Portable sedation device

Lead Research Organisation: Cardiff University
Department Name: Chemistry

Abstract

A wide range of medical procedures and interventions are carried out under sedation, and in even the most difficult situations the delivery of combined anaesthesia and analgesia is mandatory for surgical procedures.

Due to the lack of portable equipment or a shortage of highly trained staff, these requirements can be difficult to meet. This is particularly the case in pre-hospital medicine and in the rapidly expanding fields of sedation for painful procedures (eg gynaecological fertility treatments, dentistry). Availability of a simpler to use technology, that would allow patients to receive volatile anaesthesia/sedation in a much wider variety of places, therefore offers significant patient benefit via the possibility of pre-hospital medicine, local clinic based treatment, more rapid sedation recovery times and therefore higher patient throughput.

We have developed a novel device for the delivery of well-established volatile anaesthetic drugs using a patented formulation approach. The new delivery mechanism offers considerable advantages for simplicity of control and stability of anaesthetic release. Our program of work will generate a small, lightweight portable sedation device, suitable for use in a wide range of clinical and non-clinical settings, and suitable for use by a wide range of healthcare practitioners.

Our technology is designed to be particularly beneficial in the developing world, where access to advanced medical procedures is frequently limited by prohibitive costs of complex equipment, and the availability of the very highly trained staff required to use them.

Developing this sedation device will provide valuable healthcare benefits in its own right, but the program of work to develop it will also generate essential safety data required to unlock future development potential for the underlying formulation-based technology. Successful entry to market via sedation for short-term medical interventions will support the scientific and economic case to broaden the range of application in sedation (eg for long-term sedation intensive care patients), and ultimately for commercial development of the parent device which was designed for induction and maintenance of anaesthesia.

Technical Summary

Patients often require sedation in challenging situations, and it is then that they most require drugs to be delivered simply and reliably with minimal compromise to their respiratory and cardiovascular function. This is difficult to achieve with intravenous agents which are hard to adjust to response and can easily accumulate. The use of breathable (volatile) sedation agents which are rapidly breathed out by patients would be an excellent and responsive way of delivering sedation in challenging circumstances. Currently, due to the lack of portable equipment or a shortage of highly trained staff to operate volatile sedation devices currently available, this can be hard to achieve, particularly in pre-hospital medicine, with critically-ill patients, and in the rapidly expanding field of sedation for painful procedures (eg gynaecological treatments, endoscopy, dentistry). Current devices are mostly modifications of the earliest types of anaesthetic devices, and therefore crude, inaccurate and difficult to use. The ability to offer sedation adjusted accurately to response would offer more rapid recovery from sedation and higher patient throughput.
We have developed a novel device to deliver established breathable sedation agents using a patented formulation approach, offering considerable benefits in control and stability of sedation drug release. Incorporation of additional control and safety measures will generate a small, lightweight, purpose designed portable sedation device, suitable for use by a wide range of healthcare practitioners, in a wide range of clinical and non-clinical settings. Commercial availability of such technology which is simple and efficient in its use, and would allow patients to receive volatile sedation/anaesthesia in a much wider variety of places would represent a significant step forward in patient care, especially in pre-hospital medicine, community-based treatment, field, military and rural healthcare, including the developing world.

Planned Impact

Our project proposes to develop a small, lightweight, portable device that will be able to provide safe, effective sedation to patients in a wide range of clinical and non-clinical settings. For example, patients requiring sedation for medical procedures such as camera procedures like colonoscopy, bone dislocation or fracture realignment, dental treatment, fertility treatment, body scans or any situations where patients are anxious. Additionally patients requiring sedation in remote or inhospitable areas, during transportation by ambulance, or in long term intensive care (when patients are critically ill). The device will enable the use of inhaled sedation (rather than sedation by injecting drugs through needles), providing rapid onset of sedation, better control of sedation level, and rapid recovery, thereby reducing procedure time.

By making the device suitable for safe use by non-anaesthetist staff, the range of patients that could benefit from it is greatly increased. This technology could therefore have a transformative impact on patient care within the NHS and via other healthcare providers worldwide. Additionaly, we anticipate the technology would provide substantial financial benefits to the NHS.

To realise the full impact of the device we need to develop it sufficiently to attract investment from global industry partner(s) capable of transforming the concept into a global product. Continuous engagement with a wide range of end-user medical staff, via publication in widely read journals, and presentation of the device at clinical conferences, will increase awareness of the technology, promoting engagement and future uptake. Discussion with potential investors to identify commercialisation routes will continue throughout the programme, with the aim to secure the most effective route to market for maximum industry uptake, and therefore maximum positive impact on patient care.

Publications

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