Patent Application
20080039864
The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout, and in which:
The present invention is directed to a cervical tenaculum having an applicator member with a longitudinal lumen and a tubular member shaped to reciprocate within the lumen. The applicator member and the tubular member are first connected one to the other by engaging protrusions extending from the distal end of the tubular member with matching grooves inside the lumen. After positioning the applicator member in the cervical os of a patient, the protrusions are disengaged from the grooves, and the tubular member is disconnected from the applicator member. The applicator member instead remains positioned in the cervical os and provides access to the uterine cavity by a clinician.
In one embodiment, the applicator member is frustoconical in shape and has grooves disposed on its outer surface, engaging and anchoring the applicator member to the walls of the cervical os in a screw-like fashion.
In another embodiment, the positioning of the applicator member in the cervical os is aided by a control arm that is connected to the applicator member and that is actuated by the clinician.
Referring to
Applicator 12 is typically made of a resilient material, such as a silicone material, that retains its basic configuration while providing for a relatively soft contact with the os of the patient. Further, when applicator member 12 is made from a silicone material, an injection molding process can be employed, reducing the manufacturing costs of the tenaculum in comparison with the metal tenacula in the prior art, and providing for a tenaculum that can be disposed after use, thereby avoiding the cleaning and sterilization processes required by tenacula in the prior art.
Applicator member 12 is dimensioned to comfortably fit into the cervical os, and typically has a distal base with a diameter of approximately 6 mm, a proximal base with a diameter of approximately 14 mm, and a lateral wall that is approximately 14 mm long. One skilled in the art will recognize that other dimensions may be used, to fit patients of different sizes.
Tubular member 14 is generally cylindrical in shape, and has an outer diameter that allows tubular member 14 to reciprocate within lumen 22. A plurality of protrusions 24 extend radially in the proximity of distal end 26 of tubular member 14. A plurality of corresponding lateral grooves 28 are carved angularly within lumen 22, with dimensions and positions that correspond to the dimensions and positions of protrusions 24. Consequently, when distal end 26 is inserted within lumen 22, protrusions 24 first travel along longitudinal grooves 30 until an alignment with lateral grooves 28 is achieved, and successively, upon an angular rotation of tubular member 14, protrusions 24 engage lateral grooves 28, creating a stable connection between applicator member 12 and tubular member 14.
One skilled in the art will recognize that protrusions 24 may have different shapes, for instance, cylindrical shapes with sharp or rounded edges, or semi-spherical shapes, and that longitudinal grooves 30 and lateral grooves 20 may be produced with corresponding shapes. Further, protrusions 24 may be positioned at the same distance from distal end 26, or may be longitudinally spaced from one another. Still further, as illustrated in
One skilled in the art will also recognize that different arrangements of lateral grooves 28 and protrusions 24 are possible. For example, in one embodiment, lateral grooves 28 may be disposed in a direction that is not perpendicular to the longitudinal axis of applicator member 12; in particular, lateral grooves 28 may be disposed in a spiral pattern inside lumen 22, and protrusion 24 may engage lateral grooves 28 after tubular member 14 is rotated inside lumen 22 with a twisting motion. In another embodiment (not shown), tubular member 14 may have a threaded distal end 26 that engages a corresponding threaded pattern in lumen 22. In this embodiment, applicator member 12 and tubular member 14 are joined and separated in the same manner as a nut with a bolt.
Tubular member 14 may have a solid cross-section, like a tubular rod, or a hollow center, like a tubular conduit. While a solid cross-section provides for greater rigidity, a hollow cross-section will enable a clinician to use tubular member 14 as conduit for inserting other instruments, like a catheter.
Referring now to
Ridges 32 may also have different contours. For example, as shown in
In the preferred embodiment, grooves 44 are disposed in a spiral pattern on outer surface 20, and are defined by grooves 44, providing applicator 12 with a screw-like shape that adheres to the inner cervical walls.
Referring now to
A method for using the above-described cervical tenaculum is described hereinafter. In a first step, applicator member 12 and tubular member 14 are connected one to the other by inserting distal end 26 of tubular member 14 into lumen 22 of applicator member 12, and by matching protrusions 24 with grooves 28. The clinician may be alerted that protrusions and grooves are in matching positions in a variety of ways, for example, by having protrusions 24 and grooves 28 match when the distal end 26 reaches distal base 16, or by having markings disposed on tubular member 14 indicate the requited depth of insertion into lumen 22. Alternatively, applicator member 12 and tubular member 14 may be supplied to the clinician in pre-assembled condition.
In a second step, the clinician rotates the tubular member 14, locking protrusions 24 in grooves 28, and achieving a stable connection between applicator member 12 and tubular member 14, so that a longitudinal translation of tubular member 14 will cause an equal translation of applicator member 12.
In a successive step, the clinician inserts the cervical tenaculum in the vaginal canal of the patient until the applicator member contacts the cervical os. If necessary, the clinician will twirl applicator member 12 by moving tubular member 14 and, if provided, by acting on control arm 48, until applicator member 12 is securely positioned in the os. Ridges 32 on applicator member 12 provide an anchoring action, preventing an undesired release of applicator member 12 due to the constrictive action of the os and movements of the patient's body.
In the next step, the clinician counter-rotates tubular member 14, disengaging protrusions 24 from grooves 28, and extracts tubular member 14 from the patient's body, while leaving applicator member 12 positioned in the cervical os. Applicator member 12 maintains then the os in a dilated position in and enables access to the uterus through the lumen of the applicator member.
While preferred embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made. The appended claims are intended to cover all such changes and modifications that fall within the spirit and scope of the invention.
