US20010044595A1 - Introducer apparatus with eversible sleeve - Google Patents

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority of provisional application Ser. No. 60/201,116 filed May 2, 2000.[0001]
TECHNICAL FIELD
• This invention relates to medical devices, more particularly to catheters introduced into body lumens.[0002]
BACKGROUND OF THE INVENTION
• Despite the efforts of medical device manufacturers to reduce the coefficient of friction for their catheters, especially those intended for introduction through a sphincter or narrow body lumen, there is very often a problem with discomfort to the patient or trauma to delicate or sensitive tissues as the catheter is being advanced. Lubricants and lubricious polymers or other coatings can reduce these effects, but not always to a sufficient degree. In the biliary system, for example, passing a biliary catheter through the Papilla of Vater and into the common bile duct very often results in swelling and subsequent closure of the opening, compromising normal drainage and making subsequent access difficult. Similar problems with discomfort or edema can be experienced by the patients when other anatomical sites are being accessed, for example, in the nasal passages, urethra, rectum, etc. While patient comfort may not be an issue when navigating internally such as within the biliary tree, the introduced device may be difficult or even impossible to advance from frictional forces acting against it, especially since these obstructions and narrowed passages often cannot be adequately visualized.[0003]
• One approach to reduce patient discomfort when introducing a catheter or similar device, is to include a sheath or sleeve which is laid down by the advancing device to prevent frictional contact between the device and the delicate lining of the bodily passage. A urethral catheter with an outer sleeve is disclosed in U.S. Pat. No. 5,779,670 to Bidwell in which the latex sleeve is fixedly and sealingly attached to the inside of the catheter by a sliding retention sled and to the outside of the catheter by a slidable collar. The sleeve allows relative movement of the catheter to the urethra without the normal friction that causes patient discomfort during introduction and wearing of the device. A lubricant fills the space created between the sleeve and the catheter which is intended to further reduce friction between the two surfaces. While the '670 concept may be suitable to traverse the urethra for purposes of draining the bladder, it is not useful for other anatomical sites and procedures in which having the sleeve attached to the inside of the catheter is not desired, such as in an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure or placement of a nasal-jejunal feeding tube or colonic decompression catheter. In these procedures, the sleeve might be used advantageously in combination with the introduced device to access a narrow duct or opening, to cannulate a stricture, or navigate over folds of tissue, but its eventual removal from the inner member passageway is typically required to complete the procedure. In the case of a feeding or decompression tube, continued presence of the sleeve over the catheter would block critical side holes. For these reasons, the Bidwell concept is not suitable for the introduction of a second medical device into the body.[0004]
• Besides the biliary system, other sites within the body present an opportunity for improved patient comfort and reduced trauma by the reduction of friction during the introduction of a device. For example, the nasal passages are especially sensitive and recent trends have brought about an increase in the number of devices, such as endoscopes and tubes, being introduced via that route concomitant with the use of analgesics or sedatives to reduce patient discomfort. Another situation where reduction of friction would be important is in the lower gastrointestinal tract where folds within the colon can provide sufficient resistance to an introduced catheter or other device where in many cases, the tip of the catheter bends back on itself, rather than continuing to advance to the treatment site. Therefore, what is needed is a friction-reducing introducer apparatus that can be used with a separate catheter, sheath, or other medical devices to permit the safe and comfortable passageway thereof into and/or through a bodily passage, and is removable from the treatment site so as not to possibly interfere with the function of the introduced device(s).[0005]
SUMMARY OF THE INVENTION
• The foregoing problems are solved and a technical advance is achieved in an apparatus for introducing a second medical device, such as an inner member or an elongated member, into a bodily passage, the introducer apparatus comprising a sleeve fixation mechanism, such as an introducer member. The sleeve fixation mechanism facilitates engagement of the sleeve with the opening of the bodily passage and can include a variety of structures, such as an introducer sheath, tube, ring-like member, barbs, or other structure which is permanently or releasably attached to a full or partial sleeve which is made of a thin, flexible material. The sleeve, which can be made of variety of biocompatible materials such as expanded polytetrafluoroethylene (ePTFE) or polyethylene film, is sufficiently flexible to be made eversible or such that one end can be inverted back through the passageway of an introducer member and loaded into the passageway of a second member, such as a catheter, that functions as a coaxial inner member and also serves as the medical device being introduced into the bodily passage. The inverted sleeve is then pulled from the inner member passageway and laid down within the bodily passage or the opening thereto by the inner member as it advances out of or through the introducer member, which is typically maintained in a nearly stationary position and generally does not enter the target bodily passage, although, such as in the case of a biliary catheter, may be introduced through other body lumens to position the inner member at the opening to a remote bodily passage.[0006]
• As a result of the cooperation between the sleeve, the introducer member, and the inner member, neither the sleeve nor the inner member frictionally slides against the bodily passage during advancement, thereby providing improved patient comfort and/or facilitating forward movement which may reduce trauma to the sphincter, duct or body lumen through which it is being introduced. In addition to reducing friction, the sleeve can act to provide a smooth track over an uneven surface, such as the tissue folds that occur within the Papilla of Vater or the intestinal tract. The sleeve is designed to be completely or functionally eversible at full deployment from the inner member passageway (maximum extension of the inner member relative to the sleeve), such that the passageway of the inner member can be at least substantially cleared and be functionally unobstructed. Typically, but not essentially, the second end of the sleeve is unattached to the inner member; however, if it attached, it has the ability to substantially clear the passageway such that the sleeve or attachment does not interfere with the passage of devices or materials through the inner member. Partial deployment of the inner member, which may also be desired in some applications, can result in a portion of the sleeve still remaining in the inner member passageway. In addition to making it simpler and cheaper to manufacture, leaving the second end unattached, makes it easier to remove the introducer assembly from the patient while maintaining the inner member in place. Additionally, it allows the passageway of the inner member to be free of obstructions and have a maximum possible diameter for passage of other devices, once the sleeve has completely everted. Alternatively, the sleeve may also be attached to the inner member in a manner, such as around the distal tip, that the sleeve can evert out of the passageway to a sufficient degree as not to interfere with the passage of a third medical device, such as a endoscope, through the inner member conduit. Attachment of the sleeve, while substantially maintaining the patency of the passageway, would be functionally equivalent to having an unattached and fully-eversible sleeve, and thus, fall within the scope of the present invention.[0007]
• In another aspect of the present invention, the introducer apparatus is adapted to permit the inner member to laterally deflect as it advances from the introducer member and causes the sleeve to evert. This can be accomplished by the addition of an asymmetrical tip to the inner member or making the inner member itself asymmetrical such that the sleeve has more drag on one side, thereby causing the inner member to deflect in that direction. This property is advantageous in certain clinical situations such as in the biliary tree where there is a bifurcation between the bile and pancreatic ducts. Another means of causing the inner member to deflect in a given direction is to modify the sleeve such that one side has a greater coefficient of friction than the other. This can be accomplished by removing a portion of sleeve longitudinally to make a half sleeve, making the sleeve out of two materials, or treating one half of the sleeve such that the half having a greater coefficient of friction causes the inner member to bend in that direction as it advances through the bodily passage.[0008]
• In still another aspect of the present invention, the introducer member and sleeve are made splittable with a predetermined split line such that they can be removed from over the inner member within the patient, without requiring its removal or causing its dislodgement. Other methods of removing the introducer member from the inner member include making the inner member twice as long as the outer so that is can be removed from the patient and left over the external portion of the indwelling inner member, or having a removable/replaceable connector on the inner member so that the introducer member can be removed over the proximal end of the inner member.[0009]
• In yet another aspect of the present invention, a tether is affixed to the second (inverted) end of the sleeve for reloading the sleeve once it has partially everted. The attachment may be such that the sleeve passageway is maintained in an open state to facilitate access by other medical devices, such as a wire guide, being introduced therethrough. This can include a reinforcing annular ring within or external to the second end of the sleeve and/or a second tether.[0010]
• In still yet another aspect of the present invention, the introducer apparatus can include means for reducing friction between the sleeve and inner member during its use. One embodiment includes folding or pleating the sleeve to shorten it within the passageway and reduce the amount of contact with the inside of the inner member passageway. This pleated sleeve unfolds as it is everted by the advancing inner member. Another method is to modify the distal end of the inner member to reduce friction. Besides changing the surface energy of the tip, including adding a second more lubricious material, the tip can be made to ease frictional movement of the sleeve by the addition of ball bearings or rollers to the tip which rotate as the sleeve is passed thereover.[0011]
• In still yet another aspect of the present invention, the introducer member comprises a short annular ring or collar that is slidable over the inner member that is being introduced therethrough, rather than an elongated introducer catheter. This embodiment has utility when directly accessing the target bodily passages from outside the body such as when placing nasal-gastric or nasal-jejunal feeding tubes, colonic decompression catheters, and urethral catheters, etc. In these types of procedures, the operator can grasp the outer ring directly adjacent the introduction site and deploy the inner member, rather than to first navigate the introducer apparatus to a remote location in the body, such as the Papilla of Vater and common bile duct. The outer ring can also be provided by forming a thickened portion of the sleeve material at or near the first end of the sleeve.[0012]
• In still yet another aspect of the present invention, either the introducer member or second member can include additional lumens for passage of other devices or injection of materials such as contrast agents with one passageway receiving the eversible sleeve and at least one other adjacent passageway remaining free to serve a different function. Contrast media, as well as other agents, can also be introduced through the sleeve itself via a plurality of apertures in the material, such as a mesh.[0013]
• In still yet another aspect of the present invention, the introducer apparatus can be placed over a nasal-gastric (NG) tube, or other medical device such that the inner member comprises a cap-like structure with the sleeve everting from within the lumen of the inner member which frictionally protects the bodily passage from the NG tube and advancing inner member. The sleeve everts from a distal chamber in the inner member which is separated by a proximal receiving chamber housing the distal end of the NG tube by a partial septum. The introducer member ring is tethered to the inner member for pulling the inner member proximally over the inner NG tube, allowing the latter to advance through the partial septum and out of the inner member for final placement.[0014]
• In still yet another aspect of the present invention, the inner member of the introducer apparatus is made radially expandable such that once it is introduced into the body, e.g., the back of the throat for placement of an NG tube, the sleeve is removed and a larger device (the NG tube) can be introduced therethrough as the inner member expands to accommodate its passageway. Embodiments of this concept include having the inner member comprise a cut, rolled tube with overlapping edges that allow for its expansion, and an inner member having a folded pleat on one or more sides that permits limited expansion of the introducer during passage of a device such as an NG tube.[0015]
• In still yet another aspect of the present invention, the inner member includes a fluid reservoir, such as a bottle for delivery of an enema. The outer member comprises a ring-like structure that slides over the neck of the bottle, the neck utilizing the eversible sleeve to reduce patient discomfort when traversing the anal sphincter as the outer member ring abuts the peri-anal area.[0016]
BRIEF DESCRIPTION OF THE DRAWINGS
• Embodiments of the present invention will now be described by way of example with reference to the accompanying drawings, in which:[0017]
• FIG. 1 depicts a side view of a first embodiment of the present invention;[0018]
• FIGS.[0019]2-3 depict enlarged partially sectioned pictorial views of the embodiment of FIG. 1;
• FIG. 4 depicts a cross-sectional view of the embodiment of FIG. 1 in situ;[0020]
• FIG. 5 depicts an enlarged partially sectioned view of an embodiment of the present invention having an asymmetrical tip;[0021]
• FIG. 6 depicts the embodiment of FIG. 5 being directionally guided within the body of a patient;[0022]
• FIGS.[0023]7-8 depict partially sectioned side views of various embodiments of the present invention having asymmetrical tips;
• FIG. 9 depicts a partially sectioned side view of an embodiment of the present invention with an asymmetrical eversible sleeve;[0024]
• FIG. 10 depicts a side view of an embodiment having a sleeve with asymmetrical properties;[0025]
• FIG. 11 depicts a side view of an embodiment with a splittable introducer apparatus and sleeve;[0026]
• FIG. 12 depicts a partially sectioned side view of an embodiment of the present invention having a tethered sleeve;[0027]
• FIG. 13 depicts a partially sectioned detail side view of an embodiment of the present invention with an open tethered sleeve;[0028]
• FIG. 14 depicts an enlarged side view of a second embodiment of the present invention having an open tethered sleeve;[0029]
• FIG. 15 depicts a partially sectioned side view of an embodiment of the present invention having a pleated sleeve;[0030]
• FIG. 16 depicts a cross-sectional view of an embodiment of the present invention having a ring-like introducer member;[0031]
• FIG. 17 depicts a cross-sectional view of an embodiment of FIG. 16, taken along line[0032]17-17;
• FIG. 18 depicts an enlarged pictorial view of the present invention in which the introducer member comprises attachment strips;[0033]
• FIG. 18A depicts a partial cross-sectional view of the embodiment of FIG. 18, taken along[0034]line18A-18A;
• FIG. 19 depicts a partially sectioned view of an embodiment of the present invention for introducing a third member;[0035]
• FIGS.[0036]20-21 depicts a cross-sectional view of embodiments of the present invention used to deliver stents;
• FIGS.[0037]22-22A depict enlarged partial views of embodiments of the present invention having a reduced friction tip;
• FIG. 23 depicts a side view of an embodiment of the present invention having a preformed introducer member;[0038]
• FIG. 24 depicts a side view of an embodiment of the present invention having a preformed inner member;[0039]
• FIG. 25 depicts an end view of an embodiment of the present invention having a dual lumen introducer;[0040]
• FIGS.[0041]26-27 depict distal end pictorial views of embodiments of the present invention having a multiple lumen introducer member;
• FIGS.[0042]28-30 depict an embodiment of the present invention being used with a bodily passage;
• FIGS.[0043]31-33 depict partially cutaway pictorial views of embodiments of the present invention having an expandable inner member;
• FIG. 34 depicts an embodiment of the present invention in which the sleeve is partially pleated;[0044]
• FIG. 35 depicts an embodiment of the present invention adapted such that it is not to be preloaded into an inner member;[0045]
• FIG. 36 depicts a partially sectioned view of an embodiment of the present invention in situ, where the sleeve is also attached about the inner member; and[0046]
• FIG. 37 depicts a side view of an embodiment of the present invention where the inner member comprises a fluid reservoir.[0047]
DETAILED DESCRIPTION
• The present invention comprises an[0048]introducer apparatus10 for reducing friction of a medical device being introduced into abodily passage26, a first embodiment of which is depicted in FIGS.1-4. Theintroducer apparatus10 comprises an introducer assembly11 that includes asleeve fixation member12, such as the illustrative introducer member, having apassageway20 therethrough and aflexible sleeve13 comprising abody76, afirst end25 and asecond end64. Thesleeve13 also includes afirst portion106 and a second portion107 (FIG. 4), with thefirst portion106, which includes thefirst end25, being attached about the introducer member by anattachment14 which preferably, but not essentially, affixes thesleeve13 at one or more attachment points110 to theouter surface75 of theintroducer member12 and is fixed against movement with respect to theintroducer member12. Although thesleeve13 is typically attached to theintroducer member12 at the ‘true’first end25 thereof, it is possible that thesleeve1 may also extend proximally beyond theattachment14 such that theattachment14 lies within what technically, could be considered thebody76 of thesleeve13; however, functionally, thefirst end25 would still occur at the point ofattachment110, especially if fixedly attached, regardless of whetherunattached sleeve13 material extended proximal to that point.
• The[0049]sleeve13 should be made of a material that allows it to be sufficiently flexible to conform to the shape of a device being placed therethrough. For most applications, the material, which is typically thin, should exhibit resistance to tearing and stretching (i.e., have good linear strength). Generally, the sleeve should be smooth and lubricious such that the sleeve, as it is laid down by the advancement of the device, or being withdrawn from the body, is atraumatic to delicate linings of the body, such as sphincters, tissue folds, ducts, and other passages. One material with particularly desirable properties is expanded polytetrafluoroethylene (ePTFE). Custom extruded ePTFE, which is available from Zeus Medical Products, Inc., Orangeburg, S.C., is produced from polytetrafluoroethylene (PTFE) tubing that is expanded under controlled conditions which advantageously adds microscopic pores throughout the material. The result is a soft, flexible material with increased linear strength. The wall thickness of thesleeve13 depends largely on the application and material used and may typically range from 0.001-0.01″ for ePTFE. A more preferred range for ePTFE when introducing a standard ERCP device would be in the 0.002-0.005″ range, most preferably around 0.0025″. Many other polymeric films, such as high-density or low-density polyethylene, have desirable properties, particularly those with adequate linear strength. Their lower cost can be significant, particularly for longer devices. Other possible materials include latex, woven fabrics, or biomaterials that can be fabricated into a thin, flexible sheet or tube of sufficient strength. The sleeve can also be coated or impregnated with other compounds and materials to achieve the desired properties.
• To achieve an[0050]attachment14 between thesleeve13 andintroducer member12, a variety of well-known methods can be used. Permanent bonding methods include, but are not limited to, a wrapping, such as with a thread or suture material; heat shrink wrap or tubing; thermal, laser, or ultrasonic welding; an adhesive, or a combination thereof. A detachable means of securing the sleeve can also be used, such as a ring, collar, elastic band, channel/groove, lower-grade adhesive, or another well-known means. In the illustrative embodiment, the single point ofattachment110 extends around the circumference of theouter surface75 of theintroducer member12; however, FIGS.18-18A depict an embodiment having more than one point ofattachment110 between thesleeve13 andintroducer member12. Theintroducer member12 can also be integrally attached to thesleeve13, thus forming an arrangement of unitary construction.
• As shown in FIGS.[0051]1-4, the introducer assembly11 is intended for use with a separatesecond member15, hereafter referred to as the inner member, that is introduced through thepassageway20 of theintroducer member12 and into a bodily passage26 (FIG. 4), such as the common bile duct or other passage. Thisinner member15 can include any of a number of medical devices such as catheters, introducer sheaths, cannulae, stents, endoscopes, retrieval or surgical devices, etc. A portion of thesleeve body76, referred to herein as thesecond portion107, resides within thepassageway22 of theinner member15 as the inner member is introduced into thebodily passage26. Thefirst portion106 of thesleeve13 is generally defined as that part of thesleeve body76 that typically remains outside of theinner member passageway22 after thesleeve13 has been loaded. Thesecond portion107 is typically inverted or preloaded into thepassageway22 with that portion of the sleeve being eversible from thepassageway22 as theinner member15 is advanced relative to theintroducer member12, to which thefirst end25 of thesleeve13 is attached. As used herein, the terms ‘evert’ or ‘eversible’ refers to the process by which thesleeve13 unfurls, unfolds, invaginates, or otherwise exits thepassageway22 into which it resides, upon which time thesleeve13 turns back on itself and conforms over the outer surface of theinner member15, forming a barrier between theinner member15 and theinner surfaces28 of thebodily passage36.
• The overall length of the[0052]second portion107 is largely determined by how far theinner member15 is typically advanced into thebodily passage26 during a particular procedure. Thesecond end64 of the sleeve is either completely unattached to theinner member15 as it resides in thepassageway20, or is releasably secured in a manner such that thesecond end64 is completely eversible from thepassageway22 of the inner member if necessary or so desired. Movement of theinner member15 relative to theintroducer member12 is therefore, not normally limited by the length of thesleeve13 and theintroducer member12, and thesleeve13 can be removed from the patient or treatment site separately from theinner member15 once thesleeve13 has completely everted from thepassageway22. Theintroducer member12 can comprise an elongate catheter, as shown in the illustrative embodiment, that houses theinner member15, or it can be much shorter in length, as shown in later examples.
• The length and shape of the sleeve can be quite variable, depending on the application. In the illustrative embodiment of FIGS.[0053]1-4, which is used as a biliary catheter for an ERCP procedure in an adult patient, the sleeve is tubular and typically measures from 6-10 cm in length, preferably 7-8 cm, so that the inner member can cannulate both the opening of the duct and any strictures that may exist therein. Preferably, it should not be so long that it cannot completely evert from theinner member15 during the procedure, since in this particular embodiment, removal of the sleeve is desired after the inner member is in position. Other procedures may require alonger sleeve13. For example, thesleeve13 used to introduce a standard feeding tube, e.g., a nasal-gastric (NG) or nasal-jejunal feeding tube, would be more in the 20-40 cm range, more preferably around 30 cm. Thesleeve13 is used to protect the feeding tube through the nasal passage past the deviation of the septum until it reaches the back of the throat where natural peristalsis takes over and helps to urge the feeding tube downward through the esophagus and into the stomach or jejunum. To assist natural peristalsis, thesleeve13 or other portion of theintroducer apparatus10 can be provided with a surface structure having a bi-directional coefficient of friction such as disclosed in a pair of co-pending applications, both entitled, “Medical Instrument Having Bi-directional Coefficients of Surface Friction,” Ser. No. 08/989,413, filed Dec. 12, 1997 and Ser. No. 09/184,331 filed Nov. 2, 1998.
• A shorter sleeve, e.g., 7-10 cm may be desired for nasal introduction if the inner member is merely serving as a short conduit for the subsequent introduction of another device, such as an endoscope, therethrough. The second device can then be introduced much more comfortably than would be otherwise possible. Conversely, a much longer sleeve, e.g., 150-160 cm, might be used for a colonic procedure. Ideally, the sleeve for a particular application, should be properly sized such that it completely everts from the inner member, if so desired, to allow it to be removed while maintaining the inner member within the patient.[0054]
• Continuing with the first embodiment, FIG. 2 depicts an[0055]introducer member12 that is an elongated catheter in which thesleeve13 has been completely inverted into thepassageway22 of theinner member15 which in turn, coaxially resides within thepassageway20 of theintroducer member12. As shown in FIG. 3, theinner member15 advances relative to theintroducer member12 with thedistal end36 or leading edge of theinner member15 urging thesleeve13 forward and thereby, pulling it out of thepassageway22 into which it has been loaded.
• FIG. 4 show the[0056]introducer apparatus10 being used within a patient. Theintroducer member12 is positioned at theopening27 of abodily passage26 into which theinner member15 is to be introduced.
• Holding the proximal portion[0057]77 (FIG. 1) of theinner member15 in place, theintroducer member12 is then urged in a proximal direction. Typically, this action causes thesleeve13, which sheaths thedistal end36 of the inner member, to grip the surface of thepassage opening27, thereby ‘self-advancing’ theinner member15 as theintroducer member12 is ‘retracted’ (as shown). In these instances, theintroducer member12 does not actually move any significant distance from the opening, despite the rearward force be applied, but rather, theinner member15 is advanced forward into thebodily passage26 although it is not actually being directly advanced by the operation. Thus, theinner member15 is described as ‘self-advancing.’ In selected embodiments or certain instances, the operator may need to directly advance theinner member15 in order to have thesleeve13 evert and lay down a protective track; however, the sleeve still provides the same protective function. For each of the illustrative embodiments, thesleeve13 lays down a track, much like the way a military tank or bulldozer moves, such that the advancinginner member15 frictionally slides against theprotective sleeve13 itself instead of directly contacting the lining28 of thebodily passage26. Because thesleeve13 does not slide against theinternal lining28 of thebodily passage26, there is minimal irritation and trauma to theopening27 andbodily passage26 during its initial introduction. Thesleeve13 protects thebodily passage26 for a distance up to its own length, after which, it completely everts from theinner member15 and any further advancement will typically result in normal frictional contact between theinner member15 and thebodily passage26. In the case of the biliary tree, it may only be important to provide protection for a short distance to traverse the Papilla of Vater, or it may be necessary or desirable to extend this protection further into the duct such as to cannulate a stricture. For certain applications, thesleeve13 should completely or functionally evert from thepassageway22 of theinner member15, or a particular application may not require that it does so.
• With respect to the embodiment of FIG. 1, which is configured for accessing the biliary tree, the[0058]introducer member12 should be at least 150 cm for an adult patient, typically 157-160 cm. Theintroducer member12 normally must be removed from the patient while theinner member15 remains in place. To accomplish this, theinner member15 is made at least twice as long as theintroducer member12 such that the entire length of theintroducer member12 can remain over theinner member15 and extend outside the patient. This is especially useful when there is aproximal connector21 on theinner member15 of this embodiment which may not permit removal of theintroducer member12 thereover. Theproximal connector21, such as a luer fitting, is useful in this embodiment because the injection of contrast media, which would be infused through theinner member15, is typically important in ERCP procedures. A removable connector may be used, such as a Tuohy-Borst adaptor, that can be unscrewed and removed to allow removal of the introducer assembly11, then reattached. A reattachableproximal connector21 is particularly advantageous when theinner member15 is made long (e.g., 400 cm) to allow the introducer member over the inner member, which remains in place within the patient. Once theintroducer member12 is discarded, the longinner member15 can be cut to a more manageable length (e.g., closer to 200 cm) before replacing theproximal connector21.
• In certain clinical procedures, it is advantageous to be able to direct or deflect the tip of the inner member as it is being advanced into the bodily passage, for example, to negotiate a particular branch when confronted with a bifurcation. FIGS.[0059]5-10 depict various means of causing theinner member15 to deflect in one particular direction over the other. In the embodiment of FIG. 5, a separatedistal tip29 is affixed at thedistal end36 of theinner member15. As depicted, thedistal tip29 is configured to be an asymmetrical-shaped tip30 which includes aproximal portion34 that is inserted into thepassageway22 of the inner member and adistal portion33 that forms the leading edge of theinner member15. Thedistal portion33 of the asymmetrical-shaped tip30 is divided longitudinally into afirst side31 and asecond side32. In the illustrative example, thefirst side31 is considerably more rounded than the flattenedsecond side32. As a result, the enlargedfirst side31 provides more drag against thesleeve13 than thesecond side32 as thesleeve13 is everting out of theinner member15, which in turn, causes thedistal end36 of theinner member15 to laterally deflect toward the direction corresponding to thefirst side31.
• FIG. 6 depicts a laterally deflectable embodiment of the present invention accessing the bile duct. When the introducer[0060]11 is advanced from anendoscope78 and placed at the Papilla ofVater27, the opening to thecommon bile duct26, there is amarker69 that indicates the direction in which theinner member15 will deflect. To accomplish this, it is essential that theinner member15 andintroducer member12 be aligned such that the means for deflection, whether part of theinner member15 or thesleeve13, is aligned with themarker69 printed on thesleeve13 orintroducer member12. This can be done by providing guide marks (not shown) on the proximal area of both the outer andinner members12,15 such that they can be rotated into alignment prior to advancement of theinner member15. Once alignment has occurred and the position of themarker69 is established endoscopically, theinner member15 is advanced into thecommon bile duct26 where it deflects into thebile duct37 as desired, avoiding thepancreatic duct38. To access thepancreatic duct38 instead, the introducer assembly would be simply rotated such that themarker69 is positioned approximately 180° in the opposite direction. Alternate methods of providing a visual marker on thesleeve13 would be to place a radiopaque marker on either thesleeve13, theinner member15 or theintroducer member12 such that the orientation of the asymmetrical tip30 can be determined under fluoroscopy when contrast media is injected into the biliary tree. It should be noted that the natural folds oftissue105 just inside thecommon bile duct26 may be utilized to help provide increased grip on thesleeve13, thereby pulling theinner member15 preferentially toward thebile duct37 branch.
• Besides incorporating a separate asymmetrical tip[0061]30 to cause the advancinginner member15 to deflect, as shown in FIG. 5, thedistal end36, or the region thereabout, of theinner member15 itself can be configured (FIGS.7-8) to provide unequal drag between thedifferent sides31,32 of the inner member, thereby causing thesleeve13 to pull theinner member15 laterally in a particular direction as it advances. In the embodiment of FIG. 7, thefirst side31 of theinner member15 includes alateral protuberance41 that increases resistance to thesleeve13 passing thereover. The resistance differential relative to thesecond side32, which lacks aprotuberance41, causes the inner member to deflect toward thefirst side31. In the embodiment of FIG. 8, thedistal end36 of theinner member15 includes abevel42 to provide different degrees of resistance to thesleeve13 between thefirst side31 and thesecond side32 of the inner member. The longsecond side32 of thebevel42 provides increased resistance over thefirst side31, therefore causing thesleeve13 to deflect the inner member in that particular direction.
• In addition to modifying the[0062]inner member15 to achieve controlled directionality during its advancement, the sleeve itself13 can be modified to achieve similar results. In FIG. 9, a sleeve is shown having adistal portion79 that is tubular in shape and aproximal portion80 in which the material on one half is removed to create apartial sleeve43 which is semi-circular in cross-section during deployment of theapparatus10. In this design, thefull sleeve13 ordistal portion79 is used to cannulate the opening to the bodily passage, whereby as thepartial sleeve43 portion everts, a situation is created in which there is a friction differential between the twosides31,32 of theinner member15 that results in theinner member15 being laterally deflected in the direction of the open portion81 of thesleeve13. Another means of accomplishing this effect is depicted in FIG. 10 whereby the sleeve is divided longitudinally into twohalves44,45, each having different properties. In the illustrative embodiment, thefirst half44 of the sleeve comprises a porous material with a plurality ofapertures109, such as a fabric mesh, while thesecond half45 comprising a material more suitable for friction reduction. One purpose of the porous material would be allow contrast media to be pushed through theapertures109 into the bodily passage to improve imaging of the target site for diagnosis or treatment. A large open mesh, e.g., 0.02-1.0 mm, would also allow drugs to be infused into the bodily passage. The amount of porous material can range from a narrow longitudinal strip, to an area comprising the majority of the circumference of thesleeve13. Another clinical application for a large open mesh would be for obtaining cytology samples, whereby withdrawal of the sleeve within the bodily passage traps cells within theapertures109 in the mesh and allows the cells to be collected for laboratory analysis.
• In another variation of the embodiment of FIG. 10, the two[0063]halves44,45 of thesleeve13 can given a different coefficient of friction, which causes the sleeve to deflect toward either thefirst side31 or thesecond side32, depending on which half of thesleeve44,45 offers the most resistance against theinner member15 as thesleeve13 as it is being everted. The first and second sleeve halves44,45 can either be made of different materials that are joined along the longitudinal axis by an appropriate means such as stitching, welding, gluing, etc., to form a tubularcomposite sleeve13, or asleeve13 of a single material can be treated to increase the coefficient of friction on one side. For example, the material could be mechanically or chemically roughed to increase friction; a second material, such as silicone beads, could be applied to the surface to increase friction; or a lubricious material could be added to reduce friction on a particular side.
• Another means of adding directionality to the introducer apparatus is to incorporate a desired amount of curvature to a component thereof during its manufacture. FIG. 23 depicts an[0064]introducer apparatus10 in which theintroducer member12 has been preformed with a particular curvature to improve accessibility to a target site in certain clinical situations. It might be desirable to limit the curvature to the very distal portion or the curvature might extend over a greater portion of theinner member15. Theinner member15 itself can be preformed with a curvature as well, as depicted in FIG. 24 to aid in certain procedures, especially an ERCP, where the ability to successfully navigate a bifurcation may be required. In the illustrative embodiment, theintroducer member12 has sufficient integrity relative to the inner member15 (i.e., stiffer materials, increased wall thickness, etc.) that it acts to constrain the curvedinner member15 into a straight configuration, wherein the inner member assumes its predetermined shape upon advancement from within theintroducer member12. In another embodiment, the curvedinner member15 would force the otherwisestraight introducer member12 to assume the inner member's predetermined shape. In still another embodiment, both theinner member15 andintroducer member12 can be both given a predetermined curvature, which may approximately match that of the other. One result of added curvature to both the outer andinner member12,15 would be to allow for an overall double curvature wherein theintroducer member12 permits a lateral access in one direction, while the advancinginner member15 can positioned such that it deflects back in a second direction (e.g., an S-curve). It should be noted that in some applications, such as an ERCP procedure, theinner member15 must be made sufficiently flexible to bend back on itself when it cannot find a suitable passageway, thereby not creating a false passage.
• Other methods for curving the[0065]inner member15 include having thesleeve13 extruded such that it includes curvature of its own. If thesleeve13 has sufficient linear strength or stiffness and theinner member15 is sufficiently pliable, thecurved sleeve13 would force theinner member15 to deflect in the direction of the curvature of thesleeve13, much like the example depicted in FIG. 24 which is also provided to illustrate a pre-curved inner member.
• FIG. 34 depicts another sleeve configuration for preferentially directing the[0066]inner member15, whereby thesleeve13 is extruded or shaped such that onehalf44 includes pleat or folds55, while theother half45 is of the typical smooth, cylindrical shape. Under selected conditions, theinner member15 would generally tend to deflect in the direction oriented with the second,smooth half45 of the sleeve.
• As discussed, using the present invention in certain types of procedures may require that the[0067]introducer member12 andsleeve13 be removed from the patient, or at least from around theinner member15, while theinner member15 remains in place. In addition to making theinner member15 such that theintroducer member12 can either be removed over the proximal end19 (i.e., a detachable hub) or the inner member is at least twice as long as theintroducer member12, another methods would include making theintroducer member12 andsleeve13 splittable as depicted in FIG. 11 such that they can be peeled back from theproximal end19 and removed without requiring disruption to theinner member15. One preferred material for asplittable introducer member12 is molecularly oriented (non-isotropic) polytetrafluoroethylene (PTFE), such as that used in the PEEL-AWAY™ Introducer Sheath (Cook Incorporated, Bloomington, Ind.). The advantages of the material is that it does not require a prescored line and as it is being split open as the progressive tear maintains a straight and predictable pathway. At theproximal end19 of theintroducer member12, the sheath has been modified to comprise two opposingears83 or tabs that are divided by opposing cut points84. The operator grabs theears83 and pulls them apart from each other, starting the split at the cut points84. Once the splitting action has commenced along opposingpredetermined split lines47, it progresses distally as the two halves of theintroducer member12 sheath are pulled apart. Depending on the design, the split continues through thesleeve attachment14 and splits thesleeve13, which may include atear line46 such as a perforation, or the split may stop at the attachment point or sleeve and the operator will then manually split the remainder of the introducer assembly11 that is now outside the patient, such as with a scalpel, taking care not to nick theinner member15. A third method of removing theintroducer member12 from over the indwellinginner member15 is depicted in FIG. 27. Theintroducer member12 includes alongitudinal opening74 or split extending the length of theintroducer member12 through which theinner member15 can be removed from thepassageway20 thereof. Theintroducer member12 can then be removed from the patient while theinner member15 remains in place.
• FIG. 12 depicts an embodiment of the present invention in which the[0068]sleeve13 is reloadable by use of atether48 attached to thesecond end64 of thesleeve13 and where theattachment point49 includes a knot or other means to secure thetether48 to thesleeve13. Thesleeve13 remains basically eversible from thepassageway22 of theinner member15; however, theinner member15 is limited in it's forward movement once it does. The evertedsleeve13 can advantageously retrieved by grasping the accessible portion of thetether48 and pulling in a proximal direction. This pulls thesleeve13 back into thepassageway22 whereby thesleeve13 again becomes inverted into theinner member15, making available to be used again, if necessary or so desired. To maintain patency of thesleeve13, the embodiment of FIG. 13 includes atether48 where theattachment point49 to thesleeve13 is located along only one side of thesecond end64 such that thesleeve passageway24 remains in an open condition and thus, better able to receive a wire guide, deliver contrast media, etc. Asecond tether52 andattachment point50 can be added to add stability and maintain patency as depicted in FIG. 14. Anannular ring51 can further serve to hold thesleeve passageway24 open and provides an anchoring point for the attachment points49,50 of therespective tethers48,52. If theannular ring51, is made of an elastic materials, it is possible for theinner member15 to push through theannular ring51 and not be limited advancement of theinner member15, especially if theannular ring51 is given a larger diameter than theinner member15 and compressed within thepassageway22. If not, thering51 will typically stop at thedistal end36 of theinner member15, limiting the further advancement thereof.
• FIG. 15 depicts an embodiment of the present invention in which the[0069]sleeve13 is configured to include a series ofpleats55, resulting in thebody76 of thesleeve13 become somewhat accordion-shaped while inverted into thepassageway22 prior to deployment. Thepleats55 permit the sleeve to unfold and expand longitudinally as it everts. This can be especially useful when the eversible sleeve must extend over a considerable distance, such as for a small bowel nasal feeding tube which can be 150 cm in length. The primary value of folding the sleeve to reduce its length is to provide less drag between thesleeve13 and the inside of theinner member passageway22, since along sleeve13 is more difficult to pull out of or load into theinner member15 due to the increased frictional load.
• FIGS.[0070]15-17 show a modification of theapparatus10 in which theintroducer member12, rather than comprising a elongated tube, is anexternal ring53 or carriage-like structure that is slidable with respect to theinner member15 that is to be introduced into the bodily passage. As shown in FIG. 16, theexternal ring53 can optionally be prevented from being removed from thedistal end36 of the inner member by inclusion of astop54 that is incorporated into theinner member15. Additionally, theexternal ring53 can include at least oneprojection92 that fits within agroove93 on theinner member15 such that theexternal ring53 cannot twist or rotate relative to theinner member15 which could also result in the twisting of thesleeve13. In its simplest form, theexternal ring53 can be made integral with thesleeve13 material such as by forming a thickened portion thereof at or near thefirst end25 of thesleeve13. Having theintroducer member12 comprise a relatively shortexternal ring53 rather than an elongated tubular member is preferable, or at least possible, in applications where theentire introducer member12 is outside the patient's body, or nearly so, such as a nasal tube or urinary catheter introduction, or when accessing the lower gastrointestinal tract via the rectum. In these instances, the clinician can grasp theexternal ring53 which generally abuts the introduction site, whereby theinner member15 spontaneously advances or is manually advanced into the bodily passage. In a remote access situation as with the biliary system, theintroducer member12 must be sufficiently long such that theproximal end19 is outside the body (FIG. 1) so that it can be manipulated from that point, rather than from within the duodenum.
• In a related embodiment shown in FIG. 37, the[0071]inner member15 comprises acontainer115, such as a bottle, used to supply fluid used in the administration of an liquid agent, such as to perform an enema. Thebottle115 includes aproximal reservoir portion116 which narrows distally to form aneck portion117 that is inserted into the patient. The introducer assembly11 includes thesleeve13, thesleeve attachment14, andouter member12, which in the illustrative embodiment, comprises a ring-like member53 with a proximal collar. The ring-like member53 is sized larger than theanal orifice118 and is designed to abut the peri-anal area119. The illustrative embodiment is configured for self-delivery whereby the patient gently inserts thedistal tip36 of the bottle (covered by forward edge of the sleeve17) into theanal orifice118. Thesleeve13, provided to reduce friction and discomfort caused by the insertion of thebottle115, then spontaneously everts as theneck117 of the bottle is drawn through theanal sphincter121 into the rectum where the contents of thebottle115 are delivered. Thewider reservoir portion116 can provide a stop to ensure that theneck portion117 traverses theanal sphincter121 without extending too far into therectum120. Thesleeve13 can either be unattached within theinterior passageway22 of thebottle115 or be eversible by attaching to theinner member15 in a manner such that it does not obstruct fluid flow therethrough (i.e., glued or otherwise bonded against thepassageway22 wall or about thedistal end36. It is not necessary to attach thering member53 to thebottle115, which can be packaged together with plastic wrap or some other means to both keep the apparatus sterile and maintain thering member53 in a fixed pre-delivery position. At deployment, theneck117 of the bottle advances through thering member53, which is held stationary against or adjacent to the peri-anal area119. The same concept, i.e.,container115 witheversible sleeve13, can be applied for delivery of therapeutic agents via the nasal passages or elsewhere in the body and maybe include a syringe, bag, pump, or other container adapted to hold and deliver a liquid, gas, or a suitably formulated solid material. Theneck portion117 may comprise various shapes and materials depending on the desired application.
• FIGS.[0072]18-18A depict an embodiment wherein theintroducer member12, rather than being a coaxial outer tube or ring, comprising a pair of longitudinal attachment strips56, such as flat wires or strips of material, that reside in opposinggrooves57 or channels formed into the outer surface of theinner member15, and through which theinner member15 passes as it advances into a bodily passage. The attachment strips56 are secured to two oppositely oriented attachment points along thesleeve13 with anattachment mechanism14 such as adhesive, stitching, etc., or they are tightly biased against thesleeve13 such that when theattachment wires56 are retracted by the operator, theinner member15 advances through the bodily passage until thesleeve13 fully everts. Theattachment wires56 may then be fully retracted along and within thegrooves57 to completely remove thesleeve13 from the patient. Optionally, the attachment strips56 can be conjoined at or near their proximal ends or to allow them to be retracted at the same rate. In should be noted that the number of longitudinal attachment strips56 is not critical to the invention. Furthermore, the embodiments of FIGS.18-18A show that thesleever fixation mechanism12 or introducer member need not be a tubular or an annular structure, but rather, can include any structure or series of structures, including an array of barbs or other fixation devices, that can attach about thefirst end25 of the sleeve and maintain thefirst portion106 of the sleeve outside the opening of the bodily passage, while facilitating the introduction of theinner member15 thereinto. For example, barbs or other structures of similar function can be configured to engage tissue about the opening of the bodily passage to facilitate introduction of the inner member, then disengage when thesleeve13 is to be discarded. In this sense, the array of barbs collectively form thesleeve fixation mechanism12, which can also be defined as the introducer member, with theinner member15 being advanced therethrough.
• FIG. 19 depicts an introducer apparatus that can be used with a third member or[0073]device59, such as nasal-gastric (NG) or nasal-jejunal (NJ) feeding tube, endoscope etc. of various sizes. Such devices can be introduced while having the benefit of the protective sleeve, yet without the sleeve directly cooperating with thethird device59. In the illustrative embodiment, the introducer member comprises anexternal ring53 and thesleeve13 inverts into aninner member15 that is separate from thethird device59. Theinner member15 acts as a distal cap that fits over thedistal end96 of thethird device59 being introduced. Theinner member15 can be advantageously made of a resilient material, such as silicone, such that it can stretch over thethird device59 that is inserted thereinto, although less-resilient materials can be used if tight cooperation between the second andthird members15,59 is not necessary. Theinner member15 comprises adistal sleeve chamber60 that houses the loadedsleeve13, and a receiving chamber70 into which thethird device59 is inserted. Themedical device59 is advanced through the introducer member12 (external ring53) and into the receiving chamber70 until it abuts thechamber septum65 which divides the twochambers60,70. Theexternal ring53 has a completecircumferential attachment14 to thesleeve13 which is inverted into thedistal sleeve chamber60. Theexternal ring53 is also attached to theproximal portion77 of theinner member15 via a first andsecond deployment tether94,95 atattachment sites71 on theintroducer member12, usually 180° apart.
• One example of how the embodiment of FIG. 19 is placed is that of a[0074]NG feeding tube59. The distal ends16,36 of the outer andinner members12,15 are placed into the opening of the nasal passage and theexternal ring53/introducer member12 is typically urged in a proximal direction to cause theinner member15 andNG feeding tube59 into be introduced into the nasal passage. Thesleeve13 protects the lining of the nasal passage from trauma resulting from the advancinginner member15 andNG feeding tube59 as they advance toward the stomach. Deployment of theNG feeding tube59 from the inner member occurs within the esophagus, once thedistal end36 of theinner member15 has passed through the sensitive nasal passages. At this point, the tetheredring53 is pulled backward until theNG tube59 pushes through theaperture66 in thechamber septum65, then into thedistal sleeve chamber60, and out thedistal end36 of theinner member15. Theexternal ring53 and tetheredsleeve13 are pulled over the external surface of the indwellingNG feeding tube59 where they are cut free, once outside the patient. To help ensure that the NG tube has sufficient column strength to penetratechamber septum65, a stiffeningstylet97 can be introduced into thepassageway98 of the NG tube to improve its pushability, whereby it is removed once theNG tube59 has been advanced through thedistal end36 of theinner member15.
• More simplified embodiments of the universal introducer concept can be found in FIGS.[0075]31-33. As depicted, theinner member15 includes anlongitudinal expansion zone103 that allows theinner member15 to radially expand, especially following removal of the introducer assembly11, to allow variously-sized devices of a larger diameter to be introduced therethrough. The embodiment of FIG. 31 includes aninner member15 withlongitudinal expansion zone103 comprising anexpansion pleat99. Theexpansion pleat99 represents an invagination in the wall of aninner member15 which is then folded over to create aninner member15 of a first, unexpanded diameter as shown in the figure. The introducer member12 (external ring53) acts as a containing mechanism to maintain theinner member15 in the first diameter. When theintroducer member12 andsleeve13 are removed from over theinner member15, it permits a third member or device59 (like that shown in FIG. 19) to be introduced through the inner member, which then assumes a larger, second diameter. Theexpansion pleat99 unfolds to allow passage of a device (e.g., an NG tube) that has a larger diameter than the first diameter of theinner member15, these advantageously providing the combination of a smaller introducer with a larger, optimally sized indwelling device.
• FIG. 32 depicts another embodiment of an expandable[0076]inner member15 having alongitudinal opening74 or split in which thelongitudinal expansion zone103 comprises an overlapping area100 of thefirst edge101 and thesecond edge102 defined by thelongitudinal opening74. In the illustrative embodiment, thefirst edge101 is folded over thesecond edge102 to create the overlapping area and give the inner member a first, unexpanded diameter that is maintained by theexternal ring53 of theintroducer member12. When theintroducer member12 and sleeve are removed, the second,inner edge102 and first, outer edge are able to slide toward one another, thereby allowing radial expansion of the inner member to the second, expanded diameter for passage of a larger diameter device. In a variation of this embodiment, depicted in FIG. 33, the first andsecond edge101,102 of the cut tube can be attached via anexpandable bridge104 of a second and usually more flexible material. Theexpandable bridge104 of thelongitudinal expansion zone103 can extend underneath thefirst edge101, forming an overlap100 similar to FIG. 32, or the first andsecond edges101,102 may not actually overlap. In the latter instance, expansion can result from folding or invaginating the flexible material of theexpandable bridge104 to permit radial expansion of theinner member15, or relying on elastic properties of theexpandable bridge104 to allow theinner member15 to assume a second, expanded diameter when a larger diameter device is passed therethrough.
• FIG. 36 depicts an embodiment of a nasal introducer used to cannulate the[0077]nasal passages112 to introduce a third member ordevice59, such as a nasal endoscope. Since thesleeve13 does not need to be separately removed from theinner member15, which is only introduced a relatively short distance to provide a conduit for passage of thethird member59, thesecond end64 of thesleeve13 is conveniently, but not essentially, affixed to theinner member15. Because thesecond member15 functions as introducer, it is generally preferable that the attachment111 ofsleeve13 to thesecond member15 be located and configured such that thepassageway22 of theinner member15 remains substantially unobstructed to facilitate passage of thethird member59. FIG. 36 shows one example of such an attachment111, which is affixed about thedistal end36 of theinner member15 with the attachment111 occurring within agroove114 formed in thedistal end36 thereof, leaving thepassageway22 clear and unobstructed after thesleeve13 has fully everted. It would still be within the scope and spirit of the invention for the attachment111 to be located such that a portion of the sleeve remains within the passageway when theinner member15 is fully extended, as long as thesleeve13 is eversible to the point where thepassageway22 is not significantly or functionally narrowed or obstructed by thesleeve13 and/or its attachment111. The term ‘eversible’ should therefore be understood to be equivalent to the concept of being ‘functionally eversible’, whereby, unlike the Bidwell '670 device with its internal ‘retention sled’ to which the sleeve is attached, the sleeve and attachment of the present invention have the capacity to clear thepassageway22 to a sufficient degree as not to interfere with the passage of athird member59 therethrough. Features described in the other accompanying embodiments may also have particular utility for the embodiment of FIG. 36, such as achannel93 to prevent theintroducer member12 from rotating relative the inner member15 (FIG. 16), and a preformed inner member15 (FIG. 24) that facilitates navigation of theinner member15 and/orthird member59 toward thenasopharynx113.
• FIG. 35 depicts an embodiment in which[0078]introducer member12 andsleeve13 can be introduced into the body without preloading thesleeve13 into theinner member15. In the illustrative example, thesecond end64 of thesleeve13 is attached to awire guide62 that was been preloaded into theintroducer member12. Thesleeve13 and wire guide62 can be coupled such that thewire guide62 can slide relative to thesleeve13 or that thesleeve13 is fixed over thewire guide62. Asleeve attachment108 is used, such as a small band, suture, adhesive, or other means of gathering and securing thesecond end64 of the sleeve, which allows thesleeve13 to become detached from thewire guide62 when the advancing inner member pulls it loose, either by sliding off theattachment member108 from around the sleeve13 (such as onto the wire guide) or causing an opening or detachment of theattachment member108 to release thesleeve13. By gathering and attaching thesecond end64 of thesleeve13 about thewire guide62, thesecond end64 is readily drawn into thepassageway22 of theinner member15 as it tracks over thewire guide62 upon advancing toward thedistal end16 of theouter member12. While attachment of thesecond end64 to thewire guide62 facilitates capture of thesleeve13 within thepassageway22 of theinner member15, it is also possible to eliminate thewire guide62, especially if not otherwise useful in the procedure, and gather theend64 of thesleeve13 by configuring theattachment mechanism108 in such a manner that it facilitates capture by the advancinginner member15. In such an embodiment, adding stiffness to, and/or gathering up the sleeve over several millimeter or centimeters (such as using a plurality of attachment bands108) would improve the reliability of thesleeve13 being effectively fed into thepassageway22 as theinner member15 is advanced.
• The eversible sleeve introducer[0079]11 of the present invention can also be used to deliverstents61 and other tubular prosthetic devices as depicted in FIGS.20-21. In the embodiment of FIG. 20, astent61, such as a self-expanding intraluminal stent, is mounted over theinner member15 and this assembly is loaded within thetubular introducer member12. Thesleeve13 is everted into thepassageway22 of theinner member15 which functions as the delivery or pusher catheter. Theinner member15 includes alip63 that maintains a force against the proximal end of thestent61 that assists in placement of thestent61 at the desired location. Thestent61 is advanced out of theintroducer member12 as thesleeve13 is everted and subsequently protects the lining of the bodily passage from the friction that would result from the advancingstent61. When thesleeve13 has finished everting from the passageway, thestent61 becomes exposed to the bodily passage into which it is to be placed. In the case of a self-expandingstent61, thesleeve13 may also provide a restraint that helps prevent its full expansion. As thesleeve13 passes over and exposes the advancing stent, the deployingstent61 is able to expand against the walls of the bodily passage. In a related embodiment shown in FIG. 21, the loadedstent61 is made of a lower profile because it is not delivered from within theintroducer member12 which otherwise adds to the outer diameter of theintroducer apparatus10. In the illustrative embodiment, thedistal end16 of theintroducer member12 does not extend over any portion of thestent61 which has been mounted over theinner member15. Theinner member15 of this embodiment also includes alip63. Without theintroducer member12 extending over thestent61, thesleeve13 provides the only restraint and protection to the stent as it is delivered. In this particular embodiment, thestent61 is sized to include aspace86 between the inside of thestent61 and the outer surface of theinner member15. Thespace86 permits theinner member15 to be readily withdrawn from within thepassageway87 of thestent61 without catching thereon and possibly causing it to be dislodged from the target area of deployment. Alternatively, the stent could be mounted on a balloon and deployed in that manner once exposed by everted sleeve and/or introducer member.
• FIG. 22 depicts an embodiment in which a series of friction reduction means[0080]68 are included about thedistal tip29 of an inner member of anintroducer apparatus10. In the illustrative embodiment, the friction reduction means68 includes threeball bearings88 or beads which a mounted in thedistal face67 of thedistal tip29. Theball bearings88 are rotatable within their mountings via friction applied by thesleeve13 as it drags thereover, therefore allowing thesleeve13 to move more freely. A similar concept is shown in FIG. 22A wherein a series ofrollers89 are mounted about the distal face, encircling thepassageway22 opening. In the illustrative embodiment, thehollow rollers89 are threaded over awire frame90 which comprises two opposing semi-circular frame halves124,125. The adjacent first ends91 of the two wire frame halves124,125 are embedded into thedistal face67 at a point alongpassageway22 opening and the seconds ends123 are embedded into thedistal face67 approximately 180° from the first ends91 along thepassageway22 opening, such that thewire frame90 is circular with eachframe half124,125 holding approximately half of therollers89.Optional supports122 mounted on thedistal face67 support thewire frame90 and provide spacers between therollers89. Other means of reducing friction include providing a highly lubricious material to the distal face67 (e.g., a highly polished metal tip annular ring), coating the end of the device with lubricious polymer coating such as SLIP-COAT® (Sterilization Technical Services, Rush, N.Y.), or changing the surface energy of thedistal face67 through other means such as ion beam bombardment.
• While the embodiments of the preceding figures generally provide for a[0081]single passageway22 through which materials or devices can be introduced to the target site, it possible to provide for one or more additional lumens in theintroducer apparatus10 separate from thepassageway22 that houses theeversible sleeve13. As depicted in FIG. 25, theinner member15 includes asecond passageway58 for passage of a device, such as awire guide62, or for injection of contrast media or other materials. In this embodiment, thesleeve13 represents apartial sleeve43. Thepartial sleeve43 allows thesecond passageway58 to remain continually open and accessible at all times, while still providing a degree of friction reduction between a portion of theinner member15 and the bodily passage. FIGS.26-27 show embodiments in which theintroducer member12 includes asecond passageway72. In the embodiment of FIG. 26, thesleeve13 and the attachment means14 to theintroducer member12 are similar to single passageway embodiments such as that of FIG. 1. Thesecond passageway72, located proximal to thesleeve attachment14, is especially useful as an injection port, but can also function to receive a wire guide, if appropriately sized. A secondmulti-lumen introducer member12 is depicted in FIG. 27 wherein thedistal end16 of the introducer member is more truncate than that of FIG. 26 and thesleeve attachment14 comprises an annular or ring structure mounted on thedistal end16 with the opening to thesecond passageway72 being positioned on the face of thedistal end16 adjacent to thesleeve13 andattachment14. Theattachment14 can either be a plastic or metal ring to secure thesleeve13 to theintroducer member12, or a ring of adhesive. As mentioned, the embodiment of FIG. 27 also includes alongitudinal opening74 to allow theintroducer member12 to be removed from over theinner member15 with thesleeve13 andattachment14 made splittable or detachable as well to allow removal over theinner member15. Obviously, it is possible to have additional passageways beyond thesecond passageway58,72 depicted in FIGS.25-27. For example thesecond passageway58,72 might be used for introduction of wire guides or medical devices while the third passageway is used for injecting contrast media.
• FIGS.[0082]28-30 depict an example of a method of using a selected embodiment of the present invention to cannulate a stricture within a bodily passage. As depicted in FIG. 28, thedistal end16 of theintroducer member12 is placed against theopening27 to thebodily passage26 where theintroducer member12 is then pulled back relative theinner member15 which is initially restrained. This allows theinner member15 to grip the opening and -advance intobodily passage26 as thesleeve13 is laid down when everting from theinner member15. In FIG. 29, theinner member15 has passed through the stricture and thesleeve13 has now completely everted from thepassageway22 of the inner member. Theinner member15 is maintained at the target site, while the introducer assembly11 is removed from the patient by one of several mean discussed above. In FIG. 30, only theinner member15 remains from theoriginal introducer apparatus10. It can serve as an introducer for awire guide62 or other medical treatment device and may be itself removed from the patient once access across the stricture is gained, leaving the wire guide and/or other device(s) in place. It should be noted that unlike procedures such as nasal, colonic, and urethral access where it is advantageous or desired to improve patient comfort during both ingress and egress of theintroducer apparatus10, it may be less important in other medical procedures, such as cannulation of certain internal sphincters and strictures, to maintain thesleeve13 in place during removal of theinner member15, the critical function of thesleeve13 having been already fulfilled.
• Any other undisclosed or incidental details of the construction or composition of the various elements of the disclosed embodiment of the present invention are not believed to be critical to the achievement of the advantages of the present invention, so long as the elements possess the attributes needed for them to perform as disclosed. The selection of these and other details of construction are believed to be well within the ability of one of even rudimentary skills in this area, in view of the present disclosure. Illustrative embodiments of the present invention have been described in considerable detail for the purpose of disclosing a practical, operative structure whereby the invention may be practiced advantageously. The designs described herein are intended to be exemplary only. The novel characteristics of the invention may be incorporated in other structural forms without departing from the spirit and scope of the invention.[0083]

Claims (49)

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.

Images