# US 12,178,694 B2 · Pancreatic stent with drainage feature

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- Number: US 12,178,694 B2
- Document ID: US12178694B2
- Status: Granted
- Kind: B2
- Application number: 17/844,625
- Filed: 2022-06-20
- Published: 2022-10-06
- Granted: 2024-12-31
- Earliest claimed: 2014-10-09
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Kevin Walsh; Gary Trendel; Paul Mannion
- Web page: https://patentgrep.com/patent/US12178694B2

## CPC

- 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 2/07: Stent-grafts
- A61F 2/885: {comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis}
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)}
- A61F 2002/041: {Bile ducts}
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61F 2240/00: Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F 2240/001: Designing or manufacturing processes
- A61F 2240/005: Templates
- 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 pancreatic stent includes a main body convertible between a compressed configuration for delivery and an expanded configuration once deployed, the main body including an inner surface defining a stent lumen and an outer surface. A plurality of drainage features are formed within the outer surface of the main body, the plurality of drainage features permitting placement of the pancreatic stent within a patient's pancreas without blocking side branches of the pancreas.

## Claims

### Claim 1

A method of draining fluid from a biliary tract, the method comprising:
inserting an expandable stent into a main pancreatic duct in a first compressed configuration, wherein the stent includes a main body and at least one drainage feature formed on an outer surface of the main body, the drainage feature including a valley defined between adjacent peaks on either side of the valley; and
expanding the stent to a second expanded configuration to permit fluid exiting side branches of the biliary tract to flow along the drainage feature into the main pancreatic duct;
wherein inserting the expandable stent into the main pancreatic duct includes inserting and expanding the stent such that the stent does not block side branches of the biliary tract that are in fluid communication with the main pancreatic duct.

### Claim 2 (depends on 1)

The method of claim 1, wherein inserting the expandable stent includes delivering the stent through a duodenum and into the main pancreatic duct.

### Claim 3 (depends on 1)

The method of claim 1, wherein the drainage feature extends helically at least partially around a circumference of the main body.

### Claim 4 (depends on 3)

The method of claim 3, wherein the drainage feature extends helically around an entirety of the circumference of the main body such that portions of the drainage feature are spaced apart longitudinally along the main body.

### Claim 5 (depends on 1)

The method of claim 1, wherein the peaks extend radially outward beyond the outer surface of the main body.

### Claim 6 (depends on 5)

The method of claim 5, wherein the valley is located at a radial outward distance that is the same as the outer surface of the main body.

### Claim 7 (depends on 1)

The method of claim 1, wherein the expandable stent further comprises a covering layer disposed over the outer surface of the main body.

### Claim 8 (depends on 7)

The method of claim 7, wherein the covering layer is a polymer covering layer and conforms to the outer surface of the main body such that it defines, at least in part, the drainage feature.

### Claim 9 (depends on 8)

The method of claim 8, wherein expanding the stent includes expanding the polymer covering layer.

### Claim 10 (depends on 1)

The method of claim 1, wherein the stent is inserted and expanded such that it permits fluid exiting the side branches to flow along the drainage feature into the main pancreatic duct and then into a duodenum.

### Claim 11

A method of draining fluid from a biliary tract, the method comprising:
inserting an expandable stent into a main pancreatic duct adjacent a duodenum with the stent in a first compressed configuration, wherein the stent includes a main body, at least one drainage feature formed on an outer surface of the main body, and a covering disposed on the outer surface of the main body, the drainage feature including a valley defined between adjacent peaks on either side of the valley; and
expanding the stent to a second expanded configuration to permit fluid exiting side branches of the biliary tract to flow along the drainage feature into the main pancreatic duct and the duodenum, wherein the covering expands as the stent expands;
wherein inserting the expandable stent into the main pancreatic duct includes inserting and expanding the stent such that it does not block side branches of the biliary tract that are in fluid communication with the main pancreatic duct.

### Claim 12 (depends on 11)

The method of claim 11, wherein inserting the expandable stent includes delivering the stent through the duodenum and into the main pancreatic duct.

### Claim 13 (depends on 11)

The method of claim 11, wherein the drainage feature extends helically at least partially around a circumference of the main body.

### Claim 14 (depends on 13)

The method of claim 13, wherein the drainage feature extends helically around an entirety of the circumference of the main body such that portions of the drainage feature are spaced apart longitudinally along the main body.

### Claim 15

A method of draining fluid from a biliary tract, the method comprising:
inserting an expandable stent into a main pancreatic duct adjacent a duodenum with the stent in a first compressed configuration, wherein the stent includes a main body, at least one drainage feature formed on an outer surface of the main body, and a covering disposed on the outer surface of the main body, the drainage feature including a valley defined between adjacent peaks on either side of the valley; and
expanding the stent to a second expanded configuration to permit fluid exiting side branches of the biliary tract to flow along the drainage feature into the main pancreatic duct and the duodenum, wherein the covering expands as the stent expands;
wherein the expandable stent includes a braided metal stent forming a high-low pattern in at least some adjoining windings, wherein the high-low pattern defines the valley between adjacent first and second peaks on either side of the valley; and
wherein the drainage feature extends helically at least partially around a circumference of the main body.

### Claim 16 (depends on 15)

The method of claim 15, wherein the braided metal stent includes a first, a second, and a third wire, the first wire following the first peak at least partially around the circumference of the main body, the second wire following the second peak at least partially around the circumference of the main body, and the third wire following the valley at least partially around the circumference of the main body.

### Claim 17 (depends on 15)

The method of claim 15, wherein the first and second peaks extend radially outward beyond the outer surface of the main body.

### Claim 18 (depends on 17)

The method of claim 17, wherein the valley is located at a radial outward distance that is the same as the outer surface of the main body.
