WO2012089881A1

WO2012089881A1 - Gastric insertion device

Info

Publication number: WO2012089881A1
Application number: PCT/ES2011/070868
Authority: WO
Inventors: Ramón ABAD BELANDO
Original assignee: Abad Belando Ramon
Priority date: 2010-12-29
Filing date: 2011-12-15
Publication date: 2012-07-05
Also published as: ES2356655B1; ES2356655A1

Abstract

The invention relates to a device for the insertion of a gastric balloon, of the type that comprises: a guide having a distal end and a proximal end; a tube for inflating the balloon, defining a distal end and a proximal end; and an inflatable balloon connected to the proximal end of the inflating tube. The invention is characterised in that the guide comprises a through-hole between the distal and proximal ends.

Description

GASTRIC INTRODUCTION DEVICE DESCRIPTION

The present invention refers to a gastric introducer device used for the treatment of obesity.

In particular, the present invention refers to a device comprising an inflatable balloon that is temporarily implanted in the stomach of obese patients and that helps achieve significant weight loss in a short period of time.

Today, there are different therapeutic treatments to treat obesity that include surgical intervention or behavioral therapy to modify behavior with respect to dietary habits, all combined with an increase in physical activity. When the patient is not motivated, pharmacological treatment can be added that inhibits intestinal fat absorption or suppresses appetite and increases satiety. However, these pharmacological treatments include an important series of side effects such as insomnia, constipation, high blood pressure or tachycardia. Even in the case of morbid obesity, there is often the possibility of a surgical intervention that is usually high risk with a mortality rate of around 2%.

The introduction of intragastric balloon treatment at the end of the 1990s, was postulated as an attractive option to lose weight in those patients who did not respond to medical therapy and who did not want or should not undergo surgery or pharmacological treatment . Said treatment comprises the use of a deflated inflatable balloon attached to the distal end of a balloon or feeding tube of the balloon that is blindly inserted through the patient's oral route and that passes through the esophageal route until it reaches the stomach. The balloon inflation tube has to be long enough so that the proximal end of said inflation tube is arranged outside the patient. Once the deflated balloon is in the stomach, a syringe is inserted through the orifice of the proximal end of said swelling tube that protrudes from the patient's mouth and a liquid or air is introduced that swells the balloon into the stomach. Once the balloon is swollen inside the stomach, the swelling tube is pulled outward causing the distal end of said tube with the balloon and automatic closure of the balloon by means of a unidirectional liquid inlet valve. Subsequently, said swelling tube is removed from inside the patient.

However, the process of placing the balloon, according to the known technique, is done by touch and blindly without being able to monitor where the balloon is connected to the inflation tube. In some cases, this technique has led to incorrect insertion of the balloon, often causing tracheal injuries. In some cases, in order to avoid the insertion of the balloon through the tracheal route, the patient was previously intuited through the tracheal route of said patient in order to have the airway secured and then the balloon attached to the swelling tube is inserted. However, the use of a respiratory probe, in addition to being annoying and requiring additional control to the control necessary for the insertion of said ball, does not ensure a correct insertion of the ball avoiding injuries.

Additionally, the union of the distal end of the swelling tube with the balloon is a weak joint that facilitates the process of disunity once the balloon is inside the stomach. Any complication during the process of inserting the assembly formed by said inflation tube attached to said balloon that requires an urgent withdrawal of said assembly, could cause an early disunity of the distal end of said tube with the balloon, leaving the balloon released anywhere between the stomach and mouth of the patient.

Document US4485805 discloses a balloon insertion device comprising a balloon attached to a balloon inflation tube and a guide tube which comprises inside a nylon filament whose distal end is attached to said balloon, so that said guide tube allows the balloon to be guided to a patient's stomach. However, this device does not allow to ensure the correct insertion of the guide tube that also requires a touch and blind placement process. Additionally, this document does not prevent the ball from being released before reaching the stomach.

It is therefore an objective of the present invention to achieve a gastric introducer device that allows to solve the aforementioned drawbacks. More particularly, it is an objective of the present invention to disclose a gastric balloon introducer device that ensures the correct insertion of the gastric balloon into the stomach, without erroneous insertions by tracheal route and without causing any type of injury. According to the present invention, this is achieved by a gastric balloon introducer device of the type comprising:

a guide tube comprising a distal end and a proximal end and comprising a through hole between said distal and proximal ends;

an inflatable balloon;

a balloon inflation tube defining a distal end and a proximal end,

wherein said inflatable balloon is connected by an end portion to the distal end of said swelling tube, characterized in that said device further comprises a filiform preguiding filament, comprising a distal end and a proximal end, adapted to be introduced by said hole through said guide tube and whose distal end is free, without any connection to said guide tube, said inflation tube or said balloon. Said filament is previously introduced by the esophageal route to the stomach so as to guide said guide tube to the stomach.

Preferably, said preguiding filament has a length greater than said guide tube.

Additionally, the distal end of said preguiding filament is free, without any attachment to said guide tube, said inflation tube or said balloon, since said distal end is the part of the preguided filament that first reaches the stomach.

Preferably, the distal end of said preguiding filament is more flexible than the proximal end of said preguiding filament, in this way a better insertion of the filament through the esophageal route to the stomach is achieved avoiding damaging the walls of said esophageal route. Preferably, said guide tube and said inflation tube are joined in parallel and adjacent position by at least one first connecting element. More preferably, said first joint element wraps part of the surfaces of said guide tube and said swelling tube in contact. In this way, we managed to optimize the process of inserting the device by inserting the guide and the swelling tube at the same time.

Additionally, said preferably deflated balloon is directly connected to said guide tube by at least a second connecting element. This arrangement of the ball attached to the guide always ensures the position of the ball avoiding the possibility of being released in another area than the stomach during the insertion process.

Preferably, the distal end of said guide has a conical shape. The conical shape of said end allows a more optimal insertion of the gastric introducer device allowing esophageal dilation.

Preferably, an end portion of said balloon opposite said portion attached to the distal end of said inflation tube makes contact with the distal end of said guide. In this way, being the balloon arranged next to the distal end of said guide, it allows to ensure the placement of said balloon in the stomach once the distal end of said guide has reached the stomach.

Preferably, said second connecting element involves part of said balloon and part of the surface of said guide tube. More preferably, said second connecting element wraps the distal end conically finished of said guide tube and an end portion of said balloon. This union allows to give a more conical shape to said union making possible a more optimal insertion of the gastric introducer device through the esophageal pathway of the patient.

According to another preferred embodiment, said balloon is wrapped by a wrap. Preferably, said wrapper that surrounds said balloon is directly attached to said guide tube by at least a second connecting element. More preferably, said second joint element wraps part of said envelope and part of the surface of said guide tube in contact with said envelope.

Preferably, said second connecting element is breakable.

Preferably, the joint between the proximal end of said inflation tube and said balloon is separable.

Preferably, said balloon comprises a self-return valve.

Preferably, said guide and said inflation tube are flexible elastic type.

For better understanding, several figures describing the different parts of a preferred embodiment of the present invention are attached by way of explanatory but not limitative example.

Figure 1 shows a perspective view of a gastric balloon introducer device according to the present invention.

Figure 2 shows an enlarged perspective view of a part of the gastric balloon introducer device according to the present invention.

Figures 3 to 10 show different perspective views of a method of using the gastric balloon introducer device according to the present invention.

Figure 1 shows an embodiment of the invention of a device -1- gastric balloon introducer comprising a guide tube -2- such as, for example, a semi-flexible probe of PVC plastic or other similar material. Said guide tube -2- comprises a distal end -22- and a proximal end -21-. Additionally said guide tube -2- comprises a through hole between said distal ends -22- and proximal -21- adapted to comprise inside said through hole a pre-guided filament -4- filiform, such that said guide tube - 2- can carry out translation movements with respect to said preguiding filament -4-. Said filament -4- is introduced into the through hole of said guide tube -2- through the distal end -22- and protrudes through the proximal end -21- thereof. Said filament -4- comprises a diameter, approximately 4-5 mm, equal to the internal diameter of the through hole of said guide tube -2-, so that a position of said guide tube -2- can be maintained with respect to said filament -4-. Additionally, the length of the filament -4-, approximately 3-4 m, is greater than the length of the guide tube -2-, approximately 100 cm.

Said device -1- gastric balloon introducer also comprises a tube -3- of flexible type adapted for the inflation of an inflatable balloon -5-. Said tube -3- comprises a proximal end -31- through which an irrigating element -6- such as a syringe and a distal end -32- is connected which is coupled to an end part of said inflatable balloon -5- which It is previously deflated. Said guide tube -2- and inflation tube -3- are connected in parallel and adjacent to each other by means of at least one connecting element -7-. Said connecting element -7- is of the envelope type such as for example a plastic tape or other similar material that wraps part of the surfaces of said guide tube -2- and swelling tube -3- in contact. Additionally, said deflated balloon -5- that is attached to the distal end -32- of said tube -3- is also attached to a part of said guide tube -2- by at least one connecting element -8-. Said connecting element -8- is also of the envelope type so that it can wrap part of the surface of the balloon -5- and part of the distal end -22- of said guide tube -2-. Additionally, said connecting element -8- is of the breakable type so that as the balloon swells inside the stomach, said connecting element -8- yields until it breaks leaving the balloon -5- free of its union with said guide tube -2-.

Figure 2 shows an enlarged view of the set of main elements that form the device -1- gastric balloon introducer. In said figure, the conical shape of the distal end -22- of said guide tube -2- can be observed. Said conical shape helps to expand the esophageal pathway during insertion of said device -1- through filament -4-. Additionally, at least one connecting element -8- wraps the end portion -51- of said deflated balloon -5- with a part of said distal end -22- of said guide tube -2-. Preferably, only one connecting element -8- wraps the distal end -51- of the deflated balloon -5- with the distal end -22- of the guide tube -2-. The union at this point is necessary to adapt the joint assembly guide tube -2- and balloon -5- in the most conical way possible. It is also important that the distal end -51- of the deflated balloon -5- be as close as possible to the distal end -22- of the guide tube -2-, because the latter is the part that first reaches the stomach -100- of the patient and then the balloon -5- deflated has to be swollen inside the stomach -100-.

According to a method of using a device -1- gastric balloon introducer, in an initial phase (not illustrated), an endoscopic apparatus, comprising a proximal end and a distal end, is introduced through the patient's mouth until reaching the stomach -100- so that the distal end of said endoscopic apparatus is disposed within the stomach -100- and the proximal end thereof is outside the patient's mouth. Said endoscopic apparatus allows to verify that there is no counterproductive anomaly. Said endoscopic apparatus may comprise at least one channel through which said preguiding filament -4- is introduced until reaching the stomach -100-, so as to obtain the distal end -42- of said preguiding filament -4- within the stomach - 100- and the proximal end -41- thereof outside the patient. In this way, the endoscopic apparatus serves as a guide for said preguiding element -4- to the stomach -100-, ensuring correct insertion. Additionally, the end part that ends at the distal end -42- of said preguiding filament -4- is more flexible than the opposite end part that ends at the proximal end -41- thereof. Therefore, since the distal end -42- of said preguiding filament -4- is the end that is inserted first through the channel of the endoscopic apparatus, it is necessary for said distal end -42- to have one more degree high flexibility to adapt to the curvatures from the pharynx -101-, passing through the esophageal route -102- until reaching the stomach -100-.

Subsequently, the endoscopic apparatus is removed leaving the preguided filament -4- with the proximal end -41- on the outside of the patient and the distal end -42- inside the stomach -100-, as shown in Figure 3 It should be noted that said preguiding filament -4- must be of a suitable soft material such as, for example, nititol to avoid damaging the esophageal and stomach mucus.

Subsequently, as shown in Figures 4, 5 and 6, the assembly preferably formed by the union of said guide tube -2- and said balloon inflation tube -3- is inserted by matching the distal end -22- of the guide tube -2- with the proximal end -41- of the preguiding filament -4- that is outside the patient. Subsequently, said assembly formed by the union of said guide tube -2- and said balloon inflation tube -3- slides towards the pharynx -101-, the esophagus -102- and finally the stomach -100- of the patient allowing the entrance of the preguiding filament -4- through the through hole of said guide tube -2-. On many occasions, depending on the patient, the esophageal route -102- may be slightly closed, so it is necessary to help expand said route -102- by means of the assembly formed by the union of said guide tube -2- and said tube of bloated -3-. That is why the distal end -22- of said guide tube -2- has a conical shape. Additionally, being the distal end -51- of the deflated balloon -5- adhered to the distal end -22- of said guide tube, allows said joint to take an approximately conical shape to facilitate the insertion of the device -1- by the esophageal route of the patient. Thus, a connecting element -8- is used that joins part of said distal end -22- of said guide tube -2- with the distal end of the balloon -5- in a deflated state.

On this occasion, the preguiding filament -4- guides the assembly formed by the union of said guide tube -2- and said balloon inflation tube -3-, ensuring the correct entry of said assembly directly into the stomach -100 -, avoiding the possibility that said set is directed by the tracheal route -103-.

Subsequently, once said assembly formed by the union of said guide tube -2- and said swelling tube -3- is located in the stomach -100- of the patient, a liquid is injected such as, for example, a saline solution through said swelling tube -3- by means of a syringe -6- connected to the proximal end -31- of said tube -3- that is outside the patient. Said liquid injection crosses the through hole of the tube -3- until it reaches and fills the inside of the balloon -5-. Said balloon -5- comprises a valve -51- unidirectional liquid inlet that only allows liquid to enter the ball -5-. Said filling of approximately 400 to 700 ml depending on the patient allows the balloon -5- to be inflated inside the stomach, as shown in Figure 7. Inflation of the balloon -5- causes the transfer of the connecting element -8- with the guide tube -2- that ends up breaking freeing the balloon -5- swollen inside the stomach -100-.

After inflation of the balloon -5-, the assembly formed by said inflation tube -3- and said guide tube -2- are pulled slightly outward, causing distal end -32- tube -3- with the balloon -5- and in turn the automatic closing of the ball -5- by said valve -51- unidirectional liquid inlet, as shown in Figure 8.

Once the balloon -5- is inflated and loose inside the stomach -100-, the assembly formed by the union of said guide tube -2- and said swelling tube -3- are first removed by stretching said assembly outwards and maintaining the position of said preguiding filament -4-, as shown in figure 9. Finally, the preguiding filament -4- is gently pulled out of it towards the outside of the patient, as shown in figure 10.

While the invention has been described with respect to a preferred embodiment, this should not be considered as limiting the invention, the scope of which is defined by the broader interpretation of the following claims.

Claims

1. Gastric balloon introducer device of the type comprising:

an inflatable balloon;

a balloon inflation tube defining a distal end and a proximal end;

wherein said inflatable balloon is connected by an end portion to the distal end of said swelling tube, characterized in that said device further comprises a filiform preguiding filament, comprising a distal end and a proximal end, adapted to be introduced by said hole through said guide tube and whose distal end is free, without any connection to said guide tube, said inflation tube or said balloon.

2. Gastric balloon introducer device according to claim 1, characterized in that the distal end of said preguiding filament is more flexible than the proximal end of said preguiding filament.

3. Gastric balloon introducer device according to claim 1, characterized in that said preguiding filament has a length greater than said guide tube.

4. Gastric balloon introducer device according to claim 1, characterized in that said guide tube and said inflation tube are connected in parallel and adjacently by at least one first connecting element.

5. Gastric balloon introducer device according to claim 1, characterized in that said The balloon is directly connected to said guide tube by at least a second connecting element.

6. Gastric balloon introducer device according to claim 1, characterized in that the distal end of said guide tube has a conical shape.

7. Gastric balloon introducer device according to claim 5, characterized in that an end part of said balloon opposite said part attached to the distal end of said inflation tube makes contact with the distal end of said guide tube.

8. Gastric balloon introducer device according to claim 5, characterized in that said second connecting element involves part of said balloon and part of the surface of said guide tube in contact with said balloon.

9. Gastric balloon introducer device according to claims 5 and 6, characterized in that said second connecting element wraps the distal end finished in a conical shape of said guide tube and an end portion of said balloon.

10. Gastric balloon introducer device according to claim 4, characterized in that said first connecting element wraps part of the surfaces of said guide tube and said swelling tube in contact.

11. Gastric balloon introducer device according to claim 1, characterized in that said balloon is wrapped by a wrap.

12. The gastric balloon introducer device according to claim 11, characterized in that said wrapper that surrounds said balloon is directly connected to said guide tube by means of at least a second connecting element.

13. Gastric balloon introducer device according to claim 12, characterized in that said second joint element wraps part of said envelope and part of the surface of said guide tube in contact with said envelope.

14. Gastric balloon introducer device according to claim 5, characterized in that said second connecting element is breakable.

15. Gastric balloon introducer device according to claim 1, characterized in that the joint between the proximal end of said inflation tube and said balloon is separable.

16. Gastric balloon introducer device according to any of claims 7, 8 to 11 and 15, characterized in that said balloon comprises a self-return valve.

17. Gastric balloon introducer device according to claims 7, 8, 9, 10, 13 and 15, characterized in that said guide tube and said inflation tube are of flexible elastic type.

18. Gastric balloon introducer device according to the preceding claims, characterized in that said balloon is deflated.