US20080249366A1 - System for use in performing a medical procedure and introducer device suitable for use in said system - Google Patents

Abstract

A system for performing a medical procedure and an introducer device suitable for use in the system. The system may be used, for example, to examine and/or to treat the uterus. According to one embodiment, the system includes an introducer, a morcellator, a flexible hysteroscope, and a fluid-containing syringe. The introducer is suitable for transcervical insertion into the uterus and includes a gun-shaped housing and a rigid sheath extending distally from the housing. The sheath is shaped to include an instrument lumen, a visualization lumen, and a pair of fluid lumens. The introducer also includes a first assembly within the housing for receiving the morcellator and for guiding the distal end of the morcellator into the instrument lumen and a second assembly within the housing for guiding the hysteroscope into the visualization channel. In addition, the introducer further includes an assembly for fluidly connecting the syringe to the fluid lumens.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No. 60/910,618, filed Apr. 6, 2007, and U.S. Provisional Patent Application Ser. No. 60/910,625, filed Apr. 6, 2007, both of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
• The present invention relates generally to systems for use in performing medical procedures and relates more particularly to a new system for use in performing a medical procedure and to an introducer device suitable for use in said system.
• There are many types of situations in which it is desirable for a medical procedure to be performed on a patient. Such a procedure may be diagnostic and/or therapeutic in nature. For example, in the field of gynecology, one may wish to examine and/or treat a uterus for various abnormal conditions including, but not limited to, the presence of fibroids, polyps, tumors, adhesions, or other abnormalities within a uterus; endometriosis or other abnormal bleeding; uterine prolapse; ectopic pregnancy; and fertility issues (both the inability to conceive and the desire to avoid pregnancy).
• The uterus is a pear-shaped organ made up two distinct anatomical regions: the cervix and the corpus. The cervix is a narrow cylindrical passage (about 1.5-4.0 mm in diameter) which connects at its lower end with the vagina. The corpus, which is the portion of the uterus that grows during pregnancy to carry a fetus, is shaped to include two portions: the lower uterine segment and the fundus. The cervix widens at its upper end to form the lower uterine segment of the corpus. The lower uterine segment, in turn, widens at its upper end into the fundus of the corpus. When in a relaxed state, the uterus is a flaccid organ, and the opposing walls of the corpus are typically in contact with one another. Dimensionally, the length of the uterus, measured from the cervix to the fundus, is approximately 8-10 cm, and the maximum width of the uterus, which is near the fundus, is about 4-5 cm. Extending from the fundus of the uterus on either side are fallopian tubes. The fallopian tubes are continuous with the uterine cavity and allow the passage of an egg from an ovary to the uterus where the egg may implant if fertilized.
• Conventionally, the examination and/or treatment of the uterus is typically performed as follows: First, obturators of increasing diameter are serially inserted into and then removed from the cervix to gradually dilate the cervix to about 5 mm so that a hysteroscope may be safely inserted into the cervix. (Some physicians omit this step of using obturators to dilate the cervix prior to insertion of a hysteroscope.) Then, the distal end of a hysteroscope is inserted through the cervix, and a fluid, such as a saline solution or a sugar-based aqueous solution, is transmitted through a fluid inlet channel in the hysteroscope to wash the uterus of mucus, blood and other debris that may be present, the washing fluid and debris thereafter exiting the uterus through a fluid outlet channel in the hysteroscope. Then, once the washing of the uterus is complete, the fluid outlet channel is closed and additional fluid is conducted through the fluid inlet channel into the uterus until the uterus becomes distended, i.e., the walls of the corpus are moved away from each other. Once the uterus is distended sufficiently, the fluid outlet channel is re-opened, with maintenance of the distended uterus being achieved by controlling the respective fluid inlet and outlet flow rates.
• With the uterus thus distended, examination of the uterus is performed using the visualization channel of the hysteroscope. If fibroids (i.e., benign tumors), polyps or other abnormalities are detected, such abnormalities may be removed, for example, by resection. Such resection may be achieved using an electromechanical cutting device inserted through a working channel in the hysteroscope. Tissue is then removed by contacting the cutter, which typically has a rotating cutting instrument, with the part of the uterus wall of interest. Examples of such electromechanical cutting devices, which are commonly referred to in the art as morcellators, are disclosed in, for example, U.S. Pat. No. 7,226,459, inventors Cesarini et al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savage et al., issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden et al., issued Mar. 24, 1998; U.S. Patent Application Publication No. US 2006/0047185 A1, inventors Shener et al., published Mar. 2, 2006; and PCT International Publication No. WO 99/11184, published Mar. 11, 1999, all of which are incorporated herein by reference.
• One shortcoming with the above procedure is that it typically requires that anesthesia be administered to the patient. This is because conventional hysteroscopes of the type through which an electromechanical cutting device may be inserted typically have a diameter of about 9 mm. By contrast, the cervix typically cannot be dilated to a diameter greater than about 5.5 mm without causing considerable discomfort to the patient. As a result, due to the need for anesthesia, the above procedure is typically performed in a hospital operating room and, as a result, bears a large cost due to the setting and the support personnel required.
SUMMARY OF THE INVENTION
• It is an object of the present invention to provide a novel system for use in performing a medical procedure.
• It is another object of the present invention to provide a system as described above that may be used, for example, in the examination and/or treatment of the uterus.
• It is still another object of the present invention to provide a novel introducer device for use in the above system.
• Additional objects, as well as aspects, features and advantages, of the present invention will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of the invention. In the description, reference is made to the accompanying drawings which form a part thereof and in which is shown by way of illustration various embodiments for practicing the invention. The embodiments will be described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is best defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are hereby incorporated into and constitute a part of this specification, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings wherein like reference numerals represent like parts:
• FIG. 1 is a right side view of a first embodiment of a system for use in diagnosing and/or treating a body cavity, the system being constructed according to the teachings of the present invention and being shown in a partially disassembled state;
• FIG. 2 is a right side view of the system ofFIG. 1, the system being shown in an assembled state;
• FIG. 3 is a perspective view of the introducer device shown inFIG. 1;
• FIGS. 4(a) and4(b) are exploded perspective views of the introducer device ofFIG. 1;
• FIG. 5 is a right perspective view of the introducer device ofFIG. 1, with the right half of the housing removed;
• FIG. 6 is a longitudinal section view of the introducer device ofFIG. 1;
• FIG. 7 is an enlarged fragmentary perspective view, shown in section, of the introducer device ofFIG. 1, with only the manifold, strain relief and sheath being shown;
• FIG. 8 is an enlarged distal end view of the multi-lumen sheath of the introducer device shown inFIG. 1;
• FIG. 9 is an enlarged fragmentary view of the instrument guide assembly of the introducer device shown inFIG. 1;
• FIG. 10 is a perspective view, broken away in part, of an alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 11 is a fragmentary perspective view of the introducer device shown inFIG. 10;
• FIG. 12 is an enlarged fragmentary view of the distal end of the introducer device shown inFIG. 10;
• FIG. 13 is a perspective view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 14 is an enlarged perspective view of the distal end of the introducer device shown inFIG. 13;
• FIG. 15 is a fragmentary perspective view, partly in section, of the proximal end of the introducer device shown inFIG. 13;
• FIG. 16 is a perspective view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, with the scope cover being shown in a rolled-up state;
• FIG. 17 is an enlarged fragmentary perspective view of the proximal end of the introducer device ofFIG. 16;
• FIG. 18 is an enlarged fragmentary perspective view of the distal end of the introducer device ofFIG. 16;
• FIG. 19 is an enlarged fragmentary side view of the distal end of the introducer device ofFIG. 16;
• FIG. 20 is a section view of the introducer device ofFIG. 19 taken line1-1;
• FIG. 21 is a fragmentary side view of the introducer device shown inFIG. 16, with the scope cover being shown in an unrolled state;
• FIG. 22 is a perspective view of an alternate sheath cap that may be used with the introducer device ofFIG. 16;
• FIG. 23 is a perspective view of a further alternate sheath cap that may be used with the introducer device ofFIG. 16;
• FIG. 24 is a perspective view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 25 is a fragmentary side view, broken away in part, of the introducer device shown inFIG. 24;
• FIG. 26 is an enlarged fragmentary perspective view of the distal end of the introducer device shown inFIG. 24;
• FIG. 27 is an enlarged fragmentary perspective view of the proximal end of the introducer device shown inFIG. 24;
• FIG. 28 is a perspective view of one embodiment of a protective cover for a visualization device;
• FIGS. 29(a) and29(b) are side and fragmentary end views, respectively, of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 30 is an end view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 31 is a partly schematic, perspective view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 32 is a distal end view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention;
• FIG. 33 is a fragmentary longitudinal section view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention; and
• FIG. 34 is a fragmentary side view, partly in section, of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• Referring now toFIGS. 1 and 2, there are shown various views of a first embodiment of a system that may be used in the diagnosis and/or treatment of a body cavity, the system being constructed according to the teachings of the present invention and being represented generally byreference numeral11.
• System11 may comprise anintroducer device13, avisualization device15, afluid supply device17, and atissue modifying device19.
• Referring now toFIGS. 3 through 7,introducer13 may comprise ahousing21.Housing21, in turn, may comprise aleft handle half23 and aright handle half25.Left handle half23 andright handle half25, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be joined by a plurality ofscrews27. Instead of being joined byscrews27, lefthandle half23 andright handle half25 may be joined using a suitable adhesive, crush pins, or may be welded together ultrasonically or otherwise.Left handle half23 andright handle half25 jointly define a hollow, gun-shaped structure comprising ahandle portion29 and abarrel portion31.Handle portion29 may be shaped to include anopening33 provided at itsbottom end34 and anopening35 provided along itsdistal face36 nearbottom end34. A slot33-1 may be provided inright handle half25, slot33-1 extending from opening33 towardsbarrel portion31 for a short distance.Barrel portion31 may be shaped to include anopening37 provided at itsproximal end38 and anopening39 provided at itsdistal end40. In addition,barrel portion31 may be shaped to include atransverse opening41 provided inright handle half25 at a location intermediate toproximal end38 anddistal end40.
• The interior surfaces ofleft handle half23 andright handle half25 may shaped to include complementary sets of ribs (not shown). Such ribs may provide structural reinforcement to lefthandle half23 andright handle half25 and may help to maintain the correct positioning and alignment of the components positioned withinhousing21.
• Introducer13 may further comprise a manifold45.Manifold45, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary, branched structure shaped to include a maintubular member47 and aside tubular member49.Main member47 may comprise a proximal end51, an opendistal end53, aside wall55, and alongitudinal lumen57. Proximal end51 ofmain member47 may be shaped to include atop opening59 of comparatively greater diameter and abottom opening61 of comparatively smaller diameter.Side member49 may comprise an openproximal end63, an opendistal end65, aside wall67, and alongitudinal lumen69.Lumen69 ofside member49 may be in fluid communication withlumen57 ofmain member47 through opendistal end65.
• Manifold45 may be coupled tohousing21 using a pair ofpins71 and73 that may extend fromside wall55 and that may be received withinhollow embossments75 and77, respectively, provided on the interior faces ofleft handle half23 andright handle half25, respectively. Withmanifold45 thus coupled tohousing21, proximal end51 ofmanifold45 may be positioned inbarrel portion31, withside wall55 tightly fitting withinopening39 and withdistal end53 ofmanifold45 extending distally a short distance beyonddistal end40.
• Introducer13 may further comprise astrain relief member81.Strain relief member81, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include an openproximal end83, an opendistal end85, aside wall87, and alongitudinal lumen89.Strain relief member81 may be partially inserted intolumen57 ofmanifold45 and may be tightly fitted withinlumen57 and fixedly secured thereto using a suitable adhesive or the like, withproximal end83 ofstrain relief member81 being positioned just distal to opendistal end65 ofside member49 and withdistal end85 ofstrain relief member81 extending distally a short distance beyonddistal end53 ofmain member47.
• Introducer13 may further comprise asheath91, which is also shown separately inFIG. 8.Sheath91, which may be extruded or otherwise fabricated from a suitable polymer, such as nylon12, may be a rigid, unitary structure shaped to include aproximal end92, adistal end93, and aside wall94.Sheath91 may be further shaped to include a plurality of longitudinal lumens of fixed shape and size, such lumens including atop lumen96, abottom lumen97, and a pair of side lumens98-1 and98-2. As will be discussed further below,top lumen96 may be used as an instrument lumen,bottom lumen97 may be used as a visualization lumen, and side lumens98-1 and98-2 may be used as fluid lumens.Proximal end92 ofsheath91 may be partially inserted intolumen89 ofstrain relief member81 and may be tightly fitted withinlumen89 and fixedly secured thereto using a suitable adhesive or the like, withproximal end92 ofsheath91 flush withproximal end83 ofstrain relief member81 and withdistal end93 ofsheath91 extending distally beyonddistal end85 ofstrain relief member81 for several inches.
• Sheath91, which is preferably the only component ofintroducer13 that is to be inserted into a patient, may be dimensioned to have an outer diameter of about 5.5 mm, withlumen96 having a diameter of about 3 mm,lumen97 having a diameter of about 2 mm, and lumens98-1 and98-2 each having a diameter of about 1.33 mm. By thus dimensioningsheath91, ifsheath91 is inserted through the cervix of a patient, the risk of injury to the patient and the need for anesthesia to be administered to the patient may be minimized. However, it should be understood that the above dimensions forsheath91 are merely exemplary and may be varied depending upon howsystem11 is to be used.
• In another embodiment (not shown), instead of makingsheath91 entirely of a rigid material,sheath91 may include a proximal portion made of a rigid material and a distal portion made of a flexible and/or softer material.
• Introducer13 may further comprise an instrument guide assembly mounted withinhousing21 for providing a continuous channel aligned withlumen96 into whichtissue modifying device19 may be inserted. The instrument guide assembly may comprise aguide body101.Body101, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion103, adistal portion105 and anintermediate portion107.Intermediate portion107 may be reduced in inner diameter and in outer diameter relative toproximal portion103 anddistal portion105 so that anannular seat108 is formed withinbody101 at the juncture ofintermediate portion107 anddistal portion105. The interior surface ofbody101 may taper inwardly fromproximal portion103 tointermediate portion107 to facilitate insertion ofdevice19 intointermediate portion107 and to delimit the extent to whichdevice19 may be inserted intobody101.
• Body101 may be tightly fitted within opening37 ofhousing21 and fixedly secured thereto using a suitable adhesive or the like, withdistal portion105 andintermediate portion107 ofbody101 being positioned withinbarrel portion31 ofhousing21 and withproximal portion103 ofbody101 extending throughopening37 and continuing proximally for a short distance beyondproximal end38 ofhousing21.
• The instrument guide assembly may further comprise asleeve111.Sleeve111, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary, branched structure shaped to include a maintubular member113 and aside tubular member115.Main member113 may comprise an openproximal end116, an open distal end117, and alongitudinal lumen119.Proximal end116 ofmain member113 may be shaped to be tightly fitted withindistal portion105 ofbody101 and may be bonded thereto using a suitable adhesive.Side member115 may comprise an openproximal end120, an opendistal end121 and alongitudinal lumen123.Lumen123 ofside member115 may be in fluid communication withlumen119 ofmain member113 through openproximal end120.Distal end121 ofside member115 may extend throughopening41 provided inright handle half25 ofhousing21 and may be coupled to avalve128.Valve128 may be an actively-controlled valve, such as a stopcock valve, or a passively-controlled valve, such as a spring-activated ball valve.Valve128 may be connected at its output end to a length of tubing (not shown), as well as to a fluid receptacle (not shown), for conducting, as well as collecting, outflow fluid passing throughvalve128.
• The instrument guide assembly may further comprise the combination of aseal131 and avalve133.Seal131 andvalve133 may be elastomeric members securely positioned betweenseat108 ofbody101 andproximal end116 of sleeve111 (seeFIG. 9).Seal131, which may be located proximally relative tovalve133, may include acentral opening135. Opening135 may be appropriately dimensioned so that, whentissue modifying device19 is inserted therethrough, fluid may not readily pass proximally throughseal131 around the outside ofdevice19.Valve133, which may be shaped to include a dome having a cross-slit at its top, may be designed so that, in the absence ofdevice19 being inserted therethrough, fluid may not readily pass proximally therethrough.
• The instrument guide assembly may further comprise atube141.Tube141, which may be a rigid hypotube made of stainless steel or the like, may comprise aproximal end143 and adistal end145.Proximal end143 may be fixedly mounted withinlumen119 ofsleeve111 using a suitable adhesive or the like.Distal end145 oftube141 may be tightly fitted withinlumen96 ofsheath91 and may be secured therewithin using a suitable adhesive or the like.
• Introducer13 may further comprise a visualization guide assembly mounted withinhousing21 for providing a continuous channel aligned withlumen97 into whichvisualization device15 may be inserted. The visualization guide assembly may comprise aguide body151.Body151, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion153 of comparatively greater diameter, adistal portion155 of comparatively smaller diameter, and anintermediate portion157 tapering in diameter fromproximal portion153 todistal portion155.Body151 may be disposed withinhandle portion29 ofhousing21, withproximal portion153 spaced inwardly a short distance from opening33 and withdistal portion155 facing towardsbarrel portion31.Proximal portion153 may be tightly fitted between and fixedly secured to lefthandle half23 andright handle half25 ofhousing21 using adhesive or other suitable means. As will be discussed further below,proximal portion153 may be appropriately dimensioned to receive the proximal portion ofvisualization device15, withintermediate portion157 ofbody151 being appropriately dimensioned to serve as a stop to limit the extent to whichvisualization device15 may be inserted intobody151. Anannular seat158 may be provided withindistal portion155 and may be spaced proximally relative todistal end159 ofdistal portion155.
• The visualization guide assembly may further comprise aguide connector161.Guide connector161, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion163 of comparatively greater diameter, adistal portion165 of comparatively smaller diameter, and anintermediate portion167 tapering in diameter fromproximal portion163 todistal portion165.Proximal portion163 may be shaped to be tightly fitted withindistal portion155 ofbody151 and may be bonded thereto using a suitable adhesive.
• The visualization guide assembly may further comprise the combination of aseal171 and avalve173.Seal171 andvalve173 may be elastomeric members securely positioned betweenseat158 ofbody151 andproximal portion163 ofconnector161.Seal171, which may be located proximally relative tovalve173, may include a central opening appropriately dimensioned so that, whenvisualization device15 is inserted therethrough, fluid may not readily pass proximally throughseal171 around the outside ofdevice15.Valve173, which may be shaped to include a dome having a cross-slit at its top, may be designed so that, in the absence ofdevice15 being inserted therethrough, fluid may not readily pass proximally therethrough.
• The visualization guide assembly may further comprise atube181.Tube181, which may be a flexible unitary member fabricated from a suitable polymer or other material, may comprise aproximal end183, adistal end185, and alumen186.Proximal end183 may be fixedly mounted withindistal portion165 ofconnector161 using a suitable adhesive or the like.Distal end185 oftube181 may be tightly fitted withinlumen97 ofsheath91 and may be secured therewithin using a suitable adhesive or the like.Lumen186 may be appropriately dimensioned so that the distal portion ofvisualization device15 may be inserted thereinto and, in this manner, guided bytube181 tolumen97.
• Introducer13 may further comprise a mechanism for reversiblycoupling visualization device15 to the visualization guide assembly. This mechanism may comprise acam lock191.Lock191, which may be fabricated from a rigid polymer or other suitable material, may be a unitary structure shaped to comprise alever192 and afulcrum193. Thefulcrum193 may be pivotally mounted onhousing21 using apivot pin194 inserted through atransverse opening195 infulcrum193 and securely received at its opposite ends inopenings196 and197 provided inleft handle half23 andright handle half25, respectively.Fulcrum193 may comprise aface198 adapted to frictionally engage the proximal portion ofdevice15 whenlever192 is pivoted towardshandle portion29.
• Introducer13 may further comprise atube201.Tube201, which may be fabricated from a suitable polymer or other material, may be a flexible unitary structure shaped to include aproximal end203 and adistal end205.Proximal end203 may be secured to the distal end of a luer fitting207 securely mounted within opening35 ofhousing21.Distal end205 may be positioned withinlumen69 ofmanifold45 and may be secured in place using an adhesive or other suitable means. As will be discussed further below, luer fitting207 may be connected to the output offluid supply device17. In this manner, fluid dispensed through fitting207 and intotube201 may be conducted bytube201 tomanifold45. Thereafter, the fluid inmanifold45 may flow distally through lumens98-1 and98-2 ofsheath91.
• Referring back now toFIGS. 1 and 2,visualization device15, which may be, for example, a conventional flexible hysteroscope, may comprise aproximal portion211 and adistal portion213.Proximal portion211, which may be comparatively rigid, compact in length, and wide in diameter, may comprise aninput port215, anoutput port217, and adistal end218.Distal portion213, which may be comparatively flexible, elongated in length, and narrow in diameter, may comprise adistal end219.Device15 may be appropriately dimensioned so thatdistal end218 ofproximal portion211 may be received inbody151, withdistal portion213 extending distally throughseal171,valve173,connector161,tube181 andlumen97 and withdistal end219 positioned at or a short distance beyonddistal end93 ofsheath91. Although not present in the embodiment shown,proximal portion211 ofdevice15 may be provided with notches or other physical features that may be used to mate with or otherwise engagecam lock191.Distal end219 ofdevice15 may be constructed to permit the viewing of objects at an angle, such as at a 15 degree angle, relative to the longitudinal axis ofdistal portion213. In this manner, by placingdevice15 in a particular angular orientation,device15 may be used to view the operation of the distal end oftissue modifying device15. Such an angular orientation may be ensured by orientingdevice15 so thatinput port215 is aligned with and extends through slot33-1.
• Fluid supply device17 may comprise a fluid-containing syringe (or another suitable fluid-dispensing device) having anoutput end221 that may be coupled toluer fitting207.Fluid supply device17 may comprise automated means (not shown) for dispensing fluid therefrom at a desired rate.
• Tissue modifying device19 may comprise a morcellator designed to remove fibroids, polyps, and other abnormalities from a uterus.Device19 may be appropriately dimensioned to be received within the instrument channel ofintroducer13, with thedistal end231 ofdevice19 inserted throughlumen96 ofsheath91 and extending distally beyonddistal end93 ofsheath91. Examples of morcellators suitable for use in the present invention are disclosed in, for example, U.S. Pat. No. 7,226,459, inventors Cesarini et al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savage et al., issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden et al., issued Mar. 24, 1998; U.S. Patent Application Publication No. US 2006/0047185 A1, inventors Shener et al., published Mar. 2, 2006; and PCT International Publication No. WO 99/11184, published Mar. 11, 1999, all of which are incorporated herein by reference. An additional example of a morcellator suitable for use in the present invention is disclosed in U.S. patent application Ser. No. 12/098,250, inventors Gruber et al., filed on even date herewith, which application is incorporated herein by reference.
• To preparesystem11 for use,distal end219 ofvisualization device15 may be inserted first through the visualization guide channel ofintroducer13, next throughmanifold45, and then throughlumen97 ofsheath91. Withdevice15 thus inserted intointroducer13,cam lock191 may be used to secureproximal portion211 ofdevice15 tointroducer13.Input end215 andoutput end217 ofdevice15 may then be coupled to a light source and to a camera, respectively. If desired, the camera may be omitted, andoutput end217 may be observed directly with the unaided eye.Fluid supply device17 may then be coupled to luer fitting207 ofintroducer13.Distal end93 ofsheath91 may then be inserted transcervically, i.e., through the vagina and the cervix, into the uterus of the patient. Prior to introducingdistal end93 ofsheath91 into the patient, the cervix may be gradually dilated in the conventional manner using obturators of increasing diameter. The uterus may then be washed of blood and other debris that may be present by dispensing fluid fromfluid supply device17 intointroducer13, which fluid may then exitintroducer13 distally through lumens98-1 and98-2.Valve128 may be opened during this washing procedure so that fluid and any debris present in the uterus may exit the uterus proximally throughlumen96 ofsheath91 and, thereafter, may exitintroducer13 by passing proximally throughtube141, intomain member113 ofsleeve111, throughside member115 ofsleeve111, and throughvalve128. When the washing procedure is complete,valve128 may be closed while fluid may continue to be dispensed into the uterus through lumens98-1 and98-2, thereby causing the uterus to become distended by the fluid. When the uterus becomes sufficiently distended by such fluid,valve128 may be opened while fluid may continue to be dispensed into the uterus. In this manner, the uterus may be maintained at a desired degree of distension while fluid is continuously circulated through the uterus. With the uterus thus distended with fluid,device15 may be used to examine the interior of the uterus. If abnormalities are detected that one wishes to remove, such abnormalities may be removed by insertingtissue modifying device19 distally through the instrument channel guide ofintroducer13 and then throughchannel96 ofsheath91 and then by resecting theabnormalities using device19. When treatment is complete,device19 may be withdrawn fromintroducer13, andintroducer13 anddevice15 may be withdrawn from the patient.
• Althoughsystem11 has been discussed above in connection with the diagnosis and/or treatment of the uterus of a female patient, it should be understood thatsystem11 is not limited to such a use and may be used in the diagnosis and/or treatment of other anatomies that may be apparent to those of ordinary skill in the art.
• Referring now toFIGS. 10 through 12, there are shown various view of an alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral301.
• Introducer device301, which may be used, for example, withvisualization device15,fluid supply device17 andtissue modifying device19, may comprise ahub303.Hub303, which may be fabricated from a rigid polymer or other suitable material, may be shaped to comprise aproximal end305, adistal end307 and aside wall309.Hub303 may additionally be shaped to comprise a plurality of lumens of fixed shape and size, such lumens including afirst lumen311, asecond lumen313, and athird lumen315.First lumen311 andsecond lumen313 may extend fromproximal end305 todistal end307.Third lumen315 may extend fromside wall309 todistal end307, withthird lumen315 being positioned belowfirst lumen311 and withsecond lumen313 being positioned to the side offirst lumen311 andthird lumen315. As will be discussed further below,first lumen311 may be used as a scope lumen,second lumen313 may be used as an instrument lumen, andthird lumen315 may be used as a fluid lumen.
• Hub303 may be further shaped to include athumb ring318 and a pair of finger rests319-1 and319-2 so thatintroducer device301 may be operated using the thumb, forefinger and middle finger of one hand.
• Device301 may further comprise a first Touhy-Borst valve321 and a second Touhy-Borst valve323, the distal end ofvalve321 being inserted into the proximal end offirst lumen311 and fixedly mounted therewithin, the distal end ofvalve323 being inserted into the proximal end ofsecond lumen313 and fixedly mounted therewithin.Valve321 may be appropriately dimensioned forvisualization device15, andvalve323 may be appropriately dimensioned fortissue modifying device19.
• Device301 may further comprise a length offlexible tubing331.Tubing331, in turn, may comprise aproximal end335 and adistal end337.Proximal end335 oftubing331 may be fixed to the distal end of a luer-activatedcheck valve339, anddistal end337 oftubing331 may be coupled to the proximal end oflumen315.Valve339 may be adapted for connection tofluid supply device17 and may be constructed so as to permit fluid to flow throughvalve339 only when connected tofluid supply device17.
• Device301 may further comprise aflexible sheath341.Sheath341, which may be a unitary silicone extrusion or other suitable structure, may be shaped to include aright side342 and aleft side343.Right side342 andleft side343 may jointly define aproximal end344,proximal end344 being secured withindistal end307 ofhub303.Right side342 may be shaped to include adistal end345, a toplongitudinal lumen346 and a bottomlongitudinal lumen347. The proximal end oflumen346 may be aligned with the distal end oflumen311, and the proximal end oflumen347 may be aligned with the distal end oflumen315.Left side343 may be shaped to include adistal end348 and alongitudinal lumen349.Distal end348 ofleft side343 may terminate a short distance proximal todistal end345 ofright side342. The proximal end oflumen349 may be aligned with the distal end oflumen313.
• Sheath341 may be dimensioned to have an outer diameter of about 5.5 mm, withlumen349 having a diameter of about 3 mm,lumen346 having a diameter of about 2 mm, andlumen347 having a diameter of about 1.33 mm. By thus dimensioningsheath341, ifsheath341 is inserted through the cervix of a patient, the risk of injury to the patient and the need for anesthesia to be administered to the patient may be minimized. However, it should be understood that the above dimensions forsheath341 are merely exemplary and may be varied depending upon howintroducer301 is to be used.
• Device301 may further comprise asheath cap351.Cap351, which may be a rigid, unitary, transparent structure made of polycarbonate or a similarly suitable material, may be shaped to comprise aproximal end353, a distal end355, a top lumen357 and abottom lumen359.Proximal end353 may have a transverse profile similar toright side342 and may be fixed todistal end345 ofright side342, with top lumen357 aligned withlumen346 and withbottom lumen359 aligned withlumen347. The distal end of top lumen357 may be sealed with aprotective lens360 to keep fluid and other matter from entering lumen357 and from coming into contact withvisualization device15. As can be appreciated, instead of being mounted withincap351,lens360 could be integrally formed withcap351. In this manner,visualization device15 may not need to be cleaned between uses. Distal end355 may be shaped to include adeflector361 for deflecting the flow of fluid fromlumen359 upwardly. In this manner, some of the deflected fluid may be used to washlens360, thereby keeping clear the field of view fordevice15.
• In use,distal end219 ofvisualization device15 may be inserted first throughvalve321, next throughlumen311, and then into lumen357 up tolens360.Input end215 andoutput end217 ofdevice15 may then be coupled to a light source and to a camera, respectively. If desired, the camera may be omitted, andoutput end217 may be observed directly with the unaided eye.Fluid supply device17 may then be coupled tovalve339.Cap351 andsheath341 may then be inserted transcervically into the uterus of the patient. (Prior to introducingcap351 andsheath341 into the patient, the cervix may be gradually dilated in the conventional manner using obturators of increasing diameter.) The uterus may then be washed of blood and other debris that may be present by dispensing fluid fromfluid supply device17 into the uterus throughlumen359. Fluid and debris may exit the uterus by moving proximally throughlumens349 and313 andvalve323. When the washing procedure is complete, additional fluid may be dispensed into the uterus throughlumen359 to cause the uterus to become distended. With the uterus thus distended with fluid,device15 may be used to examine the interior of the uterus. If abnormalities are detected that one wishes to remove, such abnormalities may be removed by insertingtissue modifying device19 distally first throughvalve323, next throughlumen313, and then throughlumen349 and then by resecting theabnormalities using device19. When treatment is complete,device19 may be withdrawn fromintroducer301, andintroducer301 anddevice15 may be withdrawn from the patient.
• Referring now toFIGS. 13 through 15, there are shown various views of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral401.
• Introducer device401, which may be used, for example, withvisualization device15,fluid supply device17 andtissue modifying device19, may comprise aflexible sheath403.Sheath403, which may be a unitary silicone extrusion or other suitable structure, may be shaped to include aproximal end405, adistal end407 and aside wall408. In addition,sheath403 may further comprise a toplongitudinal lumen409, a middlelongitudinal lumen411, and a bottomlongitudinal lumen413. As will be discussed further below,top lumen409 may receivedevice15,middle lumen411 may receivedevice19, andbottom lumen413 may be used as a fluid lumen. In order to minimize the diameter ofsheath401,lumen411 may be molded in a collapsed state and may expand whendevice19 is inserted thereinto.
• Device401 may further comprise a first Touhy-Borst valve421. The distal end ofvalve421 may be inserted into the proximal end ofmiddle lumen411 and may be fixedly mounted therewithin.Valve421, which may be appropriately dimensioned to receivetissue modifying device19, may include across-slit check valve425 for preventing the proximal flow of fluid from a patient therethrough.
• Device401 may further comprise a second Touhy-Borst valve423 and a length oftubing427.Valve423 may be appropriately dimensioned to receivevisualization device15. The proximal end oftubing427 may be inserted into the distal end ofvalve423 and may be fixedly mounted therewithin. The distal end oftubing427 may be inserted throughside wall408 ofsheath401 and may be spliced intotop lumen409.
• Device401 may further comprise a length offlexible tubing431. The distal end oftubing431 may be inserted throughside wall408 ofsheath403 and may be spliced intobottom lumen413. The proximal end oftubing431 may be coupled to the distal end of a balloon-type pressure indicator433, which may be designed to expand in response to elevated fluid pressure within the patient.Indicator433 may, in turn, be coupled to the distal end of a luer-activatedcheck valve435.
• Device401 may further comprise ascope cap451.Cap451, which may be a rigid, unitary, transparent structure made of polycarbonate or a similarly suitable material, may be a tubular member shaped to comprise aproximal end453, adistal end455, and alumen457.Proximal end453 ofcap451 may be fixed by an adhesive or other suitable means todistal end407 ofsheath403, withlumen457 aligned withtop lumen409 and similar in profile thereto. Distal end oflumen457 may be sealed with aprotective lens460 to keep fluid and other matter from enteringlumen457 and from coming into contact withvisualization device15. (As can be appreciated, instead of being mounted withincap451,lens460 could be integrally formed withcap451. In addition,cap451 andlens460 could be reduced in size and mounted within the distal end oftop lumen409.)
• Device401 may be used in a fashion similar to that described above fordevice301.
• Referring now toFIGS. 16 through 21, there are shown various views of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral501.
• Introducer device501, which may be used, for example, withvisualization device15,fluid supply device17 andtissue modifying device19, may comprise aflexible sheath503. In the present embodiment,sheath503 may be transparent.Sheath503, which may be a unitary polyurethane extrusion or other suitable structure, may be shaped to include aproximal end505, adistal end507 and aside wall508.Side wall508 may have a generally oval shape in transverse cross-section, with one side ofside wall508 being shaped to include alongitudinal groove511.Sheath503 may further comprise a toplongitudinal lumen513 and a bottomlongitudinal lumen515. As will be discussed further below,top lumen513 may receivedevice15, andbottom lumen515 may be used as a fluid lumen.
• Introducer device501 may further comprise a first Touhy-Borst valve521.Valve521 may comprise a pair ofpegs523 and525 extending distally from its distal end527.Peg523 may be fixedly mounted withintop lumen513 ofsheath503, and peg525 may be fixedly mounted withinbottom lumen515 ofsheath503.
• Device501 may further comprise a second Touhy-Borst valve531 and a length oftubing533.Valve531 may be appropriately dimensioned to receivevisualization device15. The proximal end oftubing533 may be inserted into the distal end ofvalve531 and may be fixedly mounted therewithin. The distal end oftubing533 may be inserted throughside wall508 ofsheath503 and may be spliced intotop lumen513. Ascope cover535, which may be used to protect the proximal end ofdevice15, may be mounted at its distal end tovalve531.Cover535, which may be made of a polyurethane film or other suitable material, may be packaged in a compact state (seeFIG. 16) and may, thereafter, be unrolled to an expanded state (seeFIG. 21). In the present embodiment, cover535 may be transparent.
• Device501 may further comprise a length offlexible tubing541. The distal end oftubing541 may be inserted throughside wall508 ofsheath503 and may be spliced intobottom lumen515. The proximal end oftubing541 may be coupled to the distal end of a balloon-type pressure indicator543 (similar to indicator433), which, in turn, may be coupled to the distal end of a luer-activatedcheck valve545.
• Device501 may further comprise asheath cap551.Cap551, which may be a rigid, unitary, transparent structure made of polycarbonate or a similarly suitable material, may be shaped to comprise aproximal end553, adistal end555, atop lumen557 and abottom lumen559.Proximal end553 may have a transverse profile generally similar to sheath503 (withcap551 additionally being shaped to include protrusions558-1 and558-2) and may be fixed todistal end507 ofsheath503 using a suitable adhesive (and, optionally, interlocking parts (not shown)), withtop lumen557 aligned withlumen513 and withbottom lumen559 aligned withlumen515. The distal end oftop lumen557 may be sealed with aprotective lens560 to keep fluid and other matter from enteringlumen557. (As can be appreciated, instead of being mounted withincap551,lens560 could be integrally formed withcap551.)Distal end555 may be shaped to include adeflector561 for deflecting the flow of fluid fromlumen559 upwardly to washlens560.
• Device501 may further comprise astretchable sleeve571.Sleeve571, which may be made of a polyurethane film or a similarly suitable material, may comprise a proximal end and adistal end575. The proximal end may be positioned proximate to the distal end of the opening invalve521.Distal end575 may be positioned betweendistal end507 ofsheath503 and distal end ofcap551. The side wall577 ofsleeve571 conforms generally to the shape ofsheath503; however, because ofgroove511 and protrusions512-1 and512-2, aninstrument lumen581 is formed betweensleeve571 andsheath503.Lumen581 is aligned with the opening invalve521 and may be used to receivetissue modifying device19. Becausesleeve571 is stretchable,lumen581 may expand to accommodatedevice19.
• Device501 may be used in a fashion similar to that described above fordevice301.
• Alternate embodiments of a sheath cap that may be used in place ofsheath cap551 are shown inFIGS. 22 and 23 and are represented generally byreference numerals561 and563, respectively.
• Referring now toFIGS. 24 through 27, there are shown various views of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral601.
• Introducer device601, which may be used, for example, withvisualization device15,fluid supply device17 andtissue modifying device19, may comprise ahub603.Hub603, which may be fabricated from a rigid polymer or other suitable material, may be shaped to comprise aproximal end605, adistal end607 and aside wall609.Hub603 may additionally be shaped to comprise a plurality of lumens of fixed shape and size, such lumens including afirst lumen611, a second lumen613, and athird lumen615.First lumen611, second lumen613 andthird lumen615 may extend fromproximal end605 todistal end607, withthird lumen615 being positioned belowfirst lumen611 and with second lumen613 being positioned to the side offirst lumen611 andthird lumen615. As will be discussed further below,first lumen611 may be used as a scope lumen, second lumen613 may be used as an instrument lumen, andthird lumen615 may be used as a fluid lumen.
• Device601 may also include anelongated handle617 having anend618 secured tohub603.
• Device601 may further comprise a first Touhy-Borst valve621 and a second Touhy-Borst valve623, the distal end ofvalve621 being inserted into the proximal end offirst lumen611 and fixedly mounted therewithin, the distal end ofvalve623 being inserted into the proximal end of second lumen613 and fixedly mounted therewithin.Valve621 may be appropriately dimensioned forvisualization device15, andvalve623 may be appropriately dimensioned fortissue modifying device19.
• Device601 may further comprise a length offlexible tubing631.Tubing631, in turn, may comprise aproximal end635 and adistal end637.Proximal end635 oftubing631 may be fixed to the distal end of aluer connector639, anddistal end637 oftubing631 may be coupled to the proximal end oflumen615.Connector639 may be adapted for connection tofluid supply device17.
• Device601 may further comprise aflexible sheath641.Sheath641, which may be a unitary polyurethane extrusion or other suitable structure, may have the shape of an “8” and may comprise atop portion643 having alongitudinal lumen644 and abottom portion645 having alongitudinal lumen646.Sheath641 may be bifurcated at its proximal end, with the proximal end oftop portion643 being fixedly mounted withinlumen611 and with the proximal end ofbottom portion645 being fixedly mounted withinlumen615.
• Device601 may further comprise aflexible sleeve651.Sleeve651, which may be made of a polyurethane film or other suitable material, may be secured along one side thereof tosheath641, with theproximal end652 ofsleeve651 being coupled to lumen613 with atube653.Sleeve651 may include alumen656 adapted to receivedevice19 or the like.Sleeve651 may assume a collapsed state when unoccupied and an expanded state when occupied bydevice19 or the like.
• Device601 may be used in a fashion similar to that described above fordevice301.
• Becauselumen644 ofsheath641 may have an open distal end, a hysteroscope orother visualization device15 positioned withinlumen644 may be exposed to contaminants from a patient. To guard against the possibility of such contamination, it may be desirable to insertvisualization device15 in a protective device prior to its insertion intointroducer601. An example of such a protective device is shown inFIG. 28 and is represented generally byreference numeral671. As can be seen,device671 may comprise a tubular body conforming generally to the shape of a flexible hysteroscope. The tubular body, which may be made of polyurethane or a similar material, may include aproximal portion673 of comparatively greater diameter and adistal portion675 of comparatively lesser diameter. A seal orlens cover677, which may be made of polycarbonate or a similar material, may be mounted at the distal end ofdistal portion675.
• Referring now toFIGS. 29(a) and29(b), there are shown side and fragmentary end views of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral701.
• Device701 may comprise one or more sheets of a thin film that are welded or otherwise joined together to define atop lumen703 and abottom lumen705.Top lumen703 may be used to receive a scope within a sterile sleeve and may have diametrical clearance to permit the conduction of fluid, such as a saline flush, therethrough.Bottom lumen705 may be used to receive an instrument, such as a morcellator. The film may have a thickness of less than about 0.0025 inch so thatlumens703 and705 are easily collapsible when unoccupied.Top lumen703 andbottom lumen705 may be interconnected by aseam707 extending from the distal ends703-1 and705-1 oflumens703 and705, respectively, to anintermediate point709 distal to proximal ends703-2 and705-2 oflumens703 and705, respectively.Point709 may be, for example, approximately 25 cm from distal ends703-1 and705-1. In this manner,device701 may be shaped to include a unitary distal portion711 and a bifurcated proximal portion713. Astabilizer715 may be inserted over bifurcated proximal portion713. The overall height h₁ofdevice701 at its distal end may be no greater than about 5.5 mm to minimize the risk of injury to the patient and the need for anesthesia.
• Referring now toFIG. 30, there is shown an end view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral721.
• Device721 may comprise a unitary flexible sheath, which may be an extruded member made of a polymer or another suitable material.Device721 may be shaped to include a toplongitudinal lumen723 and a bottomlongitudinal lumen725.Lumen723 may have a relatively fixed size and shape and may be dimensioned to receive a centrally placed scope, as well as fluid delivery tubes on opposite sides of said scope.Lumen725 may have an expandable size and shape and may be adapted to receive an instrument, such as a morcellator. Whenlumens723 and725 are unoccupied,device721 may have a diameter of about 3 mm, andlumen723 may have a diameter of about 1.5 mm.
• Referring now toFIG. 31, there is shown a partly schematic, perspective view of a further alternate embodiment of an introducer device constructed according to the teachings of the present invention, the introducer device being represented generally byreference numeral751.
• Device751, which may be used in hysteroscopic examinations, may comprise aflexible sheath753.Sheath753, which may be a unitary extruded member or other suitable structure, may be shaped to include a firstlongitudinal lumen755, a secondlongitudinal lumen757, and a thirdlongitudinal lumen759.Lumen755 may be adapted to serve as a scope channel,lumen757 may be adapted to serve as fluid delivery channel, andlumen759 may be adapted to serve as a fluid removal channel.
• Device751 may further comprise a length oftubing761 and avalve763. The distal end oftubing761 may be inserted into the proximal end oflumen759 and may be fixed therewithin. The proximal end oftubing761 may be coupled to an inlet ofvalve763.Valve763 may be a pressure-actuated valve that is constructed so that fluid fromtubing761 will flow therethrough only when a threshold fluid pressure within the patient has been reached. In this manner, the outflow of fluid from the patient and, hence, the fluid pressure within the patient and the degree of uterine distension may be regulated. Fluid pressures of 30 mmHg to 100 mmHg are commonly used to distend the uterus during hysteroscopic gynecology exams. Therefore,valve763 may be designed for a pressure somewhere in this range.Valve763 may be a passively-controlled valve, such as a duckbill valve or a ball valve, or may be a valve whose actuating threshold pressure is adjustable.
• Becausedevice751 is designed specifically solely for observation and does not include a dedicated instrument channel,device751 may have a sufficiently small transverse cross-sectional profile to permit its insertion into a patient without requiring anesthesia.
• In many of the devices described above, a conventional flexible hysteroscope may be used for observation. Such a hysteroscope typically includes a plurality of light delivery fibers surrounding one or more optic fibers. When using such a hysteroscope in devices likedevice301, which may include a lens cap at the distal end of the observation lumen, there may be some undesired reflection of the illuminating light off the lens cap towards the optic fibers. Several of the embodiments discussed below may ameliorate this phenomenon by removing the light delivery fibers from the observation lumen with its lens cap and, instead, positioning these fibers in a separate lumen.
• Referring now toFIG. 32, there is shown a distal end view of one such embodiment of an introducer device constructed according to the above-described precepts, the introducer device being represented generally byreference numeral801.
• Device801 may comprise a unitaryflexible sheath803, which may be an extruded member made of a polymer or another suitable material.Sheath803, which may have a “tear-drop”-shape in transverse cross-section, may be shaped to include anobservation lumen805, a pair of fluid delivery lumens806-1 and806-2, a pair of light delivery lumens807-1 and807-2, and aninstrument lumen809. As can be appreciated, the sizes, shapes and relative locations oflumens805,806-1 and806,807-1 and807-2, and809 may be modified as desired. In addition, the transverse cross-section ofsheath803 may be modified as desired.
• Device801 may additionally comprise atransparent lens cap811, which may be mounted at the distal end ofobservation lumen805 to provide a fluid seal to protect the optic fibers (not shown) disposed withinlumen805.
• Device801 may further comprise a firstlight fiber bundle813 fixedly mounted within light delivery lumen807-1 and a secondlight fiber bundle813 fixedly mounted within light delivery lumen807-2. The distal ends ofbundles813 may lie flush with the distal end815 ofsheath803, and the proximal ends ofbundles813 may be coupled to a light source (not shown).
• As can be appreciated, becauselight fiber bundles813 are not positioned withinobservation lumen805, the above-described phenomenon of reflection offlens cap811 is amerliorated.
• Referring now toFIG. 33, there is shown a fragmentary longitudinal section view of the distal end of an alternate embodiment of an introducer device constructed in accordance with the teachings of the present invention, the introducer device being represented generally by reference numeral851.
• Device851, which may be used for hysteroscopic examinations, may comprise anelongated tube853, which may be made of stainless steel or a similarly suitable material. Alight fiber bundle855 may be fixedly mounted withintube853. (For simplicity, the individual fibers ofbundle855 are not shown inFIG. 33.)Bundle855 may comprise adistal end857 extending distally a short distance fromtube853.End857 may be rounded to facilitate its insertion through the cervix of a patient. (End857 may alternatively be shaped to other desired geometries.)Bundle855 may further comprise acentral lumen859 extending longitudinally fromdistal end857. Anoptic fiber861, which may be encapsulated within in aprotective cover862 having alens cap863 at its distal end, may be positioned withinlumen859. Anannular space865 may be formed betweenbundle855 and cover862, withspace865 being adapted for fluid inflow to a patient. Atube866, which may be made of plastic or another suitable material, may be inserted coaxially aroundtube853, with anannular space867 being formed betweentube866 andtube853,space867 being adapted for fluid outflow. Side holes869 may be provided intube866 near its distal end871 for passage of fluid outflow therethrough in the event that the distal end ofspace867 becomes clogged.
• Referring now toFIG. 34, there is shown a fragmentary side view, partly in section, of an alternate embodiment of an introducer device constructed in accordance with the teachings of the present invention, the introducer device being represented generally byreference numeral901.
• Device901, which may be used for hysteroscopic examinations, may comprise an elongated rigidouter tube903.Tube903 may comprise an openproximal end905, an opendistal end907, aside wall909, and alongitudinal lumen911.Distal end907 may be reduced in diameter relative toproximal end905.Side wall909 may be shaped to include afirst port913 and asecond port915,first port913 being located proximally relative tosecond port915.Side wall909 may also be shaped to include a plurality oftransverse openings917 located proximate todistal end907.
• Device901 may further comprise an elongated rigidinner tube921.Tube921 may comprise an openproximal end923, an opendistal end925, aside wall927, and alongitudinal lumen929.Proximal end923 may be outwardly flared relative to the remainder oftube921 and may be fixed to the interior surface ofwall909 oftube903 at a location betweenfirst port913 andsecond port915.Distal end925 of tube may be fixed todistal end907 oftube921. In this manner,first port913 may be used for fluid inflow, which may then pass distally throughtube921, whereassecond port915 may be used for fluid outflow that has enteredtube903 throughopenings917. Thedistal end931 of ascope933 may be passed through openproximal end905 oftube903 and then throughlumen929.
• The embodiments of the present invention described above are intended to be merely exemplary and those skilled in the art shall be able to make numerous variations and modifications to it without departing from the spirit of the present invention. All such variations and modifications are intended to be within the scope of the present invention as defined in the appended claims.

Claims (4)

1. A surgical access device for providing at least one auxiliary lumen for the insertion of a surgical instrument or other therapeutic device into a patients body, said surgical access device comprising:

a first channel providing a first lumen for the insertion of a surgical instrument with a rigid shaft;

a second channel providing a second lumen for the insertion of a flexible or semi-rigid visualization device; and

at least one other lumen for the installation of a distension media.

2. An access device as inclaim 1 wherein a distal tip comprises a flexible bumper tip to enable easy passage through a cervical os.

3. An access device as inclaim 1 wherein the visualization device comprises independent members for visualization and illumination.

4. An access device as inclaim 1 wherein the instrument channel is capable of sealing on an inserted instrument when inserted or providing an outflow channel without the instrument inserted.

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