Systems, devices and methods for delivering an implant

#The present disclosure generally relates to systems, devices, and methods for delivering a supportive sling to an anatomical location in a patient. In various embodiments, the present disclosure is directed to systems, devices, and methods relating to delivery of an implant or portion thereof, such as a mesh strap and/or a sling, to an anatomical site in a patient to treat urinary incontinence.

#Pelvic floor disorders afflict many men and women. According to some studies, about 1 out of 11 women needs surgery for a pelvic floor disorder during her lifetime. The pelvic floor generally includes muscles, ligaments, and tissues that collectively act to support anatomical structures of the pelvic region, including the uterus, the rectum, the bladder, and the vagina. Pelvic floor disorders include vaginal prolapse, vaginal hernia, cystocele, rectocele, and enterocele. Such disorders are characterized in that the muscles, ligaments and/or tissues are damaged, stretched, or otherwise weakened, which causes the pelvic anatomical structures to fall or shift and protrude into each other or other anatomical structures.

#Moreover, pelvic floor disorders often cause or exacerbate female urinary incontinence (UI). One type of UI, called stress urinary incontinence (SUI), affects primarily women and is generally caused by two conditions-intrinsic sphincter deficiency (ISO) and hypermobility. These conditions may occur independently or in combination. In ISO, the urinary sphincter valve, located within the urethra, fails to close (or “coapt”) properly, causing urine to leak out of the urethra during stressful activity. In hypermobility, the pelvic floor is distended, weakened, or damaged, resulting in increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.) and consequently the bladder neck and proximal urethra rotate and descend. As a result, the urethra does not close with sufficient response time, and urine leaks out of the urethra.

#The following figures depict illustrative embodiments of the invention in which like reference numerals refer to like elements. These depicted embodiments may not be drawn to scale and are to be understood as illustrative of the invention and not as limiting in any way.

#FIG. 1 depicts a delivery device according to an illustrative embodiment of the invention.

#FIGS. 2A-C depict bottom sections of a delivery device with various types of transfer pins according to illustrative embodiments of the invention.

#The present disclosure, in various illustrative embodiments, relates to systems, methods, devices, and kits for delivering and placing a medical implant at an anatomical site in the body of a patient. In some embodiments, the systems, methods, devices, and kits disclosed herein are useful in delivering an implant to the pelvic region of a patient for pelvic floor repair and/or for treatment of urinary incontinence. The patient may be either a female patient or a male patient, but is described below for illustrative purposes as being female. In some instances, the systems and kits include devices with features that are sized and shaped to deliver the surgical implant to the pelvic region, and surgical implants sized, shaped, and constructed to support various organs within the pelvic region, or more generally to promote tissue growth in and the general stability of the pelvic region.

#In some illustrative examples, the present disclosure additionally or alternatively provides delivery devices, systems, and methods for placing an implant, such as a sling, or a portion thereof, for supporting an organ in a patient's pelvic region for treating urinary incontinence, including SUI and/or pelvic floor disorders. In certain applications, the organ includes one or more of a urethra, bladder, bladder neck, uterus, rectum, or a portion thereof. The methods include trans-vaginal approaches. In one aspect, the invention provides a delivery device for prepubicly delivering a supportive sling to the periurethral tissue of a patient, for example, under a bladder neck or mid-urethral location.

#In some embodiments, the delivery device includes a transfer pin, adapted for receiving an implant or a portion thereof, and a receiver adapted for receiving the transfer pin optionally while associated with the implant. In certain embodiments, the implant includes an implant associator for associating the implant with a transfer pin, a central region, and a plurality of extensions, such as mesh straps, that extend from the central region and are adapted for securing or anchoring at respective locations in the pelvic region of a patient to appropriately position and/or tension the implant. The extensions may be anchored to the patient's pelvic floor using delivery devices that drive the extensions through the tissues, ligaments, and/or muscle regions thereof and/or transfer the implant or a portion thereof from one portion, section, region, or component of the delivery device to another. Hence, in certain embodiments, the delivery devices as described herein provide methods for transferring a portion of an implant, such as a mesh strap, from a section of the device to another section of the device. In some embodiments, the association of a portion of an implant with an anatomical site of a patient and transfer of a portion of an implant from a section of a delivery device to another section of a delivery device occur sequentially and/or simultaneously.