Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0009—Making of catheters or other medical or surgical tubes
  • A61M25/0014—Connecting a tube to a hub
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0662—Guide tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0662—Guide tubes
  • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1078—Urinary tract
  • A61M2210/1089—Urethra

Definitions

• This invention relates generally to guideways for endoluminal access and more specifically to surgical access devices adapted to introduce surgical instrumentation into body conduits.
• Surgical access devices ofthe prior art typically include a sheath having an outside diameter and an inside diameter.
• An obturator or dilator is inserted into the sheath to facilitate introduction of the sheath into the body conduit. Once the sheath is positioned, the obturator is removed leaving a working channel for surgical instrumentation.
• the sheath has been provided in the form of an elongate tube having an axis extending between a proximal end and a distal end.
• the diameter ofthe tube is generally constant, except for a reduced diameter segment at the distal end.
• the obturator has had an enlarged structure at its proximal end, there has been no such enlargement for the sheath. This has presented a problem as the sheath has tended to migrate distally and disappear beneath the urethral meatus.
• Representative of this art is the FLEXIBLE URETEROSCOPE SHEATH manufactured and sold by Cook Urological Incorporated.
• Access devices particularly adapted for other body conduits have had enlargements at the proximal end, but these have not been specifically configured to prevent migration or facilitate the introduction of instrumentation.
• Representative of this art are the "banana peel” sheaths which split axially for removal after catheter placement.
• the present access device which includes a sheath having at its proximal end a handle specifically adapted to inhibit migration and facilitate use with instrumentation.
• the handle is formed as a radial enlargement having a distally-facing surface and a proximally- facing surface.
• the distally-facing surface has a generally concave configuration which provides a gradual enlargement inhibiting migration of the sheath into the ureter.
• the concave configuration is sized to receive adjacent fingers of a user's hand disposed in its natural position, in order to facilitate the stationary orientation ofthe sheath.
• the concave, distally-facing surface is continuous around the axis ofthe sheath so that the advantage of this concave configuration can be appreciated regardless ofthe radial orientation ofthe sheath.
• the proximal-facing surface has a generally convex configuration providing for an increased funneling of an instrument as it is inserted into the working channel ofthe sheath.
• Both the distally-facing surface and the proximally- facing surface extend radially inwardly with progressively equal distal positions along the sheath. This provides the handle with the general shape ofthe bell of a horn. This configuration is not only ergonomically comfortable, but highly practical in addressing the problems of migration, as well as instrument insertion and removal.
• the handle can be provided with characteristics permitting the handle to be moved to a preferred position along the tube ofthe sheath, and then to be fixed to the tube at that preferred location. This makes it possible to provide the sheath with any desired length, even after it has been inserted into the body conduit.
• a metal structure such as a spring, can be molded into the tube ofthe sheath to facilitate kink resistance.
• the inner dilator can be provided with a Luerlock end, permitting attachment of a sidearm adaptor (not shown). This allows for installation of contrast during sheath placement without the need to remove the guidewire.
• Fig. 1 is a perspective view illustrating a sheath ofthe present invention with an obturator or dilator adapted for use with the sheath;
• Fig. 2 is a perspective view illustrating the obturator operatively disposed within the sheath;
• Fig. 3 is an axial cross-section view taken along lines 3-3 of Fig. 2 and illustrating the obturator operatively disposed within a tube and "handle" of the sheath;
• Fig. 4 is an enlarged radial cross-section view of the handle assembly illustrated in Fig. 3;
• Fig. 5 is a side-elevation view of the sheath and obturator operatively disposed in the urethra and illustrating a preferred configuration for the handle assembly of the sheath;
• Fig. 6 is a side-elevation view similar to Fig. 5 of a further embodiment of the handle assembly ofthe present invention.
• Fig. 7 is a side-elevation view partially in phantom and exploded to illustrate components of another preferred embodiment ofthe handle assembly providing for sheath length adjustment;
• Fig. 8 is a side-elevation view illustrating the components of Fig. 7 in an assembled configuration
• Fig. 9 is a radial cross-section view taken along lines 9-9 of Fig. 8;
• Fig. 10 is a perspective, disassembled view of a further embodiment of a handle assembly permitting length adjustment
• Fig. 11 is a perspective, assembled view ofthe components illustrated in Fig. 10.
• Fig. 12 is a side-elevation view partially in fragment and illustrating a spring embodiment of the tube associated with the sheath ofthe present invention.
• a ureteral access sheath is illustrated in Figure 1 and designated generally by the reference numeral 10.
• the sheath 10 is illustrated in combination with a separate, but associated, dilator or obturator 12.
• the sheath 10 has the general configuration of an elongate tube 14 having an axis 16 which extends between a proximal end 18 and a distal end 21.
• a handle 23 is disposed at the proximal end 18 ofthe tube 14 and provides access into a working channel 25 of the tube 14.
• the obturator 12 will typically have the configuration of an elongate rod 30 extending between a proximal end 32 and a distal end 34.
• a knob 36 is disposed at the proximal end 32 and a tapered tip 38 is formed at the distal end 34.
• the obturator 12 is adapted to be inserted into the working channel 25 ofthe sheath 10 with the knob 36 extending proximally of the sheath 10, and the distal end 34 extending distally ofthe sheath 10.
• This operative position ofthe obturator 12 within the sheath 10 is illustrated in the assembled view of Figure 2.
• An axial cross-section view ofthe assembled combination is illustrated in Figure 3 where the rod 30 of the obturator 12 is more clearly shown within the working channel 25 ofthe sheath 10.
• the releasable lock (not shown) can be provided to removably attach the obturator 12 to the sheath 10.
• the obturator 12 and sheath 10 can then be passed as a single unit over the guidewire. This arrangement precludes inadvertent advancement of the sheath 10 in front ofthe obturator 12, which could greatly impede proper passage of the sheath and potentially the ureter.
• the handle 23 associated with the sheath 10 is of particular interest to the invention and is illustrated in the enlarged, axial cross-section view of Figure 4. From this view it can be seen that the handle 23 has the general configuration ofthe bell of a horn.
• the handle 23 has a distally-facing surface 41 on the outside ofthe handle 23, and a proximally- facing surface 43 on the inside ofthe handle 23. Both of these surfaces 41 and 43 in the preferred embodiment are continuous and have a generally conical configuration.
• the distally-facing surface 41 is generally concave, while the proximally- facing surface 43 is generally convex.
• the handle 23 can be provided with two small holes 45, 46 for passage of sutures 47 and 48, respectively.
• the sutures 47, 48 can be clamped with hemostats (not shown) to the surgical drapes, thereby preventing distal migration ofthe sheath and loss of ureteral access.
• hemostats not shown
• proximally-facing surface 43 One ofthe purposes ofthe proximally- facing surface 43 is to funnel the obturator 12 and other surgical instrumentation into the working channel 25 ofthe sheath 10.
• this proximally-facing surface functions as a funnel with a radius which decreases with progressive distal positions along the axis 16.
• the proximally-facing surface 43 guides the instrument along a decreasingly decreasing radius into the working channel 25 ofthe sheath 10.
• Providing the surface 43 with a generally convex configuration further facilitates this funneling feature ofthe invention.
• the surface 43 is convex, its radius decreases at a decreasing rate with progressively equal distal positions along the axis 16.
• the distally-facing surface 41 is intended to facilitate engagement ofthe sheath 10 by a user's hand held in its most natural state.
• adjacent fingers 50 and 52 of the user's hands are illustrated schematically by the circles 50 and 52. In the natural state, the palm of the user's hands would be facing the user in the proximal direction, to the left in Figure 5.
• the sheath 10 is adapted to be operatively positioned between the fingers 50 and 52 with the handle 23 positioned so that the distally-facing surface 41 is in juxtaposition to the fingers 50 and 52. This fit is facilitated by forming the surface 41 with a size and configuration generally similar to the fingers 50 and 52, as illustrated in Figure 5.
• the distally- facing surface 41 having a generally conical configuration, it has a radius which decreases with progressive distal positions along the axis 16.
• the radius of the surface 41 decreases at a decreasing rate with progressively equal distal positions along the axis 16.
• FIG. 5 is particularly adapted to facilitate insertion of a surgical instrument, such as the obturator 12, it will be appreciated that removal of the instrument also creates withdrawal forces on the sheath 10.
• a handle 61 is similar to the handle 23, except that the outer, distally-facing surface 43 is curved distally outwardly to form a proximally-facing outer surface 63.
• the two surfaces 41 and 63 form a continuous surface which defines an annular recess sized and configured to receive the fingers 50 and 52.
• Figures 7-9 illustrated a further embodiment involving a handle, such as the handles 23 or 61, which is movable relative to the tube 14 ofthe sheath 10.
• This embodiment is particularly desirable as it permits the tube 14 to be cut in situ, at the operative site, to a preferred length. With a sheath of this type, only a single access device need be present at the operative site. Multiple sheaths having different lengths are not required to be present in order to have a sheath ofthe desired length.
• this embodiment ofthe sheath 10 includes the tube 14 which is slidingly engageable by a handle assembly 72 that includes a sleeve 74 and a funnel 76.
• the sleeve 74 is formed as a cylinder 77 having an interior bore 78 and external threads 81.
• An elastomeric element 83 is disposed within the bore 78 and is provided with an axial lumen 84 appropriately sized to receive the tube 14.
• the funnel 76 is formed similar to the handle 23, but includes two concentric cylinders 85 and 87 which extend distally.
• the outer cylinder 85 is provided with interior threads 90, which are sized to receive the external threads 81 ofthe sleeve 74.
• the inner cylinder 87 ofthe funnel 76 is provided with an outer diameter less than the inner diameter ofthe bore 78. This inner cylinder 87 extends to a distal surface 92.
• the funnel 76 is moved axially over the sleeve 74 and the internal threads 90 are screwed onto the external threads 81. Further rotation ofthe funnel 76 relative to the sleeve 74, causes the distal surface 92 ofthe inner cylinder 87 to axially compress the elastomeric element 83. This compression causes the element 83 to expand inwardly decreasing the diameter of its lumen 84 and thereby increasing the frictional engagement ofthe handle assembly 72 relative to the tube 14.
• the tube 14 can be cut to a predetermined length, either before or after mounting the handle assembly 72 on the tube 14. Axial movement ofthe handle assembly 72 to a desired proximal location on the tube 14 provides the sheath 10 with the desired length. Operation ofthe handle 72 in the manner previously discussed will fix the assembly 72 on the tube 14 at this desired location.
• a movable handle assembly 96 includes a funnel 98 similar to the handle 23. It also includes a cylinder 99 which extends distally within portions 101 which have a reduced diameter.
• a separate finger clamp 102 includes a cylinder 104 which has a diameter which is dependent upon operation of finger tabs 103 and 105. When these tabs 103 and 105 are compressed, the cylinder 104 has a relatively large diameter. When the tabs 103 and 105 are not compressed, the cylinder 104 is biased toward a reduced diameter.
• This finger clamp 102 is intended to be operatively disposed over the thin portions 101 of the cylinder 99, as illustrated in Figure 11.
• the entire handle assembly 96 can be moved along the tube 14 by compressing the finger tabs 103 and 105 ofthe clamp 102.
• the tube 14 can then be cut, for example, with scissors 106, to any desired length. Compressing the finger tabs 103 and 105 will permit the handle assembly 96 to be moved to a distal position, as illustrated in Figure 11, where the tabs 103 and 105 can be released to compress the thin portions 101 and maintain the handle assembly 96 in a fixed relationship with the tube 14.
• the tube 14 is formed with an inner plastic body 110, surrounded by a metal spring coil 1 12, which is further covered by an outer body 114.
• This particular embodiment of the tube 14 provides a high degree of kink resistance and can be used with any of the handle assemblies previously discussed.
• the inner body 1 10 provides a smooth surface within the sheath 10, which facilitates passage of instrumentation.
• the spring coil 112 adds kink resistance to the tube 14, while the outer body 114 provides a suitable covering for the coils ofthe spring 112.
• the tube 14 can be used with the various handle assemblies disclosed.
• the handle assemblies can be embodied in many different forms to provide at least one curved outer surface which is sized and configured to receive the fingers of a user's hand in a normal position.
• This desired outer shape can be combined with a funnel configuration at the proximal end ofthe sheath, will add further advantages to these various embodiments.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Epidemiology (AREA)
• Surgical Instruments (AREA)
• Endoscopes (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Priority Applications (3)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

Country Status (5)

Cited By (3)

Families Citing this family (83)

Citations (2)

Family Cites Families (37)

• 1999
  • 1999-04-30 US US09/303,485 patent/US6471684B2/en not_active Expired - Lifetime
• 2000
  • 2000-04-26 CA CA002368769A patent/CA2368769C/en not_active Expired - Lifetime
  • 2000-04-26 EP EP12190918.8A patent/EP2617455B1/en not_active Expired - Lifetime
  • 2000-04-26 EP EP00931958A patent/EP1173248B1/en not_active Expired - Lifetime
  • 2000-04-26 WO PCT/US2000/011219 patent/WO2000066212A1/en not_active Ceased
  • 2000-04-26 EP EP12190914.7A patent/EP2617454B1/en not_active Expired - Lifetime
  • 2000-04-26 EP EP11170611.5A patent/EP2368594B1/en not_active Expired - Lifetime
  • 2000-04-26 JP JP2000615093A patent/JP2002542902A/ja active Pending
• 2001
  • 2001-06-13 US US09/882,630 patent/US7135015B2/en not_active Expired - Lifetime
• 2008
  • 2008-08-25 JP JP2008215704A patent/JP2009034522A/ja not_active Abandoned

Patent Citations (2)

Non-Patent Citations (1)

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