Elastomeric articles with embedded electronic devices and methods of making the same

Abstract

A method for manufacturing a medical component comprises: preparing a first sheet of elastic material; arranging at least one electronic device in the first sheet of elastic material to obtain an elastic preform; and arranging the elastic preform in a mold and molding the elastic preform in the mold to cure the elastic material and form the medical component with the at least one electronic device embedded therein.

Description

[0001] This application is a divisional application of the patent application with application number 201880037372.8, application date June 6, 2018, and invention name “Elastomer article with embedded electronic devices and manufacturing method thereof”. Technical Field

[0002] The present invention relates generally to elastomeric articles having electronic devices embedded therein, and more particularly to molded elastomeric articles having one or more embedded electronic devices.

[0003] The present invention relates to a method of manufacturing a component (such as a piston, plunger, closure or stopper) of a medical device (such as a cartridge, syringe or vial), the component comprising a molded elastomeric body and at least one electronic device embedded in the elastomeric material of the component and completely encapsulated thereby. Background Art

[0004] It is desirable to enable a drug delivery device to communicate the device's operating status (e.g., pre-use and / or dosing completion status), identification information, other conditions (e.g., ambient temperature), etc. to enable patient monitoring or for similar purposes. Such devices are referred to as "smart" devices.

[0005] Conventional "smart" devices tend to include multiple parts of at least two different materials. For example, a known syringe plunger device is formed of two pieces, one piece is formed of an elastic material, and the other piece is formed of a different plastic or elastic material, with an electronic circuit at the interface between the two plunger pieces. Other conventional "smart" devices include conventional electronic components (including sensors) in the plunger, where the electronic components are encapsulated in a first part formed of a first elastic material that can be formed at a lower temperature that the electronic components can withstand, and then the first part is encapsulated in a second elastic material to form the plunger. That is, the prior art smart plunger is a three-piece plunger.

[0006] The present invention provides new and improved methods of making elastomeric articles with embedded electronics for containing medications. For example, embodiments of the methods of the present invention avoid thermal damage to sensitive electronics and ensure complete encapsulation and protection of sensitive electronics from operating environmental conditions. The methods of the present invention also allow for better control over how the electronics are positioned and can better address the requirements of the electronics. Summary of the invention

[0007] The present invention relates to a method of manufacturing a component (such as a piston, plunger, closure or stopper) of a medical device (such as a cartridge, syringe or vial), the component comprising a molded elastomeric body and at least one electronic device embedded in the elastomeric material of the component and completely encapsulated thereby.

[0008] A preferred embodiment of the present invention relates to a method for manufacturing a medical component. The method comprises: preparing a first elastic material sheet; arranging at least one electronic device in the first elastic material sheet to obtain an elastic preform; and arranging the elastic preform in a mold and molding the elastic preform in the mold to cure the elastic material and form a medical component having the at least one electronic device embedded therein.

[0009] Another preferred embodiment of the present invention is directed to a method of manufacturing a medical component. The method includes preparing a tube of an uncured or partially cured elastic material. The tube has a first end, an opposite second end, and a hollow interior extending between the first end and the second end. The method also includes: arranging at least one electronic device in the hollow interior to obtain an elastic preform; and subjecting the elastic preform to a molding process selected from the group consisting of: compression molding, bladder molding, and thermoforming, so as to cure the elastic material and form a medical component having the at least one electronic device embedded therein.

[0010] Another preferred embodiment of the present invention is directed to a method of manufacturing a medical component. The method includes molding a shaped piece of elastomeric material. The shaped piece has an inverted shape of the medical component to be formed. The method also includes: arranging at least one electronic device in contact with the shaped piece; and inverting the shaped piece on the at least one electronic device to form a medical component with the at least one electronic device embedded therein.

[0011] Another preferred embodiment of the present invention is directed to a method of manufacturing a medical component, the method comprising: molding the medical component from an elastomeric material using one or more molding processes; and inserting at least one electronic device into a body of the molded medical component.

[0012] Another preferred embodiment of the present invention is directed to a method of manufacturing a medical component, the method comprising molding a first member of the medical component with an elastic material. The first member comprises a first end defined by a closed bottom wall, a second end opposite to an open end, a side wall extending between the first end and the second end, and an internal recess configured to accommodate a portion of at least one electronic device. The method further comprises: positioning the at least one electronic device within the recess of the first member to form an assembly; and overmolding the assembly with the elastic material to form a medical component having at least one electronic device embedded therein.

[0013] Another preferred embodiment of the present invention relates to a component for a container to be filled with a dispensed drug, the component comprising an integral body formed of an elastic material and at least one electronic device embedded in the integral body and encapsulated by the elastic material, wherein the integral body is configured to contact the inner surface of the container.

[0014] Another preferred embodiment of the present invention relates to a component for a container to be filled with a pharmaceutical drug, the component comprising an integral body formed of an elastic material and at least one magnetic material embedded in the integral body and encapsulated by the elastic material, wherein the integral body is configured to contact the inner surface of the container.

[0015] Another preferred embodiment of the present invention relates to a container containing insulin or its derivatives, preparations or analogs, and a component made of an elastic material and including at least one electronic device or at least one magnetic material embedded therein.

[0016] Advantageous developments of the invention can be implemented individually or in combination with one another. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the invention, the drawings show presently preferred embodiments. However, it should be understood that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0018] Figure 1A-1B A method for manufacturing a medical component in a one-step molding process according to a preferred embodiment of the present invention is shown;

[0019] Figure 2A-2E A method for manufacturing a medical component in a one-step molding process according to other preferred embodiments of the present invention is shown;

[0020] Figures 3A-3H Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0021] Figures 4A-4C Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0022] Figures 5A-5C Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0023] Figure 6A medical component including an electronic device embedded in the medical component according to another preferred embodiment of the present invention is shown;

[0024] Figure 7 Schematically illustrates a method for manufacturing a medical component according to another preferred embodiment of the present invention;

[0025] Figure 8 Schematically illustrates a method for manufacturing a medical component according to another preferred embodiment of the present invention;

[0026] Figures 9A-9C A method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention is shown;

[0027] Figures 10A-10C Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0028] Figures 11A-11B Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0029] Figures 12A-12B Schematically illustrating a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0030] Figures 13A-13C Shown for Figures 12A-12B and different configurations of the push rod or needle provided with an electronic device in the methods shown in 14-16;

[0031] Fig.14 The schematic diagram shows the use of a preferred embodiment according to the present invention. Figures 13A-13C A method for embedding an electronic device in a medical component by using a push rod or needle as shown in FIG.

[0032] Fig.15 is a schematic diagram of a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0033] Fig.16 is a schematic diagram of a method for manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention;

[0034] Figures 17A-17C A medical component having slots of various configurations according to another preferred embodiment of the present invention is shown;

[0035] Figures 18A-18C A method for manufacturing a medical component in a two-step molding process according to another preferred embodiment of the present invention is shown;

[0036] Figures 19A-19C A method for manufacturing a medical component in a two-step molding process according to another preferred embodiment of the present invention is shown;

[0037] Figures 20A-20B is through Figures 19A-19C A cross-sectional view of a portion of a component manufactured by the method shown in ;

[0038] Figures 21A-21D A method for manufacturing a medical component in a two-step molding process according to another preferred embodiment of the present invention is shown;

[0039] Figures 22A-22D Shown by Figures 21A-21D Various medical components manufactured by the method shown in; and

[0040] Figures 23A-23B A method of manufacturing a medical component in a one-step molding process according to another preferred embodiment of the present invention is shown. DETAILED DESCRIPTION

[0041] In the following description, certain terms are used for convenience only and not for limitation. The words "proximal", "distal", "upward", "downward", "bottom" and "top" refer to directions in the drawings to which reference is made. According to the present invention, the words "inwardly" and "outwardly" refer to directions toward and away from the geometric center of the device and its designated parts, respectively. Unless expressly set forth herein, the terms "a", "an" and "the" are not limited to one element, but should be interpreted as meaning "at least one". The terms include the words noted above, their derivatives, and words of similar meaning.

[0042] Referring to the drawings in detail, wherein like numerals refer to like elements throughout the several views, Figure 1A-23B A preferred embodiment of a medical component 10 of a medical device having an electronic device 12 embedded therein and a method of manufacturing such a medical component 10 is shown. For the sake of brevity, the medical component 10 will be referred to as a "medical component" below. It will be understood that the medical component 10 can be used in any known medical device, and more particularly, can be used in any container having a cavity or chamber that can be filled with a substance. For example, the container can be, but is not limited to, a syringe, a cartridge, a vial, etc. More particularly, the medical device can be a cartridge, a syringe with a needle, a needle-free syringe, an inhaler, a solid dosage form dispenser, a pen-type injector, an automatic injector, a wearable injector, a vial, etc.

[0043] Those skilled in the art will appreciate that the term "piston" may be used interchangeably herein with the terms "plunger," "stopper," "closure," and the like.

[0044] The medical component 10 is preferably made of a polymer material, and more preferably made of an elastic material. In a preferred embodiment, the elastic material is a thermosetting elastomer or a thermoplastic elastomer (TPE). For example, the elastic material used for the elastomeric closure can be, for example, a synthetic rubber or a natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber (e.g., bromobutyl rubber), ethylene propylene terpolymer, silicone rubber, combinations thereof, etc. Preferably, the elastic material is a butyl or halogenated butyl elastomer.

[0045] The medical component 10 can be, for example, a cartridge piston (plunger, stopper or closure), a syringe piston (plunger, stopper or closure), a vial piston (plunger, stopper or closure), a seal, a gasket, a component of a prefilled syringe, a sleeve or a container stopper, a tempered ball, a top cover, a liner, a gasket, or any other component / device that can contact a pure pharmaceutical material or a drug. In a preferred embodiment, the pharmaceutical drug that can be used with the medical component 10 is insulin (or any derivative, formulation or analog thereof). For example, as used herein, the term "insulin" refers to insulin, insulin analogs, insulin derivatives or mixtures thereof, including human insulin or human insulin analogs or derivatives. Examples of insulin analogs include, but are not limited to: Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin or Des(B30) human insulin. Examples of insulin derivatives include, but are not limited to: B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB 29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithochyl-Y-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0046] In particular, for some diabetics, the dosage changes frequently and needs to be calculated based on meals, time and preparations. Therefore, patients may have to inject insulin multiple times a day, such as rapid-release (mealtime) insulin or long-acting (once a day) insulin. The intelligent device of the present invention is convenient for calculating dosage, tracking dosage (that is, which medicine, amount and time) and preventing accidental overdose / insufficiency of dosage. Therefore, the improved integration of insulin therapy can obviously help minimize the impact of diabetes on patients and help to provide feedback for caregivers to better manage treatment. This dosage calculation / tracking feature is also useful for many other types of prescription drugs and many other types of diseases or illnesses, such as but not limited to multiple sclerosis and arthritis. The intelligent device of the present invention is particularly relevant to biopharmaceuticals / enzymes, for example, for monitoring transportation conditions (for example, ensuring cold chain and / or dark storage to maintain drug efficacy), because these types of drugs are significantly less stable than many other drugs, and therefore will benefit from "smart" technology to ensure consistency and patient safety. However, it will be understood that medical component 10 can be used with any known or undeveloped prescription drugs.

[0047] For the sake of brevity, the invention is generally described herein with reference to a syringe piston or plunger tip.

[0048] The electronic device 12 may include any known electronic circuit, electronic coding, microprocessor, sensor, etc. For example, the electronic device 12 may include one or more of the following: an integrated circuit (or electronic chip or microchip), a radio frequency identification (RFID) chip / coil / antenna and supporting components, a near field communication (NFC) chip, an EEPROM chip, a solid-state memory, a muscle wire, a piezoelectric sensor or actuator, a thermal sensor (e.g., a thermistor or a PTC thermistor), a pressure sensor, a liquid level sensor, a dosage sensor, a mechanical sensor, an electromagnetic sensor, an optical sensor, a pneumatic sensor, a hydraulic sensor, a photosensitive sensor, a flow sensor, a power source (e.g., an RF induction coil, a micro button battery, a supercapacitor), a tactile feedback device (e.g., an LED or a piezoelectric device), etc. The electronic device 12 may further be equipped with a communication unit, preferably a wireless communication unit, through which the content of the stored data can be retrieved on demand. For example, the electronic device 12 may include an RFID element that enables wireless communication with a corresponding reading device. In this way, counterfeit medical components can be easily detected.

[0049] For all embodiments disclosed herein, the time, heat, and pressure of each molding step will depend on various factors, such as the specific elastomeric material used, and whether the desired result is partial curing of the elastomeric material or complete curing of the elastomeric material. Such elastomeric materials and molding processes (e.g., compression molding, injection molding, overmolding, etc.) are well known in the art, and a detailed description of the time, temperature, and pressure specifications for each molding step is not necessary for a complete understanding of the present invention. For example, each molding step of the embodiments disclosed herein is preferably performed at a temperature of about 120° C. to 310° C. and a pressure of about 40 kg / cm 2 Up to 350kg / cm 2 The process is carried out under a pressure of for a few seconds (e.g., less than 10 seconds) to 30 minutes, and more preferably at a temperature of about 120° C. to 220° C. and about 40 kg / cm 2 Up to 70kg / cm 2 for about 30 seconds to 30 minutes, most preferably at a temperature of about 140°C to 220°C and a pressure of about 40 kg / cm 2 Up to 70kg / cm 2 The reaction mixture is stirred at 400 °C for about 2 minutes to 15 minutes under pressure.

[0050] Those skilled in the art will appreciate that for heat-sensitive devices, the medical component 10 may be molded so that only a partial cure occurs. Thereafter, the medical component 10 may be post-cured, if desired, by a secondary process such as oven post-curing, microwave curing, electron beam curing, etc. For example, the post-curing process may be performed at a temperature of about 120° C. to 310° C. for up to 24 hours.

[0051] refer to Figures 1A-2E , various embodiments of a method for manufacturing a medical component 10 using a mold 14 and a first elastomer sheet 16 in a one-step molding process, more particularly in a one-step compression molding process, are shown. The mold 14 includes an upper mold half 15 having an open cavity 15a and a lower mold half 17 having an open cavity 17a. Each open cavity 15a, 17a is preferably an open heated mold cavity. In a preferred embodiment, the mold 14 includes a plurality of upper mold halves 15 and lower mold halves 17, and corresponding open cavities 15a, 17a arranged in an array.

[0052] The first elastomeric sheet 16 is preferably formed of one or more elastomeric materials (ie, one or more of the above-mentioned elastomeric materials) in a partially cured stage. The process conditions of this molding step are about 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2of about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and about 40 kg / cm 2 Up to 70kg / cm 2 The first elastomeric sheet 16 is thus essentially an elastomeric preform. The first elastomeric sheet 16 has a first surface 19 and an opposing second surface 21 .

[0053] exist Figure 1A-1B In the embodiment of the present invention, the bottom surface 23 of the open cavity 17a of the lower mold half 17 defines a flat surface. The bottom surface 23 also corresponds to the inner bottom surface of the lower mold half 17. The first elastomeric sheet 16 includes at least one electronic device 12 arranged or embedded therein. More specifically, the electronic device 12 is positioned within the first elastomeric sheet 16 so that the exposed surface or distal surface 12a of the electronic device 12 is flush with the second surface 21. In a preferred embodiment, the first elastomeric sheet 16 includes a plurality of electronic devices 12 arranged in an array corresponding to the array of the open cavities 15a, 17a.

[0054] exist Figure 1A-1B In an embodiment of the present invention, the first elastomeric sheet 16 further includes a protective film 24 or barrier film on the side of the second surface 21. The protective film 24 has a first surface 26 and an opposite second surface 28. The protective film 24 is provided so as to cover the distal surface 12a of each electronic device 12, so that the first surface 26 of the protective film 24 is in direct contact with the distal surface 12a of each electronic device 12. It will be understood that the protective film 24 can be provided only in the area of ​​the electronic device 12 or can be provided so as to cover the entire second surface 21 of the first elastomeric sheet 16.

[0055] In accordance with Figure 1A-1BIn the manufacturing method of an embodiment of the present invention, the first elastomer sheet 16 is positioned on the lower mold half 17 so that the position of each electronic device 12 is aligned with the position of the corresponding open cavity 17a. In the assembly position, the second surface 28 of the protective film 24 is in contact with the bottom surface 23 and more particularly directly in contact. Each electronic device 12 is preferably maintained in an appropriate position within the open cavity 17a by vacuum assistance. The assembly is then subjected to compression molding to fully cure the elastic material. More particularly, the mold 14 is closed so that each upper mold half 15 covers each corresponding lower mold half 17, and heat and pressure are applied to cause the elastic material of the first elastomer sheet 16 to flow, thereby forcing the flowing elastic material to contact all areas of each open cavity 15a, 17a until the elastic material has been cured to form the medical component 10.

[0056] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0057] The resulting cured shape includes one electronic device 12 per mold portion. Each resulting medical component 10 includes one electronic device 12 that is completely encapsulated by the cured elastomeric material 30 and the protective film 24. The protective film 24 can be any polymer or ceramic film that will enable an electrical or optical path to the electronic device 12, but still provide barrier properties for the encapsulation of the electronic device 12. In a preferred embodiment, the protective film 24 is a fluoropolymer film. Preferably, the fluoropolymer protective film 24 is disposed on a surface of the medical component 10 that is configured to contact the dispensed drug (i.e., the interface or contact surface).

[0058] Fluoropolymers are well known in the art, and a detailed description of fluoropolymers is not necessary for a complete understanding of the present invention. Examples of fluoropolymers include, but are not limited to, polytetrafluoroethylene (PTFE), homopolymers and copolymers of tetrafluoroethylene (TFE), perfluoroalkoxy polymer resins (PFA), copolymers of hexafluoropropylene and tetrafluoroethylene, polyethylene tetrafluoroethylene (PETFE), polyvinyl fluoride (PVF), fluorinated ethylene propylene copolymers (FEP), polyethylene chlorotrifluoroethylene (PECTFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE) and derivatives thereof. Preferably, the protective film 24 is made of form.

[0059] exist Figure 2A-2E In the embodiment of the present invention, the bottom surface 23 of the opening cavity 17a of each lower mold half 17 is recessed so as to be spaced apart from the first elastomer sheet 16 in the assembly position. Therefore, during compression molding, the elastic material of the first elastomer sheet 16 can flow into the space between the first elastomer sheet 16 and the bottom surface 23, so that the electronic device 12 is completely encapsulated by the elastic material. Figure 2A-2E In the embodiment of the present invention, the first elastomeric sheet 16 does not need to include the protective film 24.

[0060] exist Figure 2A In an embodiment of the present invention, each lower mold half 17 includes at least one protrusion 32, and more preferably a plurality of protrusions 32, for holding the electronic device 12 in place within the open cavity 17a during the compression molding process, for example, to keep the electronic device 12 centered. More particularly, the plurality of protrusions 32 form a base 18 on which the first elastomeric sheet 16 and more particularly the electronic device 12 rests during compression molding, such that the distal surface 12a of the electronic device 12 is spaced apart from the bottom surface 23 of the cavity 17a. Thus, during compression molding, the electronic device 12 is securely held in place, and the elastic material can flow into the space between the electronic device 12 and the bottom surface 23, such that the electronic device 12 is completely encapsulated by the elastic material in the finished medical component 10. Due to the interaction between the base 18 and the first elastomeric sheet 16 during the compression molding process, the finished medical component 10 can include a plurality of recesses or voids 34 at locations corresponding to the locations of the distal ends of the protrusions 32 of the base 18.

[0061] exist Figure 2BIn the embodiment of the present invention, a plurality of electronic devices 12 are embedded in the first elastomeric sheet 16, so that both the opposite distal surfaces 12a and the proximal surfaces 12b of the electronic devices 12 are exposed. The openings 15a, 17a of the upper and lower mold halves 15, 17 are recessed in the respective walls of the upper and lower mold halves 15, 17, so that during compression molding, the elastic material flows around the electronic devices 12, thereby ensuring that the electronic devices 12 are completely encapsulated by the elastic material in the finished medical component 10.

[0062] exist Figure 2E In one variation shown in , the first elastomeric sheet 16 is subjected to freezing temperatures (i.e., frozen) prior to being positioned in the mold 14. This enables the first elastomeric sheet 16 to better maintain its shape during a portion of the curing cycle and also allows for excellent control of the placement of the encapsulated electronic devices 12 during the one-step molding process. The frozen first elastomeric sheet 16 is then positioned over the lower mold half 17 so that the position of each electronic device 12 is aligned with the position of the corresponding open cavity 17a. The bottom surface of the cavity 17a of each lower mold half 17 is recessed so as to be spaced apart from the first elastomeric sheet 16 in the assembled position.

[0063] Next, the second elastomer sheet 44 is positioned above the frozen first elastomer sheet 16. However, the second elastomer sheet 44 is not frozen. Therefore, during the molding process (e.g., compression molding), the elastic material of the second elastomer sheet 44 flows faster than the elastic material of the frozen first elastomer sheet 16 to allow better control of the alignment of the electronic device 12 during compression molding. The elastic material of the first elastomer sheet 16 and the second elastomer sheet 44 are able to flow into the space of each open cavity 15a, 17a so that each electronic device 12 is completely encapsulated by the elastic material. It will be understood that the first elastomer sheet 16 and the second elastomer sheet 44 can be formed of the same elastic material or different elastic materials.

[0064] The process conditions of the molding step are about 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0065] exist Figure 2C In an embodiment of the present invention, the lower mold half 17 includes a protrusion 36 that cooperates with a corresponding recess 38 formed in the electronic device 12 to hold the electronic device 12 in place during compression molding. The protrusion 36 is therefore an alignment pin. In another embodiment, the protrusion 36 and the recess 38 can be provided with mating threads. Similarly, the openings 15a, 17a of the upper mold half 15 and the lower mold half 17 are recessed in the corresponding walls of the upper mold half 15 and the lower mold half 17, so that during compression molding, the elastic material flows around the electronic device 12, thereby ensuring that the electronic device 12 is completely encapsulated by the elastic material in the finished medical component 10.

[0066] Figure 2D An embodiment is depicted in which the electronic device 12 includes a protrusion 40 that cooperates with a corresponding recess 42 formed in the wall of the lower mold half 17. The body of the electronic device 12 is embedded in the first elastomeric sheet 16, similar to Figure 2B , and the protrusion 40 extends outwardly from the first elastomeric sheet 16. In another embodiment, the protrusion 40 and the recess 42 may be provided with mating threads. Likewise, the openings 15a, 17a of the upper and lower mold halves 15, 17 are recessed in the respective walls of the upper and lower mold halves 15, 17, so that during compression molding, the elastic material flows around the electronic device 12, thereby ensuring that the electronic device 12 is completely encapsulated by the elastic material in the finished medical component 10.

[0067] refer to Figures 3A-3H , shows an embodiment of a method for manufacturing a medical component 10 using an elastomeric tube 116 in a one-step molding process. The molding process can be any known molding process (e.g., compression molding, injection molding, etc.). The elastomeric tube 116 is preferably formed of one or more elastomeric materials (i.e., one or more of the above-mentioned elastomeric materials) in an uncured or partially cured (i.e., semi-cured) state. The process conditions of the molding step are 120° C. to 310° C. and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0068] The elastomeric tube 116 is essentially an elastomeric preform. The elastomeric tube 116 is generally cylindrical with a hollow interior 123 and has a first end 119 and an opposite second end 121. The portion of the tube 116 including the first end 119 is hereinafter referred to as the first half of the tube 116, and the portion of the tube 116 including the second end 121 is hereinafter referred to as the second half of the tube 116.

[0069] After forming the uncured or semi-cured elastomeric tube 116, one or more electronic devices 12 are positioned within the hollow interior 123 of the tube 116. Next, one of a variety of processes may be performed to secure the electronic device 12 in place. For example, Figure 3C As shown, the first and second halves of the tube 116 can be crimped or clamped together while the elastic material remains soft, pliable and tacky to maintain the electronic device 12 in place. Figure 3D As shown, an extruded elastomeric rod or plug 124 may be positioned within the hollow interior 123 in the first and second halves (i.e., on either side of the electronic device 12) to secure the electronic device 12 in place. Figure 3E As shown, preformed elastic sheets 126 (each of which includes one or more protrusions 128) can be positioned on either end 119, 121 of tube 116 so that protrusions 128 are received within hollow interior 123 of tube 116, thereby securing electronic device 12 in place. Alternatively, if electronic device 12 has already sufficiently secured itself within hollow interior 123 (e.g., due to its size), no further processing is required, such as Figure 3F Those skilled in the art will appreciate that it is possible to perform Figures 3C-3F A combination of the aforementioned processes. For example, Figure 3C The process can be used on the first half of the tube 116, while Figure 3D The process may be used on the second half of tube 116 .

[0070] Finally, if Figure 3G-3H As shown, an uncured or semi-cured elastomeric tube 116 having an electronic device 12 fixed therein is placed within the mold 114, and heat and pressure are applied to cause the elastic material of the elastomeric tube 116 to flow, and the flowing elastic material fills any voids (i.e., within the hollow interior 123) while maintaining the electronic device 12 centered (see Figure 3H The molding process is performed under predetermined time, heat and pressure conditions until the elastic material has solidified to form the medical component 10 .

[0071] The mold 114 includes an upper mold half 115 having an open cavity 115a and a lower mold half 117 having an open cavity 117a. Each open cavity 115a, 117a is preferably an open heated mold cavity. In a preferred embodiment, the mold 114 includes a plurality of upper mold halves 115 and lower mold halves 117, and corresponding open cavities 115a, 117a arranged in an array. Therefore, a plurality of semi-cured elastomer tubes 116 having electronic devices 12 fixed therein can be simultaneously compression molded to form the medical component 10.

[0072] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0073] refer to Figures 4A-4C , shows an alternative embodiment for preparing an uncured or semi-cured elastomeric tube 116 and an electronic device 12 assembly. Specifically, referring to Figure 4A , an uncured or semi-cured elastic sheet 130 can be formed under predetermined time, heat and pressure conditions in a molding step / process. The process conditions of the molding step are 120°C to 310°C and about 40kg / cm2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0074] The sheet 130 is a generally planar and flat sheet having a first end 132 and an opposite second end 134. The electronic device 12 is placed on the planar surface of the sheet 130 proximate to the first end 132 and more particularly proximate to the geometric center of the first end 132. The first end 132 of the sheet 130 is then rolled over the electronic device 12 and continues to roll toward the second end 134. Thus, the sheet 130 is wrapped around the electronic device 12, thereby forming an uncured or semi-cured elastomeric tube 116 having the electronic device 12 positioned within the center of the hollow interior 123 of the tube 116, as shown in 4B-4C. Next, the tube 116 and the electronic device 12 are subjected to the above-referenced Figures 3A-3H The fixing and molding processes described above are used to form the medical component 10.

[0075] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0076] Alternatively, if Figures 5A-5C As shown, a plurality of tubes 116 can be formed simultaneously. Specifically, a plurality of electronic devices 12 are placed on the surface of the semi-cured elastic sheet 130 at spaced intervals near the first end 132 (see Figure 5A ). Next, we will Figure 4A In the same manner as described above, the sheet 130 is rolled up on the electronic device 12 and wrapped around the electronic device 12. Next, refer to Figure 5B-5C , to separate the spaced apart cutting sheets 130 of the electronic devices 12, thereby forming a plurality of semi-cured elastomeric tubes 116, each tube 116 having an electronic device 12 positioned within the center of its hollow interior 123. Finally, each tube 116 and electronic device 12 is subjected to the above-described conditions of time, heat, and pressure. Figures 3A-3H The fixing and molding processes are described to form a plurality of medical components 10 .

[0077] refer to Figure 6-8 , shows another embodiment of a method for manufacturing a medical component 10 in a one-step molding process (e.g., compression molding, injection molding, secondary molding, etc.). Specifically, the electronic device 12 is initially embedded in a form 86 or a receiving member formed of a heat-resistant and elastic material. More particularly, the form 86 is preferably formed of a thermally stable material. For example, the form 86 can be formed of materials including but not limited to: ceramic materials, including but not limited to alumina or silicates (e.g., quartz, porcelain, or glass); metal materials, including but not limited to stainless steel, titanium, aluminum, and / or anodized aluminum; or polymer materials, including but not limited to polyamides, fluoropolymers (including but not limited to polytetrafluoroethylene (PTFE) or glass fiber PTFE), or polyaryletherketones (PAEK) (including but not limited to polyetherketoneketone (PEKK), polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), and polyetheretherketone (PEEK)). In one embodiment, the form 86 may include an insulating material such as a foam or aerogel for thermal insulation, or a high temperature resistant polymer for electronic isolation of the electronic device 12. Such a material would have various advantages. For example, by providing thermal insulation, cryogenic storage can be used to minimize the time that the electronic device 12 is exposed to high temperatures. Furthermore, a mechanically strong forming member 86 is preferred so that particularly fragile or sensitive electronic devices 12, such as micro-electromechanical systems or shock / acceleration sensors, can be used.

[0078] Preferably, the size and shape of the former 86 corresponds to the desired size and shape of the medical component 10 to be formed.

[0079] Next, in one embodiment, Figure 6 As shown, the molded part 86 having the electronic device 12 is placed in the mold, and the elastic material 30 is overmolded onto the molded part 86 under predetermined time, heat and pressure conditions to form the medical component 10 including the elastic material 30. The process conditions of this molding step are 120° C. to 310° C. and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0080] In one variation, for example, where the form 86 is formed from a metallic material, the mold may be provided with a magnetic material (not shown) to facilitate accurate positioning and placement of the form 86 during molding.

[0081] In another embodiment, Figure 7 As shown, an uncured or semi-cured elastomeric tube 116 as described above, and more particularly an uncured or semi-cured integral elastomeric tube 116, is formed, and a forming piece 86 provided with an electronic device 12 is inserted into the hollow interior 123 of the tube 116. More particularly, the tube 116 is stretched over the outer surface of the forming piece 86 and mechanically formed to the forming piece 86. Thereafter, the assembly is subjected to the application of heat and pressure to cure and shrink-wrap the elastic material of the tube 116 to the forming piece 86. For example, a bladder molding process may be employed to thermoform the elastic material of the tube 116 around the hard body of the forming piece 86 and provide a sufficiently smooth surface for sealing performance.

[0082] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0083] Alternatively, a process may be employed in which the elastomeric material of the uncured or semi-cured elastomeric tube 116 is compression molded and simultaneously rolled onto a smooth surface or wheel to impart specific surface properties.

[0084] exist Figure 7 In a variation of the embodiment of , a sealing element (not shown), such as an O-ring, may be utilized during the heating step to ensure that the elastomeric material of the uncured or semi-cured elastomeric tube 116 is completely sealed to the form 86. In one embodiment, the elastomeric material of the tube 116 is hermetically sealed to the form 86 to provide additional barrier properties by completely enclosing any impurities associated with the material used to form the form 86 having the electronic device 12 embedded therein.

[0085] In one embodiment, Figure 8 As shown, instead of using an elastic material 30, or an uncured or semi-cured elastomeric tube 116, a plurality of sealing elements 152, such as O-rings, are utilized. The molded member 86 is generally Figure 6-7 The same as the molded part. However, a plurality of substantially equidistant, axially spaced and radially extending sealing elements 152 are disposed around the molded part 86, rather than the elastic material 30 of the previous embodiment of the present invention, or the uncured or semi-cured elastomeric tube 116. The assembly is then subjected to a compression molding process to form the medical component 10. Compression molding is performed for bonding as required. The process conditions for this molding step are 120° C. to 310° C. and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0086] In another embodiment (not shown), disposed around the former 86 is a thin chemically resistant cover surrounded by a plurality of substantially equidistant, axially spaced and radially extending sealing elements 152. The cover may be molded separately and applied to the former 86, or may be applied directly to the former 86 during the molding process of the former and molded with the former to enable compatibility with contact with the drug product. The cover may be formed of any chemically resistant or impermeable material, including but not limited to fluoropolymers (see above examples) or other inert plastic materials lacking the necessary elastomeric qualities for sealing, including but not limited to ethylene tetrafluoroethylene (ETFE), PTFE, perfluoroalkoxyalkane (PFA), polyvinylidene fluoride (PVDF), etc. The assembly is then subjected to the above-described compression molding process, wherein the sealing elements 152 and the cover may be fully cured with the former 86.

[0087] refer to Figures 9A-9C , shows another embodiment of a method for manufacturing a medical component 10 in a one-step molding process under predetermined time, heat and pressure conditions. First, a first elastomeric sheet 16 comprising an elastic material is formed. The first elastomeric sheet 16 can be in a fully cured state, or in a partially or semi-cured state. Next, the first elastomeric sheet 16 is molded into an inverted shape 88 (i.e., from the inside out) by any known molding process (e.g., compression molding, injection molding, etc.) under predetermined time, heat and pressure conditions. More specifically, the elastic material is molded into a shape that is an inverted shape of the shape of the medical component 10 to be formed. The process conditions of this molding step are 120°C to 310°C and about 40kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0088] Next, if Fig. 9B As shown, the inverted molded article 88 is brought into contact with the electronic device 12 and inverted and rolled over the body of the electronic device 12 to encapsulate the electronic device 12. The article 88 is then shaped and stretched, if necessary, to achieve the desired shape and form of the medical component 10. More specifically, the inverted molded article 88 is thermoformed into the shape of the medical component 10. Also, as shown in FIG. Fig. 9C As shown, in the medical component 10, the trim edge 90 of the elastomeric body is enclosed so that the outer trim edge resulting from conventional molding processes is eliminated. The time, heat, and pressure used for the thermoforming process will depend on various factors, such as the specific elastomeric material used.

[0089] refer to Figures 10A-11B , showing other embodiments of methods for manufacturing medical components 10 in a bladder molding process under predetermined time, heat and pressure conditions. The mold 14 is similar to the above Figure 2E The mold described in the process.

[0090] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0091] Specifically, refer to Figures 10A-10C In the method of this embodiment, the uncured or partially cured elastic sheet 130 includes one or more dimples 146 or recesses. Each dimple 146 is configured to accommodate the electronic device 12. Therefore, a preform is formed by inserting the electronic device 12 into each dimple 146 of the uncured or partially cured elastic sheet 130. Then, the preform is arranged in the mold 14. Thereafter, air pressure is applied from one side of the mold 14 through the air valve 148 to force the elastomer sheet 130 and the electronic device 12 into the opposite open cavity 15a (see Figures 10A-10B ). The elastic material is stretched (e.g., by thermoforming) into the final shape and size of the medical component 10 and then consolidated or cured by the application of heat. Finally, additional elastic material 150 may be injection molded into the mold 14 to fill any voids in the medical component 10 (see Fig. 10C ). The elastic material 150 injected later may be the same as or different from the material of the elastomer sheet 130 .

[0092] refer to Figures 11A-11B In an alternative embodiment, external pressure is applied to compression mold the elastomeric sheet 130 and form it into the medical component 10. Specifically, a preform of the elastomeric sheet 130 having the electronic device 12 arranged in each of the recesses 146 is positioned in the mold 14 so that each recess 146 is positioned within one of the cavities (e.g., the open cavity 15a), such as Fig.11A Next, the bladder mold 14 is expanded so that external pressure and heat are applied to the elastomeric sheet 130 to form the elastomeric material into the shape and size of the medical component 10, as shown. Fig. 11B shown.

[0093] refer to Figure 12A-14 , another embodiment of a method of manufacturing a medical component 10 in a one-step molding process under predetermined time, heat and pressure conditions is shown. Specifically, the medical component 10 is preferably molded into any desired shape by a conventional one-step compression molding process. However, it will be understood that any known molding process (e.g., insert molding, injection molding, etc.) may be utilized. Figures 12A-12B In FIG. 1 , the medical component 10 is shown as a piston for a syringe, a cartridge or a vial.

[0094] The process conditions of the molding step are 120°C to 310°C and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0095] Next, one or more electronic devices 12 may be inserted or injection molded into the molded medical component 10 by any known technique so that the one or more electronic devices 12 are embedded at a desired location in the medical component 10. For example, a push rod or needle 13 (including but not limited to a push rod or a needle 13) including an electronic device 12 disposed therein may be inserted or injection molded into the molded medical component 10 by any known technique. Figures 13A-13C Any of the configurations shown in ) can be used to injection mold the electronic device 12 into the medical component 10, such as Fig.14 As shown. For example, the electronic device 12 can be embedded in the medical component 10 just below its distal surface (e.g., a surface configured to contact the dispensed drug to be delivered to the patient via the medical device for light and / or temperature measurement) or near its lateral surface (e.g., so as to easily communicate with an external sensor). In this way, the position of the electronic device can be easily adjusted to any desired position. The electronic device 12 is held in place by the elasticity of the elastomer itself.

[0096] Alternatively, if Fig.15 As shown, one or more guide holes 78 may be formed in the molded medical component 10 and the electronic device 12 may then be inserted into the body of the medical component 10 through the guide holes 78 .

[0097] In another embodiment, Figures 17A-17CAs shown, the medical component 10 can be molded under the process conditions discussed above so as to already include one or more cavities 80, each of which is configured to accommodate one or more electronic devices 12. At the entrance of each cavity 80, and particularly on the surface of the molded component, a notch 82 is preferably provided to facilitate the insertion of the electronic device 12 into the cavity 80. The notch 82 can have any known form. For example, the notch 82 can be a double convex opening, a BiteValve, a TM , multiple slits, etc. After the electronic device 12 is inserted into the cavity 80 , the piston rod can also be passed through the same slot 82 and inserted into the cavity 80 .

[0098] Alternatively, the cavity 80 and notch 82 may be formed when the elastomer is only in a partially cured form, the electronic device 12 is then positioned within the cavity 80 in the partially cured body, and the partially cured body is then compression molded to cure the elastomer to form the medical component 10, with the notch 82 closed by compression. The process conditions for this molding step are 120° C. to 310° C. and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0099] In another embodiment, Fig.16As shown, after the medical component 10 has been molded, under any of the process conditions discussed above, the electronic device 12 can be inserted or embedded in the medical component 10 via the piston rod 84. More specifically, the piston rod 84 has a first end 84a formed as a point and an opposite second end 84b. The first end 84a of the point is provided with the electronic device 12, which is embedded in the first end or firmly or permanently attached to the first end. Starting from the first end 84a of the point, the piston rod 84 is then inserted into the medical component 10. The medical component 10 can optionally have a cavity 80 and a notch 82, as described above with reference to Figures 17A-17C discussed.

[0100] The first end 84a of the tip may then remain attached to the piston rod 84 for power transfer and / or communication with the electronic device 12. The elimination of wireless communication may prevent the possibility of interference, allow for greater power transfer with lower losses, and make tampering / spoofing of the signal more difficult. The piercing tip may be made of any known material, such as stainless steel or injection molded plastic.

[0101] refer to Figures 18A-18C , 19A-19C and 21A-21C, show other embodiments of methods of manufacturing the medical component 10 in a two-step molding process. Figures 18A-18C , 19A-19C and 21A-21C, the medical component 10 is depicted as a piston for exemplary purposes, but it will be understood that all of the methods discussed herein can be used to form any medical component.

[0102] refer to Figures 18A-18C The method includes forming a first component 50 or base component by molding an elastic material (e.g., a thermosetting elastomer or a thermoplastic elastomer). It will be understood that the first component 50 can have any suitable shape corresponding to the shape of the medical component 10 to be formed. However, due to Figures 18A-18C Referring to the medical component 10 , the first member 50 has a generally cylindrical shape. Preferably, the first member 50 defines a drug contacting end of the medical component 10 .

[0103] The first member 50 preferably has a closed bottom wall 52, an open top end 54, and a side wall 56 extending therebetween. The closed bottom wall 52, the open top end 54, and the outer side wall 56 define an interior 58 of the first member 50. The interior 58 preferably includes an inner side wall 60 surrounding a recess 62. The recess 62 is sized and shaped to receive a portion of the electronic device 12 therein.

[0104] In order to manufacture Figures 18A-18CThe medical component 10 of the embodiment is first formed into a first member 50 in a partially cured state by any known molding method (e.g., compression molding, insert molding, injection molding, etc.). The process conditions of the molding step are 120° C. to 310° C. or higher and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0105] Then, if Fig.18B As shown, the electronic device 12 is nested within the recess 62 of the first member 50, so that the electronic device 12 rests on or near the closed bottom wall 52. It will be appreciated that any known positioning mechanism or any of the positioning mechanisms described herein may be used to secure the electronic device 12 in place within the recess 62. For example, the electronic device 12 and the closed bottom wall 52 may be provided with corresponding (i.e., mating) protrusions (e.g., threads or smooth pins) and recesses or depressions to achieve the purpose of enabling more robust placement and positioning of the electronic device 12.

[0106] Finally, in a second molding step, as Fig.18C As shown, additional elastic material is overmolded onto the assembled electronic device 12 and first member 50 and cured to form a finished medical component 10, wherein the electronic device 12 is completely encapsulated by the elastic material. The process conditions of this molding step are 120°C to 310°C and about 40kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0107] Preferably, the overmolded elastomeric material is the same elastomeric material used to form the first member 50, but it will be appreciated that a different elastomeric material may be used.

[0108] In another embodiment, Figures 19A-19C As shown in 20A-20B, instead of a secondary molding process, a second member 66 is formed (e.g., molded under predetermined time, heat and pressure conditions as discussed herein) and assembled with the first member 50 to form the medical component 10. More particularly, the second member 66 is preferably molded from the same elastic material used to form the first member 50, but it will be understood that a different elastic material may be used. The second member 66 preferably has a closed bottom wall 68, opposing open ends 70, and side walls 72 extending therebetween. The closed bottom wall 68, the open ends 70, and the outer side walls 72 define an internal recess 74 of the second member 66. The size and shape of the internal recess 74 are preferably set to accommodate the remainder of the electronic device 12 therein. Where desired, the second member 66 preferably has a shape and size that complements the shape and size of the first member 50 to achieve the desired shape and size of the medical component 10.

[0109] In order to manufacture Figures 19A-20B The medical component 10 of the embodiment of the present invention is first formed separately from the first component 50 and the second component 66 in a partially cured state by any known molding method under predetermined time, heat and pressure conditions as discussed herein. The process conditions of these molding steps are 120°C to 310°C and about 40kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 220kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0110] The electronic device 12 is then nested within the recess 62 of the first member 50 such that the electronic device 12 rests on or near the closed bottom wall 52. It will be appreciated that any known positioning mechanism or any of the positioning mechanisms described herein may be used to secure the electronic device 12 in place within the recess 62. Next, the second member 66 is assembled with the first member 50 in a mold such that the open top ends 54, 70 contact each other at the interface 76 and the electronic device 12 is received within the recesses 62, 74 of the first member 50 and the second member 66.

[0111] Next, according to one embodiment, the assembled first and second members 50 and 66 are bonded or welded together by heating the entire assembly in the mold under predetermined time, heat and pressure conditions to completely cure the elastic material. The process conditions for this molding step are 120°C to 310°C and about 40kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0112] Optionally, as Figures 20A-20BAs shown, a curable adhesive layer 92 may be placed at the interface 76 prior to heating to facilitate bonding of the first component 50 and the second component 66. This process of utilizing pre-molded first and second components 50, 66 avoids the possibility of viscous flow of the elastomer damaging the electronic device 12, which would occur, for example, in a one-step overmolding process.

[0113] Alternatively, according to another embodiment, a partial curing process may be implemented. More specifically, the first member 50 and the second member 66 may be initially molded in a fully cured state. The process conditions for these molding steps are 120° C. to 310° C. and about 40 kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0114] Next, the electronic device 12 and the first component 50 and the second component 66 are assembled as discussed above and bonded or welded together at the interface 76 where the glue layer 92 is optionally provided by a directed energy source (such as but not limited to ultrasonic welding, microwave heating / curing, and laser heating / curing) that produces localized curing of the elastomeric material and the glue at the interface 76. The localized curing process protects the encapsulated electronic device 12 from being affected by extreme conditions. The process conditions for this localized curing step are 120°C to 310°C and about 40kg / cm 2 Up to 350kg / cm 2 For several seconds to 30 minutes, more preferably about 120°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2 For about 30 seconds to 30 minutes, most preferably about 140°C to 220°C and about 40 kg / cm 2 Up to 70kg / cm 2In one embodiment, the process conditions are 150°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 In another embodiment, the process conditions are 160°C to 165°C and about 50 kg / cm 2 In another embodiment, the process conditions are 160°C to 175°C and 40 kg / cm 2 Up to 70kg / cm 2 Up to about 8 minutes.

[0115] refer to Figures 21A-21D , shows another embodiment of a method of manufacturing a medical component 10 in a two-step molding process. First, a first component 50 is molded, as described herein with respect to Figures 18A-20B Next, the main body of the second member 66 is overmolded onto the first member 50 (similar to Figures 18A-18C process), or formed separately and welded to the first member 50 (similar to Figures 19A-20B The body of the second member 66 preferably includes a capsule or cavity 94 configured to accommodate the electronic device 12, and an opening 96, for example, at a surface opposite to the drug contact surface of the first member 50 or at a lateral surface, through which the electronic device 12 is inserted so as to be embedded in the cavity 94 within the medical component 10.

[0116] Figures 22A-22D Various embodiments of the structure and arrangement of a medical component 10 provided with electronic devices 12 are shown.

[0117] In any of the embodiments disclosed herein, the retractable retaining pins 98 or protrusions can be used to secure the electronic device 12 in place during a molding process (e.g., compression molding, injection molding, etc., preferably injection molding), such as Figures 23A-23B Specifically, a plurality of retaining pins 98 are initially used to center the electronic device 12 when placed in the mold 14. Next, the molding process begins, and the elastic material 30 begins to surround the aligned electronic device 12. When the elastic material 30 sufficiently surrounds the aligned electronic device 12 (i.e., to the extent that the electronic device 12 will not be easily moved from its center), the retaining pins 98 are retracted toward the mold 14 and away from the electronic device 12, thereby allowing the elastic material 30 to completely encapsulate the electronic device 12.

[0118] A fully encapsulated electronic device 12 as achieved by any of the methods described herein has the advantage that it is completely protected from the environment and will likely be capable of steam sterilization.

[0119] The electronic device 12 or package according to any one of the embodiments described herein can be combined with sensing technology, such as a sensor, to measure / detect the temperature of the medical device / component itself or the surrounding environment, the pressure in the medical device, the pressure difference that may occur on the medical component 10 (e.g., a piston) due to the generation of gas in the container due to the decomposition of the drug, the capacitance for the liquid level or piston position, or the exposure of light-sensitive drugs. According to any one of the embodiments described herein, the electronic device 12 or package can also be combined with tracking technology, such as an electronic device, to identify information encoded in an EEPROM or NFC chip. The electronic device 12 can include a serial number or an expiration date and can be trackable, for example, to determine whether the drug is under recall. The electronic device 12 can also be used to confirm that the medical component 10 is an official product, not a third-party gray market copy or other counterfeit. The electronic device 12 can also be used, for example, by RFID inspection to ensure that the medical component 10 is a suitable delivery device for the drug to be distributed. The electronic device 12 can also be used to control the distribution of drugs from the medical component 10 and automatically update the inventory level.

[0120] The electronic device 12 or package according to any of the embodiments described herein may also incorporate measurement technology, such as for measuring or detecting the position of the piston and / or the delivery rate of the drug during use (e.g., by monitoring the movement rate of the piston), or for providing feedback about when the piston reaches a preset dosage point (e.g., the electronic device 12 can be used to drive tactile feedback in the medical component 10). In the case where the medical component 10 is a replaceable component, the electronic device 12 can be used to determine when replacement should be performed or whether drug exposure should be limited. The electronic device 12 can also be used to detect tampering. For example, the electronic device 12 may include a resistive foil whose value changes if the resistive foil is punctured by a needle.

[0121] The electronic device 12 or package according to any one of the embodiments described herein can also be combined with various other types of technology. For example, the electronic device 12 can be combined with muscle wire (flexinol or shape memory actuator wire) technology in the shape of a coil in the rubber medical component 10 connected to the electronic device 12. When the current flows through the muscle wire, the muscle wire contracts. This functionality can be used, for example, to tighten / relax the medical component 10 so that it is easier or more difficult to move. The electronic device 12 can also be combined with piezoelectric technology (including but not limited to PVDF as a piezoelectric material or piezoelectric device) to stir the medicine contained in the medical component 10 before use. Another possible use of the electronic device 12 is to start induction heating before use to heat the medicine contained in the medical component 10, or if a tampering or misuse alarm is triggered or if the patient is trying to distribute the medicine after the expiration date of the medicine, then intentionally produce damage to the medicine. The electronic device 12 can also enable electrical contact to be achieved between the medical component 10 and the actuating rod to power the piston electronics and confirm whether the medicine contained in the medical device is correct, the monitoring date, etc.

[0122] In addition to the electronic device 12, the present invention may also be implemented to encapsulate other materials within the medical component 10. For example, any of the methods described herein may be used to encapsulate or embed an incompressible material within the elastomeric body of the medical component 10 to change the mechanical properties of the medical component 10. Alternatively, any of the methods described herein may be used to encapsulate or embed a dense material within the elastomeric body of the medical component 10 to change the weight of the medical component 10, for example, for gravity or acceleration induced manipulation purposes of the medical component 10. Alternatively, any of the methods described herein may be used to encapsulate or embed a magnet or magnetic material within the elastomeric body of the medical component 10 such that the magnet or magnetic material is configured to interact with an external sensor or magnetic packaging.

[0123] Those skilled in the art will appreciate that changes may be made to the above embodiments without departing from the broad inventive concept of the present invention. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. A method for manufacturing a medical component, the method comprising: partially curing the first sheet of elastic material; placing at least one electronic device in said first sheet of elastic material to obtain an elastic preform; applying a fluoropolymer protective film on one surface of the elastomeric preform such that the fluoropolymer protective film enables an electrical or optical path to the at least one electronic device but still provides barrier properties for encapsulation of the at least one electronic device and such that the fluoropolymer protective film covers an exposed surface of the at least one electronic device; aligning the elastic preform covered by the fluoropolymer protective film in a mold so that the at least one electronic device is received in an open cavity defined by the mold, The elastic preform covered by the protective film is molded to cure the elastic material and form the medical component having the at least one electronic device embedded therein. 2 . The method of claim 1 , wherein the fluoropolymer protective film is disposed on a surface of the medical component configured to contact a dispensed drug.

3. The method of claim 1, wherein: The mold comprises an upper mold half including an open cavity and a lower mold half including the open cavity; The bottom surface of the opening cavity of the lower half mold is recessed so as to be spaced apart from the elastic preform; and Molding the elastic preform includes flowing the elastic material into a space between the elastic preform and the bottom surface to encapsulate the at least one electronic device.

4. The method according to claim 3, wherein: Arranging at least one electronic device in the first sheet of elastic material to obtain the elastic preform comprises: arranging a plurality of electronic devices in the first sheet of elastic material, the at least one electronic device being one of the plurality of electronic devices; The lower mold half includes a plurality of open cavities, and the open cavity of the lower mold half is one of the plurality of open cavities of the lower mold half; and Aligning the elastic preform in the mold includes positioning the elastic preform on the lower mold half such that each of the plurality of electronic devices is aligned with a corresponding open cavity of the plurality of open cavities.

5. The method of claim 1, wherein one of the mold and the elastic preform includes elements for facilitating positioning of the elastic preform and / or centering of the at least one electronic device during molding.

6. The method of claim 1, further comprising: at least partially freezing the elastic preform to form a partially frozen elastic preform; preparing a second elastic material sheet; Aligning the elastic preform further comprises: positioning the partially frozen elastic preform and the second elastic material sheet in the mold, the mold having a lower half and an upper half, the first elastic material sheet being in direct contact with the lower half; and Molding the elastic preform further includes applying heat and pressure to the partially frozen elastic preform and the second sheet of elastic material in the mold to form the medical component with the at least one electronic device embedded therein.

7. A method according to any one of the preceding claims, wherein the elastomeric material is a thermosetting elastomer or a thermoplastic elastomer.

8. The method according to any one of claims 1 to 6, wherein the elastomeric material is a butyl elastomer or a halogenated butyl elastomer.

9. The method according to claim 1, wherein the elastic preform is molded at a temperature in the range of 120°C to 310°C and at a pressure of 40 kg / cm 2 Up to 350kg / cm 2 The test is carried out under a range of pressures and lasts up to 30 minutes.

10. The method according to claim 1, wherein the elastic preform is molded at a temperature in the range of 120°C to 220°C and at a pressure of 40 kg / cm 2 Up to 70kg / cm 2 The pressure is within the range of 30 seconds to 30 minutes.

11. The method according to claim 1, wherein the elastic preform is molded at a temperature in the range of 140°C to 220°C and at a pressure of 40 kg / cm 2 Up to 70kg / cm 2 The pressure is within the range of 2 minutes to 15 minutes.

12. The method according to claim 1, wherein the elastic preform is molded at a temperature in the range of 160°C to 165°C and at a pressure of 50 kg / cm 2 The pressure is maintained for 15 minutes.

13. The method according to claim 1, wherein the elastic preform is molded at a temperature in the range of 160°C to 175°C and at a pressure of 40 kg / cm 2 Up to 70kg / cm 2 The pressure is within the range of 10000 and the duration is 8 minutes.

14. A medical component for a container manufactured by the method of claim 1, the container to be filled with a dispensed drug, the medical component comprising an integral body configured to contact an inner surface of the container.

15. A container containing insulin or an insulin derivative, an insulin preparation or an insulin analogue and comprising a component according to claim 14.

16. A container as claimed in claim 15, wherein the insulin analogue is selected from the group consisting of: Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein the proline at position B28 is substituted by Asp, Lys, Leu, Val or Ala, and wherein the Lys at position B29 can be substituted by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

17. The container of claim 15, wherein the insulin derivative is selected from the group consisting of: B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30- N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholesyl-Y-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(w-carboxyheptadecanoyl) human insulin.

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