WO2019215748A1

WO2019215748A1 - System and method of sterilization and packaging of a medical device

Info

Publication number: WO2019215748A1
Application number: PCT/IN2018/050414
Authority: WO
Inventors: Deveshkumar Mahendralal KOTHWALA; Rajnikant Gandalal Vyas; Dr. Pramod Kumar MINOCHA
Original assignee: Meril Life Sciences Pvt Ltd
Priority date: 2018-05-07
Filing date: 2018-06-25
Publication date: 2019-11-14

Abstract

The present invention discloses a system and a method of integrated sterilization and packaging of a medical device. The present invention discloses a system for simultaneous sterilization of an assembly of a protective package containing a medical device. The protective package includes without limitation a fluid container, a tray and a pouch.

Description

SYSTEM AND METHOD OF STERILIZATION AND PACKAGING OF A MEDICAL DEVICE

FIELD OF INVENTION

[001] The present invention relates to a system and a method for sterilizing and packaging a medical device. More particularly, the invention relates to a packaging assembly and a method to sterilize and package a crimped stent-graft assembly and a balloon catheter.

BACKGROUND

[002] Medical devices are required to be sterilized prior and/or post packaging to prevent pathological propagation. The pre-packaging sterilization is necessary to ensure that the medical device is not contaminated at the time of packaging. Conventionally, the post packaging sterilization is recommended immediately after the release of medical device from the package and prior to deployment of the medical device in a human body to eliminate any possibility of contamination.

[003] Several sterilization methods like liquid chemical sterilization, ethylene oxide (ETO) gas sterilization, gamma ray and steam sterilization are currently in use for sterilizing the medical devices. If the sterilization method is not compatible with the medical device, it may hamper the properties of the medical devices. Therefore, the medical devices like endo- prostheses, delivery catheters, balloon catheters, surgical instrument etc. are conventionally sterilized using ETO sterilization. However, the medical devices which are chemically sensitive namely, covered endo prostheses like stent-graft assembly, coated endo-prostheses, etc. need liquid chemical sterilization. The ETO sterilization is not recommended for such medical devices as the cover/graft material or coating present on them may degrade due to oxygen degradation.

[004] The use of separate sterilization method leads to a complex and lengthy procedure to pack a medical device containing two different components having different properties such as a stent- graft assembly mounted on a balloon of a balloon catheter. Moreover, the medical device is prone to contamination while transferring the sterile medical device into the package after the pre packaging sterilization or while preparing it for rinsing before implantation into the human body.

SUMMARY

1

SUBSTITUTE SHEETS (RULE 26) SUMMARY

[005] Embodiments of the present disclosure provide a system and a method of integrated sterilization and packaging of a medical device. For example, the present invention discloses a system for simultaneous sterilization of an assembly of a protective package containing a medical device. The protective package includes without limitation a fluid container, a tray and a pouch. The medical device includes without limitation a crimped stent-graft assembly and a balloon catheter.

[006] In accordance with an embodiment, the packaging assembly of the present invention undergoes dual sterilization . Initially, the crimped stent-graft assembly provided in the fluid container is sterilized via for example, liquid chemical sterilization and thereafter, the packaging assembly is sterilized as a whole via for example, terminal gas sterilization. In an embodiment, the chemical sterilization may be performed by a combination of per acetic acid and ethanol. I n an exemplary embodiment the gas sterilization is performed using ethylene oxide (ETO sterilization).

[007] In an exemplary packaging method of the present invention, the fluid container may store the medical device in a storage solution after liquid chemical sterilization. In an embodiment, the tray includes multiple slots. A first slot of tray may hold the fluid container containing the medical device while a second slot holds a hub portion of the balloon catheter to achieve optimal and effective packaging of all components of the medical device. In an embodiment, the tray holding the medical device may be inserted in the pouch for final packaging and terminal gas sterilization. [008] The packaging assembly of the present invention provides a package for transportation and long term storage of the medical device. During transportation and storage, the packaging assembly of the present invention protects the sterility, properties and efficiency of the medical device and its components during the entire shelf life of the medical device. Further, the packaging assembly and method of the sterilization and packaging of the present invention provides a ready to use medical device where on releasing the medical device from the packaging assembly and prior to implantation in a human body, no further rinsing or sterilization of the medical device is required. [009] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The figures, and detailed description, which follow, more particularly exemplify these embodiments.

[0010] BRIEF DESCRIPTION OF DRAWINGS [0011] FIG. 1 illustrates a top view of an exemplary embodiment of the protective package including fluid container, tray and pouch

[0012] FIG. 2 illustrates a cross sectional view of the fluid container of protective package depicted in FIG. 1

[0013] FIG. 3a illustrates a cross sectional view of the hub of fluid container depicted in FIG. 2. [0014] FIG. 3b illustrates a front view of the cap of the proximal port provided on the hub depicted in FIG. 3a.

[0015] FIG. 3c illustrates a cross-sectional view of the cap of the proximal port provided on the hub depicted in FIG. 3a.

[0016] FIG. 4a illustrates a cross sectional view of the lock of the fluid container depicted in FIG. 2. [0017] FIG. 4b illustrates a cross sectional view of the cap of the lock depicted in FIG. 4a.

[0018] FIG. 5a illustrates a top cross- sectional view of the tray of the protective package depicted in FIG. 1.

[0019] FIG. 5b illustrates a front- view of the clip placed in the third slot of the tray depicted in FIG. 5a. [0020] FIG. 5c illustrates a side-view of the clip placed in the third slot of the tray depicted in FIG.

5a.

[0021] FIG. 5d illustrates a front- view of the needle placed in the fourth slot of the tray depicted in FIG. 5a.

[0022] FIG. 6 illustrates a flowchart of the method of sterilization and packaging of the medical device in the protective package depicted in FIG.l. [0023] FIG. 6a illustrates an exploded cross-sectional view of the fluid container of Fig 2 to depict the placement of stent-graft assembly and the balloon catheter in fluid container as described in the method depicted in FIG. 6.

[0024] DETAILED DESCRIPTION [0025] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases. [0026] Wherever possible, same reference numbers will be used throughout the drawings to refer to same or like parts. Moreover, references to various elements described herein are made collectively or individually when there may be more than one element of the same type. However, such references are merely exemplary in nature. It may be noted that any reference to elements in the singular may also be construed to relate to the plural and vice-versa without limiting the scope of the disclosure to the exact number or type of such elements unless set forth explicitly in the appended claims.

[0027] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. In the present description and claims, the term proximal end refers to an end of an element that is closer to a user while the distal end refers to an end of the element which is farther from the user.

[0028] An exemplary embodiment of the present invention as represented in FIG. 1, describes a protective package 100 having a fluid container 110, a tray 160 and a pouch 190 for sterilizing and packaging a medical device.

[0029] The protective package 100 of the present invention provides a single and complete system to sterilize each component of the medical device which conventionally requires separate sterilization. Further, the packaging assembly and method of the sterilization and packaging of the present invention provides a ready to use medical device where on releasing the medical device from packaging assembly and prior to implantation in human body no further rinsing or sterilization of the medical device is required. The components of the medical device can include but are not limited to an endo-prostheses, covered endo-prostheses, coated endo-prostheses, surgical instrument, endo- prostheses delivery catheters and balloon catheters. For example, the medical device packaged and sterilized in the present invention may have a crimped stent-graft assembly mounted distally on a balloon of a percutaneous transluminal coronary angioplasty balloon catheter (PTCA catheter).

[0030] In an embodiment, the fluid container 110 (see description of FIG 2) of the protective package 100 may be provided to hold a crimped stent-graft assembly of the medical device. The tray 160 may be provided as a base to hold the fluid container with stent-graft assembly and the hub portion of the balloon catheter (as described in FIG. 5a). The pouch 190 may be sealable and may be provided to package the tray 160 containing fluid container 110 and the hub portion of the balloon catheter.

[0031] As represented in FIG. 2 the fluid container 110 may have a proximal end 114, a distal end 116, a lumen 118, a hub 120 and a lock 150. The fluid container 110 may have a tubular body along a longitudinal axis. The hub 120 may be attached to the proximal end 114 while the lock 150 may be attached to the distal end 116 of the fluid container 110. The lumen 118 may extend from the proximal end 114 to the distal end 116. In an embodiment, the lumen 118 may have a diameter within a range of 2.50 mm to 3.50 mm. [0032] Additionally, the hub 120 may have plurality of means to introduce and release sterilization and/or storage solutions into/out of the lumen 118 of the fluid container 110. Similarly, the lock 150 may have a means to introduce and release sterilization and/or storage solutions into/out of the lumen 118 (as described in FIG 3 and 4a). [0033] In an embodiment, the fluid container 110 may be transparent and made of silicon. In alternate embodiments, the fluid container 110 may be made of polyvinyl chloride (PVC), polyolefin, polyurethane, polyethylene, polypropylene, nylon, fluoroploymer and polytetrafluoroethylene (PTFE).

[0034] In an embodiment as represented in FIG. 3a, the hub 120 may have an outer surface 122, an inner surface (not shown), a plurality of ports (124, 126 and 128), a lumen 130 and a cap 140. In an exemplary embodiment, the hub 120 may have a proximal port 124, a distal port 126 and a third port 128. In an exemplary embodiment, the third port 128 may be positioned vertically on the hub 120. The outer surface of the hub 120 may have a rectangular peripheral region 132 and a triangular peripheral region 134 for facilitating smooth grip and handling. The triangular peripheral region 134 may extend from the proximal port 124 to the third port 128 while the rectangular peripheral region 132 may extend from the proximal port 124 to the distal port 126 on an opposite side of the triangular peripheral region 134.

[0035] In an embodiment, the lumen 130 may extend from the proximal port 124 to the distal port 126. The proximal port 124 may have a tubular body and an opening. The opening of the proximal port 124 opens up in the lumen 130 and allows the introduction of medical device, and/or sterilizing/storage solutions into the fluid container 110. In an embodiment, the outer surface of the proximal port 124 may have a plurality of threads (for example to adhere to a specification - ISO 594-1/2) to form a haemostatic valve on engagement with the corresponding threads (described in Fig 3b and 3c description) of the cap 140. [0036] As represented in figures 3b and 3c (internal cross-section of cap), the cap 140 has an outer surface 142, an inner surface 144 and a cavity 146. The outer surface 142 may have a plurality of grooves to provide a firm grip and smooth rotation of cap during closing and releasing of the cap 140. In an embodiment, the inner surface 144 may have a plurality of threads. The plurality of threads on the inner surface 144 may form a haemostatic valve on engagement with the corresponding threads of the proximal port 124 to stop any leakage during sterilization and packaging. The cavity 146 may have a tubular body and an opening to allow introduction of a medical device, and/or sterilizing/storage solutions into the lumen 130. The diameter of the cavity 146 may be less than the diameter of the lumen 130 and may fit in the proximal port 124 opening, thereby forming a seal between the overlapping region of the proximal port 124 opening and cavity 146.

[0037] In an embodiment, the distal port 126 may have a tapered tubular body to fit in the opening of proximal end 114 of the lumen 118 to form close configuration of the fluid container 110. The overlapping engagement of the distal port 126 and proximal end 114 provides a leak- proof sealing at the time of sterilization and/or packaging.

[0038] In an embodiment, the third port 128 has a tubular body, an outer surface, an inner surface, an opening and a cap. The third port 128 may open into the lumen 130 of the hub 120. The third port 128 may help in maintaining sterilizing/storage solution quantity in the fluid container 110 and may also serve as a means of filling and/or draining of fluids from the fluid container 110. In an embodiment, to comply with the standard ISO 594-1/2, the outer surface of the third port 128 has a 2.5mm threading corresponding to the threading of the cap provided to close the opening of the vertical port 128.

[0039] As represented in figures 4a and 4b, the lock 150 may have an outer surface 152, an inner surface (not shown), a proximal section 154, a distal section 156 and a lumen (not shown). The lock 150 may be of any type to prevent leakage. The lock may be for example, a luer lock. The lumen may extend from the proximal section 154 to distal section 156 and may have an increased diameter in the distal section 156. The proximal section 154 may have a tapered tubular body while the distal section 156 may have a tubular body. In an embodiment, the upper surface at the distal section 156 may have a 2.5mm threading to engage with a cap 158 (FIG. 4b) for closing the fluid container 110.

[0040] The cap 158 may have an outer surface with grooves for easy close and release function (FIG. 4b). In an embodiment, the cap 158 may have a central tubular body extending from the inner surface of the cap 158 to tightly seal or close the lumen of the lock 150. [0041] In an embodiment, the hub 120, cap 140, lock 150 and cap 158 may be made of but not limited to a gas permeable or a non-permeable material. In an exemplary embodiment of the present invention, the hub 120, cap 140, lock 150 and cap 158 may be made up of a poly- corbonated material which generally has the requisite mechanical and other properties for sterile packaging for medical devices.

[0042] In an exemplary embodiment as represented in FIG. 5a, the tray 160 of the protective package 100 includes a plurality of slots. In an exemplary embodiment, the tray includes a first slot 162, a second slot 166, a third slot 168 and a fourth slot 170.

[0043] In an embodiment, the first slot 162 includes a cavity 164 with a depth. In an exemplary embodiment, the first slot 162 has a circular configuration to properly hold the entire length of the medical device. In an embodiment, the cavity 164 may have a plurality of locking means and a plurality of extensions. The plurality of locking means may be provided to securely hold the fluid container 110 containing crimped stent -graft assembly. In an exemplary embodiment, to hold the hub 120, the cavity 164 includes a tubular extension 164b. Similarly, in an embodiment to hold the lock 150, the cavity 164 includes an extension 164c on both sides of the periphery corresponding to the dimensions of the lock 150. In an embodiment, the second slot 166 holds the hub portion of the balloon catheter which is positioned outside the fluid container 110 and not required to undergo liquid chemical sterilization. In an embodiment, the second slot 166 is provided adjacent to the first slot 162 and shares the cavity 164 of the same. The shape and dimensions of the second slot 166 may correspond to the shape and dimensions of the hub portion of the balloon catheter.

[0044] In an exemplary embodiment, the third slot 168 and fourth slot 170 individually have at least one locking means to hold a corresponding accessory. The third slot 168 may hold an accessory having a polygonal shape like a clip (FIG 5b and 5c), while the fourth slot 170 may hold an accessory having a tubular body like a flushing needle (FIG. 5d). The accessory may include an accessory of the medical device or an accessory required in the process of optimal delivery of the medical device into the patient body. The third slot 168 and the fourth slot 170 may be placed in the middle of the tray 160 adjacent to each other (FIG. 5a).

[0045] In an embodiment, the tray 160 may be of any geometry or a combination of geometries for example; one part of the tray 160 may be rectangular while the other part of the tray may be circular in shape. In an embodiment, the tray 160 may be made up of a suitable material which is permeable to sterilizing gas and which generally has the requisite mechanical and other properties for sterile packaging for medical products like a spun high density polyethylene such as TYVEK^® (2FS, 1059B and 1073B) from DuPont^®. [0046] In an exemplary embodiment, the tray 160 may be placed in the pouch 190. The pouch 190 may be made at least in part of a material which is permeable to sterilizing gas such as (TYYEK^® from DuPont^®). The protective pouch may have any configuration including but not limited to a bag, tube, box, or other sealed container that maintains the sterility of the medical device until it is withdrawn from the packaging for use. [0047] The medical device contained in the protective package 100 of the present invention may undergo dual sterilization. Initially, the stent-graft assembly may be sterilized in the fluid container 110 using a sterilizing solution. Thereafter, the fluid container 110 with sterilized stent-graft assembly and the hub portion of the balloon catheter is packed in the tray 160 and pouch 190 and thereafter sterilized by ethylene oxide gas at terminal sterilization. [0048] In accordance with an embodiment of the present invention, FIG. 6 represents a flowchart depicting an exemplary method 600 of dual sterilization and packaging of the medical device. In the initial step of dual sterilization, the distal portion of the medical device i.e. the crimped stent- graft assembly is sterilized by a liquid chemical solution or sterilizing solution. While the complete assembly including the protective packaging 100 and the medical device as a whole may be sterilized by terminal gas sterilization.

[0049] In an exemplary embodiment of method 600, at step 610, the lumen 118 of the fluid container 110 is filled with a sterilizing solution. The sterilizing solution is then pre-incubated by placing the fluid container 110 in an incubator at 27 °C + 2 °C temperature for 2 hrs. The sterilizing solution used in step 610 may be provided as a disinfectant to sterilize the stent-graft assembly. One or more disinfectants including but not limited to propylene oxide, per-acetic acid, hydrogen peroxide, ethanol or a combination there of can be used. In an exemplary embodiment, the sterilizing solution may contain a combination of 0.5 % per- acetic acid and 20% ethanol in a neutralizing buffer (phosphate buffer saline; PBS). In another embodiment of the present invention, the concentration of per-acetic acid concentration may vary between 0.3% and 1.0% whereas the concentration of ethanol may vary between 10% and 30%.

[0050] At step 620, the crimped stent- graft assembly may be placed into the lumen 118 of the fluid container 110. In an embodiment, the crimped stent-graft assembly mounted on the balloon of the balloon catheter is introduced into the lumen 118 through the opening of the proximal port 124 of the hub 120 (FIG. 6a). The stent-graft assembly is then incubated in the sterilizing solution at 37°C + 1 °C temperature for at least 6 days.

[0051] In an embodiment, the incubation temperature, duration and content of different components of sterilizing solution may vary depending upon the material and surface area of fluid container 110 as well as stent-graft assembly. Further, the incubation temperature may vary between 30 °C and 37 °C whereas the time duration of incubation may vary in a range of 1 day to 6 days.

[0052] At step 630, after the incubation step, the sterilizing solution is drained out from the lumen 118 of the fluid container 110 by opening the lock 150. [0053] At step 640, a sterile saline solution containing 0.9% sodium chloride but not limited to use of standard physiological saline is filled in the lumen 118 through the third port 128 to rinse the stent-graft assembly.

[0054] At step 650, the sterile saline solution is drained out from the fluid container 110 through the opening of the lock 150. [0055] At step 660, the rinsing steps 640 and 650 are repeated multiple times, say twice, to remove the traces of the chemical sterilant solution from the stent-graft assembly and the fluid container 110 is then filled with a storage solution containing 0.9% sodium chloride but not limited to the use of standard physiological saline through the third port 128.

[0056] At step 670, the fluid container 110 containing the stent-graft assembly is placed in the cavity 164 and the hub portion of the balloon catheter is placed in the cavity 164 and second slot 166 of the tray 160.

[0057] At step 680, the tray 160 holding the fluid container 110 and the hub portion of balloon catheter is inserted in the pouch 190. [0058] At step 690, the pouch 190 containing the tray 160 is sterilized by the ethylene oxide gas. The sterilizing gases to be used with the present invention include the known gaseous sterilants, such as formaldehyde, ethylene oxide, betapropiolactone, propylene oxide and phenol.

[0059] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used.

Claims

WE CLAIM

1. A packaging assembly containing a ready-to-use medical device, the assembly comprising: a. a fluid container including a lumen holding a medical device, the lumen contains one of a sterilizing solution or a storage solution, wherein the fluid container is subjected to an initial sterilization when the lumen contains the medical device in the sterilizing solution, wherein the sterilizing solution is replaced by the storage solution in the lumen post sterilization; b. a tray for housing a medical accessory and the initial sterilized fluid container containing the storage solution and the medical device; and c. a pouch for packaging the tray, the pouch being subjected to a terminal sterilization.

2. The packaging assembly for the medical device as claimed in claim 1 wherein the fluid

container comprises a hub and a lock, the hub positioned at a proximal end of the lumen and the lock is positioned at a distal end of the lumen.

3. The packaging assembly for the medical device as claimed in claim 2 wherein the lock is a luer lock.

4. The packaging assembly for the medical device as claimed in claim 2 wherein at least one of the hub or the lock is configured to introduce or release the sterilizing solution or the storage solution in the lumen of the fluid container.

5. The packaging assembly for the medical device as claimed in claim 1 wherein the sterilizing solution comprises a combination of 0.5 % per-acetic acid and 20% ethanol in a neutralizing buffer.

6. The packaging assembly for the medical device as claimed in claim 1 wherein the storage

solution comprises 0.9% sodium chloride.

7. The packaging assembly for the medical device as claimed in claim 1 wherein the initial

sterilization comprises liquid chemical sterilization.

8. The packaging assembly for the medical device as claimed in claim 1 wherein the terminal sterilization comprises a gas sterilization using Ethylene oxide.

9. A method of packaging the medical device, the method comprising: a. placing a medical device in a lumen of a fluid container, the fluid container including a hub, a lock and the lumen extending there between, b. introducing a sterilizing solution in the lumen of the fluid container; c. sterilizing the fluid container containing the medical device by subjecting it to an initial sterilization; d. removing the sterilizing solution from the lumen of the fluid container; e. introducing a storage solution in the lumen of the fluid container resulting in a sterilized fluid container; f. placing the sterilized fluid container in a tray; g. placing the tray in a pouch; and h. sterilizing the pouch by subjecting it to a terminal sterilization.

10. The packaging method as claimed in claim 9 wherein the initial sterilization comprises liquid chemical sterilization.

11. The packaging method as claimed in claim 9 wherein the terminal sterilization comprises a gas sterilization using Ethylene oxide.