US-20260124054-A1 - APPARATUS FOR TREATING GERD

US20260124054A1US 20260124054 A1US20260124054 A1US 20260124054A1US-20260124054-A1

Abstract

An implantable device for the treatment of acid reflux disease has a body including an outer surface adapted to rest against a patient's fundus wall. The device, when implanted in a patient, fills a volume in the patient's abdomen in the cardia area and above the cardia of the patient, when standing. The body prevents the cardia from moving through the diaphragm opening into the thorax, thereby preventing reflux by keeping the abdominal pressure supporting the cardia sphincter muscle. The device may be affixed to stomach tissue. The device may also be invaginated or otherwise indirectly secured in position.

Inventors

Peter Mats Forsell

Assignees

Peter Mats Forsell

Dates

Publication Date: 20260507
Application Date: 20260105
Priority Date: 20081010

Claims (20)

1 . An apparatus for treating reflux disease of a human or animal mammal patient, the apparatus comprising an implantable movement restriction device adapted to be at least partly invaginated by the patient's stomach fundus wall and having an outer surface that includes a biocompatible material, wherein a substantial part of the outer surface of the movement restriction device is adapted to rest against the stomach wall without injuring the latter in a position between the patient's diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, when the movement restriction device is invaginated, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax, so as to maintain the supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen, the movement restriction device having a size of at least 125 mm3 and a circumference of at least 15 mm.
2 . The apparatus according to claim 1 , further comprising an implantable first fixation device that, when implanted in the patient, secures the movement restriction device in a position that restricts the movement of the cardiac notch of the stomach towards the patient's diaphragm, with the outer surface of the movement restriction device substantially contacting the patient's stomach fundus wall.
3 . The apparatus according to claim 1 , wherein the movement restriction device is non-adjustable from outside the patient's body when implanted in the patient.
4 . The apparatus according to claim 2 , wherein the first fixation device comprises a tissue growth promoting structure for long term attachment of the movement restriction device to the stomach wall without invagination.
5 . The apparatus according to claim 4 , wherein the tissue growth promoting structure comprises a net like structure.
6 . The apparatus according to claim 5 , wherein the tissue growth promoting structure further comprises sutures or staples that, when implanted in the patient, attach the net like structure to the fundus stomach wall.
7 . The apparatus according to claim 2 , wherein the first fixation device comprises sutures or staples that, when implanted in the patient, attach together portions of the fundus stomach wall that enclose the movement restriction device to secure the movement restriction device in said position.
8 . The apparatus according to claim 7 , wherein the sutures or staplers, when implanted in the patient to attach together portions of the fundus stomach wall, invaginate the movement restriction device in the fundus stomach wall to thereby keep the movement restriction device in place.
9 . The apparatus according to claim 8 , wherein the sutures or staplers, when implanted in a patient with the movement restriction device, attach together portions of the fundus stomach wall so at to invaginate the movement restriction device from inside of the patient's stomach wall.
10 . The apparatus according to claim 8 , wherein the sutures or staplers, when implanted in a patient with the movement restriction device, attach together portions of the fundus stomach wall so at to invaginate the filing movement restriction device from outside of the patient's stomach wall.
11 . The apparatus according to claim 2 , further comprising a second fixation device that, when implanted in the patient with the movement restriction device, secures, indirectly or directly, the movement restriction device to the esophagus close to the patient's angle of His.
12 . The apparatus according to claim 11 , wherein the second fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, attach the fundus wall and a wall of the patient's esophagus to hold the movement restriction device in said position.
13 . The apparatus according to claim 11 , further comprising a third fixation device that, when implanted in the patient with the movement restriction device, secures, indirectly or directly, the movement restriction device to the patient's diaphragm muscle or associated muscles.
14 . The apparatus according to claim 13 , wherein the third fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, attach the fundus wall and the diaphragm muscle or associated muscles to hold the movement restriction device in said position.
15 . The apparatus according to claim 1 , wherein the movement restriction device comprises a body adapted to be at least partly invaginated by the patient's stomach fundus wall and having an outer surface that includes a biocompatible material, a substantial part of the outer surface of the body being adapted to rest against the stomach wall in said position between the patient's diaphragm and the portion of the lower part of the invaginated stomach fundus wall.
16 . The apparatus according to claim 15 , wherein the body is substantially egg shaped.
17 . The apparatus according to claim 15 , wherein the body is substantially shaped like an egg with an indented middle section.
18 . The apparatus according to claim 15 , wherein the body is substantially shaped like a bent egg.
19 . The apparatus according to claim 15 , wherein the body is substantially spherically shaped.
20 . The apparatus according to claim 15 , wherein the body has rounded contours without too sharp edges that would be damaging to the patient's stomach wall.

Description

This application is a continuation of U.S. patent application Ser. No. 18/864,855, filed Jan. 10, 2023,which is a continuation of U.S. patent application Ser. No. 12/864,855, filed Jul. 27, 2010, which is the U.S. national phase of International Application No. PCT/SE 2009/000059, filed Jan. 29, 2009, which designated the U.S. and claims priority to U.S. Provisional Application No. 61/006,719, filed Jan. 29, 2008, and Swedish Patent Application No. 0802138-8, filed Oct. 10, 2008, the entire contents of each of which are hereby incorporated by reference. TECHNICAL FIELD The present invention relates to an apparatus for treating Gastroesophageal Reflux Disease (GERD). BACKGROUND Gastroesophageal Reflux Disease (GERD), or acid reflux disease, is a chronic condition resulting in mucosal damage in the esophagus produced by the recurring occurrence of acid reflux in the esophagus. This is commonly due to transient or permanent changes in the barrier between the esophagus and the stomach. This can be due to incompetence of the lower esophageal sphincter (LES), transient LES relaxation, impaired expulsion of gastric reflux from the esophagus, or a hiatal hernia. Gastroesophageal Reflux Disease can be treated in a number of different ways. Treatments include, but are not limited to, both medical and surgical treatments. A standard surgical treatment, which sometimes is preferred over longtime use of medication, is Nissen fundoplication surgery, in which the upper curve of the stomach (the fundus) is wrapped around the LES to strengthen the sphincter and prevent acid reflux and to repair a hiatal hernia. The procedure is often done laparoscopically. Another surgical treatment which has been used is the Anglechik prosthesis, in which a device formed like a horseshoe is placed around the esophagus above the cardia. The intended effect is to prevent the cardia from slipping up into the thorax cavity. However, this device has a number of complications, including migrating through and damaging the esophagus. From experience with implantation of medical devices, it is known that sutures between an implanted device and human tissue will not hold over the long term. For long term implantation of a device, there are two possibilities to keep the device in place. A first solution has been to suture human tissue to human tissue, to thereby keep the device in place. A second approach has been to provide sutures holding a device in place in the short term and to allow in-growth of human tissue into the device for holding the device in place over the long term. A problem with providing an implantable device associated with the esophagus is that the outer surface of the esophagus is only comprised of esophagus muscle tissue, which is very easy to damage or migrate through. This is probably one reason why the Anglechik prosthesis described above has resulted in many complications, such as migration. The stomach, on the other hand, has a serosa on its outside, thereby providing a much stronger membrane for suturing. Thus, suturing a device directly to the stomach wall provides a better result than suturing an implanted device to the esophagus. Today, there exists a need for a long term treatment of GERD that is more effective than prior treatments and which does not result in any severe complications. SUMMARY OF THE INVENTION It is an object of the present invention to overcome, or at least reduce, some of the problems associated with existing surgical treatments of Gastroesophageal Reflux Disease (GERD). It is another object of the present invention to provide an apparatus for treating gastroesophageal reflux disease. These objects and others are obtained by apparatus described in the appended claims. Thus, by providing an apparatus for the treatment of acid reflux disease including an implantable movement restriction device having an outer surface that includes a biocompatible material, wherein the movement restriction device is adapted to rest with at least a part of its outer surface against the patient's stomach fundus wall, in a position between the patient's diaphragm and the fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, an apparatus for treating Gastroesophageal Reflux Disease is obtained. The movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm and restricts movement of the cardiac notch of the patient's stomach towards the patient's diaphragm thereby preventing the cardia from sliding through the patient's diaphragm opening into the patient's thorax, maintaining the supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen. Fixation device are adapted to secure the movement restriction device in said position. By adapting the outer surface of the implanted movement restriction device to rest against the wall of the fundus, there is a minimal risk of complicatio