Ostomy, temporary or permanent, generally results from a surgery due to cancer, such as bowel cancer or bladder cancer, or from inflammatory bowel disease (IBD). It may also result from surgery performed on patients with birth defects such as Hirschsprung disease, or to address problems resulting from an imperforate anus, which causes a change in the way urine or stool exits the body. These may result in bodily wastes being rerouted from the usual path. The bodily wastes such as faecal matter, urine and mucus are diverted through a surgically created opening called a stoma into an external prosthetic device known as Ostomy pouch or Ostomy bag, which is connected outside the body.
The most common types of ostomies are:
The ostomy pouching system can be a one-piece or a two-piece flexible system consisting of a bag and a flange (skin barrier) that sits against the patient’s skin. The flange may be flat or convex. The one-piece system combines both the barrier and pouch into one convenient unit; during a replacement, the whole system has to be removed. The two-piece system is made up of a barrier and a pouch separately. The two pieces are connected together with a coupling ring, and during a replacement, the existing bag is removed and a new one is fixed while the flange/barrier remains in place.
Fig. 1. One and Two-piece Ostomy System (source)
In a one-piece system, the pouch and skin barrier/flange are fixed permanently together. The pouch collects the waste while the skin barrier/flange gets fixed around the stoma to protect the skin. It is easy to apply or remove such pouching systems. However, a two-piece system does provide the user some options and flexibility, as it requires the ostomate to only change the ostomy bag and not the skin barrier/flange. The user can then clean the pouch and reattach it, or just discard the soiled pouch and attach a new pouch. This makes the pouch replacement quicker and more convenient.
The challenges in the ostomy pouching system can be categorized under three main heads:
In the recent past, innovators have attempted to address the above-mentioned drawbacks in the ostomy pouching system. Relevant patents associated with the technology and the corresponding clinical trials have been presented below.
The TIES® System, developed by the Norway-based OstomyCure, is a novel device without skin barriers and ostomy pouches. A small tube of titanium is implanted into the abdominal wall of the patient, and the intestine and soft tissue are allowed to grow into it. The implant then becomes an extension of the intestine and protrudes only a few millimeters, where it is sealed with a lid such that the patient can open it to drain when needed. The lid simply functions as a stopper. This innovative product is designed to avoid the skin infections and leakages that may occur in an ileostomy bag. The device drastically reduces skin problems, as it only needs to be cleaned with tap water, with no disinfectants or glue needed. The new solution (implant and lid) aims to make the patient's life easier and more comfortable, thus enhancing the quality of life. The TIES® implant has received the European Union’s CE Mark. [1,2]
Fig. 2. TIES® System (source)
OstomyCure has a granted patent, US9615961B2, titled Percutaneous implant and ostomy method; which discloses a percutaneous ostomy implant for implantation into the abdominal wall of a patient. The implant comprises (a) a first cylinder of a connecting member, for mounting an external detachable device that is configured to receive an intestine segment within it to form a stoma, (b) a second cylinder of the same diameter as the first, containing a tubular mesh structure and a radially-extending dermal anchor with a first ingrowth mesh positioned on the second cylinder to engage the abdominal wall beneath the dermis structure to secure the implant in the axial direction, and (c) an inner fourth ingrowth mesh in the form of a cylindrical tube that is of a smaller diameter extending below the third ingrowth mesh.
Fig. 3. Percutaneous implant
A clinical study was registered in the US to assess the performance, safety and durability of the TIES implant designed to enable continence control for patients who would otherwise need to wear an ileostomy bag. As per clinicaltrial.gov, the multicentre, open-label, single-arm clinical study would assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy. Eligible subjects would undergo a conventional ileostomy procedure under general anaesthesia and have the TIES® port implanted. As of April 2018, the TIES® system had been evaluated in 11 patients in 2 clinical studies. The study was aimed at collecting more data that will assess the performance, durability, safety and the impact that the TIES® system has on a patient's quality of life. The study was scheduled to enrol 50 patients across Europe that require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease. The study subjects were expected to participate for approximately 1 year, following surgical placement of the TIES® port. Participation would involve a screening period, surgical implantation of the device (in-patient) and scheduled follow-up assessments upto a year post-implant. The estimated study completion date was June 2020.
A clinical trial was also registered in ANZCTR (Austrialian, New Zealand Clinical Trials Registry) to study the safety and performance of the TIES percutaneous titanium implant in patients undergoing surgery for permanent ileostomy or repair of a pre-existing permanent ileostomy . As the CE mark was obtained based on data from the first 5 subjects, phase II was no longer planned.
The Alfred SmartBag is a novel device from 11 Health, a London-based medical technology (medtech) start-up, launched in 2013 by Michael Seres and Adam Bloom. The Alfred SmartBag is the world's first smart ostomy bag that alerts the patients through its unique features such as the ability to track output level, monitor stoma irritation and detect output state, all with wireless connectivity; to capture data and sync to the Cloud via Bluetooth and mobile data. The potential advantage is that the device can prevent unexpected bag overfilling, breakage and sudden incidents at night time/work place. The Alfred SmartBag improves the quality of life of patients who may be constantly worried about leakage. The volume and output recordings can also be stored and emailed to the patient's health care providers, with potential to reduce ostomy-related dehydration through more accurate volume recording and sharing. [5, 6]
Fig. 4. Alfred smart bag (source)
11 Health closed £1.3m in funding over 3 rounds. Their latest funding was raised on Sep 12, 2016 from a seed round to develop its ostomy bag healthcare device. The investors were DigitalHealth.London Accelerator programme and SBRI Healthcare. 
11 Health has a US patent application (US20190133810A1, titled Ostomy monitoring system and method) that is relevant to this technology. The invention discloses an ostomy bag/wafer comprising an adhesive layer that adheres to skin around a stoma; a flexible sensor layer coupled with the adhesive layer for measuring metrics such as bag fill, leakage, skin irritation and phase of stoma output, among others. The sensors can include a temperature sensor and/or capacitive sensor.
Fig. 5. Ostomy monitoring system
A clinical trial is currently in progress to study the efficacy of the Alfred SmartBag used as a continuous ostomy monitoring system, by tracking the volumetric filling of the pouch through an integrated thermistor and capacitive sensors, and the potential leakage and skin irritation through integrated thermistors in the wafer. 11 Health Technologies has collaborated with Cleveland Clinic for its clinical trial on the Alfred SmartBag. The estimated study completion date is September, 2021. The clinicaltrials.gov number is NCT03982875. Other study ID No.: 11HCCF 
Ostoform, a Dublin-based medtech startup founded in 2016 by Kevin Kelleher and Rhona Hunt, is a spin-out from the Bio Innovate programme at the University of Limerick. The company has developed a novel medical device that significantly reduces skin complications amongst people who use ostomy appliances. Ostoform’s device has an innovative seal and the design uses FLOWASSIST™ protection, a combination of advanced absorbent and non-absorbent materials that prevent acidic output from contacting the patient’s skin. The mouldable seal is placed around the stoma to direct the flow of ostomy effluent away from the skin and into the ostomy bag. Consequently, the skin is better protected, and if already damaged, heals quickly and more effectively. 
Fig. 6. Ostoform Seal (source)
Ostoform has a PCT application no. WO2019229267A2, titled Improvements in ostomy attachments. The patent discloses an ostomy attachment comprising a flexible annular seal configured to partially surround a stoma, the flexible annular seal comprising first face and the second face both bounded by an inner and outer rim, wherein the inner rim is concentrically arranged within the outer rim; and - an ostomy seal liner configured to engage with the inner rim, and comprising a stabilising extension.
Fig. 7. Ostomy attachment
The annular seal is formed of absorbent material which is a hydrocolloid, whereas ostomy seal liner is formed on non-absorbent material comprising two resiliently deformable arms. The ostomy seal liner further comprises a central section to which one resiliently deformable arm is attached. The central section comprises a spout that is disposed beneath the stoma and/or is configured to direct ostomy output, away from a patient’s skin, and into an ostomy bag.
Ostoform has completed a patient trial, with 12 patients wearing the device for 6 weeks. On an average, a 45 % reduction in skin complications was identified. Additional benefits include better usability, increased patient confidence and improved quality of life[10, 11]. Ostoform exhibited in the US for the first time at the national Wound, Ostomy and Continence Nurse Society’s annual conference, held in Nashville Tennessee during July 2019. More information around the product’s launch in the US or Europe is awaited. The company has secured €1.2 million in new funding for its device. The Investors are Halo Business Angel Network, SOSV investments, EASME - EU Executive Agency for SMEs and Allied Irish Bank. 
According to Ostoform’s publication titled “Changes in peristomal skin condition and user experience of a novel ostomy barrier ring with assisted flow: A 6-week feasibility study”, the study was conducted to evaluate the novel barrier ring with an assisted flow mechanism by assessing changes in peristomal moisture-associated skin damage (MASD) and perceptions of comfort, security, handling, and discretion in persons with an ileostomy for 6 months or longer. Based on the study, it was concluded that the barrier ring’s non-absorbent spout component for assisted flow was designed to minimize the amount of effluent contacting the peristomal skin, and initial participant data from the 6-week feasibility study suggested that the device was effective for prevention of peristomal MASD. In addition, participant ratings relating to the usability of the novel barrier were high. A trial with a larger participant sample size was recommended to provide more definitive evidence of device efficacy.
With no publication subsequent to this being available, it is assumed that the company has gone in for a larger trial. It is possible that once the trial is completed, the product will be ready for commercialization.
SphinX is a product of Crimson Healthcare, an Indian company founded in 2015 by Pranav Chopra. Sphinx is a novel device that was initially developed under the School of International Biodesign (SIB) funded by the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India. It is a supported Fellowship Programme centered at All India Institute of Medical Sciences (AIIMS) and Indian Institute of Technology, Delhi (IITD), in collaboration with International partners. DBT has engaged Biotech Consortium India Limited (BCIL) for comprehensive Intellectual Property Management and Technology Transfer/Licensing under SIB. The technology was licensed by DBT to Crimson Healthcare in 2016 . Crimson Healthcare received crucial early stage grant funding from BIRAC (Dept of Biotechnology) through its BIG programme with a grant worth 50 Lakhs for proof of concept of the SphinX device. 
Fig. 8. SphinX (source)
SphinX is a soft and pliable device that, when inserted into the stoma, creates a sleeve around the inside of the stoma portion of the intestine. The port on the outside can be plugged, which re-creates continence. SphinX remains in the intestine with the help of a robust anchoring mechanism. It also creates a safe and secure seal to prevent any stool leakage. The patient may open the plug at his/her convenience and evacuate the stool in a simple, cheap disposable bag. The insertable device is made up of a soft biocompatible polymer that ensures safety during insertion and usage. The device avoids wearing of the pouch constantly, and therefore, reduces complications such as skin excoriation, dermatitis and pain resulting from constant wearing. As of now, no information is available on the status of its commercialization.
Department of Biotechnology (DBT) Patent application number 3697/DEL/2014, titled Ostomy management device, discloses an ostomy port insertable inside a stoma on a patient’s abdomen, the ostomy port comprising an outer flange placed at the periphery of the stoma; wherein the outer flange has a collapsible chamber to collect instilling fluid in its non-operating stat, a fixation element for anchoring the ostomy management device inside the intestine, where it expands after displacement of the instilling fluid contained in the outer flange to the fixation element.
Fig. 9. Ostomy port
The patent application is still under prosecution at the Indian Patent Office. The first examination report (FER) was issued by the Indian Patent Office on 14th Feb 2020. Response of the applicant to the FER is awaited. There is no other news regarding the commercialization of the product. The applicant filed a PCT application and entered the US and European Patent Office in the National phase. Among these, the EP application EP3215075B1 titled Ostomy Management Device got granted on May 29, 2019, whereas US20170367871A1 is still under examination, awaiting grant.
The company aims to complete the development of the ostomy management system and launch the product in India by early 2020.
The Self-Sealing Therapy Ostomy Pouch (S2TOP) was developed by Eden Medical (earlier Korosensor.com, Inc) as an outcome of a proposal that was submitted to the National Institute of Health (NIH) for developing an ostomy pouch that would stop leakage and avoid skin breakdown. The S2TOP was meant to detect leakage, inform the patient and prevent leakage occurrence; providing better patient comfort and well-being, thus eliminating the cycle of misery due to ineffective seals and skin breakdown. The S2TOP was intended to integrate a self-contained temperature-activated pump system into the wafer barrier to dispense a bio-friendly sealant directly into the stoma area to stop effluent leakage. This research was funded in 2015 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), an institute within NIH, with a funding amount of $257,158. 
The research program resulted in two patents - US9046085B2 and US10531977. The US patent US9046085B2, granted in June 2015, titled Miniature pumps, discloses a pump comprising a chamber for storing liquid, gel, gas, or any other medium, capable of dispensing the substance when activated. The pump includes an environmentally-responsive plug layer that can contract in size; for example, when exposed to temperature, to allow the stored activation fluid to flow from the first chamber to the second, and onto the layer of absorbent material to cause the same to swell in size. The expansion of the absorbent material causes the diaphragm to flex into a chamber that holds the dispensable substance, forcing the same out of the pump through exit ports.
The first patent disclosed above got granted on June 2, 2015. The second patent US10531977, titled Thermoresponsive skin barrier appliances, got granted recently i.e., on January 14, 2020; and it is interesting to see that it got reassigned to Coloplast on October O4, 2018, much before grant date. 
StomaLife is an ostomy device that uses a novel valve system with a pressure relief feature to provide stoma continence and allow control over faecal discharge and gas release. The device also uses a novel magnetic retention system that secures it to the stoma site without the use of adhesives and the associated skin irritation and infection. The benefits of StomaLife are reduced skin irritation and infection, odor and sound control, leak prevention, waste material flow control and on-demand gas release. StomaLife prevents the need for messy and unsightly bags. [17,18]
StomaLife is a proprietary valve system from StomaLIfe Pty. Ltd. that is partially implanted around the stoma. It consists of three functional components:
Fig. 10. StomaLife Valve (source)
There have been a few product recalls in the Ostomy devices area, which are presented below:
ConvaTec Inc. recalled Flexi-seal FMS Control Kit in the year 2014 (Class I recall) since it did not have a 510K (Pre-market approval). In addition, an internal assessment of the product performance and a review of the customer feedback confirmed that Flexi-Seal Control did not meet expectations of customers. Specifically, the auto-valve feature that is unique to the Flexi-Seal Control was not performing consistently.
Coloplast recalled the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. This led to a Class II product recall in the year 2014.
The major players in the area of Ostomy are Coloplast Corp., Convatec PLC and Hollister Inc., based on the number of products in the market and their patent filings in the ostomy area.
Coloplast Corp, a Danish company founded in 1957, manufactures stoma management, wound care and incontinence management products. Coloplast’s products include colostomy and urostomy bags as well as stoma maintenance equipment. Coloplast has launched multiple products over the last several years, which are presented below:
Evolution of Coloplast products:
Fig. 11. Evolution of Coloplast products (source)
The latest product from Coloplast is the Sensura Mio concave pouching system, introduced in the year 2018. The star-shaped baseplate of the device fits securely over bulges, hernias and curves. The petals of the baseplate hug the body without creasing or folding. The ring stabilizes the centre zone so the stoma gets the necessary support, and guides where to put pressure while fitting.
Patents matching the recently launched Senura Mio Concave product of Coloplast are presented below:
US10470918B2, titled Ostomy Wafer, discloses an ostomy wafer comprising a central peristomal area surrounding a stoma-receiving hole, wherein the area is continuous and extends radially to define a continuous band of material around the stoma receiving hole; a first petal spaced apart from a second petal, wherein the apex of the first and second petals is convex and each of the petals extends away from the continuous band of material. The petal lengths are measured from the stoma receiving hole to the apex of the petals.
Fig. 12. Ostomy wafer
EP3346961A1 titled Ostomy Device discloses an ostomy base plate comprising a flexible top film, having two sections, and having an elastic skin-friendly adhesive on its proximal surface, a stoma-receiving hole providing an inner boundary of first section, being adjacent and extending radially from through-going hole, and second section surrounding first section, an outer boundary of the second section defining the base plate, and release liners, the base plate having a convex shape for initial engagement with a peristomal skin surface and can be inverted to a concave shape for proper fixation to the peristomal skin surface for permanent engagement.
Fig. 13. Ostomy base plate
A few recent interesting patent filings from Coloplast:
PCT application No.WO2019161862A1 titled Sensor assembly part and a base plate and an ostomy pouch for an ostomy appliance and a device for connecting to a base plate and/or a sensor assembly part discloses an ostomy appliance system comprising a monitor device for connecting to the base plate, and an ostomy pouch. The base plate comprises a top layer, adhesive layer, and an electrode assembly; and a monitor interface for connecting the base plate to a monitor device for leakage classification and detection thus monitoring the operation of the ostomy appliance.
Fig. 14. Base plate and monitoring device
US patent no. 10531977 titled Thermoresponsive skin barrier appliances discloses thermoresponsive ostomy skin barrier appliances that are capable of sensing and responding to stoma leakage by deploying an amount of sealant from a miniature pump system to prevent further leakage. The ostomy apparatus substrate comprises of top and bottom surfaces and a central aperture, where the substrate is disposed between upper and lower hydrocolloid layers, a moisture sensor disposed on top surface of substrate, and another disposed on bottom surface of the substrate; the two moisture sensors are configured to detect effluent and send an activation signal to the pump containing a flowable substance.
This patent was granted on January 14, 2020. Interestingly, this patent has been reassigned by Eden medical Inc. to Coloplast on 10/04/2018.
ConvaTec Group plc is an international medical product and technology company, headquartered in Deeside, United Kingdom, offering products and services in the areas of wound and skin care, ostomy care, continence and critical care, and infusion devices. In Jan 2020, ConvaTec launched ConvaMax™ superabsorber wound dressing for the management of highly exuding wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers and dehisced surgical wounds. ConvaMax™ superabsorber manages excess moisture to help protect skin integrity where there is a real risk of skin damage due to high levels of exudate. Also, ConvaTec has come up with the latest addition of one-piece ostomy in the ostomy area i.e., Esteem™+ Flex Convex system, which fits the contours. Convex wafers are designed to help manage irregular stomas and abdomens to help reduce leakage and simplify stoma management.
Fig. 15. Esteem™+ Flex Convex system (source)
A quick look at Covatec’s patent portfolio (year-wise breakup given in Fig. 15) shows a large number of patent applications filed in 2019. There were 23 GB patents of which 22 patents were related to ostomy appliances. It may be noted that GB D0 publications are related to applications that have been filed at the GB patent office, and they will be published only after 18 months. Therefore, at this point of time, it is not clear what inventions are covered by these applications.
Fig. 16. Technology trend - ConvaTec
Hollister Inc., headquartered in Illinois, United States; develops, manufactures, and markets healthcare products worldwide. The company offers products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Hollister Inc. has introduced its new product with ceramide-infused barrier i.e. “CeraPlus” skin barrier. Ceramide is a natural component of human skin that helps prevent water loss, which can lead to skin dryness and damage. The barrier protects the skin's natural moisture barrier and helps maintain good peristomal skin health.
Fig. 17. CeraPlus” skin barrier (source)
The following patent is related to the ceramide infusion barrier:
EP3634324A1 titled Skin barrier including skin friendly ingredients discloses an ostomy appliance formed from skin barrier material or stoma sealing material, wherein the appliance comprises skin friendly ingredients provided only on the skin contact surface. The skin friendly ingredient is selected from vitamin E, ceramide, cholesterol, fatty acids, micro-pockets of pH buffers, polysaccharides, and anti-wrinkle agents.
Fig. 18. Skin barrier
A few interesting patent filings from Hollister Inc. are listed below:
WO2020076609A1 titled Ostomy appliance comprising thermal sensors
The invention discloses an ostomy appliance comprising of a skin barrier, and a leak detection system to which a thermal sensor and thermistor is integrated to measure a change in temperature of the ostomy appliance. The thermal sensor is connected to an electrical interface and used for detecting thermal property of ostomy appliance.
Fig. 19. Ostomy appliance with sensor
WO2020076607A1 titled Ostomy appliance having conductive ink circuit for leakage detection
The invention discloses an ostomy appliance for leak detection comprising a substrate, and Radio Frequency Identification (RFID) circuit disposed on the substrate, comprising of a RFID transponder having an antenna and a conductive ink connected in series with the antenna and the RFID transponder. The conductive ink is dissolvable and gets dissolved when exposed to moisture. The RFID circuit is in a closed condition when the conductive ink extends continuously between the RFID transponder and the antenna and the RFID circuit is in an open condition when a portion of the conductive ink is dissolved. The controller connected to power supply is configured to determine leakage condition based on the signal from the RFID.
Fig. 20. Ostomy appliance with leakage detection (source)
Salts Healthcare, headquartered in Birmingham, UK, is another player to be watched on account of its interesting products and patents. The company is split into two divisions: Salts Stoma Care, which designs and manufactures stoma care devices and additional products; and Medilink, a national network of 19 Dispensing Care Centres that supply and dispense stoma care and continence products by all manufacturers. It has introduced a new version, Confidence BE® Soft Convex, wherein the Soft Convex wafer fits more closely to the body, helping leak prevention. The Clever Active Chamber filter system helps prevent ballooning, pancaking and odor.
Fig. 21. Confidence BE® Soft Convex
Recent patent publications from Salts Healthcare are presented below:
GB257730A titled An ostomy appliance
The invention discloses an ostomy appliance, multi-layer filter for location over an aperture or vent, provided in the wall of the ostomy bag. The filter comprises of a hydrophobic layer, preferably formed from Polytetrafluoroethylene (PTFE), which is positioned directly adjacent the vent or wall when the filter is attached to the ostomy product. A de-odorizing layer, formed from a carbon-based material, is positioned adjacent the hydrophobic layer, with a gas and liquid impermeable layer placed adjacent to the de-odorizing layer.
Salts Healthcare has also filed 4 patent applications in the GB patent office in the year 2019-20, with all patents related to Ostomy appliances or their manufacture. As GB patents are not published patent specifications, one has to wait for 18 months to know the latest innovation.
Ostomy systems with convex-shaped ostomy devices have gained significant attention from manufacturers, as they fit securely to the body contours. New appliances, such as ostomy bags integrated with features such as sensors to detect leakages, implantable lids to avoid carrying of ostomy bags and skin-friendly ostomy barriers to overcome skin inflammations are expected to be launched in future. This will happen once they pass the clinical trials successfully; also given their efficacy, accuracy and cost-effectiveness.