This invention relates to surgical devices that may be particularly useful for removing polyps or submucosal dissections during endoscopic procedures and/or tissue dissection and excision during NOTES.
Endoscopic procedures are well known. Natural orifices transluminal endoscopic surgery (NOTES) is a promising technology, but obstacles remain that inhibit the commercial use of the procedures in human patients including, for example, tissue dissection and excision. There remains a need for surgical tools for endoscopic surgeries.
Some embodiments of the invention are directed to endoscopic medical devices for removing tissue. The devices include: (a) a forceps with an elongate shaft slidably residing in a first working channel of an endoscope and having an externally accessible forceps control; and (b) a snare with an elongate shaft comprising a wire loop slidably residing in the first working channel of the endoscope, the snare having an externally accessible snare control. The forceps and snare shafts reside adjacent to and substantially parallel to each other inside the first working channel of the endoscope, one above or to the side of the other. In use, the forceps and snare cooperate so that the forceps control directs the forceps to extend out of the endoscopic first working channel and grasp target tissue, then the snare control directs the snare loop to exit the working channel while the snare loop encircles the forceps shaft and extends a distance sufficient to surround the forceps and grasped tissue so that the forceps and the snare loop cooperate while the snare excises the grasped target tissue.
The snare loop can be a closed loop that resides about the forceps shaft inside the working channel of the endoscope prior to extension from the working channel.
The snare loop can be configured to angulate with respect to the forceps to be able to take on different angles relative to the forceps.
The snare loop can be configured to move from an orientation that is substantially parallel to the forceps to an orientation that is between 30-60 degrees relative to a longitudinally extending centerline of the forceps.
The snare loop is configured to enlarge upon exiting the working channel.
Yet other embodiments are directed to methods of excising target tissue (e.g., a polyp). The methods include: (a) providing a medical tool having a forceps with an elongate shaft and a snare with an elongate shaft; (b) inserting the medical tool into a single working channel of an endoscope; (c) extending the forceps out of the working channel to grasp target tissue during an endoscopic procedure; then (d) extending the snare out of the working channel a distance while the snare loop surrounds the forceps shaft; then (e) surrounding the forceps and the grasped tissue with the snare loop; and (f) excising the target tissue using the snare loop while the forceps remains attached to the grasped target tissue.
The method may optionally also include angling the wire loop about the forceps shaft between about 30-60 degrees from an axially extending centerline of the forceps shaft during the extending step.
Other embodiments are directed to endoscopic tools. The tools include: (a) a forceps tool with an elongate shaft; and (b) a second tool with an elongate shaft. Each tool is configured to reside inside a single working channel of an endoscope.
The second tool can be a clip delivery device holding a deployable clip that attaches to local tissue.
The second tool can be at least one of a snare, secondary forceps, knob, scissors, knife, needle-knife or needle.
The forceps and second tool can be configured to cooperate for submucosal dissection during endoscopy and/or tissue dissection and excision during a NOTES procedure.
Yet other embodiments are directed to methods of removing polyps or a submucosal dissection. The methods include: (a) providing a medical device with a forceps and a second cooperating tool adapted to reside in a single working channel of an endoscope; (b) extending the forceps out of the working channel to grasp target tissue; then (c) using the second tool to carry out the submucosal dissection of the grasped tissue.
The second tool can include a wire snare.
The second tool can include at least one of a knife, a needle, a needle-knife or a knob.
Other embodiments are directed to methods of repairing a perforation during an endoscopic procedure. The methods include: (a) providing a medical device with a forceps and a second cooperating tool releasably holding a clip, both tools adapted to reside together in a single working channel of an endoscope; (b) extending the forceps out of the working channel to grasp target tissue to pull the target tissue to make a perforation smaller; then (c) using the second tool to attach the clip to close the perforation while the forceps holds the grasped tissue.
The foregoing and other objects and aspects of the present invention are explained in detail in the specification set forth below.
It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
The present invention will now be described more fully hereinafter with reference to the accompanying figures, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Like numbers refer to like elements throughout. In the figures, certain layers, components or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise. In addition, the sequence of operations (or steps) is not limited to the order presented in the figures and/or claims unless specifically indicated otherwise. In the drawings, the thickness of lines, layers, features, components and/or regions may be exaggerated for clarity and broken lines illustrate optional features or operations, unless specified otherwise.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms, “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and/or “including” when used in this specification, specify the presence of stated features, regions, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, steps, operations, elements, components, and/or groups thereof.
It will be understood that when a feature, such as a layer, region or substrate, is referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when an element is referred to as being “directly on” another feature or element, there are no intervening elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other element or intervening elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another element, there are no intervening elements present. Although described or shown with respect to one embodiment, the features so described or shown can apply to other embodiments.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the present application and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Embodiments of the invention are useful for veterinarian and human uses as well as for animal studies. That is, methods and devices provided by embodiments of the invention can be configured for any species of interest, e.g., mammalian including human, simian, mouse, rat, lagomorph, bovine, ovine, caprine, porcine, equine, feline, canine, and the like.
Embodiments of the invention may be particularly suitable for removing polyps during an endoscopic procedure, including, for example, an endoscopic polypectomy, submucosal dissection of flat polyps, and flat mucosa associated with certain conditions such as Barrett's esophagus. For the latter, embodiments of the surgical devices can remove relatively large areas of mucosal tissue which are not otherwise amenable to endoscopy therapy at this time. It is also contemplated that devices according to some embodiments may be helpful in creating submucosal tunnels for identification of specific nerves or group of neurons, such as for a gastric pacemaker. Particular embodiments are directed to NOTES procedures in human patients including, for example, tissue dissection and/or excision, and potentially safe closure of an opening.
Generally stated, embodiments of the invention are directed to endoscopic devices with at least two tools that can work independently of each other and move relative to the other, but that synergistically allow for surgical procedures, such as, for example, polyp removal.
Referring now to
The forceps 20f can be deployed first to grab and pull or push tissue to provide traction so that the other tool 30 can be used to snare the tissue, inject the tissue, cut or dissect the tissue, control bleeding such as by placing a closure clip, or the like. Thus, the second (or more) tool 30 can be a snare, a secondary forceps, a needle, a needle-knife, a knob, scissors, or a delivery tool that places a clip to close a hole in tissue. Once the endoscope is in a desired position in the body, the primary forceps 20f can be deployed from the endoscope. Then, once the primary forceps 20f is in position attached to target tissue, the second tool 30 can be deployed from the working channel. The second tool 30 can perform the desired action on the grasped tissue, e.g., one or more of tissue dissection, cutting, cauterization, snaring, injection, and the like.
The depths of the at least two independently operable, but cooperating, tools 20, 30 can be selectively and individually varied. By varying the depth of the two tools 20, 30, and allowing the tools to cooperate, the primary forceps 20f can apply traction, and dissection and/or excision of the tissue can be accomplished through endoscopy as the device 10 is able to provide an element of triangulation.
The at least two tools 20, 30 can be provided in a catheter, tube, collar or sleeve (not shown) that resides in the working channel 100 or they may be used in the working channel without such a catheter, tube, collar or sleeve.
In some embodiments, the other cooperating tool 30, as shown in
The tool 30 includes an elongate shaft 32. The elongate shaft 32 can connect to a control unit 50, such as an individual hand control unit 35 (
The forceps 20f can extend through the loop 31 of the snare before, during or after it exits the working channel 100. The snare loop 31 can be angled upward between about 20-90 degrees, typically between about 30-60 degrees, from an axially extending center line of the shaft 20s and/or shaft 30s. That is, the snare loop can angle upward with respect to the forceps and define an angle associated with a line drawn through a centerline of a distal end of the snare shaft relative to a line drawn through a center or end of the loop.
The control units 25, 35 are configured to direct the forceps 20f and snare to exit the working channel 100.
As shown in
In operation, the snare loop 31 can reside about the forceps 20f. Each of these tools 20f, 30s can have independent mobility. The forceps 20f can be a straight forceps with jaws of various size. The snare 30s can also vary in size. The snare 30s can angulate so that the loop 31 can extend from the working channel 100 and open at a plurality of different orientations. For example, as shown in
The forceps 20f typically extends and retracts about a substantially straight line. The forceps shaft 20s can be held in a sleeve or catheter with a guide channel that slidably engages the forceps shaft 30s to maintain a desired orientation. The loop 31 can be held in a compressed configuration inside the channel 100 and can expand upon release, typically to increase in size between about 10-200%.
As shown in
It is believed that, currently, flat polyps are difficult to grasp as the conventional snare tends to keep sliding over the tissue without grasping.
The forceps 20f and scissors 30s combination can be configured so that the forceps 20f and scissors 30s are housed in the same working channel 100 of the endoscope as shown in
Scissors 30s can be advanced to proceed with dissection. The scissors can also be attached to a cautery cable to use cauterization during dissection. The tissue plane can be generated by pulling the forceps that will give some triangulation. These two devices can extend out of the same channel 100 in the same plane, but at different angulations as discussed above.
With respect to the tool shown in
With respect to the device 10 shown in
With respect to the device shown in
With respect to the embodiment shown in
The devices and tools are particularly suitable for endoscopic procedures and more particularly, NOTES procedures.
The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. In the claims, means-plus-function clauses, if used, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.
This application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/449,181, filed Mar. 4, 2011, and is a continuation in part of U.S. patent application Ser. No. 13/295,417 filed Nov. 14, 2011, the contents of these documents are hereby incorporated by reference as if recited in full herein.
Number | Date | Country | |
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61449181 | Mar 2011 | US |
Number | Date | Country | |
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Parent | 13295417 | Nov 2011 | US |
Child | 13410556 | US |