WO2023129065A1

WO2023129065A1 - Percutaneous endoscopic gastrostomy set with balloon

Info

Publication number: WO2023129065A1
Application number: PCT/TR2022/051635
Authority: WO
Inventors: Bulent OZCAN; Murat KEKILLI
Original assignee: Gazi Universitesi Rektorlugu
Priority date: 2021-12-29
Filing date: 2022-12-27
Publication date: 2023-07-06

Abstract

The present invention relates to a medical tube placement set to provide a safe and error-free way for operations such as drainage of digestive juices and infusion of drug solution, enteral feeding. The present invention particularly relates to a percutaneous endoscopic gastrostomy set comprising a non-ruptured balloon catheter. The set of the present invention comprises Teflon catheter, dilatation adapter, placement adapter for dilatation and balloon, 260 cm guidewire, 20 F Balloon gastrostomy tube, clamp catheter, 25±1 Gauge injection needle, cover for case, surgical blade with handle, seldinger needle, 150 cm guide wire coated with Teflon, and gauze patch.

Description

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET WITH BALLOON

Technical Field of the Invention

The present invention relates to a set for placing a medical tube into a stomach to provide a safe and error-free way for operations such as drainage of digestive juices and infusion of drug solution, enteral feeding. The present invention relates to placing a balloon feeding catheter from the outside after dilation from the stomach while performing the first PEG procedure.

State of the Art

Enteral nutrition is a form of nutrition in which the nutrients needed daily are given to the patient with the help of a catheter. In this type of nutrition, if the person's digestive system is working but cannot be fed orally, they are given liquid by placing a tube through the nose into the stomach or intestine. Because naturally, patients who are not fed orally cannot get the calories, minerals and vitamins they require daily. Therefore, these nutrients should be administered to these patients via “enteral nutrition products” in liquid or powder form. In addition, some necessary drugs can be given by this method. Enteral feeding can be via nasogastric tube (catheter), nasojejunal tube, gastrostomy, and feeding jejunostomy. Percutaneous Endoscopic Gastrostomy (PEG) is the placement of a tube through the abdominal wall into the stomach in order to provide nutrition to patients who cannot be fed orally. In other words, PEG is the process of creating a gastrocutaneous fistula for enteral nutrition. This method is especially necessary for feeding patients who have been hospitalized in intensive care units for a long time and whose swallowing reflex has been lost due to any segmental reason. Enteral feeding can be performed temporarily with a nasogastric tube. These tubes are easy to place and retrieve. However, these tubes are not very suitable for feeding and cannot be kept on the patient for a long time. The best method for longterm enteral feeding is gastrostomy. PEG is one of the most suitable options for nutrition in cases where enteral nutrition cannot be performed in any manner. When enteral nutrition with PEG is provided, the structural and functional properties of the gastrointestinal tract are preserved. The most widely applied PEG sets in the world are divided into two as pull and push according to the placement methods [1 ],

Pull-type PEG set is a feeding catheter inserted through the oral cavity and placed into the stomach inner wall in the form of an inverted mushroom. In the pull-type PEG application method, antibiotic prophylaxis and intravenous sedation and local anesthesia are applied before the application. Subsequently, gastroscopy is performed, the stomach is inflated with air and transilluminated. The placement region is selected and a small incision of 5-8 mm is made. The intravenous catheter is quickly placed through the abdominal and stomach walls and the needle is removed. The guide wire is grasped with the clamp. The clamp, guidewire, and gastroscope are pulled through the mouth. Subsequently, the PEG tube is connected to the guide wire. PEG is withdrawn from the mouth, esophagus, stomach, stomach wall, and abdominal wall. The gastroscope is replaced to confirm the position of the PEG. Tension is applied to the PEG to gently approach the stomach and abdominal wall. Subsequently, the external support is applied to the secure location. Pull-type PEG has a low risk of infection during surgical procedures. Pull-type PEG can be performed under light sedation and no sutures are required to fix the stomach to the skin surface. The opened PEG wound can heal quickly and the patient can start feeding within 4-6 hours after the procedure. However, the pull-type PEG cannot be placed without an endoscopy system and it is absolutely necessary to have an endoscopy system for replacement. Burned bumper syndrome is possible since the inverted mushroom-shaped disc surface is hard [2],

The push-type PEG set is one of the vital nutritional methods used in patients who cannot be treated with the pull-type set. Although the stomach of the patient to be treated is pierced from the outside as an empty organ, the resistance power is low, and if piercing is attempted without support, vital organs around the stomach may be damaged. Therefore sutures are made to fix the outer surface of the stomach to the skin surface in order to open a feeding channel from the outside. In push-type PEG, feeding tube replacement can be performed without surgical or endoscopic intervention in the post-PEG replacement procedures. However, in push-type PEG, for the procedure, the stomach should be fixed to the abdomen from at least three points, the gastropexy sutures should be removed, and it should be performed in the operating room conditions accompanied by deep sedation. Making a large incision on the stomach and skin surface may cause high infection in the patient and stoma wounds may take a long time to heal after the procedure. After push-type PEG application, patients may experience severe pain and may have to use painkillers for a long time. In addition, patients start feeding later than push-type PEG [3],

When a change is required in patients who previously had a PEG (Percutaneous Endoscopic Gastrostomy) set, gastroenterology is placed in a short time from the navel by percutaneous procedure, without the need for endoscopy, by means of the balloon catheter system. The balloon in the catheter part remaining inside the patient is inflated, fixed to the patient, and is prevented from coming out of the patient's stomach. A balloon catheter is a type of "soft" catheter with an inflatable "balloon" at the tip that is used during a catheterization procedure to widen a narrow opening or passage in the body. Balloon catheters are placed, then inflated to perform the necessary procedure and deflated when removed, and taken out of the body.

The two most common procedures based on the balloon catheter are coronary angioplasty and urinary catheterization [4],

In the state of the art, the patent document numbered US8437833B2 relates to placing feeding tubes or catheters into the body of a patient. A system and method places a percutaneous gastrostomy device into a patient's body cavity by using a magnetic gastrostomy tube and a medical sensing device. The magnetic gastrostomy tube has a ferromagnetic element attached to its distal end. Various embodiments allow a needle to be passed from the magnetic sensing device outside the patient to a magnetic gastrostomy tube inside the patient, or alternatively, to be passed from the magnetic gastrostomy tube inside the patient to the magnetic sensing device outside the patient. After a needle makes a hole between the patient's outside and the body cavity, a medical wire can be passed through the hole and then the medical wire can be used to place the percutaneous gastrostomy device.

The patent document numbered US7976495B2 in the state of the art relates to feeding tubes for delivery of nutritional products to the intestinal tract and methods for placement of feeding tubes therein. The feeding tube comprises an elongate shaft having a distal end and proximal end. The feeding tube also comprises a coupling structure for coupling the feeding tube to a pull wire, the coupling structure be proximal of the distal end of the feeding tube shaft. The feeding tube further comprises a guiding structure for aligning the pull wire with the distal end of the shaft. The feeding tube is introduced within the patient by attaching the previously placed pull wire to the coupling and guiding structures of the feeding tube, and then pulling the pull wire so as to pull the feeding tube into and through the gastrointestinal tract of the patient.

PEG sets cannot be attached or exchanged without an endoscopy system. The hard surfaces of the discs in these sets cause the buried bumper syndrome. In addition, the procedures should be performed under hospital conditions. Making a large incision on the stomach and skin surface may cause high infection in the patient and stoma wounds may take a long time to heal after the procedure. Therefore, patients may have severe pain and may have to use pain relievers for a long time. Said large wounds cause trauma to the patients. It is necessitated making an improvement in the relevant technical field due to the inadequacies and limitations of the sets in the state of the art, causing buried tampon syndrome or infection, delayed healing of post-application wounds and severe pain in patients from these wounds.

Brief Description and Objects of the Invention

The present invention discloses a percutaneous endoscopic gastrostomy set with a balloon catheter for placing a medical tube into the stomach in order to provide a safe and error-free route for operations such as drainage of digestive juices and infusion of drug solution, enteral feeding.

The object of the present invention is to provide a set that provides a short-term, risk- free and comfortable operation during application.

Another object of the present invention is to provide an easier service for the patient and their relatives in the second PEG exchange.

Another object of the present invention is to eliminate the possibility of buried bumper syndrome.

Yet another object of the present invention is to provide a dilatation that allows the procedure to be performed by applying less force and by less traumatizing the patient. In the invention, a more slippery and stronger support is obtained by using polycarbonate, which is a hard and smooth material, as the dilatation material. In addition, while pulling the dilatation catheter tip outward from the abdomen, the dilatation catheter, which is loaded on the guiding wire, can be pushed from the rear end outside the mouth, and it can be supported to pass the catheter through the stomach onto the skin surface.

The present invention provides a set guided by a dilatation catheter that can be changed without the need for an endoscopy system, does not cause infection, does not cause large wounds during application and does not cause trauma to patients.

Description of the Figures

Figure 1 illustrates the gastrostomy tube dilatation catheter with balloon.

Figure 2 illustrates the view of the application of guiding wires on the patient.

Figure 3 illustrates the different view of the application of guide wires on the patient.

Figure 4 illustrates the view of the balloon gastrostomy tube dilatation catheter on the patient.

Description of the References Included in Figures

1 . Balloon catheter

2. Skin disc

3. Balloon inflation inlet

4. Feeding inlet

5. 260 cm guiding wire

6. 150 cm guiding wire

Detailed Description of the Invention

The present invention relates to a set for placing a medical tube into a stomach to provide a safe and error-free way for operations such as drainage of digestive juices and infusion of drug solution, enteral feeding. The present invention relates to placing a balloon feeding catheter from the outside after dilation from the stomach while performing the first PEG procedure. Percutaneous endoscopic gastrostomy set of the present invention comprises dilatation catheter, dilatation adapter, placement adapter for dilatation and balloon, 260 cm guidewire, 20 F Balloon gastrostomy tube, clamp catheter, 25±1 Gauge injection needle, cover for case, surgical blade with handle, seidinger needle, 150 cm guide wire, and gauze patch.

The dilatation catheter included in the set has the dimensions of 3.5 mm x 2000 mm. The dimensions of the dilatation adapter, starting from the distal end, are 2 mmx30 mmx2 mm, 50 mmx4 mmx15 mm with its segmental structure expanding backwards from the end and with the preservation of the measured part, it expands to the next part with slight curves and increases in size. Said dilatation and balloon placement adapter is made of polycarbonate material, and the dimensions of this adapter are 3.6mmx80mmx3.6mmx15mm. Using polycarbonate, which is a harder and smoother material, provides a slippery and strong support. The guiding wires with a length of 1500 mm and 2600 mm are coated with Teflon. In the present invention, a more slippery and stronger support is obtained by using polycarbonate, which is a hard and smooth material, as the dilatation material. In addition, while pulling the dilatation catheter tip outward from the abdomen, the dilatation catheter, which is loaded on the guiding wire, can be pushed from the rear end outside the mouth, and it can be supported to pass the catheter through the stomach onto the skin surface.

The application method of said set comprises the process steps of; i. Preparing for the surgical procedure from the abdomen and then applying anesthetic agent, ii. Piercing the stomach with a seidinger needle, and introducing 2 guiding wires into the stomach, iii. Removing the wire from the mouth by holding it with the help of a clamp, iv. Fixing the dilatation catheter with a rope at the tip of the wire and passing the other guiding wire through the catheter v. Bringing the fixed dilatation catheter to the area where the guiding wire is inserted through the hole pierced into the stomach, by pulling up the part of the fixed dilatation catheter outside the abdomen of the guiding wire through the stomach, vi. Pulling the guiding rope upwards by pressing the outer surface of the stomach with a hand, and also passing the dilatation catheter to the abdominal region by pushing from the rear end of the catheter outside the mouth area, vii. Removing the extracted dilatation catheter 30 cm out of the abdomen, viii. Mounting the dilatation adapter with the end of the catheter at a distance of 5 cm from the stomach side of the catheter, ix. Placing the the balloon gastrostomy tube behind the dilatation catheter, which is fixed by mounting, x. Placing the gastrostomy tube loaded on the catheter into the stomach by taking support from the fixed guiding wire in the catheter, and fixing the balloon in the stomach by inflating, xi. Pulling the catheter, one end of which is outside the patient's mouth, from inside the stomach to the outside, and ending the procedure by checking the placed balloon gastrostomy tube and stomach area.

In the first step, the 1500 mm and 2600 mm guiding wires, which are introduced into the stomach via the seidinger needle, are held with the clamp catheter and removed from the patient's oral cavity through the endoscope channel. Thus, pushing the line of 1500 mm and 2600 mm guiding wires, one end of which is outside the abdomen, completes the first step. In the second step, the loop thread on the dilatation catheter tip is fixed with a 1500 mm guiding wire, and is inserted into a 2600 mm guiding wire and a 2000 mm dilatation catheter is introduced into to the stomach cavity. In the third step, the other end of the dilatation catheter, one end of which is in the region where the PEG tube will be inserted, is placed on the guiding wire, remains outside the patient's mouth area. In the fourth step, 1500 mm guide wire, located on the skin surface outside the abdomen, is started to be pulled upwards in order to remove the dilatation catheter to which it is fixed, at the same time, the 2600 mm guide is kept fixed, the dilatation catheter outside the mouth is pushed in order to support the dilatation made towards the stomach, and the tip of the catheter is brought out 30 cm and the dilatation process is completed. In the fifth step, dilatation and balloon placement adapter is mounted to end at a distance of 5 cm from the stomach side of the protruding catheter. Balloon gastrostomy tube or button gastrostomy tube is placed behind the dilatation catheter, which is mounted and fixed in the sixth step. In the seventh step, the gastrostomy tube loaded on the catheter is placed into the stomach by taking support from the guiding wire fixed in the catheter, and the balloon is inflated and fixed in the stomach. In the eighth step, the catheter, one end of which is outside the patient's mouth, is pulled out from the stomach and the "Gastrostomy tube with balloon" placed and the stomach region are checked and the procedure is terminated. The present invention that combines pull and push PEG sets and makes them more practical can place a PEG tube with balloon with an outside-in dilatation catheter into the dilated stomach by pulling it out from the inside and pushing through the back of the catheter. In the present invention, a fine channel is formed for the passage of a catheter between the stomach and the outer abdomen by expanding out of the stomach with the dilatation catheter in the set.

With the application of said set, the second PEG change can be performed at the patient's home or even at the bedside with the help of a healthcare professional. In the application of the set according to the present invention, smaller wounds can be opened to the patient and thereby healing the wound in a short time. Thus, patients can start feeding within a few hours. The opening of smaller wounds during the application facilitates the work of the health personnel who perform the application. The set according to the present invention enables application by applying less force. Low force application minimizes patient trauma. In the application of the set, which is the subject of the invention, strong and easy dilation is provided by dilating the stomach outwards. REFERENCES

1 ] Cetin, D. A. (2020). Percutaneous endoscopic gastrostomy: Single center experience. Laparoscopic Endoscopic Surgical Science. https://doi.Org/10.14744/less.2020.46873 2] DELEGGE1 , M. (2001 ). Pull forces required for PEG tube placement using the standard Ponsky pull technique. The American Journal of Gastroenterology, 96(9), S52. https://doi.Org/10.1016/s0002-9270(01 )02900-8

3] Endoscopic Push-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure. (2019). Case Medical Research, https://doi.org/10.31525/ct1 - nct04151030

4] Fujita, T., Tanabe, M., Kobayashi, T., Washida, Y., Kato, M., lida, E., Shimizu, K., & Matsunaga, N. (2012). Percutaneous Gastrostomy Tube Placement Using a Balloon Catheter in Patients With Head and Neck Cancer. Journal of Parenteral and Enteral Nutrition, 37(1 ), 117-122. https://doi.Org/10.1177/0148607111435264

Claims

1. A percutaneous endoscopic gastrostomy set with a non-ruptured balloon catheter in order to provide a safe and error-free route for operations such as drainage of digestive juices and infusion of drug solution, enteral feeding, characterized by comprising; dilatation catheter, dilatation adapter, placement adapter for dilatation and balloon, 260 cm guidewire, 20 F Balloon gastrostomy tube, clamp catheter, 25±1 Gauge injection needle, cover for case, surgical blade with handle, seidinger needle, 150 cm guide wire, and gauze patch.

2. A percutaneous endoscopic gastrostomy set according to Claim 1 , characterized in that, said dilatation catheter has the dimensions of 3.5 mmx2000 mm.

3. A percutaneous endoscopic gastrostomy set according to Claim 1 , characterized in that, 10 cm long Teflon coated guiding wire is mounted on the end of said dilatation adapter.

4. A percutaneous endoscopic gastrostomy set according to Claim 1 or 3, characterized in that, the dimensions of said dilatation adapter are in segmental structure expanding backwards from the end, while the dimensions of the part are preserved, it expands to the next part with slight curves and its dimensions are enlarged, and its dimensions, starting from the distal end, are 2 mmx30 mmx2 mm, 50 mmx4 mmx15 mm.

5. A percutaneous endoscopic gastrostomy set according to Claim 1 , characterized in that, said dilatation and balloon placement adapter is made of polycarbonate material.

6. A percutaneous endoscopic gastrostomy set according to Claim 1 or 5, characterized in that, the dimensions of said dilatation and balloon placement adapter are 3.6 mmx80 mmx3.6 mmx15 mm.

7. A percutaneous endoscopic gastrostomy set according to Claim 1 , characterized in that, said 1500 mm and 2600 mm guiding wires are coated with Teflon.