The Insides® Neo is intended to be used in paediatric patients who have a loop enterostomy, abcarian enterostomy or end enterostomy with mucous fistula allowing access to the distal intestine. The device is intended to act as a conduit to aid the transfer of chyme from an ostomy appliance into a stoma. The device can be used in a range of environments including hospitals, A&E, and clinics.
The Insides® Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patient’s intestinal tract.
The Insides® Neo is not suitable for patients who:
Patient management should be carried out as per standard operating procedures at the local clinical institution. The following patient management and assessment guidelines can be used as guidance in treating patients with CRT using The Insides® Neo.
‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins™‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
Inclusion criteria
1 A double enterostomy or enteroatmospheric fistula with proximal and distal outlets that can be contained (separately or together) in a HollisterTM PouchkinsTM 3887 or Coloplast Sensura® Mio 18700 ostomy appliance.
2 The distal limb must be able to be intubated with a feeding tube with a minimum size of 4 Fr. Please speak with the clinical team for any patient that falls outside of this range
3 We recommend you do not use The Insides Neo if the ostomy appliance is changed more than every 12 hours, to reduce assembly burden. We recommend manual chyme reinfusion is utilised until the ostomy appliance lasts >12 hours.
4 Only on expressed breast milk or formula
5 Adequate nursing education to administer therapy
6 Family support of the therapy for their child
Exclusion criteria
1 Eating solid foods
2 Cannot cover double enterostomy, separated stomas or fistula with specified ostomy appliance (if separated stomas, the patient will require 2 devices)
3 Have active clostridium difficile infection
Contrast Imaging
If there is concern with the patency of the distal tract, contrast imaging is recommended. If there is no distal anastomosis, it may not be needed. Contrast imaging ensures the distal intestine is patient for chyme reinfusion.
Tube Size
A generic ENFit feeding tube with a gauge of 6 Fr is recommended with The Insides® Neo. The connector must be ENFit to be able to work with The Insides® Neo. If the patient’s chyme is thicker, an 8 Fr generic ENFit feeding tube may be necessary.
Nutrition
The Insides® Neo is started when a patient is stabilised on either nasogastric, orogastric and/or parenteral nutrition, supplemented with breast milk, for their nutritional needs. As the patient progresses on The Insides® Neo and breast milk is increased, the nasogastric, orogastric and/or parenteral nutrition requirements can reduce.
Sepsis
All infective sources must be resolved before starting The Insides® Neo
Prolapsed or Herniated stomas
After careful clinical evaluation, patients may be able to use/continue to use The Insides® Neo if a generic ENFit feeding tube can safely be inserted and secured in the distal limb of the stoma.
Contraindications to reinfusing chyme into the distal limb
Carer
Person who assists with an Ostomy Appliance change
Chyme
Content which exits from the stoma
Feeding Tube
A tube inserted into the Stoma which supplies nutrition
Healthcare Professional
Surgeons/Doctors/Nurses
Intestines
An organ in the body which food flows through
Ostomy Appliance
A bag which sits on the stomach and collects content from the Stoma
Stoma
A surgically created opening on the abdomen
THE INSIDES® Neo is a medical device accessory for paediatric patients. It is supplied as an accessory to either the Coloplast Sensura® Mio Baby 2-piece Flex Bag, or the Hollister Pouchkins™ Newborn One-Piece Ostomy Pouch-Flat barrier.
THE INSIDES® Neo consists a of a housing, adapter and clip. The device works to refeed chyme from an ostomy appliance, into the distal limb of the intestinal tract through the stoma.
The housing and adapter are assembled together through the drain port of an ostomy appliance. An ENFit feeding tube is connected to the housing and is inserted into the distal limb of the stoma; the clip secures the tube inplace. When the ostomy appliance fills with chyme, a syringe is connected to the adapter and the plunger of the syringe can be drawn to pull fluid from the ostomy appliance into the syringe. The plunger is depressed to push the fluidthrough the feeding tube, into the intestinal tract.
THE INSIDES® Neo is replaced with the bag change, up to a maximum of four days after installation.
THE INSIDES® Neo is for single patient use only.
THE INSIDES® Neo is intended to be used in paediatric patients who have aloop enterostomy, abcarian enterostomy or end enterostomy with mucous fistula allowing access to the distal intestine. The device is intended to act as aconduit to aid the transfer of chyme from an ostomy appliance into a stoma. The device can be used in a range of environments including hospitals, A&E and clinics.
THE INSIDES® Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patient’s intestinal tract to help sustain their nutrition and gut health.
THE INSIDES® Neo is not suitable for patients who:
Contact your healthcare professional if any of the following occurs:
For safe and effective operation of THE INSIDES® Neo, please familiarize yourself with the following information. Please read and keep all safety and use instructions.
Warnings about patient suitability:
THE INSIDES® Neo should not be used on patients on a solid food diet. – Particles will cause blockages in the device resulting in patient harm.
Do not refeed chyme if patients have potential or suspected intestinal wall defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm
Patients on medication may need to have their dosages reviewed by their healthcare professional while using THE INSIDES® Neo. Reinfusion of chyme can increase the dosage of medications received by the patient. – This could cause patient toxicity.
Warnings about refeeding:
Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.
Activation of latent colonic Clostridium difficile infection could occur when THE INSIDES® Neo is first used. This will only occur in patients with this bacterium existing in their intestine. This infection could be accompanied by symptoms such as watery diarrhoea, fevers, abdominal pain and malaise. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
THE INSIDES® Neo is only to be used as instructed by your healthcare professional to refeed chyme into the distal bowel. – Refeeding other fluids or medication could cause patient harm.
Do not refeed chyme at a fast rate. – This may cause patient harm such as perforation or damage to the intestine.
Chyme should be reinfused at a slow rate. – A high rate may cause bloating, nausea or discomfort.
Depress plunger of syringe slowly while refeeding chyme. – High pressure may cause patient harm.
If no chyme enters the syringe when it is drawn, ensure the housing is submerged in fluid and the valves are clear of any debris. – Blocking the device could cause damage and result in patient harm.
Do not refeed from incorrect vessels. – Contamination could lead to patient infection.
Do not refeed air into the intestinal tract. – Refeeding air may cause patient discomfort.
Warnings about device misuse:
Failure to carefully follow all applicable instructions may result in injury to the patient, or attendants and may have an adverse effect on outcome.
No modification of this equipment is allowed. – Alterations could cause rough surfaces that damage the bowel or skin; modification could result in product failure.
Use of THE INSIDES® Neo past its recommended life could expose patients to toxins. – Allergic reaction; patient toxicity could occur.
THE INSIDES® Neo should be disposed of in accordance with device disposal advice. – Biological waste in used products can cause contamination.
THE INSIDES® Neo products are single use ONLY and are not to be reused in a patient or shared – Contamination could lead to patient infection.
If the packaging of THE INSIDES® Neo is damaged prior to use, discard product. – Contamination could lead to patient infection.
THE INSIDES® Neo must be disposed of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. – Incorrect disposal may lead to infection in people coming into contact with the device.
Warnings about accessories:
THE INSIDES® Neo should only be used with approved ostomy appliance. – Contamination could cause patient toxicity.
If, after the insertion of the Feeding Tube by the Healthcare Professional, the stoma stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
Only a healthcare professional can insert the feeding tube. If the tube falls out, contact your healthcare professional for a replacement. – Incorrect insertion of the tube may cause patient harm.
THE INSIDES® Neo may be used with tube extensions that could cause a strangulation risk to young children. – Chords may become entangled around small children’s necks.
Read the warnings prior to setting up THE INSIDES® Neo.
Any users who come into contact with THE INSIDES® Neo or its associated accessories must wash their hands prior to use.
Hollister™ Accessory
Coloplast® Accessory
WARNING: Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.
The plug should be wiped down with an EPA recommended disinfectant wipe, or similar, each time it is detached from the main body of the device to remove any visible chyme.
No other part of THE INSIDES® Neo should be cleaned as it can result in contamination of the product and may result in patient harm.
O-Ring Moves during Assembly
If the o-ring moves out of its designated groove during assembly, it can be moved back into the original groove.
Insert the housing through the drain port at a slower speed with more lubricant.
Chyme leaking from device
Ensure the components of the device are assembled correctly. If the device is still leaking, remove and replace the device.
THE INSIDES® Neo blocks
Remove and replace the device.
Reflux
There may always be a small amount of reflux when refeeding is occurring. To decrease the amount of reflux, decrease the speed at which chyme is directed into the distal limb.
The device is not repairable and does not contain any repairable parts. Please refer queries relating to the device to the manufacturer or your local representative.
The device does not require preventative maintenance.
The Insides Company warrants that the device, when used in accordance with the instructions for use, shall be free from defects in workmanship and materials and will perform in accordance with The Insides Company official published product specifications for a period of 2 years from the date of purchase by the customer. This warranty is subject to the limitations and exceptions set out in detail here:
www.theinsides.co/warranty-statement.
All accessories should be used as specified by the manufacturer. Off-label use of accessories may result in harmto the patient.
Ostomy Appliance
Feeding Tube
Syringe Driver
All copyright, design, patent and intellectual property rights existing in our designs and products and in the images, text and design of our website / marketing material are the property of The Insides Company. See www.insidescompany.com for more information.
‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins‘ in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
Before using this document, thoroughly read The Insides® Neo Instructions for Use. This work instruction is to act as a visual prompt and reminder of the key tasks but does not contain all the necessary information.
Along with normal patient management, the following patient management and assessment is recommended for a patient using The Insides® Neo.
Rate of Refeeding
It is recommended a syringe infusion pump is used to reinfuse the patient’s chyme via The Insides® Neo. This ensures the reinfusion is controlled and comfortable for the patient. Each patient will have their own tolerance for the rate of refeeding. As a general guide:
Monitoring Bowel Movements
Patients will likely have a bowel movement within the first three days of starting chyme reinfusion with The Insides® Neo. If a bowel movement has not happened within three days, urgent assessment is required.
Ostomy Appliance
The Insides® Neo couples with a Hollister™ Newborn Pouch “Pouchkins™” 3778 and Coloplast® “Sensura® Mio Baby”. This ostomy appliance must be changed when it leaks and The Insides® Neo must be changed at the same time. The Insides® Neo can be used for up to four days.
Assessment of Pain and Discomfort
Regular assessment of abdominal distention and discomfort is necessary. This should be completed a minimum of every 4 – 6 hours.
Device Troubleshooting
Please refer to the Frequently Asked Questions for troubleshooting The Insides® Neo
‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins™‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
Q: What do I do if the tube falls out?
A: Gently ‘thread’ the feeding tube back into the fistula to the pre-determined marking. Use The Insides® Neo Clip to secure the tube to the bag. Ensure that the tube fits in the groove, on the back of The Insides® Neo Clip. This will stop it from slipping. In addition, it can be helpful to gently advance the feeding tube into the mucous fistula an extra 10 mm with the understanding that when you secure it with The Insides® Neo Clip, it will slip out slightly and sit at the correct marking on the feeding tube.
Q: What do I do if the O-ring dislodges?
A: If the O-ring has moved, you can slide it back in place. To prevent the O-ring from moving, use water-based lubricant and a gentle, slow, push and twist motion when inserting the housing through the port of the ostomy appliance.
Q: Why is chyme leaking from the bottom of the bag?
A: There are two things that could be happening.
• If the housing is not in place, it will leak through the port of the ostomy appliance.
• If the adapter is not properly connected to the housing, chyme may leak out through the device. Ensure to push the adapter all the way, until you hear and feel a ‘click’ and this should resolve the issue. You should be able to see the nose of the housing in the centre of the adaptor. The adaptor should sit flush against the end of the ostomy appliance.
Q: What should I do if the infusion pump keeps alarming ‘Occlusion’
A: A few things to try if the pump is continuously alarming ‘occlusion’.
• Is the chyme too thick? You may need to consider a larger sized feeding tube.
• Check that all the lines are open, unclamped and unkinked from the pump, all the way to the patient (including the feeding tube).
• Change the extension set (The tubing between The Insides® Neo and the infusion pump). The extension set should be replaced every 24 hours, but sometimes a small blockage may form, and it will need to be replaced more frequently.
• Check the patency of the feeding tube. Stop your infusion and gently withdraw the tube from the fistula so it sits in the stoma bag. (Do not take off the ostomy appliance.) Flush a small amount of sterile water or chyme manually through the tube. There may be a small blockage you can dislodge using the method of “push and pull” with the syringe. If you are unable to flush the feeding tube, you will need to remove and replace the ostomy appliance. Consider a larger gauge feeding tube at this time.
Q: Why am I unable to syringe chyme out of the bag when I can see there is chyme in there?
A: Ensure chyme is sitting at the bottom of the bag. The Insides® Neo draws chyme through the valves in the housing, therefore must be submerged in chyme.
Q: What ostomy appliances does The Insides® Neo work with? Will more brands be added?
A: At the moment, HollisterTM Newborn Pouch “PouchkinsTM” 3778 and Coloplast® “Sensura® Mio Baby, 18700” appliances work with the device. The Housing component is custom fit to prevent leakage from the bung of the ostomy appliance. Other brands will be included soon with device iterations.
Q: What is the size of the tubing inside the stoma bag?
A: The feeding tube is not supplied with the device and we do not provide information around tube use. We do suggest a naso-gastric tube of either 6 or 8 Fr size. The shorter the tube the easier it is to coil in the ostomy appliance. 40cm to 50cm are suitable tube lengths with an ENFitTM coupling. There are ENFitTM adaptors available if required. There is further guidance here: https://training.theinsides.co/knowledge/prior-to-reinfusing-with-the-insidesr-neo
Q: I have some concerns about how The Insides® Neo handles thick/viscous chyme, and how to address this?
A: The patients will only be on parenteral nutrition/enteral nutrition/breast milk (if they're eating solids, The Insides® Neo is contraindicated). The Insides® Neo will be able to handle Curds that may form in the ostomy appliance. Note: If the nursing team are using a syringe driver to reinfuse, the extension set between the syringe and Adapter on the ostomy appliance, will likely need to be changed daily because it may block.
Q: What feeding tube and syringe is required for the Adapter and the Housing?
A: EnFit™ connection. If yourhospital does not use ENFit compatible gastric feeding tubes or syringes, anadaptor will be required. We suggest the shortest tube possible so there isless coiled tube sitting in the neonatal ostomy appliance.
The Nutrisafe range ofgastric feeding tubes and syringes are NOT compatible with The Insides Neo. Ifdecompression of the distal bowel is required in addition to chyme reinfusiontherapy, there is a small number of dual line/bifurcated ENFit compatiblegastric tubes available. Please contact the clinical team at The InsidesCompany for further information.
Q: Can babies with an ECF/Fistula use The Insides® Neo?
A: If a baby develops an ECF they can use The Insides® Neo if it fits within the confines of the Hollister 3778 ostomy appliance or Coloplast 18700 ostomy appliance.
Q: Does refeeding with The Insides Neo supplement total parenteral nutrition (TPN) or replace TPN?
A: The Insides® Neo is intended to supplement and replace TPN.
Neonates/Babies have a similar goal to adults where the primary goal is to wean off or reduce the amount of TPN being administered.
To wean off TPN, this is achieved by increasing the volume of chyme reinfusion and utilising one of the three nutritional sources below. This reduces/removes the risk of complications associated with being on TPN. Once weaned, a neonate/baby will maintain their nutrition by chyme reinfusion (with The Insides Neo) and one of the following means:
• Naso-gastric enteral nutrition feeds (e.g. Pepti-Junior) and naso-gastric breast milk (expressed from Mum) or,
• Only naso-gastric enteral nutrition feeds or,
• Only naso-gastric breast milk
Q: I am reluctant to keep the ostomy appliance in situ for longer than 1 day, what should I do?
A: A hydrocolloid, which is the adhesive portion of the base plate that sticks to the skin, is designed to sit on the skin for up to 7 days and creates a homeostatic environment. Hydrocolloid mimics the skin and allows for trans epidermal water loss (TEWL) and preventing maceration.
Taking ostomy appliances off daily, increases the risk of skin striping. Skin stripping is taking the top layer of skin off at a microscopic level. If this occurs, it increases the risk of skin infection and encourages dysregulation of the cutaneous biome that could cause other skin anomalies.
The longer an ostomy appliance can stay on the skin, the better. The use of an adhesive remover when removing the pouch is recommended by all ostomy appliance manufacturers and is regularly encouraged by all stoma nurses, especially in neonates, to reduce the risk of skin stripping, irrespective of how long it has been on the skin.
The stoma bag is leaking too often, what can I do to make it last longer?
If appropriate and accessible, try a hydrocolloid seal which is an ostomy accessory. Dry the skin and apply the seal to the peri-stomal skin so that it is flush with the stoma mucosa and then apply the ostomy appliance over the top. This provides extra protection to peri-stomal skin, absorbs the high volume of chyme passing over it and “plugs” gaps to prevent leak paths. If appropriate, contact your local stomal therapy nurse or stoma bag manufacturer representative to guide in solutions
‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins™‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
* Please print the Patient Card with A5 paper
All copyright, design and intellectual property rights existing in our designs and products and in the images text and design of our website are the property of The Insides® Company. The innovations developed by The Insides® Company are covered in one or more pending patents.
The following are pending patents of The Insides® Company：
WO2019073365(A1)
WO2019171335(A1)
WO2022224175A1
The following are registered patents of The Insides® Company：
CN111818885B
AU2018349270B2
The following are registered designs of The Insides® Company：
CN307984577S
30202300143W
30202300144U
AU202217736
AU202217737
EP015007939-0001
EP015007939-0002
UK6253298
UK6253299
NZ430941
NZ430942
The following are trademarks of The Insides® Company：
The Insides
The Insides Company
Please contact the company for an updated list of IP.
‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins™‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.
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© 2024 The Insides Company. All copyright, design, patent and intellectual property rights existing in our designs and products and in the images, text and design of our website / marketing material are the property of The Insides Company.
