# US 10,869,661 B2 · Shape memory filament for suture management

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- Number: US 10,869,661 B2
- Document ID: US10869661B2
- Status: Granted
- Kind: B2
- Application number: 16/010,482
- Filed: 2018-06-17
- Published: 2018-10-18
- Granted: 2020-12-22
- Earliest claimed: 2006-10-05
- Assignees: DePuy Mitek, LLC
- Applicants: DePuy Mitek, LLC; Thomas P. Knapp
- Inventors: Thomas P. Knapp; Bernhard Uihlein; Stanley O. Thompson; Timothy J. Coonahan; Jon Taylor
- Web page: https://patentgrep.com/patent/US10869661B2

## CPC

- A61B 17/0485: {Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61B 17/06066: {Needles, e.g. needle tip configurations}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/061: {hollow or tubular}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A member of a rigid flexible elastic material, the member including a body portion and an aperture portion with the member adapted for delivery through an axial longitudinal channel of a percutaneous delivery subsystem, the aperture portion including an expanded mode having a lateral dimension greater than an inner diameter of the channel when the aperture portion extends outside the channel and a collapsed mode wherein the lateral dimension is not greater than the inner diameter of the channel when the aperture portion is within the channel, the channel including a first axial opening and a second axial opening with the aperture portion transitioning from the expanded mode to the collapsed mode when inserted into the openings and the aperture transitioning from the collapsed mode to the expanded mode when exiting from the openings.

## Claims

### Claim 1

A percutaneous suture management system for disposition of a suture inside a body cavity having a portion of skin overlying the body cavity, comprising:
a tissue-penetrating member, for delivery of the suture to the body cavity, including a proximal end and a distal end opposing said proximal end, said distal end having a skin-piercing element configured to pierce the portion of skin with said tissue-penetrating member having an internal channel extending between a proximal opening at said proximal end and a distal opening at said distal end, said distal opening proximate said skin-piercing element and said internal channel having an inner diameter and a channel length; and
a discrete member independent from said tissue-penetrating member and configured to be delivered through said internal channel from a first particular end of said ends to a second particular end of said ends, said discrete member including a single rigid shape memory alloy monofilament wound about itself and producing both a wound body portion and an aperture portion, said body portion having a body portion width less than said inner diameter and a body portion length greater than said channel length, said aperture portion including an expanded configuration having an expanded width greater than said inner diameter and a collapsed configuration having a collapsed width less than said inner diameter, said aperture portion configured to transition from said expanded configuration to said collapsed configuration when entering into said proximal opening and when entering into said distal opening, and further said aperture portion configured to automatically expand from said collapsed configuration to said expanded configuration when exiting from said proximal opening and when exiting from said distal opening;
wherein said aperture portion is configured to form a predetermined perimeter having N number of hard discrete bends, wherein N is a number that is 6 or greater.

### Claim 2 (depends on 1)

The percutaneous suture management system of claim 1 wherein N is equal to 6.

### Claim 3 (depends on 1)

The percutaneous suture management system of claim 1 wherein N is equal to 8.

### Claim 4 (depends on 3)

The percutaneous suture management system of claim 3 wherein said predetermined perimeter includes a generalized elongated hexagon shape.

### Claim 5 (depends on 1)

The percutaneous suture management system of claim 1 wherein said single rigid shape memory alloy monofilament further produces a leader portion extending from said aperture portion to an end of said discrete member opposite of said wound body portion, said leader portion configured to join said aperture portion at a pair of said hard discrete bends with said leader portion including a twisted portion of said single rigid shape memory alloy monofilament.

### Claim 6 (depends on 5)

The percutaneous suture management system of claim 5 wherein said twisted portion includes at least one complete twist and fewer than three complete twists of said single rigid shape memory alloy monofilament.

### Claim 7 (depends on 5)

The percutaneous suture management system of claim 5 wherein said leader portion has a leader portion width less than said channel diameter.

### Claim 8 (depends on 1)

The percutaneous suture management system of claim 1 wherein said discrete member is configured with said body portion rigid to be pushed/pulled through said internal channel while said aperture portion repeatedly transitions between said expanded mode and said collapsed mode permitting multiple uses of said discrete member.

### Claim 9 (depends on 1)

The percutaneous suture management system of claim 1 wherein said discrete member is configured to support a pull force loading of at least a hundred foot-pounds.

### Claim 10 (depends on 1)

The percutaneous suture management system of claim 1 wherein said single rigid shape memory monofilament includes a metal shape memory material.

### Claim 11 (depends on 1)

The percutaneous suture management system of claim 1 wherein said tissue-penetrating member includes a needle having a needle gauge no larger than an 18 gauge.

### Claim 12 (depends on 1)

The percutaneous suture management system of claim 1 wherein said skin-piercing element includes a needle having a nominal outside diameter no larger than an 18 needle gauge.

### Claim 13 (depends on 11)

The percutaneous suture management system of claim 11 wherein said needle includes an axial longitudinal channel that includes said internal channel.

### Claim 14 (depends on 1)

The percutaneous suture management system of claim 1 wherein said channel diameter is no greater than an 18 needle gauge nominal inner diameter.

### Claim 15 (depends on 14)

The percutaneous suture management system of claim 14 wherein N is equal to 6.

### Claim 16 (depends on 14)

The percutaneous suture management system of claim 14 wherein N is equal to 8.

### Claim 17 (depends on 16)

The percutaneous suture management system of claim 16 wherein said predetermined perimeter is a generalized elongated hexagon shape.

### Claim 18 (depends on 14)

The percutaneous suture management system of claim 14 wherein said single rigid shape memory alloy monofilament further produces a leader portion extending from said aperture portion to an end of said discrete member opposite of said wound body portion, said leader portion configured to join said aperture portion at a pair of said hard discrete bends with said leader portion including a twisted portion of said single rigid shape memory alloy monofilament.

### Claim 19 (depends on 18)

The percutaneous suture management system of claim 18 wherein said twisted portion includes at least one complete twist and fewer than three complete twists of said single rigid shape memory alloy monofilament.

### Claim 20 (depends on 18)

The percutaneous suture management system of claim 18 wherein said leader portion has a leader portion width less than said channel diameter.

### Claim 21 (depends on 14)

The percutaneous suture management system of claim 14 wherein said discrete member is configured with said body portion rigid to be pushed/pulled through said internal channel while said aperture portion repeatedly transitions between said expanded mode and said collapsed mode permitting multiple uses of said discrete member.

### Claim 22 (depends on 14)

The percutaneous suture management system of claim 14 wherein said discrete member is configured to support a pull force loading of at least a hundred foot-pounds.

### Claim 23 (depends on 14)

The percutaneous suture management system of claim 14 wherein said single rigid shape memory monofilament includes a metal shape memory material.

### Claim 24 (depends on 14)

The percutaneous suture management system of claim 14 wherein said tissue-penetrating member includes a needle having a needle gauge no larger than an 18 gauge.

### Claim 25 (depends on 14)

The percutaneous suture management system of claim 14 wherein said skin-piercing element includes a needle having a nominal outside diameter no larger than an 18 needle gauge.

### Claim 26 (depends on 24)

The percutaneous suture management system of claim 24 wherein said needle includes an axial longitudinal channel that includes said internal channel.

### Claim 27 (depends on 1)

The percutaneous suture management system of claim 1 wherein said discrete member consists essentially of said single rigid shape memory alloy monofilament wound about itself.

### Claim 28

A management apparatus for disposition of a suture into a body cavity through a portion of skin overlying the body cavity, comprising:
a delivery system defining an internal channel extending between a first end and a second end spaced apart from said first end by a channel length, said internal channel having an inner diameter; and
a discrete member independent from said delivery system and configured to be presented through said internal channel from a first particular one of said ends to a second particular one of said ends, said discrete member including a single rigid shape memory alloy monofilament wound about itself and producing both a wound body portion and an aperture portion, said body portion having a body portion width less than said inner diameter and a body portion length greater than said channel length, said aperture portion including an expanded configuration having an expanded width greater than said inner diameter and a collapsed configuration having a collapsed width less than said inner diameter, said aperture portion configured to transition from said expanded configuration to said collapsed configuration when entering into either of said ends, and further said aperture portion configured to automatically expand from said collapsed configuration to said expanded configuration when exiting from either of said ends;
wherein said aperture portion is configured to form a predetermined perimeter having N number of hard discrete bends, wherein N is a number that is 6 or greater.

### Claim 29 (depends on 28)

The suture management apparatus of claim 28 wherein N is equal to 6.

### Claim 30 (depends on 28)

The suture management apparatus of claim 28 wherein N is equal to 8.

### Claim 31 (depends on 30)

The suture management apparatus of claim 30 wherein said predetermined perimeter is a generalized elongated hexagon shape.

### Claim 32 (depends on 28)

The suture management apparatus of claim 28 wherein said single rigid shape memory alloy monofilament further produces a leader portion extending from said aperture portion to an end of said discrete member opposite of said wound body portion, said leader portion configured to join said aperture portion at a pair of said hard discrete bends with said leader portion including a twisted portion of said single rigid shape memory alloy monofilament.

### Claim 33 (depends on 32)

The suture management apparatus of claim 32 wherein said twisted portion includes at least one complete twist and fewer than three complete twists of said single rigid shape memory alloy monofilament.

### Claim 34 (depends on 32)

The suture management apparatus of claim 32 wherein said leader portion has a leader portion width less than the channel diameter.

### Claim 35 (depends on 28)

The suture management apparatus of claim 28 wherein said discrete member is configured with said body portion rigid to be repeatedly pushed/pulled through said internal channel while said aperture portion repeatedly and responsively transitions between said expanded mode and said collapsed mode permitting multiple uses of said discrete member.

### Claim 36 (depends on 28)

The suture management apparatus of claim 28 wherein said discrete member is configured to support a pull force loading of at least a hundred foot-pounds.

### Claim 37 (depends on 28)

The suture management apparatus of claim 28 wherein said single rigid shape memory monofilament includes a metal shape memory material.

### Claim 38 (depends on 28)

The suture management apparatus of claim 28 wherein said delivery system includes a needle having a needle gauge no larger than an 18 gauge.

### Claim 39 (depends on 28)

The suture management apparatus of claim 28 wherein said delivery system includes a needle having a nominal outside diameter no larger than an 18 needle gauge.

### Claim 40 (depends on 38)

The suture management apparatus of claim 38 wherein said needle includes an axial longitudinal channel that includes said internal channel.

### Claim 41 (depends on 28)

The suture control apparatus of claim 28 wherein said discrete member is further configured to be inserted into both ends of said internal channel.

### Claim 42 (depends on 28)

The suture control apparatus of claim 28 wherein said discrete member consists essentially of said single rigid shape memory alloy monofilament wound about itself.

### Claim 43

A control apparatus for disposition of a suture into a body cavity through a portion of skin overlying the body cavity, comprising:
a percutaneous delivery system defining an internal channel extending between a first end and a second end spaced apart from said first end by a channel length, said internal channel having an inner diameter;
a discrete member independent from said percutaneous delivery system and configured to be delivered through said internal channel from one of said ends to a different one of said ends, said discrete member including a single rigid shape memory alloy monofilament wound about itself and producing both a wound body portion and an aperture portion, said body portion having a body portion width less than said inner diameter and a body portion length greater than said channel length, said aperture portion including an expanded configuration having an expanded width greater than said inner diameter and a collapsed configuration having a collapsed width less than said inner diameter, said aperture portion configured to transition from said expanded configuration to said collapsed configuration when entering into either of said ends, and further said aperture portion configured to automatically expand from said collapsed configuration to said expanded configuration when exiting from either of said ends;
wherein said aperture portion is configured to form a predetermined perimeter having N number of hard discrete bends, wherein N is a number that is 6 or greater.

### Claim 44 (depends on 43)

The suture control apparatus of claim 43 wherein said discrete member is further configured to be inserted into both ends of said internal channel.

### Claim 45 (depends on 43)

The suture control apparatus of claim 43 wherein said discrete member consists essentially of said single rigid shape memory alloy monofilament wound about itself.
