# US 2021/0220159 A1 · Devices and methods for placing a gastrointestinal device

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- Number: US 2021/0220159 A1
- Document ID: US20210220159A1
- Status: Published application
- Kind: A1
- Application number: 17/103,522
- Filed: 2020-11-24
- Published: 2021-07-22
- Earliest claimed: 2015-02-13
- Assignees: GI Dynamics, Inc.
- Applicants: GI Dynamics, Inc.
- Inventors: James LOPER; Ryan HANLON; Andres CHAMORRO, III
- Web page: https://patentgrep.com/patent/US20210220159A1

## CPC

- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- A61F 5/0089: {Instruments for placement or removal}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/013: {One-way gripping collars}
- A61M 25/0136: {Handles therefor}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract comprises a container assembly; a gastrointestinal implant device that includes proximal and distal ends stored within the container assembly, the proximal end including an anchor and the distal end including a sleeve, coupled to the anchor and folded into the container assembly; and an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein. The inner extension comprises an atraumatic tip, such as a ball, that includes a guidewire rail. Further, a handle is provided that retains or captures an inner catheter within the handle. Within the handle is an elongated element that surrounds a portion of the catheter. A button on a side of the handle is configured to cause engagement of the catheter via the element when the button is depressed.

## Claims

### Claim 1

A catheter handle for a delivery system of a gastrointestinal device, the catheter handle comprising:
an inner catheter movable within the handle;
an elongated element within the handle, the element surrounding a portion of the inner catheter, an inner diameter of the element being about the same as or greater than an outer diameter of the inner catheter; and
a button on a side of the handle, the button configured to cause engagement of the inner catheter via the element when the button is depressed, thereby retaining the inner catheter within the handle.

### Claim 2 (depends on 1)

The catheter handle of claim 1, wherein the elongated element includes slots and the button includes ramped teeth aligned with the slots, and wherein the button is configured to cause the ramped teeth to engage the inner catheter via the slots when the button is depressed and press the inner catheter against the element, thereby retaining the inner catheter within the handle.

### Claim 3 (depends on 2)

The catheter handle of claim 2, wherein the slots are transverse slots spaced along a length of the elongated element on two sides of the element.

### Claim 4 (depends on 3)

The catheter handle of claim 3, wherein the slots on one side of the elongated element are offset from the slots on the other side of the element.

### Claim 5 (depends on 4)

The catheter handle of claim 4, wherein the slots are ramped, and wherein the ramped teeth and ramped slots define multiple complementary features.

### Claim 6 (depends on 1)

The catheter handle of claim 1, further including a resilient element configured to non-plastically deform when the button is depressed and to provide a restoring force to cause the ramped teeth to disengage the inner catheter when the button is released.

### Claim 7 (depends on 1)

The catheter handle of claim 1, wherein the elongated element is a surround tube, and wherein the button is configured to bend the surround tube and non-plastically deform the inner catheter when the button is depressed, thereby retaining the inner catheter within the handle.

### Claim 8 (depends on 7)

The catheter handle of claim 7, wherein:
(a) the surround tube comprises a silicone tube,
(b) the button comprises a rigid thermoplastic, and/or
(c) the button bends the surround tube between ends of the surround tube, the ends being held in place by the handle.

### Claim at position 9

9-10. (canceled)

### Claim 11 (depends on 1)

The catheter handle of claim 1, wherein the elongated element is a lever including a lever jaw, and wherein the button is configured to cause the lever to rotate about a pivot and the lever jaw to engage the inner catheter when the button is depressed, thereby retaining the inner catheter within the handle.

### Claim 12 (depends on 11)

The catheter handle of claim 11, wherein:
(a) the lever defines a lumen through which the inner catheter extends;
(b) the lever is configured to translate a force with which the button is depressed into a force with which the inner catheter is engaged at an amplification ratio in the range of about 1:1 to about 2:1; and/or
(c) the lever jaw includes directional teeth; and/or further including a resilient element configured to non-plastically deform when the button is depressed and to provide a restoring force to cause the lever jaw to disengage the inner catheter when the button is released.

### Claim at position 12

13-15. (canceled)

### Claim 16 (depends on 1)

The catheter handle of claim 1, wherein the inner catheter comprises an inner extension catheter configured to draw a portion of a sleeve from an anchor and from a container assembly as the anchor is retained therein.

### Claim 17

A method of retaining an inner catheter for delivery of a gastrointestinal device, the method comprising:
surrounding a portion of an inner catheter that is movably disposed within a handle with an elongated element within the handle;
depressing a button on a side of the handle, to engage the inner catheter via the elongated element; and
retaining the inner catheter within the handle based on the resulting engagement of the inner catheter.

### Claim 18 (depends on 17)

The method of claim 17, wherein:
(a) the elongated element includes slots and the button includes ramped teeth aligned with the slots, and wherein depressing the button causes the ramped teeth to engage the inner catheter via the slots and press the inner catheter against the element;
(b) the elongated element is a surround tube, and wherein depressing the button bends the surround tube and non-plastically deforms the inner catheter;
(c) the elongated element is a lever including a lever jaw, and wherein depressing the button causes the lever to rotate about a pivot and the jaw of the lever to engage the inner catheter; and/or
(d) the method further comprising advancing the inner catheter retained within the handle into a lumen of an outer catheter.

### Claim at position 16

19-21. (canceled)

### Claim 22 (depends on 18)

The method of claim 18, further comprising drawing a portion of a sleeve from an anchor, and from a container assembly, as the anchor is retained therein, using the inner catheter.

### Claim at position 18

23-24. (canceled)

### Claim 25

A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract, the system comprising:
a container assembly;
a gastrointestinal implant device that includes a proximal end and a distal end stored within the container assembly, the proximal end including an anchor and the distal end including a floppy sleeve, coupled to the anchor and folded into the container assembly; and
an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein;
the inner extension comprising an atraumatic tip that comprises a guidewire rail.

### Claim 26 (depends on 25)

The delivery system of claim 25, wherein:
(a) the inner extension comprises a catheter releasably secured to the distal end of the sleeve,
(b) the atraumatic tip comprises a ball; and/or
(c) the guidewire rail comprises a channel that runs within the interior of the atraumatic tip.

### Claim at position 21

27-28. (canceled)

### Claim 29 (depends on 26)

The delivery system of claim 26, wherein the guidewire rail runs from a distal center of the atraumatic tip to a proximal off-center side of the atraumatic tip.

### Claim 30

A method for placing a gastrointestinal device in a mammalian gastrointestinal tract, the method comprising:
guiding a delivery system over a guidewire within the gastrointestinal tract by advancing an atraumatic tip over the guidewire as the guidewire runs through a guidewire rail of the atraumatic tip; and
drawing the gastrointestinal device out of a container assembly using an inner extension from the container assembly, the inner extension comprising the atraumatic tip at a distal end of the inner extension.

### Claim 31 (depends on 30)

The method of claim 30, wherein:
(a) the inner extension comprises a catheter releasably secured to the distal end of the gastrointestinal device;
(b) the atraumatic tip comprises a ball; and/or
(c) the guidewire rail comprises a channel that runs within the interior of the atraumatic tip.

### Claim at position 25

32-33. (canceled)

### Claim 34 (depends on 31)

The method of claim 31, wherein the guidewire rail runs from a distal center of the atraumatic tip to a proximal off-center side of the atraumatic tip.