Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2000-07-26
2002-09-03
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S139000, C606S146000
Reexamination Certificate
active
06443963
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to surgical devices and procedures and, more particularly, to an apparatus and method for suturing or repairing soft tissue injuries such as, for example, tears in the meniscus of the knee.
BACKGROUND OF THE INVENTION
The meniscus is the intra-articular cartilage found in the joint that separates the femur from the tibia, that is, the knee joint. Proper functioning of the knee joint depends, in part, upon the meniscus'ability to provide the joint with biomechanical stability and shock absorption during ambulation. Frequently, the meniscus is injured or torn, causing joint instability, pain in the knee, and resultant difficulties in ambulation. Two common surgical techniques are used in an effort to alleviate the pain associated with this type of injury. The first of these techniques is referred to as a menisectomy, which is the removal of the piece of tissue that has torn away from the greater meniscus. Depending upon the severity of the tear in the meniscal tissue, the surgeon may regard this as the best surgical option for the patient. The second technique involves the installation of a surgical implant into the segments of torn meniscal tissue to promote the fusion of the tissue and facilitate normal healing of the injury. In many cases, the surgeon will regard this latter option as more desirable than the former, since it is far less radical and potentially has fewer degenerative consequences, such as the development of osteoarthritis, for the patient over time.
Presently known devices and methods for delivering a surgical suture or suture-like implant into the meniscus or other soft tissue for repairing a tear in that tissue are unsatisfactory in several regards. Specifically, the prior art devices and methods may frequently prolong otherwise elegant surgical procedures by imparting the procedure with unnecessary mechanical inefficiencies. For example, the inability of prior art devices to pass suture or implant material into and out of soft tissue through the same body portal necessitates that a plurality of incisions be made into a patient's body, thereby increasing the level of trauma experienced by the patient during the procedure. Additionally, prior art rotating suture or implant feeding mechanisms employ counter-intuitive methods of operation that require the surgeon to rotate the wheel mechanism in a direction that is opposite the direction in which the surgeon desires to feed the suture or implant material. Moreover, currently known devices are incapable of accommodating variably dimensioned suture or implant materials, thereby presenting the surgeon with two equally undesirable options: First, the surgeon must use a single suture or implant material having a particular diameter or thickness, regardless of the needs of the patient; or, second, the surgeon must employ a plurality of surgical instruments, each capable of accommodating particularly dimensioned suture or implant material, which necessarily increases the number of steps required to complete the procedure and likely prolongs its duration.
In view of the foregoing, a need exists for an improved apparatus and method for repairing an injury to soft tissue which overcomes the shortcomings of the prior art. Thus, there is a need for an apparatus and method which enable a surgeon to pass a suture or other generally elongated implant material into and out of injured, torn, or detached soft tissue in essentially the same direction. There is also a need, especially in the case of arthroscopic surgeries, for an apparatus and method which are capable of passing a suture or implant material into and out of a joint space through a single body portal, thereby reducing the number of incisions required to accomplish the procedure. There is also a need for a single apparatus which is capable of delivering sutures or implant materials of various diameters or thicknesses. There is also a need for an apparatus having a rotating suture or implant feeding mechanism that permits the surgeon to rotate the feed mechanism in the same direction that the surgeon desires the suture or implant material to be fed. There is also a need for an apparatus capable of passing a plurality of tissue-piercing devices and suture legs through soft tissue at one time. There is also a need for an apparatus which can selectively orient the suture or implant material in either a horizontal, vertical, or diagonal direction, depending upon the needs of the patient and/or the desires of the surgeon. There is also a need for an apparatus and method for passing a suture or implant through soft tissue and grasping the end of the suture or implant on the opposite side of the soft tissue. Additionally, there is a need for an apparatus and method for passing a needle through a body portal and to the site of soft tissue injury while also protecting the surrounding tissue and nerves from damage that can be caused by the passage of that needle.
SUMMARY OF THE INVENTION
The present invention is an apparatus and method for delivering or installing a surgical suture or suture-like implant into soft tissue, such as the meniscus of the knee for example, for the reattachment or repair of that tissue. The apparatus and method of the invention facilitate ease of placement of the suture or implant by the surgeon, protect the surrounding tissue and nerves from damage during its use, and permit all suturing to occur through a single body portal. The present invention can be used in either open or arthroscopic surgical procedures and can be used for any tears in the meniscus or for other injuries to soft tissue which require a suture or implant to be passed through the tissue to facilitate reapproximation and healing of that tissue. In accordance with the invention, an injury to soft tissue, such as a tear in the meniscus of the knee joint or detachment of soft tissue from bone, is repaired through a single body portal by installing a surgical suture across the injury, tear, or detachment and passing that suture back through the body portal so that the suture can be joined and the injury, tear, or detachment can be reapproximated by the surgeon while working through the single body portal. It should be understood that the device of the instant invention can be used to pass suture or suture-like implants equally effectively. Thus, wherever the terms “implant” or “implant material” are used herein, it should be understood that the principles of the present invention apply equally to the use of all manner of surgical suture or suture-like materials.
The apparatus of the instant invention includes a guide structure which can be inserted through a body portal and brought into proximity with particular soft tissue. The guide structure is suitably configured to guide a length of suture or surgical implant material through the soft tissue and to bring legs of the length of implant material into proximity with each other. The guide structure includes a suitable, selectively moveable, tissue-piercing device, such as a needle for example, capable of piercing soft tissue and of being withdrawn from the soft tissue so that suitable suture or implant material then can be fed through the guide structure and into the soft tissue. The guide structure further is configured to be withdrawn toward the body portal and from the body in a manner which causes the guide structure to become disengaged from the length of implant material while leaving the length of implant material extending through the soft tissue and the legs of the length of implant material in proximity with each other. This then permits the surgeon, at his or her discretion, to join the approximated portions of implant material to accomplish the repair or reattachment of the soft tissue. However, it should be understood that the present invention does not require that the portions of the length of implant material be joined, nor is the present invention limited or restricted in any way to the joining of these portions of implant material.
In an exemplar
Baldwin Jeffrey P
Hatch Laird L.
Hunter Robert E.
Vinluan Jenine S.
Fish & Richardson P.C.
Jackson Gary
Orthopaedic Biosystems Ltd.
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