Tesi etd-04062024-031448
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Tipo di tesi
Dottorato
Autore
AL-HADDAD, HIND ADIL JAAFAR
URN
etd-04062024-031448
Titolo
Advancing Implantable Artificial Pancreas Based on Ingestible Pills
Settore scientifico disciplinare
ING-IND/34
Corso di studi
Istituto di Biorobotica - PHD IN BIOROBOTICA
Commissione
relatore Prof. RICOTTI, LEONARDO
Membro Prof. DARIO, PAOLO
Membro Prof. DARIO, PAOLO
Parole chiave
- Type 1 diabetes
- non-invasive refilling
- implantable device
- drug-carrying capsule
- ingestible capsule
- insulin stability
- thermoplastic elastomer
- intestinal tissue compression
- magnetic docking
- hermetic sealing
- in-vivo test
- trans-intestinal port.
Data inizio appello
29/10/2024;
Disponibilità
parziale
Riassunto analitico
The thesis aimed to enhance type 1 diabetes mellitus (T1DM) management by developing a fully implantable artificial pancreas (AP). T1DM is characterized by the autoimmune destruction of pancreatic beta cells, necessitating insulin dependency for glucose regulation. The most common available AP, which utilizes continuous insulin delivery and subcutaneous blood glucose measurement, often leads to delayed responses and suboptimal outcomes. Intraperitoneal (IP) insulin delivery via an implantable AP has emerged as a promising alternative. However, the available systems have drawbacks, requiring periodic invasive refilling procedures that cause complications and discomfort to the patient. This thesis aimed to address these issues by creating an optimized AP tailored to human anatomy, featuring IP insulin delivery and a noninvasive refilling mechanism using ingestible insulin-carrying pills.
The research methodology focused on optimizing various subsystems of the AP. Firstly, a novel refilling system was developed. This system consisted of an ingestible capsule made of ISO 13485-compliant thermoplastic elastomer material, a sequentially activated magnetic docking system validated through simulations and bench tests, and a punching system allowing long-term operation without compromising the hermetic sealing integrity of the AP. Secondly, the insulin infusion system was enhanced with a six-roller peristaltic pump delivering insulin within recommended baseline values for basal and bolus modes and a reservoir optimized for efficient insulin aspiration from the sealed capsule.
Further advancements included improvements to the onboard communication system and wireless charging, enabling autonomous operation and long-term monitoring without battery replacements. These enhancements improved control and monitoring capabilities. Animal implantation studies were conducted following the secure hermetic sealing of the devices to validate the safety of the implantation procedure and the device's interaction with tissue over a six-week period in porcine models.
Additionally, a novel trans-intestinal port structure was designed and developed to facilitate the transfer of insulin from the capsule to the implant, avoiding repeated tissue punching and the associated potential damages. The stability of this new structure was evaluated using bench and ex vivo tests. A six-week in vivo study in a porcine model examined the structure's stability, verified the surgical procedure's success, and assessed its effects on the overall health of the animals.
In summary, the research presented an advanced approach to T1DM management by addressing key challenges and demonstrating promising outcomes for future clinical applications.
The research methodology focused on optimizing various subsystems of the AP. Firstly, a novel refilling system was developed. This system consisted of an ingestible capsule made of ISO 13485-compliant thermoplastic elastomer material, a sequentially activated magnetic docking system validated through simulations and bench tests, and a punching system allowing long-term operation without compromising the hermetic sealing integrity of the AP. Secondly, the insulin infusion system was enhanced with a six-roller peristaltic pump delivering insulin within recommended baseline values for basal and bolus modes and a reservoir optimized for efficient insulin aspiration from the sealed capsule.
Further advancements included improvements to the onboard communication system and wireless charging, enabling autonomous operation and long-term monitoring without battery replacements. These enhancements improved control and monitoring capabilities. Animal implantation studies were conducted following the secure hermetic sealing of the devices to validate the safety of the implantation procedure and the device's interaction with tissue over a six-week period in porcine models.
Additionally, a novel trans-intestinal port structure was designed and developed to facilitate the transfer of insulin from the capsule to the implant, avoiding repeated tissue punching and the associated potential damages. The stability of this new structure was evaluated using bench and ex vivo tests. A six-week in vivo study in a porcine model examined the structure's stability, verified the surgical procedure's success, and assessed its effects on the overall health of the animals.
In summary, the research presented an advanced approach to T1DM management by addressing key challenges and demonstrating promising outcomes for future clinical applications.
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