Surgery – Instruments – Suture retaining means
Reexamination Certificate
2000-03-29
2001-11-20
Reca, Henry J. (Department: 3731)
Surgery
Instruments
Suture retaining means
C606S104000, C606S139000, C128S898000
Reexamination Certificate
active
06319272
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a bone anchor implantation device for use in maintaining or improving urinary continence.
BACKGROUND OF THE INVENTION
Urinary incontinence is a widespread problem in the United States and throughout the world. Urinary incontinence affects people of all ages and can severely impact a patient both physiologically and psychologically.
In approximately 30% of the women suffering from urinary incontinence, incontinence is caused by intrinsic sphincter deficiency (ISD), a condition in which the valves of the urethral sphincter do not properly coapt In approximately another 30% of incontinent women, incontinence is caused by hypermobility, a condition in which the muscles around the bladder relax, causing the bladder neck and proximal urethra to rotate and descend in response to increases in intraabdominal pressure. Hypermobility may be the result of pregnancy or other conditions which weaken the muscles. In an additional group of women with urinary incontinence, the condition is caused by a combination of ISD and hypermobility.
In males, urinary incontinence may be the consequence of post radical prostatectomy, which can destroy the valves of the urethral sphincter.
In addition to the conditions described above, urinary incontinence has a number of other causes, including birth defects, disease, injury, aging, and urinary tract infections.
Numerous approaches for treating urinary incontinence are available. For example, several procedures for stabilizing and/or slightly compressing the urethra so as to prevent the leakage of urine have been developed. The stabilizing or compressive force may be applied directly by sutures passing through the soft tissue surrounding the urethra or, alternatively, may be applied by means of a sling suspended by sutures. In many procedures bone anchors are inserted into the pubic bone or symphysis pubis in order to anchor the sutures to the bone. The present invention simplifies such procedures and firther reduces their invasiveness.
SUMMARY OF THE INVENTION
The present invention relates to devices and methods for inserting anchors, such as bone anchors, into a bone or tissue.
One aspect of the present invention is a bone anchor implantation device comprising an elongated member having a first end and a second end. A bone anchor is releasably engaged to the elongated member in the vicinity of the first end. A protective sheath is mounted over the bone anchor. The protective sheath is axially movable relative to the bone anchor such that the bone anchor is exposed from the sheath as the bone anchor is pressed into a bone by the elongated member.
In one embodiment of the present invention, the device for inserting a bone anchor into bone comprises a first handle and a second handle. The first handle has a releasably-attached bone anchor at a first end of the first handle. The bone anchor extends from the first handle. The second handle is adjacent to the first handle. The second handle has a cannula extending therefrom at a first end of said second handle such that the bone anchor is located within the cannula. The first and second handles are movable with respect to each other to effect extension of the bone anchor out of the cannula.
In one aspect of this embodiment, the first handle has an inserter shaft attached to the first end of the first handle. The inserter shaft has a proximal end and a distal end and is adapted to releasably engage a bone anchor. The second handle has a proximal end and a distal end and is hingedly attached to the first handle. The cannula has a proximal end, a distal end, and a central bone extending therethrough. The cannula is aligned with the inserter shaft such that the inserter shaft is inside the central bone of the cannula and is extendable and retractable therefrom.
In another aspect of this embodiment, the device further comprises a biasing member disposed between the first handle and the second handle. The biasing member applies a force biasing the first handle and the second handle apart. The biasing member may comprise a spring disposed between the first handle and the second handle.
In yet another aspect of this embodiment, the device is adapted for transvaginal insertion of a bone anchor.
The device may further comprise a locking mechanism for locking the device in a position in which the inserter shaft is fully retracted in the cannula.
In one version of the device, the locking mechanism also locks the device in a position in which the inserter shaft is fully extended from the cannula.
Preferably, the inserter shaft has a pair of longitudinal grooves therein for receiving a suture.
In a further preferred embodiment, the cannula has a pair of longitudinal slots therein for receiving a suture. Preferably, the grooves in the inserter shaft and the slots in the cannula are aligned and coextensive.
In a preferred version of the device the inserter shaft and the cannula are curved.
Alternatively, the inserter shaft and the cannula are straight.
Preferably, the inserter shaft is at an angle of approximately 90° relative to the first handle and the cannula is at an angle of approximately 90° relative to the second handle.
In one version of the device, a hinge is disposed between the proximal end of the first handle and the proximal end of the second handle.
Preferably, the distal end of the cannula has a sharp point adapted for piercing tissue.
In yet another aspect of the device, a protective cap is located at the distal end of the cannula.
Another aspect of the invention is a method for inserting a bone anchor into a bone. One stop of the method comprise positioning an inserter device against tissue overlying the bone. The inserter device has a first handle having a releasably-attached bone anchor extending therefrom at a first end of the first handle. A second handle is located adjacent to the first handle. The second handle has a cannula extending therefrom at a first end of the second handle and the bone anchor is located within the cannula. Another step of the method comprises inserting the cannula through tissue overlying the bone. A further step of the method comprises moving the first handle and the second handle with respect to each other to force the bone anchor out of the cannula and into the bone.
In one aspect of the method, the bone anchor is implanted transvaginally into the pubic bone. Preferably, the bone anchor is implanted in posterior pubic bone. In a further preferred embodiment of the method the bone anchor is implanted lateral to the symphysis pubis and cephalad to the inferior edge of the pubic bone.
Preferably, at least one bone anchor is implanted on either side of the urethra.
The method may further comprise compressing or stabilizing the bladder neck with a suture attached to the bone anchor. In addition, the method may further comprise the steps of creating an opening in the tissue between the vaginal wall and the urethra, positioning a sling in the opening, and compressing or stabilizing the bladder neck with the sling using sutures connected between the sling and the bone anchors.
In one version of the method, two bone anchors are implanted on each side of the urethra. In this version, one bone anchor on each side of the urethra may be located lateral to the symphysis pubis and cephalad to the inferior edge of the pubic bone. The second bone anchor may be located on the cephalad aspect of the ramus.
Yet another aspect of the present invention is a device for inserting a bone anchor into a bone comprising a handle, a shaft, and a bone anchor mount for releasably engaging a bone anchor. The handle has a proximal end and a distal end. The shaft has a first end and a second end. The first end of the shaft is connected to the distal end of said handle. The bone anchor mount is connected to the second end of the shaft and oriented toward the handle so that the bone anchor may be inserted by applying a retrograde force to the bone anchor.
The device may further comprise a protective sheath connected to said bone anchor mount for isolating
Brenneman Rodney
Gellman Barry N.
Morin Armand A.
Sauvageau David
Boston Scientific Corporation
Reca Henry J.
Testa Hurwitz & Thibeault LLP
Woo Julian W.
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