# US 2014/0155783 A1 · Systems and methods for variable stiffness tethers

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- Number: US 2014/0155783 A1
- Document ID: US20140155783A1
- Status: Published application
- Kind: A1
- Application number: 14/000,177
- Filed: 2012-02-17
- Published: 2014-06-05
- Earliest claimed: 2011-02-18
- Assignees: Guided Delivery Systems, Inc.
- Inventors: Niel F. Starksen; Joe Eder
- Web page: https://patentgrep.com/patent/US20140155783A1

## CPC

- 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}
- D07B 5/005: {characterised by their outer shape or surface properties}
- A61F 2/2466: {Delivery devices therefor}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/09: Guide wires
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61M 2025/0018: {having a plug, e.g. an inflatable plug for closing catheter lumens}
- A61M 2025/0064: {which become stiffer or softer when heated}
- D07B 7/169: {for interconnecting two cable or rope ends, e.g. by splicing or sewing (fixation or holding of the ends prior to or during splicing D07B7/162; joining the rope or cable components individually or joining the rope ends by permanent means such as welding, gluing or crimp sleeve D07B7/167; preparing the splice by opening the ends D07B7/18)}
- D07B 2201/1004: General structure or appearance
- D07B 2401/206: Improving radial flexibility
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- D07B: ROPES OR CABLES IN GENERAL (joining ropes or cables to one another or to other objects B65H69/00, F16G11/00; {mountaineering ropes A63B29/02}; mechanical finishing or dressing of ropes D02J; {braiding D04C}; decorative ropes or cords D04D; suspension cables for bridges E01D19/16; specially adapted for driving, or for being driven by, pulleys or other gearing elements F16G9/00; electric cables or joints insofar as electrical aspects are essential H01B, H01R)
- 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

Described herein are devices and methods for guide elements configured with variable stiffness, with one or more flexible portions and one or more stiff portions. The flexible portion is be used as a tensioning element of a cinchable implant to tighten or compress tissues while the stiff portion is used to facilitate the insertion or withdrawal of portions of the implant or instruments acting on the implant. The guide element is further configured to be separated or severed between the flexible and stiff portions so that a flexible portion is left within the body as part of the implant, while the stiff portion is withdrawn from the body after implantation is completed.

## Claims

### Claim 1

A guidewire element comprising:
a rigid proximal portion;
a flexible distal portion;
an attachment portion configured to releasably attach the flexible distal portion to the rigid proximal portion; and
wherein the flexible distal portion is configured to be used as a tensioning element.

### Claim 2 (depends on 1)

The guidewire element of claim 1, wherein the flexible portion has a first torsional stiffness and the rigid portion has a second torsional stiffness that is higher than the first torsional stiffness.

### Claim 3 (depends on 1)

The guidewire element of claim 1, wherein the force required to cause the rigid portion to yield in a compression test is greater than the force required to cause the flexible portion to yield in a compression test.

### Claim 4 (depends on 1)

The guidewire element of claim 1, wherein the proximal portion comprises a first portion and a second portion, wherein the first portion is more rigid than the second portion.

### Claim 5 (depends on 1)

The guidewire element of claim 1, wherein the attachment portion comprises a first clasp attached to the rigid proximal portion, a second clasp that interfits with the first clasp attached to the flexible distal portion, and a pull-wire slidably insertable within the first and second clasps, wherein in a first protracted configuration the pull-wire secures the engagement between the first and second clasps, and in a second retracted configuration the pull-wire releases the engagement between the first and second clasps.

### Claim 6 (depends on 1)

The guidewire element of claim 1, wherein the attachment portion comprises a temperature-sensitive polymer segment that is attached between the rigid proximal portion and the flexible distal portion, wherein the temperature-sensitive polymer segment is configured to weaken when heated.

### Claim 7 (depends on 1)

The guidewire element of claim 1, wherein the attachment portion comprises a metal segment that is attached between the rigid proximal portion and the flexible distal portion, wherein the metal segment is configured to weaken when heated.

### Claim 8 (depends on 7)

The guidewire element of claim 7, wherein the attachment portion comprises a metal segment susceptible to electrolytic dissolution that is attached between the rigid proximal portion and the flexible distal portion, wherein the metal segment is configured to dissolve when subjected to an electrical charge.

### Claim 9 (depends on 1)

The guidewire element of claim 1, wherein the attachment portion comprises a plug attached to the flexible distal portion, wherein the rigid proximal portion comprises a lumen that is sized and shaped to frictionally retain the plug.

### Claim 10 (depends on 1)

The guidewire element of claim 1, wherein the attachment portion comprises a screw joint, wherein the external thread of the screw joint is attached to the rigid proximal portion and the internal thread of the screw joint is attached to the flexible distal portion.

### Claim 11 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion and the proximal portion are made from a same material and said proximal portion is stiffened by applying a stiffening agent.

### Claim 12 (depends on 11)

The guidewire element as in claim 11, wherein the material is biodegradable.

### Claim 13 (depends on 11)

The guidewire element as in claim 11, wherein the material is non-biodegradable.

### Claim 14 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion is in the range of from about 5 cm to about 30 cm in length.

### Claim 15 (depends on 1)

The guidewire element as in claim 1, wherein a ratio of the axial length of the distal portion to the axial length of the proximal portion is in the range of from about 0.05 to about 0.5.

### Claim 16 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion is a monofilament and the proximal portion is braided.

### Claim 17 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion is braided and the proximal portion is monofilament.

### Claim 18 (depends on 1)

The guidewire element as in claim 1, wherein the proximal portion comprise a larger outer diameter than the distal portion.

### Claim 19 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion is made from a first material; wherein the proximal portion comprises at least one filament, and wherein the filament made from a second material stiffer than the first material.

### Claim 20 (depends on 1)

The guidewire element as in claim 1, wherein the distal portion and the proximal portion are coated with different materials.

### Claim 21

A tether-anchor assembly comprising:
a tether comprising a rigid proximal portion and a flexible distal portion releasably attached the rigid proximal portion; and
a tissue-piercing anchor comprising an eyelet, wherein the flexible distal portion of the tether is coupled to the eyelet.

### Claim 22 (depends on 21)

The tether-anchor assembly of claim 21, wherein the anchor is fixedly coupled to said flexible distal portion of said tether via a knot assembly.

### Claim 23 (depends on 21)

The tether-anchor assembly of claim 21, wherein the flexible portion has a first torsional stiffness and the rigid portion has a second torsional stiffness that is higher than the first torsional stiffness.

### Claim 24 (depends on 21)

The tether-anchor assembly of claim 21, wherein the force required to cause the rigid portion to yield in a compression test is greater than the force required to cause the flexible portion to yield in a compression test.

### Claim 25 (depends on 21)

The tether-anchor assembly of claim 21, wherein the proximal portion comprises a first portion and a second portion, wherein the first portion is more rigid than the second portion.

### Claim 26

A tether, comprising:
a core element having a distal portion and a proximal portion;
wherein said proximal portion is located in a tubular sheath, said sheath having a higher torsional stiffness than said core element; and
wherein said distal portion is configured to be used as a tensioning element and detachable from said proximal portion of said core element.

### Claim 27 (depends on 26)

The tether as in claim 26, wherein said sheath is made from a biodegradable material.

### Claim 28 (depends on 26)

The tether as in claim 26, wherein said sheath is made from a non-biodegradable material.

### Claim 29 (depends on 26)

The tether as in claim 26, wherein said distal portion is in the range of from about 5 cm to about 30 cm in length.

### Claim 30 (depends on 26)

The tether as in claim 26, wherein said sheath is slidably disposed along longitudinal axis of said core element.

### Claim 31

A tether, comprising:
a core element having a distal portion and a proximal portion;
wherein said proximal portion is coated with a material to increase proximal torsional stiffness of said core element; and
wherein said distal portion is configured to be used as a tensioning element and detachable from said proximal portion of said core element.

### Claim 32

A method of using a tether having a flexible distal portion and a rigid proximal portion, comprising:
advancing said tether to a predetermined location;
advancing a surgical device over said tether;
detaching said distal portion from said proximal portion; and
proximally withdrawing said proximal portion.

### Claim 33 (depends on 32)

The method as in claim 32, wherein detaching said distal portion further comprises advancing a cutting device over said tether and cutting said distal portion from said proximal portion.

### Claim 34 (depends on 32)

The method as in claim 32, further comprising positioning a plurality of anchors along said distal portion.

### Claim 35 (depends on 34)

The method as in claim 34, further comprising attaching the plurality of anchors to cardiac tissue.
