Anatomical fixation implant

Abstract

This invention relates in general to a bioabsorbable surgical tissue fixation implant (nail) and, more particularly to an implant for the fixation of soft tissue to bone. In one embodiment of the invention, the fixation implant generally includes at least one shaft configured to securely fit into a hole formed in bone. The shaft is of sufficient length relative to the interior diameter of the hole and, in some preferred embodiments, has locking protuberances, like threads, ridges, or barbs, that resist removal of the shaft from the hole in the bone when different types of forces, such as tensile or bending forces, are applied to the implant. The shaft is generally cylindrical in shape, however, in various embodiments of the invention, different cross-sections could be used. In a preferred embodiment of the present invention, the implant has a flattened and bent end portion emerging from only one side of the shaft. At the other side of the implant the outer surface of the shaft and the emerging end portion form a smooth surface, without any projections. This smooth surface at the end of the implant prevents irritation of the surrounding tissue. The end portion has a mating surface configured to grip a portion of the soft tissue surrounding the hole between the bone and the mating surface. The longitudinal axis of the shaft is oriented at an angle of less than 90 degrees relative to the mating surface. In this fashion, the implant anchors soft tissue, such as rotator cuff tissue, to bone.

Description

[0001] This invention relates in general to a bioabsorbable surgical tissue fixation implant (nail) and, more particularly to an implant for the fixation of soft tissue to bone.[0002] In such procedures as rotator cuff surgery or labrum rupture fixation surgery and hand tendon surgery, tendons or other soft tissues are fixed to bone. The tendons or other tissue are often secured to bone by feeding the soft tissue through holes formed in the bone and suturing the tissue in place. Another method of securing soft tissue to bone employs a fixation device which essentially tacks the tendon to bone. Unless the tendon or other soft tissue is completely immobilized, the fixation device must be securely embedded in the bone to hold the tendon or other soft tissue stationary against the bone surface, resisting those forces tending to pull the tendon or soft tissue away from the bone surface, until the tendon or soft tissue has become attached to the bone. Another method of securing tendon and...

AI Technical Summary

Benefits of technology

[0009] It is another object of this invention to provide a fixation implant for the fixation of rotator cuff or labrum tissue to bone and / or cartilage surface in which the size of the fixation implant is minimized.

[0011] It is further an object of this invention to provide a fixation implant which may be economically manufactured and which may be efficiently and reliably employed in the fixation of soft tissue to bone.

[0022] As shown in FIG. 2C, the bioabsorbable implant 4 of the invention is inserted into a drill hole 5a in a bone 5. The implant 4 secures soft tissue 6 onto the surface of the bone 5 around the hole 5a and below the end portion 4c. To ensure that the implant is securely positioned in hole 5a, the shaft 4a has a maximum width greater than the interior diameter of said drill hole 5a in bone 5. At one side of the implant 4 the outer surface of the shaft 4a curves smoothly to the top of the implant. This smooth-surfaced area, 4d, has no projections and will not, therefore, irritate any surrounding tissue. The end portion 4c has a mating surface 4f configured to grip a portion of soft tissue 6 around said hole 5a between the bone 5 and the end 4c. The longitudinal axis of the shaft 4a is oriented at an angle of less than 90 degrees relative to the mating surface 4f. The shaft may have a longitudinal hole 4b inside of it. Such cannulated implants are especially advantageous because they can be inserted into a drill hole along a guide wire, with minimally invasive, arthroscopic surgical techniques.

[0029] However, a general feature of orientation, fiber-reinforcement or self-reinforcement of the implants of this invention is that many of the reinforcing elements are oriented in such a way that they can carry effectively the different external loads (such as tensile, bending and shear loads) that are directed to the healing tissue (for example, loads to the shoulder joint caused by the movements of the muscles in the arm and / or in the upper part of patient's body).

[0030] According to an advantageous embodiment of the invention, the implant, or a special coating layer on its surface, may contain one or more bioactive substances, such as antibiotics, chemotherapeutic substances, angiogenic growth factors, substances accelerating the healing of the wound, growth hormones, and the like. Such bioactive implants are especially advantageous in surgical use, because they chemically contribute to the healing of the damaged tissue in addition to providing mechanical support.

[0032] According to an advantageous embodiment of the invention, the end portion can be "overbended" in relation to the angle a between the mating surface of the bone and the drill hole in the bone. This means that the angle .beta. of FIG. 2 is smaller than the anatomical angle .alpha. of FIG. 1. When the implant is pushed tightly into a drill hole in bone, angle .beta. opens slightly to mate on the bone surface and a compression force is developed within the head of the implant. This compression is advantageous in securing the soft tissue to the bone.

Problems solved by technology

However, the presently known bioabsorbable fixation implants for attaching soft tissue to bone have encountered several problems in clinical use, especially in rotator cuff or labrum rupture fixation.

Additionally, that part of the symmetric head (on the right side of the shaft in FIG. 1) which does not bind the soft tissue, is unnecessary for healing and can irritate the rim of the joint cavity.

However, this implant is expressly restricted to those applications where no forces will be exerted on the implant that will tend to pull it out of the bone.

This implant does not effectively grip the drill hole in the bone to resist tensile forces, because the leg portion is constructed so that it is easily pulled in a direction parallel to the longitudinal axis of said hole.

Therefore, the high muscular forces which load the labrum or rotator cuff during healing would pull the leg portion at least partially from the drill hole during healing, causing severe complications.

Another problematic feature of the implant of U.S. Pat. No. 5,634,926 is that the enlarged end, even if non-symmetrical, still projects in all directions from the leg portion.

Thus, the portion of the end that is directed to the rim of the joint cavity in labrum or rotator cuff fixation is ineffective and unnecessary for soft tissue fixation and can cause irritation to the rim of the joint cavity.

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