US20120204521A1

US20120204521A1 - Medical device package vacuum sealer and burst tester

Info

Publication number: US20120204521A1
Application number: US13/029,003
Authority: US
Inventors: Charlie Webb
Original assignee: Van der Stahl Scientific Inc
Current assignee: Van der Stahl Scientific Inc
Priority date: 2011-02-16
Filing date: 2011-02-16
Publication date: 2012-08-16

Abstract

One example embodiment includes a system for sealing and burst testing a medical device package. The system includes a nozzle, where the nozzle is configured to be inserted into a medical device package. The system also includes an air pump, where the air pump is configured to remove air from the medical device package through the nozzle and insert air into the medical device package through the nozzle for burst testing. The system further includes a sealer, where the sealer is configured to seal the medical device package.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

Not applicable.

BACKGROUND OF THE INVENTION

Packages sealed by medical sealers must meet government standards; therefore, the seal integrity of packages must be routinely tested during production to assure there will be no loss of device sterility. There are different tests for evaluating seal strength and integrity, the most common being peel testing, burst testing and visual testing. Peel testing is a common way to determine seal strength utilizing destructive methodology. Burst testing is another common test methodology for whole pouch testing to understand package limits by sacrificing pouch through air inflation to the point of burst.
These test modalities are used when developing the preliminary Design of Experiments for the validation processes, as well as for routine testing for the process of quality assurance. The visual process is used most often as an in-process system of seal inspection as it is non-destructive. Peel testing measures the strength of seal in pounds, or newtons, while visual testing analyzes seal integrity for anomalies such as pleating, cracking, bubbling, etc. Burst testing provides feedback as to the total package value, as seals and material are pushed to discover the weakest point of the pouch.
However, basic medical pouch sealers used in the art today do not include a mechanism for thorough evaluation of whole package total strength. Currently, when a medical packager seals a pouch using a medical sealer, he or she must occasionally pull a pouch out of production to test the seal. Testing the seal usually involve taking the pouch to a lab where the material is cut into a one-inch strip and pulling the material apart using, for example, an industrial ASTM F-88 seal strength test to determine the integrity of the seal. This can lead to a lag time in discovering problems in medical device package integrity. In particular, problems may not become apparent for some time which means more medical devices that have to be repackaged and a loss of production time.
Accordingly, there is a need in the art for a system that is capable of completing medical device package testing for the whole medical device package. Additionally, there is a need in the art for the system to test the medical device package at the site of sealing. Further, there is a need in the art for the system to discover problems quickly.

BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
One example embodiment includes a system for sealing and burst testing a medical device package. The system includes a nozzle, where the nozzle is configured to be inserted into a medical device package. The system also includes an air pump, where the air pump is configured to remove air from the medical device package through the nozzle and insert air into the medical device package through the nozzle for burst testing. The system further includes a sealer, where the sealer is configured to seal the medical device package.
Another example embodiment includes a system for sealing and burst testing a medical device package. The system includes a nozzle, where the nozzle is configured to be inserted into a medical device package. The system also includes an air pump, where the air pump is configured to remove air from the medical device package through the nozzle and insert air into the medical device package through the nozzle. The system further includes a sealer, where the sealer is configured to seal the medical device package, and a logic device, where the logic device is configured to control the operation to of the air pump and the sealer.
Another example embodiment includes a system for sealing and burst testing a medical device package. The system includes a system housing and a sealer supported by the system housing, the sealer forming a seal on a medical device package by localized heating to a temperature that melts at least a portion of the medical device package. The system includes a nozzle supported by the system housing, where the nozzle is configured to be inserted into the medical device package, and an air pump supported by the system housing. The air pump is configured to remove air from the medical device package through the nozzle and insert air into the medical device package through the nozzle. The system also includes a logic device supported by the system housing and coordinating with both the sealer and the air pump. During a sealing operation, the logic device instructs the air pump to remove air from the medical device package. During a burst testing operation, the logic device instructs the air pump to reverse air flow and insert air into the medical device package. The logic device measures the maximum air pressure which is attained within the medical device package during the burst testing operation and compares the maximum air pressure to a predetermined threshold.
These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of some example embodiments of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 illustrates an example of a system for sealing a medical device package;

FIG. 2 illustrates a block diagram of the components of the system for sealing a medical device package;

FIG. 3 illustrates an example of a medical device package in the process of being sealed;

FIG. 4 illustrates an example of a medical device package in the process of being tested; and

FIG. 5 is a flow chart illustrating a method of sealing and testing a medical device package.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS

Reference will now be made to the figures wherein like structures will be provided with like reference designations. It is understood that the figures are diagrammatic and schematic representations of some embodiments of the invention, and are not limiting of the present invention, nor are they necessarily drawn to scale.
FIG. 1 illustrates an example of a system 100 for sealing a medical device package. In at least one implementation, the system 100 can be used to seal a medical device package such that the medical device remains sterile until needed in a medical procedure. In particular, the sterilized medical device can be vacuum sealed in a medical device package such that the medical device cannot come in contact with outside contaminates, such as air, bacteria, biological fluids or other contaminates.
FIG. 1 shows that the system 100 can include a housing 105. In at least one implementation, the housing 105 is configured to surround the other elements of the system 100. For example, the housing 105 can ensure that electrical elements are properly insulated from one another and from outside electrical signals or from other debris such as dust. Additionally or alternatively, the housing 105 can serve to ensure that the other elements of the system 100 are oriented correctly relative to one another. One of skill in the art will appreciate that the housing 105 can cover all of the other components of the system 100 or only a portion thereof and that the housing 105 need not be exterior to the other components of the system 100.
FIG. 1 also shows that the system 100 can include a sealer 110. In at least one implementation, the sealer 110 is configured to seal the medical device package. In particular, the sealer 110 can melt a portion of the medical device package to provide a seal that is air tight and water resistant. As used in the specification and the claims the term air tight shall mean that the seal does not allow air to pass through the seal. I.e., the seal allows the medical device package to maintain vacuum pressure, or other non-ambient air pressure within the medical device package.
FIG. 1 shows that the sealer 110 can include a jaw mechanism 115. In at least one implementation, the jaw mechanism 115 can include an upper jaw and a lower jaw. A solenoid, pneumatic piston or other device can engage the jaw mechanism 115 to pull the upper jaw down onto the lower jaw, or vice versa, in order to apply the necessary pressure to the flexible package or pouch. The pressure exerted by the jaw mechanism 115 can be controlled by a control knob, controlled electronically or controlled in some other manner to ensure that the pressure is consistent.
In at least one implementation, the sealer 110 can also include a heating element. The heating element can flash heat to a predetermined temperature to melt at least a portion of the packaging material. The heating element can maintain the temperature for a specific time to create a bond among the two sides of the medical device package. Pieces of Teflon, Sarcon, and glass cloth can be disposed on either side of the jaw mechanism 115 to prevent the medical device packaging materials from sticking to the jaw mechanism 115.
FIG. 1 further shows that the system 100 can include a nozzle 120. In at least one implementation, the nozzle 120 is configured to be inserted into a medical device package. The nozzle 120 can then be used to remove air from the medical device package or insert air into the medical device package, as described below. In particular, the medical device package can be substantially sealed then the nozzle 120 can be inserted into the unsealed portion of the medical device package. The air can then be removed during a sealing operation or inserted during a burst testing operation, as described below.
FIG. 1 also shows that the system 100 can include a data port 125. In at least one implementation, the data port 125 can be used to transmit data between the system 100 and an external system. For example, the data port 125 can be used to transmit burst testing results. Additionally or alternatively, the data port 125 can be used to receive software updates or to change settings of the system 100.
FIG. 1 further shows that the system 100 can include a display 130. In at least one implementation, the display 130 can provide status updates to a user. For example, the display 130 can display the results of recent burst testing operations. Additionally or alternatively, the display 130 can be used to change settings of the system 100. For example, the display 130 can include a touch screen display that is allows a user to look up and modify settings of the system 100.
FIG. 2 illustrates a block diagram of the components of the system 100 for sealing a medical device package. In at least one implementation, the components of the system 100 can be used to seal a medical device package, as described above. One of skill in the art will appreciate that the components can be combined, separated or connected in alternative schemes without restriction, unless otherwise stated in the specification or the claims.
FIG. 2 shows that the system 100 can include a logic device 205. In at least one implementation, a logic device 205 can include any device capable of performing logic functions. For example, the logic device 205 can perform Boolean logic or can produce a pre-determined output based on input. The logic device 205 can include ROM memory, programmable logic device (PLD), programmable array logic (PAL), generic array logic (GAL), complex programmable logic device (CPLD), field programmable gate arrays (FPGA), logic gates, processors or any other device capable of performing logic functions.
In at least one implementation, the logic device 205 can control the functions of the other components of the system 100. In particular, the logic device 205 can ensure that the components of the system 100 perform their desired function at the appropriate time and in the appropriate manner. The timing of functions can be critical to ensure that the medical device package is sealed properly to keep the medical device stored in a sanitary condition.
FIG. 2 shows that the logic device 205 is connected to the sealer 110. In at least one implementation, the sealer 110 is configured to seal the medical device packaging, as described above. For example, the medical device packaging can be partially or completely sealed prior to insertion of the medical device. The sealer 110 can then be used to complete the seal of the medical device packaging after the medical device has been inserted.
In at least one implementation, the logic device 205 can control the operation of the sealer 110. In particular, after the air is removed from the medical device package, the logic device 205 can control the jaw mechanism 115 to hold the medical device package closed. The logic device 205 can then turn on the heating element 210 to complete the seal. After the seal has set, the logic device 205 can open the jaw mechanism 115 to release the medical device package. The logic device 205 can use a sensor to determine when to move from one step to the next or can time each step to occur at the appropriate time.
FIG. 2 also shows that the system 100 can include a nozzle insertion device 215. In at least one implementation, the nozzle insertion device 215 can move the nozzle 120 into and out of the medical device package. One of skill in the art will appreciate that the nozzle 120 insertion or removal can be accomplished by moving the nozzle or the medical device package or in any other manner. For example, the nozzle 120 can be moved while the medical device package is held stationary by the jaw mechanism 115. Alternatively, the jaw mechanism 110 or an operator can move the medical device package onto the nozzle 120.
FIG. 2 shows that the logic device 205 can be connected to the nozzle insertion device 215. In at least one implementation, the logic device 205 can control the insertion or removal of the nozzle 120 into or out of the medical device package respectively. For example, when the medical device package is in place, the logic device 205 can move the nozzle 120 using the nozzle insertion device 215 such that a portion of the nozzle 120 is within the medical device package and capable of allowing air to be removed from the medical device package, as described below. Alternatively, when the air has been removed from the medical device package, the logic device 205 can instruct the nozzle insertion device 215 to remove the nozzle 120 from the medical device package so that the sealer 110 can seal the medical device package.
FIG. 2 further shows that the system 100 can include an air pump 220. In at least one implementation, the air pump 220 can be connected to the nozzle 120 for removing air from the medical device packaging. For example, the air pump 220 can remove air from the medical device package before the medical device package is sealed. Additionally or alternatively, the air pump 220 can insert air into the medical device package in order to determine if the seal meets the required safety standards.
In at least one implementation, the logic device 205 can be capable of controlling the air pump 220. In particular, the logic device 205 can pump air from the medical device package during a sealing operation. Alternatively, the logic device 205 can reverse the air flow through the nozzle 120 such that the air pump 220 is inserting air into the medical device package during a burst testing operation.
FIG. 2 shows that the air pump 220 can include an air pressure sensor 225. In at least one implementation, the air pressure sensor 225 can measure the air pressure within the medical device package. For example, if the air pump 220 is removing air form the medical device package during a sealing operation the air pressure sensor 225 can determine when an acceptable amount of air has been removed. Additionally or alternatively, the air pressure sensor 225 can determine the maximum air pressure attained within the medical device package before the package bursts during a testing operation.
In at least one implementation, the logic device 205 can compare the maximum air pressure attained within the medical device package to determine if the seal conforms to the required standards. For example, the air pressure required to burst the package can be compared to the ASTM F1140 requirements for Internal Pressurization Failure Resistance of Unrestrained Packages and or the ISO 11607 standard for packaging for terminally sterilized medical devices which references are incorporated herein by reference in their entirety. If the maximum air pressure indicates that the seal was inadequate, the logic device 205 can stop operation of the system 100 and alert a user so that the user can determine if the seals are being created adequately or if changes or repairs need to be made.
FIG. 2 further shows that the system 100 can include a memory 230. In at least one implementation, the memory 230 can include any device capable of storing data in computer readable form. The memory 230 can include volatile memory and non-volatile memory. Volatile memory can include dynamic random access memory (DRAM), static random access memory (SRAM), thyristor random access memory (T-RAM), zero capacitor random access memory (Z-RAM), twin transistor random access memory (TTRAM), delay line memory, selectron tube and williams tube. Non-volatile memory can include read-only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, ferroelectric random access memory (FeRAM), magnetoresistive random access memory (MRAM), phase change random access memory (PRAM, aka PCM, PRAM, PCRAM, ovonic unified Memory, chalcogenide random access memory and C-RAM), conductive-bridging random access memory (CBRAM aka. programmable metallization cell or PMC), silicon-oxide-nitride-oxide-silicon (SONOS), resistive random-access memory (RRAM), racetrack memory, nano random access memory (NRAM), millipede, drum memory, magnetic core memory, plated wire memory, bubble memory and twistor memory.
In at least one implementation, the memory 230 can be used to store results of the comparisons done by the logic device 205. I.e., the memory 230 can store the results of recent tests to be accessed as desired by a user. Additionally or alternatively, the memory 230 can store the required standards, against which the measured air pressure will be compared by the logic device 205.
FIG. 3 illustrates an example of a medical device package 305 in the process of being sealed. In at least one implementation, the medical device package 305 is configured to allow a medical device 310 to be stored in a sterile environment. In particular, the sterilized medical device 310 can be vacuum sealed in the medical device package 305 such that the medical device 310 cannot come in contact with outside contaminates, such as air, bacteria, biological fluids or other contaminates.
FIG. 3 shows that the medical device package 305 can include presealed portions 315. In at least one implementation, the presealed portions 315 can be sealed prior to the insertion of the medical device 310 into the medical device package 305. Additionally or alternatively, the presealed portions 315 can be sealed after the medical device 310 has been inserted into the medical device package 305.
FIG. 3 also shows that the medical device package 305 can be placed with the nozzle 120 within the medical device package 305. In particular, the nozzle 120 can be placed within the medical device package 305 to remove the air from the medical device package 305 during a sealing operation. The nozzle 120 can be flat or substantially flat in order to allow the medical device package 305 to be sealed, as described above.
FIG. 3 further shows that the jaw mechanism 115 can be closed around a portion of the medical device package 305. In at least one implementation, the jaw mechanism 115 can hold the unsealed portion of the medical device package 305 during air removal and sealing. This can allow the air within the medical device package 305 to be removed through the nozzle 120. I.e., the nozzle 120 remains the only open area through which air can enter or exit the medical device package 305. The unsealed portion of the medical device package 305 can then be sealed using a heating mechanism, as described above.
FIG. 4 illustrates an example of a medical device package 305 in the process of being tested. In at least one implementation, the test determines the pressure at which any portion of the seals in the medical device package 305 burst or fail. I.e., the pressure at which any portion of the seals burst is determined and compared against applicable standards to ensure that the seals are sufficient to protect the medical device 310 against contaminates. One of skill in the art will appreciate that the burst testing operation can be completed immediately after the sealing operation. That is, the same system can be used to seal the medical device package 305 and test the seals.
FIG. 4 shows that the medical device package 305 can remain with the nozzle 120 within the medical device package 305. In at least one implementation, the nozzle 120 can remain within the medical device package 305 to insert air into the medical device package 305 during a burst testing operation. I.e., the nozzle 120 can be used to insert air into the medical device package 305, until the medical device package 305 bursts and the maximum air pressure attained can be measured and compared to the applicable standards for a burst testing operation.
FIG. 4 further shows that the jaw mechanism 115 can be opened during the testing operation. In at least one implementation, the jaw mechanism 115 can be opened to ensure that any resistance of the seals to bursting is not enhanced by the closed jaw mechanism 115. I.e., the burst testing operation can be performed with the jaw mechanism 115 open to ensure that the seals alone are tested.
In at least one implementation, the air pressure can be monitored during insertion of the air into the medical device package 305. The maximum pressure attained can then be compared to a minimum acceptable threshold. If the maximum pressure meets or exceeds the minimum acceptable threshold, the seal is deemed to be acceptable. If the maximum pressure is lower than the minimum acceptable threshold, the seal is deemed unacceptable and the operator is alerted to the failure.
FIG. 5 is a flow chart illustrating a method 500 of sealing and testing a medical device package. In at least one implementation, the medical device package can be tested to ensure that it conforms to governmental regulations or other packaging requirements. The testing can be done at regular intervals or when there is need for immediate testing. One of skill in the art will appreciate that the method 500 can be used with the system 100 of FIG. 1; however, the method 500 can be used with a system other than the system 100 of FIG. 1.
FIG. 5 shows that the method 500 can include sealing a medical device package 505. In at least one implementation, the medical device package can have the air removed before the sealing operation. Removing the air can help thwart the possible decay of imbedded drugs on the medical device by removing the ambient air that would contact the medical device placed within the medical device package. In particular, the lack of air can prevent unwanted bursting or popping of the medical device package. Additionally or alternatively, the lack of air can prevent pathogens from growing within the medical device package.
FIG. 5 also shows that the method 500 can include inflating the medical device package 510. In at least one implementation, the medical device package can be inflated until it bursts. The medical device package can be inflated using a nozzle left in place when the medical device package is sealed. Additionally or alternatively, a nozzle can be inserted into the medical device package for the purpose of inflating the package.
FIG. 5 further shows that the method 500 can include determining whether the burst pressure exceeds the maximum allowable threshold 515. In at least one implementation, the air pressure within the medical device package can be monitored while air is being added to the medical device package with the burst pressure indicating the maximum air pressure attained within the medical device package.
FIG. 5 also shows that the method 500 can include deeming the test successful if the burst pressure is equal to or exceeds the maximum allowable threshold 520. In contrast, the method 500 can include deeming the test a failure if the burst pressure does not exceed the maximum allowable threshold 525. In at least one implementation, if the test is a failure, a user can be notified or other corrective action can be taken to ensure that the medical device packaging is being properly sealed.
One of skill in the art will appreciate that, for this and other processes and methods disclosed herein, the functions performed in the processes and methods may be implemented in differing order. Furthermore, the outlined steps and operations are only provided as examples, and some of the steps and operations may be optional, combined into fewer steps and operations, or expanded into additional steps and operations without detracting from the essence of the disclosed embodiments.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A system for sealing and burst testing a medical device package, the system comprising:

a nozzle, wherein the nozzle is configured to be inserted into a medical device package;

an air pump, wherein the air pump is configured to:

remove air from the medical device package through the nozzle; and

insert air into the medical device package through the nozzle for burst testing; and

a sealer, wherein the sealer is configured to seal the medical device package.

2. The system of claim 1 further comprising a sensor, wherein the sensor is configured to measure the air pressure within the medical device package.

3. The system of claim 2, wherein the sensor instructs the sealer to seal the medical device package when the air pressure goes below a threshold pressure.

4. The system of claim 2, wherein the sensor is configured to measure the air pressure at which the medical device package bursts.

5. The system of claim 1, wherein the nozzle is configured to be retracted from the medical device package prior to the sealer sealing at least a portion of the medical device package.

6. The system of claim 1, wherein the air pump is further configured to reverse the direction of air flow.

7. The system of claim 1, wherein the air pump is configured to insert air into the medical device package until the medical device package bursts.

8. The system of claim 1, wherein the sealer is configured to melt at least a portion of the medical device package.

9. The system of claim 1 further comprising an insertion device, wherein the insertion device is configured to insert the nozzle into the unsealed medical device package.

10. The system of claim 9, wherein the insertion device is configured to insert the nozzle into the sealed medical device package.

11. A system for sealing and burst testing a medical device package, the system comprising:

a nozzle, wherein the nozzle is configured to be inserted into a medical device package,

an air pump, wherein the air pump is configured to:

remove air from the medical device package through the nozzle; and

insert air into the medical device package through the nozzle;

a sealer, wherein the sealer is configured to seal the medical device package; and

a logic device, wherein the logic device is configured to control the operation to of the air pump and the sealer.

12. The system of claim 11, wherein the logic device includes a processor.

13. The system of claim 11, wherein the logic device instructs the air pump to remove air from the medical device package during a sealing operation.

14. The system of claim 13, wherein the air pump continues to remove air from the medical device package until the air pressure drops below a predetermined threshold.

15. The system of claim 11, wherein the logic device is configured to notify an operator if the air pressure fails to drop below the predetermined threshold after a certain period of time.

16. A system for sealing and burst testing a medical device package, the system comprising:

a system housing;

a sealer supported by the system housing, the sealer forming a seal on a medical device package by localized heating to a temperature that melts at least a portion of the medical device package;

a nozzle supported by the system housing, wherein the nozzle is configured to be inserted into the medical device package,

an air pump supported by the system housing, wherein the air pump is configured to:

remove air from the medical device package through the nozzle; and

insert air into the medical device package through the nozzle; and

a logic device supported by the system housing and coordinating with both the sealer and the air pump;

wherein, during a sealing operation, the logic device instructs the air pump to remove air from the medical device package;

wherein, during a burst testing operation, the logic device instructs the air pump to reverse air flow and insert air into the medical device package;

wherein the logic device measures the maximum air pressure which is attained within the medical device package during the burst testing operation; and

wherein the logic device compares the maximum air pressure to a predetermined threshold.

17. The system of claim 16, wherein the logic device stops operation and notifies an operator if the maximum air pressure is below the predetermined threshold.

18. The system of claim 16, wherein the logic device is configured to perform a burst testing operation after the system has performed a predetermined number of sealing operations without a burst testing operation.

19. The system of claim 16 further comprising a memory, wherein the memory is configured to record the results of prior burst testing operations.

20. The system of claim 16 further comprising an output port, wherein the output port is configured to transmit the result of the comparison by the logic device of the maximum air pressure to the predetermined threshold.