DEVICES, SYSTEMS AND METHODS FOR DISC AND MENISCUS REPAIR

摘要

Arising from the discovery that a non-immunogenic poly-synthetic bioadhesive based on polyphenolic proteins produced by sandcastle worms (Phragmatopoma californica) may be used to anneal tears of the meniscus and annulus fibroses and repair spinal disc herniations, herein disclosed are suture-less meniscal and disc repair devices, systems and methods that may be implemented least invasively, in fluid filled or dry/semi-dry environments using simple instrumentation and without the need for suturing or the placement of anchors. The present invention is less technically demanding for the practioner and thus expected enhance outcomes and represent a distinct advancement over prior art techniques presently available.

主权项

1. An application assembly for delivering a two-part poly-synthetic bioadhesive to a remote surgical site of interest, said device comprising:
i. a tubular applicator body having open proximal and distal ends and first and second adjacent parallel lumens extending therebetween, wherein said first and second lumens are configured to receive first and second components of said two part poly-synethetic bioadhesive; ii. an elongate tubular section extending from the distal end of said tubular applicator body, wherein said elongate tubular section comprises adjacent parallel first and second elongate tubes encased by an elongate polymeric sheath and having open proximal and distal ends, further wherein the proximal end of said first tube is attached to and in exclusive fluid communication with said first lumen and the proximal end of said second tube is attached to and in exclusive fluid communication with said second lumen, respectively; iii. a mixing element comprising (i) a tubular proximal portion having adjacent parallel first and second chambers, wherein said first chamber is configured to attach to the distal end and be in exclusive fluid communication with said first elongate tube and said second chamber is configured to attach to the distal end and be in exclusive fluid communication with said second elongate tube, and (ii) a distal portion in fluid communication with both said first and second chambers that includes a helical arm configured for the mixing said first and second bioadhesive components upon flow from said first and second lumen, into and through said first and second elongate tubes and said first and second chambers, and into said distal portion of the mixing element; iv. a nozzle element comprising a proximal portion configured to receive said mixing element and attach to the distal end of said elongate tubular section and a distal portion for dispensing mixed material to said remote surgical site of interest; and v. a plunging element comprising a proximal flange portion and first and second distally extending elongate members, wherein said first elongate member is sized and positioned to be slidably received by said first lumen and said second elongate member is sized and positioned to be received by second first lumen, wherein said plunging element serves to displace the said first and second bioadhesive components from said first and second lumen, into and through said first and second elongate tubes and said first and second chambers, and eject the mixed material from the distal portion of said nozzle element to said remote surgical site of interest.