# US 7,815,589 B2 · Methods and apparatus for anchoring within the gastrointestinal tract

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 7,815,589 B2
- Document ID: US7815589B2
- Status: Granted
- Kind: B2
- Application number: 10/858,852
- Filed: 2004-06-01
- Published: 2005-06-09
- Granted: 2010-10-19
- Earliest claimed: 2003-12-09
- Assignees: GI Dynamics, Inc.
- Inventors: John C. Meade; Andy H. Levine; David A. Melanson; John F. Cvinar
- Web page: https://patentgrep.com/patent/US7815589B2

## CPC

- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- 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)
- A61F 2/848: having means for fixation to the vessel wall, e.g. barbs
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61B 17/12: for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B 2017/0419: {H-fasteners}
- A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle}
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2002/045: {Stomach, intestines}
- A61F 2002/8483: {Barbs}
- A61F 2002/91541: {Adjacent bands are arranged out of phase}
- A61F 2002/91558: {connected peak to peak}
- A61F 2002/9511: {the retaining means being filaments or wires}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0058: soldered or brazed or welded
- A61F 2220/0066: stapled
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.

## Claims

### Claim 1

A gastrointestinal implant device comprising:
an unsupported, flexible sleeve, open at both ends, and adapted to extend into the intestine; and
a wave anchor coupled to a proximal portion of the sleeve, the wave anchor having only a single wave in only a single revolution formed of an elongated resilient member, the single wave having an axial length within a range of about 25 millimeters to about 50 millimeters, the wave anchor defining a central lumen and accommodating a diameter of an adult human's intestine of about 45 millimeters, and the wave anchor being adapted for attachment within an animal body,
there being no wave of elongated resilient member in the gastrointestinal implant device other than said single wave.

### Claim 2 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the wave anchor is adapted for attachment in the intestine.

### Claim 3 (depends on 2)

The gastrointestinal implant device of claim 2, wherein the wave anchor is adapted for attachment in the duodenum.

### Claim 4 (depends on 2)

The gastrointestinal implant device of claim 2, wherein the wave anchor is adapted for attachment in the duodenal bulb.

### Claim 5 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the wave anchor is adapted for removable attachment in the intestine.

### Claim 6 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the elongated resilient member is formed about a central axis of the central lumen, the resilient member defining an oscillating pattern about the central axis alternating between proximal and distal ends of the wave anchor.

### Claim 7 (depends on 6)

The gastrointestinal implant device of claim 6, wherein the wave pattern has at least four oscillations.

### Claim 8 (depends on 6)

The gastrointestinal implant device of claim 6, wherein the resilient member comprises a material selected from the group consisting of: metals, alloys, plastics, and combinations thereof.

### Claim 9 (depends on 6)

The gastrointestinal implant device of claim 6, wherein the resilient member comprises a super elastic alloy.

### Claim 10 (depends on 9)

The gastrointestinal implant device of claim 9, wherein the super elastic alloy is a Nickel-Titanium alloy.

### Claim 11 (depends on 6)

The gastrointestinal implant device of claim 6, wherein the elongated resilient member includes a plurality of filaments.

### Claim 12 (depends on 11)

The gastrointestinal implant device of claim 11, wherein some of the plurality of filaments have different physical properties.

### Claim 13 (depends on 6)

The gastrointestinal implant device of claim 6, wherein the resilient member comprises a first length having an associated physical property and a second length having a different associated physical property.

### Claim 14 (depends on 13)

The gastrointestinal implant device of claim 13, wherein the physical property is resiliency.

### Claim 15 (depends on 13)

The gastrointestinal implant device of claim 13, wherein the physical property is thickness.

### Claim 16 (depends on 13)

The gastrointestinal implant device of claim 13, wherein the physical property is cross-sectional profile.

### Claim 17 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the axial length is between about 31.25 millimeters and about 37.5 millimeters.

### Claim 18 (depends on 1)

The gastrointestinal implant device of claim 1, further comprising a feature for attaching the wave anchor within a natural lumen of the gastrointestinal tract.

### Claim 19 (depends on 18)

The gastrointestinal implant device of claim 18, wherein the feature for attaching is selected from the group consisting of: mechanical fasteners, chemical fasteners, and combinations thereof.

### Claim 20 (depends on 19)

The gastrointestinal implant device of claim 19, wherein the chemical fastener includes a surgical adhesive.

### Claim 21 (depends on 18)

The gastrointestinal implant device of claim 18, wherein the feature for attaching is selected from the group consisting of: barbs, sutures, staples, and combinations thereof.

### Claim 22 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the implant device is attached using a first plurality of barbs.

### Claim 23 (depends on 22)

The gastrointestinal implant device of claim 22, wherein each of the plurality of barbs comprises an elongated member, attached at one end to the wave anchor, the other end extending generally outward from the central axis, the barb sized to engage muscular tissue of the surrounding intestine.

### Claim 24 (depends on 22)

The gastrointestinal implant device of claim 22, wherein the plurality of barbs are erodible.

### Claim 25 (depends on 22)

The gastrointestinal implant device of claim 22, wherein the first plurality barbs are axially distributed and located substantially at one of the ends of the device.

### Claim 26 (depends on 25)

The gastrointestinal implant device of claim 25, further comprising a second plurality of axially-distributed barbs located between the first plurality of barbs and the other end of the device.

### Claim 27

A gastrointestinal implant device comprising:
an unsupported, flexible sleeve, open at both ends, and adapted to extend into the intestine; and
an anchor coupled to a proximal portion of the sleeve, the anchor adapted for engaging a wall of a gastrointestinal tract within an animal body, the anchor having only a single annular wave pattern formed of an elongated resilient member in only a single revolution about a central axis, and the annular wave pattern defining an oscillating pattern about the central axis alternating between first and second axial ends of the anchor, the first and second axial ends being separated by an axial length that is within a range of about 25 millimeters and about 50 millimeters, the anchor defining a central lumen and accommodating a diameter of an adult human's intestine of about 45 millimeters.

### Claim 28

A gastrointestinal implant device comprising:
flexible sleeve means, open at both ends, for extending into the intestine of an animal body; and
wave anchor means for attaching a proximal portion of the sleeve within the animal body, the wave anchor means having only a single wave in only a single revolution of an elongated resilient member, the single wave having an axial length of within a range of about 25 millimeters and about 50 millimeters, the wave anchor defining a central lumen and accommodating a diameter of an adult human's intestine of about 45 millimeters,
there being no wave of elongated resilient member in the gastrointestinal implant device other than said single wave.
