System and methods of use for preparing and testing pre-sutured tendon constructs

Patent metadata

Field	Value
Publication number	US-10271964-B1
Application number	US-201815880959-A
Country	US
Kind code	B1
Filing date	Jan 26, 2018
Priority date	Jan 26, 2018
Publication date	Apr 30, 2019
Grant date	Apr 30, 2019

Abstract

There is disclosed a customizable system and methods of use for manufacturing and testing a variety of pre-sutured allograft tendon constructs sutured according to a variety of stitching patterns and featuring a variety of tissue lengths and types. One embodiment includes a triple-channel base having first, second, and third longitudinal channels extending between first and second ends of the base, as well as a plurality of tendon-manipulation accessories. Each of the tendon-manipulation accessories includes a locking-base assembly for selectively securing the accessory to the base such that the multiple tendon-manipulation accessories may be secured to the triple-channel base in a variety of custom arrangements suitable for preparing the variety of pre-sutured constructs and/or for pre-tensioning or testing the variety of the pre-sutured constructs. Other embodiments are also disclosed.

First claim

What is claimed is:

1. A customizable system for manufacturing and testing a pre-sutured tendon construct, comprising:
a base having first, second, and third longitudinal channels extending between first and second ends of the base; and
a plurality of tendon-manipulation accessories, each having a locking base assembly for selectively securing each of the tendon-manipulation accessories along one of the first, the second, or the third longitudinal channels so as to configure two or more of the tendon-manipulation accessories in two or more custom arrangements suitable for each of preparing the pre-sutured tendon construct and pre-tensioning the pre-sutured tendon construct.

2. The customizable system of claim 1 , wherein the plurality of the tendon-manipulation accessories comprise at least one or more holder assemblies, one or more saddle assemblies, one or more tendon-clamp assemblies, one or more tall tension-hook assemblies, one or more short tension-hook assemblies, one or more pulley-tension assemblies, and one or more post assemblies.

3. The customizable system of claim 1 , wherein the two or more of the custom arrangements comprise a first custom arrangement suitable for preparing a first pre-sutured tendon construct, the first custom arrangement comprising a tendon-clamp assembly secured at a first longitudinal position and a tall tension-hook assembly secured at a second longitudinal position within a select one of the first, the second, or the third longitudinal channels of the base, the tendon-clamp assembly and the tall tension-hook assembly each positioned so as to stretch a tendon portion therebetween.

4. The customizable system of claim 3 , wherein the two or more of the custom arrangements further comprise a second custom arrangement suitable for preparing a second pre-sutured tendon construct, the second custom arrangement comprising:
first and second opposing saddle assemblies secured within the first channel;
first and second opposing holder assemblies secured within the first channel, the first and the second holder assemblies outwardly bounding the first and the second saddle assemblies; and
third and fourth opposing holder assemblies secured within the third channel, the first, the second, the third, and the fourth holder assemblies positioned so as to stretch the first pre-sutured tendon construct between the first and the second saddle assemblies.

5. The customizable system of claim 4 , wherein the two or more of the custom arrangements further comprise a third custom arrangement suitable for pre-tensioning the first or the second pre-sutured tendon construct, the third custom arrangement comprising:
a short tension-hook assembly secured within the first channel;
a pulley-tension assembly secured within the second channel, the pulley-tension assembly having a pulley; and
a post assembly secured within the third channel, the short tension-hook assembly, the pulley-tension assembly, and the post assembly positioned longitudinally between the first and the second ends of the base so as to stretch the first or the second pre-sutured tendon construct around the pulley of the pulley-tension assembly at a testing tensile force.

6. The customizable system of claim 5 , wherein a distance between the first and the second ends of the base is less than a length of the first pre-sutured tendon construct and less than a length of the second pre-sutured tendon construct.

7. The customizable system of claim 1 , wherein the plurality of the tendon-manipulation accessories are configurable in a plurality of additional custom arrangements suitable for preparing a plurality of additional pre-sutured tendon constructs and for testing the plurality of the additional pre-sutured tendon constructs.

8. A soft-tissue construct preparation and testing tool, comprising:
a triple-channel base extending longitudinally between a first end and a second end;
a pulley-tension assembly having a pulley secured at a first longitudinal position within a second channel of the triple-channel base;
a tension-hook assembly secured at a second longitudinal position within a first channel of the triple-channel base; and
a post assembly secured at the second longitudinal position within a third channel of the triple-channel base, wherein:
a pre-sutured soft-tissue construct extends from a first end attached to the post assembly, about the pulley of the pulley-tension assembly, to a second end attached to the tension-hook assembly;
increasing a distance between the first and the second longitudinal positions increases a tension placed upon the pre-sutured soft-tissue construct and registers a proportional tension-force measurement on the tension-hook assembly; and
a distance between the first and the second ends of the triple-channel base is less than a distance between the first and the second ends of the pre-sutured soft-tissue construct.

9. The soft-tissue construct preparation and testing tool of claim 8 , wherein the post assembly comprises:
a locking-base assembly configured to secure the post assembly at a plurality of longitudinal positions within the third channel of the triple-channel base; and
a post extending upward from the locking-base assembly, the post configured to receive and retain a suture extending from the first end of the pre-sutured soft-tissue construct.

10. The soft-tissue construct preparation and testing tool of claim 8 , wherein the tension-hook assembly comprises:
a locking-base assembly configured to secure the tension-hook assembly at a plurality of longitudinal positions within the first channel of the triple-channel base; and
a force gauge affixed to the locking-base assembly, the force gauge including:
a compression spring bounded by a housing having an indicator channel marked by a progression of force indicia, an indicator positioned at a proximal end of the housing, and a retainer disk positioned at a distal end of the housing;
a hook having a first end extending distally from the housing and a second end coupled with the indicator such that a distal translation of the hook compresses the compression spring and registers the proportional tension-force measurement between the indicator and the force indicia.

11. The soft-tissue construct preparation and testing tool of claim 8 , wherein the pulley-tension assembly further comprises:
a locking-base assembly configured to secure the pulley-tension assembly at a plurality of longitudinal positions within the second channel of the triple-channel base; and
a pusher assembly disposed between the locking-base assembly and the pulley, the pusher assembly comprising:
a mounting slidably engaged with the second channel;
a pusher block affixed to the mounting, the pusher block having a threaded aperture extending from a proximal end adjacent the locking-base assembly to a distal end adjacent the pulley; and
a pusher threadably engaged with the threaded aperture, wherein rotating the pusher in a first direction translates the pusher distally against the pulley, thereby incrementally increasing the distance between the first and the second longitudinal positions to incrementally increase the tension placed upon the pre-sutured soft-tissue construct and register the proportional tension-force measurement on the tension-hook assembly.

12. The soft-tissue construct preparation and testing tool of claim 11 , the locking-base assembly including:
a lock base having top and bottom plates separated by an offset; and
a threaded swivel extending through the top and the bottom plates, wherein the top and the bottom plates move toward a closed position when the swivel is rotated in a first direction and

Assignees

• Allosource

Inventors

• Samaniego Adrian C
• Franklin Wendy Desiree
• Yi Han Sarah Song
• Compton Jesse
• Bull Marina

Classifications

• A61F2/4657

  Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06) · CPC title

• G01L5/06

  using mechanical means {(G01L5/042, G01L5/045 take precedence)} · CPC title

• A61F2/4644 Primary

  Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C) · CPC title

• G01L1/04

  by measuring elastic deformation of gauges, e.g. of springs · CPC title

• A61F2/08 Primary

  Muscles; Tendons; Ligaments · CPC title