Surgery – Instruments – Suturing needle
Reissue Patent
2001-03-29
2002-08-06
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Suturing needle
Reissue Patent
active
RE037815
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to suturing needle assemblies and methods of use thereof and more particularly to suturing needle assemblies for enabling simultaneous passage of suture and introduction of local anesthetic into body tissue. Methods of using the suturing needle assemblies include cystopexy, cystourethropexy, urethropexy and uteropexy procedures.
Stress urinary incontinence is a very common problem among females and is defined as involuntary loss of urine during coughing, laughing, sneezing or other physical activity. The most common cause of stress urinary incontinence among females is urethral hypermobility, significant displacement or prolapse of the urethra and bladder neck during strenuous physical activity, or the intrinsic urethral sphincter deficiency. Labor during childbirth, pelvic surgeries and menopause, among other conditions, lead to defects in the endopelvic fascia and the weakening of the support structures of the urethra and the bladder. During intrinsic sphincter deficiency the urethral sphincter is unable to generate enough resistance to retain urine in the bladder. This type of incontinence is commonly seen after vaginal surgeries, trauma, radiation, neurological disorders, aging or menopause. Patients with intrinsic sphincter deficiency may leak urine continuously or with minimal exertion.
Currently available methods of surgical treatment are expensive, invasive, require general anesthesia and are contraindicated in patients with other medical problems which put them into a higher surgical risk group. These methods (e.g. Kelly plication, Pereyra, Marshall-Marchetti-Krantz, Burch, Paravaginal repair) require incision that increases the risk of morbidity from the procedure. Patients with employment cannot afford to leave work for the time required for recovery from the conventional procedures, and these patients choose to suffer from urinary incontinence rather than being disabled temporarily. Commonly available procedures do not provide correction of urethral hypermobility or the intrinsic sphincter deficiency and simultaneous correction of the anatomical defects leading to cystocele and the drop in bladder neck.
Marshall-Marchetti-Krantz described a procedure where periurethral tissue is approximated to the symphysis pubis. This procedure involves abdominal incision and related complications including osteitis pubis. Burch described a procedure where the vaginal wall lateral to the bladder neck is elevated towards the cooper's ligament. This procedure also involves abdominal incision and related complications, including bladder damage with the suture material accidentally placed in the bladder as well as postoperative symptomatic enterocele and rectocele. The paravaginal repair involves reapproximating the endopelvic fascia to the pelvic wall at the arcus tendineus. This procedure also involves abdominal incision and related complications.
Pereyra described a technique where vaginal tissue on each side of the urethra is sutured to the fascia of the abdominal wall. This procedure also involves incision and related complications including injury to the surgeon's fingers with the risk of transmission of HIV, hepatitis and other infectious diseases.
Kelly plication involves dissection of vaginal wall and plication of pubocervical fascia. Procedures for intrinsic sphincter deficiency are sling procedures, artificial sphincter or the periurethral bulking injections. Sling procedures and artificial sphincter are more invasive procedures requiring extensive use of synthetic materials. Periurethral injections are expensive and provide only temporary relief.
Against this background, a need exists for surgical devices and procedures offering the least invasive, safe and effective alternative to existing methods for the surgical treatment of urinary incontinence.
It is, therefore, an object of the present invention to provide surgical tools and methods for overcoming the problems and limitations of the prior art.
Another object of the present invention is to provide suturing needle assemblies and surgical procedures for enabling simultaneous passage of suture and introduction of local anesthetic into body tissue.
Another object is to provide such needle assemblies and procedures which are used for surgical management of female urinary incontinence and other pelvic floor disorders under local anesthesia without the need for use of general anesthesia.
A further object of the invention is the provision of such needle assemblies and procedures for use in the surgical management of female urinary incontinence and other pelvic floor disorders without requiring an incision in the patient.
Still another object is to provide such needle assemblies and procedures which reduce the risk of complications, such as bleeding and infections.
Yet another object of the present invention is the provision such needle assemblies and procedures which enable patients to go home more promptly after surgery.
Another object is to provide such needle assemblies and procedures which permit the surgeon to safely perform the procedures of this invention on patients in whom traditional procedures are contraindicated due to other medical conditions.
A further object of the invention is the provision of such needle assemblies and procedures which reduce the cost of traditional surgical procedures for management of female urinary incontinence and other pelvic floor disorders.
Another object is to provide needle assemblies and procedures and procedures for use of the needle assemblies which enable the procedures to be performed in a physician's office, outpatient surgery center or mobile medical unit so as to provide patients from rural areas access to modern medical care.
Another object is to provide needle assemblies and procedures for surgical management of female urinary incontinence and other pelvic floor disorders which reduce the chance of injury or transmission of infectious disease to the surgeon.
A further object of the invention is the provision of needle assemblies and methods of using the needle assemblies for surgical management of female urinary incontinence and other pelvic floor disorders which reduces the cost of surgery by eliminating the cost of inpatient care after surgery and by eliminating the cost for general anesthesia.
Another object is to provide such needle assemblies and procedures which reduce the possibility of accidental damage to organs of the patient during the surgical procedures.
Another object is to provide instruments and surgical techniques which allow for permanent correction of the anatomical defects leading to pelvic organ prolapse and urinary incontinence.
A further object is to provide instruments and surgical techniques that are minimally invasive and which provide a bigger, stronger area of anchoring on the abdominal muscles.
Still another object is to provide instruments and surgical techniques which decrease the chances of sutures cutting through.
Another object is to provide instruments and surgical techniques where there is no synthetic support material under the bladder or on the abdomen.
A further object is to provide instruments and surgical techniques for their use wherein the techniques are easy to perform, reproducible and safe for the surgeon and the patient.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages are realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
SUMMARY OF THE INVENTION
To achieve these and other objects, the present invention provides a suturing needle assembly for enabling simultaneous passage of suture and introduction of local anesthetic into body tissue, the assembly comprising: a hollow needle body defining an interior passageway and further defining first and second ends having first and second openings therein, respectivel
Ho (Jackie ) Tan-Uyen T.
Kettlestrings Donald A.
Milano Michael J.
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