US20140187866A1 - Biopsy inlet valve - Google Patents

Abstract

A valve apparatus device provides surgical instruments with sealable access to an inlet port of an endoscope instrument channel. The valve has a hollow body with a distal end that releasably attaches to the inlet port, and a flexible diaphragm seal dividing the body into a proximal chamber and a distal chamber. An instrument opening extends through the diaphragm seal for the passage of instruments therethrough, and connects the chambers together. The diaphragm seal is configured to seal with a surgical instrument inserted into the instrument opening. At least one fluid transfer member is provided to fluidly interconnect the proximal chamber to the distal chamber when the surgical instrument is sealed within the instrument opening.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application hereby claims the benefit of the provisional patent application of the same title, Ser. No. 61/383,777 filed on Sep. 17, 2010, the disclosure of which is hereby incorporated by reference in its entirety with the exception of formerly filed paragraphs [003]-[005].
FIELD OF THE APPARATUS
• The present apparatus relates, in general, to valves and to a biopsy inlet valve for use with the instrument channel inlet port of an endoscope
BACKGROUND
• Endoscopes are well-known in the art and are commonly used for numerous medical procedures that involve intubation of the esophagus and gastro-intestinal tract. As such, many devices and accessory instruments have been developed that relate to the operation of an endoscope. One such device well-known in the endoscopic art field is commonly referred to as a biopsy valve.
• A biopsy valve attaches to the instrument channel inlet port of an endoscope, and provides sealable access thereto. In the beginning of an exemplary endoscopic procedure, the biopsy valve is attached to the inlet of the accessory instrument channel to close off the channel, and the endoscope is then inserted into a body cavity or lumen of a patient. The body cavity or lumen is then insufflated by the endoscope to improve visualization and to provide a working space therein. In doing so, a positive pressure is created in the body and in the channel. The pressure is retained or held back by use of the attached biopsy valve. At least one opening within the biopsy valve is configured to expand and grip and seal around the accessory instrument shaft when instruments are inserted into the biopsy valve, and to squeegee liquids from the outer surface of the instrument as it is withdrawn. The at least one opening is configured to close when the instrument is removed to prevent insufflation loss.
BRIEF SUMMARY
• The apparatus overcomes the above-noted and other deficiencies of the prior art by providing a valve that provides a surgical instrument with sealed access to an inlet port of an endoscope instrument channel. The valve comprises a hollow tubular body having a distal end of the hollow configured to removably attach to the inlet port. A proximal end of the hollow is sealed with a removable cap. An internal wall separates the hollow into a proximal chamber and a distal chamber. A sealable instrument opening has a first portion extending through the cap, and a second portion extending through the wall for surgical instrument access to the inlet port through the valve. And, an interconnection member provides fluid communication between the proximal and distal chambers when the surgical instrument is sealed within the sealable instrument opening extending through the internal wall,
• In one aspect of the apparatus, a valve provides a surgical instrument with sealed access to an inlet port of an endoscope instrument channel. The valve comprises a hollow tubular body with a distal end of the hollow configured to removably attach to the inlet port. A flexible diaphragm having an instrument opening extending therethrough is positioned within the hollow to separate the hollow into a proximal chamber and a distal chamber that communicate through the instrument opening. The instrument opening is further configured to seal against the surgical instrument when the instrument is inserted therein. And, a pressure transfer member is configured to equalize pressure between the proximal and distal chambers when the instrument opening is sealed against the surgical instrument.
• In yet another aspect of the apparatus, a valve provides a surgical instrument with sealable access to an inlet port of an endoscope instrument channel. The valve comprises a hollow tubular body having a distal end of the hollow configured to removably attach to the inlet port. A flexible seal separates the hollow into a proximal chamber and a distal chamber, the flexible seal also having an instrument seal opening extending therethrough between the proximal and said distal chambers. At least one orifice connects the proximal chamber to the distal chamber. Wherein when at least one of the surgical instruments accesses the inlet port of the endoscope instrument channel through the valve, and the surgical instruments seals with the instrument seal opening, the at least one orifice provides fluid communication between said proximal and distal chambers.
• These and other objects and advantages of the present apparatus shall be made apparent from the accompanying drawings and the description thereof.
BRIEF DESCRIPTION OF THE FIGURES
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the improved biopsy valve apparatus, and, together with the general description of the improved biopsy valve given above, and the detailed description of the embodiments given below, serve to explain the principles of the present improved biopsy valve apparatus.
• FIG. 1 is a side view of an improved biopsy inlet valve shown attached to an instrument port of an endoscope ,with a cap of the biopsy valve in a closed position, and with a syringe and a surgical instrument poised for insertion into the biopsy valve;
• FIG. 2 is an isometric view of a proximal side of the valve ofFIG. 1 with the cap shown in an open position;
• FIG. 3 is an isometric view of a proximal end of the closed valve ofFIG. 1;
• FIG. 4 is a cross-sectional side view of the closed valve poised above an inlet port of the endoscope with a surgical instrument poised above the valve;
• FIG. 5 is a cross-sectional side view showing the closed valve installed on the inlet port of the endoscope with the surgical instrument extending through the valve and into the endoscope;
• FIG. 6 is an enlarged isometric view of the open cap shown inFIG. 2;
• FIG. 7 is a cross-sectional side view of a prior art valve attached to an endoscope showing a non-moving surgical instrument inserted through the valve and into the endoscope, and showing fluids within the prior art valve and endoscope;
• FIG. 8 is a cross-sectional view of the prior art valve ofFIG. 7 showing the surgical instrument moving upwards to evert a diaphragm seal of the valve, and showing fluids drawn upwards by the everted diaphragm seal;
• FIG. 9 is a cross-sectional side view of the valve and endoscope ofFIG. 1 showing a non-moving surgical instrument inserted therein and showing fluids draining down towards the endoscope , the fluids moving from a distal chamber to a proximal chamber of the valve through one or more an orifices connecting the chambers;
• FIG. 10 is a cross-sectional side view of the valve ofFIG. 9 showing an upwards moving surgical instrument everting the diaphragm seal which drained the fluids from the upper chamber into the lower chamber to maintain a constant pressure between the proximal and distal chambers of the valve;
• FIG. 11 is an isometric proximal view of an alternate embodiment of a valve having a flat diaphragm seal; and
• FIG. 12 is an isometric distal view of the valve ofFIG. 11.
DETAILED DESCRIPTION
• The following description of certain examples of the apparatus should not be used to limit the scope of the present apparatus. Other examples, features, aspects, embodiments, and advantages of the apparatus will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the apparatus. As will be realized, the apparatus is capable of other different and obvious aspects, all without departing from the spirit of the apparatus. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. Indeed, the invention as described by the claims is broader than and unlimited by the preferred embodiments, and the terms in the claims have their full ordinary meaning.
• FIG. 1 is a side view showing abiopsy valve30 of the present apparatus attached onto aninstrument inlet port22 of a partially cross sectionedendoscope20.Biopsy valve30 provides access to theinstrument inlet port22 through a sealedinstrument passage32 extending throughvalve30 along an axis “A” to provide passage to the sealedinstrument passage32. Theinlet port22 operably connects to aninstrument channel24 that extends through theendoscope20 from theinlet port22 to the surgical site. One or moresurgical instruments100 can access the surgical site through thebiopsy valve30 by being inserted into theinlet port22 and into theinstrument channel24. Othersurgical instruments100 such as amedical device104 or a saline filledsyringe102 can be inserted into theinstrument passage32 for tasks such tissue resection or washing theinstrument channel24, respectively.Multiple instruments100 such as a guide wire and a cannula can be simultaneously inserted into the improvedbiopsy valve30.
• Thevalve30 is highly adaptable for use to seal off theinlet port22, and to allow access by aninstrument100, or for irrigation of the endoscope instrument channel. It should be understood by those with ordinary skill in the art that a wide variety ofendoscopic instruments100 can be used in the practice of the present apparatus, such as for example, snares, retrieval nets or forceps. It should also be understood by those with ordinary skill in the art that a wide variety of irrigation sources can be used in the practice of the present invention, such as for example liquid filled syringes, electrical fluid pump devices, and manual or foot actuated liquid pump devices.
• FIGS. 1-4 show thebiopsy valve30 of the present apparatus.Biopsy valve30 comprises a generallycylindrical body34 connected to aflip cap36 by astrap38.Flip cap36 can be in an open position shown inFIG. 2, or can removably seal to thebody34 in a closed position as shown inFIGS. 1,3, and4.Body34,flip cap36, andstrap38 can be integrally molded, or assembled from a plurality of parts, and can be formed from one or more materials. These materials can include but are not limited to one or more of a rubber or an elastomeric material such as a thermoplastic elastomer (TPE), flexible plastic, rigid plastics, rigid materials such as metals, rubbers, or combinations thereof. As shown inFIG. 3,closed flip cap36 is configured to removably seal against a proximal end40 (FIG. 2) of thebody34, and is held in this closed position by the locking engagement of theflip cap36 with thebody34. Thebiopsy valve30 can be used with theflip cap36 in the open or closed position, and can seal with small and larger shaft sizes of theinstrument100.Instrument passage32 extends through thevalve30 in the open or the closed cap position, and provides passage for instruments therethrough.Instrument passage32 extends throughbody34 when theflip cap36 is open, and extends through bothflip cap36 andbody34 when theflip cap36 is closed.
• Turning toFIG. 2, thevalve30 is shown in an open position and a self closing slit46 can be seen extending through anelastomeric floor47 of theflip cap36. Theslit46 moves into position to align with theinstrument passage32 when theflip cap36 is moved into the closed position.Slit46 permits the insertion ofvarious devices100 into thecap36 and further into theinstrument passage32, such as for example, a guidewire, needles, and irrigation tubes.Slit46 creates a pressure tight seal with theinstruments100.Body34 can include adiaphragm seal54 that defines a hollow of the valve as aproximal chamber48 recessed below theproximal end40 of thebody34 and as a distal chamber50 (FIG. 4) below thediaphragm seal54.Proximal chamber48 may include acircular body slot44 configured to lock with acircular cap rib42 extending fromcap36.Diaphragm seal54 can define a floor for theproximal chamber48, and a recessed ceiling for thedistal chamber50. Thediaphragm seal54 is flexible to receive instruments therethrough, and in embodiments, can be uniformly spaced about a longitudinal axis extending through the biopsy valve.
• Whereas thediaphragm seal54 inFIG. 2 is shown as a conical diaphragm, thediaphragm seal54 of the present apparatus is not limited thereto but can be any other shape such as, for example, aflat diaphragm254 as shown inFIGS. 11 and 12 which will be discussed later. InFIG. 2, aninstrument opening52 extends centrally through the distal most portion of theconical diaphragm seal54 to communicate with thedistal chamber50 located below the conical diaphragm seal54 (FIG. 4). When theflip cap36 is open, large diameter insertedinstruments100 can pass through instrument opening52 to seal against theconical diaphragm seal54, or when theflip cap36 is closed, can seal with bothdiaphragm seal54 and the self closing slit46 in theflip cap36. Closing theflip cap36 allows smaller diameter instruments to seal with theslit36 rather than with the instrument opening52 ofdiaphragm seal54. Theconical diaphragm seal54 and the self closing slit46 within thefloor47 can be constructed from an elastomeric or flexible material that is normally biased to a home position shown inFIG. 4, and can return to the position ofFIG. 4 after a deflection.
• For example, if a distal or proximal force is applied to theconical diaphragm seal54, theseal54 can move distal or proximal from the normal conical position in response to the force. Once the biasing force is removed, theconical diaphragm seal54 will return to the normal position unless blocked.
• At least oneorifice64 or member can be provided to connect theproximal chamber48 to thedistal chamber50 to provide fluid communication therebetween. A fluid280 can be agas80, anincompressible liquid180, or a combination thereof, and can include body fluids such as blood, mucous, small particles of solids or semi-solids, and the like. In the exemplary embodiment shown inFIGS. 2,4,5,9, and10, the at least oneorifice64 can extend through theconical diaphragm seal54 to interconnect the proximal anddistal chambers48,50, and to transfer fluids betweenchambers48,50 in response to movement of theconical diaphragm seal54.
• At least oneorifice64 or member is not limited to the design shown inFIGS. 2,4,5,9, and10. In another alternate exemplary embodiment of theorifice64, the orifice can extend through thebody34 rather than theseal54 to connect the proximal anddistal chambers48,50 (not shown). In yet another alternate embodiment,orifice64 can extend through a pipe or other connection member that communicates between the proximal and distal chambers,48,50 (not shown). Alternately, theexemplary orifice64 can extend through thebody34, or connectchambers48,50 together in any other manner through any other part or features. The number oforifices64 extending through theconical diaphragm seal54 can vary, and can be more than one. Theorifice64 can be placed in any orientation and spacing as long as there is at least one. The at least oneorifice64 can be any size or shape, and can include at least one arcuate portion, a straight portion or an irregular portion thereof. For example, all or part oforifice64 can be round, oval, square, triangular, hexagonal, arcuate, regular, irregular, a slit, or any other shape. Theorifice64 can be uniform or non-uniform along a length thereof and the sides oforifice64 can be smooth, irregular, stepped, tapered, or arcuate.Orifice64 can have an axis (not shown) extending between the proximal and distal ends of theorifice64, and the axis of theorifice64 can be straight, skewed, curved, spiraled, stepped and the like along the length thereof, and the axis can be parallel or non-parallel to the longitudinal axis ofbody34.Orifice64 can remain normally open such as a fixed diameter hole, or can open and close like a valve. Anexemplary orifice64 that functions as a valve is well within in the spirit of the apparatus, and examples thereof can comprise but are not limited to a slit cut into theconical diaphragm seal54 to act as a pressure valve, or a duck billed valve (not shown) that is recessed into or protrudes from thediaphragm seal54. Theorifice64 of the present apparatus can be any size or shape, and in an exemplary embodiment thereof,orifice64 can be circular with a diameter between about 0.006 inches to about 0.10 inches. Alternately, in another exemplary embodiment,circular orifice64 can have a diameter between about 0.010 inches to about 0.040 inches. And in yet another exemplary embodiment,circular orifice64 has a diameter between about 0.020 inches to about 0.030 inches.
• As shown in at leastFIG. 2, at least oneorifice64 can be three orifices equally spaced around theconical diaphragm seal54 and inFIG. 2, two of the three exemplary orifices can be seen. A step can be placed within the sectionedorifice64 as shown in at leastFIGS. 4 and 5. One exemplary use of the at least oneorifice64 is to equalize fluid pressure between theproximal chamber48 anddistal chamber50. It is of note that when thevalve30 is on theendoscope20, the at least oneorifice64 can equalize pressure between the proximal and thedistal chambers48,50 when thecap36 is open (FIG. 2) or closed (FIG. 3). The advantages of the at least oneorifice64 will be discussed in greater detail below.
• As best shown inFIG. 3, thefloor47 is recessed into a top of theflip cap36 and is surrounded by a taperedguide surface58. The taper of theguide surface58 assists the operator during surgery by guidingsurgical instrument100 into the center of theflip cap36, and into theslit46 of theinstrument opening52. Agrip tab60 extends from theflip cap36 and is configured to be grasped between an operators thumb and index finger. Pulling on thegrip tab60 releases flipcap36 fromcylindrical body34 and moves the flip cap to the open position ofFIG. 2.
• FIG. 4 is a cross section of abiopsy valve30 with theflip cap36 closed. The biopsy valve is shown moving down towards theinlet port22 of theendoscope20 to attach thereto. Asurgical instrument100 is poised to enter theinstrument passage32 of thebiopsy valve30 oncevalve30 is releasably secured onto theinlet port22. As shown inFIG. 4, when theflip cap36 is closed,instrument passage32 comprises theslit46 extending throughflip cap36, aproximal chamber48 inbody34, thedistal chamber50 inbody34, and the instrument opening52 connectingproximal chamber48 todistal chambers50. In the cross sectional view, it can be seen that theconical diaphragm seal54 further comprises aring seal56 that extends distally intoproximal chamber48 with circular instrument opening52 extending therethrough.Ring seal56 provides greater sealing area, increased tear resistance, and is configured to seal withsurgical instruments100 having a circular diameter about equal to or larger than theopening52.Ring seal56 is designed to allowinstrument100 to slip therethrough while maintaining a seal therewith, but in certain conditions, thering seal56 can grip the shaft of aninstrument100 tightly before slipping and can move theconical diaphragm seal54 in the direction of movement of theinstrument100.
• InFIG. 4, theconical diaphragm seal54 can be seen separating a hollow bore of thebody34 into aproximal chamber48 and adistal chamber50.Distal chamber50 can further comprise at least oneattachment member62 such as a groove configured to releasably secure thebiopsy valve30 to theinstrument inlet port22. At least oneorifice64 can be seen extending longitudinally throughconical diaphragm seal54 to interconnect the proximal anddistal chambers48,50. The exemplary at least oneorifice64 will be discussed in greater detail below.
• FIG. 5 shows thebiopsy valve30 releasably attached to theinlet port22 of theendoscope20 to create a seal therewith.Surgical instrument100 is shown inserted into thebiopsy valve30, and into theinlet port22 of theendoscope20. Theinstrument inlet port22 is shown received into thedistal chamber50 of thebody34 where theattachment feature62 is releasably gripping theinstrument inlet port22. The insertion ofsurgical instrument100 creates a pressure tight seal with the self closing slit46 of theinstrument passage32. Thesurgical instrument100 extends downward throughproximal chamber48 of thebody34, through the circular instrument opening52 inconical diaphragm seal54, and into the proximaldistal chamber50.Ring seal56 grips and seals with the shaft ofsurgical instrument100 as it passes through theinstrument opening52. Bothring seal56 and slit46 are configured to squeegee the shaft of thesurgical instrument100. The exemplary at least oneorifice64 is shown connectingproximal chamber48 withdistal chamber50 even wheninstrument100 is inserted as shown.
• FIG. 6 shows an enlarged view of a distal side of theflip cap36 to illustrate an exemplary feature thereof.Flip cap36 is connected toflexible strap38. InFIG. 6, acylindrical cap ring68 extends upwards fromflip cap36 withcap rib42 extending radially in a ring outward therefrom. A distal side of the recessedfloor47 can be seen surrounded bycap ring68 withslit46 centrally located therein. A pair ofreinforcement members70 flank slit46 with each end ofslit46 adjacent to amember70.Reinforcement members70 provide two exemplary functions. First,reinforcement members70 are placed adjacent to each end of theslit46 to reduce the risk of a crack or tear propagating across thefloor47 from an instrument insertion. When aninstrument100 is inserted therein, theslit46 expands and creates high stress concentrations at each end of theslit46. Thereinforcement members70 advantageously provide extra material at the highly stressed ends of theslit46, and the extra material spreads out the high stress concentrations. Thus,reinforcement members70 dilute higher stress values to lower stress values and reduce the chances of tearing theslit46.Reinforcement members70 can also be extended across thefloor47 to have a second exemplary function in that they stiffen the recessedfloor47. Stiffening thefloor47 with stiffeners (aka reinforcement members70) reduces up and down oil canning deflections of thefloor47 from asurgical instrument100 being pushed into or pulled from theslit46, and helps ensure that the two surfaces on either side of theslit46 return to the same plane as the remainder of thefloor47 to reduce a potential leak path.
• FIGS. 7 and 8 show a priorart biopsy valve130 attached to theinstrument inlet port22 of anendoscope20 during a surgery. At the beginning of a surgery, some surgeons place a small amount of saline or fluid at the entrance of the valve to “wet” the instrument shaft as it passes through the valve. The wetted shaft lubricates the seal as it passes, and reduces the force required to insert or withdraw the instrument. Fluids can be carried through a seal with a moving wet shaft. During a surgery, the physician's view of the internal work site can be clouded by blood, mucous, or fecal matter necessitating removal of an inserted instrument, and a cleansing application of a water spray down the instrument channel of the scope. When an instrument is re-inserted into the channel, the cleansing water spray or various body fluids can ooze from the surgical work site into a narrow gap between an exterior of the instrument and the instrument channel via capillary action. These fluids can then be pushed towards the biopsy valve by internal insufflation pressures, or by being carried along into theendoscope20 by a withdrawing instrument shaft. Additionally, if the biopsy valve has adiaphragm seal154, theflexible diaphragm seal154 can a pumping action can be created by an outward “oil can” movement of the flexible diaphragm. In some cases, thediaphragm seal154 can evert outward as shown inFIG. 8. It is believed that when the everteddiaphragm seal154 is released by the withdrawn instrument, thediaphragm154 may snap inward towards the original “at rest” position ofFIG. 7. The snap return movement of thediaphragm seal154 may impact or push on the pooledfluids80,180 within, and create higher fluid pressure at biopsy valve seals147,154.
• FIGS. 7 and 8 show the behavior of a priorart biopsy valve130 during use, particularly in the control of agas80 and a liquid180. Priorart biopsy valve130 is intended to be exemplary in nature and is not limited to the depicted shape or configuration shown. The priorart biopsy valve130 comprises aprior body134 with aremovable cap136. A priorproximal chamber148 and a priordistal chamber150 are separated by aprior diaphragm seal154 withinbody134. Aprior opening152 extends through a center of theprior diaphragm seal154 and a priorannular seal156 can be formed with or aroundopening152. InFIGS. 7 and 8, opening152 is show sealed around aninstrument100 inserted through priorart biopsy valve130 and intoinlet port22 ofendoscope20. Once theinstrument100 forms a seal withprior diaphragm seal154, the priorproximal chamber148 and a priordistal chamber150 are separate chambers that cannot communicate. Pressure differentials can be created therebetween as theinstrument100 moves in and out ofendoscope20 in response to surgeon manipulation. This motion deflects theprior diaphragm seal154 of the priorart biopsy valve130. Theprior diaphragm seal154 is constructed at least in part from an elastomeric material, is normally biased to the position shown inFIG. 7, and will return to the normal position after deflection. Aprior slit146 extends through aprior floor147 of theremovable cap136 and slit146 is shown held open by the shaft ofinstrument100. Theprior floor147 is also constructed at least in part from an elastomeric material and has a normally cupped position shown inFIG. 7 when the shaft ofinstrument100 is at rest. InFIG. 8 the shaft is moving upwards.Liquids180 are shown pooled within theinlet port22 and in thebiopsy valve130 and all spaces within the priorart biopsy valve130 that are not filled withliquids180 are filled withgas80.
• During the course of the surgery shown inFIGS. 7 and 8, varioussurgical instruments100 have been inserted and removed through the priorart biopsy valve130, and several saline washes have been applied to rinse theinstrument channel24 of the endoscope. As shown inFIG. 7, the saline and body fluids within the patient and endoscope have formed the liquid180 which has migrated during surgery from the up and down movement of theinstrument100 to create a pool within theinlet port22 and within the priorart biopsy valve130. This upwards migration can be caused by insufflation pressure within the patient, and by upward movement of the instrument shaft, A pool ofliquid180 has risen to be within the prior distal chamber140 and is just below contact with a distal portion of adiaphragm seal154 of the prior artdevice biopsy seal130. A small amount ofliquid180 has puddled within theproximal chamber148 from movement of awet instrument shaft100. The liquid180 is trapped within theproximal chamber148 until theinstrument100 is removed, at which point the liquid180 can drain into the pool ofliquid180 below through a centralprior opening152 indiaphragm seal154.
• InFIG. 8, the surgeon is rapidly removing thesurgical instrument100 from theendoscope20 and the priorart biopsy valve130, and the rapid upward movement has drawn more liquid180 along with the shaft ofinstrument100 and into thedistal chamber150. The rapid withdrawing motion ofsurgical instrument100 has also everted the conically shapeddiaphragm seal154 and bowed theprior floor147 upward as shown. The everteddiaphragm seal154 has decreased the volume of the sealedproximal chamber148, increased the pressure therein, and moved theliquids80 trapped within closer to the upward bowingprior slit146.
• The upward movement and eversion ofprior diaphragm seal154 can create a suction to convert theseal154 into a diaphragm pump that can draw additional liquid180 upward. InFIG. 6 the normal at rest position of thediaphragm seal154 is shown as an upside down cone (dashed outline), and the new everted position ofdiaphragm seal154 is a right side up cone. A double conic volume ofliquid180 equal to the difference between those two conical positions can be sucked upwards towards or into theprior biopsy valve130.
• InFIG. 8, the shaft ofinstrument100 is moving upward and is nearly ready to be released from the cylindrical priorannual seal156. When theinstrument shaft100 moves upwards an amount sufficient to disengage from the everteddiaphragm seal154, the everteddiaphragm seal154 is free to revert back to the normal non-everted cone shape ofFIG. 5. As thediaphragm seal154 snaps or returns to the normal position, pressure is applied onto the liquid180 captured within the distal chamber, and the liquid180 water flows or jets into theproximal chamber148 through the centralprior opening152 within the diaphragm seal154 (not shown). As the shaft ofinstrument100 exits theprior slit146 of theremovable cap136, the upwardly bowedprior floor147 snaps back to the normal horizontal position shown inFIG. 5 (not shown).
• FIGS. 9 and 10 show how thepresent biopsy valve130 with at least oneorifice66 offers unexpected fluid handling improvements over the prior art designs. InFIG. 9, theimproved biopsy valve30 is shown attached to theinlet port22 of theendoscope20 with thesurgical instrument100 inserted therein to access a surgical site through aninstrument channel24 ofendoscope20. During the surgery, liquid180 comprising saline and body fluids have migrated to pool in theinlet port22 below theimproved biopsy valve130. The liquid180 has migrated to that position from a combination of surgical site insufflation pressure, and from fluids carried along with movement of the shaft ofinstrument100 within theendoscope20.Liquid180 has been carried into theproximal chamber48 by the movement of the wet shaft of theinstrument100 and has pooled in theconical diaphragm seal54. The liquid180 has risen in theconical diaphragm seal54 until the liquid180 reaches a bottom edge of one or more orifices64. Once that occurs, anyadditional liquid180 within the cone will flow downward throughorifices64, into thedistal chamber50, and into theinlet port22. InFIG. 9, theexcess liquid180 is shown flowing down theleftmost orifice64 and is moving from theproximal chamber48 and into thedistal chamber50. Should theinstrument100 move upward,conical diaphragm seal54 will deflect upwards into theproximal chamber48, pressurize the upper orproximal chamber48, and forcefluids180 and/orgas80 into theorifice64 and into thedistal chamber50 until chamber pressures match. Should theconical diaphragm seal54 of this description move downward into thedistal chamber50,gas80 will migrate intoproximal chamber48 to equalize pressures. Thus, at least oneorifice64 can act as a pressure control valve or member to equalize pressure differentials between the proximal anddistal chambers48,50, and provide passage of fluids such asliquids180 and/orgas80 therebetween.
• FIG. 10 shows theinstrument100 being rapidly withdrawn from theimproved biopsy valve30.Conical diaphragm seal54 has moved upwards into theproximal chamber48 to increase the pressure therein, forcingliquids80 to drain into thedistal chamber50 and then intoinlet port22. In this view, the proximal anddistal chambers48,50 are equally pressurized withgas80. It is of note that unlike the prior art device, the placement oforifices64 into theconical diaphragm seal54 convert the upwardly moving and everting conical diaphragm seal from a diaphragm pump to a chamber pressure equalizer. Once theinstrument100 moves out of the instrument opening52, theconical diaphragm seal54 snaps or moves from the everted position ofFIG. 10 to the normal conical shape ofFIG. 9 andgas80 shifts from thedistal chamber50 to theproximal chamber48 throughorifices64 and instrument opening52 until pressures are equal. The reader is advised to note thatliquids80 are not involved in this process and have been moved away from the movingconical diaphragm seal54 by the inclusion oforifices64 therein.
• An additional advantage of theimproved biopsy valve30 is that theorifices64 have been observed to work as drains. For example, when theimproved biopsy valve30 is placed on anendoscope20 with theflip cap36 open, the addition ofliquid180 around an insertedinstrument100 was observed to drain into theorifices64 and not towards the operator.
• Likewise, an additional advantage of theimproved biopsy valve30 was observed when suction was applied to theendoscope20 with asurgical instrument100 inserted therein. While suction is primarily directed to a distal end of theendoscope20 to enhance the procedure being performed, if thecap36 of thevalve30 is open, the suction can create a negative pressure on theinstrument channel24 and on the at least oneorifice64, and can suck fluids back down thechannel24 and away from the user.
• Another advantage of theimproved biopsy valve30 is that the area of the openings extending through theconical diaphragm seal54 is increased beyond the instrument opening52 by the addition of theorifices64. With prior art designs, the area of the openings through thebiopsy valve130 is limited by the diameter or area of theprior opening152 extending through a center of theprior diaphragm seal154. With theimproved biopsy valve30, the increased area of the openings results in higher volume of fluid flow through theimproved biopsy valve30, and provides improved pressure washing of theendoscope20.
• Another alternate exemplary embodiment of the present apparatus is shown inFIGS. 10 and 11 wherebiopsy valve230 has aflat diaphragm seal254. Theflat diaphragm seal254 separates thebiopsy valve230 into an interior proximal chamber248 (FIG. 11) and a distal chamber250 (FIG. 12). A central instrument opening252 extends throughflat diaphragm seal254 for passage of an instrument therethrough. At least oneorifice264 extends throughflat diaphragm seal254 to equalize fluid pressure interiorproximal chamber248 anddistal chamber250 when an instrument is sealed withincentral instrument opening252. This pressure equalization process via one ormore orifices264 is described above.Biopsy valve230 also comprises abody248, aflip cap236, and astrap238 extending therebetween. A slit266 extends throughflip cap236 for instrument passage and sealing.FIG. 12 shows a bottom view of thebiopsy valve230 to show theflat diaphragm seal254 forming a ceiling of thedistal chamber250.
• An optional embodiment ofribs275 can be added to theflat diaphragm seal254 for additional stiffness.Rib members275 can reduce proximal and distal deflection of theflat diaphragm seal254. Stiffenermembers275 are not limited to ribs, but can be any shape or member that reduces deflection of thediaphragm seal254.Ribs275 are shown on the distal side of thediaphragm seal254, but can be formed or attached to either side thereof. Stiffenermembers275 can be used singly or in combination with theorifices64, and in exemplary embodiments, can comprise one or more ribs attached to a conical (not shown) or flat diaphragm seal254 (FIG. 12). The ribs, orstiffener members275, can extend radially outward along thediaphragm seal254 from a ring seal256 towards thebody234.
• Alternately, in other embodiments, theflat diaphragm seal254 can be domed, rectangular, pyramidal or any other shape.
• It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
• While the present improved biopsy valve apparatus has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.
• For example, thebody30 can be formed all or in part from a non-elastomeric material such as a rigid plastic, a deformable plastic, or a generally rigid plastic molded in sufficient thinness to act as a flexible plastic.

Claims (21)

What is claimed is:

1-21. (canceled)

22. A valve for providing access to an inlet port of an endoscope, the valve comprising:

a tubular body having a distal end and a proximal end, the distal end configured to removably attach to the inlet port;

an internal wall separating the tubular body into a proximal chamber and a distal chamber;

a sealable opening extending through the internal wall; and

a passage between the proximal chamber and the distal chamber and remote from the sealable opening.

23. The valve ofclaim 22 wherein at least a portion of the internal wall is deflectable in the proximal direction.

24. The valve ofclaim 22 wherein at least a portion of the internal wall is deflectable in the distal direction.

25. The valve ofclaim 22 wherein the internal wall is a flat disk.

26. The valve ofclaim 22 wherein the internal wail is a tapered cone.

27. The valve ofclaim 22 wherein the tapered cone is tapered in the distal direction.

28. The valve ofclaim 22 wherein the sealable opening is a slit.

29. The valve ofclaim 28 comprising at least one reinforcement member adjacent to an end of the slit.

30. The valve ofclaim 29 wherein the at least one reinforcement member is configured to reduce crack propagation from the end of the slit.

31. The valve ofclaim 22 wherein the internal wall comprises a ring seal around the sealable opening.

32. The valve ofclaim 22 wherein the internal wall comprises at least one stiffening rib thereon to reduce deflection of the internal wall.

33. The valve ofclaim 22 wherein at least a portion of the valve is formed from an elastomeric material.

34. A valve for providing an instrument with sealable access to an inlet port of an endoscope instrument channel, the valve comprising:

a tubular body;

a flexible diaphragm having an opening extending therethrough and positioned within the tubular body to separate the tubular body into a proximal chamber and a distal chamber, the opening further configured to seal against an instrument when the instrument is inserted therein; and

a pressure transfer member configured to equalize pressure between the proximal chamber and the distal chamber when the opening is sealed.

35. The valve ofclaim 34 wherein the pressure transfer member is a passage communicating between the proximal chamber and the distal chamber and independent from the instrument opening.

36. The valve ofclaim 34 wherein at least a portion of the pressure transfer member is arcuate.

37. The valve ofclaim 34 wherein at least a portion of the pressure transfer member is straight.

38. A valve for providing an instrument with sealable access to an inlet port of an endoscope, the valve comprising:

a tubular body having a distal end, the distal end configured to removably attach to the inlet port;

a flexible seal separating the tubular body into a proximal chamber and a distal chamber, the flexible seal having an instrument opening extending therethrough and between the proximal chamber and the distal chamber;

at least one orifice connecting the proximal chamber and the distal chamber;

wherein the at least one orifice is open when the flexible seal is closed.

39. The valve ofclaim 38 wherein the at least one orifice connecting the proximal chamber and the distal chamber extends through the flexible seal.

40. The valve ofclaim 38 wherein the flexible seal comprises a plurality of orifices.

41. The valve ofclaim 38 wherein the instrument opening is centrally located within the flexible seal, and the flexible seal comprises three orifices equally spaced around the instrument opening.

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