The present disclosure generally relates to removal of calculi and foreign bodies.
Kidney stones may be removed in a plurality of ways. Common methods of treatment include Extracorporeal Shock Wave Lithotripsy (ESWL), Percutaneous Nephrolithotomy (PN) and Ureteroscopy. ESWL may often lead to kidney damage, postoperative complications, and a high recurrence rate. PN is an invasive procedure that involves an incision through the skin through which a device is guided into the kidney, necessitating extended recovery time.
Compared to patients treated using ESWL or PN, ureteroscopy patients recover more quickly and suffer fewer post-operative complications. However, ureteroscopy procedures create stone fragments that may take hours to remove. Fragments are an issue with all treatment methods because fragments greater than 1 mm are clinically significant and, if left in the system, can re-aggregate and form additional stones. Consequently, up to fifty percent of all stone-formers have another stone after their first treatment.
Physicians performing ureteroscopy procedures emphasize that the duration of the procedure is the most important aspect of the surgery that needs improving. Current methods of ureteroscopy take the physician only 15-20 minutes to break up the stone, but potentially another hour or more removing all of the stone fragments resulting from the lithotripsy. The physician must search through the urinary system and into the calyces of the kidney to locate these fragments, as their movement is completely sporadic.
This brief overview is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This brief overview is not intended to identify key features or essential features of the claimed subject matter. Nor is this brief overview intended to be used to limit the claimed subject matter's scope.
The embodiments of the present disclosure may provide an apparatus used in ureteroscopy, a widespread method of treating kidney stones by enclosing the stone in a sheath before breaking it into a plurality of fragments with a fragmenting device. The configuration of the disclosed mesh top to a sheath may improve the practice of ureteroscopy by facilitating the removal of kidney stone fragments. The apparatus may comprise a sheath; a mesh top comprising: a first end having an opening into the interior of the mesh top, and a second end being attached to the sheath; and an enclosing means, wherein the mesh top is configured to: receive an object within an interior of the mesh top, enclose, via the enclosing means, the object within the mesh top, receive a fragmenting device through a second end, and retain fragments of the object caused by an operation of the fragmenting device.
Both the foregoing brief overview and the following detailed description provide examples and are explanatory only. Accordingly, the foregoing brief overview and the following detailed description should not be considered to be restrictive. Further, features or variations may be provided in addition to those set forth herein. For example, embodiments may be directed to various feature combinations and sub-combinations described in the detailed description.
The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate various embodiments of the present disclosure. The drawings contain representations of various trademarks and copyrights owned by the Applicant. In addition, the drawings may contain other marks owned by third parties and are being used for illustrative purposes only. All rights to various trademarks and copyrights represented herein, except those belonging to their respective owners, are vested in and the property of the Applicant. The Applicant retains and reserves all rights in their trademarks and copyrights included herein, and grant permission to reproduce the material only in connection with reproduction of the granted patent and for no other purpose.
Furthermore, the drawings may contain text or captions that may explain certain embodiments of the present disclosure. This text is included for illustrative, non-limiting, explanatory purposes of certain embodiments detailed in the present disclosure. In the drawings:
As a preliminary matter, it will readily be understood by one having ordinary skill in the relevant art that the present disclosure has broad utility and application. As should be understood, any embodiment may incorporate only one or a plurality of the above-disclosed aspects of the disclosure and may further incorporate only one or a plurality of the above-disclosed features. Furthermore, any embodiment discussed and identified as being “preferred” is considered to be part of a best mode contemplated for carrying out the embodiments of the present disclosure. Other embodiments also may be discussed for additional illustrative purposes in providing a full and enabling disclosure. As should be understood, any embodiment may incorporate only one or a plurality of the above-disclosed aspects of the display and may further incorporate only one or a plurality of the above-disclosed features. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present disclosure.
Accordingly, while embodiments are described herein in detail in relation to one or more embodiments, it is to be understood that this disclosure is illustrative and exemplary of the present disclosure, and are made merely for the purposes of providing a full and enabling disclosure. The detailed disclosure herein of one or more embodiments is not intended, nor is to be construed, to limit the scope of patent protection afforded in any claim of a patent issuing here from, which scope is to be defined by the claims and the equivalents thereof. It is not intended that the scope of patent protection be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself.
Thus, for example, any sequence(s) and/or temporal order of steps of various processes or methods that are described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal order, the steps of any such processes or methods are not limited to being carried out in any particular sequence or order, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and orders while still falling within the scope of the present invention. Accordingly, it is intended that the scope of patent protection is to be defined by the issued claim(s) rather than the description set forth herein.
Additionally, it is important to note that each term used herein refers to that which an ordinary artisan would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein—as understood by the ordinary artisan based on the contextual use of such term—differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the ordinary artisan should prevail.
Regarding applicability of 35 U.S.C. §112, ¶6, no claim element is intended to be read in accordance with this statutory provision unless the explicit phrase “means for” or “step for” is actually used in such claim element, whereupon this statutory provision is intended to apply in the interpretation of such claim element.
Furthermore, it is important to note that, as used herein, “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. When used herein to join a list of items, “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. Finally, when used herein to join a list of items, “and” denotes “all of the items of the list.”
The following detailed description refers to the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the following description to refer to the same or similar elements. While many embodiments of the disclosure may be described, modifications, adaptations, and other implementations are possible. For example, substitutions, additions, or modifications may be made to the elements illustrated in the drawings, and the methods described herein may be modified by substituting, reordering, or adding stages to the disclosed methods. Accordingly, the following detailed description does not limit the disclosure. Instead, the proper scope of the disclosure is defined by the appended claims. The present disclosure contains headers. It should be understood that these headers are used as references and are not to be construed as limiting upon the subjected matter disclosed under the header.
The present discloser includes many aspects and features. Moreover, while many aspects and features relate to, and are described in, the context of kidney stone removal, embodiments of the present disclosure are not limited to use only in this context.
Consistent with embodiments of the present disclosure, an apparatus for the removal of calculi and foreign bodies may be provided. This overview is provided to introduce a selection of concepts in a simplified form that are further described below. This overview is not intended to identify key features or essential features of the claimed subject matter. Nor is this overview intended to be used to limit the claimed subject matter's scope. The apparatus implementing a sheath for removal of foreign bodies may be used by individuals or companies to assist in the process of removing kidney stones.
The embodiments of the present disclosure may provide a cylindrical mesh top configurable to a sheath used in ureteroscopy. Although the disclosed mode of implementation of the mesh top is illustrated with reference to the capture of kidney stones, it should be understood that the embodiments disclosed herein may be adapted to accommodate the capture of calculi and foreign bodies (e.g., renal calculi or kidney stone fragments). Furthermore, although the disclosed mode of implementation is illustrated within a kidney, it should be understood that the embodiments disclosed herein may be used within the body (i.e. throughout the ureter or renal pelvis).
Enclosing means 115 may be regulated by, for example, but not limited to, a tension cord operated through a channel 120 by a tension switch. Such regulation would enable a closing of open end 112 of mesh top 110. It should be understood that enclosing means 115, tension cord channel 120, and a tension switch may be replaced with any suitable contraction mechanism used to close open-end 112. In some embodiments, tension cord channel 120 may be used as a “backbone” to mesh top 110, providing structural stability throughout use in a ureteroscopy procedure.
During the ureteroscopy procedure, sheath 105 may be employed to encompass and pass a plurality of devices into the kidney including, but not limited to, a lithotripter. Although the embodiments disclosed herein reference a lithotripter, any suitable fragmenting device may be employed throughout the various embodiments of the present disclosure. Mesh top 110 consistent with embodiments of the present disclosure may be designed to accommodate various lithotripters configured to pass through sheath 105, including, for example, but not limited to, electrohydraulic, pneumatic, ultrasonic, or laser devices. Embodiments of the present disclosure may be employ such lithotripters to fragment a kidney stone once the kidney stone is received within mesh top 110 and open end 112 has been closed to secure the foreign body within mesh top 110.
Unlike conventional lithotripter applications, however, embodiments of the present disclosure may call upon the initiation of the fragmentation process once the stone is captured within enclosed mesh top 110. In this way, once fragmented, the fragments of the stone may remain within the enclosed mesh top 110 without escaping back into the kidney, thereby eliminating the process of individual fragment collection.
Still consistent with embodiments of the present disclosure, and as will be further detailed below, mesh top 110 may be comprised of a flexible, interwoven fabric (e.g., a braided closed-loop material) designed for expansion and contraction along an inner diameter of mesh top 110. For example, as a stone is received through open end 112, the force of the stone against mesh top 110 may cause a radial expansion of mesh top 110. The compressive force, in turn, may cause open end 112 to dilate (e.g., an increase in the mesh top's inner diameter). The expansion may facilitate the entry of a stone into mesh top 110.
Further still, as the resultant stone fragments are pulled out of the kidney (by removal of the sheath), the friction between the walls of the passage and mesh top 110 may create a tension, causing mesh top 110 to stretch and elongate. In turn, the extension causes mesh top 110 to more tightly enclose the fragments (due to the decreased inner diameter), thereby ensuring that fragments remain securely within mesh top 110. Consequently, the removal of a plurality of calculi fragments may be facilitated in one pass, reducing the time, discomfort, and risk of recurrence associated with treatment.
By enclosing the stone in mesh top 110 before the fragmentation process, embodiments of the present disclosure may eliminate the need to locate and remove resultant fragments, thereby shortening total procedure time substantially. Moreover, since the resultant fragments are readily captured within the enclosed mesh top 110 and subsequently, are removed, re-aggregation will not occur, reducing readmissions for that reason. Accordingly, patients and their families, hospitals, physicians, and payers will benefit from the use of the embodiments disclosed herein.
Both the foregoing overview and the following detailed description provide examples and are explanatory only. Accordingly, the foregoing overview and the following detailed description should not be considered to be restrictive. Further, features or variations may be provided in addition to those set forth herein. For example, embodiments may be directed to various feature combinations and sub-combinations described in the detailed description.
Apparatus 100 may comprise, but not be limited to, for example, a sheath 105, a mesh top 110, an enclosing means 115, and a tension cord channel 120. The sheath 105 may be comprised of a hydrophilic coating material, such as, for example, but not limited to a Fluorinated ethylene propylene (FEP)-coated outer sheath. The sheath 105 may provide a working channel for the procedure. A dilator (not shown) may enable deployment of apparatus 100 through a urethra of a subject (e.g., a patient with kidney stones). The dilator may be coated in hydrophilic material, such as, for example, but not limited to Polytetrafluoroethylene (PTFE).
A mesh top 110 may be implemented for capturing calculi or foreign body within the kidney of the subject (i.e., kidney stone). Mesh top 110 may be fabricated from a braided closed-loop material. The material may be comprised of for example, but not limited to, nitinol per ASTM F2063. An enclosing means 115, such as, for example, but not limited to, a loop knot tying mechanism, may be implemented towards an open end 112 of mesh top 110. In some embodiments, enclosing means 115 may be integrated within the fabric of mesh top 110 and positioned approximately towards open end 112. The closing means 115 may be comprised of, but not limited to, for example, a monofilament prolene line.
A channel for a monofilament prolene closure line 120 may run through sheath 105. The line tension may be controlled by a tension switch implemented at an end of sheath 105. In this way, increasing tension in the line may cause a tightening of the loop knot, thereby enclosing open end 112 of mesh top 110.
It should be understood that enclosing means 115, tension cord channel 120, handle, and ratcheting means 205 may be replaced with any suitable contraction mechanism used to close open-end 112. In some embodiments, the material of sheath 105 may be extruded over the mesh top 110 to create junction. Still other techniques and methods may be employed in combing the sheath 105 with mesh top 110.
Although the stages illustrated by the flow charts are disclosed in a particular order, it should be understood that the order is disclosed for illustrative purposes only. Stages may be combined, separated, reordered, and various intermediary stages may exist. Accordingly, it should be understood that the various stages illustrated within the flow chart may be, in various embodiments, performed in arrangements that differ from the ones illustrated. Moreover, various stages may be added or removed from the flow charts without altering or deterring from the fundamental scope of the depicted methods and systems disclosed herein. Ways to implement the stages of method 300 will be described in greater detail below. Further, although method 300 describes a method for kidney stone removal in a specific way, apparatus 100 may not be limited to such procedures.
Method 300 may begin at starting block 305 and proceed to stage 310 where apparatus 100 may be inserted into the kidney through the urethra. Prior to insertion, an insertion channel of the subject (e.g., urethra) may undergo dilation. Further still, a guide-wire may first be inserted into the channel (e.g., into the kidney through the urethra).
Next, a ureteroscope may be inserted through the sheath 105 of apparatus 100.
From stage 310, where apparatus 100 is inserted into the kidney, method 300 may advance to stage 320 where target object 410 may be captured within mesh top 110 of inserted apparatus 100. In some embodiments, capturing device (e.g., stone basket) may be employed to grasp and move target object 410 into mesh top 110.
Capturing device 705 may be inserted into the kidney through apparatus 100. An operator may navigate capturing device 705 towards target object 410 and grasp target object 410. Capturing device 705 may be controlled by an operator and, upon grasping of object 410, may be pulled, along with object 410, into mesh top 110, as shown in
Referring now to
Once object 410 is captured in stage 320, method 300 may continue to stage 330 where object 410 may be physically fragmented.
Having fragmentation occur in a controlled fragmentation zone has plurality of advantages. For instance, the fragments may all be contained within mesh top 410, thereby eliminating the need to repeat the navigation and capture process for stone fragments. Additional advantages are listed below.
After object 410 is fragmented in stage 330, method 300 may proceed to stage 340 where the apparatus and stone pieces may be removed. Fragments, may more easily pass through the subject's channel (e.g., urethra) upon the withdrawal of apparatus 100 from the channel. Furthermore, withdrawal of apparatus 100 may create a friction between the subject's channel and mesh top 100. In some embodiments of the present disclosure, the friction may cause an extension of mesh top 110 which, in turn, due to mesh top 100's braided fabric design, cause a tightening (or decrease of inner diameter) of mesh top 100's grasp of object fragments.
Apparatus 100 is may be easily incorporated into current procedures. For example, the stages illustrated by method 300 (some of which are undertaken to currently perform a ureteroscopy procedure) may remain substantially the same (with exception to, at least, the enclosure of object 410 within mesh top 110 prior to fragmentation. In this way, apparatus 100 may make a large impact with very little disturbance to the performance of conventional ureteroscopy procedures.
Additional advances of the various embodiments disclosed herein include, but are not limited to, for example:
This is more practical because a practicing physician (e.g., apparatus 100's user) may not face a large learning curve as they may simply replace their existing sheath's with apparatus 100,
While the specification includes examples, the disclosure's scope is indicated by the following claims. Furthermore, while the specification has been described in language specific to structural features and/or methodological acts, the claims are not limited to the features or acts described above. Rather, the specific features and acts described above are disclosed as example for embodiments of the disclosure.
Insofar as the description above and the accompanying drawing disclose any additional subject matter that is not within the scope of the claims below, the disclosures are not dedicated to the public and the right to file one or more applications to claims such additional disclosures is reserved.
Although very narrow claims are presented herein, it should be recognized the scope of this disclosure is much broader than presented by the claims. It is intended that broader claims will be submitted in an application that claims the benefit of priority from this application.
Under provisions of 35 U.S.C. §119(e), the Applicants claim the benefit of U.S. provisional application No. 61/984979, filed Apr. 28, 2014 by the same inventors, which is incorporated herein by reference. It is intended that each of the referenced applications may be applicable to the concepts and embodiments disclosed herein, even if such concepts and embodiments are disclosed in the referenced applications with different limitations and configurations and described using different examples and terminology.
Number | Date | Country | |
---|---|---|---|
61984979 | Apr 2014 | US |