The present disclosure includes examples of tissue fixation devices. Specifically, the tissue fixation devices described herein may be used with a uterine manipulator to grasp, retain and release cervical tissue. It will be appreciated that the disclosed embodiments may have applications outside of uterine manipulation, and may be used on other bodily tissues.
In some surgical procedures, it is desirable to control the position and orientation of an organ, such as a uterus, to help the surgeon operate on the uterus or on other parts of the body adjacent to the uterus. Uterine manipulator devices can be used to position and orient a uterus during surgery. U.S. Patent Application Publication No. US2012/0109147 discloses an example uterine manipulator system. Typical uterine manipulator systems consist of a bell-housing or cup shaped member that fits around the cervix and a rod member that is inserted through the cervix and into the uterus. The bell housing can be sized and shaped to compress the cervical tissue against the rod member to help the surgeon grasp the cervix and manipulate the position and orientation of the uterus. The bell housing can also provide a cutting guide to facilitate incision placement, for example colpotomy incisions and incisions requiring a safe distance from the ureters and uterine arteries. However, if the cervical tissue fixation within the bell housing is insufficient, a uniform colpotomy incision is difficult to achieve. Furthermore, the risk of damaging surrounding tissues, such as the ureters and uterine arteries, will increase if the tissue fixation is insufficient. The compressive forces imparted to the cervical tissue between the bell housing and the rod member are usually not sufficient enough to tightly grasp the cervix and ensure safe incision placement. Accordingly, it has been known to include a balloon in combination with the rod member which can be inflated inside of the uterus to provide additional pressure on the cervical tissue between the balloon and the bell housing to force the cervical tissue down into the bell housing and increase the gripping force of the bell housing on the cervix. However, the internal balloon may not create optimal tissue fixation, especially in patients with anatomical abnormalities, rigid tissues, scar tissue, and the like. Additionally, the balloon may leak or become accidentally “nicked” by other surgical instruments during the surgical procedure. This may result in loss of tissue fixation that can delay and complicate surgical incisions and/or removal of the uterus through the vagina in the case of a hysterectomy procedure. Moreover, it may not be desirable to use a balloon inside of a uterus containing cancerous cells, because the cancerous cells can be broken loose by the balloon and spread to other parts of the body. Sufficient tissue fixation is typically not achieved with a balloon, as is evidenced by workarounds currently used by many surgeons. For example, surgeons are known to use adjunctive stitches through the cervix which are then tied to the instrument to increase tissue fixation. This workaround adds additional steps to the surgery and further complicates things by making it difficult to quickly remove the bell housing and/or uterine manipulator from the patient if an emergency situation arises, such as the need to defibrillate the patient's heart.
Accordingly, it is desirable to provide a device that achieves reliable tissue fixation, with or without a balloon, that will last throughout the entire surgical procedure and that will not be compromised by rigid tissue, anatomical abnormalities, scar tissue, cancerous tissue, or the like. In some cases, it may also be desirable to generate tissue fixation close to certain incision sites, such as the colpotomy incision site, to increase the control, placement and precision of the incision. It is also desirable to provide a device that employs a simple actuation mechanism to quickly and easily engage and disengage the tissue fixation mechanism during surgery.
An example of the present technology disclosed herein includes a tissue fixation assembly shaped to be attached to a uterine manipulator. The assembly includes a housing, a fixation member carriage with deployable fixation members, and a cap. The fixation member carriage and fixation members are captured between the housing and the cap. In one example, a suture is attached to the fixation member carriage and is actuatable to move the fixation member carriage to deploy or retract the fixation members. The assembly may be inserted into a vagina and receive cervical tissue within the housing. The fixation members may then be deployed inwardly from the housing to grip the cervical tissue. The fixation members may also be locked in the deployed position to maintain the grip on the tissue. The fixation members may also be easily retracted to release the tissue and remove the device as needed.
Those of skill in the art will recognize that the following description is merely illustrative of the principles of the disclosure, which may be applied in various ways to provide many different alternative embodiments and may be applicable outside the fields of surgery or medical devices. While the present disclosure is made in the context of tissue fixation related to the cervix, for the purposes of illustrating the concepts of the design, it is contemplated that the present design and/or variations thereof may be suited to other uses for grasping any bodily tissue. Moreover, the devices and methods set forth herein may be used in open, percutaneous, and/or minimally invasive procedures.
All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Standard medical planes of reference and descriptive terminology are employed in this specification. A sagittal plane divides a body into right and left portions. A mid-sagittal plane divides the body into equal right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. Anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. These descriptive terms may be applied to an animate or inanimate body.