Abstract
A stone or tissue capture device comprises a shaft with a deployable sweeping/containment structure at its distal end. The shaft is adapted to be removably placed over and connected to a conventional endoscope. The combination of the capture device and endoscope can be introduced into the various body lumens to capture, fragment/excise, and remove stones or tissue from the bladder and kidney, stomach, peritoneum, and from lumens such as the ureter, colon, hepatic ducts, airways, or blood vessels.
Claims
1. A method for controlling tissue during endoscopic debulking or biopsy of a body lumen, said method comprising: mounting a perforate containment structure over a distal end of a viewing scope introduced into the body lumen; deploying the perforate containment structure distally from the viewing scope so as to form a conical shape forward of the viewing element and working channel of the scope, the deployed perforate containment structure having an open distal end; positioning the scope adjacent a growth or target tissue; and fragmenting or excising the growth or target tissue through or with the scope, while containing at least some of the fragmented or excised growth or target tissue within the containment structure.
2. A method as in claim 1, wherein irrigation is employed to clear vision and to position at least a portion the growth or target tissue against the perforate containment structure.
3. A method as in claim 1, wherein fragmenting or excising the target tissue comprises taking multiple biopsies.
4. A method as in claim 1, wherein a diameter of the deployed perforate containment member is larger than an outside diameter of the scope.
5. A method as in claim 4, wherein the diameter of the deployed perforate containment member is at least twice the outside diameter of the scope.
6. A method as in claim 1, wherein the body lumen is the stomach, kidney, bladder, or peritoneal cavity.
7. A method as in claim 1, further comprising closing the open distal end of the deployed perforate containment structure with the fragmented or excised growth or target tissue contained therein, wherein closing the distal end of the containment structure comprises reducing a diameter of the distal end.
8. A method as in claim 7, wherein the open distal end of the deployed perforate containment structure is closed prior to the fragmented or excised growth or target tissue being removed through or with the scope.
9. A method as in claim 7, wherein closing the open distal end of the deployed perforate containment structure comprises drawing a tether coupled to the open distal end.
10. A method as in claim 9, wherein the tether passes through a mid-section of the perforate containment structure before coupling to the distal end of the perforate containment structure.
11. A method as in claim 1, wherein deploying the perforate containment structure comprises dilating the body lumen.
12. A method as in claim 1, wherein positioning the scope adjacent the growth or target tissue comprises passing the growth or target tissue through the open distal end of the deployed perforate containment structure to be contained within the cone of the perforate containment structure.
13. A method for controlling tissue during endoscopic debulking or biopsy of a body duct or vessel, said method comprising: mounting a perforate containment structure over a distal end of a viewing scope introduced into the body duct or vessel lumen with a partial or full occlusion; deploying the perforate containment structure distally from the viewing scope so as to form a conical shape forward of the viewing element and working channel of the scope, the conical shape being at least the full diameter of the lumen, the deployed perforate containment structure in the conical shape having an open distal end, and the deployed perforate containment structure expanding or dilating a region of the body duct or vessel between the tip of the scope and the target growth or tissue; and fragmenting or excising the growth or target tissue through the scope, while containing at least some of the fragmented or excised growth or target tissue within the containment structure, the fragmented or excised growth or target tissue having been passed into the deployed perforate containment structure through the open distal end before removal from the body duct or vessel.
14. A method as in claim 13, wherein the body duct or vessel is a ureter, colon, hepatic duct, airway, or blood vessel.
15. A method as in claim 13, further comprising closing the open distal end of the deployed perforate containment structure with the fragmented or excised growth or target tissue contained therein.
16. A method as in claim 15, wherein the open distal end of the deployed perforate containment structure is closed prior to the fragmented or excised growth or target tissue being removed from the body duct or vessel through or with the scope.
17. A method as in claim 16, wherein closing the open distal end of the deployed perforate containment structure comprises drawing a tether of the open distal end.
18. A method as in claim 17, wherein the tether passes through a mid-section of the perforate containment structure before coupling to the distal end of the perforate containment structure.
19. A method as in claim 13, wherein irrigation is employed to clear vision and to position the fragmented or excised growth or target tissue against the perforate containment structure.
20. A method as in claim 13, wherein fragmenting or excising the growth or target tissue comprises taking multiple biopsies.
21. A method as in claim 13, wherein a diameter of the deployed perforate containment member is larger than an outside diameter of the scope.
22. A method as in claim 21, wherein the diameter of the deployed perforate containment member is at least twice the outside diameter of the scope.
23. A method as in claim 13, further comprising removing the fragmented or excised growth or target tissue from the body duct or vessel through or with the viewing scope.
24. A method as in claim 23, wherein removing the fragmented or excised growth or target tissue comprises removing a first portion of the growth or target tissue while a second portion of the growth or target tissue remains contained within the containment structure.
25. A method as in claim 1, further comprising removing the fragmented or excised growth or target tissue from the body duct or vessel through or with the viewing scope.
26. A method as in claim 25, wherein removing the fragmented or excised growth or target tissue comprises removing a first portion of the growth or target tissue while a second portion of the growth or target tissue remains contained within the containment structure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
[0023] FIG. 1 is a perspective view of a stone capture device constructed in accordance with the principles of the present invention.
[0024] FIG. 2 is a perspective view of a viewing scope in the form of a commercially available ureteroscope having a steerable distal end.
[0025] FIG. 3 is a detailed view of the distal end of the stone capture device of the present invention.
[0026] FIGS. 4A and 4B illustrate the distal end of the stone capture device with a partially deployed sweeping structure.
[0027] FIGS. 5A and 5B illustrate the distal end of the stone capture device with a fully deployed sweeping structure.
[0028] FIG. 6 illustrates the initial placement of the stone capture device and viewing scope of the present invention through the urinary tract into a kidney.
[0029] FIGS. 7A-7D illustrate deployment of the sweeping structure on the stone capture device for capturing, fragmenting, and removing a stone within the kidney.
[0030] FIGS. 8A-8C illustrate the structure and use of an alternative embodiment of the sweeping structure of the present invention.
[0031] FIG. 9 illustrates the use of the stone capture device in a bladder.
[0032] FIGS. 10A-10B illustrates the use of the stone capture device in a duct or vessel.
DETAILED DESCRIPTION OF THE INVENTION
[0033] Referring to FIG. 1, a stone capture device 10 constructed in accordance with the principles of the present invention comprises a sheath 12 having a proximal end 14 and a distal end 16. A deployable sweeping structure 18 is disposed at the distal end of the sheath 12 and is shiftable between a low profile tubular configuration (shown in full line) and an open or deployed concave configuration (shown in broken line). A hub 20 is typically provided at the proximal end 14 of the sheath 12.
[0034] The stone capture device 10 of the present invention is intended to be mounted over the steerable shaft 24 of a conventional viewing scope (26, FIG. 2), typically a ureteroscope, such as those commercially available from Olympus/ACMI. The viewing scope 26 further comprises a control handle 28 attached to a proximal end of the shaft 24. The control handle 28 includes a steering lever 30 which can be advanced and retracted to selectively deflect or “steer” a distal region 32 of the shaft 24, as shown in broken line. The control handle 28 will further include a connector for compiling a light source and an optical element of the viewing scope to a suitable screen and power source (not shown).
[0035] As shown in FIG. 3, a distal tip 40 of the steerable shaft 24 of the viewing scope 26 is introduced through the entire length of the sheath 12 of the stone capture device 10 so that said distal end is received in and attached to a distal tip 42 of the deployable sweeping structure. The deployable sweeping structure 18 is typically a woven or braided mesh, typically formed from polymeric or wire filaments or fibers, so that axial compression of the sweeping structure 18 from its tubular configuration (illustrated in FIG. 3) to a foreshortened configuration (as shown in FIGS. 4A and 5A, will cause the sweeping structure to assume a concave configuration, more particularly a conical configuration. Usually, the sweeping structure will be fabricated so that it preferentially bends and everts about a weakened region 44, as shown in FIGS. 4A and 5A. Thus, a distal most portion 46 of the sweeping structure 18 will preferentially evert into a proximal most portion 48. Thus, as the steerable shaft 24 is progressively pulled proximally, as shown by the arrows in FIGS. 4A and 5A, the steering structure progressively shortens with the forward diameter or width becoming larger.
[0036] The sweeping structure in its tubular configuration, as shown in FIG. 3, has only a single wall and is thus relatively flexible, typically having a bending stiffness in the ranges set forth above. As the sweeping structure 18 is everted, however, the wall becomes doubled, increasing the bending stiffness within the ranges set forth above. The relatively flexible tubular configuration is desirable since it will be over the steerable distal region 32 of the viewing scope. Thus, the viewing scope may be steered even while the sweeping structure 18 is over it. When the sweeping structure is deployed, however, it will have more stiffness and rigidity to facilitate engaging and manipulating the urinary stones within the kidney or bladder. As the deployed sweeping structure is distal to the distal end of the steerable shaft 24, however, the structure will not interfere with steering and advancement.
[0037] The sweeping structure mesh is preferably constructed from a wire braid. Usually eight to 36 wires are used to construct braid. The wire will usually be formed from a flexible metal or polymer material such as a superelastic nickel-titanium alloy (nitinol), a nylon, or a polyethylene terephthalate (PET).
[0038] The sweeping structure 18 will further include a mechanism for drawing the open end closed after it has been partially or fully deployed. In the exemplary embodiments of FIGS. 3, 4A-B, and 5A-B, the structure to close the end is a simple filament or suture 60 which passes through the mid-section of the sweeping structure which becomes the forward edge of the sweeping structure after deployment. Thus, by pulling on the filament, the filament acts as a purse string to draw the sweeping structure closed, as illustrated in FIG. 7D discussed below.
[0039] The viewing scope 26 will be introduced into the urinary tract UT with a stone capture device 10 disposed thereover, as illustrated in FIG. 6. The assembly of the viewing scope 26 and the stone capture device 10 is introduced in the same manner as a conventional ureteroscope without the stone capture device. That is, a distal end of the assembly of the present invention will be introduced through the urethra URTH into the bladder B, and optionally further through the ureter URE and into the kidney K. Once in the kidney, the non-deployed sweeping structure 18 and the distal region 32 of the viewing scope may be steered together using the lever 30 of the viewing scope which selectively deflects a distal portion of the shaft 24 of the viewing scope 26.
[0040] As illustrated in FIG. 7A, the kidney K may have a number of kidney stones KS therein. The sweeping structure 18 and distal region 32 may be steered while the physician views through the optical element 70 of the viewing scope (illustrated in FIGS. 4B and 5B). While viewing, illumination will be provided by a light source 72 on the viewing scope. Once a target kidney stone KS is located, as shown in FIG. 7A, the sweeping structure 18 may be deployed, as shown in FIG. 7B. The combination stone capture device 10 and viewing scope 26 (FIG. 2) may then be advanced, while continuing to optically view the region, until the deployed sweeping structure 18 engages a wall of the kidney, as shown in FIG. 7C, to capture the kidney stone between the sweeping structure and the wall. An optical (laser) fiber 80 or other stone fragmentation device may then be introduced through the working channel 74 (FIGS. 4B and 5B) of the viewing scope and advanced into the region where the stone is captured. By applying laser or other energy to the stone, the stone will be fragmented. Preferably, irrigation medium will be introduced simultaneously through the working channel to sweep the resulting stone fragments into the double-walled mesh of the deployed sweeping structure, thus simultaneously clearing the scope's field of view and entrapping the stone fragments therein. Occasionally, stones in the kidney are trapped within one of the cul-de-sac-like calices of the kidney. The sweeping structure may be advantageously deployed over the mouth of such a calyx to contain the stone and fragments produced by the lithotripsy process, in exactly the same manner as above. After the stone has been fragmented sufficiently, and the stone fragments captured, the filaments 60 may be retracted in order to close the sweeping structure 18 over the stone fragments, as shown in FIG. 7D. At that point, the combined assembly of the stone capture device 10 and the viewing scope 26 may be withdrawn from the urinary tract. After the procedure is complete, the stone capture device 10 may be removed from the viewing scope 26, and the stone capture device will usually be disposed of in a conventional manner. The viewing scope, however, can be sterilized and reused in subsequent procedures.
[0041] Referring now to FIGS. 8A-8C, an alternative perforate sweeping structure 100 comprises a carrier sleeve 102 attached at the distal end of a hypotube or other elongate tubular member 104. A pusher rod 106 extends coaxially through an inner passage or lumen of the hypotube 104 and is attached to a perforate sweeping structure 108 which is in a proximally retracted, radially collapsed configuration as shown in FIG. 8A. By pushing on the rod 106, typically using handle 110 while holding on to a second handle 112 which is attached at the proximal end of the hypotube 104, the self-expanding perforate sweeping structure 108 can be distally advanced so that it is released from the sleeve 102 and expands into an open conical configuration, as shown in FIG. 8B. A proximal end 112 of the perforate sweeping structure 108 will also expand to open and align with a passage or lumen 114 (FIG. 8A) which runs through the carrier sleeve 102.
[0042] The sweeping structure assembly 100 may then advance over a viewing scope 120 (FIG. 8B) by advancing a proximal end of the scope into the passage 114 of the sleeve 102. The hypotube 104 may be used to distally advance the sleeve 102 over the viewing structure 120 until the sleeve 102 approaches a distal end 122 of the viewing scope 120, as best seen in FIG. 8B. At that point, the viewing scope 120 and/or the assembly of sleeve 102 and hypotube 104 may be manipulated to cause the deployed perforate sweeping structure 108 to capture kidney stones KS therein. By then engaging a distal periphery 124 of the perforate sweeping structure 108 against the wall W, of the body cavity, kidney stones KS may be captured and energy applied through an optical fiber advanced through a working channel of the viewing scope 120 in order to disrupt the stones. After the stones are disrupted into a plurality of small fragments, the hypotube 104 may be retracted proximally in order to draw and collapse the sweeping structure 108 back into the passage 114 of sleeve 102 (as shown in FIG. 8C), optionally after the viewing scope 120 has been at least partially retracted therein. The viewing scope and sweeping structure assembly 100 may then be withdrawn from the body cavity to remove the stones.
[0043] FIG. 9 illustrates the use of the stone capture device 10 in the bladder B for retention and removal of a bladder stone BS or a growth G or malignancy. The device 10 is utilized in a similar manner as in the kidney K as illustrated in FIG. 7A-D. The everted porous cone 18 is not utilized as a sweeping structure, but is still utilized as a containment device to isolate and to trap tissue fragments removed during debulking. In the case of biopsy rather than removal or debulking, the containment structure 18 is similarly used to isolate the region to be sampled, then will serve to collect those samples for simultaneous removal.
[0044] FIG. 10 illustrates the use of the device 10 in a duct or vessel such as a ureter, colon, hepatic duct, airway, or blood vessel where there is not a large body cavity relative to the endoscope. In this case, the device 10 is shown in use in the ureter URE where there is situated a growth G or stone S shown completely obstructing the duct lumen. FIG. 10A illustrates the growth G distorting the ureter URE, so that the ureter is partly obstructed adjacent to the growth, not allowing good access by ureteroscope 12 to growth G. FIG. 10B illustrates the deployment of everted porous cone 18, again as a containment structure but also as a dilation structure to improve visualization and access to growth G. Once the procedure is completed, multiple fragments may be removed simultaneously as in FIG. 7D.
[0045] While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.
