Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
  • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

Definitions

• This invention relates generally to medical devices, and more particularly to devices useful during medical procedures for disintegrating stones, calculus or the like located in a passage in the body.
• Kidney stones for example, are commonly treated by ultrasonic lithotripsy, electrohydraulic lithotripsy, laser ablation or lithotripsy, shock wave lithotripsy (ESWL), or by other procedures.
• kidney stones typically entail infusing a relatively large volume of fluid into the renal system (renal pelvis, bladder, ureters and so on) to facilitate the passage of an endoscope or one or more catheters through the renal system.
• an endoscope or one or more catheters After the disintegration of kidney stones it is possible for some of the resulting fragments of the stones to migrate up the ureter towards or even into the kidney. Such migration is highly undesirable and can in some extreme cases require the performance of a percutaneous nephrostomy to drain the kidney after the disintegration procedure.
• the fragments might well possess sufficient energy from the disintegration procedure to force themselves between the nonporous anchor and the ureteral wall or other body passage.
• the ureteral wall or other wall itself might even be damaged by such forcing, or by unduly severe expansion or inflation of the anchor in order to prevent such forcing.
• Catheters or anchors used for other purposes do not solve these problems.
• U.S. Patent No. 3,996,938 discloses a flexible catheter for removing blood clots (thrombi) from the vascular system.
• the catheter includes a mesh sleeve positioned between the round ended tip of a flexible plunger wire and the end of an elongate flexible portion of a guide tube, in which the plunger wire slidably extends through the guide tube.
• the mesh is normally tubular or cylindrical in shape, but is expanded by drawing the plunger wire back. The catheter is withdrawn while the mesh is still expanded, carrying the clot or clots with it.
• the elongate flexible portion of the guide tube is preferably formed of tightly wound spring wire.
• the device of the Clark, III, patent may function adequately, it may be subject to several drawbacks during its use.
• the device provides no protection for the mesh sleeve or for the elongated flexible portion (the wound spring wire) before, during or after its introduction into the body.
• wound wire coils or springs of relatively small diameters e_.g., less than or equal to about 3 French, are undesirably subject to deformation due to elongation and/or compression during use.
• U.S. Patent No. 5,041 ,093 (Chu, Aug. 20, 1 991 ) discloses a drainage catheter which includes an elongated flexible tubular member having a woven or braided foraminous tube near its distal end as an anchor.
• the foraminous tube is translatable from an extended or cylindrical configuration (in which it is easy to place the catheter in the organ to be drained) to an ovoid or other anchoring configuration.
• the Chu patent does not disclose any means for protecting the woven tube before or during introduction.
• the Chu patent appears to contain no suggestion as to how the device disclosed in it could be or should be modified to possess a structure or pore size suitable for blocking fragments of kidney stones, gall stones or the like, or that it could be or should be modified so that the foraminous tube is dimensioned to closely match the diameter of the vessel or other body passage in which the anchor is disposed.
• U.S. Patent No. 4,921 ,484 (Hillstead, May 1 , 1 990) discloses a mesh balloon catheter device which includes a catheter, a tubular mesh of woven interlaced filaments connected to the distal end of the catheter, and a mechanism for moving the distal end of the tubular mesh towards the proximal end of the tubular mesh so that the mesh balloons laterally outward.
• the mechanism for moving the distal end of the tubular mesh includes a handle, and the mesh is disclosed as being useful for holding the catheter in place in the bladder or bile tract, or for filtration in either a drainage application or as an addition to a coronary angioplasty balloon catheter procedure.
• the device disclosed in the Hillstead patent appears to be subject to many of the limitations and drawbacks noted above.
• U.S. Patent No. 4,790,81 2 discloses an apparatus for removing a target object from a body passageway.
• the apparatus includes a cutting tip and a downstream parachute basket made of spiral wire for catching fragments produced by the cutting tip.
• the apparatus is disclosed as being useful for fragmenting relatively hard objects such as atheroma or kidney stones.
• the basket may be stowed within a sheath catheter and can include a porous fabric web between the spiral wires of the parachute.
• the specification of the patent, at column 6, lines 45-63 notes that the apparatus may be used, without the parachute basket, in conjunction with conventional shock wave lithotripsy (ESWL) techniques for the removal of kidney stones.
• ESWL shock wave lithotripsy
• the foregoing problems are solved and a technical advance is achieved in an illustrative occluder for the ureter or another body passage.
• Applicant has discovered that the migration of fragments of stones, calculus or the like resulting from ultrasonic lithotripsy, electrohydraulic lithotripsy, laser ablation or lithotripsy, or the like, can reliably be limited by the insertion of a particular occluder into a body passage such as an ureter before disintegration of the stones, calculus or the like.
• the occluder comprises an elongated mandrel and a flexible tubular shaped arrangement mounted around the mandrel for relative longitudinal movement along the mandrel.
• the arrangement comprises a first flexible tubular shaped part mounted for relative reciprocal movement along the mandrel and a second flexible part with a proximal region connected to the first part and with a distal region connected to a distal part of the mandrel.
• the second and first parts are constructed in such a manner that the second part radially expands when longitudinally compressed by longitudinal movement of the first part in a distal direction.
• the second part when radially expanded forms a filter to occlude the body passage whilst simultaneously permitting flow of fluid in the body passage.
• the second part is in the form of a braid formed from one or more strands or wires extending between the distal end of the first part and the distal end of the mandrel.
• the braid extends over at least a part of the first part with the proximal end of the braid connected to the external surface of the first part.
• an introducer sheath is able to surround the first and second parts when the second part is in a non-radially expanded phase.
• the first part is in the form of a flexible coil capable of longitudinally compressing and radially expanding the second part.
• the first part can either be in the form of a flexible tube with or without a helical channel cut in the outer surface, or it can be in the form of a coil.
• the second part can be in the form of a woven braid or in the form of a coil which has a flexibility and pitch enabling it to radially expand when longitudinally compressed.
• the proximal end of the second part can be connected to the distal end of the first part, or they can be in an overlapping relationship.
• the first part It is not essential for the first part to be a coil, and it is not essential for the second part to be a multi-stranded braid.
• the second part must possess two properties. Firstly, it must be sufficiently flexible so that the occluder works in a satisfactory manner and secondly, it must be able to impart positive distal movement to the second part, when the first part is pushed in a distal direction relative to the mandrel. Both of these properties can be achieved by a thin plastic tube with a longitudinally extending helix cut in the outer surface.
• the second part need not be formed from a plurality of woven strands. One strand can be sufficient.
• the term "braid" implies a weaving action of which a fine wire coil should function satisfactorly providing the pitch was suitable.
• the braid does not need to be "position over" the "coil” . It can be nearly connected the distal end of the coil, and that connection is only needed for the purposes of withdrawal.
• the radial expansion can be achieved by a mere pushing action.
• a "proximal segment” is not required on the mandrel; however, lack thereof, would make the operation of the handle somewhat complicated.
• the occluder includes a collapsed but expandable filter which is positioned above the stone, calculus or the like, and which is then expanded before the disintegration procedure is performed. Such positioning is preferably carried out under ureteroscopic (direct vision) control.
• an occluder insertable into a body passage for limiting the migration of fragments resulting from the disintegration of stones, calculus or the like which first comprises an elongated mandrel and a coil closely positioned over part of the mandrel.
• the coil has proximal and distal ends defining proximal and distal segments of the mandrel which are not covered by the coil.
• the occluder also comprises a braid positioned over and encircling all of the distal segment of the mandrel and preferably, although not necessarily, positioned over and encircling at least part of the wire coil.
• the coil is preferably wound from flat wire, while the braid is preferably formed from a woven plurality of strands.
• the distal end of the elongated mandrel is fixed with respect to the distal end of the braid, while the proximal end of the braid is fixed with respect to the coil.
• the coil and the elongated mandrel are longitudinally moveable with respect to one another between relatively adjacent and relatively spaced-apart positions; movement to their relatively adjacent position expands the braid radially so as to occlude the body passage and form a filter which blocks the migration of fragments in the body passage while allowing the flow of fluid in the body passage. This simultaneously permits some of the energy employed during disintegration of the stones, calculus or the like to be dispersed both upstream and downstream in the passage.
• the occluder additionally comprises a handle connected to the proximal end of the mandrel and to the proximal end of the coil, for moving the mandrel and coil between their two relative positions.
• the occluder further comprises a protective outer sheath slidable over the braid when the wound coil and the elongated mandrel are in their relatively spaced-apart position.
• the occluder is insertable into a body passage for limiting the migration of fragments resulting from the disintegration of stones, calculus or the like in the passage, comprising: an elongated mandrel having a proximal end and a distal end; a coil closely positioned over part of the elongated mandrel, the coil having a proximal end and a distal end, the proximal and distal ends of the coil defining a proximal segment and a distal segment of the elongated mandrel not covered by the coil; and a braid positioned over and encircling all of the distal segment of the elongated mandrel and at least part of the wire coil, the braid having a proximal end and a distal end; wherein the coil and the elongated mandrel are longitudinally moveable with respect to one another between relatively adjacent and relatively spaced-apart positions; wherein the distal end of the elong
• the occluder is insertable into a body passage for limiting the migration of fragments resulting from the disintegration of stones, calculus or the like in the passage, comprising: an elongated mandrel having a proximal end and a distal end; a coil wound from flat wire and closely positioned over part of the elongated mandrel, the coil having a proximal end and a distal end, the proximal and distal ends of the coil defining a proximal segment and a distal segment of the elongated mandrel not covered by the coil; the coil and the elongated mandrel being longitudinally moveable with respect to one another between relatively adjacent and relatively spaced-apart positions; a braid formed from a woven plurality of strands and positioned over and encircling all of the distal segment of the elongated mandrel, the braid having a
• This second aspect of the occluder differs from the first aspect in that the coil is wound from flat wire, in that the braid is formed from a woven plurality of strands, in that the proximal end of the braid is affixed to the distal end of the coil, and in that it further includes an outer sheath slidable over the braid when the coil and mandrel are in their relatively spaced-apart position.
• an occluder is insertable into a body passage for limiting the migration of fragments resulting from the disintegration of stones, calculus or the like in the passage, comprising: an elongated mandrel having a proximal end and a distal end; a coil wound from flat wire and closely positioned over part of the elongated mandrel, the coil having a proximal end and a distal end, the proximal and distal ends of the coil defining a proximal segment and a distal segment of the elongated mandrel not covered by the coil; the coil and the elongated mandrel being longitudinally moveable with respect to one another between relatively adjacent and relatively spaced-apart positions; a braid formed from a woven plurality of strands and positioned over and encircling all of the distal segment of the elongated mandrel and the substantial length of the wire coil, the braid having a proximal end and a dis
• the ureteral or other occluder is particularly advantageous in that the migration of large fragments of stone, calculus or the like further up the ureter or other body passage is affirmatively avoided, since the filter not only traps such fragments, but allows at least some of the energy applied during the disintegration procedure to be dispersed both up and down the ureter or other body passage. It must be remembered, however, that while the occluder finds its greatest utility as a ureteral occluder, and while its preferred embodiment is disclosed as a ureteral occluder, the occluder can also be used in a variety of other body passages, including
• FIG. 1 is a side view of the preferred embodiment of the occluder
• FIG. 2 is a partial cross-sectional view of the preferred embodiment of the occluder
• FIG. 3 is a cross-sectional view of the occluder of FIG. 1 taken along line 3 - 3;
• FIG. 4 is a side view of the preferred embodiment of the occluder during use
• FIG. 5 is another side view of the preferred embodiment of the occluder during use
• FIG. 6 is a partial cross-sectional view of another preferred embodiment of the occluder.
• an occluder 10 is thereshown, which is insertable into a body passage for limiting the migration of fragments resulting from the disintegration of stones, calculus or the like in the passage.
• the occluder 10 first comprises an elongated mandrel 1 2 having a proximal end 14 and a distal end 1 6.
• the mandrel 1 2 is composed of a medical grade material such as stainless steel or another alloy, nitinol, or a synthetic material.
• the mandrel 1 2 is conveniently composed of a 0.229 mm (0.009 in.) wire, and is about 86 cm long.
• the particular dimensions of the mandrel 1 2 should of course be selected in view of the body passage in which the occluder 1 0 is to be placed.
• the occluder 1 0 next comprises a coil 1 8 closely positioned over part of the mandrel
• the coil 1 8 is composed of a medical grade material such as stainless steel or another alloy, nitinol, or a synthetic material.
• the coil 1 8 is preferably wound from a flat metal wire and conveniently has an overall diameter of 0.457 mm (0.01 8 in.). Also preferably, when the occluder 1 0 is employed in the ureter, the coil 1 8 has an overall length of about 75 cm.
• the coil 1 8 has a proximal end 20 and a distal end 22, which respectively define a proximal segment 24 and a distal segment 26 of the elongated mandrel not covered by the coil 1 8.
• the proximal uncovered segment 24 of the mandrel 1 2 is about 8 cm in length, while the distal uncovered segment 26 of the mandrel 1 2 is about 3 cm in length.
• the occluder 1 0 further comprises a braid 28 positioned over and encircling all of the distal segment 26 of the elongated mandrel 1 2.
• the braid can be woven or formed from one or more strands of wire.
• the braid 28 is also positioned over and encircles at least part of, and preferably covers the substantial length of, the coil 1 8.
• the braid 28 has a proximal end 32 and a distal end 34, the proximal end 32 of the braid 28 being fixed with respect to the coil 1 8, and the distal end 1 6 of the mandrel 1 2 being fixed with respect to the distal end 34 of the braid 28.
• the braid 28 is preferably formed from a woven plurality of strands 30.
• the strands 30 are composed of a suitable medical grade material, such as nitinol, stainless steel, another metal alloy or a polymer.
• a 3 mm segment of soft solder connects the distal end 34 of the braid 28 to the distal end 1 6 of the mandrel 1 2, while about a 2 to 3 mm segment of hard solder affixes the proximal end 32 of the braid to the coil 1 8, preferably to the proximal end 20 of the coil 1 8.
• about a 2 to 3 mm segment of soft solder also secures the braid 28 to the distal end 22 of the coil 1 8, between the proximal and distal ends 32 and 34 of the braid 28. This essentially makes the tip of the occluder 1 0, formed by the distal end 34 of the braid 28 and the distal end 1 6 of the mandrel 1 2, atraumatic.
• a further round bead of solder can be placed on the braid distal end 34 and the mandrel distal end 1 6.
• a small metal ball can be soldered or otherwise attached to them.
• the coil 1 8 and the elongated mandrel 1 2 are thus both secured to the braid 28, the coil 1 8 and mandrel 1 2 must still be longitudinally moveable with respect to one another. It is therefore important that the two segments of solder affixing the braid 28 to the coil 1 8 be applied in a manner which does not interfere with such relative movement.
• the coil 1 8 and the elongated mandrel 1 2 are moveable between two positions, one in which their distal ends 22 and 1 6 are relatively adjacent (designated herein as “the relatively adjacent position"), and another in which their distal ends 22 and 1 6 are relatively more distant from one another (designated herein as “the relatively spaced-apart position”). It is this latter spaced- apart position that is shown in FIGs. 1 and 2.
• the braid 28 is generally cylindrically shaped.
• the occluder 1 0 preferably further comprises a mechanism for causing relative movement of the coil 1 8 and the mandrel 1 2.
• a mechanism for causing relative movement of the coil 1 8 and the mandrel 1 2 is exempli- fied by a handle 44 connected to the proximal end 1 4 of the mandrel 1 2 and the proximal end 20 of the coil 1 8.
• One of the coil 18 and the mandrel 12 is fixed to the handle 44, while the other is slidably connected to the handle 44.
• the proximal end 1 4 of the elongated mandrel 1 2 is affixed to the handle 44, while the proximal end 20 of the coil 1 8 is slidably connected to the handle 44 by a coil slider 46 contained in the handle 44.
• the coil slider 46 slides over the uncovered proximal segment 24 of the mandrel 1 2.
• a variety of conventional elements can be used to connect the mandrel 1 2 to the handle 44, and the coil 1 8 to the handle 44, in particular, to the coil slider 46.
• the occluder 1 0 preferably further comprises an outer sheath 38 slidable over the braid 28 when the coil 1 8 and the elongated mandrel 1 2 are in their relatively spaced-apart position.
• the sheath 38 is conveniently operated by and connected to the handle 44 by a sheath slider 48 contained in the handle 44.
• the sheath slider 48 fits over the coil 1 8 and mandrel 1 2, distal to the proximal end 20 of the coil 1 8. Withdrawal of the sheath 38 so as to expose the braid 28 is shown in FIG. 4.
• a variety of conventional connecting elements can be used to connect the outer sheath 38 to the handle 44, and in particular, to the sheath slider 48.
• wound wire coils of relatively small overall diameter, equal to or less than about 3 French are subject to elongation and compressive deformation when introduced into body passages.
• the preferred occluder overcomes the drawbacks of such deformation by allowing the braid 28 to extend the substantial length of the coil 1 8, thereby supporting it and avoiding the undesired deformation.
• wound wire coils are generally able to sustain themselves during introduction into body passages, so the support provided by the braid 28 in smaller occluders isn't necessary in larger occluders.
• the braid 28 need not cover the entire coil 1 8, but need only be connected to the distal end 1 6 of the mandrel 1 2 and the distal end 20 of the coil 1 8. More particularly, the proximal end 32 of the braid 28 can be fixed to the distal end 22 of the coil 1 8 by about a 2 to 3 mm segment of either hard or soft solder.
• Such occluders are otherwise constructed in the same manner as the occluder 10 shown in FIGs. 1 through 5, and include the outer sheath 38 slidable over the braid 28 when the coil 1 8 and mandrel 1 2 are in their relatively spaced-apart position.
• the occluder 1 0 is first arranged as shown in FIG. 1 , with the coil slider 46 moved proximally so that the braid 28 is in a generally cylindrical shape, and with the sheath slider 48 moved distally so that the sheath 38 covers the braid 28.
• the patient is then prepared for the introduction of the occluder 1 0 into the desired body passage and for performance of the disintegration procedure. For example, it may be desirable before lithotripsy of kidney stones to infuse the renal system of the patient with a suitable fluid.
• the occluder 1 0 is introduced into the ureter until the braid 28 lies upstream of the stone, calculus or the like to be disintegrated.
• introduction is most conveniently carried out via ureteroscopic (direct vision) control, although other monitoring methods may be suitable for other body passages.
• the sheath slider 48 on the handle 44 is moved proximally so as to withdraw the sheath 38 from the braid 28 (Fig. 4).
• the coil slider 46 is then moved distally (Fig. 5) to radially expand the braid 28 so as to occlude the ureter or other body passage and form the filter 36 which blocks the migration of fragments while allowing the flow of fluid and the dispersion of at least part of the energy to be applied for disintegrating the stone, calculus or the like.
• the desired lithotripsy or ablative procedure is then performed, with assurance that undesired migration of fragments is prevented.
• the coil slider 46 is moved proximally to collapse the filter 36, and the sheath slider 48 is moved distally to slide the outer sheath 38 over the braid 28.
• the occluder 1 0 is then removed from the ureter or other body passage. It should be clear that the occluder for the ureter or another body passage is particularly advantageous in that the undesired migration of fragments of stone, calculus or the like is affirmatively prevented, while at least some of the energy applied during the disintegration procedure is dispersed both up and down the ureter or other body passage.
• This occluder is useful in performing surgical procedures, and therefore finds applicability in human and veterinary medicine. It is to be understood, however, that the above-described occluder is merely an illustrative embodiment of the principles of this invention, and that other occluders and methods for using them may be devised by those skilled in the art, without departing from the spirit and scope of the invention. It is also to be understood that the occluder is directed to embodiments both comprising and consisting of the disclosed parts.

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• Health & Medical Sciences (AREA)
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• Life Sciences & Earth Sciences (AREA)
• Molecular Biology (AREA)
• General Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)
• Prostheses (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Filtering Materials (AREA)
• Manufacture Of Alloys Or Alloy Compounds (AREA)

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• 1997
  • 1997-12-31 AU AU57192/98A patent/AU5719298A/en not_active Abandoned
  • 1997-12-31 KR KR1019997005931A patent/KR20000062380A/ko not_active Application Discontinuation
  • 1997-12-31 EP EP97953447A patent/EP0955912A1/de not_active Withdrawn
  • 1997-12-31 CA CA002271751A patent/CA2271751A1/en not_active Abandoned
  • 1997-12-31 JP JP53020898A patent/JP2001507598A/ja active Pending
  • 1997-12-31 WO PCT/US1997/023881 patent/WO1998029043A1/en not_active Application Discontinuation

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