STERILIZABLE MEDICAL PACKAGING WITH LIVING PORES

Abstract

A sterilizable medical packaging with living pores according to this invention is made of a specific blend of polyolefin polymers and additives wherein during the production process, the mixture is extruded to form a fine heterophasic substrate film comprising a rigid tough phase of a very fine crystalline lattice network which contributes to the strengthening and toughening of the film substrate, and a soft elastic phase of dispersing amorphous domains which fulfills the crystalline network thoroughly. Under pressure in sterilization process, these amorphous regions will enlarge their interstitial volumes, enabling the sub-micrometer pores to allow for gas phase sterilant to permeate through the packaging to sterilize the medical products inside, and these living pores will close automatically when the packaging is removed from the sterile chambers into a common atmosphere. Without any open dead pore structure, but by having a balance set of heterophase structures and some hydrophilic additives, this novel packaging can undergo all common sterilization methods, especially by ethylene oxide or steam, so that the film is ideally used for sterile medical packaging with an excellent microbial barrier that distinctly ensure product's sterility and prolong its shelf life, even in a poor storage condition.

Claims

1. A sterilizable medical packaging with living pores comprising: at least 50 percent by weight of an isotactic polypropylene homopolymer; 100-2,500 ppm of a nucleating agent, and 0.1-2 percent by weight of a hydrophilic filler; wherein the above compositions are mixed and plasticized at temperature in range of 180-250 C. and cooled down with cooling rate in range of 1-10 C. per second to form a sterilized medical substrate film packaging.

2. The sterilizable medical packaging with living pores according to claim 1 wherein the nucleating agent is selected from a group of sorbitol derivatives, or 1,3,5-benzenetrisamide derivatives, or their combinations thereof.

3. The sterilizable medical packaging with living pores according to claim 1 wherein the hydrophilic filler is selected from a silica, or polyethylene oxide or their combinations thereof.

4. The sterilizable medical packaging with living pores according to claim 1 wherein the packaging comprises non-fibrous, non-opened dead pores plastic film packaging.

5. The sterilizable medical packaging with living pores according to claim 1 wherein the ratio of tensile strength of said packaging's film substrate in transverse direct per machine direction is greater than 0.7.

6. The sterilizable medical packaging with living pores according to claim 1 wherein the ratio of an elongation of said packaging's film substrate in machine direction per transverse direction is greater than 1, and the elongation in machine direction is greater than 200%.

7. The sterilizable medical packaging with living pores according to claim 1 wherein the average pore size is less than 1 micron.

8. The sterilizable medical packaging with living pores according to claim 1 wherein the water vapor transmission rate of said packaging at modified negative pressure, 45 kPa, is at least 10 g/m.sup.2/day.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0009] The present invention is related to a sterilizable medical packaging with living pores comprising a set of living pores, wherein the packaging is preferably a plastic film packaging, but without any open dead pores or containing non-fibrous web made of semi-crystalline polyolefin materials. Presently, the most common thermoplastic materials used in plastic packaging are polyethylene, polypropylene, polybutylene, and especially isotactic polypropylene which is used as main raw material. Nevertheless, these commodity plastics which undergo common processing by any commercial film/sheet forming processeslike blown film extrusion, cast film extrusion, with or without further orientation stretchingwill not provide a sterile medical packaging that can undergo and withstand all common sterilization methods especially by steam sterilization and ethylene oxide sterilization methods as their dense structures would often obstruct steams or sterilant gas permeability, so the pressure will damage or deform the packaging during in sterilization procedure.

[0010] To overcome this problem, the sterilizable medical packaging with living pores according to this invention, therefore, comprises a unique formulation of polyolefin blend with specific additives are proposed. A blend of polyolefins such as, but not limited to, polyethylene, polypropylene, polybutylene, copolymer of C2-C8 alpha olefins, preferably comprising at least 50 percent by weight of isotactic polypropylene homopolymer, most preferably high molecular weight, high crystallinity isotactic polypropylene homopolymer with low melt flow index of less than 5; a functional additive comprising 100-2,500 ppm of nucleating agent such as, but not limited to, sorbitol derivatives, 1,3,5-benzenetrisamide derivatives, which can induce very fine crystalline lattices of isotactic polypropylene that toughens the packaging structure by increasing tensile strength of the film substrate, especially in transverse direction, while their percentage of elongation remains high; and 0.1-2 percent by weight of hydrophilic filler selected from silica with average size of 5 microns or less, polyethylene oxide with molecular weight of more than 1,000 or blends thereof to provide amphiphilic paths improving gas permeability, especially water-vapor transmission rate to in one embodiment, the water vapor transmission rate of said packaging at modified negative pressure, 45 kPa, is at least 10 g/m.sup.2/day, and other common additives as required.

[0011] In one preferred embodiment, the above compound mixtures are heated and plasticized with 180-250 C. in an extruder, such as, but not limited to, a blown film extruder to form a film-like substrate material with a cooling rate in range of 1-10 C./second, and undergo common process, similar to other packaging, such as treating with corona discharge, printing, slit sealing and cutting, to become a sterilizable medical packaging with living pores according to this invention.

[0012] With the specific formula and film forming process's condition, the resulting sterilizable medical packaging with living pores according to this invention has a unique structure that gives an excellent barrier to microbes or other impurities as its structure has excluded the open dead pores. The ratio of tensile strength of said packaging in transverse direct per machine direction is greater than 0.7, the ratio of an elongation of said packaging in machine direction per transverse direction is greater than 1, and the elongation in machine direction is greater than 200%.

[0013] With its heterophase structure, in one embodiment, comprising a rigid tough network of crystalline lattice of isotactic polypropylene, which attributes the overall strength of the plastic packaging, meanwhile the other soft, elastic amorphous region that disperses all around the interface of the crystalline network plays a main role in gas permeability. In addition, with the balance of both regions, a rigid, tough crystalline network and a soft elastic amorphous interface gives this unique heterophase structure an extraordinary physical property and performance similar to having a set of living pores. The resulting sterilizable medical packaging with living pores will provide a good barrier where it can be stored in common atmosphere or open air, but under controlled pressure in sterilized chamber, especially in negative pressure during evacuation process, the interstitial volume between crystalline interface will enlarge, enabling the sub-micrometer pores that are dispersing thoroughly through the matrix to allow water vapor or sterilant gas to permeate through the packaging to sterilize any products that need to be sterilized, such as medical products. Without dead, open-pores, this sterilizable medical packaging with living pores according to this invention will prolong the product shelf life and give a better performance in maintaining sterility even in severe conditions like in war services or field applications.

[0014] Although this invention has been disclosed in the context of certain embodiment and examples, it will be understood by those skilled in the art that the present invention extends is beyond the specifically disclosed embodiment to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof.