The present disclosed subject matter is directed to medical instruments used to manipulate a uterus during laparoscopic examination or surgery a method associated therewith. In particular, the disclosed subject matter is directed to structure on a handle that allows for a movable tip to be easily joined to the handle and remain secured on the handle until disengagement of the tip from the handle is desired.
Gynecologists frequently examine the internal pelvic organs of a patient by using a laparoscope. The medical procedures may include laparoscopic tubal occlusion and fertility studies. During such laparoscopic procedures, it is frequently necessary for the uterus to be repositioned in order to obtain an X-ray or to perform surgery.
Instruments have been developed to aid the surgical team in these procedures, and particularly to manipulate the uterus into a desired orientation. For example, the instruments and systems disclosed in commonly owned U.S. Pat. Nos. 5,409,496 and 5,540,700, the disclosures of both of these patents incorporated by reference herein, disclose reusable handles to which disposable tips are connected when use is desired. Attachment of the tips may be difficult to personnel lacking sufficient strength or dexterity in their hands and fingers.
The present disclosed subject matter provides an improved system for mounting a tip, such as a disposable tip, to a handle. The system is suitable for use in laparoscopies procedures as well as chromopertubation. The system includes a snap-drum at the end of a movable end of the handle. The snap-drum allows for the easy attachment of a tip by a single directional (unidirectional) short rotation or twist (through an arc of approximately 180°), free of multiple twists and turns. The snap-drum is constructed to allow for an easy and secure attachment of the tip, including by operators with minimal strength and/or dexterity. Also, this construction allows for those other than highly trained personnel to attach tips to handles, such that upon attachment, the tip will be properly oriented on the handle for proper use. This saves time, as the next procedure can begin immediately, once the tip is secured on the handle.
The disclosed subject matter is directed to an apparatus for uterine manipulation. The apparatus includes a handle unit including a proximal end and a distal end. The handle unit includes a movable member at a proximal end of the handle unit, and a drum at the distal end of the handle unit. The drum is operatively coupled to the movable member, such that movement of the movable member moves the drum about a predetermined range of motion. The drum also includes a body and a head extending from the body, the head configured for receiving the proximal end of a tip member, for example, a disposable tip, that is attached to and retained on the head by a substantially single directional (unidirectional) rotation.
Another embodiment of the disclosed subject matter includes an apparatus for uterine manipulation. The apparatus includes a handle unit including a proximal end and a distal end. The handle unit includes a movable member at a proximal end of the handle unit, and a drum at the distal end of the handle unit. The drum is operatively coupled to the movable member, such that movement of the movable member moves the drum about a predetermined range of motion (for example, approximately a 140° arc). The drum includes a body and a head extending from the body. The head includes a base coupled to the body, at least one fin extending from the base; and a slot corresponding to the at least one fin. The slot extends through a portion of the at least one fin and the base, and is, for example, pitched at an angle of approximately 30°-50° with respect to the vertical (a longitudinal axis extending through drum from the head to the body).
Another embodiment of the disclosed subject matter is directed to a method for attaching a tip member (or tip) to a handle unit to form a uterine manipulation apparatus. The method includes providing a handle unit including a proximal end and a distal end. The handle unit includes a movable member at a proximal end of the handle unit, and a drum (for example, a snap-drum) at the distal end of the handle unit. The drum is operatively coupled to the movable member, such that movement of the movable member moves the drum about a predetermined range of motion. The drum includes a body and a head extending from the body, and the head includes a base that is coupled with the body, at least one fin extending from the base, and a slot corresponding to the at least one fin, the slot extending through a portion of the at least one fin and the base. A tip member is provided that includes an elongated shaft including a proximal end and a distal end. The tip member also includes a boot of resilient material connected to the proximal end of the shaft, with the boot including structure defining a substantially enclosed recessed area distal to a substantially annular radially inwardly extending lip, for releasably coupling to the head of the handle unit. The tip member and handle unit, at the head, are brought into contact, such that the lip is caught by the slot. The tip member and/or the handle unit are rotated such that the lip extends over the base, whereby the tip is attached to the head of the drum.
Another embodiment is directed to an apparatus for uterine manipulation. The apparatus includes a handle unit including a proximal end and a distal end. The handle unit also includes a movable member at the proximal end, and a drum member, for example, a snap-drum, at the distal end. The drum member is operatively coupled to the movable member, such that movement of the movable member moves the drum member about a range of motion corresponding to the movement of the movable member. The drum member includes a base and least one slot extending through the base, of a width sufficient for catching a portion of a lip of a tip member when the tip member is placed into contact with the drum member.
Attention is now directed to the drawings, where like numerals or characters indicate corresponding or like components. In the drawings:
In this document, references to proximal ends, sides and directions, and distal ends, sides, and directions, respectively, correspond to the proximal 20a, 22a and distal 20b, 22b ends, as established for the uterine manipulator 20 and frame 22. Additionally, in this document, references are made to directions, such as upper, lower, top, bottom, up, down, upward, downward, front, rear, above, below, left, right, lateral and variations thereof. These directional references are exemplary, to show the disclosed subject matter in an exemplary orientation, and are in no way limiting.
As may be seen in
In greater detail, the frame 22 is of a modified I-beam construction as shown in
As may be seen in
The handle 24 is preferably generally machined or alternatively molded of synthetic resin (for example, also autoclavable) in an inverted L-shape, and is provided with a graspable section 70 defining a central opening 72 which both reduces weight and enables the user to pass a length of fabric or other supporting material therethrough to suspend the handle 24 during surgery. The handle 24 further includes an arm 74 projecting from the graspable section 70 which includes an aperture 76 as seen in
The handle 24 includes a top relieved area 78 along the remote part of the arm 74 for permitting the connecting means 30 to swing through a desired range of motion, and a similar bottom relieved area 80 on the bottom side of the remote part of the arm 74. The graspable section 70 further includes a bore 82 opening toward the rear or proximal side of the uterine manipulator 20 for receiving a spring 84 and a rod 86, which serve in locking the handle 24 in the desired position relative to the frame 22.
To that end, the proximal end of the handle 24 mounts a locking pawl 88 which is part of the locking mechanism 32. The pawl 88 is pivotally connected to the handle 24 by a pin 90. The pawl 88 includes a thumb latch 92 and catch 94. The thumb latch 92 is normally biased away from the handle 24 by the rod 86, whereby the catch 94 engages a selected notch 96 on the proximal end 22a of the frame 22. The pawl 88 is preferably molded of synthetic resin material, and is, for example, autoclavable.
Snap-drum 26, as shown in detail in
A channel (bore) 104 extends internally through the snap-drum 26, from an opening 104a in the rim 102. The channel 104 receives a shaft 114 (detailed further below), that extends proximally from the tip 34, therein.
The head 100 also includes fins 106a, 106b, which project generally distally from the rim 102. The fins 106a, 106b are, for example, symmetric. The fins 106a, 106b extend, for example, along the longitudinal axis A3 and, for example, are coplanar, with a plane formed by Axis A1 and longitudinal axis A3. Each fin 106a, 106b includes an inclined portion 106c, extending from the rim 102, at its rounded edge 102a′, and terminating in a flat portion 106b, at the distal end of the head 100. Slots 107a, 107b, also symmetric as positioned on the head 100, are at opposite lateral sides of the respective fin 106a, 106b. The slots 107a, 107b run diagonally through the head 100, and are formed in rounded portion 102a of the rim 102, and a portion of the respective fin 106a, 106b. The slots 107a, 107b are uniform in width and are pitched or angled with respect to the a vertical axis AA extending through the snap-drum 26. The pitch or angle, represented by α, may be, for example, approximately 30°-50° degrees, and as a further example, approximately 45°. These slots 107a, 107b, for example, function similar to that of screw threads, as they serve to catch the lip 126 of the boot 116 at the proximal end of the tip 34, for engaging the tip 34 during, when the tip 34 is being attached to the snap-drum 26, by being rotated on to the head 100 of the snap-drum 26. A neck 108 of reduced diameter connects the body 98 to the head 100, permitting enhanced connection of the tip 34 to the head 100, as the lip 126 ultimately fits over the proximal side 103p of the rim 102, for a secure engagement of the tip 34 on the snap-drum 26 (as shown in
The pivot pin 28 is, for example, of metal such as stainless steel (for example, which is autoclavable) and may be a rivet or provided with a threaded fastener at one end to provide a secure connection between the handle 24 and the frame 22.
The handle 24 and the snap-drum 26 are connected by connecting means 30, which include a pair of wires 110 and 112. The wires 110 and 112, are, for example, made of metal, such as stainless steel, that is autoclavable.
The wires 110 and 112 are bent at the proximal and distal (remote) ends thereof to fit into corresponding holes in the arm 74 and body 98, respectively. The body 98 is provided with corresponding relieved areas on each side to permit movement of the snap-drum 26 without interference between the wires 110 and 112 and the sidewalls 40 and 42.
As may be seen from
The tip 34, as shown in
The tip 34 includes an elongated shaft 115 extending distally from a boot 116 of the aforementioned material which is circular in cross-section, as seen in
Each tube 118 and 122 is provided with the appropriate fittings to connect with respective controlled sources of pressurized air and dye. For example, the dye tube 122 at its free end may include a luer lock connector 125 for attachment to a dye syringe.
The boot 116 includes an annular radially inward projecting lip 126 (with an edge 126′), the lip 126 which presents an opening 127 to receive the head 100 of the uterine manipulator 20 therethrough, the lip 126 fitting normally proximate to the head 100 and into the neck 108. Remote to the lip 126 is a circular relieved area 128 which receives the head 100 and is complementally configured, including a remotely projecting slot or void 130 for receiving the fins 106a, 106b. The boot 116 thus effectively surrounds the head 100, the boot 116 being provided with a tapered distal or remote surface 132 for ease of insertion into the vaginal cavity.
As shown in
Throughout the attachment process, the rotation is single directional, like that of a screw, as the slots 107a, 107b, act like screw threads. The pitch of the slots 107a, 107b, coupled with their location with respect to the corresponding fins 106a, 106b allows for the attachment of the tip 34 by the aforementioned single directional rotation over an arc length of approximately 180°, or an approximately half rotation. Additional rotations in the direction opposite the arrow 152 are also permissible, should minor adjustments be desired. The now attached tip 34 is shown in
With the tip 34 now attached to the uterine manipulator 20, the physician or operator may now connect the balloon tube 118 to a source of pressurized air (not shown), while similarly connecting the dye tube 122 to a source of medical dye (not shown) as appropriate to the examination. The tip 34 is inserted into the vaginal cavity of the patient until the tip is properly positioned in the patient's uterus. During insertion, the handle 24 may be locked in a position whereby the shaft 114 is substantially aligned with the longitudinal axis of the frame 22 by positioning the catch 94 in the desired notch 96. While the uterine manipulator 20 is shown in
Once inserted, the handle 24 and proximal end of the frame 22 will project from the vaginal cavity. With the patient in a normally supine position with knees elevated, the graspable portion of the handle will be oriented upward. The physician then pivots the handle 24 relative to the frame about a pivot axis (A1) defined by the pivot pin 28, the pivot axis thus being parallel to but spaced forwardly or remote from the longitudinal axis (A2) of the graspable handle 24 and perpendicular to the longitudinal axis (A3) of the frame 22, the axes A1-A3 shown in
With the uterus properly positioned, the physician can inflate the balloon 120 to occlude the uterine passage and then inject dye or perform other functions as may be necessary. Advantageously, the handle 22 readily locks in the desired pivoted position unless the physician or operator depresses the latch 92 to release the catch 94. Thus, to reposition the tip 34, the physician or operator depresses the latch 92 on the pawl 90, pivots the handle 24 relative to the frame 22, and releases the latch 92 to lock the tip 34 into the desired orientation. After the procedure is complete, the balloon 120 is deflated, the tip 34 is positioned in substantial alignment with the longitudinal axis A3 (
If the physician or operator's hands must be freed during the procedure, a length of gauze or other material may be looped through the central opening 72 in the handle 24, as shown in
Turning back to
While preferred embodiments of the disclosed subject matter have been described, so as to enable one of skill in the art to practice the disclosed subject matter, the preceding description is intended to be exemplary only. It should not be used to limit the scope of the disclosed subject matter, which should be determined by reference to the following claims.
This application is related to and claims priority from U.S. Provisional Patent Application Ser. No. 60/891,144, entitled: Uterine Manipulator, filed on Feb. 22, 2007, the disclosure of which is incorporated by reference herein.
Number | Date | Country | |
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60891144 | Feb 2007 | US |