Apparatus for treating GERD

Patent metadata

Field	Value
Publication number	US-11020258-B2
Application number	US-86483309-A
Country	US
Kind code	B2
Filing date	Jan 29, 2009
Priority date	Jan 29, 2008
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

An apparatus for the treatment of acid reflux disease has an implantable movement restriction device adapted to be at least partly invaginated by a patient's stomach fundus wall. 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, 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 has a size of at least 125 mm3 and a circumference of at least 15 mm.

First claim

The invention claimed is:

1. An apparatus for treating reflux disease in a human or animal mammal patient, by restricting movement of the cardia, the apparatus comprising:
an implantable movement restriction device being adapted for treating reflux disease in a human or animal mammal patient, by restricting the movement of the cardia, the implantable movement restriction device having an outer surface including a biocompatible material, the movement restriction device being adapted to rest with at least a part of its outer surface against the patient's stomach fundus wall, and being adapted to be kept in place contacting the stomach fundus wall without reducing food passage in the stomach of the patient when implanted and in function, and 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, when the movement restriction device is implanted in the patient, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax, the movement restriction device being adapted to contact directly or indirectly the diaphragm muscle to prevent such sliding of the cardia through the patient's diaphragm, so as to maintain supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen, the movement restriction device having a maximal volume of less than 200 cc,
wherein the movement restriction device is adapted to be secured to the patient's esophagus, preventing such sliding of the cardia through the patient's diaphragm by keeping the movement restriction device secured to the esophagus in said position, when the movement restriction device is implanted,
wherein the apparatus comprises an esophagus fixation device that, when implanted in the patient with the movement restriction device, is adapted to secure the movement restriction device to the esophagus close to the patient's angle of His, and
wherein the movement restriction device is adapted to be fully invaginated in at least a portion of the fundus stomach wall from an outside of the patient's stomach wall.

2. The apparatus according to claim 1 , further comprising a fundus fixation device that, when implanted in the patient, is adapted to keep the movement restriction device against or attached to the fundus wall to keep the movement restriction device in said position.

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 esophagus 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.

6. The apparatus according to claim 5 , wherein the tissue growth promoting structure further comprises sutures or staples that, when implanted in the patient, are adapted to attach the net to the fundus stomach wall.

7. The apparatus according to claim 2 , wherein the fundus fixation device or esophagus fixation device is comprised of sutures or staples, and when implanted in the patient to attach together portions of the fundus stomach wall, is adapted to keep the movement restriction device in place.

8. The apparatus according to claim 7 , wherein the movement restriction device is adapted to be invaginated in at least a portion of the fundus stomach wall from inside of the patient's stomach wall.

9. The apparatus according to claim 2 , wherein the fundus fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, are adapted to attach the fundus wall and a wall of the patient's esophagus to hold the movement restriction device in said position.

10. The apparatus according to claim 2 , further comprising a fixation device that, when implanted in the patient with the movement restriction device, is adapted to secure, indirectly or directly, the movement restriction device to the patient's diaphragm muscle or muscles associated with the diaphragm.

11. The apparatus according to claim 10 , wherein the fundus fixation device or esophagus fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, are adapted to attach the fundus wall and the diaphragm muscle or associated muscles to hold the movement restriction device in said position.

12. 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, a substantial part of an outer surface of the body being adapted to rest against the stomach wall in said position between the patient's diaphragm and a portion of a lower part of the invaginated stomach fundus wall.

13. The apparatus according to claim 12 , wherein the body is substantially egg shaped.

14. The apparatus according to claim 12 , wherein the body is substantially shaped like an egg with an indented middle section.

15. The apparatus according to claim 12 , wherein the body is substantially spherically shaped.

16. The apparatus according to claim 12 , wherein the body has rounded contours without sharp edges that would be damaging to the patient's stomach wall.

17. The apparatus according to claim 1 , wherein the movement restriction device is adapted to be invaginated by the patient's stomach fundus wall.

18. The apparatus according to claim 1 , further comprising a fluid or gel receiving member for receiving fluid to inflate the movement restriction device.

19. The apparatus according to claim 1 being adapted to be pushed or pulled through a trocar for laparoscopic use, wherein the movement restriction device comprises at least one of
a changeable form which allows the movement restriction device to pass through a laparoscopic trocar or a gastroscopic trocar or instrument,
a changeable form which allows the movement restriction device to assume a slender form having a smaller diameter than that of a trocar for laparoscopic use, whereby when changed to said slender form the movement restriction device can be pushed or pulled through the trocar,
at least one holding device adapted to be used for pushing or pulling the movement restriction device through the trocar for laparoscopic use, and
at least two separate pieces adapted to be inserted into a hollow body and further adapted to be put together to form one unitary piece inside the hollow body, thereby allowing the hollow body to pass through the trocar for laparoscopic use.

20. The apparatus according to claim 1 , wherein a wall of the movement restriction device is provided with at least one layer or coating comprising at least one of: chemically vapor deposited poly(p-xylene) polymer, polytetrafluoroethylene, and polyurethane.

21. The apparatus according to claim 1 , wherein the movement restriction device comprises a body, and wherein the apparatus is adapted to regulate a size of the body after being implanted in the patient, the body comprising an inflatable chamber and at least one of:
an injection port where the inflatable chamber of the body is filled with a fluid through the injection port,
a subcutaneously placed reservoir adapted to be connected to the inflatable chamber

Assignees

• Forsell Peter

Inventors

• Forsell Peter

Classifications

• A61F2/04 Primary

  Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95) · CPC title

• A61F5/0026

  Anti-eating devices using electrical stimulation · CPC title

• A61F5/0013

  Implantable devices or invasive measures · CPC title

• A61B17/064

  Surgical staples, {i.e. penetrating the tissue} · CPC title

• A61F5/0083 Primary

  Reducing the size of the stomach, e.g. gastroplasty (surgical interventions A61B17/00) · CPC title