A system and method for manufacturing a user-specific implant

Abstract

This invention describes manufacturing of an implant that is customised to a user. Specifically, the invention provides a low-cost manufacturing process for voice prosthesis production. The manufacturing process is modular, allows for manual moulding and includes an intelligent cyber-physical system (iCPS) to optimise cost and the manufacturing process steps.

Description

A System And Method For Manufacturing A User-specific ImplantRelated Applications

[0001] The present invention claims priority to Singapore patent application no. 10202400767P filed on 18 March 2024, the disclosure of which is incorporated in its entirety'.Field of Invention

[0002] The present invention relates to manufacture of implants to meet user-specific specifications. In particular the invention provides a low-cost intelligent cyber-physical system (iCPS), using voice prosthesis fabrication for illustration.Background

[0003] Total laryngectomy (TL) involves the removal of a patient’s voice box and results in the loss of voicing capability. To restore the ability to speak, the current gold standard for rehabilitation is the implantation of a voice prosthesis. However, voice prosthesis devices available in the market are extremely expensive and are largely unaffordable for some people. This has resulted in poor market penetration with many lower-income patients opting to sacrifice quality for cost and resorting to primitive imitations of existing voice prosthesis at low-costs. This situation indicates the presence of a largely7untapped market, especially considering the projected increase in the number of patients suffering from voice illnesses in the coming years.

[0004] With recent advancements in digital manufacturing and additive manufacturing using medical grade silicone, this invention makes use of additive manufacturing such as 3D printing to produce the body and valve flap of voice prosthesis in a single step. This process can fabricate personalized voice prosthesis on-demand. This optimization aims to improve the fabrication process and reduces time to market. Aided by an intelligent cyber-physical system (iCPS), which guides the rapid setup, training, and workflow implementation of a cyber-physical system (CPS) workcell, the low-cost manufacturing process of this invention has the potential to enable rapid expansion and market penetration into areas that existing products have failed to reach.

[0005] Although many types of voice prostheses are available commercially and under research, trans-prosthetic and periprosthetic leakages continue to be a problem. One problem faced by all prostheses is the misfit of size in the fistula. Fistulas usually have irregular cross- sectional areas; therefore, it is hard to achieve an accurate fit since the current prostheses in the market have similar geometric shapes and fixed size ranges. A tight fit of the prosthesis will lead to the formation of granulation tissue, while a loose fit may result in periprosthetic leakages.

[0006] Several attempts have been done to try and overcome these issues. It has been proposed to use a modified flap mechanism to reduce transprosthetic leakages. However, a potential problem with flap-valve prosthesis is the loosening of the polymeric hinge due to cyclic stress, leading to transprosthetic leakages.

[0007] A prosthesis design with a defonnable esophageal flange was also investigated. Although it was effective in preventing leakages, the air flow resistance in the prosthesis was high, thus requiring patients to exert during speech.

[0008] To address issues of periprosthetic leakages, enlarged collars were used to fill up additional space between the prosthesis and the tissue that results from fistula enlargement. The drawback of such a method is that it causes uneven stress distribution due to the irregular shape of the fistula, potentially causing granulation and further widening.

[0009] Current commercial voice prostheses are manufactured using typical injection moulding - vulcanizing medical grade silicone rubber under high pressure and temperature around the range of 100°C to 200°C. A second hardening is used to stabilize the product at 150°C-200°C for 3 to 10 hours. The valve flap is attached at an angle of 10 to 50 degrees with respect to the original position during the second hardening process. Finally, a valve seat is inserted to create a bias force keeping the valve closed. As a result, there is a high initial investment for moulding design and injection moulding infrastructure coupled with the multi-stage process of fabrication, assembly, sterilization, and packaging exacerbate the costs of fabrication for the voice prostheses.

[0010] In summary, the key issues with current voice prosthetic devices in the market arc as follows:• Extremely expensive (approximately 600 SGD per voice prosthesis) o Large sections of a population do not have tire financial means for the device. o Has resulted in poor market penetration of the current main companies producing voice prosthesis.• Limited flange sizes resulting in poor fitting for patients.• Potentially low lifespan (large variances, with some as short as 1 month).

[0011] This invention overcomes the disadvantages of the existing prior art by simplifying tire manufacturing process thereby reducing tire cost per voice prosthesis produced; and allowing on-demand rapid configuration and fabrication of moulds that are specific to patient needs.Summary

[0012] The following presents a simplified summary to provide a basic understanding of the present invention. This summary is not an extensive overview of the present invention and is not intended to identify key features of the invention. Rather, it is to present some of the inventive concepts of this invention in a generalised form as a prelude to the detailed description that is to follow.

[0013] One of the advantages of tire invention is that its modular configuration enables rapid configuration of mould of the voice prosthetic implant according to patient-specific parameters.

[0014] In one embodiment, the implant is 3D printable; this 3D printing allows manufacturing at a low cost; in addition, the manufacturing process can be rapidly repeatable.

[0015] The invention is operable to achieve a low volume, low-cost and on-demand fabrication because it comprises a manual injection mould. Mass personalised production at low cost is also achieved due to the inclusion of an intelligent cyber-physical system (iCPS) into the invention system.

[0016] The present invention seeks a manufacturing system for a customised product for a user comprising: a device configured to capture one or more dimensional parameters of auser; a moulding subsystem for manufacturing the customized product: an artificial intelligence training and guidance subsystem is configured to receive the dimensional parameters to generate one or more manufacturing process steps; a cyber-physical system in communication with an artificial intelligence training and guidance subsystem to organise the manufacturing process steps to manufacture the customised product.

[0017] In a preferred embodiment, additionally, the artificial intelligence system training and guidance subsystem optimises a workcell layout based on pre-defined criteria using virtual reality and augmented reality technology.

[0018] In another preferred embodiment, the pre-defined criteria comprise a manufacturing room’s geometrical features and resource distributions.

[0019] Tire invention also seeks to protect a manufacturing system wherein the cyberphysical system organises the manufacturing steps and resources into reusable components; augments an operator of the system in decision-making; enables dynamic scheduling and resource allocation; monitors performance of the operator; and / or optimises the manufacturing process.

[0020] Additionally, the moulding subsystem comprises assembling a mould and injecting liquid silicone rubber into the assembled mould to manufacture the customised product, or 3D printing of the customised product.

[0021] The present inspection also seeks to protect a manufacturing process for a customised product for a user, the manufacturing process comprising: capturing the user-specific parameters; creating mould parts that match the user-specific parameters; assembling and holding the mould parts together to form a compounded mould; configuring an artificial intelligence training and guidance subsystem to receive and analyse the user-specific parameters to generate one or more manufacturing process steps; and configuring a cyber-physical subsystem in communication with the artificial intelligence training and guidance subsystem to organise the manufacturing process steps and resources into reusable components, augmenting an operator of the system in decision-making; enabling dynamic scheduling and resource allocation: monitoring performance of the operator; and / or optimising the manufacturing process.

[0022] In addition, the uscr-spccific parameters refer to dimensions of the user’s throats, and the manufacturing process further comprises populating tunable parameters, such as, an anterior flange thickness, a posterior flange thickness, an anterior flange diameter, a posterior flange diameter, a body outer diameter, a body length, a body inner major diameter, a body inner minor diameter, a valve angle, a valve thickness and a tail length.

[0023] In a preferred embodiment of the manufacturing process, the customized product is manufactured by using additive manufacturing, including 3D pnnting.

[0024] In another embodiment of the manufacturing process, the customised product is a medical implant, including a voice prosthesis.

[0025] The scope of protection of this invention is not confined to voice prosthesis. It extends to a range of medical and non-medical products or prostheses.Brief Desc ription of the Drawings

[0026] This invention will be described by way of non-limiting embodiments of the present invention, with reference to the accompanying drawings, in which:

[0027] FIG. 1 illustrates a known voice prosthesis.

[0028] FIG. 2 illustrates a modular mould for making a voice prosthesis according to an embodiment of the present invention;

[0029] FIG. 3 illustrates an exploded view of the modular mould shown in FIG. 2.

[0030] FIG. 4 is a diagram showing the fabrication process steps of a patient-specific voice prosthesis using the modular mould shown in FIG. 2

[0031] FIG. 5 illustrates comparative moulds made using various fabrication methods

[0032] FIG. 6 illustrates a schematic of flow and leak testing apparatus for a voice prosthesis.

[0033] FIG. 7 illustrates a prototype of the developed flow and leak testing apparatus.

[0034] FIG. 8 illustrates an intelligent cyber-physical system (1CPS) framework being employed in the fabrication of a voice prosthesis according to this invention.Detailed Description

[0035] For locally advanced laryngeal and pharyngeal cancer, total laryneactomy (TL) is often used as a surgical treatment. In TL, the entire larynx is detached from the trachea and excised. A tracheostoma is subsequently constructed with the remaining trachea for breathing. With the loss of the larynx and hence the ability to speak, the patient is often subjected to disabling psychosocial and economic consequences. Uris can be mitigated by various voice rehabilitation techniques (for eg., electrolarynx, esophageal speech or tracheoesophageal speech) to restore a limited portion of their ability to speak.

[0036] Tracheoesophageal speech is currently considered to be the best method for voice rehabilitation and is achieved by surgically implanting a voice prosthesis between a posterior tracheal wall and an anterior esophageal wall. The voice prosthesis enables air from the lungs and trachea to be diverted into the esophagus, up and through the mouth for speech, aiming to restore approximately 80% of the patient's voicing capability.

[0037] One or more specific and alternative embodiments of the present invention will now be described with reference to the attached drawings. It shall be apparent to one skilled in the art, however, that this invention may be practised without such specific details. Some of the details may not be described at length so as not to obscure the invention. For ease of reference, common reference numerals or series of numerals will be used throughout the figures when referring to the same or similar features common to the figures.

[0038] With the issues discussed earlier and taking into consideration designs of a voice prosthesis that are already in the public domain, such as, an implant 101 illustrated in FIG 1 , preferred embodiments of the invention arc illustrated using a modular mould 200 and a process 400 for fabricating of a voice prosthesis 100 (as seen in FIG. 4)

[0039] The modular mould 200 is now descnbed with reference to FIG. 2.

[0040] FIG. 2 shows the modular mould 200 for making the voice prosthesis 100. The mould 200 uses modular parts of an injection mould. The parts of the mould replicate a posterior valve 201, a posterior hood 202, a posterior flange 203, a shaft 204, an anterior flange 205, an anterior valve 206 and a tail 207 that are dimensioned to user-specific parameters.

[0041] FIG. 3 illustrates an exploded view of the modular mould 200 shown in FIG. 2. The mould 200 enables generation of various pennutation of voice prosthesis sizes depending on user-specific parameters.

[0042] The invention manufacturc / fabrication process of filling the mould is manually controlled and can be perfonned with ease, enabling rapid adoption of the fabrication process 400 by low-skilled workers.

[0043] The mould 200 shown in FIGs. 2 and 3 constitutes several parts that require substantially 11 dimensional parameters for making the voice prosthesis 100 according to the present invention; these dimensional parameters are variables that are changed to match user-specific needs. For example, these dimensional variable parameters for making the voice prosthesis include:1. an anterior flange thickness;2. a posterior flange thickness:3. an anterior flange diameter;4. a posterior flange diameter;5. a body outer diameter;6. a body length,7. a body inner major diameter;8. a body inner minor diameter;9. a valve angle;10. a valve thickness; and1 1. a tail length.

[0044] Each part of the mould 200 can be assembled with the support of guiding pins: the mould parts are then clamped together before a liquid silicone rubber (LSR) is manually injected. Naturally the invention includes the mould 200 with more parts or a fewer number of parts.

[0045] FIG. 4 shows a manufacture or fabncation process 400 flow according to an embodiment of the invention. The process steps are in relation to the fabrication of the prosthesis 100, with illustration for a voice prosthesis. The scope of protection of the invention includes processes that may or may not be in the following order being described.

[0046] As seen from FIG. 4, in step 401 , user or patient specific parameters are received from clinicians. These user-specific parameters (i.e. individual dimensions of the patients’ throats) arc used to populate the tunable parameters described above.

[0047] In step 402, the mould parts are assembled, for example, for 3D printing; other methods may be employed by using available mould parts that match the user dimensions. Subsequently, in step 403, liquid silicone rubber (LSR) is mixed, and degassed by vacuuming in step 404; the degassed LSR is then injected manually into the assembled mould, in step 405.

[0048] After LSR injection, the mould 200 is left to cure, in step 406; in step 407, the mould is opened up, and the moulded implant 100 is left for the LSR to stabilize (in step 408) for some time according to tire LSR specifications.

[0049] FIG. 4 also shows pictures depicting the various steps of moulding the implant 100.

[0050] To evaluate cost and fabrication speed of the above manufacturing process flow, a total of 11 moulds were made using different manufacturing methods; to evaluate surface finish of the moulded implant 100, different materials of the mould parts were used, such as metal and plastic . Some of these moulds are shown in FIG . 5. For example, the moulds were made from metal 3D printing (501), from subtractive machining (502), PolyJet™ 3D printing (503), fused deposition modelling (FDM) (504).

[0051] The above cost, surface finish and fabrication speed data were compared to a mould made by a known computer numerical control (CNC) machining. Some of the findings identified that the implant 100 obtained with 3D printed moulds are considerably cheaper (approximately in the range of 4 to 10 times) than moulds made by CNC machining. Both the invention moulds and the CNC-machined moulds were evaluated for their design, focusing on its clamping and alignment, and effect on minimum wall thicknesses. All materials were found to be suitable for use with the present invention.

[0052] The moulded implants 100 were also tested with a flow testing apparatus shown in FIGs. 6 and 7. The flow testing apparatus includes a reservoir 501 to evaluate effectiveness of the valve seal in respect of a fluid flow to the esophagus 502. A compressed air supply 505 is connected to the trachea 504 for simulating speech when the stoma 503 is closed.

[0053] An issue limiting the production and distribution of products in general is the reliance on conventional mass production and centralized manufacturing methods. These conventional methods are often mismatched with the inherently low-volume, patient-specific nature of implants (generally, medical implants) manufacturing, which frequently results in patients having to conform to the specifications of the products rather than the product being tailored to the patients.

[0054] The above manufacture process 400 flow is operable to overcome the above limitations by decentralizing the fabrication steps, thereby reducing the footprint and bridging the gap between the product and customer / patients. The invention is further enhanced by employing an intelligent cyber-physical system (iCPS) 800; the iCPS 800 allows rapid setup, training, and workflow implementation of a CPS workcell 803 for fabricating on-demand personalized voice prosthesis. For example, the iCPS 800 is designed to lower tire cost of making the voice prosthesis 100 and to expedite product distribution in the market. Since the production steps and resources in the iCPS 800 are reusable, the cost and time of development can be significantly reduced.

[0055] Furthermore, the production steps and resources can be dynamically scheduled and allocated, enabling resource sharing and collaboration that culminate in enhanced flexibility and agility beyond that of conventional manufacturing systems. This has the potential to decrease production time, especially when dealing with a large variety of products. Theapplication of virtual reality (VR) and augmented reality (AR) in training and guidance reduces the time needed for set-up and wastage, while also allowing for rapid training without the additional manpower costs associated with a dedicated trainer employed for the fabrication process.

[0056] In the invention 1CPS 800, an artificial intelligence (Al) or smart training and guidance subsystem 807 automatically configures an optimized workcell layout based on pre-defined criteria, such as the room’s geometrical features and resource distributions. Then, the Al training and guidance subsystem 807 trains and guides the human operator in the processes of mould design, mould fabrication, and prosthesis moulding by utilising VR and AR technology. When the features of the user or patient are inputted into the intelligent cyber-physical system (iCPS) 800, the AT training and guidance subsystem 807 is employed to suggest dimensions for the voice prosthesis 100 that allows conforming to the user / patient’s needs. The feasibility' of these dimensions canthen be validated by' simulations for optimization.

[0057] On the other hand, the iCPS 800 components of this invention streamlines the production processes by organizing the production steps and resources into reusable components, augmenting human operators in decision-making, and enabling dynamic scheduling and resource allocation. The iCPS 800 is also used to closely' monitor performance of human operators, to intervene the production appropriately, and to communicate collected data with the smart Al training and guidance subsystem 807. In addition, the product lifecycle is monitored, with the collected data fed back into the iCPS 800 system for future improvements.

[0058] An overview of the iCPS 800 is shown in FIG. 8. The iCPS 800 framework for voice prosthesis 100 production includes a process controller 801, a CPS builder 802 and a production workcell 803 integrated to carry' out the above manufacturing process flow shown in FIG. 4. As shown in FIG. 8, the process controller 801 includes a cognitive engine 804, a conflict resolver engine 805 and a scheduler engine 806. The cognitive engine 804 and the conflict resolver engine 805 constitute the smart / AI training and guidance subsystem 807, whilst the CPS builder 802 and the production workcells 803 constitute the cyber-physical subsystem 808.

[0059] In one embodiment, a user / operator employs the cognitive engine to select an ontology relating to the intended implant. A weighting factor is applied to the selected ontology, and a reasonable output is sent to the conflict resolver engine; processed information from the conflict resolver engine is then output to the scheduler engine. The scheduler engine then communicates with the production workcell 803. Information from the scheduler engine may be processed by a content interpreter, a production builder and an executor mapper before output from the scheduler engine is made use of by the production workcell 803. The production builder may optimize the production steps by reiterating with the process controller 801 before the scheduler engine communicates again with the production workcell 803. Middleware data in the production workcell 803 may be adjusted by the human operator before the data is transferred to a 3D pnnter for manufacturing of the customized implant 100

[0060] In the production workcell, middleware data in the production workcell 803 may be adjusted by the human operator before the production data is transferred to a 3D printer for manufacturing of the customized implant. In addition, the production data may be simulated by a quality controller and the process controller 801 before finally sending the production data to the 3D printer.

[0061] While specific embodiments have been described and illustrated, it is understood that many changes, modifications, variations and combinations of variations disclosed in the text description and drawings thereof could be made to the present invention without departing from the scope of the present invention. For example, the invention process can be used for the manufacture of other medical or non-mcdical implants.

Claims

CLAIMS1. A manufacturing system for a product customised for a user comprising: a device configu red to capture one or more dimensional parameters of a user, a moulding subsystem for manufacturing the product; an artificial intelligence training and guidance subsystem is configured to receive the dimensional parameters to generate one or more manufacturing process steps; a cyber-physical subsystem (CPS) in communication with the artificial intelligence training and guidance subsystem to organise the manufacturing process steps to manufacture the user customised product,2. The manufacturing system according to claim 1, wherein the artificial intelligence training and guidance subsystem optimises a workcell layout based on pre-defined criteria using virtual reality and augmented reality technology.

3. The manufacturing system according to claim 2, wherein the pre-defined criteria comprise a manufacturing room’s geometrical features and resource distributions.

4. The manufacturing system according to any one of claims 1 to 3, wherein the cyberphysical subsystem (CPS) organises the manufacturing process steps and resources into reusable components; augments an operator of the sy stem in decision-making; enables dy namic scheduling and resource allocation; monitors performance of the operator; and / or optimises the manufacturing process.

5. The manufacturing system according to claim 4, further comprises a process controller in communication with a CPS builder and a production workcell.

6. The manufacturing system according to claim 5, wherein the process controller further comprises a cognitive engine, a conflict resolver engine and a scheduler engine.

7. The manufacturing system according to claim 4 or 5, wherein the CPS builder further comprises a context interpreter engine, a CPS builder engine and an executor mapper.

8. The manufacturing system according to any one of claims 5 to 7, wficrcin data in the production workcell are stored as printer middleware.

9. The manufacturing system according to claim 8, wherein the printer middleware is simulated by a quality controller and production data is optimised by the process controller and the CPS builder engine before final operation by the printer.

10. The manufacturing system according to any one of claims 1 to 4, wherein the moulding subsystem comprises assembling a mould and injecting liquid silicone rubber into the assembled mould to manufacture the user customised product, or 3D printing of the user customised product.

11. A manufacturing process for a user customised product, comprising: capturing the user-specific parameters: creating mould parts that match the user-specific parameters; assembling and joining the mould parts together to form a compound mould; configuring an artificial intelligence training and guidance subsystem to receive and analyse the user-specific parameters to generate one or more manufacturing process steps, and configuring a cyber-physical subsystem in communication with the artificial intelligence training and guidance subsystem to organise the manufacturing process steps and resources into reusable components, augmenting an operator of the manufacturing process in decision-making; enabling dynamic scheduling and resource allocation; monitoring performance of the operator; and / or optimising the manufacturing process.

12. The manufacturing process according to claim 11, wherein the user-specific parameters comprises dimensions of the user’s throat, and the process further comprises populating tunable parameters in creating the mould parts, wherein the tunable parameters comprise an anterior flange thickness, a posterior flange thickness, an anterior flange diameter, a posterior flange diameter, a body outer diameter, a body length, a body inner major diameter, a body inner minor diameter, a valve angle, a valve thickness and a tail length for manufacturing the user customised product.

13. The manufacturing process according to claim 11 or 12, wherein the user customised product is manufactured using additive manufacturing, including 3D printing.

14. The manufacturing process according to any one of claims 1 1 to 13, wherein the user customised product is a medical implant, including a voice prosthesis.

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