Apparatus for treating GERD

• US 11,090,179 B2
• Filed: 10/12/2009
• Issued: 08/17/2021
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US13/123,261
• Publication Number:
  US 20110196391A1
• Time in Patent Office: 4,327 Days
• Field of Search: 606139, 606144-148, 606151, 606153, 606191, 606192, 600 37, 623 2364, 623 2365, 623 2367, 446120, 446122, 446123-128, 63 9, 63 153, 63 39
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00827 : Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/308 : with suction cups
• CPC Class Codes: A61F 2/04 : Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 : Stomach, intestines
• CPC Class Codes: A61F 2005/0016 : comprising measuring means
• CPC Class Codes: A61F 2005/002 : for sensing mechanical parameters
• CPC Class Codes: A61F 2005/0023 : for sensing chemical parameters
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 : adjustable
• CPC Class Codes: A61F 5/0003 : Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0013 : Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0026 : Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/003 : inflatable
• CPC Class Codes: A61F 5/0033 : with more than one chamber
• CPC Class Codes: A61F 5/0036 : Intragastrical devices
• CPC Class Codes: A61F 5/004 : remotely adjustable
• CPC Class Codes: A61F 5/0043 : using injection ports
• CPC Class Codes: A61F 5/0046 : with wireless means
• CPC Class Codes: A61F 5/005 : Gastric bands
• CPC Class Codes: A61F 5/0063 : wrapping the stomach
• CPC Class Codes: A61F 5/0069 : in the wall of the stomach
• CPC Class Codes: A61F 5/0073 : in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 : Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0083 : Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The present invention relates to a reflux disease treatment apparatus, comprising an implantable movement restriction device with an elongated shape that maintains cardia in the correct position and an implantable stimulation device adapted to engage with the cardia sphincter of a patient. The movement has proximal and a distal end, wherein the distal end is adapted to stabilize and hold the distal end. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The distal end can be further adapted to treat obesity, for example by stretching the wall of the stomach or filling out a volume of the stomach.

Claims

1. An apparatus for treating reflux disease in a patient, comprising at least a first, a second and a third segment adapted to be assembled into an implantable movement restriction device having a size and shape allowing it to be completely invaginated by a wall portion of the fundus of the stomach of the patient, 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, wherein the first, second and third segments comprises interconnecting recesses and protrusions configured to fixate the first, second and third segments to each other by means of form fitting between the interconnecting recesses and protrusions so as to form the implantable movement restriction device,

wherein the assembled implantable movement restriction device has an outer surface for resting against the wall portion of the fundus of the stomach of the patient, wherein the outer surface has an elliptical point.

2. The apparatus according to claim 1, wherein the implantable movement restriction device is an elongated movement restriction device having a distal invaginated part and a proximal part, and wherein the distal invaginated part of the elongated movement restriction device has sufficient length to stabilize the proximal part of the elongated movement restriction device to prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax.

3. The apparatus according to claim 2, wherein a circumference of the distal invaginated part of the elongated movement restriction device is sufficient to stabilize the proximal part of the elongated movement restriction device to prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax.

4. The apparatus according to claim 2, wherein the proximal part of the movement restriction device has a size of at least 125 mm³ and a circumference of at least 15 mm.

5. The apparatus according to claim 2, wherein the apparatus further comprises a second fixation device that, when implanted in the patient with the proximal part of the movement restriction device, secures, indirectly or directly, the movement restriction device to the oesophagus close to the patient'"'"'s angle of His.

6. The apparatus according to claim 5, 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 oesophagus to hold the movement restriction device in place.

7. The apparatus according to claim 5, wherein the apparatus further comprises a third fixation device that, when implanted in the patient with the proximal part of the movement restriction device, secures, indirectly or directly, the movement restriction device to the patient'"'"'s diaphragm muscle or other muscle tissue.

8. The apparatus according to claim 7, 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 other muscle tissue to hold the movement restriction device in place.

9. The apparatus according to claim 2, wherein the proximal part of the movement restriction device comprises a body adapted to be invaginated by the patient'"'"'s stomach fundus wall and having an outer surface that includes a biocompatible material, a part of the outer surface of the body being adapted to rest against the stomach wall between the patient'"'"'s diaphragm and a portion of a lower part of the invaginated stomach fundus wall.

10. The apparatus according to claim 9, wherein the body has a substantially curved shape.

11. The apparatus according to claim 2, wherein the proximal and distal invaginated part together form a curved elongated device adapted to be implanted substantially parallel to a food passageway and further adapted to be invaginated in the stomach wall substantially perpendicular to an elongated extension.

12. The apparatus according to claim 2, comprising

electronics, or an energy source, or electronics and an energy source, said electronics, or energy source, or electronics and energy source being enclosed within the proximal part, distal invaginated part, or both proximal and distal invaginated parts.

13. The apparatus according to claim 1, wherein the apparatus further comprises a tissue growth promoting structure for long term attachment of the implantable movement restriction device to the stomach wall.

14. The apparatus according to claim 13, wherein the tissue growth promoting structure comprises a net like structure.

15. The apparatus according to claim 14, 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.

16. The apparatus according to claim 1, wherein the apparatus further comprises a fixation device further comprising 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 place.

17. The apparatus according to claim 16, wherein the sutures or staples, 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.

18. The apparatus according to claim 16, wherein the sutures or staples, when implanted in a patient with the movement restriction device, attach together portions of the fundus stomach wall so as to invaginate the movement restriction device from inside of the patient'"'"'s stomach wall.

19. The apparatus according to claim 16, wherein the sutures or staples attach together portions of the fundus stomach wall so as to invaginate the movement restriction device from outside of the patient'"'"'s stomach wall.

20. An apparatus for treating reflux disease in a patient, comprising at least a first and a second segment adapted to be assembled into an implantable movement restriction device having a size and shape allowing it to be completely invaginated by a wall portion of the fundus of the stomach of the patient, 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, wherein the first and second segments comprise interconnecting recesses and protrusions configured to fixate the first and second segments to each other by means of form fitting between the interconnecting recesses and protrusions so as to form the implantable movement restriction device,

wherein the assembled implantable movement restriction device has an outer surface for resting against the wall portion of the fundus of the stomach of the patient, wherein the outer surface has an elliptical point.