Introducer apparatus with eversible sleeve

Abstract

Disclosed is an introducer apparatus comprising an sleeve fixation mechanism or introducer member, such as a catheter, introducer, or ring-like structure, which is attached to a protective sleeve comprising a thin flexible material such a polymeric film. The sleeve is inverted into the passageway of a second member, such as a catheter, feeding tube, introducer, etc., that is advanced through the passageway of the introducer member and is introduced into a bodily passage of a patient, such as the bile duct, nasal passages, colon, etc. The sleeve everts from the passageway of the second member during its advancement to lay down a friction-reducing surface. The sleeve prevents frictional contact between the second member and delicate or sensitive tissues.

What is claimed is:  
     
         1 . An introducer apparatus for providing a reduced-friction pathway into a bodily passage of a patient, comprising: 
 an introducer member having a distal end and a proximal end;    a sleeve comprising a flexible material and which includes a first end, a second end, a first body portion, and a second body portion, the first body portion attached to the introducer member, the second body portion, which includes the second end, moveable responsive to movement of a second member sized for introduction through the introducer member into the bodily passage;    whereby the second body portion is eversible from a passageway of the second member such that the second member passageway, upon full deployment of the second member, is at least substantially unobstructed; and    whereby the sleeve provides a reduced-friction pathway for at least a portion of the second member during advancement thereof into the bodily passage.    
     
     
         2 . The apparatus of    claim 1   , wherein the sleeve is an elongate tubular member having a passageway therethrough.  
     
     
         3 . The apparatus of    claim 2   , wherein the sleeve comprises a thin polymeric film.  
     
     
         4 . The apparatus of    claim 3   , wherein the sleeve comprises expanded polytetrafluoroethylene.  
     
     
         5 . The apparatus of    claim 3   , wherein the sleeve comprises polyethylene.  
     
     
         6 . The apparatus of    claim 2   , wherein the sleeve body includes a plurality of apertures disposed thereabout.  
     
     
         7 . The apparatus of    claim 2   , wherein the sleeve includes properties such that the second member, upon forward advancement with the sleeve, is biased in a predetermined direction, due at least in part to the properties of the sleeve.  
     
     
         8 . The apparatus of    claim 1   , wherein the sleeve body includes a circumferentially open portion extending at least partially along the length thereof.  
     
     
         9 . The apparatus of    claim 8   , wherein the sleeve body is a non-tubular in shape, such that it extends only partially around the circumference of the introducer member to which it is attached.  
     
     
         10 . The apparatus of    claim 1   , wherein the apparatus includes the second member.  
     
     
         11 . The apparatus of    claim 1   , wherein the introducer member comprises an elongate tube.  
     
     
         12 . The apparatus of    claim 11    wherein the elongate tube has a first end and a second end, and is of such a length that when the first end is located within the patient's duodenum, the second end is located outside of the patient.  
     
     
         13 . The apparatus of    claim 11   , wherein the elongate tube includes at least a second passageway extending therethrough.  
     
     
         14 . The apparatus of    claim 11   , wherein the introducer member includes at least one longitudinal predetermined split line that permits, with manipulation by the operator, external access to the passageway of the introducer member for purposes of removal of the inner member therefrom.  
     
     
         15 . The apparatus of    claim 1   , wherein the introducer member comprises a ring-like member.  
     
     
         16 . The apparatus of    claim 1   , wherein the introducer member comprises a plurality of longitudinal members that are configured to cooperate with the second member such that they are slidable relative to the second member to evert the sleeve from the passageway thereof.  
     
     
         17 . The apparatus of    claim 1   , wherein the sleeve further includes a tether attached about the second end thereof, the tether sized such that the operator can reload the sleeve back into the second member from the proximal end of the introducer member.  
     
     
         18 . The apparatus of    claim 1   , wherein the first end of the sleeve is permanently attached about the introducer member.  
     
     
         19 . The apparatus of    claim 1   , wherein the first end of the sleeve is releasably attached about the introducer member.  
     
     
         20 . The apparatus of    claim 1   , wherein the second end of the sleeve is loadable into the passageway of the second member.  
     
     
         21 . The apparatus of    claim 1   , wherein the sleeve further comprises a series of pleats, the pleats adapted to unfold longitudinally as the sleeve everts from the passageway of the inner member.  
     
     
         22 . The apparatus of    claim 1   , wherein the introducer member includes a second passageway therein.  
     
     
         23 . An introducer apparatus for providing a reduced-friction pathway into a bodily passage of a patient, comprising: 
 an introducer member having a distal end, a proximal end, and a passageway extending therethrough;    a second member having a distal end and a proximal end, the second member being slidably disposed within the passageway of the introducer member;    a sleeve comprising a flexible material and which includes a first end, a second end, a first body portion, and a second body portion, the first body portion attached to the introducer member about the first end, the second body portion, which includes the second end, being loadable into the passageway of the second member;    whereby the second body portion is eversible from the second member passageway responsive to movement of the second member, such that the passageway, upon full deployment of the second member, is at least substantially unobstructed; and    whereby the sleeve provides a reduced-friction pathway for at least a portion of the second member during advancement thereof into the bodily passage.    
     
     
         24 . The apparatus of    claim 23   , wherein the sleeve is at least 6 cm in length.  
     
     
         25 . The apparatus of    claim 23   , wherein the sleeve is at least 20 cm in length and the introducer member comprises a feeding tube.  
     
     
         26 . The apparatus of    claim 23   , wherein the introducer member comprises an elongate tube.  
     
     
         27 . The apparatus of    claim 23   , wherein the introducer member and second member each comprise catheters having a length of at least 150 cm.  
     
     
         28 . The apparatus of    claim 23   , wherein the introducer member comprises a ring-like member, the introducer member adapted for being maintained in a position at least substantially external to the body passage during introduction of the second member thereinto.  
     
     
         29 . The apparatus of    claim 23   , wherein the introducer member includes a second passageway, the second passageway being located relative to the point of attachment such that second passageway is not obstructed by a portion of the sleeve during use of the apparatus.  
     
     
         30 . The apparatus of    claim 23   , wherein the distal end of the second member includes a friction-reducing mechanism located thereabout to facilitate passage of the sleeve thereover.  
     
     
         31 . The apparatus of    claim 23   , wherein the second member is configured such that the second member, upon forward advancement with the sleeve, is biased in a predetermined direction.  
     
     
         32 . The apparatus of    claim 31   , wherein the distal end of the second member is asymmetrical in shape.  
     
     
         33 . The apparatus of    claim 23   , wherein the second member is adapted for delivery of a stent.  
     
     
         34 . The apparatus of    claim 23   , wherein the apparatus is adapted for the introduction of a third member upon deployment of the second member.  
     
     
         35 . The apparatus of    claim 34   , wherein the third member is preloaded within the passageway of the second member, the proximal end of the second member being configured to receive at least a portion of the third member.  
     
     
         36 . The apparatus of    claim 23   , wherein the second member includes an expandable zone extending longitudinally therealong such that the passageway of the second member can be expanded in diameter.  
     
     
         37 . The apparatus of    claim 23   , wherein the introducer member comprises a plurality of longitudinal attachment strips adapted for attaching the sleeve to the introducer member, at least selected ones of the plurality of longitudinal attachment strips being slidably disposed within channels formed in the introducer member.  
     
     
         38 . The apparatus of    claim 23   , wherein the second end of the sleeve is attached to the second member.  
     
     
         39 . The apparatus of    claim 23   , wherein the second member includes a fluid reservoir portion adapted for the delivery of fluids therefrom.  
     
     
         40 . An introducer apparatus for providing a reduced-friction pathway into a bodily passage of a patient, comprising: 
 an introducer member having a distal end and a proximal end;    a sleeve comprising a flexible material and which includes a first end, a second end, a first body portion, and a second body portion, the first body portion attached to the introducer member, the second body portion, which includes the second end, moveable responsive to movement of a second member sized for introduction through the introducer member into the bodily passage;    whereby the second body portion is unattached to the second member and eversible from a passageway thereof, such that the second member passageway, upon full deployment of the second member, is unobstructed by the sleeve; and    whereby the sleeve provides a reduced-friction pathway for at least a portion of the second member during advancement into the bodily passage.    
     
     
         41 . An arrangement for locating an elongated member within a bodily passage of a patient, wherein at least a substantial part of a flexible sleeve is to be movably located within the elongated member, wherein means are provided for fixing another part of the sleeve at a location outside of the elongated member so that when the latter is moved in a distal direction, a distal part of the elongated member engages the sleeve and unfurls it between the outside surface of the elongated member and the inside of the bodily passage.  
     
     
         42 . An arrangement according to    claim 41   , wherein a sleeve fixation mechanism is provided for clamping the said other part of the sleeve relative to part of the anatomy of the patient whilst the said substantial part of the sleeve is unfurled.  
     
     
         43 . An arrangement according to    claim 42   , wherein the said first part of the sleeve is clamped by or relative to the distal end of an introducer member through which the said elongated member is to be fed to the bodily passage.  
     
     
         44 . An arrangement according to    claim 43   , wherein the introducer member, and/or the flexible sleeve is/are made of splittable material so that one or both of them can be peeled back and removed in order to leave only the elongated member in the bodily passage.  
     
     
         45 . An arrangement according to    claim 41   , wherein means are provided for orienting the distal end of the elongated member during insertion of the latter.  
     
     
         46 . An arrangement according to    claim 41   , wherein the flexible sleeve is pleated when within the elongated member in order to minimize frictional effects.  
     
     
         47 . An arrangement according to    claim 41   , wherein the elongated member and/or the introducer member are in the form of tubes.  
     
     
         48 . A method of reducing frictional effects when introducing an elongated member having a passageway into a bodily passage, the elongated member comprising a flexible sleeve with a substantial length of the sleeve disposed in the elongated member and with a part of the sleeve fixed at a location outside of the elongated member, so that when the elongated member is moved in a distal direction, a distal part thereof engages the sleeve and unfurls it between the elongated member and the bodily passage, the sleeve being adapted such upon unfurling from within the passageway of the elongated member, the passageway is at least substantially open.  
     
     
         49 . An introducer apparatus for providing a reduced-friction pathway into a bodily passage of a patient, comprising: 
 an introducer member comprising an elongate tubular member having an outer surface, a distal end, a proximal end, and a passageway extending therethrough;    a second member comprising an elongate tubular member, the second member slidably disposed within the passageway of the introducer member;    a tubular sleeve comprising a thin polymeric film and which includes a first end, a second end, a first body portion, and a second body portion, the first body portion, which includes the first end, being attached about the outer surface of the introducer member, the second body portion, which includes the second end, being disposed with the passageway of the second member, the sleeve being responsive to movement of the second member as the second member advances relative to the introducer member; and    whereby the second body portion is completely eversible from the second member passageway, thereby providing a reduced-friction pathway for at least a portion of the second member as it is advanced into the bodily passage.