The example embodiments described herein relate generally to surgical retrieval devices and, more particularly, to surgical retrieval devices for capturing and retrieving or extracting stones, calculi, concretions, foreign bodies and the like from a human or veterinary patient. The surgical retrieval device may also be useful for biopsies and other surgical retrievals.
Minimally invasive surgical procedures have been developed for the removal of stones, calculi, concretions and the like from the biliary, vascular, and urinary systems, as well as for the removal or retrieval of foreign bodies from a variety of locations in the body. Such procedures avoid the performance of open surgical procedures such as, for example, an anatrophic nephrolithotomy. Minimally invasive procedures can instead employ percutaneous access, in which stones, calculi, concretions, foreign bodies and the like are removed through a percutaneously inserted access sheath. Several access routes are suitable, depending upon the specific system and the particular location in the system at which the stones, calculi, concretions, foreign bodies or the like are found. One access route that is infrequently used is direct percutaneous insertion of a retrieval device to remove calculi and kidney stones.
Without regard to the particular access route, percutaneous extraction may be based upon the use of catheters or similar devices to engage and remove the stones, calculi, concretions, foreign bodies and the like. Such catheters and devices typically comprise a hollow, flexible sheath and a plurality of wires positioned in and extendable from the sheath. The wires are joined or arranged so as to form a means, such as a basket or forceps for engaging the object to be retrieved when the wires are extended from the sheath. The wires may also form a continuum with the sheath. The engagement means, e.g., a basket, can be collapsed by withdrawing the wires into the sheath. A helical basket permits entry of the stone, for example, from the side of the basket, while an open ended (“eggwhip”) basket allows a head-on approach to the stone, for example. Other retrievers and graspers can include forceps or can include a wire loop or snare for encircling the body to be removed. Such devices may be used in conjunction with a nephroscope to aid the physician in seeing the operating field. Using such a device also tends to limit the size of the cannula and basket used.
During some procedures, relatively large foreign bodies are found at the site that have to be fragmented into small body pieces before removal. To fragment the larger foreign body, a ureterscope is introduced into the patient through a body passageway, such as the ureter. The ureterscope includes an integral optical system, a working channel, and a controller to maneuver the ureterscope to the target site. The surgeon then uses a laser assembly including a laser fiber, such as a holmium laser fiber, to fragment the stone. The laser assembly is then withdrawn from within the working channel and a suitable grasper is introduced through the working channel to the target site to remove any stone fragments.
In one example embodiment, an extractor includes an outer cannula having a lumen extending between a proximal end and an opposite distal end of the outer cannula. An inner cannula is movably positioned within the outer cannula. The inner cannula has a proximal end configured to be retained exteriorly of a patient and a distal end configured to be inserted into the patient. The inner cannula includes a central passage extending along a longitudinal axis of the inner cannula between the proximal end and the distal end. A plurality of secondary passages are positioned about the central passage. Each secondary passage of the plurality of secondary passages extends between the proximal end and the distal end of the inner cannula. A handle has a first section coupled to the proximal end of the inner cannula and a second section coupled to the proximal end of the outer cannula. The handle is movable between a first position and a second position to move the inner cannula within the outer cannula. An extraction mechanism, such as an annularly expanding extraction mechanism, is operatively coupled to the distal end of the inner cannula. In certain example embodiments, the annularly expanding extraction mechanism includes a plurality of fixed flexure elements positioned about a periphery of the central passage in an annular array at a confining fixed position and having a flexure position spaced longitudinally outwardly therefrom. Each movable flexure element of a plurality of corresponding movable flexure elements has an end fixed with respect to the flexure position of a corresponding fixed flexure element of the plurality of fixed flexure elements and extending therefrom in a longitudinally movable and generally transversely confined relation to a receiving portion of an adjacent fixed flexure element of the plurality of fixed flexure elements, wherein each movable flexure element extends through the adjacent fixed flexure element and a respective secondary passage of the plurality of secondary passages to couple to the first section of the handle.
In one example embodiment, an extractor includes a rigid outer cannula forming a lumen extending between a proximal end and an opposing distal end of the outer cannula. An inner cannula is slidably positioned within the lumen of the outer cannula. The inner cannula forms a central passage along a longitudinal axis of the inner cannula extending between a proximal end and an opposing distal end of the inner cannula. A plurality of secondary passages are positioned about the central passage and extend along at least a portion of a length of the inner cannula between the proximal end and the distal end of the inner cannula. An annularly expanding and retracting extraction mechanism at the distal end of the inner cannula is operable to capture and extract kidney stones from within a lumen of a patient.
In another example embodiment, a method for using an extractor to remove a kidney stone percutaneously includes providing a percutaneous tract to a target site in a kidney in a patient's body, the target site including the kidney stone. An outer cannula of the extractor is advanced through the percutaneous tract to the target site. An inner cannula of the extractor is advanced through the outer cannula until a distal end of the inner cannula reaches the targeted site. A handle of the extractor grasping by an operator to expand an extraction mechanism at the distal end of the inner cannula to engage and capture the kidney stone to be extracted. With the kidney stone positioned within the extraction mechanism, the kidney stone is fragmented with a laser assembly to facilitate removing smaller pieces of the kidney stone from within the patient's body. The inner cannula is withdrawn from the patient outwardly of the installed percutaneous tract with the kidney stone fragmented.
The detailed description is set forth with reference to the accompanying figures. The use of the same reference numbers in different figures indicates similar or identical items or features.
Example embodiments are disclosed herein. It is understood, however, that the disclosed embodiments are merely exemplary and may be embodied in various and alternative forms. The figures are not necessarily to scale; some figures may be configured to show the details of a particular component. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a representative basis for the claims and/or teaching one skilled in the art to practice the embodiments.
Referring to the figures, an example extractor 10, e.g., a percutaneous extractor, is useful in grasping and removing kidney stones from a patient. In example embodiments, the kidney stones are reduced in size, e.g., fragmented, by a procedure in which laser energy, electro-hydraulic energy, or sound energy is applied to reduce the kidney stones in size for easier removal, as described in greater detail below. Referring further to
In example embodiments, outer cannula 12 has a length of 25.00 inches (63.50 centimeters (cm)) to 50.00 inches (127.00 cm), and, more particularly, a length of 28.00 inches (71.12 cm) to 45.00 inches (114.30 cm), suitable to allow the surgeon to reach the multiple poles of the patient's kidney by percutaneous introduction, for example. In alternative embodiments, outer cannula 12 may have any suitable length less than 25.0 inches or greater than 50.00 inches. Outer cannula 12 has an outer diameter of 0.010 inch (0.03 cm) to 0.118 inch (0.3 cm), and, more particularly, an outer diameter of 0.014 inch (0.0356 cm) to 0.063 inch (0.1400 cm). In example embodiments, outer cannula 12 has a wall thickness of at least 0.010 inch, and more particularly 0.014 inch, and even more particularly 0.015 inch. As the wall thickness increases, outer cannula 12 becomes more rigid. This rigidity enables the surgeon to control the nephroscope and to maneuver the nephroscope into a desired position. The surgeon thus delivers outer cannula 12 to the desired location within the operating field. An inner diameter of outer cannula 12 may range from 0.080 inch to 0.175 inch (from 6 Fr. to 13.5 Fr.). It is understood that in example embodiments the thickness of the outer cannula wall is maintained at a minimum of 0.015 inch, but an outer cannula wall thickness less than 0.015 inch may also be suitable.
In example embodiments, a sheath or other suitable coating or covering is positioned about an outer surface of outer cannula 12. In example embodiments, the sheath has a hydrophilic outer surface to facilitate movement of outer cannula 12 within the patient. For example, the sheath may be made of a suitable lubricious polymer material including, without limitation, a fluoropolymer liner, e.g., as polytetrafluoroethylene (PTFE) or Teflon® material, or another lubricious material such as polyethylene, polypropylene, nylon or polyurethane, for smooth movement of outer cannula 12 during introduction of extractor 10 into the patient and removal of extractor 10 from the patient. The sheath also protects the internal components of extractor 10, as described below. The sheath is desirably thin, for example, having a thickness of 0.10 millimeters (mm) to 0.4 mm (i.e., a thickness of 0.004 inch to 0.015 inch).
In example embodiments, an inner cannula 20 is slidably positioned within lumen 14 of outer cannula 12. An outer diameter of inner cannula 20 is sized such that inner cannula 20 is easily movable within lumen 14 of outer cannula 12 defining an inner diameter of outer cannula 12. In example embodiments, inner cannula 20 has a diameter of at least 0.065 inch (about 5 Fr); however, inner cannula 20 may have any suitable diameter provided that inner cannula 20 is movable within lumen 14 and capable of operating as described herein. Referring further to
In example embodiments, an annularly expanding and retracting extraction mechanism 32 is operatively coupled to distal end 28 of inner cannula 20. Extraction mechanism 32 is operable to capture and extract kidney stones or other foreign bodies from within a cavity or a lumen of the patient. As shown in
At distal end 28 of inner cannula 20, flexible tubular members 40 extend distally from corresponding secondary passage 30. An outwardly extending distal end section 42 of each flexible tubular member 40 constitutes a longitudinally fixed flexure element 44 forming a part of extraction mechanism 32. A plurality of wires 46, e.g., three wires, are associated with respective flexible tubular members 40. Wires 46 are preferably made of stainless steel, although other materials, e.g., electrically conducting or electrically insulating materials, may be used. Each wire 46 has a length of at least twice a length of flexible tubular members 40. Each wire 46 is bent at a midportion thereof so as to define a fixed wire section 48 and a movable wire section 50.
Each fixed wire sections 48 extends within a respective flexible tubular member 40 with the bend being disposed in a flexure position on the longitudinally fixed flexure elements 44 at a distal free end of flexible tubular member 40. Fixed wire sections 48 are fixed with respect to the respective flexible tubular member 40. Fixed wire section 48 transitions into an associated movable wire section 50 which extends distally from respective tubular member 40 and into an adjacent flexible tubular member 40. Movable wire section 50 extends through the adjacent flexible tubular member 40 and passes through the respective secondary passage 30 to operatively couple to a handle 60 of extractor 10 at proximal end 14 of outer cannula 12 and proximal end 26 of inner cannula 20. Handle 60 is configured for operating annularly expanding and retracting extraction mechanism 32.
Referring further to
In an alternative example embodiment as shown in
During such motion, extraction mechanism 32 and laser assembly 80 including a laser fiber 88 (shown in
In the use of extractor 10 in a percutaneous kidney stone removal procedure, the standard preparatory procedures and standard auxiliary equipment are used. Initially, a suitable percutaneous tract to the kidney in the patient's body is provided and an adequate visualization of the collecting system of the kidney by means of a scope is established through the percutaneous track. Outer cannula 12 is advanced through the percutaneous track to the target site. Next, distal end 28 of inner cannula 20 is advanced through outer cannula 12. Inner cannula 20 is advanced until distal end 28 of inner cannula 20 reaches the targeted area where the stone is to be removed. This advancement is accomplished by manually feeding extractor 10 through a working channel in the scope. When distal end 28 of inner cannula 20 reaches the target area as determined by visual inspection of the scope, the operator grasps handle 60 and moves first section 62 toward second section 64. An extent of the distal movement is sufficient to expand extraction mechanism 32, such as shown in
As handle 60 is moved, the proximal ends of movable wire sections 50 are moved therewith. Because movable wire sections 50 are captured peripherally throughout their extent, the movement of the proximal ends causes the opposite distal ends to move outwardly of the distal ends of flexible tubular members 40 or fixed flexure elements 44. Because the distal ends of movable wire sections 50 are fixed to adjacent fixed flexure elements 44 by virtue of the fixture of integral fixed wire section 48 therewith, the movement of the distal end portions of movable wire sections 50 outwardly of fixed flexure elements 44 causes fixed flexure elements 44 to be flexed radially outwardly at the free ends and the outwardly extending end portions of movable wire sections 50 to flex arcuately outwardly beyond the distal free ends of fixed flexure elements 44.
When handle 60 reaches the deployed position, as shown in
The deployment configuration whether maximal or less enables the operator to move the expanded extraction mechanism 32 longitudinally over the targeted kidney stone until it is captured therein. This longitudinal forward movement is a more natural movement to effect capture of the stone in the kidney's collecting system as compared with a lateral movement. Nevertheless, alternatively, it is possible to loop the most convenient arcuate flexure element over the stone to position it inside the deployed extraction mechanism 32. During the looping movement, it is noted that fixed flexure elements 44 which are not associated with the movable flexure element used to loop the stone as well as the movable flexure elements associated therewith provide structure to engage the stone as the looping movement progresses, thus establishing the full entry of the stone within extraction mechanism 32. The deployment movement is determined to take place in a coordinated relation with the position of the stone within the kidney collecting system. The advancing longitudinal movement or the looping movement can be a coordinated part of the deployment movement or fully sequential. In this way, either the annular series of outwardly arcuately flexed movable flexure elements are moved around the stone or the selected movable flexure element more or less is reached out and looped over the stone. In this coordinated movement, it is noted that there are no sharp points ever presented to deal with which might start hemorrhaging. Other suitable extraction mechanisms, e.g., other baskets, can be used to replace extraction mechanism 32 as described herein.
Once the stone is positioned within the expanded extraction mechanism 32, the operator moves handle 60 in a proximal rearward direction away from the deployed position toward the insertion position shown in
With the stone tightly engaged within extraction mechanism 32, laser assembly 80 is utilized to fragment the stone to facilitate removing smaller pieces of stone from within the patient's kidney. Once the stone has been fragmented, inner cannula 20 can be withdrawn from the patient outwardly of the installed percutaneous tract. Note that during this fixed withdrawing movement the broader fixed flexure elements 44 are leading. The use of laser assembly 80 in cooperation with extraction mechanism 32 allows for localizing the area in which the kidney stone resides, as well as producing smaller stone fragments that are easier to remove. This also minimizes surgical time and reduces the need for clear visualization during the procedure. Extraction mechanism 32 and a placement of laser assembly 80 in central passage 22 allows the surgeon to hold the stone directly in line with laser fiber 88 with the wires of extraction mechanism outside the line of the laser fiber sight, reducing the incidence of damage to extraction mechanism 32.
Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as illustrative forms of implementing the claims.
One skilled in the art will realize that a virtually unlimited number of variations to the above descriptions are possible, and that the examples and the accompanying figures are merely to illustrate one or more examples of implementations.
It will be understood by those skilled in the art that various other modifications can be made, and equivalents can be substituted, without departing from claimed subject matter. Additionally, many modifications can be made to adapt a particular situation to the teachings of claimed subject matter without departing from the central concept described herein. Therefore, it is intended that claimed subject matter not be limited to the particular embodiments disclosed, but that such claimed subject matter can also include all embodiments falling within the scope of the appended claims, and equivalents thereof.
In the detailed description above, numerous specific details are set forth to provide a thorough understanding of claimed subject matter. However, it will be understood by those skilled in the art that claimed subject matter can be practiced without these specific details. In other instances, methods, devices, or systems that would be known by one of ordinary skill have not been described in detail so as not to obscure claimed subject matter.
Reference throughout this specification to “one embodiment” or “an embodiment” can mean that a particular feature, structure, or characteristic described in connection with a particular embodiment can be included in at least one embodiment of claimed subject matter. Thus, appearances of the phrase “in one embodiment” or “an embodiment” in various places throughout this specification are not necessarily intended to refer to the same embodiment or to any one particular embodiment described. Furthermore, it is to be understood that particular features, structures, or characteristics described can be combined in various ways in one or more embodiments. In general, of course, these and other issues can vary with the particular context of usage. Therefore, the particular context of the description or the usage of these terms can provide helpful guidance regarding inferences to be drawn for that context.
This application is a continuation of U.S. application Ser. No. 16/440,114, filed on Jun. 13, 2019, which claims priority from U.S. Provisional Application No. 62/684,894, filed on Jun. 14, 2018, the entirety of which is hereby fully incorporated by reference herein.
Number | Date | Country | |
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62684894 | Jun 2018 | US |
Number | Date | Country | |
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Parent | 16440114 | Jun 2019 | US |
Child | 16937111 | US |