# Patent

## Title
Apparatus and method for suspending a uterus

## Abstract

An inter-vaginal device for performing a uterine suspension includes a rigid body for manipulating the uterus and implanting a suspension member, such as a mesh, for securing the uterus to an anchoring site (e.g., into a pelvic muscle or ligament). In one embodiment, a method includes inserting at least a portion of a uterine suspension member through an anterior or posterior vaginal incision. An end of the suspension member is anchored to a selected portion of a pelvic tissue. At least a portion of the suspension member is attached to a vaginal apex. A uterine manipulator is advanced in a direction toward the selected portion of the pelvic tissue such that at least a portion of a uterus is moved upward.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. provisional patent Application No. 60/721,366, filed Sep. 28, 2005, entitled “Apparatus and Method for Suspending a Uterus,” the disclosure of which is hereby incorporated by reference in its entirety.


BACKGROUND
The present invention relates generally to the field of medical devices, and in particular to an apparatus and method for suspending a uterus of a human or animal subject.
Many women with uterine prolapse would like for their condition to be surgically corrected, but avoid or delay undergoing an operation because they wish to avoid hysterectomy. The potential reasons for avoiding hysterectomy vary widely including plans for future childbearing, concern about the invasiveness of the procedure or the difficulty of the recuperation, or fear of diminished sexual function. Some women are simply reluctant to “give up” this part of their body so closely associated with their reproductive health, childbearing, and femininity.
Uterine prolapse can be effectively treated without hysterectomy, with low morbidity and high rates of patient satisfaction. A properly performed uterine suspension surgery often results in a significantly better anatomic outcome than hysterectomy. Yet, many hysterectomy procedures are performed for pelvic prolapse. One reason why most patients remain unaware of the uterine-sparing option is because with the exception of a few dedicated sub-specialists, most surgeons receive no training in these techniques. In addition, known techniques and equipment can be difficult and require involved specialized training that many general practitioners have not undertaken.
Thus a need exists for an improved apparatus and method for providing a minimally invasive hysteropexy that can be incorporated into mainstream gynecologic practice.
SUMMARY OF THE INVENTION
An apparatus, method and kit for performing a uterine suspension procedure are disclosed herein. In one embodiment, an inter-vaginal device for performing a uterine suspension includes a rigid body for manipulating the uterus and implanting a suspension member, such as a mesh, for securing the uterus to an anchoring site (e.g., into a pelvic muscle or ligament). In another embodiment, a method includes inserting at least a portion of a uterine suspension member through an anterior or posterior vaginal incision. An end of the suspension member is anchored to a selected portion of a pelvic tissue with anchoring methods that may include tying off with sutures, or directly affixing the suspension member to the pelvic tissue with, for example, self-affixing mesh arms. At least a portion of the suspension member can be attached to a vaginal apex or adjacent to the vaginal apex to further facilitate scarring. A uterine manipulator can be advanced in a direction toward the selected portion of the pelvic tissue such that at least a portion of a uterus is moved upward.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic illustration of various components that can be used in a method according to an embodiment of the invention.
FIG. 2 is a side perspective view of a device for performing a uterine suspension and a uterine suspension member according to an embodiment of the invention.
FIG. 3 is a front pictorial representation of a placement of a suspension member around a uterus using the device of FIG. 2.
FIG. 4 is a flowchart illustrating a method according to an embodiment of the invention.
FIG. 5 is a flowchart illustrating a method according to another embodiment of the invention.



DETAILED DESCRIPTION
The invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
In some embodiments, the invention includes a device for performing a uterine suspension comprising a substantially rigid body having a handle at a distal end thereof, a lumen through the substantially rigid body for housing sutures of a suspension member; and a uterine manipulator at a proximal end thereof. The uterine manipulator can further include a prong for insertion into the uterus; a tenaculum clip for securing the uterine manipulator to the cervix; and a pair of wings for aiding in securing the suspension member to the vagina. Optionally, the uterine suspension device can be included in a kit, along with a mesh or graft for a cystocele and/or a rectocele augmentation.
In another embodiment. the invention includes a method of performing a uterine suspension. The method can include the steps of making an anterior or posterior vaginal incision; palpating ischial spines bilaterally; inserting the suspension member through the vaginal incision; placing suspension sutures of the suspension member or a portion of the suspension member (e.g., self-affixing tanged mesh) into a sacrospinous or iliococcygeus anchoring site; inserting the uterine manipulator through the cervix and securing it thereto; fastening the suspension member to the corners of the vaginal apex or placing the suspension member adjacent to the vaginal apex; applying gentle traction on the sutures or the self-affixing mesh; advancing the uterine manipulator to the anchoring site; removing the device; tying the sutures or adjusting the self-affixing mesh to the appropriate tension; and closing the vaginal incision.
In still another embodiment, the invention includes a suspension member, the suspension member includes at least one suture having an anchoring member at a first end and a free end for manipulation by a practitioner, wherein the suture is woven through the suspension member for providing accordion-type folds. In some embodiments, the suspension member is constructed of a self-affixing mesh material requiring passage of mesh arms rather than sutures through the pelvic tissue/anchoring site.
Advantageously, the device of the invention will introduce a minimally invasive, uterine-sparing prolapse surgery that can be incorporated into mainstream gynecologic practice. The device can provide an effective, simple and reproducible uterine suspension technique for general gynecologic surgeons. The procedures described herein have the potential to attract countless women with uterine prolapse who would otherwise have avoided an operation, and increase the market of women choosing the described surgery for treatment of their prolapse condition.
These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the brief description of the drawings and detailed description of the invention are exemplary and explanatory of some embodiments of the invention, and are not restrictive of the invention, as claimed.
FIG. 1 is a schematic illustration of various components that can be used in a uterine suspension procedure to treat, for example, a uterine prolapse. A suspension device 110 can include a body 112 having a uterine manipulator device 118 disposed at a proximal end of the body 112. The suspension device can be, for example, a suspension device 10 described in more detail with reference to FIG. 2. In some embodiments, the body 112 is substantially rigid and defines a lumen (not shown in FIG. 1) extending between a proximal end and a distal end of the body 112. The uterine manipulator device 118 can include, for example, a prong 134 configured to be inserted through a cervix, and a clip 136, such as a tenaculum clip, with a sharp point configured to secure the uterine manipulator device 118 to the cervix during a uterine suspension procedure, as will be described in more detail below with reference to the uterine manipulator 18.
The suspension device 110 can be used to help secure a uterine suspension member 120 within a pelvic region P of a patient. A suspension member 120 can be formed, for example, with a mesh material and configured to be anchored on one end to a pelvic tissue T1 such as a sacrospinous ligament or a levator muscle, such as the iliococcygeus muscle, and on another end to a pelvic tissue T2 disposed on an opposite side of the uterus of the patient. Another portion of the suspension member 120 can be configured to be attached to a vaginal apex V of the patient. An example embodiment of a suspension member 20 is described in more detail below with reference to FIG. 2. An anchoring member 144 that includes a pair of winged portions (not shown in FIG. 1) can be releasably coupled to the uterine manipulator 118 of the suspension device 110 and inserted into a vagina of the patient using the suspension device 110. An example embodiment of an anchoring member 44 is described below with reference to FIG. 2. The anchoring member 144 can be released from the suspension device 120 and used to help secure the suspension member 120 within the pelvic region P of the patient. The suspension device 110 can also be used to move or manipulate the uterus during a uterine suspension procedure to place the uterus into a correct anatomical position.
With reference now to FIG. 2, an inter-vaginal uterine suspension device 10 for performing a vaginal hysteropexy is shown by way of an example embodiment. The uterine suspension device 10 includes a substantially rigid body 12 having a shaft 14 with a handle 16 at its distal end and a uterine manipulator portion 18 at its proximal end. Preferably, the handle 16 is an ergonomic handle, and those skilled in the art will understand that various handles can be employed without deviating from the scope of the present invention.
The substantially rigid body 12 is used to implant a suspension member 20 around the uterus so as to secure the uterus to a muscle or ligament in the deep pelvic area. The body 12 can be constructed of an inert and biocompatible material such as, for example, a metal such as titanium or stainless steel or a plastic, although those skilled in the art will understand that various materials can be employed without deviating from the scope of the present invention. The rigid body 12 can be reusable or it can be disposable. If the body is reusable, then the materials of construction are preferably autoclavable or otherwise capable of sterilization.
The suspension member 20 is configured generally in the shape of a “U” having a pair of arms 22 and 24. The suspension member 20 can be formed, for example, of polypropylene or prolene mesh, although those skilled in the art will understand that various other biocompatible and biologically inert materials can be used as well for the suspension member 20. Additionally, the suspension member 20 may not be a “mesh” but instead be a band of an inert and biologically compatible material.
At least one, and preferably two tensioning sutures 26 and 28 are woven into the suspension member 20 for providing a suspension member with an accordion-type design (or accordion-type folds). A first anchor 30 is located at the proximal end of the suture 26, and a second anchor 32 is located at the proximal end of the suture 28. The anchors 30 and 32 anchor or attach the sutures 26 and 28 to an anchoring site, which is typically a pelvic muscle or ligament. The distal ends of the pair of sutures 26 and 28 are woven into the suspension member 20 and pass through a lumen 29 through the shaft 14 and out of the body 12 of the device 10 near the handle 16 so that the practitioner can manipulate the sutures with one hand while gripping the handle 16 with the other hand to manipulate the uterus.
The uterine manipulator portion 18 can include a substantially rigid prong 34 for insertion through the cervix into the uterus, a tenaculum (or a tenaculum clip) 36 with a sharp point for securing the uterine manipulator to the cervix, and an anchoring member 44 having a pair of wings 38 and 40 for anchoring the suspension member 20 to the vagina, can be coupled to the uterine manipulator 18. The wings 38 and 40 can be constructed of a malleable, “shape-memory” plastic, which allows for a comfortable fit into the vaginal fornices. Also, the wings 38 and 40 can each include at least one, and in some embodiments, a plurality of apertures 42 therein so that the practitioner can connect or suture the suspension member 20 to the vagina through the apertures. The wings 38 and 40 spread into the lateral corners of the vagina so that the suspension member 20 can be secured to the vagina.
In one embodiment, a method of performing a vaginal uterine suspension begins by administering anesthesia to the patient. For example, either a general anesthesia or an epidural anesthesia can be used. A practitioner makes an anterior or posterior vaginal incision, performs a standard anterior colporrhaphy dissection, and palpates the ischial spines bilaterally, all of which are generally well known to those skilled in the art. As the uterine suspension device 10 is inserted into the vagina, the practitioner inserts the suspension member 20 through the anterior (or posterior) vaginal incision. The ends of the suspension member 20, i.e., the sutures 26 and 28, are anchored in a pelvic muscle or ligament such that the suspension member generally surrounds the uterus. In some embodiments, the first suture 28 with anchor 32 is anchored into the sacrospinous ligament or the levator muscle (such as the iliococcygeus muscle) and the second suture 26 with anchor 30 is anchored into the sacrospinous or levator muscle on the opposite side, as depicted in FIG. 3. For example, a suturing device, such as, the CAPIO device manufactured by Boston Scientific can be used to place the sutures, although those skilled in the art will understand that various other suturing devices and techniques can be employed as well, including using a needle trocar to perforate the muscle or ligament and anchor the suture, or attach the suspension device 20 directly to the muscle. For example, the suspension device 20 can be formed with a mesh material that can be anchored directly to the tissue or muscle. Some iterations may involve fixation of mesh arms with no sutures/knot tying, by passing tension-free self-affixing mesh through the tissue or muscle.
The prong 34 of the uterine manipulator 18 is inserted through the cervix into the uterus and is fastened thereto with the tenaculum clip 36. In so doing, the wings 38 and 40 coupled to the device 10 are positioned into the lateral corners of the vaginal apex. The suspension member 20 is fastened to the corners of the vaginal apex by suturing the suspension member 20 to the inside of the vagina through the apertures 42 in the wings 38 and 40. For example, sutures can be placed 2 cm lateral to the midline on each side. Optionally, the practitioner can use bioabsorbable anchors or sutures to secure the suspension member 20 to the vagina. Also optionally, if an augmentation is planned, an anterior or posterior graft can be secured with the same anchors at the vaginal apical corners.
The practitioner applies gentle traction on the sutures 26 and 28 (i.e., pulling the sutures rearwardly from the device 10) while simultaneously slowly advancing the uterine manipulator 18 in a direction generally towards the anchoring site e.g., the sacrospinous ligament or the iliococcygeus muscle). In so doing, the cervix along with the uterus is pushed up while the suspension member 20 shortens because of its accordion design and recreates the cardinal-uterosacral attachments between the vaginal apex and the pelvic sidewall. The practitioner removes the device 10, withdrawing it over the sutures 26 and 28, which are held at constant tension. The practitioner ties the sutures 26 and 28, without tension, leaving them inside the vaginal incision. The vagina is closed after completion of anterior compartment repair (i.e. colporrhaphy, graft placement).
FIG. 4 illustrates a method according to an embodiment of the invention. A method includes at 50 repositioning a uterus of a patient into a normal anatomic position. At 52, the uterus is supported in the normal anatomic position with a uterine suspension member secured to a vaginal apex of the patient. In some embodiments, the repositioning of the uterus includes at 54, advancing a uterine manipulator in a direction toward a selected portion of a pelvic tissue such that at least a portion of the uterus is moved upward. In some embodiments, the uterine suspension member is positioned across the vaginal apex and an end of the uterine suspension member is anchored or secured to a portion of pelvic tissue, and the uterine suspension member is also secured to the vaginal apex, at 56. In some embodiments, a first end of the uterine suspension member is secured to a first portion of pelvic tissue and a second end of the uterine suspension member is secured to a second portion of pelvic tissue, at 58. In some embodiments, an end of the uterine suspension member is secured to a sacrospinous ligament. In some embodiments, the uterine suspension member is positioned around the uterus and secured to a levator muscle.
FIG. 5 illustrates a method according to another embodiment of the invention. A method includes at 60 inserting at least a portion of a uterine suspension member through an anterior or posterior vaginal incision. An end of the suspension member is anchored to a selected portion of a pelvic tissue at 62. The pelvic tissue can be, for example, a sacrospinous ligament, or a levator muscle, such as an iliococcygeus muscle. In some embodiments, the anchoring an end of the suspension member includes anchoring an end of a suture coupled to the suspension member to the selected portion of the pelvic tissue.
At 64, at least a portion of the suspension member is attached to a vaginal apex. In some embodiments, the attaching the at least a portion of the suspension member to the vaginal apex includes at 66, coupling an anchoring member disposed within an interior of the vagina to the suspension member such that a portion of a wall of the vagina is disposed between the suspension member and the anchoring member. In some embodiments, the attaching at least a portion of the suspension member to the vaginal apex includes attaching the suspension member at a first corner of the vaginal apex and attaching the suspension member at a second corner of the vaginal apex. In some embodiments, the suspension member has a first end and a second end, and the second end of the suspension member is anchored to a second selected portion of a pelvic tissue on an opposite side of the uterus at 68.
At 70, a uterine manipulator can be optionally advanced in a direction toward the selected portion of tissue such that at least a portion of a uterus is moved upward. At 72, in some embodiments, simultaneously with the advancing the uterine manipulator, traction is applied to a suture coupled to the suspension member.
In some embodiments, a kit can be provided that includes at least one suspension member, such as suspension member 20, and a medical device, such as suspension device 10. The suspension member can have an end configured to be anchored to a pelvic tissue within a patient and a portion configured to be attached to a vaginal apex of the patient. The medical device can be used during a uterine suspension procedure to assist in securing the suspension member within a pelvic region of the patient. A kit can also include an anchoring member, such as anchoring member 44, configured to be disposed within an interior of a vagina of the patient and coupleable to the suspension member to help secure the suspension member to the vagina. A kit can also include at least one mesh or a graft to be used in a procedure such as a cystocele or rectocele augmentation.
CONCLUSION
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents.
The previous description of the embodiments is provided to enable any person skilled in the art to make or use the invention. While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
For example, a variety of different suspension members 20 can be used in any of the uterine suspension procedures described herein. A suspension member can be a variety of different configurations, shapes and/or sizes and be formed with various different materials not specifically described. The suspension device 10 can include any combination or sub-combination of the various features and components described herein. Further, other configurations for a suspension device can be used to perform the uterine suspension procedures described herein, while still remaining within the scope of the invention.

## Claims

1. A method, comprising:
inserting a uterine suspension member through an anterior vaginal incision of a vagina;
repositioning a uterus of a patient into a normal anatomic position;
positioning the uterine suspension member such that the uterine suspension member generally surrounds the uterus and a portion of the uterine suspension member is disposed between a front of the patient and the uterus of the patient; and
supporting the uterus in the normal anatomic position with the uterine suspension member secured to a vaginal apex of the patient.

2. The method of claim 1, wherein the repositioning includes advancing a uterine manipulator in a direction toward a selected portion of a pelvic tissue such that at least a portion of the uterus is moved upward.

3. The method of claim 1, further comprising:
positioning the uterine suspension member across the vaginal apex and a cervix of the patient and anchoring an end of the uterine suspension member to a portion of pelvic tissue.

4. The method of claim 1, further comprising:
positioning the uterine suspension member across the vaginal apex and a cervix of the patient and securing a first end of the uterine suspension member to a first portion of pelvic tissue and securing a second end of the uterine suspension member to a second portion of pelvic tissue.

5. The method of claim 1, further comprising:
positioning the uterine suspension member across a vaginal apex and a cervix of the patient and securing an end of the uterine suspension member to a sacrospinous ligament.

6. The method of claim 1, further comprising:
positioning the uterine suspension member across the vaginal apex and a cervix of the patient and securing the uterine suspension member to a levator muscle.

7. The method of claim 1, further comprising:
positioning the uterine suspension member across the vaginal apex and a cervix and securing a first end of the uterine suspension member to a first portion of pelvic tissue and securing a second end of the uterine suspension member to a second portion of pelvic tissue using a suture material.

8. The method of claim 1, further comprising:
inserting an anchoring member into an interior of the vagina; and
coupling the anchoring member to the suspension member with a suture such that a portion of a wall of the vagina is disposed between the suspension member and the anchoring member and the anchoring member remains disposed within the vagina.

9. The method of claim 1, wherein the positioning includes positioning the uterine suspension member such that it forms a “U” shape.

10. The method of claim 1, further comprising:
passing a first portion of the uterine suspension member on a first side of the uterus; and
passing a second portion of the uterine suspension member on a second side of the uterus.

11. A method, comprising:
inserting a uterine suspension member through an anterior vaginal incision of a vagina of a patient;
positioning the uterine suspension member such that a portion of the uterine suspension member is disposed between a front of the patient and a uterus of the patient; and
supporting the uterus of the patient with the uterine suspension member, the supporting including anchoring an end of the suspension member to a selected portion of a pelvic tissue and securing at least a portion of the suspension member to a vaginal apex of the vagina.

12. The method of claim 11, further comprising:
advancing a uterine manipulator in a direction toward the selected portion of the pelvic tissue such that at least a portion of a uterus is moved upward.

13. The method of claim 11, wherein the end of the suspension member is a first end, the selected portion of a pelvic tissue is a first selected portion of a pelvic tissue, the method further comprising:
prior to the securing, anchoring a second end of the suspension member to a second selected portion of a pelvic tissue on an opposite side of a uterus.

14. The method of claim 11, wherein the securing the at least a portion of the suspension member to the vaginal apex, includes securing the suspension member at a first corner of the vaginal apex and securing the suspension member at a second corner of the vaginal apex.

15. The method of claim 11, wherein the pelvic tissue is a sacrospinous ligament.

16. The method of claim 11, wherein the pelvic tissue is an iliococcygeus muscle.

17. The method of claim 11, wherein the anchoring an end of the suspension member includes disposing an anchor coupled to the suspension member to the selected portion of the pelvic tissue.

18. The method of claim 11, wherein the anchoring an end of the suspension member includes disposing an end of a suture coupled to the suspension member to the selected portion of the pelvic tissue, the method further comprising:
advancing a uterine manipulator in a direction toward the selected portion of the pelvic tissue such that at least a portion of a uterus is moved upward; and
simultaneously with the advancing the uterine manipulator, applying traction to the suture.

19. The method of claim 11, further comprising:
inserting an anchoring member into an interior of the vagina; and
coupling the anchoring member to the suspension member with a suture such that a portion of a wall of the vagina is disposed between the suspension member and the anchoring member and the anchoring member remains disposed within the vagina.

20. The method of claim 11, wherein the positioning includes positioning the uterine suspension member such that the uterine suspension member forms a “U” shape.

21. A method, comprising:
inserting a uterine suspension member through an anterior vaginal incision of a vagina;
positioning the uterine suspension member such that the uterine suspension member forms a “U” shape and generally surrounds the uterus; and
supporting the uterus with a first portion of the uterine suspension member secured to a first sacrospinous ligament and a second portion of the uterine suspension member secured to a second sacrospinous ligament on an opposite side of the patient's body.

22. The method of claim 21, wherein the positioning includes advancing a uterine manipulator in a direction toward a selected portion of a pelvic tissue.

23. The method of claim 21, further comprising:
inserting an anchoring member into the vagina; and
coupling the anchoring member to the suspension member with a suture such that a portion of a wall of the vagina is disposed between the suspension member and the anchoring member and the anchoring member remains disposed within the vagina.

24. The method of claim 21, further comprising:
inserting an anchoring member into the vagina, the anchoring member including a first wing portion and a second wing portion;
placing the first wing portion and the second wing portion in opposite lateral corners of the vagina; and
coupling the anchoring member to the suspension member with a suture such that a portion of a wall of the vagina is disposed between the suspension member and the anchoring member and the anchoring member remains disposed within the vagina.

25. The method of claim 21, further comprising:
repositioning a uterus of a patient such that at least a portion of the uterus is moved within the patient.

26. The method of claim 21, wherein the securing includes securing a third portion of the uterine suspension member to a vaginal apex of the patient.

27. The method of claim 21, further comprising:
passing the first portion of the uterine suspension member on a first side of the uterus; and
passing the second portion of the uterine suspension member on a second side of the uterus.

28. The method of claim 21, wherein the positioning includes disposing a portion of the uterine suspension member between a front of the patient and the uterus of the patient.