Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2001-06-07
2003-12-09
Reip, David O. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C411S034000
Reexamination Certificate
active
06660008
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to methods and apparatus for attaching soft tissue to bone, and more particularly to anchors and methods for securing connective tissue, such as ligaments or tendons, to bone. The invention has particular application to arthroscopic surgical techniques for reattaching the rotator cuff to the humeral head, in order to repair the rotator cuff.
It is an increasingly common problem for tendons and other soft, connective tissues to tear or to detach from associated bone. One such type of tear or detachment is a “rotator cuff” tear, wherein the supraspinatus tendon separates from the humerus, causing pain and loss of ability to elevate and externally rotate the arm. Complete separation can occur if the shoulder is subjected to gross trauma, but typically, the tear begins as a small lesion, especially in older patients.
To repair a torn rotator cuff, the typical course today is to do so surgically, through a large incision. This approach is presently taken in almost 99% of rotator cuff repair cases. There are two types of open surgical approaches for repair of the rotator cuff, one known as the “classic open” and the other as the “mini-open”. The classic open approach requires a large incision and complete detachment of the deltoid muscle from the acromion to facilitate exposure. The cuff is debrided to ensure suture attachment to viable tissue and to create a reasonable edge approximation. In addition, the humeral head is abraded or notched at the proposed soft tissue to bone reattachment point, as healing is enhanced on a raw bone surface. A series of small diameter holes, referred to as “transosseous tunnels”, are “punched” through the bone laterally from the abraded or notched surface to a point on the outside surface of the greater tuberosity, commonly a distance of 2 to 3 cm. Finally, the cuff is sutured and secured to the bone by pulling the suture ends through the transosseous tunnels and tying them together using the bone between two successive tunnels as a bridge, after which the deltoid muscle must be surgically reattached to the acromion. Because of this maneuver, the deltoid requires postoperative protection, thus retarding rehabilitation and possibly resulting in residual weakness. Complete rehabilitation takes approximately 9 to 12 months.
The mini-open technique, which represents the current growing trend and the majority of all surgical repair procedures, differs from the classic approach by gaining access through a smaller incision and splitting rather than detaching the deltoid. Additionally, this procedure is typically performed in conjunction with arthroscopic acromial decompression. Once the deltoid is split, it is retracted to expose the rotator cuff tear. As before, the cuff is debrided, the humeral head is abraded, and the so-called “transosseous tunnels”, are “punched” through the bone or suture anchors are inserted. Following the suturing of the rotator cuff to the humeral head, the split deltoid is surgically repaired.
Although the above described surgical techniques are the current standard of care for rotator cuff repair, they are associated with a great deal of patient discomfort and a lengthy recovery time, ranging from at least four months to one year or more. It is the above described manipulation of the deltoid muscle together with the large skin incision that causes the majority of patient discomfort and an increased recovery time.
Less invasive arthroscopic techniques are beginning to be developed in an effort to address the shortcomings of open surgical repair. Working through small trocar portals that minimize disruption of the deltoid muscle, a few surgeons have been able to reattach the rotator cuff using various bone anchor and suture configurations. The rotator cuff is sutured intracorporeally and an anchor is driven into bone at a location appropriate for repair. Rather than thread the suture through transosseous tunnels which are difficult or impossible to create arthroscopically using current techniques, the repair is completed by tying the cuff down against bone using the anchor and suture. Early results of less invasive techniques are encouraging, with a substantial reduction in both patient recovery time and discomfort. The major stumbling block for many surgeons is the extreme difficulty in performing the procedure with the currently available tools and techniques.
There are various bone anchor designs available for use by an orthopedic surgeon for attachment of soft tissues to bone. The basic commonality between the designs is that they create an attachment point in the bone for a suture that may then be passed through the soft tissues and tied, thereby immobilizing the soft tissue. This attachment point may be accomplished by different means. Screws are known for creating such attachments, but suffer from a number of disadvantages, including their tendency to loosen over time, requiring a second procedure to later remove them, and their requirement for a relatively flat attachment geometry.
Another approach is to utilize the difference in density in the cortical bone (the tough, dense outer layer of bone) and the cancellous bone (the less dense, airy and somewhat vascular interior of the bone). There is a clear demarcation between the cortical bone and cancellous bone, where the cortical bone presents a kind of hard shell over the less dense cancellous bone. In one prior art approach that utilizes this physiological construct, the anchor is designed so that it has a longer axis and a shorter axis and is usually pre-threaded with suture. These designs use a hole in the cortical bone through which an anchor is inserted. The hole is drilled such that the shorter axis of the anchor will fit through the diameter of the hole, with the longer axis of the anchor being parallel to the axis of the drilled hole. After deployment in to the cancellous bone, the anchor is rotated 90° so that the long axis is aligned perpendicularly to the axis of the hole. The suture is pulled, and the anchor is seated up against the inside surface of the cortical layer of bone. Due to the mismatch in the dimensions of the long axis of the anchor and the hole diameter, the anchor cannot be retracted proximally from the hole, thus providing resistance to pull-out.
Examples of such an approach are seen in U.S. Pat. No. 5,879,372 to Bartlett and U.S. Pat. No. 6,007,4567 to Bonutti. Depending upon the density of the cancellous bone, these devices may be somewhat difficult to deploy. If the cancellous bone density is high, it is difficult to force the inserted anchor to rotated into a secured position.
It is possible to utilize other anchor geometry to take advantage of the cortical and cancellous bone interface. Various methods of creating an expanded or tortuous frontal area beneath the cortical surface have been described in the prior art. An example of this approach is seen is U.S. Pat. No. 5,797,963 to McDevitt. This patent describes a sub-cortical anchor that utilizes a tapered flaring tool which deploys fingers circumferentially disposed about the periphery of the anchor to engage the cancellous bone and to resist retraction through the limited diameter hole in the cortical bone. A similar approach is disclosed in U.S. Pat. Nos. 5,690,649 and 6,022,373, both to Li. The Li patents describe an anchor that incorporates two cylindrical halves with fingers that are interdigitated. When a force is imposed on the two halves, the interlocked fingers cause the deflection and deployment of the concomitant adjacent fingers on the opposite half, creating the expanded areas that resists pullout. In all of these designs, the expanding mechanism is adapted to resist axial loading, but there is no disclosure that they are capable of rotational fixation.
Still other prior art approaches have attempted to us a “pop rivet” approach. This type of design requires a hole in the cortical bone into which a split shaft is inserted. The split shaft is hollow, and has a tapered plug leading into its inner lumen. The tapered pl
Foerster Seth A.
Gordon Norman S.
Tran Minh
Nguyen Victor
Opus Medical, Inc.
Reip David O.
Stout Donald E.
Stout, Uxa Buyan & Mullins, LLP
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