Sling delivery system and method of use
First Claim
Patent Images
1. A surgical device for treating a patient comprising:
- at least one needle;
at least one atraumatic dilator having a connection means for conveniently and securely connecting the dilator to the at least one needle during a surgical procedure, and a sling material having a length sufficient for the sling material to extend from an abdominal wall of the patient to the urethra of a patient and back to the abdominal wall of a patient, and means for associating the sling with the dilator.
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Abstract
An apparatus and method of use are disclosed to treat urological disorders. The biocompatible device includes a handle, needle, dilator and sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the sling to be adjusted during and/or after implantation. The device and treatment procedure are highly effective and produce little to no side effects or complications. Further, operative risks, pain, infections and post operative stays are reduced, thereby improving patient quality of life.
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Citations
31 Claims
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1. A surgical device for treating a patient comprising:
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at least one needle;
at least one atraumatic dilator having a connection means for conveniently and securely connecting the dilator to the at least one needle during a surgical procedure, and a sling material having a length sufficient for the sling material to extend from an abdominal wall of the patient to the urethra of a patient and back to the abdominal wall of a patient, and means for associating the sling with the dilator. - View Dependent Claims (2, 3, 4, 5)
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6. A sling assembly for use in treating a patient comprising:
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a surgical mesh having a length sufficient to extend from a pubic space of the patient beneath the urethra to an abdomen of the patient on either side of a bladder of the patient;
a dilator for passage through tissue of the patient, the dilator being associated with an end of the surgical mesh; and
including surfaces that are sized and shaped to atraumatically deflect tissue during passage of the dilator through tissue, the dilator including an association means that is sized and shaped for association between the dilator and a surgical needle during a surgical procedure so that the needle can pull the dilator and surgical mesh through tissue of a patient. - View Dependent Claims (7, 8, 9)
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10. A surgical kit assembly for treating a patient comprising:
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at least two needles, each of the needles sized and shaped to extend substantially between an abdominal wall and a pubic region of a patient;
at least two dilators permanently attachable to the needles;
a length of implantable material with a pair of ends, means for associating the ends of the implantable material with the dilators; and
at least two handles corresponding to the needles, the handles being releasably attachable to either end of the needles. - View Dependent Claims (11, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 29, 30)
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12. A method of treating urinary incontinence in a patient comprising the steps of:
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creating a pathway in tissue that extends between an abdominal wall of the patient to a pubic space of the patient;
dilating the pathways;
pulling an implantable support material into the pathways while the pathways are being dilated; and
positioning the implantable support material in a therapeutically effective anatomical position relative to tissue of the patient that is intended to be supported.
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13. A sling system for use in treating a patient comprising:
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at least one curved needle having opposing ends;
a sling material adapted to be associated with one end of the at least one needle, the sling material being sized and shaped to extend beneath a patient'"'"'s urethra up to a patient'"'"'s abdomen;
the needle being adapted to pull the sling through tissue of a patient, and an atraumatic dilator for deflecting tissue as the needle pulls the sling through tissue.
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14. A method of treating urinary incontinence in a patient comprising the steps of:
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creating at least one incision in vaginal tissue, creating at least one suprapubic incision, providing an assembly comprising a synthetic implantable material, and a protective sheath situated about the implantable material, the sheath constructed of a material that affords visual examination of the implantable material and that affords passage of the assembly through tissue of the patient, at least one needle that is sized, shaped and designed to either i) initially pass the needle from the vaginal incision to the supra pubic incision, or ii) initially pass the needle from the supra pubic incision to the vaginal incision; and
means for associating the needle with the assembly,selecting to either initially pass the needle from the vaginal incision to the supra pubic incision, or to initially pass the needle from the supra-pubic incision to the vaginal incision;
passing the assembly through tissue of the patient using the needle according to the selection to locate the implantable material in a therapeutically effective position relative to the urethra of the patient; and
removing the protective sheath.
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15. A surgical needle for implanting a sling of a sling assembly that includes a dilator, the needle comprising:
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an elongate arcuate portion that is sized and shaped to withstand forces encountered during a sling implantation procedure;
a first end having attachment means for associating the first end with either a releasably attachable handle or a dilator of the sling assembly, and a second end having attachment means for associating the second end with either a releasably attachable handle or a dilator of the sling assembly.
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17. A method of implanting a sling to treat urinary incontinence in a female patient comprising the steps of:
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creating at least one incision in vaginal tissue, creating at least one suprapubic incision, initially passing an end of a curved needle guide through the suprapubic incision, identifying the posterior portion of the patient'"'"'s pubic bone with the end of the needle to controllably move the end of the needle toward the vaginal incision and to avoid damaging structures such as the urethra and bladder of the patient, passing the end of the needle through the vaginal incision, associating a sling with the needle, and implanting the sling in a therapeutically effective position.
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27. A method of implanting a sling to treat urinary incontinence in a patient comprising the steps of:
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creating at least one incision in vaginal tissue, creating at least one suprapubic incision, placing a curved needle with a removable handle between the vaginal incision and the suprapubic incision, then removing the handle, then associating a sling with the needle, and implanting the sling in a therapeutically effective position.
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31. A method of implanting a sling to treat urinary incontinence in a male patient comprising the steps of:
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creating at least one perineal incision, creating at least one suprapubic incision, initially passing an end of a curved needle guide through the suprapubic incision, identifying the posterior portion of the patient'"'"'s pubic bone with the end of the needle to controllably move the end of the needle toward the perineal incision and to avoid damaging sensitive tissues, passing the end of the needle through the perineal incision, associating a sling with the needle, and implanting the sling in a therapeutically effective position.
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Specification