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The Insides Neo

Pediatric chyme reinfusion therapy
Neonatal Clinical Guideline for Chyme Reinfusion Therapy

Goals of Chyme Reinfusion Therapy

  • Growth and weight gain1-5.
  • Reduce/wean off parenteral nutrition (PN) requirements1-5.
  • Normalisation of renal and liver function via reintroduction of GI feeding and increased length of intestine available for absorption1-5.
  • Increase gut maturation and development1-5.

 

Definitions

  • Chyme (“kʌɪm”)– A pulpy semi-fluid composition of partly digested food, fluid, stomach acid/gastric juices, and digestive enzymes. Chyme is nutrient rich and is readily absorbed in the small intestine, allowing for nutrients and fluid to be absorbed.
  • Chyme Reinfusion Therapy (CRT) – The reintroduction of a patient’s chyme into the efferent or distal limb of their small intestine mucous fistula2.
  • Double Barrel Enterostomy/End Enterostomy with mucus fistula (stoma) – A surgical procedure where the intestine has a diseased portion resected, and the proximal and distal limbs are brought to the skin surface together and secured to create a stoma.
  • Loop Enterostomy (stoma) – A surgical procedure where a loop of the small intestine is brought to the skin surface, an opening is created and secured to create astoma.
  • Abcarian Enterostomy – A surgical procedure where the intestine has a diseased portion resected, and the proximal limb is brought out with the distal limb but it is partially sutured to the skin with the rest inside the abdomen.
  • Parenteral Nutrition (PN) – Nutrition that is administered via an intravenous route to provide a patient with nutrition to sustain life.
  • Enteral Nutrition (EN) – Nutrition that is administered directly into the stomach or intestine to provide a patient with nutrition to sustain life. It is generally administered via a nasogastric tube (NG) or orogastric tube (OG).
  • Expressed Breast Milk (EBM)/Human breast milk (HBM) – Breast milk from mother or donor that is administered through a NG or OG6.

 

Chyme Reinfusion Therapy Techniques

  • Manual CRT –A process of collecting and sieving the patient’s own chyme then manually syringing it into the patient’s downstream (distal) intestine via a feeding tube installed in the intestine. This is an open system, generally performed by nursing staff.
  • CRT with The Insides® Neo – A closed system. Once The Insides® Neo has been assembled with the ostomy appliance (See IFU-16 The Insides® Neo Instructions for Use), CRT can be performed.

 

Healthcare Professional Training

  • Health care professionals must receive formal training and be proficient in installation, set up, and troubleshooting of The Insides® They must also have experience managing patients undergoing CRT.
  • Training will be provided by the manufacturer for use of The Insides® Neo, with full access to the Training Hub for additional training materials. Found here: https://www.theinsides.co/training-hub/the-insides-neo/home

 

 

Indications for use

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.

 

Intended Use

The Insides® Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patient’s intestinal tract.

 

Contraindications

The Insides® Neo is not suitable for patients who:

  • Do not have two available stomal openings with proximal and distal intestinal limbs.
  • Have started solid foods.
  • Have active Clostridium difficile.
  • Do not have a carer that can assist in the use of the product.
  • Cannot cover their stoma with the specified ostomy appliance.
  • Cannot have chyme refed into their distal limb.

 

Prior to reinfusing with The Insides® Neo

  • Read The Insides® Neo Instructions for Use, Including the Warnings. Ensure that a patient clinical risk assessment is carried out.
  • Contrast imaging can be used to evaluate the patency of the patient’s distal tract. If patients have potential or suspected intestinal wall defects, CRT is NOT recommended.
  • A generic ENFitTM feeding tube suitable to be used with the patient can be used with The Insides® Neo. The connector must be ENFitTM to be able to work with The Insides® Neo. Suggested sizes are 6 Fr and 8 Fr.
  • CRT with The Insides® Neo is a replacement or supplement for PN and EN. As the patient progresses on The Insides® Neo, EBM or HBM delivered via a NG or OG tube, is increased as the source of nutrition for the patient while the PN and EN is reduced.  
  • All infective sources must be resolved before starting The Insides® Neo.
  • Assess prolapsed or herniated stomas. Patients may be able to use/continue to use The Insides® Neo after careful clinical evaluation, and if a generic ENFitTM feeding tube can safely be inserted and secured in the distal limb of the stoma.
  • Some conditions may preclude chyme being refed into the distal limb:
    • Imperforate anus - The Insides® Neo can only be used to perform CRT once successful dilation of the neo anus is achieved.
    • Hirschsprung’s - The Insides® Neo cannot be used to perform CRT with patients who have suspected Hirschsprung’s disease in the distal limb of their stoma.
    • Feed Intolerance/only tolerating trophic feeds – If a patient can only tolerate trophic feeds (1 ml every 4 hours to keep the distal intestine ‘open’) this is a contraindication until further clinical assessment is undertaken.

 

 

Patient Management

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.

  • Rate of Refeeding
    A syringe infusion pump should be 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:
    • It is safe to use chyme that has been sitting in the ostomy appliance for up to 12 hours.
      • If bolus reinfusing - chyme that has been sitting in the ostomy appliance for up to 12 hours and is reinfused within the 12-hour window
      • If continuous reinfusion – Chyme that is collected in 6 hours and then reinfused over the following 6 hours, totalling 12 hours.
    • Use The Insides® Neo every 4-6 hours to withdraw chyme from the ostomy appliance. This full syringe is placed into the syringe infusion pump and reinfused over the next 4 – 6 hours.
    • Depending on the patient’s condition, when the patient starts chyme reinfusion with The Insides® Neo, consider reinfusing half of their output for the first day and discarding the other half.
      • ie., if they pass 20 ml of chyme in 4 hours, only reinfuse 10 ml over the next 4 hours.
    • If the patient has a high output and the refeeding rate is approaching 8-10ml/hour, monitor for signs of reflux from the distal mucus fistula. If there is reflux, reduce the refeeding rate so chyme can be absorbed. Discuss a maximum refeeding rate with the clinical team so that chyme reinfusion is optimised for the patient. This may mean some chyme is discarded initially until the patient can tolerate a higher refeeding rate. The refeeding rate should be reviewed regularly. Reflux can be assessed in the following ways:
      • Chyme can be seen flowing back into the ostomy appliance from the distal limb.
      • The volume in the syringe is more than the last time chyme was withdrawn from the ostomy appliance using The Insides® This is due to the refluxed chyme mixing with fresh chyme.

 

  • 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.
  • 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.
  • Ostomy Appliance
    The Insides® Neo couples with a Hollister™ Newborn Pouch “Pouchkins™” or a Coloplast® “SenSura® Mio Baby”. These ostomy appliances must be changed when they leak and The Insides® Neo must be changed at the same time. The Insides® Neo can be used for up to four days.

 

Safety

  • Read The Insides® Neo Instructions for Use.
  • Observe and comply with all manufacturer warnings and patient contraindications when using The Insides® Neo.
  • If the patient is experiencing pain during installation or use of The Insides® Neo, this is not normal, and a clinical assessment should be performed to evaluate cause. The Insides® Neo may not be suitable.

 

Clinical Support

 

Reference

  1. Al-Harbi K, Walton JM, Gardner V, Chessell L, Fitzgerald PG. (1999). Mucous fistula refeeding in neonates with short bowel syndrome. J Pediatr Surg., 34(7):1100-1103. doi:10.1016/S0022-3468(99)90575-4
  2. Bhat, S., Cameron, N., Sharma, P., Bissett, I. & O’Grady, G. (2020). Chyme recycling in the management of small bowel double enterostomy in pediatric and neonatal populations: A systematic review. Clinical Nutrition ESPEN, 37. 1-8. Doi.org/10.1016/j.clnesp.2020.03.013
  3. Haddock CA, Stanger JD, Albersheim SG, Casey LM, Butterworth SA. (2015). Mucous fistula refeeding in neonates with enterostomies. J Pediatr Surg., 50(5):779-782. doi:10.1016/j.jpedsurg.2015.02.041
  4. Lau ECT, Fung ACH, Wong KKY, Tam PKH. (2016). Beneficial effects of mucous fistula refeeding in necrotizing enterocolitis neonates with enterostomies. J Pediatr Surg., 51(12):1914-1916. doi:10.1016/j.jpedsurg.2016.09.010
  5. Wong KKY, Lan LCL, Lin SCL, Chan AWS, Tam PKH. (2004). Mucous Fistula Refeeding in Premature Neonates With Enterostomies. J Pediatr Gastroenterol Nutr., 39(1):43. doi:10.1097/00005176-200407000-00009
  6. Amin, S., Pappas, C., Iyengar, H. and Maheshwari, A. (2013). Short Bowel Syndrome in the Nicu. Perinatol, 40(1). doi: 10.1016/j.clp.2012.12.003

 

‘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.

 

 

Patient Evaluation Checklist

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

Prior to Reinfusing with The Insides Neo

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

  • Trophic Feeds
    • If a patient can only tolerate trophic feeds (1ml every 4 hours to keep the distal intestine ‘open’), this is a contraindication until further clinical assessment is undertaken.
  • Imperforate Anus
    • The Insides® Neo can only be used to perform chyme reinfusion once successful dilation of the neo anus is achieved.
  • Hirschsprung’s
    • The Insides® Neo cannot be used to perform chyme reinfusion with patients who have Hirschsprung’s disease.

The Insides Neo Instructions for Use

Definitions


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

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.

Indication for Use

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.

Intended Use

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.

Contraindications

THE INSIDES® Neo is not suitable for patients who:

  • Do not have two available stomal openings with proximal and distal intestinal limbs.
  • Cannot have chyme refed into their distal limb
  • Have started solid foods
  • Have active Clostridium difficile
  • Do not have a carer that can assist in the use of the product
  • Cannot cover their stoma with the specified stoma appliance

Warnings

Contact your healthcare professional if any of the following occurs:

  • Decreased refeeding, due to any reason, for 24 hours or longer
  • Profuse or watery diarrhoea
  • Fevers, chills
  • Vomiting
  • THE INSIDES® Neo stops working

 

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.

 

User Guide

Read the warnings prior to setting up THE INSIDES® Neo.  

1. Prior To Use

Any users who come into contact with THE INSIDES® Neo or its associated accessories must wash their hands prior to use.

2. Assembling THE INSIDES® Neo

  1. Wash your hands, prepare a clean workspace and don appropriate PPE.
  2. Prepare the ostomy appliance, feeding tube, and THE INSIDES® Neo. Refer to the “Accessories” section for compatible ostomy appliances and feeding tubes.

Hollister™ Accessory

  1. Connect the feeding tube to the housing.
  2. Remove the drain port from the ostomy appliance if required.
  3. Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
  4. Insert the housing of THE INSIDES® Neo into the ostomy bag through the large opening, until the housing is at the bottom of the ostomy appliance. Gently press and twist in a clockwise direction to allow the device to move through the drain port. If the black O-ring shifts when the device is pushed through the ostomy appliance, return the O-ring the correct position.
  5. Connect the adaptor to the housing by pressing it into place. You should hear a click.
  6. Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
  7. Coil the tube and place it in the bag so that nearly all of the tube sits inside of the bag. The length of tube outside the bag will be inserted into the distal limb of the patient’s intestinal tract.
  8. Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

  1. Connect the feeding tube to the housing.
  2. Remove the drain port from the ostomy appliance if required.
  3. Dip the nose of the adapter into a water-based lubricant.
  4. Insert the adapter through the drain port, from the outside into the bag.
  5. Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
  6. Connect the housing to the adapter by clicking it into place, you should hear a click.
  7. Coil the tube and place it in the bag so that nearly all of the tube sits inside of the bag. The length of tube outside the bag will be inserted into the distal limb of the patient’s intestinal tract.
  8. Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

3. Setting up the patient with THE INSIDES® Neo

  1. Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
  2. Apply a hydrocolloid around the stoma.
  3. Remove the sticker to expose the adhesive of the ostomy appliance.
  4. While holding the bag, insert the tube into the distal limb of the stoma.
  5. Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
  6. Use the clip to secure the tube to the side of the ostomy appliance, near to the stoma. The tube may need to be recoiled before placing the clip.
  7. Ensure the plug at the base of the ostomy appliance is in place. This will prevent leaks from the ostomy appliance.

4.  Refeeding with THE INSIDES® Neo

WARNING: Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.

  1. Remove the plug off the adaptor.
  2. Connect a feeding tube extension to adaptor of THE INSIDES® Neo, and a Syringe to the extension. If you are refeeding manually, connect the syringe directly to THEINSIDES®
  3. Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
  4. Fill the syringe with chyme by drawing back the plunger of the syringe. The syringe can be purged of air at this time if required.

    Note: Only chyme which has been sitting outside the body for less than 12 hours can be refed into the distal limb, refer to WARNINGS. 

  5. To refeed chyme into the distal limb, either:
    1. Manually depress the plunger of the syringe. This should be performed very slowly to reduce reflux or change of damage to the intestine. Or;
    2. Insert the syringe into an enteral feeding syringe pump to refeed the chyme at a rate suitable for the patient.
  6. Once the plunger has been fully depressed:
  7. The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
  8. The syringe plunger can be drawn back to refill with chyme for further refeeding.

 

5.  Replacing THE INSIDES® Neo 

  1. THE INSIDES® Neo is replaced with the usual bag change or at a maximum of 4 days.
  2. Remove the ostomy appliance along with THE INSIDES® Neo, and feeding tube
  3. Refer to STEP 2 and STEP 3 for replacement of THE INSIDES® Neo

 

6.  Disposing of THE INSIDES® Neo 

  1. After use, handle and dispose of THE INSIDES® Neo in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. This information can be sourced from your local authority or from the supplier of the medical device in your region.

 

Cleaning and Disinfection 

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.

 

Troubleshooting Guide

 

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. 

Product Specifications 

 

Servicing

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.

Warranty Statement

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.

Accessories

All accessories should be used as specified by the manufacturer. Off-label use of accessories may result in harmto the patient.

Ostomy Appliance

  • Hollister Pouchkins™ Newborn One-Piece Ostomy Pouch – Flat Barrier (3778)
  • Coloplast SenSura® Mio Baby 2-piece Flex bag (18700)

Feeding Tube

  • All suitable ENFit enteral feeding tubes

Syringe Driver

  • All suitable enteral feeding syringe pumps

Safety Signs and Symbol Glossary

Intellectual Property

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.

Contact Information

The Insides Neo Visual Guide

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. 

Patient Management while Reinfusing with The Insides Neo

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:

  • Use The Insides® Neo every 4-6 hours to withdraw chyme from the ostomy appliance. This full syringe is placed into the syringe infusion pump, and reinfused over the next 4 – 6 hours.
  • Depending on the patient’s condition, when the patient starts chyme reinfusing with The Insides® Neo, consider reinfusing half of their output for the first day and discarding the other half.
    • i.e., if they pass 20 ml of chyme in 4 hours, only reinfuse 10 ml over the next 4 hours.
  • If your patient has a high output and the refeeding rate is approaching 8-10ml/hour, monitor for signs of reflux from the distal mucus fistula. If there is reflux, reduce the refeeding rate so chyme can be absorbed. Discuss with the clinical team a maximum refeeding rate so that chyme reinfusion is optimised for the patient. This may mean some chyme is discarded initially until the patient can tolerate a higher refeeding rate. The refeeding rate should be reviewed regularly. Reflux can be assessed in the following ways:
    • Chyme can be seen flowing back into the ostomy appliance
    • The volume in the syringe is more than the last time chyme was withdrawn from the ostomy appliance using The Insides® This is due to the refluxed chyme mixing with fresh chyme.

 

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.

 

Frequently Asked Questions

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.

The Insides Neo Patient Card

* Please print the Patient Card with A5 paper

Intellectual Property

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

The Insides System - fistuloclysis, distal feeding, best, alternative to parenteral nutrition, fistula, ostomy, ileostomy, chyme, enteral, oral nutrition, enteromate, intestinal failure, colon cancer, bowel cancer, gut cancer, ostomy appliance, high output, chyme, dehydration, defunctioned, ileus, lars, microbiome, lower interior resection syndrome, incontinent, incontinence, gut health, reversal surgery

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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