FUNCTIONAL UTERINE MANIPULATOR
20210204980 · 2021-07-08
Inventors
Cpc classification
A61B34/70
HUMAN NECESSITIES
A61B17/4241
HUMAN NECESSITIES
A61B17/42
HUMAN NECESSITIES
International classification
A61B17/42
HUMAN NECESSITIES
Abstract
A uterine manipulator can include a shaft including a first end, a second end, and a channel along an axis of the shaft, a handle coupled to the first end of the shaft, and a triangular balloon coupled to the second end of the shaft. The triangular balloon can be configured to inflate upon insertion into a vagina via a fluid injected into the channel of the shaft.
Claims
1. A uterine manipulator, comprising: a shaft including a proximal end, and a distal end; a manipulator handle coupled to the proximal end of the shaft; a balloon coupled to the distal end of the shaft; and a cutting assembly rotatably disposed about the shaft, the cutting assembly including: a tube slid over the shaft and rotatably disposed about the shaft; a cutting handle coupled to a proximal portion of the tube; a cup to receive at least a portion of a fornix of a patient, the cup being coupled to a distal portion of the tube; and a retractable cutter extending distally with respect to the cup, the retractable cutter being movable from a first retracted position to a second, extended position, wherein the retractable cutter extends distally beyond the cup when in the second position, wherein the cutting assembly can be rotated about the shaft by the cutting handle to allow the retractable cutter to travel in a circle at a junction of a cervix and a vagina to permit transection of a uterus and a cervix from a vagina, and further wherein the cup rotates in unison with the retractable cutter when the cutting assembly is rotated about the shaft during a cutting operation.
2. The uterine manipulator of claim 1, wherein the retractable cutter passes through a channel defined in the cup, and further wherein the retractable cutter slides with respect to the channel defined in the cup when it is advanced and retracted.
3. The uterine manipulator of claim 1, wherein the retractable cutter is coupled to a slidable actuator, and further wherein advancing the slidable actuator distally and proximally causes the retractable cutter to extend and retract, respectively.
4. The uterine manipulator of claim 3, wherein the slidable actuator is coupled to the retractable cutter.
5. The uterine manipulator of claim 3, wherein the slidable actuator is coupled to a connector, and further wherein the connector is coupled to the retractable cutter.
6. The uterine manipulator of claim 1, wherein the retractable cutter is coupled to an electrical conductor, wherein the electrical conductor is at least partially surrounded by a tubular member, and further wherein the electrical conductor and tubular member are slidably disposed with respect to each other.
7. The uterine manipulator of claim 1, wherein the cutting handle, tube, retractable cutter, and cup are configured to rotate about the shaft in unison.
8. The uterine manipulator of claim 1, wherein the retractable cutter includes a blade.
9. The uterine manipulator of claim 1, further comprising an electrical connector to couple to an electrosurgical unit, the electrical connector being configured to be coupled to the retractable cutter.
10. An electrosurgical system comprising the uterine manipulator of claim 1 coupled to an electrosurgical unit, wherein current can be selectively routed from the electrosurgical unit to the retractable cutter.
11. The uterine manipulator of claim 3, wherein the slidable actuator is configured to rotate about the shaft with the cup.
12. A uterine manipulator, comprising: a shaft including a proximal end, and a distal end; a manipulator handle coupled to the proximal end of the shaft; a balloon coupled to the distal end of the shaft; a cutting assembly rotatably disposed about the shaft, the cutting assembly including: a tube slid over the shaft and rotatably disposed about the shaft; a cutting handle coupled to a proximal portion of the tube; a cup to receive at least a portion of a fornix of a patient, the cup being coupled to a distal portion of the tube; a retractable cutter coupled to the cup, wherein the cutting assembly can be rotated about the shaft by the cutting handle to allow the retractable cutter to travel in a circle at a junction of a cervix and a vagina to permit transection of a uterus and a cervix from a vagina; an outer tubular member surrounding the tube of the cutting assembly; and a pneumooccluder disposed on the outer tubular member, the pneumooccluder including a balloon coupled to a filling tube.
13. The uterine manipulator of claim 12, wherein the cup and tube of the cutting assembly can be moved with respect to the outer tubular member when the balloon is inflated inside of a vagina of a patient.
14. The uterine manipulator of claim 12, wherein the tube of the cutting assembly can be rotated about the shaft of the uterine manipulator without requiring rotation of the balloon of the pneumooccluder.
15. A method of performing a hysterectomy on a patient with a uterine manipulator including a cutting assembly rotatably disposed about a shaft of the uterine manipulator, the cutting assembly including a cup portion, a cutting handle and a retractable cutter, the method comprising: inserting the uterine manipulator into the vagina until the cup portion reaches a juncture between the patient's vagina and the patient's cervix; electrically energizing and advancing the retractable cutter distally with respect to the cup portion into tissue to cut the tissue; and rotating the cup portion and retractable cutter of the cutting assembly about the shaft to separate the patient's vagina from the patient's cervix by manipulating the cutting handle.
16. The method of claim 15, wherein the uterine manipulator further includes an outer tubular member surrounding the cutting assembly, the outer tubular member including a pneumooccluder balloon disposed thereon, and wherein the method further comprises rotating the cutting assembly with respect to the outer tubular member during the rotating step.
17. The method of claim 15, wherein the retractable cutter is advanced distally with respect to the cup portion by sliding the retractable cutter with respect to the cup portion.
18. The method of claim 15, wherein the retractable cutter is advanced distally with respect to the cup portion by sliding the retractable cutter with respect to the cup portion along a channel defined in the cup portion.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0026]
[0027] As shown in
[0028] As shown in
[0029] As shown in
[0030] In at least one embodiment, an additional mechanism (for example, in the handle 12), can be used to control both pivot points 50, 52. For example, if the additional mechanism is actuated in a first direction, both pivot points 50, 52 can be locked in place. If the additional mechanism is actuated in a second direction, both pivot points 50, 52 can be unlocked and maneuverable. The shaft 14 can be constructed of a non-rigid, flexible material to facilitate insertion of the uterine manipulator 10 into the uterus 114.
[0031] The tip assembly 16 can act as an umbrella-like expansion component capable of being adjusted between a retracted position and an expanded position. As a result, the tip assembly 16 can replace conventional intra-uterine balloon elements. The tip assembly 16 can be situated into the retracted position, as shown in
[0032] The expansion elements 28 can be spring-like elements capable of being in compression (e.g., shortened in length) and in tension (e.g., lengthened). Pulling the expansion actuator 36 away from the handle housing 34 can cause the expansion elements 28 to compress and expand outward circumferentially, situating the tip assembly 16 into the expanded position. Pushing the expansion actuator 36 back into the handle housing 34 causes the expansion elements 28 to retract back into tension and lengthen, situating the tip assembly 16 into the retracted position. Alternatively, the expansion actuator 36 can be twisted or rotated, rather than pulled and pushed from the handle housing 34, to adjust the expansion elements 28.
[0033] As shown in
[0034] Pulling the expansion actuator 36 outward from the handle housing 34 causes the expansion connectors 48 to pull the expansion tip 24, and the tip shaft 26, further into the tip housing 32. Because the expansion elements 28 rest against the edge 72 of the tip housing 32, they are compressed (i.e., shortened in length) when the expansion tip 24 and the tip shaft 26 are forced into the tip housing 32. Shortening of the expansion elements 28 causes them to expand in their circumferential direction, therefore situating the tip assembly 16 into the expanded position. In the reverse, pressing the expansion actuator 36 back into the housing releases the pulling tension of the expansion connectors 48 on the expansion tip 24. The expansion elements 28 can be in a resting state when in tension and thus, without the pulling tension by the expansion connectors 48, the expansion elements 28 will revert back to their resting, retracted state, thereby pulling the expansion tip 24 and the tip shaft 26 back out from the tip housing 32 and situating the tip assembly 16 into the retracted position.
[0035] Referring back to
[0036] The cutting assembly 18 can be rotated about the shaft 14 (e.g., by the cutting handle 78), allowing the cutter 84 to travel in a circle at the junction of the cervix 112 and the vagina 110 and permitting complete transection of the uterus 114 and the cervix 112 from the vagina 110. The spring 81 can help distribute rotational forces evenly across the tube 76 when the cutting assembly 18 is rotated, for example, to prevent the tube 76 from breaking due to excess torque concentrated along one portion of the tube 76.
[0037] The electrical connector assembly 22 can advance the cutter 84 outward from the cup portion 82 to achieve the detachment procedure described above, and can retract the cutter 84 inward to facilitate insertion of the uterine manipulator 10 into the uterus 114 without piercing the vaginal walls 120 prior to proper positioning of the uterine manipulator 10. The electrical connector assembly 22 can provide an electrical connection between the cutter 84 and an electrosurgical unit (not shown) in order to provide hemostasis during the detachment procedure. The electrical connector assembly 22 can include a handle 94, a cap 96, a button 98, tubing 100, 102, and electrical connectors 104, 106. On one end of the electrical connector assembly 22 (i.e., adjacent to the cap 96), the tubing 100 and the electrical connectors 104 can be routed to the electrosurgical unit. On the other end of the electrical connector assembly 22, the tubing 102 and the electrical connectors 106 can be routed to the cutter 84. The electrical connectors 104,106 can be electrically connected through the button 98 so that current can be routed from the electrosurgical unit to the cutter 84. The electrical connectors 106 can be coupled to the cutter 84 and the button 98 so that pressing the button 98 forward and backward causes the cutter 84 to extend and retract, respectively.
[0038] Referring to
[0039] Thus, the uterine manipulator 10 can be inserted into a patient's vagina 110 while in the retracted position, as shown in
[0040] At least one embodiment can include any combination of one or more of the above-described components and/or other conventional uterine manipulator components. The above-described components, such as the cutting assembly 18, the tip assembly 16, and the pneumooccluder 20 can function independently from one another and therefore can be individually incorporated into a uterine manipulator with or without the other components. For example, it may be preferable to include the pneumooccluder 20 as described above with some previous approaches to best execute a specific pelvic procedure.
[0041] Referring to
[0042]
[0043] Twisting or rotating the expansion actuator 336 in a first direction causes the expansion elements 328 to compress and expand outward circumferentially, situating the tip assembly 316 into the expanded position. Twisting or rotating the expansion actuator 336 in a second, opposite direction causes the expansion elements 328 to retract back into tension and lengthen, situating the tip assembly 316 into the retracted position.
[0044] The cutting assembly 318 can be rotatable about the shaft 314. More specifically, as shown in
[0045] Referring to
[0046] The inner groove 210 of the cup portion 202 can be taller than the outer groove 208 to prevent the cutter 206 from being pulled inward (instead of upward or outward) as the instrument 218 pulls the cutter 206. In addition, the laparoscopic instrument 218 can include an outer insulation cover 219 that is pushed forward while the cutter 206 is pulled out of the grooves 208, 210. That is, the cutter 206 is pulled into or received in the laparoscopic instrument 218 so that the cutter 206 is covered by the laparoscopic instrument 218 during operation, thereby enhancing safety given that the cutting wire or blade (which can be carrying electrical current, as described below) is not exposed at any given time.
[0047] The cutter 206 can either cut the vagina without electrical current (“cold”) or with an electrical current, based on surgeon preference. For example, a distal end of the laparoscopic instrument 218 can connect to an electrosurgical unit (not shown) or electrical connector assembly, which can conduct monopolar or bipolar current. Accordingly, once the laparoscopic instrument 218 grasps the cutter 206, current is passed through the instrument 218 and to the cutter wire 206. Different operations can be conducted based on monopolar or bipolar configurations. For example, in a monopolar configuration, the cutter 206 can be pulled out of the cup portion 202 along its entire circumference and removed via the laparoscopic instrument 218 (as described above with reference to
[0048] In a bipolar configuration, the cutter 206 can be a shorter wire than the monopolar configuration, for example, about 2 centimeters (cm) to about 3 cm. The cutter 206 can be pulled through the vaginal tissue by the laparoscopic instrument 218, remaining at the 12 o'clock position, and then the cup portion 202 can be rotated about the shaft as the cutter 206 is held in place. One pole of the bipolar current can be through the laparoscopic instrument 218 (connected to the cutter wire 206) and the other pole can be through the cup portion 202.
[0049] In at least one embodiment, the shorter cutter 206 can be held between the grooves 208, 210 by a small ball (not shown) at a distal end of the cutter 206. The ball can help the cutter 206 slide around the circumference of the cup portion 202 but also prevents the entire cutter 206 from being pulled out from between the grooves 208, 210 as the laparoscopic instrument 218 pulls the cutter 206. Once the cutter 206 has traversed the entire circumference of the cup portion 202, a break or opening (not shown) between the grooves 208, 210 can allow the ball to be pulled out from the cup portion 202 and into the laparoscopic instrument 218 for removal. This ball configuration can be used with bipolar or monopolar applications. In bipolar applications, a small metal lining inside of the grooves 208, 210 can electrically connect the cup portion 202 to the ball (which is electrically connected to the laparoscopic instrument 218).
[0050] The uterine manipulator 10, 300, 400, or at least one or more components of the uterine manipulator 10, 300, can be used with orifice-assisted small incision surgeries (OASIS). In such surgeries, instrumentation can be inserted through a patient's belly button as well as the patient's vagina 110. The optical axis (e.g., of a laparoscope inserted through the belly button) can be decoupled from the operative axis (e.g., of a surgical tool inserted through the vagina 110). The uterine manipulator 10, 300 can include an extension tool to assist with OASIS procedures.
[0051] The present disclosure has described one or more preferred embodiments.
[0052] However, it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.