# US 11,432,821 B2 · Arterial-venous occlusion apparatus

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- Number: US 11,432,821 B2
- Document ID: US11432821B2
- Status: Granted
- Kind: B2
- Application number: 15/064,415
- Filed: 2016-03-08
- Published: 2016-09-15
- Granted: 2022-09-06
- Earliest claimed: 2015-03-09
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Patrick Haverkost; Joel Groff; Kent Harrison; Joseph Connolly; Gary Pederson; Mary-Claire Anderson; David Raab
- Web page: https://patentgrep.com/patent/US11432821B2

## CPC

- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/12109: {in a blood vessel}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/00867: {shape memory effect}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Expandable occlusive plugs and methods of using them are disclosed. The devices generally include a tubular body bearing multiple slits defining leaves, which expand radially outward when the ends of the device are brought toward one another.

## Claims

### Claim 1

A system for treating a patient, the system comprising:
a tubular body having a sidewall, the sidewall including a plurality of cuts about a circumference thereof, each of the plurality of cuts extending longitudinally and radially along a portion of a length of the sidewall, the tubular body further comprising at least two circumferential regions defined by termini of the plurality of cuts,
wherein the tubular body is configured to move between an elongated configuration characterized by a first distance between the circumferential regions and a deployed configuration in which the circumferential regions are separated by a second distance less than the first distance, such that a plurality of portions of the sidewall radially between the plurality of cuts of a first of the at least two circumferential regions are buckled or bent and displaced radially outward to define a first plurality of leaves and a plurality of portions of the sidewall radially between the plurality of cuts of a second of the at least two circumferential regions are buckled or bent and displaced radially outward to define a second plurality of leaves, wherein, in the deployed configuration, each leaf of the first plurality of leaves has a degree of twist in a first orientation and each leaf of the second plurality of leaves has a degree of twist in a second orientation, the first orientation being substantially opposite to the second orientation; and
a plurality of fibers configured to promote clotting coupled to and extending proximally from a proximal end of the tubular body when the tubular body is in the deployed configuration.

### Claim 2 (depends on 1)

The system of claim 1, wherein the sidewall includes a shape memory material.

### Claim 3 (depends on 1)

The system of claim 1, wherein the tubular body assumes the elongated configuration when radially constrained within a catheter, and assumes the deployed configuration when unconstrained.

### Claim 4 (depends on 1)

The system of claim 1, wherein each fiber of the plurality of fibers is coupled to a corresponding portion of the plurality of portions of the sidewall radially between the plurality of cuts.

### Claim 5 (depends on 1)

The system according to claim 1, further comprising a membrane covering at least a portion of the tubular body.

### Claim 6 (depends on 5)

The system according to claim 5, wherein the membrane defines at least one discoid shape when the tubular body is in the deployed configuration.

### Claim 7 (depends on 5)

The system according to claim 5, wherein the membrane covers one or both of the first or second plurality of leaves.

### Claim 8 (depends on 7)

The system according to claim 7, wherein the membrane includes a slit.

### Claim 9 (depends on 5)

The system according to claim 5, wherein the membrane is a polymer applied to the tubular body by one of dip coating, spray coating, or application of heat to a heat-shrink tubing.

### Claim 10

A system for treating a patient, the system comprising:
a tubular body having a sidewall, the sidewall including a plurality of cuts about a circumference thereof, each of the plurality of cuts extending longitudinally and radially along a portion of a length of the sidewall, the tubular body further comprising at least two circumferential regions defined by termini of the plurality of cuts;
a guidewire;
a microcatheter; and
a plurality of fibers configured to promote clotting coupled to and extending proximally from a proximal end of the tubular body;
wherein:
(a) the tubular body is configured to move between an elongated configuration characterized by a first distance between the circumferential regions and a deployed configuration in which the circumferential regions are separated by a second distance less than the first distance, such that a plurality of portions of the sidewall radially between the plurality of cuts of a first of the at least at least two circumferential regions are buckled or bent and displaced radially outward to define a first plurality of leaves, and a plurality of portions of the sidewall radially between the plurality of cuts of a second of the at least two circumferential regions are buckled or bent and displaced radially outward to define a second plurality of leaves, wherein, in the deployed configuration, each leaf of the first plurality of leaves has a degree of twist in a first orientation and each leaf of the second plurality of leaves has a degree of twist in a second orientation, the first orientation being substantially opposite to the second orientation,
(b) the guidewire has an outer diameter less than an inner diameter of a lumen defined by the tubular body in the elongated configuration,
(c) the microcatheter has an inner diameter greater than an outer diameter of the tubular body in the elongated configuration but less than an outer diameter of the tubular body in the deployed configuration;
(d) the plurality of fibers extends from the proximal end of the tubular body when the tubular body is in the deployed configuration.

### Claim 11 (depends on 10)

The system according to claim 10, further comprising a pushrod slidably disposed within the microcatheter and having an outer diameter greater than an inner diameter defined by the tubular body in the elongated configuration.

### Claim 12 (depends on 11)

The system according to claim 11, wherein the tubular body includes a structure sized and shaped to interlock with a structure on the pushrod.

### Claim 13 (depends on 10)

The system of claim 10, wherein each fiber of the plurality of fibers is coupled to a corresponding portion of the plurality of portions of the sidewall radially between the plurality of cuts.

### Claim 14

A method of treating a patient, comprising:
inserting a system into the patient, the system comprising:
a tubular body having a sidewall, the sidewall including a plurality of cuts about a circumference thereof, each of the plurality of cuts extending longitudinally and radially along a portion of a length of the sidewall, the tubular body further comprising at least two circumferential regions defined by termini of the plurality of cuts, and a plurality of fibers configured to promote clotting coupled to and extending proximally from a proximal end of the tubular body;
wherein the tubular body is configured to move between an elongated configuration characterized by a first distance between the circumferential regions and a deployed configuration in which the circumferential regions are separated by a second distance less than the first distance, such that a plurality of portions of the sidewall radially between the plurality of cuts of a first of the at least two circumferential regions are buckled or bent and displaced radially outward to define a first plurality of leaves, and
a plurality of portions of the sidewall radially between the plurality of cuts of a second of the at least two circumferential regions are buckled or bent and displaced radially outward to define a second plurality of leaves, wherein, in the deployed configuration, each leaf of the first plurality of leaves has a degree of twist in a first orientation and each leaf of the second plurality of leaves has a degree of twist in a second orientation, the first orientation being substantially opposite to the second orientation;
wherein the plurality of fibers extends from the proximal end of the tubular body when the tubular body is in the deployed configuration.

### Claim 15 (depends on 14)

The method of claim 14, wherein the step of inserting the system into the patient comprises the steps of:
inserting the tubular body, in the elongated configuration, through a microcatheter into a body lumen of the patient; and
advancing the tubular body through a distal opening in the microcatheter, wherein the tubular body assumes the deployed configuration when advanced outside the microcatheter.

### Claim 16 (depends on 15)

The method of claim 15, wherein the system includes a guidewire and a pushrod, and wherein the tubular body is advanced over the guidewire and through the microcatheter.

### Claim 17 (depends on 16)

The method of claim 16, wherein the tubular body is advanced through the distal opening in the microcatheter by retracting the microcatheter over the tubular body and pushrod.

### Claim 18 (depends on 16)

The method of claim 16, wherein the tubular body is advanced through the distal opening in the microcatheter by advancing the pushrod toward the distal opening.

### Claim 19 (depends on 16)

The method of claim 16, further comprising a step of inserting an implant in the body lumen adjacent to the tubular body.

### Claim 20 (depends on 19)

The method of claim 19, wherein the implant is a second tubular member, an embolic coil, an embolic particle, a liquid embolic, or a material comprising a radioisotope, or some combination thereof.
