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The apparent simplicity of 3D printing, from art projects to DIY guns, belies its enormous promise in healthcare. 3D printing  –also known as additive manufacturing– historically refers to the process whereby material is sequentially deposited onto a powder bed with inkjet printer heads. It’s not new: it has been used in industrial design since the 1980s, however in the last decade, 3D printing has become adapted for medical application inspiring enthusiasm across the healthcare community.

3-D printing can offer the healthcare industry numerous solutions:

  • For making models of anatomically complex patients can guide surgeons in preoperative strategies. This has helped in decision making in complicated cardiac surgery (1) and neurosurgery (2); and also for clinical/surgical planning or in medical education and research (3)
  • For creating bespoke biomechanical parts. Health conditions that stem from biomechanical issues (like broken and misaligned bones, and aging joints) tend to have great anatomical variance. Using scans to determine exact dimensions, bespoke 3D printed products will fit any anatomy with greater intricacy than those manufactured using traditional methods (without requiring retooling). The specificity of 3D printing to the patient’s anatomy also makes it potentially very useful for dental implants and hearing aids
  • For producing structures critical for repairing complex and delicate organs like the heart valves, blood vessels and nerve tissue. A recent study demonstrated how 3D printed flexible silicon scaffolds (containing biochemical growth cues) could act as nerve guides to repair sciatic nerve damage in rats(4); moreover, the nerve had a complex morphology (Y-shaped) demonstrating non-linear regeneration. Implants can even be made from bioresorbable materials so that they effectively break down after they have performed their function (5)
  • For use with living tissue: initially layering numbers of cells (albeit very thin and only temporarily viable), the hope is to be able to create larger viable sections in the future, looking toward 3D printing of implantable liver tissue and ultimately replicated organs.
  • For manufacturing medical equipment on-site, which may be pertinent in poorer countries or warzones. In fact, this feature has been demonstrated by printing stethoscopes in Gaza after a blockade on medical supplies was imposed (6). Looking further into the distance, a solar-powered 3D printer has been developed for space stations in Mars!

3D Printing affords design freedom with rapid creation of specialised and complex products with complex anatomical geometries –allowing a concept to be directly translated into an end product in a convenient, cost-efficient manner.

Its potential value in healthcare is illustrated by the growth in research in this field: already to date in 2015, there have been more scientifically published reports of 3D printing than in all of 2014, which have increased more than a 4-fold since 2011. Of course, this is wonderful for research, but will 3D printing actually impact healthcare in the long-term, or will it be confined to niche markets? Hopefully, savings from eliminating development time, production, assembly lines, delivery, and warehousing of parts, and the subsequent savings made from using fewer materials and labour should lead to a real reduction production costs. Wide-ranging and longitudinal studies on large samples are necessary to assess the real impact of this technology in surgical procedures and healthcare as a whole.

 

If you would like to comment on any of the issues raised by this article, particularly from your own experience or insight, Healthcare-Arena would welcome your views.

References

  • Schmauss D, Gerber N, Sodian R. Three-dimensional printing of models for surgical planning in patients with primary cardiac tumors. The Journal of thoracic and cardiovascular surgery. 2013;145(5):1407-8. Epub 2013/01/15.
  • Spottiswoode BS, van den Heever DJ, Chang Y, Engelhardt S, Du Plessis S, Nicolls F, et al. Preoperative three-dimensional model creation of magnetic resonance brain images as a tool to assist neurosurgical planning. Stereotactic and functional neurosurgery. 2013;91(3):162-9. Epub 2013/03/01.
  • Naftulin JS, Kimchi EY, Cash SS. Streamlined, Inexpensive 3D Printing of the Brain and Skull. PloS one. 2015;10(8):e0136198. Epub 2015/08/22.
  • http://onlinelibrary.wiley.com/doi/10.1002/adfm.201501760/abstract.
  • Zopf DA, Hollister SJ, Nelson ME, Ohye RG, Green GE. Bioresorbable airway splint created with a three-dimensional printer. The New England journal of medicine. 2013;368(21):2043-5. Epub 2013/05/24.
  • http://www.huffingtonpost.com/entry/tarek-loubani-3d-printing-stethoscope-gaza_55f2f570e4b077ca094ec2f5.

Accurate long-term pulse oximetry monitoring with greater patient comfort, lower cost and application beyond the ICU

Image courtesy Xhale Assurance

FDA Approval of the Nasal Alar SpO2 Sensor

On the 18th of March 2015, Xhale Assurance, developer of the patented Assurance® Nasal Alar SpO2™ Sensor, announced its approval by the US Food and Drug Administration (FDA) and the global launch of this second-generation pulse oximetry sensor (1,2). The new Xhale Assurance® Nasal AlarSpO2™ Sensor is compatible with the majority of pulse oximetry monitors used in many different healthcare settings. Pentland Medical is now marketing this product as the Nasal Alar SpO2 Sensor (3).

Oxygen Supplementation in Patient Treatment

Acute and chronic medical conditions can be associated with hypoxia and require supplemental oxygen therapy. The acute medical conditions include attacks of asthma, pneumonia or respiratory distress syndrome (RDS). In premature babies, oxygen supplementation is given for the condition of bronchopulmonary dysplasia (BPD).

The chronic conditions requiring oxygen supplementation include chronic obstructive pulmonary disease (COPD), heart failure and sleep apnoea. In the treatment of these conditions, oxygen is usually administered through a nasal continuous positive airway pressure (NCPAP) machine, a nasal tube or a ventilator.

Pulse Oximetry in the Evaluation of Blood Oxygenation

It is important to monitor the requirements for and effects of oxygen supplementation as too much oxygen can be as harmful as too little. Pulse oximetry is a non-invasive method used to measure the oxygen level (or oxygen saturation) in the blood of the peripheral tissues, usually using a sensor attached to the finger.

The technology is based on detection of the light absorptive characteristics of oxygenated haemoglobin and the pulsating properties of the blood flow in the peripheral arteries and arterioles. With each heartbeat, there is a small increase in vascular volume, with an associated increase in oxygen-rich haemoglobin.

The pulse oximeter consists of a clip-like sensor that houses a light source, a light detector, and a microprocessor. One side of the sensor contains an infrared and a red light source which are transmitted through the tissues to the light detector on the other side. The oxygen-rich haemoglobin absorbs more of the infrared light; oxygen-poor hemoglobin absorbs more of the red light. The microprocessor calculates these differences and converts the information to a digital readout of the amount of oxygen being carried in the blood. This information enables the attending physician or nurse to evaluate the need for supplemental oxygen.

Use and Advantages of the Nasal Alar SpO2 Sensor

The Nasal Alar SpO2 Sensor fits comfortably on the nasal ala that is lateral to the nostril (nares) and does not require any adhesive to keep it secure (3). The Nasal Alar SpO2 Sensor can be easily removed and reapplied for use during the patient’s hospital stay (3). The nasal ala is a highly vascular region that is fed anatomically by both the external and internal carotid arteries. This multi-directional arterial supply provides strong, reliable photoplethysmography signals that respond rapidly to changes in the patient’s arterial oxygen saturation. These signals can be lost when using sensors located on the finger (4).

The nasal alar site has the following advantages:

  1. This site has no clinically significant sympathetic tone and, therefore, does not lose signal due to the patient being cold, anxious or stressed.
  2. This site is less affected when patients experience diminished peripheral perfusion, as in cardiovascular disease, hypovolaemia or following medications that cause vascular changes.
  3. The nasal alar site is less subject to signal distortion due to sensor interference from ambient light.
  4. The strong signal from this location provides consistent accuracy, even at very low oxygen saturations.
  5. The nasal alar site location makes the sensor less likely to be dislodged, which reduces alarms.
  6. The nasal alar attachment site is easily accessed by an anaesthetist during surgery; the non-adhesive attachment makes the sensors easy to reposition.

Clinical Evaluation of the Nasal Alar SpO2 Sensor

Recent studies support the feasibility and accuracy of nasal alar pulse oximetry (5). The many unique features of this nasal alar pulse oximetry sensor have encouraged clinical studies to evaluate its role beyond the operating theatre, in patients with acute, chronic or long-term medical conditions.

In February 2015, the results of a usability and acceptance study for the use of the Nasal Alar SpO2 Sensor in a non-hospital setting, showed that 50 volunteer subjects were able to wear the sensor for seven days (6). All 50 study participants reported that, when compared to wearing a finger pulse oximeter, the Nasal Alar SpO2 Sensor was more comfortable and interfered less with daily living activities (6). Although the use of oximeter sensors at sites such as the finger and forehead have been associated with skin pressure complications, there are no reported complications from the use of the Nasal Alar SpO2 Sensor (6,7).

The benefits of the Nasal Alar SpO2 Sensor include.

  1. Reliable, consistent and accurate oxygen saturation measurement, that is unaffected by reduced peripheral perfusion.
  2. Sensitive and rapid detection of changes in oxygen saturation.
  3. Ease of access to the alar nasal sensor attachment site, even during surgery.
  4. Comfort when wearing the sensor for long periods of time, with no complications.
  5. The nasal alar location of the sensor resists monitoring fluctuations or signal distortion due to ambient light or motion.
  6. Cost savings, when compared to finger and forehead sensors.

Cost: Nasal Alar SpO2 Sensor

The Nasal Alar SpO2 Sensor costs less than £20 ($30 USD) each (3). Patient studies have shown that the sensors are durable which means a significant cost saving can be expected in longer term monitoring (8). Digital sensors cost £8 ($12 USD), and forehead sensors are up to £16 ($24 USD). In the US, the average stay in ICU is 3.8 days and during this time, digital sensors will require replacement (8).

In conclusion, these results indicate that the Nasal Alar SpO2 Sensor can be used comfortably, safely, effectively and at relatively low cost, not only in the operating room during anaesthesia or in intensive care, but also in a variety of situations within and outside the hospital.

This report has been received and reviewed by Dr Richard Melker, Xhale Assurance, on 25th June, 2015, prior to online publication.

If you would like to comment on any of the issues raised by this article, particularly from your own experience or insight, Healthcare-Arena would welcome your views.

References

(1) Xhale website. http://xhale.com Accessed June 18, 2015

(2) Press Release. Xhale Assurance Announces FDA Approval of its Second Generation Nasal Alar SpO2 Sensor. March 18, 2015. http://xhale.com/xhale-assurance-announces-fda-approval-of-its-second-generation-nasal-alar-SpO2-sensor/ Accessed June 18, 2015

(3) Pentland Medical. Nasal Alar SpO2 Sensor. Product information. http://www.pentlandmedical.co.uk/index.php/products/pulse-oximetry-sensor/ Accessed June 18, 2015

(4) Davis DP, Aguilar S, Sonnleitner C, Cohen M, Jennings M. Latency and loss of pulse oximetry signal with the use of digital probes during pre-hospital rapid-sequence intubation. Prehosp Emerg Care 2011;15(1):18-22. http://informahealthcare.com/doi/abs/10.3109/10903127.2010.514091 Accessed June 18, 2015

(5) Morey TE, Rice MJ, Vasilopoulos T, Dennis DM, Melker RJ. Feasibility and accuracy of nasal alar pulse oximetry. Br J Anaesth 2014;112(6):1109-14. http://bja.oxfordjournals.org/content/112/6/1109.long Accessed June 18, 2015

(6) Melker, RJ, et al. Usability/Acceptance Study Final Report Xhale Assurance Nasal Alar Sensor. Feb. 2015. Unpublished data. On file, Xhale Assurance.

(7) Lee M, Eisenkraft JB, Forehead pulse oximeter-associated pressure injury. A Case Rep. 2014 Jan 15;2(2):13-5. doi: 10.1097/ACC.0b013e3182a66b29. http://www.ncbi.nlm.nih.gov/pubmed/25611043 Accessed June 18, 2015

(8) Pfuntner A, Wier LM, Steiner C. Costs for Hospital Stays in the United States, 2010. HCUP Statistical Brief #146. January 2013. Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb146.pdf. Accessed June 18, 2015

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