# US 12,213,869 B2 · Method for treating reflux disease

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- Number: US 12,213,869 B2
- Document ID: US12213869B2
- Status: Granted
- Kind: B2
- Application number: 18/221,911
- Filed: 2023-07-14
- Published: 2024-01-25
- Granted: 2025-02-04
- Earliest claimed: 2008-01-29
- Applicants: Peter Forsell
- Inventors: Peter Forsell
- Web page: https://patentgrep.com/patent/US12213869B2

## CPC

- A61F 5/0083: {Reducing the size of the stomach, e.g. gastroplasty (surgical interventions A61B17/00)}
- A61B 1/32: Devices for opening or enlarging the visual field, e.g. of a tube of the body
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61F 2/04: 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)
- A61B 1/04: combined with photographic or television appliances
- A61B 1/06: with illuminating arrangements
- A61B 1/2736: {Gastroscopes}
- A61B 1/3132: {for laparoscopy}
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- 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}
- A61B 17/30: Surgical pincettes, i.e. surgical tweezers {without pivotal connections (for holding suture needles or materials A61B17/0483)}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/3474: {Insufflating needles, e.g. Veress needles}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00278: {Transorgan operations, e.g. transgastric}
- A61B 2017/00561: {creating a vacuum}
- A61B 2017/00818: {Treatment of the gastro-intestinal system}
- A61B 2017/00827: {Treatment of gastro-esophageal reflux}
- A61B 2017/081: {Tissue approximator (A61B2017/1103, A61B17/8866 take precedence)}
- A61B 2017/306: {holding by means of suction}
- A61B 2017/308: {with suction cups}
- 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)}
- A61F 5/0013: {Implantable devices or invasive measures}
- A61F 5/0026: {Anti-eating devices using electrical stimulation}
- A61F 5/003: {inflatable}
- A61F 5/0033: {with more than one chamber}
- A61F 5/0036: {Intragastrical devices}
- A61F 5/004: {remotely adjustable}
- A61F 5/0043: {using injection ports}
- A61F 5/0046: {with wireless means}
- A61F 5/005: {Gastric bands}
- A61F 5/0063: {wrapping the stomach}
- A61F 5/0069: {in the wall of the stomach}
- A61F 5/0073: {in the abdominal cavity, e.g. not attached to the stomach}
- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- A61F 5/0079: {Pyloric or esophageal obstructions}
- A61F 5/0086: {using clamps, folding means or the like}
- A61F 5/0089: {Instruments for placement or removal}
- A61F 2002/044: {Oesophagi or esophagi or gullets}
- A61F 2002/045: {Stomach, intestines}
- A61F 2005/0016: {comprising measuring means}
- A61F 2005/002: {for sensing mechanical parameters}
- A61F 2005/0023: {for sensing chemical parameters}
- A61F 2250/0001: Means for transferring electromagnetic energy to implants
- A61F 2250/0004: adjustable
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The present invention relates to a reflux disease treatment apparatus, apparatus, comprising an implantable movement restriction device that maintains cardia in the correct position and an implantable stimulation device adapted to engage with the cardia sphincter of a patient. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The invention can be combined with various methods for treating obesity, in particular methods that creates satiety by stretching the wall of the stomach or fills out a volume of the stomach.

## Claims

### Claim 1

A method of treating a reflux disease in a patient by implanting a movement restriction device, the method comprising the steps of:
affixing the stomach fundus wall to the patient's esophagus;
introducing the movement restriction device into the body of the patient; and
affixing the movement restriction device against the stomach fundus wall of the patient;
thereby restricting movement of the cardiac notch of the patient's stomach in relation to the patient's diaphragm muscle, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax.

### Claim 2 (depends on 1)

The method according to claim 1, wherein affixing the movement restriction device against said stomach fundus wall is achieved by suturing or stapling of stomach fundus wall tissue.

### Claim 3 (depends on 1)

The method according to claim 1, wherein affixing the stomach fundus wall to the patient's esophagus is achieved by suturing or stapling.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the stomach fundus wall is affixed to a lower portion of the patient's esophagus.

### Claim 5 (depends on 1)

The method according to claim 1, further comprising providing an apparatus for regulating the movement restriction device and operating said apparatus to regulate the movement restriction device.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the movement restriction device comprises a filling body, wherein regulation of the movement restriction device includes changing a volume of the filling body when implanted.

### Claim 7 (depends on 6)

The method according to claim 6, comprising providing a syringe for injecting a volume of fluid into the filling body.

### Claim 8 (depends on 1)

The method according to claim 1, comprising a step of creating a pouch comprising stomach fundus wall tissue of the patient and invaginating the movement restriction device in said pouch to thereby fully enclose the device in the pouch.

### Claim 9 (depends on 1)

The method according to claim 1, comprising a step of creating a pouch comprising stomach fundus wall tissue and invaginating the movement restriction device in said pouch wherein the step of creating the pouch and invaginating the movement restriction device in the pouch comprises invaginating the movement restriction device such that the movement restriction device is not fully enclosed in the pouch, wherein the pouch is at least partly open comprising at least one of the method steps of:
creating a pouch that exhibits only one opening, and
creating a pouch that exhibits two openings and extends non-circumferentially around the stomach.

### Claim 10 (depends on 9)

The method according to claim 9, wherein a volume of the pouch is more than 15 milliliters.

### Claim 11 (depends on 1)

The method according to claim 1, comprising:
placing the movement restriction device on an outside of the stomach fundus wall of the patient;
creating a pouch comprising stomach fundus wall tissue for the movement restriction device; and
invaginating the movement restriction device in the pouch;
and wherein the method step of affixing the movement restriction device against said stomach fundus wall is achieved by suturing or stapling of stomach fundus wall tissue.

### Claim 12 (depends on 1)

The method according to claim 1, comprising:
placing the movement restriction device on an inside of the stomach fundus wall of the patient;
creating a pouch comprising stomach fundus wall tissue for the movement restriction device; and
invaginating the movement restriction device in the pouch;
and wherein the method step of affixing the movement restriction device against said stomach fundus wall is achieved by suturing or stapling of stomach fundus wall tissue.

### Claim 13 (depends on 1)

The method of treating reflux disease according to claim 1, wherein the step of affixing the movement restriction device against the stomach fundus wall comprises the steps of:
using a first fixation device comprising a tissue growth promoting structure for
attachment of the movement restriction device to the stomach fundus wall, and
suturing the first fixation device to the stomach fundus wall with a contact surface towards the stomach fundus wall.

### Claim 14 (depends on 13)

The method of treating reflux disease according to claim 13, wherein the tissue growth promoting structure for attachment of the movement restriction device to the stomach fundus wall comprises a net and sutures or staples that attach the net to the stomach fundus wall, wherein the method further comprises the step of:
suturing or stapling the net to the stomach fundus wall, thereby allowing by the net in-growth of human tissue for holding the movement restriction device in place against the stomach fundus wall.