During minimally invasive surgery, conventional trocars (e.g., narrow tubes) are used through incisions to support instruments that will be operating within the body. See, for example,
Applying a large force to conventional bags (e.g., when attempting to retrieve a large specimen through a small incision) also risks rupturing the bag and potentially seeding bacteria, bile, stones, tumor cells, etc. from the specimen. One suboptimal solution for conventional bags is to widen the incision to accommodate the specimen, but this results in more patient pain, increased rate of hernia formation. Another suboptimal solution for conventional bags is to break up the specimen into smaller pieces (e.g., morcellation), but morcellation is a time consuming and cumbersome process that destroys the integrity of the specimen for pathologic analysis.
The Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.
One aspect of the present disclosure provides a laparoscopic device to remove a specimen through a laparoscopic incision by compressing the specimen and elongating the specimen along a longitudinal axis and reducing cross-sectional area.
One aspect of the present disclosure provides a device including a rod with a tip and a channel formed in the tip. The device also includes a containment member including a first end and a second end opposite the first end. The second end is coupled to the tip, and the containment member includes an opening positioned at the first end. The device further includes a string coupled to the opening of the containment member. The string extends through the channel in the tip.
In some embodiments, the device further includes a sheath defining a passageway; wherein the rod is positioned at least partially within the passageway and movable with respect to the sheath; and wherein the string extends through the passageway; wherein the opening in the containment member is oriented toward the sheath.
In some embodiments, the rod includes a rod passageway, and wherein the string extends through the rod passageway, and wherein the string includes a graspable member coupled to an end of the string.
In some embodiments, the containment member is a first containment member and the device further includes a second containment member. The first containment member is positioned at least partially within the second containment member.
In some embodiments, the first containment member is a mesh sleeve.
In some embodiments, the second containment member is impermeable to fluid.
In some embodiments, the second containment member includes a third end and a fourth end opposite the third end. The second containment member includes a second opening positioned at the third end.
In some embodiments, a drawstring is coupled to the second opening; wherein the second opening at least partially closes in response to actuation of the drawstring.
In some embodiments, the string is a first string and the device further includes a second string coupled to the opening of the containment member. The second string is further coupled to a user-actuated tightening mechanism.
In some embodiments, the opening of the containment member enlarges in response to actuation of the first string, and wherein a specimen positioned within the containment member is compressed in response to actuation of the second string.
In some embodiments, the string is one of a plurality strings coupled to the opening of the containment member, wherein the opening enlarges in response to actuation of the plurality of strings.
In some embodiments, the string is a first string, and the device further includes a second string, a third string, and a fourth string; wherein the second string is coupled to the opening within a range of 90 degrees to 120 degrees from the first string, the third string is coupled to the opening within a range of 60 degrees to 90 degrees from the second string, and the fourth string is coupled to the opening within a range of 60 degrees to 90 degrees from the third string.
In some embodiments, the rod defines a longitudinal axis and the opening faces a plane that is perpendicular to the longitudinal axis.
In some embodiments, the device further includes a handle coupled to the rod, wherein the handle includes a slot configured to releasably secure the string.
One aspect of the present disclosure provides a device including a rod with a tip and a containment member including a first end and a second end opposite the first end. The second end is coupled to the tip; and wherein the containment member includes an opening positioned at the first end. The device further includes a string looped around the opening of the containment member. The opening at least partially closes in response to actuation of the string.
In some embodiments, the device further includes a user-actuated tightening mechanism and wherein the string is coupled to the user-actuated tightening mechanism. A specimen positioned within the containment member is compressed in response to actuation of the first string by the tightening mechanism.
In some embodiments, the device further includes a handle coupled to the rod, wherein the handle includes a groove that at least partially receives the user-actuated tightening mechanism.
In some embodiments, the user-actuated tightening mechanism includes a faceted circumferential surface that is rotatable relative to the groove.
In some embodiments, the device further includes a sheath defining a passageway; wherein the rod is positioned at least partially within the passageway and movable with respect to the sheath. The string extends through the passageway; and wherein the opening in the containment member is oriented toward the sheath.
In some embodiments, the rod includes a rod passageway, and wherein the string extends through the rod passageway,
In some embodiments, the containment member is a first containment member and the device further includes a second containment member. The first containment member is positioned at least partially within the second containment member.
In some embodiments, the first containment member is a mesh sleeve, and wherein the second containment member is impermeable to fluid.
In some embodiments, the second containment member includes a third end and a fourth end opposite the third end, wherein the second containment member includes a second opening positioned at the third end.
In some embodiments, a drawstring is coupled to the second opening. The second opening at least partially closes in response to actuation of the drawstring.
In some embodiments, the string is a compression string and the device further includes an expansion string coupled to the opening of the containment member. A channel is formed in the tip and the expansion string extends through the channel.
In some embodiments, the opening of the containment member enlarges in response to actuation of the expansion string, and wherein a specimen positioned within the containment member is compressed in response to actuation of the compression string.
In some embodiments, the rod defines a longitudinal axis and the opening faces a plane that is perpendicular to the longitudinal axis.
One aspect of the present disclosure provides a device including a first rod with a first rod end, a second rod with a second rod end, and a containment member including a first end and a second end opposite the first end. The first end is coupled to the first rod end of the first rod and the second end is coupled to the second rod end of the second rod. The containment member includes an opening positioned at the first end of the containment member. The second rod is movable with respect to the first rod to elongate the containment member.
In some embodiments, the device further includes a sheath with a passageway, wherein the first rod and the second rod extend through the passageway.
In some embodiments, the second rod end moves away from the first rod end to elongate the containment member.
In some embodiments, the second rod is movable with respect to the first rod to adjust a cross-sectional area of the opening.
In some embodiments, the second rod end moves toward the first rod end to increase the cross-sectional area of the opening.
In some embodiments, the containment member is flexible and includes a mesh sleeve.
In some embodiments, the second end of the containment member is closed.
In some embodiments, the device further includes a string coupled to the opening; wherein the opening is movable between an open configuration and a sealed configuration in response to actuation of the string.
In some embodiments, the device further includes a first lock movable between an unlocked position in which the first rod is movable with respect to the second rod and a locked position in which the first rod is fixed relative to the second rod.
In some embodiments, the device further includes a second lock movable between an unlocked position in which the first rod is movable with respect to a sheath and a locked position in which the first rod is fixed relative to the sheath.
In some embodiments, the first rod includes a first handle and the second rod includes a second handle.
Other aspects of the disclosure will become apparent by consideration of the detailed description and accompanying drawings.
The accompanying figures and examples are provided by way of illustration and not by way of limitation. The foregoing aspects and other features of the disclosure are explained in the following description, taken in connection with the accompanying example figures (also “FIG.”) relating to one or more embodiments.
Before any embodiments are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present disclosure. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates.
Articles “a” and “an” are used herein to refer to one or to more than one (i.e., at least one) of the grammatical object of the article. By way of example, “an element” means at least one element and can include more than one element.
“About” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result.
The use herein of the terms “including,” “comprising,” or “having,” and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof as well as additional elements. As used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations where interpreted in the alternative (“or”).
As used herein, the transitional phrase “consisting essentially of” (and grammatical variants) is to be interpreted as encompassing the recited materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. Thus, the term “consisting essentially of” as used herein should not be interpreted as equivalent to “comprising.”
Moreover, the present disclosure also contemplates that in some embodiments, any feature or combination of features set forth herein can be excluded or omitted. To illustrate, if the specification states that an apparatus comprises components A, B, and C, it is specifically intended that any of A, B or C, or a combination thereof, can be omitted and disclaimed singularly or in any combination.
Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure.
As used herein, the term “subject” and “patient” are used interchangeably herein and generally refer to humans. In some embodiments, the subject comprises a human who is undergoing a laparoscopic surgical procedure with a device as prescribed herein.
Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.
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As described in further detail herein, the second rod 26 is movable with respect to the first rod 22 to elongate the specimen containment member 30 along the longitudinal axis 34. Elongating (i.e., increasing the length) of the specimen containment member 30 along the axis 34 generates a compression on the specimen 14 contained therein. In the illustrated embodiment, the second distal rod end 62 moves away from the first distal rod end 50 to stretch and elongate the specimen containment member 30. In some embodiments, the device 10 includes a ratchet or other mechanically advantaged means of stretching apart the opposite ends 70, 74 of the specimen containment member 30.
In some embodiments, the specimen containment member 30 is flexible. In some embodiments, the specimen containment member 30 is impermeable (i.e., made of an impermeable material) to prevent fluid and/or material from penetrating through the walls of the specimen containment member 30. In some embodiments, the specimen containment member is a bag made of, for example, a medical grade thermoplastic or urethane. In some embodiments, the specimen containment member 30 includes a braided sleeve. The braided sleeve can aid in compression of a specimen 14 positioned within the specimen containment member 30 by translating linear motion created between the ends 70, 74 into radially compressive force to help reduce the diameter of the specimen 14. In some embodiments, the specimen containment member 30 achieves compressibility of the specimen 14 up to approximately 75%, depending on tissue type. In some embodiments, the braided sleeve is a weave. In some embodiments, the specimen containment member 30 is a braided sleeve with no secondary impermeable layer. In some embodiments, the braided sleeve is formed by rolling two ends of a braided tube back on top of themselves, similar to an Arthrex® finger trap, and fixing those two ends at or near the distal rod end 62. In some embodiments, the specimen containment member 30 is an elongated mesh bag. In some embodiments, the specimen containment member 30 includes a synthetic material (e.g., a synthetic mesh). In some embodiments, the specimen containment member 30 includes more than one layer of material. In some embodiments, the specimen containment member 30 is less than approximately 2 mm thick. In some embodiments, an entrance of the specimen containment member 30 flairs outward to help facilitate insertion of tissue into the specimen containment member 30.
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In the illustrated embodiment, the device 10 is a single use specimen retrieval tool configured to reduce the cross-sectional area and maintain alignment of the specimen 14 along an axis of removal (i.e., the longitudinal axis 34), thereby increasing ease of extraction. In some embodiments, the device 10 is prepackaged, sterilized, single use. The opening 82 is at the proximal end 70 of the specimen containment member 30 and is oriented toward the sheath 18 such that fluid from the specimen 14 during compression and extraction does not drip into the body cavity. In other words, the proximal opening 82 advantageously keeps specimen fluid within the specimen containment member 30. In some embodiments, the opening 82 is oriented towards the laparoscopic port site such that the entrance of the opening 82 is the first portion of the specimen containment member that is removed from the patient during tissue extraction, which reduces the chances of specimen contamination within the body of the patient. In some embodiments, the opening 82 is oriented toward the laparoscopic port site to aid with loading the specimen. A specimen opening facing away from the laparoscopic port site may be difficult to load during laparoscopic surgery due to the difficulties in visualization and working against gravity while loading the specimen.
A method of removing a specimen from a body cavity is disclosed herein with
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The sheath 318 includes a passageway 338 and the rod 322 extends through the passageway 338. The rod 322 includes a distal rod end 342 coupled to the specimen containment member 334. In some embodiments, the distal rod end 342 is an atraumatic tip. The specimen containment member 334 includes a proximal end 346 and a distal end 350 opposite the proximal end 346. In the illustrated embodiment, the distal end 350 is closed and is coupled to the distal rod end 342. The proximal end 346 of the specimen containment member 334 includes an opening 354 and is coupled to the sheath 318. In other words, the opening 354 positioned at the proximal end 346 of the specimen containment member 334. The opening 354 is oriented toward the sheath 318. As described herein, the rod 322 is movable with respect to the sheath 318 to compress the specimen containment member 334. In the illustrated embodiment, the distal rod end 342 moves away from the sheath 318 to elongate the specimen containment member 334 and to compress and align the specimen 314. In some embodiments, the specimen containment member 334 is flexible, impermeable, and/or includes a braided sleeve.
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In the illustrated embodiment, the rod assembly 414 (also referred to herein as “a rod”) includes a support rod 454, an elongated body 458 coupled to the support rod 454, and a tip 462 at the distal end of the support rod 454. In the illustrated embodiment, the tip 462 is an atraumatic tip. The rod assembly 414 includes a channel 466 (e.g., groove, passageway, etc.) formed in the tip 462. In other embodiments, the channel 466 is any means of allowing the strings 426 to change directions. In some embodiments, the rod assembly 414 includes a rod passageway 470 and the strings 426, 430, 434 extend through the rod passageway 470. In some embodiments, the rod passageway 470 is formed in the elongated body 458. In some embodiments, the elongated body 458 has a larger diameter than a support rod 454. The rod assembly 414 defines a longitudinal axis 474 and the rod passageway 470 extends along the longitudinal axis 474. In some embodiments, the elongated body 458 is made of a medical grade thermoplastic and is of a diameter smaller than the outer sheath 446 such that the elongated body 458 slides within the outer sheath 446. In some embodiments, the elongated support rod 454 is made of a medical grade metal such as stainless steel.
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In the illustrated embodiment, the first containment member 418 includes a first end 478 and a second end 482 opposite the first end 478. The second end 482 is coupled to the tip 462 and an opening 486 is positioned at the first end 478. In the illustrated embodiment, the opening 486 in the containment member 418 is oriented toward the sheath 446 and the handle 438 (e.g., proximally oriented). In some embodiments, the opening 486 faces or lies within a plane that is perpendicular to the longitudinal axis 474 of the rod assembly 414.
In some embodiments, the containment member 418 is a compression mesh sleeve. In some embodiments, the mesh sleeve is braided, knit, or woven. In some embodiments, the mesh is a medical grade thermoplastic. Multiple configurations of mesh may be utilized depending on the type of tissue to be extracted from the patient. For example, a mesh made from a plain weave oriented at approximately 45 degrees composed of monofilament fibers with a diameter within a range of approximately 0.1 mm and approximately 0.4 mm. The monofilament fibers are doubled over on themselves and compose an overall mesh sleeve with a longitudinal length within a range of approximately 80 mm to approximately 200 mm. In other embodiments, the containment member 418 is a bag made of flexible medical grade materials such as a thermoplastic or urethane. Other configurations may be useful depending on the specific tissue type to be removed. In the illustrated embodiment, second end 482 (e.g., the distal end) of the containment member 418 is fixed at the atraumatic tip 462 with, for example, medical grade adhesive. The first end 478 (e.g., the proximal end) of the containment member 418 selectively translates about, along, or adjacent to the elongated support rod 454.
In the illustrated embodiment, the first containment member 418 is positioned at least partially within the second containment member 422. The second containment member 422 includes a third end 490 (e.g., a proximal end) and a fourth end 494 (e.g., a distal end) opposite the third end 490. The second containment member 422 includes a second opening 498 positioned at the third end 490. The second opening 498 is generally oriented toward the proximal end of the device 410. In some embodiments, the second opening 498 has a diameter within a range of approximately 40 mm and approximately 80 mm. In some embodiments, the second containment member 422 is impermeable to fluid, such that fluid from the specimen 412 in the first containment member 418 does not leak into the body cavity during removal. In some embodiments, the second containment member 422 is a flexible bag made of a medical grade plastic or urethane. In the illustrated embodiment, the second containment member 422 is translucent or transparent so that a user can visualize the configuration of the enclosed first containment member 418. In the illustrated embodiment, the second containment member 422 completely contains the first containment member 418 to minimize the leaking of fluids during subsequent tissue specimen removal. With reference to
As detailed herein, the drawstring 434 is coupled to the second opening 498 and the second opening 498 at least partially closes in response to actuation of the drawstring 434. In some embodiments, the drawstring 434 is a medical grade braided suture, such as nylon. In some embodiments, the drawstring 434 includes a slip knot 436 positioned near the second containment member 422. In the illustrated embodiment, the drawstring 434 includes a graspable member 437 coupled to an end of the drawstring 434.
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In the illustrated embodiment, the first string 426A and second string 426B are positioned approximately 120 degrees apart; the second string 426B and the third string 426C are positioned approximately 60 degrees apart; and the fourth string 426D and the third string 426C are positioned approximately 60 degrees apart. In other words, there are three compression mesh expansion strings 426B, 426C, 426D located at approximately 120, 180, and 240 degrees from the elongated support rod 454 and a fourth compression mesh expansion string 426A located at approximately 0 degrees from the elongated support rod 454. In some embodiments, the opening 486 flexes or re-orients, in addition to enlarging, at an angle away from the support rod 454 in response to actuation of the strings 426. In other words, the strings 426 are secured around the circumference of the opening 486 such that actuation of the strings 426 causes the opening 486 to enlarge and angle away from the longitudinal axis 474 of the rod assembly 414. Angling the opening 486 in response to actuation of the strings 426 advantageously makes it easier to position the specimen 412 within the containment member 418. In other words, the illustrated configuration biases the first containment member 418 to open partially out and away from the elongated support rod 454, facilitating more facile placement of the tissue specimen 412 into the first containment member 418.
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To open or expand the first containment member 418, the expansion strings 426 are actuated by a user. As a result, the first containment member 418 pulls distally when tension is placed on the expansion strings 426. As the first containment member 418 is contracted (e.g., the relative distance between the proximal end and distal end of the first containment member 418 is reduced) the orientation of the woven fibers in the compression mesh become more perpendicular to the longitudinal axis 474 and the first containment member 418 expands in diameter. As such, loading of the tissue specimen 412 is facilitated while reducing the overall size of the first containment member 418, which can further aid in the insertion and removal through the laparoscopic port site.
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In some embodiments, once the specimen 412 is placed inside the first containment member 418, the user may (but is not required to) release the tension from the mesh expansion strings 424 and let the first containment member 418 relax to an unstressed state. In the illustrated embodiment, with the expansion strings 426 releasably secured in the friction slot 440, if the user forgets to release the mesh expansion strings 426, the strings 426 will tend to release on their own automatically due to opposing pull directions.
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When the user wants to compress down the tissue specimen 412 within the first containment member 418, the user actuates the tightening mechanism 442. In the illustrated embodiment, the user rotates the knob 502 and as the knob 502 rotates, the compression string 430 is wound around the post 506. In the illustrated embodiment, the knob 502 has four extensions. With reference to
As the compression string 430 wraps around the tightening post 506, the string 430 pulls on the containment member 418 is a proximal direction. As the compression string 430 is actuated, the first opening 486 of the first containment member 418 is closed or at least partially closed because the compression string 430 is looped or routed about the circumference of the first opening 486. In other words, the first opening 486 at least partially closes in response to actuation of the compression string 430. Simultaneously, the first containment member 418 is elongated and the fibers of the mesh weave align along the longitudinal axis 474. This reduces the overall diameter of the compression mesh 418, creating a circumferential compressive force around the tissue specimen 412. In other words, the specimen 412 positioned within the first containment member 418 is compressed in response to actuation of the compression string 430 by the user activating the tightening mechanism 442.
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In some embodiments, the elongated support rod 454 provides a visual cue to the user when maximum tension is reached by the tightening mechanism 442 by starting to deflect. Depending on the desired tissue compression, the stiffness and dimensions of the elongated support rod 454 can be selected to provide the visual bending cue at the proper tension range.
Other mesh compression tightening mechanisms are contemplated, including but not limited to an integrated rotational ratcheting system, such as the BOA dial system by BOA Technology Inc., other ratcheting systems, a pulley system routed to provide mechanical advantage, and others. In some embodiment, no mechanical advantage is provided and the user pulls directly on the compression mesh tightening string and selectively locks it in place using, for example, a string lock element.
After elongating the first containment member 418 and compressing the specimen 412, the device 410 and the compressed specimen 412 are removable from a small laparoscopic incision. In other words, once the tissue specimen 412 is compressed, the user can then easily remove the device 410 and the tissue specimen 412 from the patient body cavity.
As such, the devices 10, 210, 310, 410 disclosed herein are used to remove a specimen (e.g., a gallbladder) during minimally invasive surgery (e.g., laparoscopic, robotic, VATC, retroperitonescopy) without the need to enlarge incisions on the patient or risk the rupture of the specimen bag due to difficult extraction.
One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent herein. The present disclosure described herein are exemplary embodiments and are not intended as limitations on the scope of the present disclosure. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the present disclosure as defined by the scope of the claims.
No admission is made that any reference, including any non-patent or patent document cited in this specification, constitutes prior art. In particular, it will be understood that, unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. All references cited herein are fully incorporated by reference, unless explicitly indicated otherwise. The present disclosure shall control in the event there are any disparities between any definitions and/or description found in the cited references.
Various features and advantages are set forth in the following claims.
This application claims priority to U.S. Provisional Patent Application No. 63/239,459, filed on Sep. 1, 2021, the entire contents of which are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/042121 | 8/31/2022 | WO |
Number | Date | Country | |
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63239459 | Sep 2021 | US |