WO2012166091A1

WO2012166091A1 - Non-sterilizable single use medical device and method for preventing reuse

Info

Publication number: WO2012166091A1
Application number: PCT/US2011/038338
Authority: WO
Inventors: Mordechai I. GURALNIK
Original assignee: Steritrol Llc
Priority date: 2011-05-27
Filing date: 2011-05-27
Publication date: 2012-12-06

Abstract

A single use medical device is disclosed which comprises a a body and a capillary tube having a first open end and a second open end adapted to draw up liquid when said first or second open end comes in contact with a bodily fluid during a first use of said medical device, thereby rendering said medical device non-sterilizable.

Description

NON-STERILIZABLE SINGLE USE MEDICAL DEVICE AND METHOD FOR

PREVENTING REUSE BACKGROUND OF THE INVENTION

[0001] This invention relates to the field of medical devices, more particularly to medical devices intended for single use.

[0002] Modern medical devices are either designed for multiple uses or for single use.

Multiple use medical devices are designed to be sterilizable by various methods, for example sterilizing solutions, gamma irradiation, ethylene oxide gas sterilization, and autoclaving. Such multiple use devices are made of appropriately designed and tested materials which have qualities and strength that will support multiple sterilization cycles by such various methods.

[0003] Single use devices are designed for single use only and are intended to be sterilized only at or close to the time of manufacturing, and to be disposed of after being used once. The materials used in these single use devices are selected for their qualities and how they will perform during manufacturing and a single sterilization cycle, on towards actual medical use for that particular device, but are not designed, constructed, or tested for multiple use. The testing and quality control programs for these latter type devices are not designed to support multiple use cycles, including multiple sterilization procedures. Further, there is no assurance or testing that provides data that such single use devices can adequately be re- sterilized. Single use devices are made of less expensive materials than a corresponding sterilizable multiple use device and are therefore less expensive than the multiple use versions.

[0004] One example of a single use device is in the form of a general surgical scalpel which is less expensive than a multiple use general surgical scalpel. The single use scalpel is inexpensive and best disposed of following one use. Such scalpels can be made so inexpensively that sterilization may in fact cost more than a new scalpel. Furthermore, the sterilization procedure may weaken or compromise the integrity of the device. In addition, a single use scalpel will include a fresh blade will be as sharp and new as possible, providing incentive not to reuse such a scalpel.

[0005] As such, these single use scalpels are manufactured under conditions that support only that single use. They are not tested for multiple sterilization cycles, nor for extended

performance cycles as a medical device. [0006] With some devices and in some geographical locations, and in situations where there is no insurance coverage for medical device purchases, there is motivation to reuse single use devices contrary to the instructions and intent of the manufacturer. In these scenarios, the original manufacture of the device completes a first sterilization cycle at or near time of manufacturer, with adequate testing and quality assurance to support a single use. The device is then used as prescribed. Following this point, the single use device is inappropriately resterilized a second time, and then reused. This may occur for several reuse cycles, none of which being supported or considered when manufacturing the device. These devices may fail in a variety of fashions, including mechanically, sterility, and/or performance.

[0007] It is an object of the present invention to prevent resterilization and reuse of a medical device against the directions and intent of the manufacturer.

[0008] It is another object of the invention to provide an indicator of a first use and that a device should be disposed of rather than being reused.

SUMMARY OF THE INVENTION

[0009] This object, and others which will become apparent from the following disclosure and drawings, are achieved by the present invention which comprises, in one aspect, a device that will not allow a recycling and resterilization accomplished by including one or more capillary tubes arranged so as to contact bodily fluid during a first use of the device and to draw in by capillary action such fluid, which becomes an indicator that the device has been used, and which also prevents resterilization. The invention is a single use medical device comprising a body and a capillary tube having a first open end and a second open end adapted to draw up liquid when said first or second open end comes in contact with a bodily fluid during a first use of said medical device, thereby rendering said medical device non-steralizable.

[0010] The device of the present invention employs capillary action to draw up blood and/or body fluids to render it non-reusable. Since the blood or other bodily fluid is within a capillary tube, it can not be removed by common sterilization techniques. In some embodiments the bodily fluid drawn into the capillary tubes during first use is visible through either a transparent viewing window or through a transparent portion of the device such as a transparent handle. In other embodiments only the opening of the capillary tube is visible and the bodily fluid which has been drawn into the capillary tube is visible at the opening. In embodiments where the capillary tube is on the outside of the body of the device, the presence of bodily fluid will be visible along the tube and at one or both open ends.

[0011] The body of the device can be made from any material used in prior art or future medical devices which are designed to come in contact with bodily fluid. Some examples of such materials are polycarbonate, acrylic, polyurethane, ABS, ceramic, silicone, and metal. The device can be molded from conventional plastics such as polycarbonate or ABS, for example, in a mold wherein steel mandrels can be used to form the capillary tubes during molding, or preformed capillary tubes can be placed in a mold prior to filling the mold with plastic. A preformed capillary tube can include a steel mandrel which can be removed after the molding step. In certain embodiments the capillary tube extends outside the periphery of the molded article and is then cut off so as to form openings to the capillary tubes at locations where the device is designed to contact bodily fluid during first use.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Fig. 1 is a perspective view of a prior art device for performing surgery such as c- sections, as described in Lafauci, et al., U.S. Pat. 7,881,885.

[0013] Fig. 2 is a perspective view of a single use device for performing c-sections illustrating an embodiment of the invention.

[0014] Fig. 3 is a top plan view of the device of Fig. 2.

[0015] Fig. 4A is an off-center cross-section through IV-IV of Fig. 2 wherein the plane of view is above the blade.

[0016] Fig. 4B is the cross-section view of Fig. 4A, illustrating the capillary tubes drawing in bodily fluid.

[0017] Fig. 5A is a cross-sectional view of a mold being filled with molten plastic to form a device according to the invention.

[0018] Fig. 5B is the cross-sectional view of the mold of Fig. 5A wherein the mold has been filled with the molten plastic.

[0019] Fig. 5C is a cross section of transparent embodiment of the device molded in Fig. 5B, removed from the mold and with excess capillary tubes being cut off to form a final device.

[0020] Fig. 6A is a cross-sectional view of a mold being filled with molten plastic to form a device according to the invention wherein the capillary tubes are preformed and placed in the mold. [0021] Fig. 6B is the cross-sectional view of the mold of Fig. 6A wherein the mold has been filled with the molten plastic.

[0022] Fig. 6C is a plan view of a transparent embodiment of the device molded in Fig. 6B, removed from the mold and with excess capillary tubes being illustrated.

[0023] Fig. 6D is a plan view of a transparent embodiment of the device of Fig. 6C, with excess capillary tubes cut off.

DETAILED DESCRIPTION

[0024] While the invention can be embodied in many different forms, there is shown in the drawings and discussed herein a few specific embodiments with the understanding that the present disclosure is to be considered only as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments illustrated.

[0025] Referring now to Fig. 1, a perspective view of a prior art device 10 for performing surgery such as c-sections, as described in Lafauci, et al., U.S. Pat. 7,881,885, having a handle 11 with grips 13 and blade 12 is illustrated. The invention in certain embodiments is an

improvement to the Lafauci c-section device, but of course the invention can be used to improve a very wide variety of other single use devices or can make it possible to make devices which have historically been for multiple use into single use versions.

[0026] Fig. 2 is a perspective view of a single use device 13 for performing c-sections illustrating an embodiment of the invention having capillary tubes 16A-16E molded into handle 11 having openings 15 at locations which will come into contact with bodily fluid such as amniotic fluid and blood during a C-section when the device 13 is used. The bodily fluid is drawn into the capillary tubes by capillary action and therefore the capillary tubes must be of suitable small diameter to perform their intended function.

[0027] A transparent window 17 is provided in handle 11 for viewing at least one of the capillary tubes 16A-16E. The visible portion of the capillary tubes 18 can be viewed through transparent window 17. Thumb rest protrusions 19 are provided in this embodiment.

[0028] Fig. 3 is a top plan view of the device of Fig. 2 wherein the portion 18 of capillary tubes 16A-16E visible through window 17 of the capillary tubes is shown.

[0029] Fig. 4A is an off-center cross-section through IV-IV of Fig. 2 wherein the plane of view is above the blade 12. In this embodiment, the capillary tubes 16 are preformed.

[0030] Fig. 4B illustrates blood 20 being drawn into capillary tubes 16. [0031] Fig. 5A is a cross- sectional view of a mold 22 being filled with molten plastic 24 to form a device 13 according to the invention wherein molten plastic 24 is introduced through gate 23 and fills mold cavity 21 wherein the mold includes steel mandrels 25 at locations where capillary tubes are desired.

[0032] Fig. 5B illustrates the mold of Fig. 5A with the mold cavity 21 being filled with molten plastic.

[0033] Fig. 5C is is a cross section of transparent embodiment of the device 13 molded in Fig. 5B, removed from the mold and with excess capillary tubes 26 being cut off to form a final device. Capillary tubes 26 differ from capillary tubes 16 in Figs. 4A-4B and 6A-6D in that capillary tubes 26 are formed in situ in the mold around the mandrels 25.

[0034] Fig. 6A is a cross-sectional view of a mold cavity 21 being filled with molten plastic 24 to form a device according to the invention wherein the capillary tubes 16 with mandrels 25 are preformed and placed in the mold cavity 21. The mandrels 25 are used to prevent the preformed capillary tubes 16 from collapsing during the molding process.

[0035] Fig. 6B is the cross-sectional view of the mold cavity 21 of Fig. 6A wherein the mold has been filled and handle 14 has been formed, carrying blade 12.

[0036] Fig. 6C is a plan view of a transparent embodiment of the device 13 molded in Fig. 6B, removed from the mold and with excess capillary tubes being illustrated.

[0037] Fig. 6D is a plan view of a transparent embodiment of the device 13 of Fig. 6C, with excess capillary tubes 16 cut off.

[0038] When the plastic handle 14 is manufactured with capillary veins 16 or 25, it is preferably made of clear plastic, such as Lexan polycarbonate or the like. The clear or partially clear plastic allows the user to readily notice that the device has sucked up blood or bodily fluids.

[0039] In operation the capillary action that is built into the plastic handle sucks up blood or fluids when the device comes in contact with blood or fluids during routine use of the device.

[0040] Any plastic or metal or other material making up the body or various parts of a medical device can be manufactured with capillary veins that run from a proximal end to the location in contact with body fluids, and away from that area, creating a vein or other pattern that will suck up fluid during the procedure, thereby clearly demonstrating the device has been used and no longer sterile. [0041] Among the bodily fluids which devices of the invention may come in contact with are, for example, blood, urine, saliva, tears, ear wax, and feces, plasma, interstitial fluid, extracellular fluid, intracellular fluid, lymph fluid, and milk.

[0042] One example is for a clear type plastic or similar material to have one or more capillary veins created during manufacturing. Another is for capillary tubes to be embedded into the device during manufacture. Another is to have capillary tubes attached to sides of device towards the end or after manufacturing of the base device. Plastic capillary tubes can be sonically or otherwise welded post manufacture. This can be surface, or if available, a groove can be left in the device where the capillary tube will be attached.

[0043] The capillary tubes or channel can be straight or curved.

[0044] The capillary tubes can be made as channels within the device, or independent tubes placed within the mold during manufacturing, or can be externally attached, or in grooves or slots or openings or positions, left in place for the purpose of attaching the capillary tubes.

[0045] The capillary tubes filled with blood and / or body fluids will be difficult to clean out, and further, very difficult to resterilize, thereby prompting the safer route of using a new sterile device.

[0046] The stainless steel blade is inserted in place during the molding process.

[0047] The diameter of the capillary channels can vary depending on efficiency in drawing up various bodily fluids during first use. In general the inside diameter of the tubes can vary, depending on a particular intended application, the expected type of bodily fluid to be drawn in to the tube or tubes by capillary action, and other factors. Usually the diameter of the tube will be from about 1 mm to about 2 mm, although lower and greater diameters can be used as long as they function effectively to draw bodily fluids during use. In some embodiments the inside diameter of the tubes is about 1.3 mm. However, variations would be expected based on overall dimensions and actual use conditions for the device.

[0048] The current invention takes direct aim at preventing the reprocessing and reuse of single use devices, which have been manufactured and sterilized at performance standards for only a single use cycle.

[0049] Single use devices can be compromised by the various methods of sterilization, gas, gamma, heat, solution. Porous plastics and combination plastic and metal devices, can fail under stressed conditions. Without proper testing of sterilization methods, these are rendered unsafe for reuse.

[0050] The present invention, therefore, is well adapted to carry out the objects and attain the ends and advantages mentioned, as well as others inherent therein. While the invention has been depicted and described and is defined by reference to particular preferred embodiments of the invention, such references do not imply a limitation on the invention, and no such limitation is to be inferred. The invention is capable of considerable modification, alteration and equivalents in form and function, as will occur to those ordinarily skilled in the pertinent arts. The depicted and described preferred embodiments of the invention are exemplary only and are not exhaustive of the scope of the invention. Consequently, the invention is intended to be limited only by the spirit and scope of the appended claims, giving full cognizance to equivalents in all respects.

Claims

CLAIMS What is claimed is:

1. A single use medical device comprising a body and a capillary tube having a first open end and a second open end adapted to draw up liquid when said first or second open end comes in contact with a bodily fluid during a first use of said medical device, thereby rendering said medical device non-steralizable.

2. The single use medical device of claim 1 wherein said bodily fluid is one or more fluid selected from the group consisting of blood, urine, saliva, tears, ear wax, and feces, plasma, interstitial fluid, extracellular fluid, intracellular fluid, lymph fluid, and milk.

3. The single use medical device of claim 1 wherein said body is molded of a material selected from the group consisting of polycarbonate, acrylic, polyurethane, ABS, ceramic, silicone, and metal.

4. The single use device of claim 1 wherein the tubes are molded in said body

5. The single use device of claim 1 wherein the tubes are applied to the outside of the body.

6. The single use device of claim 1 wherein the tubes are applied in grooves on said body.

7. The single use device of claim 1 wherein the tubes are preformed and applied on said body or are placed in an injection mold during manufacture so that the tubes are within said body.

8. The single use device of claim 1 wherein the tubes have an inside diameter which causes the tube to draw in fluid by capillary action.

9. The single use device of claim 1 wherein the tubes have an inside diameter of about 1 to 2 mm.

10. The single use device of claim 1 wherein the tubes have an inside diameter of about 1.3 mm.

11. The single use medical device of claim 1 wherein presence of bodily fluid drawn into a capillary tube is visible either at the end of the tube or along a portion of the length of the tube and functions as an indication that the single use device has been used.

12. The single use medical device of claim 1 wherein the body is comprised of a material selected from the group consisting of molded plastic, metal, ceramic, and silicone.