WO2011107318A1

WO2011107318A1 - Implant

Info

Publication number: WO2011107318A1
Application number: PCT/EP2011/051709
Authority: WO
Inventors: Mario Bechtold; Clemens Bulitta; Friedrich Fuchs; Aleksandar Juloski; Rainer Kuth; Karl-Heinz Maier; Philip Mewes; Sebastian Schmidt
Original assignee: Siemens Aktiengesellschaft
Priority date: 2010-03-05
Filing date: 2011-02-07
Publication date: 2011-09-09
Also published as: DE102010010418A1

Abstract

An implant (14) contains a sealing element (16) that can be introduced into the interior (17) of the stomach (4) of a patient (2) and is arranged there such that it can be moved between a release position (P_F) opening the stomach entrance (10) and a sealing position (P_D) closing the stomach entrance (10), and a magnet arrangement (20), comprising a first magnet element (18a) arranged on the sealing element and a second magnet element (18b) which is arranged in such a way that it holds the sealing element (16) in the sealing position (P_D) with a holding force (F_H).

Description

Description Implant The invention relates to an implant.

A known human disease is the Refluxösophagi ^¬ tis (Gastro Esophageal Reflux Disease, GERD), also often referred to as gastroesophageal reflux disease or chronic heartburn. Here- in is an inflammatory disease of SpeI ^¬ seröhre, which is caused by the abnormal reflux of long Magensäu ^¬ re thereinto. Causes of GERD include too large emissions of stomach acid, which the Pe ^¬ ristaltik the esophagus can no longer cope, one affects esophageal peristalsis, which can not be attributed properly and a normal ejection of stomach acid, and a malfunction of the internal sphincter, which separates the esophagus from the stomach. In many elderly people and especially those with a high overweight, the closing effect of the stomach entrance is too ^low . This places highly acidic stomach contents into the feed tube ^¬ where it leads to chronic inflammation, which can develop into cancer.

In GERD, it is especially at night, so when lying down, after meals or bending over and lifting loads to acid regurgitation of gastric juice or heartburn. In the case of GERD is known to prescribe the patient a fat ^¬ diet and tobacco and alcohol avoidance and if a weight reduction. To alleviate nocturnal discomfort when lying down, it is known to perform an elevation of the upper body or a tilting of the bed, or to use wedge pillows. It is also known for patients to do without late supper and, for example, to stop eating after 4 to 6 pm. As a drug therapy antacids are known to cause a rapid symptom relief. Proton pump inhibitors are known for long-term therapy. Even in serious cases, an operative intervention is known which is carried out minimally invasively or laparoscopically. Here, the esophagus is constricted at the Ver ^¬ bond to the stomach by means of a seam. The standard ^¬ operational method here is the fundoplication in the Modi-fication Nissen-Rosetti. The upper part of the stomach is pulled around the esophagus and fixed with sutures. Thus, a cuff is formed which reduces the esophagus to the stomach ^¬ input to its natural diameter. Although this method of operation is very successful, it requires a very experienced surgeon and takes a relatively long time.

Alternatively, a project "Biovalve", funded by the Bavarian Research Foundation, is involved, including the Klinikum Rechts der Isar in Munich, where a ring-shaped implant is placed laparoscopically outside the stomach, but within the abdomen, in such a way that it obstructs the esophagus The stomach entrance is thereby brought to its natural diameter and the sphincter can fulfill its function again.As the implant has a special foamed structure of thermoplastic polyurethane in the radially inner area, the tissue of the esophagus grows on the inner circumference of the implant, whose slipping is thus excluded.

The object of the invention is to propose an improved In ^¬ Plantat for a patient. The invention is based on the idea to provide an apparatus that is not upgraded in a known manner the sphincter of the stomach again, but by itself prevented from the backflow of Ma ^¬ gensäure into the esophagus or at least verrin- siege. The invention is based on the basic idea to provide an artificial gasket for the gastric entrance, which is able to close the stomach entrance. The invention is furthermore based on the idea of combining the opening or closing of the artificial sealing element with magnetic support or realizing a magnetic manipulability of the sealing element.

The object is achieved by an implant according to patent claim 1. The implant comprises a sealing element which can be introduced into the interior of the stomach of a patient. Geninneren in Ma ^¬ the sealing element is movably arranged so that it can change the entrance to the stomach releasing release position and a stomach inlet closing position between a sealing.

The implant also includes a magnet assembly. The Mag ^¬ netanordnung comprises two magnetic elements, wherein the first magnetic element is arranged on the sealing element. The second magnetic element is arranged so that it is - at least when the sealing member is in the sealing position, the log message ^¬ ment, by magnetic interaction with the first magnetic element, holding by a holding force in the sealing position. In other words, therefore, the second magnetic element acts on the sealing element via the first magnetic element in order to seal it in the sealing position on the stomach inlet. The magnetic elements can each be either magnetizable or permanently magnetic.

The gastric entrance confines the stomach to the esophagus, the stomach outlet to the duodenum of the patient. The sealing element is constructed so large that it can never pass through a patient's stomach inlet or outlet. This ensures that the sealing element remains permanently in the stomach of the patient. In other words, therefore, the sealing element in its smallest surface dimension is such that it is larger than the largest expected surface dimension of the Gastrointestinal or outgoing of a human is. With a minimal extension of a surface dimension of more than approx. 2 cm, for example, the sealing element can not pass from the inside of the stomach either the stomach entrance or the stomach exit of a person.

From the sealing position, the sealing element against the holding ^¬ force of the magnet assembly is releasable. The holding force is dimensioned di ^¬ that - for example, for the purpose of food micrograph - can be overcome to the sealing element of the

To bring sealing position into the release position. This allows food from the esophagus to enter the stomach unhindered. In other words, the sealing element acts as künstli ^¬ cher magnetic closure of the stomach towards the esophagus. The implant is placed, for example by means of a gastro ^¬ Skops or swallowed into the stomach. As a rule, the elements of the implant are only extended to their final size during the stomach in order to be able to pass, for example, the esophagus and the stomach inlet during insertion of the implant. Folding, folding, modular or other techniques are conceivable here. The invention solves a very common problem in gastroenterology by providing a low cost implant solution. The implant does not require its own energy supply and is dimensioned with regard to the magnet arrangement so that closing or opening of the stomach entrance can be activated or deactivated at any time by the patient himself or takes place automatically.

In a first embodiment of the invention, the second magnetic element can be arranged outside the patient. The second magnetic element can then be moved freely outside the patient and each brought into the appropriate position to apply the sealing element in the sealing position with the holding force. The second magnetic element can under certain circumstances, depending on the orientation, the sealing element also be deliberately brought from the release to the sealing position or vice versa. This is possible for example by a suitable placement of the second sealing element in certain relative positions to the patient.

In a preferred embodiment, the second magnetic element can be arranged on a resting bearing of the patient. In practice, for example, the patient installs the second magnetic element in the form of a large permanent magnet or electromagnet on his bed as a resting rest. The second magnetic element is e.g. attached to such a location and in a position that is tuned to a typical reclining position of the patient. Since the patient is usually in his typical reclining position throughout the night, the magnetic elements act together and the sealing element is held in the sealing position throughout the night.

In an alternative variant of this embodiment, the second magnetic element is not at the rest camp, but can be arranged on the body of the patient. The arrangement takes place here on the outside of the patient. For example, the patient installs a corresponding magnetic element on his or her back or chest by means of a band or bag sewn into the sleepwear. Again, the attachment is chosen so that in the corresponding position, the second magnetic element holds the sealing element in the sealing position. One of the ^¬-like embodiment is independent from the reclining position of the patient and can also be applied during the day by the patient is wearing the second magnet with it.

Alternatively, in a preferred embodiment, the second magnetic element may also be arrangeable inside the patient, wherein the magnetic element is in this case arranged in the region of the gastrointestinal ^¬ above. Here are two variants, namely the second magnetic element inside the stomach or outside the stomach, that is inside the abdominal cavity of the stomach Patients, to place. The arrangement in the interior of the stomach can be performed endoscopically, the arrangement outside the stomach usually minimally invasive. Since the second magnet is disposed in the loading area of the stomach ^¬ input, where in the

Sealing position and the sealing element and thus the first Mag ^¬ netelement is here, smaller and weaker Mag ^¬ Neten can be used as in the above embodiment, when the magnet is placed outside the patient, since the distance to the first magnetic element is significantly smaller and thus smaller magnetic field strengths generated by the second magnet to generate the holding force ausrei ^¬ chen.

In a preferred embodiment, the first magnetic element itself represents the sealing element. ^Magnetic element and sealing element thus merge into a single component. In other words, a magnetic sealing element is used.

In a preferred embodiment, the magnet system is dimensioned such that the largest possible, acting on the first magnetic ^¬ element attraction force is smaller than the weight of the sealing element. In the weight force, the first magnetic element is taken into account, as it forms together with the sealing element usually an integral component.

Thus, the sealing element - also known as gastric ^{obstruction ¬ ¬} - has the tendency to fall by its weight from the stomach ^¬ entrance down to the stomach floor when the patient is in an upright position.

In an alternative embodiment, the magnet system is dimensioned such that the force of attraction of the sealing element acting on the first magnetic element in the sealing position then remains in the sealing position when no food is supplied to the stomach. In other words, the stomach entrance remains closed even in the upright position of the patient until it receives food. If the patient takes food itself, the sealing element opens due to the increased pressure in the esophagus.

In a further embodiment, the sealing element has a density which is smaller than that of average gastric fluid or gastric contents. Again, if necessary, the sealing element is again addressed together with the attached to it first magnetic element. As an approximation, the density of water can also be used as a reference here. In other words, the sealing element floats on the gastric fluid and thus automatically reaches near the stomach entrance, where the second sealing element acts magnetically attractive and thus automatically closes the gastric inlet after food intake, ie after sufficient filling of the stomach with gastric fluid , In other words, so after a meal, or when the patient is lying, the closure floating freely on the surface of the gastric fluid. The magneti ^¬ cal force of the second magnetic element then pulls the closure to the stomach entrance and closes it. When lying down no more gastric juice enters the esophagus.

This embodiment can be combined well with the above-mentioned, in which the sealing element falls off the gastric inlet by the weight force when the stomach is emptying in the upright position of the patient.

In an alternative embodiment, which can also be combined herewith, the sealing element has a density which is greater than that of gastric fluid. In an upright position of the patient, the occlusion sinks to the stomach base, the stomach entrance is initially free, even if the stomach is filled. To close the patient, for example, briefly lift the buttocks with his legs in a supine position. The closure then sinks towards the stomach entrance and is held there magnetically until the patient again assumes an upright position. In a further embodiment, the sealing element has a disc shape. This is particularly suitable to close the just ^¬ round stomach entrance. Such a sealing element can then be fixed in a further embodiment at a point of its edge region in the manner of a pivoting flap on the edge of the stomach entrance. In other words, therefore, the sealing element is attached to the stomach entrance on one side, for example, sewn or stapled. The second magnetic element as a counter-magnet is then also mounted In ^¬ play at the edge of the entrance to the stomach, but depending ^¬ opposite the fixing position of the sealing element. When the esophagus is empty, the sealing element is attracted by the two ^¬ ten magnets, and remain closed. When the patient takes food, the valve opens due to the increased pressure in the esophagus.

In a further embodiment, the implant has an opening element acting on at least one of the magnetic elements in an opening operation. In the opening operation verrin ^¬ siege the opening element, the holding force of the magnetic elements or more than offset this. Thereby opening the sealing element is facilitated or the sealing element is actively opened on this public ^¬ voltage operation even.

Also, in the event that the magnetic closure formed by the two magnetic elements does not self-open by the pressure of food entering through the esophagus, a magnet may be brought as an opening element in the vicinity of the first or second magnet from the outside to the resulting To decrease or overcompensate for attraction to the first Magnetele ^¬ ment, ie to cause a kind of rejection in the direction away from the second magnetic element.

In a preferred variant of this embodiment, therefore, the opening element is a magnetic opening element which generates a field in the opening operation, which in the sealing position of the sealing element in the region of the first magnetic element, that is in the decisive effective range of the second magnetic element is directed opposite to the magnetic field of the second magnetic element. For a further description of the invention reference is made to the embodiments of the drawings. They show, in each case in a schematic outline sketch:

1 shows a stomach of a patient with an inserted implant, FIG. 2 shows the patient from FIG. 1 with an alternative implant lying down or resting on a resting bed, FIG.

3 shows the stomach of the patient from FIG. 1 with an alternative implant, FIG.

4 shows the patient from Fig.l with an alternative implant with opening element.

Fig. 1 shows a section of a patient 2, namely the stomach 4 with a part of the esophagus 6 and the

Duodenum 8. At the boundary between the stomach 4 and storage seröhre 6, there is thus at the upper stomach end of the stomach ^¬ input 10. At the opposite, lower end of the stomach 4 is the leading to the duodenum 8 gastric outlet 12. As the patient 2 by Reflux esophagitis (GERD) suffers, this is supplied with an implant 14 according to the invention. The implant 14 comprises a sealing element 16 to which a first magnetic element 18a is attached. The sealing element 16 has been introduced into the patient's interior 17 of the stomach 4 and is now permanently arranged there. The first magnetic element 18a together with a second magnetic member 18b, a magnet assembly 20. The second solenoid ^¬ element 18b is in the position shown in Fig.l embodiment domestic nerhalb of the patient 2, namely in the abdominal cavity, but outside of the stomach 4 and the esophagus 6 ordered on ^¬ . It is located in the area of the stomach entrance 10 and is outside the stomach buildin ^¬ Untitled 4 to the esophagus or 6.

Fig.l shows the sealing element 16 in a sealing position P _D , in which it closes the stomach entrance 10 to the esophagus 6 out. The magnet arrangement 20 is in this case dimensioned so that the sealing element 16 is held in the sealing position P _D by the magnetic interaction between the first and second magnetic elements 18 a, b with a holding force F _H.

For the purpose of food intake, the holding force F _{H can be} over ^¬ wound and the sealing element 16 of the shown

Seal position P _{D are brought} into a dashed line release P ^¬ position P _F. This is done in that ma- genin stop 22 through the esophagus 6 and presses the entrance to the stomach 10 through the esophageal peristalsis 6 against the log Tele ^¬ element 16 and this lifts from the stomach entrance. The first magnetic element 18a moves away from the second magnet characterized ^¬ element 18b, the force of attraction between the two is decreasing, that is, the force is less than the retaining force F ^¬ _H. The weight F _G of sealing element 16 and magnetic ^¬ element 18 a finally prevails, and the sealing element 16 falls into the release position P _F , since the patient is upright.

In a first embodiment, sealing element 16 and first magnetic element 18 a overall have a greater density than the stomach contents 22. Then, the sealing element 16, as shown in broken lines in Fig.l, lie on the bottom of the stomach 4 until the patient, for example, a skew

(raised buttocks while lying down) occupies, so that the Dichtele ^¬ ment 16 due to its weight F _G in the direction of the Ma ^¬ geneingangs 10 decreases. Once it enters the effective range of the Mag ^¬ netelements 18b - the attraction of Magnetan- order 20 outweighs the weight F _G - returns it back into the position shown in Fig.l sealing position P _D back, due to the holding force F _H. It stays there, for example, as long as the patient stays lying down. 2 shows an alternative embodiment of an implant 14, wherein the second magnetic element is not mounted in the attachments ^¬ ren of the patient 2, but on the outer side, namely at the back 24 18b. This is possible, for example, by sticking to the patient. Also, the patient may wear the magnetic element 18b, for example, in a bag or a harness on the body. Again, the magnetic element 18b generates a holding force F _H , which holds the sealing element 16 together with the first magnetic element 18a in the sealing position P _D.

In another alternative, a section of a bed of the patient 2 is Darge ^¬ is in Figure 2 also as a couch 26th The magnetic element 18b is then not ducks 2 directly on Pati- but (shown in phantom) is introduced ^¬ on the couch 26 so that the holding force F _H generated when the patient 2 on the couch 26 in a usual position, for example his usual sleeping lays, resting. 2 also shows an embodiment of a sealing element 16, which is identical to the first magnetic element 18a. In other words, the magnetic element 18a is shaped as a sealing ^¬ element 16 and represents a single component. Figure 3 shows a further embodiment of the implant 14, in which a donut-shaped second magnetic element 18b just ^¬ least in the area of the cardia 10 in the interior of the patien ^¬ th 2, but now in contrast to Fig.l, also in the interior of the stomach 4 is placed. The second magnetic element 18b is sewn to the stomach wall, for example.

In addition, here the sealing element 16 is carried out together with the Mag ^¬ netelement 18a such that its weight ^¬ force F _G , that is the weight of both elements, greater than the holding force F _H between the first and second magnetic element 18a, b. In half or not ge ^¬ filled with contents of the stomach 22 stomach 4, therefore always falls, the sealing element 16 in the upright position of the patient in the direction of Erdanzie- force, and thus usually away from the stomach entrance 10, down.

In the embodiment shown, the density of the sealing element 16 and the magnetic element 18a is also lower than that of the stomach contents 22. If the stomach 4 with stomach contents 22 fills up during the intake of food, the sealing element 16 floats on the stomach contents 22 and gradually returns In the vicinity of the stomach entrance 10. Here too, the sealing element 16 closes the stomach entrance 10 in the sealing position P _D , as soon as it enters the effective range of the magnetic element 18b. In a full stomach 4 the sealing element 16 then adheres to the Mag ^¬ netelement 18b due to the additional lift force on through the gastric contents 22 in the sealing position P _D.

4 shows a sealing element 16 in the form of a disc, which is fixed, for example sewn, to a circumferential position of its edge region 28 in the manner of a pivoting flap on the edge 30 of the stomach entrance 10. So there is a kind of flap joint formed. On the opposite side of the hinged joint, the first magnetic element 18a is attached to the sealing element 16.

In the position shown in Figure 4, the sealing element 16 is pivoted to a release position P _F , since during a

Swallowing gastric contents 22 into the stomach 4 flows. If the swallowing process of the patient 4 is over, then no gastric contents 22 flow more. Also on the edge 30, the magnetic element 18 b is attached to a valve joint approximately opposite circumferential position of the stomach entrance 10. Due to its magnetic attraction to the magnetic element 18a, the holding force F _H is again generated, whereupon the sealing element 16 pivots in the manner of a pivoting flap shown in dashed lines Dichtpo ^¬ position P _D and the stomach inlet 10 closes again.

4 shows in a further embodiment, an additional opening element 32 of the implant 14, which is arranged in the outer ^¬ space 34, that is, outside of the patient 2 and operated there. The stopping of the opening member 32 in the position shown in Fig.4 to the patient 2 means an opening operation B ₀ . In this, it generates an opening force ^¬ F _0, which overcompensated the holding force F _H, and therefore the flap-shaped sealing element 16 moves into the position shown released position P ^¬ _F. Thus, an influx of stomach contents 22 by stopping the opening member 32 can be facilitated.

In other words, the opening element 32 generates an ope- ning force F ₀ in the form of a magnetic field which is directed opposite to the shown in Figure 4. Movement ^¬ area of the magnetic element 18a the magnetic ^¬ field of the magnetic element 18b and since ^¬ overcompensated with the retaining force F _H.

Claims

claims

1. implant (14), with a in the interior (17) of the Ma ^¬ gene (4) of a patient (2) einbringbaren and there between the stomach entrance (10) releasing release position (P _F ) and the stomach entrance (10) occlusive

Sealing position (P _D ) movably arranged sealing element (16), with a magnet arrangement (20), comprising a first on

Magnetic element (18a) arranged sealing element, and a second magnetic element (18b), which is arranged so that it

Sealing element (16) with a holding force (F _H ) in the sealing posi ^¬ tion (P _D ) holds.

2. Implant (14) according to claim 1, wherein the second magnetic element (18b) in the outer space (34) of the patient (2) can be arranged.

3. implant (14) according to claim 2, wherein the second magnetic element (18b) can be arranged on a resting camp of the patient.

4. implant (14) according to claim 2, wherein the second magnetic ^¬ element (18 b) on the body of the patient (2) can be arranged.

5. Implant (14) according to claim 1, wherein the second magnetic element (18b) in the interior (17) of the patient (2) in the region of

Stomach entrance (10) can be arranged.

6. Implant (14) according to one of the preceding claims, wherein the first magnetic element (18a) is the sealing element (16).

7. implant (14) according to one of claims 1 to 6, wherein the magnet assembly (20) is dimensioned so that the largest possible ^¬ on the first magnetic element (18 a) acting holding force ^¬ (F _H ) smaller than the weight force (F _a ) of the sealing element (16).

8. Implant (14) according to one of claims 1 to 6, wherein the magnet arrangement (20) is dimensioned such that the in the sealing position (P _D ) on the first Magnetele ^¬ ment (18 a) acting holding force (F _H ) holds the sealing element (16) in the sealing position (P _D ) when the stomach (4) no food is supplied.

9. implant (14) according to any one of claims 1 to 8, wherein the sealing element (16) has a density which is smaller derje ^¬ nigen of stomach contents (22).

10. implant (14) according to one of claims 1 to 8, wherein the sealing element (16) has a density which is greater derje ^¬ nigen of stomach contents (22).

11. Implant (14) according to one of the preceding claims, wherein the sealing element (16) has a disc shape.

12. Implant (14) according to claim 11, wherein the sealing element (16) with its edge region (28) at the edge (30) of the Magenein ^¬ gangs (10) is fixed in the manner of a pivoting flap.

13. implant (14) according to any one of the preceding claims, with a in an opening operation (B ₀ ) on at least one of the magnetic elements (18a, b) acting, the holding ^¬ force (F _H ) reducing or overcompensating Öffnungsele- element (32) ,

14. The implant (14) according to claim 13, wherein the Öffnungsele ^¬ ment (32) is a magnetic opening element that generates a magnetic field in Publ ^¬ drying operation (B _0), the sition in the Dichtpo- (P _D) of the sealing element ( 16) in the region of the first Mag ^¬ netelements (18 a) opposite to the magnetic field of the second Magnetele ^¬ ment (18 b).