The present disclosure relates generally to surgery. More particularly, the present disclosure relates to methods, devices, and systems for retracting fibroids.
During laparoscopic procedures, large segments of tissue and/or organs may need to be maneuvered, retracted, and/or removed from the body. For example, during laparoscopic myomectomies, fibroids may need to be retracted and/or removed from the body.
Fibroids are benign tumors of the uterine myometria, i.e., muscle, and are the most common tumor of the female pelvis. Fibroid tumors affect up to 30% of women of childbearing age and can cause significant symptoms such as discomfort, pelvic pain, menorrhagia, pressure, anemia, compression, infertility, and miscarriage. Fibroids may be located in the myometrium, adjacent to the endometrium (i.e., submucosal), or in the outer layer of the uterus (i.e., subserosal). Most commonly, fibroids are a smooth muscle overgrowth that arise within the walls of the myometrium and can grow to be several centimeters in diameter.
Surgical myomectomy is a laparoscopic surgical procedure performed by a surgeon to spare the tissue of the uterus. Unfortunately, due to the limited spatial access through the uterus, laparoscopic myomectomy remains technically challenging. A surgeon must access the uterus through a small incision and dissect the fibroid from the uterine wall with limited access and with limited directions of traction of tissue. Moreover, once the fibroid is dissected from the uterine wall the fibroid must be morcellated to remove the fibroid through the incision.
There is a continuing need for improved instruments and methods for retracting and dissecting fibroids during myomectomy procedures including laparoscopic myomectomy.
In an aspect of the present disclosure, a retraction instrument includes a tube, an actuator and a first coil. The tube defines a passage therethrough. The actuator has a handle that has a shaft extending distally therefrom through the passage of the tube. The first coil is disposed adjacent a distal end of the shaft. The first coil is configured to secure the shaft to tissue.
In aspects, the first coil extends distally from the distal end of the shaft. The first coil may include a straight configuration in which the first coil is substantially linear and a coiled configuration in which the first coil is substantially non-linear and configured to secure the first coil within tissue. The first coil may be configured to transition from the straight configuration to the coiled configuration as the first coil is inserted into tissue.
In some aspects, the shaft has a retracted position in which the first coil is disposed within the tube and an extended position in which the first coil is positioned distal of the tube.
In certain aspects, the retraction instrument includes a second coil that is secured to a distal portion of the tube and extends distally from the distal portion of the tube. The first coil may be wound in a first direction, e.g., clockwise, and the second coil may be wound in a second opposite direction, e.g., counter-clockwise. The first coil may have a first diameter and the second coil may have a second diameter which is greater than the first diameter. The first coil may have a substantially constant diameter.
In particular aspects, the retraction instrument includes a rod that extends through the actuator to a tip that is disposed distal of the distal end of the shaft. The first coil may include a leading end that is secured to the tip and a trailing end that is secured to the shaft. The first coil may wind about the shaft between the leading and trailing ends. The first coil may have a contracted configuration in which the first coil defines a first diameter and an expanded configuration in which the first coil defines a second diameter greater than the first diameter. The rod may be rotatable relative to the shaft to transition the first coil between the contracted and expanded configuration. The first diameter may be less than a diameter of the passage.
In another aspect of the present disclosure, a method of retracting tissue within a body cavity is also disclosed. The method includes inserting a retraction instrument into the body cavity of a patient, engaging tissue within the body cavity with a first coil of the retraction instrument to secure the retraction instrument to the tissue, and retracting the tissue with the retraction instrument.
In aspects, engaging the tissue within the body cavity with the first coil includes rotating a handle of the retraction instrument in a first direction to rotate a shaft connected to the first coil to secure the first coil within the tissue. The method may include rotating a tube of the retraction instrument in a second direction that is opposite the first direction to secure a second coil extending from the tube in the tissue.
In some aspects, engaging the tissue within the body cavity with the first coil includes rotating a rod relative to a shaft of the retraction instrument to transition the first coil between a contracted configuration and an expanded configuration. The trailing end of the first coil may be secured to the shaft and a leading end of the first coil may be secured to a tip of the rod.
In another aspect of the present disclosure, a method of retracting tissue includes securing a first retraction coil to tissue, securing a second retraction coil to the tissue, and grasping an eyelet of the first retraction coil to retract the tissue.
In aspects, securing the first retraction coil to the tissue includes inserting a tip of the first retraction coil into the tissue with a coil of the first retraction coil disposed in a straight configuration and allowing the first retraction coil to transition to a coiled configuration which the first retraction coil is disposed within the tissue.
Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein.
Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein:
Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” refers to the portion of the device or component thereof that is closer to the clinician and the term “distal” refers to the portion of the device or component thereof that is farther from the clinician.
Referring now to
The actuator 30 includes a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 is fixed to the handle 32 such that the shaft 34 moves with the handle 32 as detailed below. The handle 32 is translatable along the longitudinal axis A-A between a retracted position (
The coil 40 is secured to the shaft 34 and is extendable from the distal portion 24 of the tube 20. The coil 40 is made from a super elastic material that has a straight configuration (
More particularly, shape memory alloys (SMAs) are a family of alloys having anthropomorphic qualities of memory and trainability and are particularly well suited for use with medical instruments. SMAs have been applied to such items as actuators for control systems, steerable catheters and clamps. One of the most common SMAs is Nitinol which can retain shape memories for two different physical configurations and changes shape as a function of temperature. SMAs have also been developed based on copper, zinc and aluminum and have similar shape memory retaining features.
SMAs undergo a crystalline phase transition upon applied temperature and/or stress variations. A particularly useful attribute of SMAs is that after it is deformed by temperature/stress, it can completely recover its original shape on being returned to the original temperature. The ability of an alloy to possess shape memory is a result of the fact that the alloy undergoes a reversible transformation from an austenite state to a martensite state with a change in temperature (or stress-induced condition). This transformation is referred to as a thermoelastic martensite transformation.
Under normal conditions, the thermoelastic martensite transformation occurs over a temperature range which varies with the composition of the alloy, itself, and the type of thermal-mechanical processing by which it was manufactured. In other words, the temperature at which a shape is “memorized” by an SMA is a function of the temperature at which the martensite and austenite crystals form in that particular alloy. For example, Nitinol alloys can be fabricated so that the shape memory effect will occur over a wide range of temperatures, e.g., −270° to +100° Celsius.
Many SMAs are also known to display stress-induced martensite (SIM) which occurs when the alloy is deformed from its original austenite state to a martensite state by subjecting the alloy to a stress condition. For example and with respect to
With reference to
Referring to
As the coil 40 penetrates into the fibroid F, a portion 44 of the coil 40 that is disposed within the fibroid F transitions from the straight configuration to the coiled configuration to secure the coil 40 to the fibroid F. The portion 44 of the coil 40 secures the shaft 34 of the actuator 30 to the fibroid F. With the fibroid F secured, another instrument (not shown) may be used to dissect the fibroid F from surrounding tissue such that the fibroid F can be removed from the body cavity. In embodiments, the handle 32 and/or the tube 20 of the surgical instrument 10 may be manipulated to aid in the dissection of the fibroid F.
With the fibroid F dissected from surrounding tissue, the handle 32 is retracted to draw the fibroid F towards the distal portion 24 of the tube 20. The fibroid F may be drawn into the passage 26 of the tube 20 and the entire instrument 10 may be withdrawn from the body cavity to remove the fibroid F from the body cavity.
In embodiments, a morcellator may be utilized to reduce the size of the fibroid F to allow the fibroid F to be removed from the access point (incision or natural body orifice) of the body cavity. In some embodiments, a portion of the fibroid F may be removed through the tube 20 by fully retracting the handle 32 such that the portion of the fibroid F is removed from the body cavity through the tube 20. The coil 40 and the shaft 34 may then be reinserted through the tube 20 to engage another portion of the fibroid F to remove the other portion of the fibroid F through the tube 20. This process may be repeated until the entire fibroid F is removed from the body cavity.
With reference to
The actuator 130 includes a handle 132 and a shaft 134 extending distally from the handle 132. The shaft 134 is fixed to the handle 132 such that the shaft 134 moves with the handle 132. Specifically, the handle 132 is translatable along the longitudinal axis A-A between a retracted position (
The coil 140 includes a trailing end 142, a leading end 144, and winds 146 disposed between the trailing and leading ends 142, 144. The trailing end 142 is secured to an outer surface of the shaft 134 and the leading end 144 is secured to the tip 138 of the rod 136. The coil 140 has a helical shape such that the winds 146 of the coil 140 wrap about the shaft 134. The coil 140 may be formed of a metal, e.g., surgical steel or spring steel, and may be formed of a super elastic material, e.g., Nitnol.
With particular reference to
Referring to
When the coil 140 is in the retracted position and the extended position as shown in
Referring to
In use, the retraction instrument 110 is inserted into a body cavity with the coil 140 in the retracted configuration in a similar manner to the retraction instrument 10 detailed above. The tip 138 of the rod 136 is positioned adjacent a fibroid F with the longitudinal axis A-A of the retraction instrument 110 passing through the fibroid F. The coil 140 is then transitioned into the extended position by pushing the handle 132 distally such that the tip 138 is driven into the fibroid F with the coil 140 in a contracted configuration. The tip 138 may be sharpened to aid in penetration of the fibroid F.
With the tip 138 disposed within the fibroid F, the rod 136 is rotated relative to the shaft 134 to transition the coil 140 towards the expanded configuration. As the coil 140 transitions towards the expanded configuration, the winds 146 of the coil 140 expand into and secure the shaft 134 and the rod 136 to the fibroid F. With the fibroid F secured to the shaft 134 and the rod 136, the retraction instrument 110 can be manipulated to dissect and remove the fibroid F from the body cavity in a manner similar to the retraction instrument 10 detailed above.
With reference to
The actuator 230 includes a handle 232 and a shaft 234 extending distally from the handle 232. The shaft 234 is fixed to the handle 232 such that the shaft 234 moves with the handle 232. Specifically, the handle 232 is translatable along the longitudinal axis A-A between a retracted position (not shown) and an extended position to translate the shaft 234 through the passage 226 of the tube 220. The handle 232 may be sized to prevent the handle 232 from passing through the passage 226. The handle 232 is also rotatable about the longitudinal axis A-A such that the shaft 234 may be rotated about the longitudinal axis A-A. In embodiments, the handle 232 is retractable such that the entire shaft 234 may be withdrawn from the passage 226 of the tube 220.
The coil assembly 240 includes a first coil 242 and a second coil 246. The first coil 242 is fixed to and extends distally from the shaft 234 to a first tip 244. The first coil 242 is a helical coil that is wound in a first direction, e.g., clockwise. The first coil 242 may be have a constant diameter, e.g., first diameter D1, or may have a constantly decreasing diameter from the first diameter D1 such that the first tip 244 is disposed along the longitudinal axis A-A. The first coil 242 cooperates with rotation of the handle 242. The second coil 246 is fixed to and extends distally from the distal portion 224 of the tube 220 to a second tip 248. The second coil 246 is a helical coil that is wound in a second direction opposite the first direction, e.g., counter-clockwise. The second coil 246 has a constant diameter, e.g., second diameter D2, that is greater than the first diameter D1. The second diameter D2 is large enough to allow the shaft 234 and the first coil 242 to pass through the second coil 246. The second coil 246 cooperates with rotation of the tube 220. The first and second coils 242, 244 may be rigid or may be at least partially flexible. The first and second tips 244, 248 may be sharpened to facilitate penetration of tissue as detailed below.
When the handle 232 is in the retracted position, the first coil 242 is disposed within the distal portion 242 of the tube 220. In the retracted position, the first tip 244 of the first coil 242 is disposed within the distal portion 242 or may be positioned distal of the distal portion 242. When the handle 232 is in the extended position, the first coil 242 is positioned distal of the second tip 248 of the second coil 248. In the extended position, at least the first tip 244 of the first coil 242 is positioned distal of the second tip 248. In the extended position, the entire first coil 242 may be positioned distal of the second tip 248.
In use, the retraction instrument 210 is inserted into a body cavity with the first coil 242 retracted within the distal portion 224 of the tube 220 in a similar manner to the retraction instrument 10 detailed above. The second tip 248 of the second coil 248 is positioned within the body cavity adjacent a fibroid F with the longitudinal axis A-A of the retraction instrument 210 passing through the fibroid F. The handle 232 is then pushed in a direction towards the fibroid F to extend the first coil 242 from within the tube 220 such that the first tip 244 engages the fibroid F. The handle 232 is then rotated in the first direction, e.g., clockwise, to drive the first tip 244, and thus the first coil 242, into the fibroid F. With the first coil 242 disposed within the fibroid F, the tube 220 is advanced towards the fibroid F until the second tip 248 of the second coil 246 engages the fibroid F. The tube 220 is then rotated in the second direction opposite the first direction, e.g., counter-clockwise, to drive the second tip 248, and thus the second coil 246, into the fibroid F. With the first and second coils 242, 246 disposed within the fibroid F, the retraction instrument 210 can be manipulated to dissect and remove the fibroid F from the body cavity in a manner similar to the retraction instrument 10 detailed above.
With reference to
In use, one or more retraction coils 310 are inserted into a fibroid F to provide an attachment point for a surgical instrument 390. Specifically, the eyelet 322 of the retraction coil 310 may be grasped by a surgical instrument 390, e.g., a grasper, and positioned adjacent the fibroid F with the tip 326 of the retraction coil 310 engaged with the fibroid F. The surgical instrument 390 is then rotated to drive the tip 326, and thus the coil 324, into the fibroid F. The surgical instrument 390 may be used to drive additional retraction coils 310 into the fibroid F.
With the retraction coil 310 secured in the fibroid F, the surgical instrument 390, or another surgical instrument (not shown), may grasp or be passed through the eyelet 322 to manipulate the fibroid F such that the fibroid F may be dissected from tissue and/or removed from a body cavity.
With reference to
In use, the retraction coil 410 is inserted into a fibroid F by driving the tip 426 into the fibroid F with the shaft 424 in the straight configuration. The tip 426 may be sharpened to aid in penetration of tissue. When the shaft 424 is disposed within the fibroid F, the shaft 424 transitions to the coiled configuration to secure the retraction coil 410 into the fibroid F. A surgical instrument such as surgical instrument 390 (
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.
This application claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 62/702,399, filed on Jul. 24, 2018, the contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62702399 | Jul 2018 | US |