Patent Application
20160256151
The present invention relates generally to implants, tools, devices, systems, apparatuses, and related methods for treating pelvic conditions including but not limited to incontinence and prolapse conditions in men and women, for example, as can be treated by sacral colpopexy procedures.
Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., urinary or fecal), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor.
Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina, and is often associated with a rectocele, cystocele or enterocele. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. One known method of repairing vaginal vault prolapse is by suturing to the supraspinous ligament or attaching the vaginal vault through mesh or fascia to the sacrum. In particular, abdominal sacral colpopexy procedures are considered to be particularly effective treatments; however, such procedures can be relatively invasive and are somewhat complicated.
An additional consideration is that many patients suffering from vaginal vault prolapse also require a surgical procedure to correct stress urinary incontinence that is either symptomatic or latent. Unfortunately, in order to correct one or more of these issues, the procedures that are often used involve lengthy surgical procedure times and/or lengthy recovery periods. Some of these treatments include, for example, abdominal sacralcolpopexy (SCP), which may be performed laparoscopically, and transvaginal sacralcolpopexy (TSCP), wherein these procedures are performed using a variety of different instruments, implants, and surgical methods. It is known to repair vaginal vault prolapse by suturing the vaginal vault (e.g., by stitches) to the supraspinous ligament or by attaching the vaginal vault through mesh or fascia to the sacrum.
There is ongoing need to provide physicians with improved methods and associated instruments for treating pelvic conditions including incontinence, vaginal prolapse (e.g., vaginal vault prolapse), and other pelvic organ prolapse conditions, wherein such methods can include those that are minimally invasive, safe, and highly effective.
Tools, systems, and methods as described herein can be used to treat pelvic conditions such as incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, hysterectomies, and the like. In accordance with the invention, sacral colpopexy procedures can be performed through an abdominal opening, laparoscopically, or transvaginally, which procedures will require different approaches, each of which can use certain embodiments of devices and/or methods of the invention.
One procedure that can be used to treat vaginal prolapse conditions is sacral colpopexy. An aspect of certain sacral colpopexy procedures is to place a fixation element (e.g., an anchor such as a bone anchor or soft tissue anchor) into tissue of a posterior pelvic region to secure an implant to the tissue. This aspect of the procedure requires a surgeon to place a tissue anchor at a location deep inside a posterior pelvic region.
Surgical tools and procedural improvements are disclosed herein. Certain embodiments of tools and methods are used for attaching sutures, mesh, or other devices to the anatomy, such as for treating incontinence and/or prolapse. Embodiments of the tools can be used for deploying sutures through a retractor and into the peritoneum, for example. This can be useful for a number of different procedures that require suturing in the peritoneal space, such as sacral colpopexy (e.g., for attaching mesh material to the sacral promontory and for closing the peritoneal membrane over the mesh), high uterosacral suspension procedures (e.g., for passing suture through a tissue structure and fixating the suture to that tissue structure), McCall culdoplasty (i.e., a method of supporting the vaginal cuff by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material that can be drawn toward the midline to help close off the cul-de-sac), uterosacral suspension procedures, and the like.
In accordance with the invention, a suturing instrument is disclosed, which is designed to allow for a relatively simple procedure for passing a suture through tissue in a tightly confined space. In one embodiment, the suturing instrument provides for semi-automated, one-handed operation, which also provides for improved needle control. In a particular embodiment, the instrument includes a curved needle with a hook tip that is operated by a slider in a handle. Movement of the slider toward and away from a distal end of the instrument causes the needle to pierce and retract from the target tissue in a predetermined sequence, thereby positioning suture material in a desired configuration in the tissue.
A suture passer is also disclosed, in accordance with the invention, which is designed to allow for a relatively simple procedure for passing a suture through tissue in a tightly confined space, such as during the process of performing a sacral colpopexy procedure. The suture passer generally includes a needle that has a hypo tube that allows a suture to be “injected” through the hypo. The needle/hypo can engage with tissue like a traditional needle, and then a suture can be advanced through the needle by using pressurized air or water to force the needle through the hypo. The needle can then be disengaged from the tissue, leaving the suture connected to the tissue.
The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:
Pelvic floor disorders include cystocele, rectocele, enterocele, and uterine and vaginal vault prolapse, levator defects, among others, in male and female patients. These disorders typically result from weakness or damage to normal pelvic support systems. The most common etiologies include childbearing, removal of the uterus, connective tissue defects, prolonged heavy physical labor and postmenopausal atrophy.
Vaginal vault prolapse is the distension of the vaginal apex, in some cases to an orientation outside of the vagina. Vaginal vault prolapse is often associated with a rectocele, cystocele or enterocele. It is known to repair vaginal vault prolapse by suturing the vaginal vault (e.g., by stitches) to the supraspinous ligament or by attaching the vaginal vault through mesh or fascia to the sacrum. Many patients suffering from vaginal vault prolapse also require a concurrent or subsequent surgical procedure to correct stress urinary incontinence that is either symptomatic or latent.
In order to place a sling to stabilize or support the bladder neck or urethra, such as for the treatment of incontinence, surgical procedures and devices are often used. There are a variety of different sling procedures, where the slings used for pubovaginal procedures vary widely in the types of material and anchoring methods. In some cases, the sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g., bone) through an abdominal and/or vaginal incision. Examples of sling procedures are disclosed, for example, in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.
A sacral colpopexy is one procedure used for providing vaginal vault suspension. It may be performed through an abdominal incision, a vaginal incision, or laparoscopically. A sacral colpopexy entails suspension (by use of an implant such as a strip of mesh) of the vaginal cuff to a region of sacral anatomy such as the sacrum (such as may be accomplished using bone screws that are implanted into the sacrum), a nearby sacrospinous ligament, uterosacral ligament, or anterior longitudinal ligament at the sacral promontory. An implant such as a synthetic mesh can be carefully customized or assembled into a special shape by the surgeon. In some sacral colpopexy procedures that also involve a hysterectomy, an implant can alternatively be attached to posterior vaginal tissue that remains after removal of the uterus and cervix, and also to anatomy to support the vaginal tissue at or around the sacrum, such as to uterosacral ligaments or to the sacrum itself (i.e., to a component of the sacral anatomy).
As used herein, the term “anchor” refers to any structure that can connect an implant to tissue of a pelvic region. The tissue may be bone, or a soft tissue such as a muscle, fascia, ligament, tendon, or the like. The anchor may be any known or future-developed structure, or a structure described herein, useful to connect an implant to such tissue, including but not limited to a clamp, a suture, a soft tissue anchor such as a self-fixating tip, a bone anchor, any of the structures described herein to be useful to connect an implant to soft tissue or bone of a pelvic region, or the like.
The suturing instruments described herein are directed to the surgical treatment of a pelvic condition including prolapse (e.g., any form of vaginal prolapse), urinary and fecal incontinence, levator defects, etc., in a male or female patient. To treat such conditions, one or more implants can be implanted in a male or a female, which implants can include a tissue support portion that can be used to support a urethra or other pelvic tissue, along with one or more extension portions (otherwise known as an end portion or arm) attached or attachable to the tissue support portion. An implant may include portions, pieces, or sections that are synthetic or made of biologic material (e.g., porcine, cadaveric, etc.). Extension portions may be a synthetic mesh, for example, such as a polypropylene mesh, a suture, a biodegradable suture, etc. The tissue support portion may be synthetic (e.g., a polypropylene mesh) or biologic. Examples of implant products that may be similar to those useful according to the present description, include those sold commercially by American Medical Systems, Inc., of Minnetonka Minn., under the trade names “Apogee”, “Perigee”, and “Elevate” for use in treating pelvic prolapse (including vaginal vault prolapse, cystocele, enterocele, etc.), and under the trade names “Sparc”, “Bioarc”, “Monarc”, “MiniArc”, “InVance”, and “AdVance” for treating urinary incontinence.
Implants as described can include a tissue fastener at one or both of its ends and can be sutured in one or more additional locations, such as by directly suturing mesh to a target tissue location. A tissue fastener at a distal end or portion of an extension portion can be any of various types, including: a self-fixating tip that is inserted into soft tissue and frictionally retained; soft tissue anchors; biologic adhesive; a soft tissue clamp that can generally include opposing, optionally biased, jaws that close to grab tissue; and opposing male and female connector elements that engage to secure an end of an extension portion to tissue. (See International Patent Application No. PCT/US2007/014120; U.S. patent application Ser. Nos. 12/223,846 and 12/669,099; and WO 2009/075800, the entireties of which are all incorporated herein by reference). An implant may also have one or more extension portions that do not include a tissue fastener, such as may be used if the distal end is designed to be secured to tissue by other methods (e.g., suturing), or is intended to pass through an obturator foramen and a tissue path around a pubic ramus bone, in which case the extension portion may optionally include a connector, dilator, or dilating connector, which connects to an elongate tool that can be used to either push or pull the connector, dilator, or dilating connector through a tissue path (e.g., to a medial incision).
According to various systems as described, one or more suturing instruments may be incorporated or used with an implant or method as described. Examples of useful tools include those that are illustrated in
Slider mechanism 22 may further include an upper contoured surface 24 or other surface treatment that provides for friction between the user's finger and the surface of the slider mechanism 22. Such a surface 24 may be provided with ridges, as shown, or can instead include a rough or textured surface, which can provide for more controlled movement of the slider relative to the handle, particularly when the user's hand is covered with a surgical glove, for example.
Connecting rod 18 includes a base member 30 extending from its distal end, which may be adhered, friction fit, or otherwise mounted to the connecting rod 18. A needle 32 is connected to the base member 30 about a hinge point 36, as can best be seen in
Slider rod 16 includes a base member 40 extending from its distal end, which may be adhered, friction fit, or otherwise mounted to the slider rod 16. First and second extending arms 42, 44 extend from a distal end of the base member 40 and are spaced from each by the width of a gap 50 that extends in a direction of the width of the base member 40. Extending arms 42, 44 each have a distal aperture 46, 48, respectively, which are adjacent to their distal ends. The arms 42, 44 preferably extend from the base member 40 at an angle relative to the longitudinal axis of the suturing instrument 10, as shown, although it is understood that the angle can be greater or smaller than shown. In addition, it is contemplated that the extension angle can be different for each of the arms 42, 44. In any case, the configuration of the arms 42, 44 can be selected or designed to allow the needle 32 to engage with suture material in a manner in accordance with the present invention, wherein one such method is described below. That is, the illustrated configuration of the arms 42, 44 is only one representative configuration of these arms, wherein it is understood that the functional capability of the arms can be accomplished with a number of different configurations.
With this embodiment, suturing instrument 10 is essentially provided as a four-bar linkage that includes the curved needle 32 that is integrated into a crank, wherein the axis of the crank is mounted at the end of a shaft. The other end of the shaft is mounted to a slider in the handle, and the connecting rod connects the crank to the body of the handle. The needle/crank is caused to rotate by movement of the slider relative to the handle, which can be facilitated via a shaft (not visible) extending between hinge point 36 and crank attachment point 54.
In one embodiment of the suturing instrument 10, the proximal end of the instrument (e.g., the handle 20) extends from the proximal end of the slider rod 16 and connecting rod 18, wherein the length of the rods 16, 18 is sufficient to allow a user to grasp and manipulate the proximal end (e.g., at the handle) as the instrument is extended through an incision or opening (e.g., through a vaginal or abdominal incision) to place the distal end of the rods 16, 18 generally at a location of a posterior pelvic region, (e.g., to place the distal shaft end at a location for placing an anchor at a component of sacral anatomy, such as an anterior longitudinal ligament at a sacral promontory). The connecting rod 18 has a longitudinal axis, and the slider rod 16 similarly has a longitudinal axis. The axes of the connecting rod 18 and slider rod 16 of a particular suturing instrument 10 can be generally parallel to each other, as shown, or can be at least slightly offset relative to each other.
The suturing instruments of the invention allow for a relatively simple manner of passing a suture through tissue in confined locations, such as can be encountered when maneuvering the device for a sacral colpopexy procedure, for example. In one method of the invention, the needle 32 is positioned as illustrated in
In another step of the suturing process, the needle 32 can then be rotated about the hinge point 36 by moving the slider 22 relative to the handle 20 (e.g., with the thumb). This movement of the needle 32 about the hinge point 36 will move the needle tip 34 toward the gap 50 between the extending arms 42, 44, as is illustrated in
After the suture 60 is engaged with the tip area of the needle 32, the slider 22 can then be moved in the opposite direction to cause the needle 32 rotate back toward the position illustrated in
In one embodiment, the slider 22 is configured to slide within an elongated slot or groove 52 of the handle 20, and also to lock within the groove 52 with a dovetail type of connection, as is illustrated in
When a suture material 126 is loaded or otherwise positioned relative to a hydrotube of suture passer 120, the force of the pressurized substance will push the suture material through the length of that tube. Suture material 126 can thereby be transported from the proximal end of suture passer 120 to the distal end 130 of the passer, such as can be facilitated by friction between pressurized water and the suture that pushes the suture material through the tube, for example. In one embodiment, the pressure is high enough that the suture material is then forced through the target tissue in the patient, thereby replacing the function of a needle or other similar component. The suture can then be grasped or otherwise manipulated relative to its location in the patient, and then the suture passer can be pulled from the patient and/or used for additional suturing procedures. In order to operate in this manner, the area of the tube that is in contact with the tissue (e.g., at the distal end 130) can be hollow with relatively sharp ends that can puncture the tissue or otherwise maintain the passer in its desired location relative to the tissue.
With continued reference to
Suturing instruments described herein can thereby be used for securing implants that are capable of supporting pelvic tissue, and can therefore be useful in conjunction with numerous methods of treating pelvic conditions, such as treating a levator hiatus, anal incontinence, etc. The implants and tools described herein can be made of conventional materials. For example, the various mesh members and portions can be constructed of polymer materials, such as a thin film or sheet material of polypropylene, polyethylene, fluoropolymers or like compatible materials, both permanent and absorbable, and the suturing instrument components can be made of standard surgical-grade materials, such as polymeric materials, stainless steel, and the like.
The disclosed systems, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulate device, implants, and the like as disclosed in the references incorporated herein are envisioned for use with the present invention as well.
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.
This application is a divisional of U.S. application Ser. No. 13/537,612, filed Jun. 29, 2012, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/503,009, filed Jun. 30, 2011 and titled “Implants, Tools, and Methods for Treatments of Pelvic Conditions”, and U.S. Provisional Patent Application No. 61/506,833, filed Jul. 12, 2011, and titled, “Implants, Tools, and Methods for Treatments of Pelvic Conditions,” which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61503009 | Jun 2011 | US | |
| 61506833 | Jul 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13537612 | Jun 2012 | US |
| Child | 15155516 | US |
