Patent Application
20180368969
The present invention relates to reinforcement devices that are used during the repair of rotator cuff injuries.
Rotator cuff/supraspinatus tendon tears are common injuries, with over 80,000 surgeries performed annually in the U.S. However, re-tears following surgery are extremely common, occurring in over 82% of repairs. The main failure mode for re-tears involves sutures tearing through tendon at the suture-tendon interface.
It would be beneficial to provide a reinforcement device to reduce the likelihood of re-tears.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
In one embodiment, the present invention is a tendon reinforcement assembly comprising a rivet having a female portion having a female free end, a female connecting end, and a female portion axial passage extending therethrough. A male portion has a male free end, a male connecting end adapted to be inserted into the female free end, and a male portion axial passage extending therethrough. The male portion axial passage extends coaxially with the female portion axial passage. A suture extends through the male portion axial passage and the female portion axial passage. The suture has a first suture end extending outwardly of the male free end and a second suture end extending outwardly of the female free end.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”
As used in this application, the word “exemplary” is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.
Additionally, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or”. That is, unless specified otherwise, or clear from context, “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then “X employs A or B” is satisfied under any of the foregoing instances. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form.
Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value of the value or range.
The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
It should be understood that the steps of the exemplary methods set forth herein are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention.
Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.
Referring to
Assembly 100, which can include a hollow rivet 102 having various diameters, is placed at suture/tendon interfaces and sutures are passed through assembly 100 rather than just through tendon as per traditional repairs. Sutures 150 are threaded through rivet 102 rather than directly through tendon. The purposes of the rivet 102 are to improve suture force distribution and to provide a protective barrier between the suture 150 and the tendon.
Rivet 102 has two main purposes: to distribute load more evenly to a tendon; and to provide a mechanical barrier between suture and tendon. Since the diameter of river 102 is greater than that of a single suture, the suture tension transferred to tendon per unit area (stress) is decreased compared to that of a single suture alone. Rivet 102 also provides a mechanical barrier to delay wear and tear of the suture through the tendon, therefore improving fatigue strength with repeated loading. In an exemplary embodiment, rivet 102 is about 6 millimeters in length.
Referring specifically to
In an exemplary embodiment, shown in
Similarly, the male portion 130 has a male free end 132 having a flange 133, a male connecting end 134 adapted to be inserted into the female free end 114, and a male portion axial passage 136 extending therethrough. The male portion axial passage 136 has a diameter of about 1 millimeter. In an exemplary embodiment, the flange 133 can be about 1 millimeter thick and about 5 millimeters in diameter.
The male portion axial passage 136 extends coaxially with the female portion axial passage 116. Similar to the transition between axial passage 116 and flange 113, the transition between axial passage 136 and flange 133 can be sharp or beveled.
Materials used for female portion 110 and male portion 130 must not elicit immune or foreign-body responses since the device is destined for in vivo use. In an exemplary embodiment, female portion 110 and male portion 130 are constructed from 316 stainless steel. Alternatively, female portion 110 and male portion 130 can be constructed from UHMWPE due to its low friction properties. Those skilled in the art, however, will recognize that female portion 110 and male portion 130 can be constructed from other biocompatible materials. Thus, materials used must perform under physiological conditions including temperature (about 37° C.), pH (between about 7.0- and about 7.5), enzymatic activity, and humidity/hydration (about 65% water).
A suture 150 extends through the male portion axial passage 136 and the female portion axial passage 116. The suture 150 has a first suture end 152 extending outwardly of the male free end 132 and a second suture end 154 extending outwardly of the female free end 112.
Rivet 102 is designed to reduce the likelihood of tearing through tendon after insertion. If rivet 102 has too small of an outer diameter, the concentration of forces may make it likely to tear through the tendon if applied forces on the assembly are too great or too extensive. Alternatively, if assembly 100 has too large of an outer diameter, an exceedingly large hole has to be formed in the tendon, which can result in subsequent tendon tears.
Stress on rivet 102 is inversely proportional to the diameter of rivet 102. As the diameter of rivet 102 increases, the compressive stress exerted by rivet 102 on the tendon tissue decreases, making suture tear-through less likely.
Referring to the graph of
In tests that were performed using rivets 102 having 3 mm, 4 mm, and 5 mm diameters that were inserted into a bovine Achilles tendon, the testing revealed that the 3 mm, 4 mm, and 5 mm rivets increased the Ultimate Tensile Strength of the suture/tendon construct by approximately 100, 225, and 300%, respectively, compared to a control suture-only tendon. See
It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.
The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/512,197, filed on May 30, 2018, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62512197 | May 2017 | US |
