performed.
Active medical device may include optical fibres or fibre optic chemical sensorsused in vivo as probes; such devices are sensitive to changes in gas or ion concentrations. U.S. Patent No. 4,200,110 discloses a fiber optic probe with an ion permeable membrane enclosure about the dlstal ends of a pair of optical fibres.
Change In colour of a pH sensitive dye Is detected. U.S. Patent Re 31,87g discloses a method for measuring concentration of an analyte in a sample that changes the colour and/or the intensity of light emitted from a fluorescent indicator attached to an optical fibre. U.S. Patent No. 5,047,208 discloses an optical sensor for blood gas measurement comprising a pH sensitive absorption dye between the end of an opticai fibre and a mirror. The mirror is located by a tube which carries a mirror spaced from and coaxlally aligned with the fibre.so the dye is located in the space. These and other patents are typical of the prior art disclosures of microscopic constructions use for in vlvo blood analysls.
Blood gas sensors are typicaily packaged in a vessel filled with solution and then sealed In a sterility protecting package as described. The solution maintains the chemlcals of the sensor fresh and ready to be used.. Optical and electrical slgnals may be~transmitted and returned through miniature wave-guldes or conductors which pass through a lumen of the blood sensor catheter during use In vivo. The ability to access 25 those miniature conductors before delivery to verify that the sensors are viable and may be used reliably is important to the manner in whlch active medical devices are handled in their distribution and ultimate application.
In accordance wlth the present invention there is provided a package for an active medical device having conductors between the dista! and proximal ends thereof 30 comprising: a film member having a pocket formed therein to define a recess shaped to recelve the active medical devlce and havlng a flange In a plane about the recess;
a wall of the recess formed as part of the pocket, the wail having at least a flat portion generally perpendicular to the plane of the flange; an opening in the flat portion for .- , .; ..
, . . :
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-3-providing access from the recess to the outside of the pocket; a lid covering the recess of the pocket and encloslng the active medical device the lld being associated with the flange of the film member and thereby containing the active medical device within a sterile field in the recess; and a junction mounted through the flat portion of the wall of the pocket to assure the sterile field wlthin the lidded recess the junction including test means for the conductors of the medical device so that electrical and optical transmissions may pass through the ]unction without removal of the lld or breach of the sterile field.
The Junctlon preferably inctudes an Inner part and an outer part which conjugateover the opening to seal the opening and ensure sterility within the recess. The Inner part preferably has a central web therein as part of the test means so the active medical device may fit thereto in position to transmit optical signals from light conductors. The central web most preferably has thereabout a plurality of spaced apart electrlcally conductive pins as another part of the test means which distally couple with the test linkage proximally recéived. A window of transparent material in the central webpermits optical signal transmission therethrough.
The inner part preferably includes a band with a brim thereabout so the band flts through the opening and ~he brim faces the wall about the opening. The outer part preferably Includes a collar with a rim thereabout so that the collar conJugates with the band of the Inner part that extends through the opening and the rim abuts in tight facing relation the wall about the opening. The brim most preferably Joins the band to support a gasket thereabout and the gasket is preferably of a resilient material for compression between the wall and the brim when the inner and outer parts are conjugate.
In a preferred embodiment threads about the band of the inner part that extends through the opening mate with complimentary threads on the collar of the outer part so that the inner and outer parts may be drawn axially together to compress the gasket against the wall.
The invention also provides a method for assembling a package for an active medical device comprising the following steps: making an opening in a wall of a recess defined by a pocket in a film member of the package which recess is shaped to receive the active medical device placing a gasket against a brim and abou~ a band of an inner part of a junction mounted through a flat portion of the wall; inserting the ~ . . . - . . .
:: : ,. .. ~ .
~096688 band through the opening in the wall so that the gasket Is fiush against the wall;
Installlng an outer part coaxially about the band whereat It extends beyond the opening to hold the gasket tightly against the wall to torm a sterile barrier; and placing a lid against 8 fiange of the film member to cover the recess and thereby contain the active 5 medical device within a sterile field in the recess.
The added step of threading a collar onto the extended band to secure the outer and inner parts may be included.
The invention further provides a method of testlng an active medlcal device in a package that provides a sterile environment comprising the following steps: piacing 10 the active medical device in a recess within the package, attaching the aclive medicai device to a Junction for transmission in and out of the package of electrical and opticai signals through the Junction; covering the recess with a lid to form a sterile field in the package; appiying electrical arid optical signals to the junction from outside the package, and receiving modified signals from the active medical device through the 1 5 Junctlon.
The Invention will be more particularly described with reference to a preferred embodiment as illustrated in the accompanylng drawlngs, In which:
Figure 1 is a perspectlve view of the package pocket showing the lid removed above the recess thereof and the active medical devlce in its packed position before 2û use and connected for testing;
Flgure 2 is a partial top view of the package for the active medical devlce of Figure 1 as would be seen if the lid were completely removed;
Flgure 3 is a partial side view in cross section of the package and the active medical device of Figure 1 as would be seen if the cross section were taken along line 25 3-3 in Figure 1;
Figure 4 is an enlarged view !n cross section of the portion of the package similar to Figure 3 and showing the detail of the junction for the active medical device passage through an opening in a wall of the package;
Figure 5 is an enlarged distal end view of the inner part of the junction as would 30 be seen from inside the package; --Figure 6 is an enlarged proximal end view of the inner part of the junction or the side that faces the wall of the package;
: . .
, , :
: , . , , ;-2096~)88 Figure 7 is an enlarged proximal end view of the outer part of She junction as would be seen from outside the package; and Figure 8 is an enlarged distai end view of the outer part of the junction or theside that abuts the wall of the package.
Figure 1 of the accompanying drawings illustrntes a package 10 for an active medical device 11 with its conductors between the distal and proximal ends thereof, and shows a perspective view of the package 10 with a lid 12 positioned above a recess 13 thereof. As used herein the terms distal and proximal are with respect to the leading end of the active medical device 11, i.e. the part that enters the patient; this is common usage in the medical field. The active medical device 11 is deplcted in its packed position before use and is attached to a Junction 14 ready for testing. The lid 12 maintains a sterile field within the package 10 and about the active medical device 11. While the active medical device 11 In the preferred embodiment is a blood gas sensing catheter, the active medical device 11 need not be medical and the package 10 need not be sterile. For example, any device could have an active component and the packaging could be sealed for cleanliness, e.g. a semlconductor in a dust free envlronment within the packaging.
The package 10 illustrateci In Figure 1 has a film member 15 having a pocket 16 formed therein to define the recess 13 shaped to receive the active medical device 11. The film member 15 preferably is a polymer sheet that has been vacuumed formed with heat and pressure. The preferred material Is a semi-rigid and transparent sheet of plastic less than 1 rnm. thlck. The fl1m member 15 Includes a flange 17 In a plane about the recess 13 and a wall 18 of the recess 13 is most preferably formed as part of the pocket 16. The wall 18 includes a least flat portion 19 generaliy perpendicular to the plane of the flange 17.
An opening 20 is preferably D shaped with a straight edge 21 and is punched or cut into the flat portion 19 for providing access from the recess 13 to the outside of the pocket 16, as shown in Figure 3. The lid 12 covers the recess 13 of the pocket 16 and encloses the active medical device 11. The lid 12 is most preferably gas 3~ permeable for use with gas sterillzation and Tyvek material is typically used. The lid 12 is associated with the flange 17 of the film member 15 and is sealed thereto by heat or solvent activated adhesive thereby containing the active medical device 11 within a sterile field in the recess i 3 therein.
': , ' : ' ' ' ~ ; ' . :
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.
~ig6~8 The disclosure herein is related to that of commonly assigned patent applicationSerial No. 07/887986; entitled, BARRIER FOFi A CONNECTOR, which describes and claims a connector for an in vivo blood gas sensing catheter. The preferred embodiment of the present package 10 is designed to receive one side of such a 5 connector which has optical fibres and electrical conductors that terminate proximaily In the connector which is adapted to be aHached to monitoring instrumentation. In such an application, the proximal end of the connector is attached to the inside portion of the 3unctlon 14 In the package 10 as shown in Figures 1, 2 and 3. Ths Junction 14 permits the transmission of optical and electrical signals even though the package 10 10 is sealed and the sterile field therewithln has not been breached.
Specifically, the aforesald connector has a conjugating part with terminal Sace features and is keyed to align the terminal face features, The terminai face features include conductors for electrical circuits and optical paths in the in vivo blood gas sensing catheter, A connection 22 occurs between the conjugating part and the 15 Junction 14 herein when the active medical device 11 of the preferred embodiment is packaged and has the features fully conjugated.
The Junotion 14 is in the preferred embodiment mounted through the flat portion 19 of the wall 18 of the pocket 16 to maintaln the sterile field within the lidded recess 13, Flgure 2 Is a partlal top view of package 10 for the active medlcal device 11 of 20 Figure 1 as would be seen if the lid 12 were completely removed, Figure 3 is a partial slde vlew in cross section of package 10 and the active medical device 11 of Figure 1 as would be seen if the cross section were taken along line 3-3 in Figure 1. Thepositioning of the connector conjugating part Is shown as it would appear in thepreferred embodiment if the active medical devlce 11 were attached to the junction 14, 25 Figure 4 is an enlarged view in cross section of the portion 19 of the package 10 and is similar to Figure 3 in showing the details of the 3unction 14 for the active medical device 11 where the junction 14 passes through the opening 20 in the wall 18 of the package 10, as seen in Figure 4.
An inner part 23 and an outer part 24 conjugate over the opening 20 to seal the 30 open!ng 20 and ensure steriiity within the recess 13. The inner and outer parts 23 and 24 are moulded rigid transparent poiymer and form the preferred embodiment of thJunction 14. The junction 14 preferabiy includes test means 25 for the conductors of the active medical device 11 so that electrical and optical transmissions may pass - ~:
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-` 20~68~
~7-through the junction 14 without removal of the lld 12 or breach of the sterile field.
Specifically as shown in Figure 5, an enlarged distal end vlew of the inner part 23 of the junction as would be seen from inslde the package 10, and Figure 6, an enlarged proximal end vlew of the inner part 23 of the junction 14 or the side that faces the wall 5 18 of the package 10, the inner part 23 may have a central web 26 therein as part of the test means 25 so that the active medical device 11 can fit thereto in position to transmit optical signals from light conductor~. in Flgure 5 a bottom slot 271s provld~d on the band 28 distally to recelve the key of the conJugatlng part and as used herein bottom is with reference to the package 10 as shown in the Figures, particularly Figure 10 1. In Figure 6 a section 29 of the band 28 facing proximally is removed to p~sition the band Z8 relativo to the opening 20 straight edge 21. The central web 26 has thereabout a plurality of spaced apart electrically conductive pins 30 as another part of the test means 25 which distally couple with the test linkage proximally received. The preferred plurality of spaced apart electrically conductive plns 30 are conductive metal 15 such as brass, bronze tin plated, silver plated or gold plated; speci~ically, part number 1364H as made and sold by Prestincert Fasteners Division of Belling Lee Umited of Middlesex, England. In the inner part 23 there are six spaced apart electronically conductive pins 30 that are parallel to one another with three above and three below the central web 26, as shown in Figures 4, 5 and 6. The spaced apart electrically 20 conductive pins 30 are best seen In side cross section 29 in the enlarged view o~ Figure
The Junctlon preferably inctudes an Inner part and an outer part which conjugateover the opening to seal the opening and ensure sterility within the recess. The Inner part preferably has a central web therein as part of the test means so the active medical device may fit thereto in position to transmit optical signals from light conductors. The central web most preferably has thereabout a plurality of spaced apart electrlcally conductive pins as another part of the test means which distally couple with the test linkage proximally recéived. A window of transparent material in the central webpermits optical signal transmission therethrough.
The inner part preferably includes a band with a brim thereabout so the band flts through the opening and ~he brim faces the wall about the opening. The outer part preferably Includes a collar with a rim thereabout so that the collar conJugates with the band of the Inner part that extends through the opening and the rim abuts in tight facing relation the wall about the opening. The brim most preferably Joins the band to support a gasket thereabout and the gasket is preferably of a resilient material for compression between the wall and the brim when the inner and outer parts are conjugate.
In a preferred embodiment threads about the band of the inner part that extends through the opening mate with complimentary threads on the collar of the outer part so that the inner and outer parts may be drawn axially together to compress the gasket against the wall.
The invention also provides a method for assembling a package for an active medical device comprising the following steps: making an opening in a wall of a recess defined by a pocket in a film member of the package which recess is shaped to receive the active medical device placing a gasket against a brim and abou~ a band of an inner part of a junction mounted through a flat portion of the wall; inserting the ~ . . . - . . .
:: : ,. .. ~ .
~096688 band through the opening in the wall so that the gasket Is fiush against the wall;
Installlng an outer part coaxially about the band whereat It extends beyond the opening to hold the gasket tightly against the wall to torm a sterile barrier; and placing a lid against 8 fiange of the film member to cover the recess and thereby contain the active 5 medical device within a sterile field in the recess.
The added step of threading a collar onto the extended band to secure the outer and inner parts may be included.
The invention further provides a method of testlng an active medlcal device in a package that provides a sterile environment comprising the following steps: piacing 10 the active medical device in a recess within the package, attaching the aclive medicai device to a Junction for transmission in and out of the package of electrical and opticai signals through the Junction; covering the recess with a lid to form a sterile field in the package; appiying electrical arid optical signals to the junction from outside the package, and receiving modified signals from the active medical device through the 1 5 Junctlon.
The Invention will be more particularly described with reference to a preferred embodiment as illustrated in the accompanylng drawlngs, In which:
Figure 1 is a perspectlve view of the package pocket showing the lid removed above the recess thereof and the active medical devlce in its packed position before 2û use and connected for testing;
Flgure 2 is a partial top view of the package for the active medical devlce of Figure 1 as would be seen if the lid were completely removed;
Flgure 3 is a partial side view in cross section of the package and the active medical device of Figure 1 as would be seen if the cross section were taken along line 25 3-3 in Figure 1;
Figure 4 is an enlarged view !n cross section of the portion of the package similar to Figure 3 and showing the detail of the junction for the active medical device passage through an opening in a wall of the package;
Figure 5 is an enlarged distal end view of the inner part of the junction as would 30 be seen from inside the package; --Figure 6 is an enlarged proximal end view of the inner part of the junction or the side that faces the wall of the package;
: . .
, , :
: , . , , ;-2096~)88 Figure 7 is an enlarged proximal end view of the outer part of She junction as would be seen from outside the package; and Figure 8 is an enlarged distai end view of the outer part of the junction or theside that abuts the wall of the package.
Figure 1 of the accompanying drawings illustrntes a package 10 for an active medical device 11 with its conductors between the distal and proximal ends thereof, and shows a perspective view of the package 10 with a lid 12 positioned above a recess 13 thereof. As used herein the terms distal and proximal are with respect to the leading end of the active medical device 11, i.e. the part that enters the patient; this is common usage in the medical field. The active medical device 11 is deplcted in its packed position before use and is attached to a Junction 14 ready for testing. The lid 12 maintains a sterile field within the package 10 and about the active medical device 11. While the active medical device 11 In the preferred embodiment is a blood gas sensing catheter, the active medical device 11 need not be medical and the package 10 need not be sterile. For example, any device could have an active component and the packaging could be sealed for cleanliness, e.g. a semlconductor in a dust free envlronment within the packaging.
The package 10 illustrateci In Figure 1 has a film member 15 having a pocket 16 formed therein to define the recess 13 shaped to receive the active medical device 11. The film member 15 preferably is a polymer sheet that has been vacuumed formed with heat and pressure. The preferred material Is a semi-rigid and transparent sheet of plastic less than 1 rnm. thlck. The fl1m member 15 Includes a flange 17 In a plane about the recess 13 and a wall 18 of the recess 13 is most preferably formed as part of the pocket 16. The wall 18 includes a least flat portion 19 generaliy perpendicular to the plane of the flange 17.
An opening 20 is preferably D shaped with a straight edge 21 and is punched or cut into the flat portion 19 for providing access from the recess 13 to the outside of the pocket 16, as shown in Figure 3. The lid 12 covers the recess 13 of the pocket 16 and encloses the active medical device 11. The lid 12 is most preferably gas 3~ permeable for use with gas sterillzation and Tyvek material is typically used. The lid 12 is associated with the flange 17 of the film member 15 and is sealed thereto by heat or solvent activated adhesive thereby containing the active medical device 11 within a sterile field in the recess i 3 therein.
': , ' : ' ' ' ~ ; ' . :
~: , ':'. ' ,:. ' ' .,, :,' ' '.
,: . : ',, :,: . ' ': ~ ,.
: ~ , , , : ' ,., :' ~: ' , : '~' ' '' :' ' . ,,, ' .
.
~ig6~8 The disclosure herein is related to that of commonly assigned patent applicationSerial No. 07/887986; entitled, BARRIER FOFi A CONNECTOR, which describes and claims a connector for an in vivo blood gas sensing catheter. The preferred embodiment of the present package 10 is designed to receive one side of such a 5 connector which has optical fibres and electrical conductors that terminate proximaily In the connector which is adapted to be aHached to monitoring instrumentation. In such an application, the proximal end of the connector is attached to the inside portion of the 3unctlon 14 In the package 10 as shown in Figures 1, 2 and 3. Ths Junction 14 permits the transmission of optical and electrical signals even though the package 10 10 is sealed and the sterile field therewithln has not been breached.
Specifically, the aforesald connector has a conjugating part with terminal Sace features and is keyed to align the terminal face features, The terminai face features include conductors for electrical circuits and optical paths in the in vivo blood gas sensing catheter, A connection 22 occurs between the conjugating part and the 15 Junction 14 herein when the active medical device 11 of the preferred embodiment is packaged and has the features fully conjugated.
The Junotion 14 is in the preferred embodiment mounted through the flat portion 19 of the wall 18 of the pocket 16 to maintaln the sterile field within the lidded recess 13, Flgure 2 Is a partlal top view of package 10 for the active medlcal device 11 of 20 Figure 1 as would be seen if the lid 12 were completely removed, Figure 3 is a partial slde vlew in cross section of package 10 and the active medical device 11 of Figure 1 as would be seen if the cross section were taken along line 3-3 in Figure 1. Thepositioning of the connector conjugating part Is shown as it would appear in thepreferred embodiment if the active medical devlce 11 were attached to the junction 14, 25 Figure 4 is an enlarged view in cross section of the portion 19 of the package 10 and is similar to Figure 3 in showing the details of the 3unction 14 for the active medical device 11 where the junction 14 passes through the opening 20 in the wall 18 of the package 10, as seen in Figure 4.
An inner part 23 and an outer part 24 conjugate over the opening 20 to seal the 30 open!ng 20 and ensure steriiity within the recess 13. The inner and outer parts 23 and 24 are moulded rigid transparent poiymer and form the preferred embodiment of thJunction 14. The junction 14 preferabiy includes test means 25 for the conductors of the active medical device 11 so that electrical and optical transmissions may pass - ~:
..
'.
-` 20~68~
~7-through the junction 14 without removal of the lld 12 or breach of the sterile field.
Specifically as shown in Figure 5, an enlarged distal end vlew of the inner part 23 of the junction as would be seen from inslde the package 10, and Figure 6, an enlarged proximal end vlew of the inner part 23 of the junction 14 or the side that faces the wall 5 18 of the package 10, the inner part 23 may have a central web 26 therein as part of the test means 25 so that the active medical device 11 can fit thereto in position to transmit optical signals from light conductor~. in Flgure 5 a bottom slot 271s provld~d on the band 28 distally to recelve the key of the conJugatlng part and as used herein bottom is with reference to the package 10 as shown in the Figures, particularly Figure 10 1. In Figure 6 a section 29 of the band 28 facing proximally is removed to p~sition the band Z8 relativo to the opening 20 straight edge 21. The central web 26 has thereabout a plurality of spaced apart electrically conductive pins 30 as another part of the test means 25 which distally couple with the test linkage proximally received. The preferred plurality of spaced apart electrically conductive plns 30 are conductive metal 15 such as brass, bronze tin plated, silver plated or gold plated; speci~ically, part number 1364H as made and sold by Prestincert Fasteners Division of Belling Lee Umited of Middlesex, England. In the inner part 23 there are six spaced apart electronically conductive pins 30 that are parallel to one another with three above and three below the central web 26, as shown in Figures 4, 5 and 6. The spaced apart electrically 20 conductive pins 30 are best seen In side cross section 29 in the enlarged view o~ Figure
4 wherein an enlarged centre bead 31 sits in a countersunk hole 32 in inner part 23 and is held therein by heat staking, glue or press fit as desired for assembly ease.A window 33 of transparent material is located in the central web 26 to permit optical signal transmission therethrough. The inner part 23 includes the band 28 with 25 a brim 34 thereabout so that the band 28 fits through the opening 20 and the brim 34 faces the wall 18 about the opening 20 as seen in Figure 4. The outer part 24 may include a collar 35 with a rim 35a thereabout so the collar 35 conjugates with the band 28 of the inner part 23 that extends through the opening 20 and the rim 35a abuts in tight facing relation to the wall 18 about the opening 20 also in Figure 4. The brim 34 30 most preferably joins the band 28 to support a gasket 36 thereabout and the gasket 36 may be of a resilient material, such as soR silicone rubber, for compression between the wall 18 and the brim 34 when the inner and outer parts 23 and 24 are conjugate.
-~
20~6~8~
Threads 37 about the band 28 of the inner part 23 that extends through the openlng 20 may in the preferred embodlment mate with compiimentary threads 38 onthe collar 35 of the outer part 24 so that the inner and outer parts 23 and 24 may be drawn axially together to compress the gasket 36 against the wall 18, as shown in
-~
20~6~8~
Threads 37 about the band 28 of the inner part 23 that extends through the openlng 20 may in the preferred embodlment mate with compiimentary threads 38 onthe collar 35 of the outer part 24 so that the inner and outer parts 23 and 24 may be drawn axially together to compress the gasket 36 against the wall 18, as shown in
5 Figure 4. Adheslve or high frequency welding may be used to secure the threaded joint between the inner and outer parts 23 and 24. Figure 7 is an enlarged proximal end view of the outer part 24 of the Junction 14 as would be seen from outside the package 10. There are three notches 39 shown in Figure 7, spaced about the collar 35 which may be engaged by a spanner tool to compress the gasket 36 by tightening the 10 threads 37 and 38 between the collar 35 and band 28. Figure 8 is an enlarged distal end vlew of the outer palt 24 of the junction 14 showing the side that abuts the wall 18 of the package 10.
A method for assembling the package 10 comprises the steps of making the opening 20 in the wall 18 of the recess 13 In the package 10, placing the gasket 36 15 against brim 34 and about the band 28 of the inner 23 of the Junction 14, inserting the band 28 through the opening 20 in the wall 18 so the gasket 36 is flush against the wall 18, and Installing the outer part 24 coaxially about the band 28 whereat it extends beyond the opening 20 to hold the gasket 36 tlghtly ~galnst the wall 1 ~ to ~orm n sterlle barrier. The added step of threading the collar 35 onto the extended band 28 to secure 20 the Inner and outer parts 23 and 24 may be Included.
A method of testing the active medical device 11 in the package 10 that provldes a sterile envlronment comprises the steps of Inserting the active medicai device 11 Into the recess 13 within the package 10, attaching the active medical device 11 to the junction 14 for thereafter allowing transmission of signals into and out of the 25 package 10 through the junction 14, applying light and electrical signals to the junction 14 from outside ~he package 10, and receiving modified signals from the active medical device 11 through the ]unction 14.
, .. . .
. . -.
- ' ' '
A method for assembling the package 10 comprises the steps of making the opening 20 in the wall 18 of the recess 13 In the package 10, placing the gasket 36 15 against brim 34 and about the band 28 of the inner 23 of the Junction 14, inserting the band 28 through the opening 20 in the wall 18 so the gasket 36 is flush against the wall 18, and Installing the outer part 24 coaxially about the band 28 whereat it extends beyond the opening 20 to hold the gasket 36 tlghtly ~galnst the wall 1 ~ to ~orm n sterlle barrier. The added step of threading the collar 35 onto the extended band 28 to secure 20 the Inner and outer parts 23 and 24 may be Included.
A method of testing the active medical device 11 in the package 10 that provldes a sterile envlronment comprises the steps of Inserting the active medicai device 11 Into the recess 13 within the package 10, attaching the active medical device 11 to the junction 14 for thereafter allowing transmission of signals into and out of the 25 package 10 through the junction 14, applying light and electrical signals to the junction 14 from outside ~he package 10, and receiving modified signals from the active medical device 11 through the ]unction 14.
, .. . .
. . -.
- ' ' '
Claims (10)
1. A package 10 for an active medical device 11 having conductors between the distal and proximal ends thereof comprising:
a film member 15 having a pocket 16 formed therein to define a recess 13 shaped to receive the active medical device 11, and having a flange 17 in a plane about the recess 13;
a wall 18 of the recess 13 formed as part of the pocket 16, the wall 18 having at least a flat portion 19 generally perpendicular to the plane of the flange 17;
an opening 20 in the flat portion 19 for providing access from the recess 13 to the outside of the pocket 16;
a lid 12 covering the recess 13 of the pocket 16 and enclosing the active medical device 11, the lid 12 being associated with the flange 17 of the film member 15 and thereby containing the active medical device 11 within a sterile field in the recess 13; and a junction 14 mounted through the flat portion 19 of the wall 18 of the pocket 16 to assure the sterile field within the lidded recess 13, the junction 14 including test means 25 for the conductors of the medical device 11 so that electrical and optical transmissions may pass through the junction 14 without the removal of the lid 12 or breach of the sterile field.
a film member 15 having a pocket 16 formed therein to define a recess 13 shaped to receive the active medical device 11, and having a flange 17 in a plane about the recess 13;
a wall 18 of the recess 13 formed as part of the pocket 16, the wall 18 having at least a flat portion 19 generally perpendicular to the plane of the flange 17;
an opening 20 in the flat portion 19 for providing access from the recess 13 to the outside of the pocket 16;
a lid 12 covering the recess 13 of the pocket 16 and enclosing the active medical device 11, the lid 12 being associated with the flange 17 of the film member 15 and thereby containing the active medical device 11 within a sterile field in the recess 13; and a junction 14 mounted through the flat portion 19 of the wall 18 of the pocket 16 to assure the sterile field within the lidded recess 13, the junction 14 including test means 25 for the conductors of the medical device 11 so that electrical and optical transmissions may pass through the junction 14 without the removal of the lid 12 or breach of the sterile field.
2. A package 10 according to Claim 1, wherein the junction 14 includes an inner part 23 and an outer part 24 which conjugate over the opening 20 to seal the opening 20 and ensure sterility within the recess 13.
3. A package 10 according to claim 1 or 2 wherein the test means 25 is on the inner part 23 and comprises a central web 26 including a window 33 of transparent material for permitting optical signal transmission therethrough so the active medical device 11 can fit thereto in position to transmit light signals from the conductors.
4. A package 10 according to claim 3, wherein the transparent window 33 has thereabout a plurality of spaced apart electrically conductive pins 30 as another part of the test means 25 which pins distally couple with the test equipment.
5. A package 10 according to any one of claims 2 to 4, wherein the inner part 23 includes a band 28 with a brim 34 thereabout so that the band 28 fits through the opening 20 and the brim 34 faces the wall 18 about the opening 20, and the outer part 24 includes a collar 35 with a rim thereabout so that the collar 35 conjugates with the band 28 of the inner part 23 that extends through the opening 20 and the rim abuts in tight facing relation the wall 18 about the opening 20.
6. A package 10 according to claim 5, wherein the brim 34 joins the band 28 to support a gasket 36 thereabout, the gasket 36 being of a resilient material for compression between the wall 18 and the brim 34 when the Inner and outer parts 23 and 24 are conjugate.
7. A package 10 according to claim 6, wherein threads 37 about the band 28 of the inner part 23 that extends through the opening 20 mate with complimentary threads 38 on the collar 35 of the outer part 24 so that the inner and outer parts 23 and 24 outer 24 and inner 23 may be drawn together along their align axis to compress the gasket 36 against the wall 18.
8. A method for assembling a package 10 for an active medical device 11 comprising the following steps:
making an opening 20 in a wall 18 of a recess 13 defined by a pocket 16, in a film member 15 of the package 10, which recess 13 is shaped to receive the active medical device;
placing a gasket 36 against a brim 34 and about a band 28 of an inner part 23 of a junction 14 mounted through a flat portion 19 of the wall 18;
inserting the band 28 through the opening 20 In the wall 18 so that the gasket 36 is flush against the wall 18;
installing an outer part 24 coaxially about the band 28 where it extends beyond the opening 20 to hold the gasket 3 tightly against the wall 18 to form a sterile barrier;
and placing a lid 12 against a flange 17 of the film member 15 to cover the recess 13 and thereby contain the active medical device 11 within a sterile field in the recess 13.
making an opening 20 in a wall 18 of a recess 13 defined by a pocket 16, in a film member 15 of the package 10, which recess 13 is shaped to receive the active medical device;
placing a gasket 36 against a brim 34 and about a band 28 of an inner part 23 of a junction 14 mounted through a flat portion 19 of the wall 18;
inserting the band 28 through the opening 20 In the wall 18 so that the gasket 36 is flush against the wall 18;
installing an outer part 24 coaxially about the band 28 where it extends beyond the opening 20 to hold the gasket 3 tightly against the wall 18 to form a sterile barrier;
and placing a lid 12 against a flange 17 of the film member 15 to cover the recess 13 and thereby contain the active medical device 11 within a sterile field in the recess 13.
9. A method according to claim 8 which includes the added step of threading a collar 35 on to the extended band 28 to secure the outer and Inner parts of the junction 14.
10. A method of testing an active medical device 11 in a package 10 that provides a sterile environment comprising the following steps:
placing the active medical device 11 in a recess 13 within the package 10;
attaching the active medical device 11 to a junction 14 for transmission in and out of the package 10 of electrical and optical signals through the junction 14;covering the recess 13 with a lid 12 to form a sterile field in the package 10;
applying electrical and optical signals to the junction 14 from outside the package 10, and receiving modified signals from the active medical device 11 through the junction 14.
placing the active medical device 11 in a recess 13 within the package 10;
attaching the active medical device 11 to a junction 14 for transmission in and out of the package 10 of electrical and optical signals through the junction 14;covering the recess 13 with a lid 12 to form a sterile field in the package 10;
applying electrical and optical signals to the junction 14 from outside the package 10, and receiving modified signals from the active medical device 11 through the junction 14.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US888,569 | 1992-05-22 | ||
| US07/888,569 US5246109A (en) | 1992-05-22 | 1992-05-22 | Package for an active medical device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2096688A1 true CA2096688A1 (en) | 1993-11-23 |
Family
ID=25393432
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002096688A Abandoned CA2096688A1 (en) | 1992-05-22 | 1993-05-20 | Package for an active medical device |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US5246109A (en) |
| EP (1) | EP0572133B1 (en) |
| JP (1) | JPH0656177A (en) |
| AT (1) | ATE146353T1 (en) |
| AU (1) | AU645720B2 (en) |
| CA (1) | CA2096688A1 (en) |
| DE (2) | DE69306659T2 (en) |
| DK (1) | DK0572133T3 (en) |
| ES (1) | ES2095009T3 (en) |
| GR (1) | GR3022265T3 (en) |
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-
1992
- 1992-05-22 US US07/888,569 patent/US5246109A/en not_active Expired - Fee Related
-
1993
- 1993-05-07 AT AT93303578T patent/ATE146353T1/en not_active IP Right Cessation
- 1993-05-07 DK DK93303578.4T patent/DK0572133T3/en active
- 1993-05-07 DE DE69306659T patent/DE69306659T2/en not_active Expired - Fee Related
- 1993-05-07 ES ES93303578T patent/ES2095009T3/en not_active Expired - Lifetime
- 1993-05-07 EP EP93303578A patent/EP0572133B1/en not_active Expired - Lifetime
- 1993-05-18 DE DE9307562U patent/DE9307562U1/en not_active Expired - Lifetime
- 1993-05-20 US US08/064,615 patent/US5357732A/en not_active Expired - Fee Related
- 1993-05-20 CA CA002096688A patent/CA2096688A1/en not_active Abandoned
- 1993-05-21 AU AU38733/93A patent/AU645720B2/en not_active Ceased
- 1993-05-21 JP JP5120134A patent/JPH0656177A/en active Pending
-
1997
- 1997-01-09 GR GR970400034T patent/GR3022265T3/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU645720B2 (en) | 1994-01-20 |
| EP0572133B1 (en) | 1996-12-18 |
| DE9307562U1 (en) | 1993-09-16 |
| EP0572133A1 (en) | 1993-12-01 |
| ATE146353T1 (en) | 1997-01-15 |
| DE69306659D1 (en) | 1997-01-30 |
| AU3873393A (en) | 1993-11-25 |
| GR3022265T3 (en) | 1997-04-30 |
| ES2095009T3 (en) | 1997-02-01 |
| JPH0656177A (en) | 1994-03-01 |
| US5357732A (en) | 1994-10-25 |
| US5246109A (en) | 1993-09-21 |
| DK0572133T3 (en) | 1997-06-02 |
| DE69306659T2 (en) | 1997-04-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |