Devices, systems and methods for tissue repair

Abstract

Devices, systems and methods are disclosed for repairing soft tissue. The surgical system allows for the creation of tissue repair by grasping, aligning and sewing or fixing tissue. For example, this system may be used for clipping together excessive capsular tissue and reducing the overall capsular volume. The deployment device includes a central grasping mechanism and an outer clip delivery system. The clip embodiments may be single or multi-component (penetration and locking base components) that penetrate tissue layers and deploy or lock to clip the tissue together. An example of the system is used to reduce the joint capsule tissue laxity and reduces the potential for subluxation or dislocation of the joint by either restricting inferior laxity (anterior or posterior) and resolving or eliminating pathologic anterior or posterior translation.

Description

[0001] This U.S. Utility Patent Application claims priority to U.S. Provisional Patent Application Ser. No. 60 / 570,627, filed May 13, 2004, and to U.S. Provisional Patent Application Ser. No. 60 / 584,585, filed Jul. 1, 2004, the contents of each of which are hereby incorporated by reference in their entirety into this disclosure.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to devices, systems and methods for tissue repair. More particularly, the present invention relates to devices, systems and methods for treating unidirectional and multidirectional instability of tissue structures. [0004] 2. Background of the Invention [0005] Tissue instability or compromise is a common occurrence in all persons, whether induced by age, repeated use, disease, accident or natural and abnormal formation. Such instability may include, for example, intentional or accidental tears, cuts, stretching, loosening, deterioration of structure, los...

AI Technical Summary

Benefits of technology

[0020] In one described embodiment, the invention relates to suture structures and related deployment devices to repair, plicate and / or reduce the capsular laxity at the glenohumeral joint, improving joint stability. However, the techniques disclosed in the examples below are adaptable and usable for all tissues and tissue systems where repair is beneficial to improve the health and function of the tissue or tissue system. Such techniques and uses, particularly relating to embodiments of the present invention, are particularly useful in applications requiring transdermal access to a particular internal tissue by penetrating one or more layers of tissue. However, such transdermal access is not limiting and the present invention may be applicable in non-transdermal applications as well, such as in fundoplication. Further, “repair” of such tissue, as defined herein and throughout this disclosure, is a slowing down or reversal of the instability such that the tissue is somehow manipulated to deal with or overcome the instability, usually involving some form of surgery. Common, but not limiting, examples include suturing, plicating, stapling, restructuring, adhering, tightening, attaching, firming or the like.

Problems solved by technology

Such instability may include, for example, intentional or accidental tears, cuts, stretching, loosening, deterioration of structure, loss of firmness, and the like.

No matter what type of instability is present or whether the tissue to be repaired is classified as orthopedic or non-orthopedic, similar issues and objectives are encountered by the surgeon, namely, creating a stable and reliable structure and doing so in as easy and reliable manner as possible.

For example, certain joints, such as hips, knees, shoulders and elbows contain tissues that are common sources of problems, whether natural or induced, that require extensive physical therapy or surgery to correct.

Of such tissues or tissue structures, a common source of medical problems occurs in the joints.

Joint instability is a complex clinical problem associated with a variety of treatment options that include the use of arthroscopic and open surgical methods.

However, adequate arthroscopic methods that approximate the clinical outcome achieved by open surgical methods for reducing excessive joint laxity have been slow to develop or have begun to show less than optimal long term clinical outcomes (e.g., thermal methods).

The shoulder joint, in particular, has inherent instability because of its large range and motion combined with the relatively shallow joint bony socket (glenoid).

Damage to or laxity of one of these stabilizing structures can result in the presentation of clinically relevant shoulder instability.

Most typically, the instability of the shoulder stems from disruption and / or looseness (excessive capsule laxity) of the shoulder capsule.

The resulting subluxation or dislocation of the joint can be painful and debilitating for the individual.

A loose shoulder capsule may be tightened readily when a standard open incision is used, but tightening the shoulder capsule arthroscopically poses significant challenges with existing instruments.

For example, the acute angles at which the surgical devices are able to approximate the soft tissue and identify regions where suturing would be desirable are limiting.

Furthermore, the ability to pass a suture and tie snug surgical knots that compress the tissue in the desired plane with a reasonable suture time is difficult if not cumbersome.

Finally, the ability to dictate the level of tissue tied is limited to the tissue needle bite size and remains difficult for the surgeon to reproducibly specify the level of tissue compression desired.

It has been demonstrated that at temperatures above 65 degrees Celsius, collagen begins to denature (e.g., unwinding of the helical structure), resulting in tissue shrinkage.

However, this technology has yielded equivocal results and progressive skepticism from shoulder surgeons.

Additional concerns of thermal capsulorrhaphy application include potential injury to the axillary nerve, bleeding, pain, and excessive swelling of the capsule.

More importantly, the technical methods used during thermal capsulorrhaphy do not allow the surgeon to control the level of plication that is desired or anticipated.

The paucity of data demonstrating the long-term mechanical characteristics and viability of these treated ligaments limits the confident and continued use of this technique.

Conventional methods for arthroscopic plication of the shoulder capsule with sutures typically involve freehand techniques that are technically challenging and often time-consuming.

An additional shortcoming common to both thermal capsular shrinkage and existing suturing techniques is that neither method can effectively control the amount of capsular tightening in a calibrated fashion.

“Over-tightening” of the anterior capsule can lead to problems such as excessive loss of external rotation, limiting shoulder joint function.

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