# US 2014/0194902 A1 · Systems and methods for attaching a prosthesis within a body lumen or hollow organ

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- Number: US 2014/0194902 A1
- Document ID: US20140194902A1
- Status: Published application
- Kind: A1
- Application number: 14/210,683
- Filed: 2014-03-14
- Published: 2014-07-10
- Earliest claimed: 2001-11-28
- Assignees: Aptus Endosystems, Inc.
- Applicants: Aptus Endosystems, Inc.
- Inventors: Lee Bolduc; Phil Houle
- Web page: https://patentgrep.com/patent/US20140194902A1

## CPC

- A61B 17/10: for applying or removing wound clamps {, e.g. containing only one clamp or staple (A61B17/076 takes precedence; containing multiple wound clamps A61B17/068)}; Wound clamp magazines
- 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 17/08: 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 17/115: Staplers for performing anastomosis, e.g. in a single operation
- A61F 2/07: Stent-grafts
- A61B 17/083: {Clips, e.g. resilient}
- A61B 2017/0649: {Coils or spirals}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61F 2/848: having means for fixation to the vessel wall, e.g. barbs
- A61F 2/89: the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61F 2002/075: {the stent being loosely attached to the graft material, e.g. by stitching}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2250/0017: differing in yarn density
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.

## Claims

### Claim at position 1

1-20. (canceled)

### Claim 21

A tool for applying an implantation force to a fastener sized and configured for implantation in tissue in response to an implantation force applied according to prescribed conditions, the tool comprising:
a tool body;
a driven member carried by the tool body and being operable to apply the implantation force;
a mechanism on the driven member to couple the fastener to the driven member to transfer the implantation force from the driven member to the fastener; and
a controller coupled to the driven member, the controller including:
an initial phase operating the driven member to apply the implantation force under conditions than are short of the prescribed conditions;
a lull phase commencing at the end of the initial phase interrupting operation of the driven member;
a final phase operating the driven member under conditions that supplement the conditions of the initial phase to achieve the prescribed conditions,
the controller requiring, after the initial phase, a prescribed command to advance from the lull phase to the final phase.

### Claim 22 (depends on 21)

The tool of claim 21, wherein the prescribed command is based, at least in part, upon input from an operator.

### Claim 23 (depends on 21)

The tool of claim 21, wherein the prescribed command is based, at least in part, upon input reflecting a sensed operating condition.

### Claim 24 (depends on 21)

The tool of claim 21, wherein:
the driven member is operable to apply a removal force to withdraw the fastener from tissue; and
the controller includes a removal phase operating the driven member to apply the removal force, the controller requiring, after the initial phase, a different prescribed command to advance from the lull phase to the removal phase.

### Claim 25 (depends on 24)

The tool of claim 24, wherein the driven member is rotated in one direction to apply the implantation force and rotated in an opposite direction to apply the removal force.

### Claim 26 (depends on 21)

The tool of claim 21, further comprising an element tethering the fastener to the tool body, the element comprising a frangible portion.

### Claim 27 (depends on 21)

The tool of claim 21, wherein the driven member is rotated to apply the implantation force.

### Claim 28 (depends on 21)

The tool of claim 21, wherein the tool body comprises a tubular member that carries the driven member and the mechanism.

### Claim 29 (depends on 21)

The tool of claim 21, wherein:
the tool body comprises internal threads and the fastener comprises a helical fastener; and
a proximal portion of the helical fastener is retained within the internal threads at the end of the initial phase.

### Claim 30 (depends on 21)

The tool of claim 21, wherein the mechanism comprises a distal portion having a configuration that corresponds to a configuration of a proximal end of the fastener, such that the proximal end of the fastener engages with the distal portion of the mechanism to couple the fastener to the mechanism throughout the initial phase.

### Claim 31 (depends on 30)

The tool of claim 30, wherein the proximal end of the fastener comprises a leg portion that engages with the distal portion of the mechanism throughout the initial phase.

### Claim 32 (depends on 21)

The tool of claim 21, wherein the fastener comprises a helical fastener.

### Claim 33

An assembly for applying an implantation force to a fastener sized and configured for implantation in tissue in response to an implantation force, the assembly comprising:
a tool body;
a driven member carried by the tool body and being operable to apply the implantation force, the driven member comprising a drive actuator to operate the driven member; and
a mechanism on the driven member operable in a first condition to couple the fastener to the driven member to transfer the implantation force from the driven member to the fastener, the mechanism being operable in a second condition to release the fastener from the driven member, the mechanism comprising a second actuator operable independent of the drive actuator to place the mechanism in the second condition.

### Claim 34 (depends on 33)

The assembly of claim 33, wherein the second actuator is operable to place the mechanism in the first condition in addition to the second actuator being operable to place the mechanism in the second condition.

### Claim 35 (depends on 33)

The assembly of claim 33, wherein the mechanism comprises means for placing the mechanism in the first condition absent operation of the second actuator.

### Claim 36 (depends on 33)

The assembly of claim 33, wherein the mechanism comprises a support element on the driven member sized and configured to assume the first condition absent operation of the second actuator.

### Claim 37 (depends on 33)

The assembly of claim 33, wherein:
the driven member is operable to apply a removal force to withdraw the fastener from tissue; and
the mechanism is operable in the first condition to couple the fastener to the driven member to transfer the removal force from the driven member to the fastener.

### Claim 38 (depends on 37)

The assembly of claim 37, wherein the driven member is rotated in one direction to apply the implantation force and rotated in an opposite direction to apply the removal force.

### Claim 39 (depends on 33)

The assembly of claim 33, wherein the tool body comprises a tubular member that carries the driven member and the mechanism.

### Claim 40 (depends on 33)

The assembly of claim 33, wherein:
the tool body comprises internal threads and the fastener comprises a helical fastener; and
a proximal portion of the helical fastener is retained within the internal threads at the end of the initial phase.

### Claim 41 (depends on 33)

The assembly of claim 33, wherein the mechanism comprises a distal portion having a configuration that corresponds to a configuration of a proximal end of the fastener, such that the proximal end of the fastener engages with the distal portion of the mechanism to couple the fastener to the mechanism throughout the initial phase.

### Claim 42 (depends on 41)

The assembly of claim 41, wherein the proximal end of the fastener comprises a leg portion that engages with the distal portion of the mechanism throughout the initial phase.

### Claim 43 (depends on 33)

The assembly of claim 33, wherein the fastener comprises a helical fastener.
