Patent ID: 12226589

Reference is made in the following detailed description to accompanying drawings, which form a part hereof, wherein like numerals may designate like parts throughout to indicate corresponding and/or analogous components. It will be appreciated that components illustrated in the figures have not necessarily been drawn to scale, such as for simplicity and/or clarity of illustration. For example, dimensions of some components may be exaggerated relative to other components. Further, it is to be understood that other embodiments may be utilized. Furthermore, structural and/or other changes may be made without departing from claimed subject matter. It should also be noted that directions and/or references, for example, up, down, top, bottom, and so on, may be used to facilitate discussion of drawings and/or are not intended to restrict application of claimed subject matter. Therefore, the following detailed description is not to be taken to limit claimed subject matter and/or equivalents.

3. Detailed Description

Reference throughout this specification to “one example,” “one feature,” “one embodiment,” “an example,” “a feature,” “an implementation,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the feature, example, or embodiment is included in at least one feature, example, or embodiment of claimed subject matter. Thus, appearances of the phrase “in one example,” “an example,” “in one implementation,” “an implementation,” “an embodiment,” or “in one embodiment” in various places throughout this specification are not necessarily all referring to the same feature, example, or embodiment. Particular features, structures, or characteristics may be combined in one or more examples, features, or embodiments. The term “patient” and “individual” may be used interchangeably herein. The terms “duct,” “ostium,” “opening,” and “orifice,” as used herein, may comprise an opening into a vessel and/or cavity of the body. It should be noted that although significant portions of the description of embodiments may be directed toward removal of a stone or other object lodged within a bile duct, embodiments are not limited to such uses, and claimed subject matter is intended to embrace various applications such as those involving other portions of the alimentary canal, other orifices and structures of a human patient, orifices and structures of an animal patient, intricate mechanical assemblies and/or structures, or any combination thereof.

A multi-lumen shaft may be used to form a removal device that may be operated in association with an endoscopic instrument to assist in removing an object, such as a stone lodged in one or more bile ducts, for example, from an individual. A stone or other object may be dislodged from a bile duct, for example, by urging the object toward an ostium or other opening, which may permit the object to pass through the opening and into the duodenum, for example. Responsive to entry into the duodenum, the object may be may be disposed of via normal discharge of solid waste from the human body, for example. Subsequent to entry of the object into the duodenum, the removal device may be stowed within an endoscopic instrument and the endoscopic instrument may be withdrawn from the body through the alimentary canal, for example.

A removal device, which may comprise a thermoplastic polyurethane expandable vessel, may be coupled to a polyurethane multi-lumen shaft, for example. A removal device may be conveyed through a working channel of an endoscopic instrument if an endoscopic device is appropriately positioned within a body cavity. A camera located at a distal end portion of an endoscopic instrument may be employed to provide imagery to a surgeon, for example, to inform the surgeon that a distal portion of an endoscopic instrument may be in position to deploy a removal device. A guide wire may be extended from the endoscopic device and advanced through an ostium, such as the hepatopancreatic ampulla. A multi-lumen shaft, which may comprise a polyurethane material, coupled to the guide wire may follow the inserted guide wire through an ostium, for example, and advanced to a location nearby a stone or other object to be removed. Contrast dye, which may be visible through a radioimaging device (i.e., x-ray machine, computer aided tomographic scanner, or the like) may be released from a multi-lumen shaft positioned proximate with an expandable vessel and may assist a surgeon in determining an approximate location of an object to be removed. At an appropriate time, a multi-lumen shaft may dispense a fluid under sufficient pressure to increase volume of an expandable vessel until the expandable vessel approaches a threshold volume. The expandable vessel may then be urged toward an ostium, in a manner that pushes the stone or other object through the ostium.

In embodiments, a multi-lumen shaft may be coupled to a thermoplastic urethane expandable vessel, for example, by way of a thermoplastic welding process. In embodiments, a thermoplastic welding process may give rise to fusing an expandable vessel to a cylinder-shaped polyurethane shaft at one or more circumferential locations of the shaft. Accordingly, an expandable vessel may be unlikely to separate from a polyurethane shaft thereby enhancing ease of removal of a stone or other object from an orifice.

Embodiments may represent a significant performance increase over conventional latex-based expandable vessels adhered to a multi-lumen shaft, for example. Latex-based vessels, for example, may be prone to breakage, leakage, and/or separation from a shaft to which a latex-based vessel may be attached. In particular conventional implementations, latex-based vessels may be affixed to a shaft using an adhesive. However, in many instances, an adhesive may not possess sufficient bond strength to resist shear and/or other stresses that may be encountered during inflation, and/or removal of objects from body orifices, for example. In response to breakage, leakage, and/or separation, which may occur in association with conventional stone or object removal procedures, a shaft and severed latex vessel may require removal from a patient so that another attempt at stone or other object removal may be performed.

Often, removal of a shaft may involve drawing of the shaft in a proximal direction through a working channel of an endoscopic device so that a new shaft and expandable vessel can be reinserted and advanced distally and into a patient's alimentary canal. The shaft and latex-based expandable vessel may be repositioned in an individual's alimentary canal and the object removal process may be reattempted. In many instances, this may give rise to an undesirable increase in surgeon and support staff time, an increase in equipment costs, and an increase patient discomfort. Accordingly, embodiments represented by claimed subject matter, which may involve use of a thermoplastic polyurethane inflatable vessel fused to a polyurethane multi-lumen shaft may represent an advantage over conventional processes by decreasing likelihood of breakage or separation, for example, of an expandable vessel. This may, in turn, reduce surgeon and support staff time, decrease equipment costs, and so forth.

A multi-lumen shaft coupled to an expandable vessel comprising material other than latex may also benefit healthcare workers, such as surgeons and support staff, involved in endoscopic procedures. For example, if an endoscopic surgeon or other individual involved in endoscopic procedures suffers from an allergy to latex, the individual may employ material handling practices to reduce exposure to latex-based materials. Further, patients who suffer from latex allergies may also experience inflammation and/or additional undesirable consequences in response to exposure to latex-based expandable vessels. Accordingly, use of medical implements coupled to thermoplastic polyurethanes, for example, may represent a means of avoiding such exposure, which may reduce undesirable consequences associated with exposure latex-based expandable vessels, for example.

A multi-lumen shaft may comprise a polyurethane material and one or more output ports for dispensing fluoroscopic contrast dye, which may permit a surgeon, radiologist, or other healthcare professional, for example, to observe areas proximate with an object to be removed. Observation of areas proximate with an object to be removed may be permitted, for example, by way of a fluoroscopic imaging device, such as an x-ray machine, computer aided tomography scanner, or the like. Dispensed contrast dye may also enable a surgeon, radiologist, or other healthcare professional to observe structures nearby an object to be removed, such as, for example, a biliary tree that may be distal from a stone or other object lodged in a bile duct.

In an embodiment, a shaft for use with an endoscopic instrument may comprise four lumens, which may be used to transport saline solution, for example, under sufficient pressure to inflate a thermoplastic urethane expandable vessel. Additional lumens may function to transport contrast dye at areas to two sides of a thermoplastic urethane expandable vessel. An additional lumen may be used to couple to a guide wire which may permit the shaft and expandable vessel coupled to the shaft to be accurately positioned at precise locations within a patient, for example.

According to one illustrative embodiment, as disclosed herein, a thermoplastic polyethylene expandable vessel may be welded to a cylinder-shaped polyurethane multi-lumen shaft. Saline solution, delivered by a multi-lumen shaft to an expandable vessel at a suitable pressure, may inflate a vessel to a diameter of, for example, between approximately 5.0 mm and approximately 25.0 mm. It has been observed that a thermoplastic polyethylene expandable vessel of approximately 5.0 mm to approximately 25.0 mm may be of sufficient girth to form a temporary seal such that, when drawn towards the ostium, for example, stones or other objects may be urged along the biliary duct, for example, through a patient's ampulla of vater (i.e., the hepatopancreatic ampulla) and into the patient's duodenum. Due at least in part to increased strength of an expandable vessel, such object removal may be performed in a single attempt.

FIG.1is a diagram of an embodiment10showing use of an endoscopic instrument and shaft deployed in an alimentary canal. In accordance with a conventional procedure involving an endoscopic instrument, endoscopic instrument100, for example, may be advanced through a patient's alimentary canal while a patient is, for example, under sedation. Endoscopic instrument100may be advanced into a patient's mouth, into the patient's esophagus, through the cardia, stomach, and pyloric valve, for example, and into a patient's duodenum. It should be noted that embodiment10represents merely a single implementation of a multi-lumen shaft used in association with an endoscopic instrument, and claimed subject matter is not limited to any particular embodiment, such as that ofFIG.1. For example, a multi-lumen shaft may be used in association with endoscopic instruments and advanced into other body cavities, including body cavities of a human patient, animal patient, or into an intricate mechanical structure, or combinations thereof, for example. Further, implementations may involve the use of other medical instruments that may be used to view internal structures of living organisms and/or mechanical apparatuses, and claimed subject matter is not limited in this respect.

Endoscopic instrument100may include camera103which, for example, may provide visual feedback to assist an endoscopic surgeon in positioning an endoscopic instrument. Although not shown inFIG.1, endoscopic instrument100may additionally comprise a lamp or other illumination source so as to enable lighting of body cavities, such as alimentary canal135. Further, although not shown explicitly inFIG.1, endoscopic instrument100may include a working channel that may permit tools, utensils, and other implements to be conveyed into, for example, a patient's alimentary canal and/or other body orifice. In the example ofFIG.1, endoscopic instrument100may be used to position multi-lumen shaft140to a location proximate with, for example, ostium120. In an embodiment, ostium120represents an opening, such as the hepatopancreatic ampulla, through which guide wire150may be advanced.

If endoscopic device100is positioned proximate with ostium120, a surgeon may advance guide wire150through ostium120. Subsequent to penetration of ostium120, multi-lumen shaft140may also be advanced through ostium120. In an embodiment, advancement of guide wire150and/or multi-lumen shaft140may be enabled, at least in part, using camera103to obtain visual feedback of structures within, for example, alimentary canal135.

Upon entry to biliary duct105, by way of ostium120, for example, multi-lumen shaft140may be at least partially advanced toward stone125and further (i.e., distally) into biliary duct105. In embodiments, for example, one or more of distal multi-lumen shaft port110and proximal multi-lumen shaft115may be used to dispense fluoroscopic contrast dye, which may be used in conjunction with a fluoroscopic device, such as an x-ray machine, computer aided tomography scanner, or the like, to provide imagery to an endoscopic surgeon. In one exemplary embodiment, an endoscopic surgeon may locate ostium120by way of camera103, and for example, upon observing the entry of guide wire150and at least a distal portion of multi-lumen shaft140into ostium120, dispense a fluoroscopic contrast dye through, for example, distal multi-lumen shaft port110. Fluoroscopic contrast dye, which may distribute within biliary duct105, may enable a surgeon to position multi-lumen shaft140relative to stone125. It should be noted, however, that some embodiments may involve positioning of a multi-lumen shaft without assistance from contrast dye, and claimed subject matter is not limited in this regard.

If positioned within biliary duct105, such as, for example, shown inFIG.1, multi-lumen shaft140may introduce saline solution into expandable vessel130. Multi-lumen shaft140may be configured to be nonreactive with saline or other solution introduced into expandable vessel130. Under an appropriate fluid pressure, expandable vessel130may expand in size until, for example, vessel130comes into contact with an inner circumference of biliary duct105. Consequently, at least in some embodiments, expandable vessel130may form a temporary seal that may preclude contrast dye emanating from distal multi-lumen shaft port110to seep or leak towards ostium120. Thus, contrast fluid may be permitted to fill biliary duct105. Filling of biliary105with contrast dye may, for example, enable an endoscopic surgeon, radiologist, or other healthcare professional to observe more distal structures that may lie within and/or be in fluid communication with biliary duct105using, for example, a radioimaging device (e.g., an x-ray machine). Thus, additional structures such as the common bile duct, pancreatic duct, cystic duct, common hepatic duct, as well as other structures may be visible if expandable vessel is permitted to form a temporary seal of at least a portion of biliary duct105. It should be noted, however, that liquids, such as contrast dye, emanating from distal multi-lumen shaft110may provide other benefits, and claimed subject matter is not limited in this respect.

As shown inFIG.1, multi-lumen shaft140may additionally comprise proximal multi-lumen shaft port115. In embodiments, proximal multi-lumen shaft port115may additionally be employed to dispense contrast dye within biliary duct105, for example. Consequently, if permitted to at least partially surround stone125, contrast dye may enable an endoscopic surgeon, radiologist, and/or other professional to monitor movement of stone125, as expandable vessel130is drawn toward ostium120. In some instances, it may be possible, for example, to observe the passing of stone125through ostium120, and into alimentary canal135. Again, however, use of contrast dye dispensed by way of distal multi-lumen shaft port110and/or proximal multi-lumen shaft port115represents one or more particular embodiments, and claimed subject matter is not limited in this respect. If stone125has emptied into alimentary canal135, for example, expandable vessel130may be decreased in size, for example, by way of drawing saline solution from the expandable vessel and through multi-lumen shaft140. Multi-lumen shaft140may then be retracted and stowed at a location internal to endoscopic device100. Stowage of multi-lumen shaft140within endoscopic device100may permit an endoscopic surgeon, for example, to remove multi-lumen shaft140and expandable vessel130from a patient.

FIG.2Ais a diagram of an embodiment of a multi-lumen shaft employed as a removal device15. Removal device15may comprise, for example, polycarbonate manifold260, polyolefin strain relief sheath265, polyurethane multi-lumen shaft270, and polyurethane expandable vessel275. In embodiments, polyolefin strain relief sheath265may surround a portion of polyurethane multi-lumen shaft270in a manner that prevents or at least reduces likelihood of improperly bending or kinking polyurethane shaft270as shaft270and expandable vessel275are passed through a working channel of an endoscopic device, such as endoscopic device100. In embodiments, polyurethane shaft270comprises a material that is nonreactive with radioimaging contrast dyes, saline solution, and/or other compressible or incompressible fluids that may be transported through polycarbonate manifold260and polyurethane shaft270for dispensing at a distal end portion of shaft270, such as a location nearby expandable vessel275, for example.

Polycarbonate manifold260may comprise one or more fluid coupling ports, such as fluid coupling ports261,262, and263, for example. In an embodiment, fluid coupling port261may be used to inject radioimaging contrast dye to a distal portion of polyurethane shaft270, such as, for example, distal output port271. Likewise, fluid coupling port262may be used to inject saline solution or other fluid, under suitable pressure, to inflate expandable vessel275by way of, for example, medial output port272(which may be obscured from view by expandable vessel275). Likewise, fluid coupling port263may be used to inject radioimaging contrast dye to a proximal output port, such as, for example, proximal output port273.

FIG.2Bis a diagram of an embodiment of a multi-lumen shaft used with the removal device. The removal device ofFIG.2may be suitable, for example, for insertion into a working channel of an endoscopic instrument, such as endoscopic instrument100ofFIG.1. However, embodiment20may be suitable for insertion into other devices and/or instruments, and claimed subject matter is not limited in this respect. In embodiments, insertion of a multi-lumen shaft into a working channel of an endoscopic instrument begins, for example, with insertion of distal end portion220. If situated within an endoscopic device, multi-lumen shaft240may be deployed, perhaps with the assistance of a camera, such as camera103shown inFIG.1, to a location proximate with an ostium or other opening into a body cavity. Beginning with guide wire250, multi-lumen shaft240may be inserted into an ostium.

If distal end portion220of multi-lumen shaft240can be positioned proximate with a stone or other object lodged in a body orifice, for example, medial multi-lumen shaft port217may dispense fluid, such as saline solution, which may increase volume of expandable vessel230. Control for dispensing of saline solution may, for example, be provided by one or more of injector controls235. As discussed with reference toFIG.1, an expandable vessel may expand to form a temporary seal within a biliary duct or other structure. If at least a partial temporary seal can be formed, by way of expansion of expandable vessel230coming into contact an inner circumference of a biliary duct, for example, contrast dye may be dispensed from one or more of distal multi-lumen shaft port210and proximal multi-lumen shaft port215. Dispensing of contrast dye from distal manifold port210may, for example, enable an endoscopic surgeon, radiologist, or other healthcare professional to observe imagery corresponding to additional structures located distally from multi-lumen shaft240, for example. Dispensing of contrast dye may also permit real-time observation, by way of a fluoroscope (i.e., x-ray machine) of withdrawal of multi-lumen shaft240as well as urging of a stone or other object toward a patient's alimentary canal using expandable vessel230, for example.

FIG.3is a diagram showing an embodiment of a multi-lumen shaft deploying an expandable vessel. InFIG.3, multi-lumen shaft340may be advanced by guiding the multi-lumen shaft to follow a guide wire (not shown inFIG.3) coupled to sealed end portion322. Multi-lumen shaft340may be inserted into a working channel of an endoscopic instrument, such as endoscopic instrument100ofFIG.1, and inserted into a patient's alimentary canal, for example. If a multi-lumen shaft has entered a body orifice, such as an ostium (e.g., the hepatopancreatic ampulla), contrast dye350may be dispensed from one or more of distal multi-lumen shaft port310and proximal multi-lumen shaft port315. Contrast dye may, at least in some embodiments, be employed to enable an endoscopic surgeon operating a fluoroscope to appropriately position multi-lumen shaft340proximate with a stone or other object for which removal may be desired. However, multi-lumen shaft340ofFIG.3may be useful in a variety of other scenarios, such as removal of objects lodged at other locations of a patient, and may make possible object removal from other living organisms and/or mechanical structures. Claimed subject matter is intended to embrace all such uses of multi-lumen shaft340.

At an appropriate time, multi-lumen shaft340may dispense saline solution into expandable vessel330way of multi-lumen shaft port317. If dispensed under a suitable pressure, for example, expandable vessel330may gain in volume until expandable vessel330occupies at least a considerable cross-section of a body orifice such as biliary duct105ofFIG.1. Expandable vessel330may be fused by way of thermoplastic welding to multi-lumen shaft340at, for example, weld zones331and332. In embodiments, use of thermoplastic polyurethane expandable vessels fused to polyurethane multi-lumen shafts, for example, may lessen a need for adhesive used for affixing expandable vessels of other compositions to multi-lumen shafts, such as shaft340. In addition, use of thermoplastic polyurethane expandable vessels fused to polyurethane multi-lumen shafts may result, at least in part, in a much stronger bond than would result if latex expandable vessels were to be affixed, via an adhesive, to a polyurethane shaft.

FIG.4is a diagram showing a cross-section of an embodiment of a multi-lumen shaft. InFIG.4, multi-lumen shaft440may comprise first lumen410, which may be used to transport fluid, such as saline solution, for dispensing at fluid output port415. InFIG.4, weld zone431and432of multi-lumen shaft440may be seen to the left and right of fluid output port415. In embodiments, weld zones431and432correspond to locations along a circumference of multi-lumen shaft440at which an expandable vessel, such as expandable vessel330ofFIG.3, may be welded and/or fused to multi-lumen shaft440. Fusing of an inflatable vessel, such as by way of thermoplastic welding, may permit an expandable vessel to be filled with fluid, such as saline solution, so as to form a temporary seal within an orifice, such as biliary duct105ofFIG.1, for example.

Multi-lumen shaft440may also include contrast dye port425, located at a proximal end portion of multi-lumen shaft440. In the embodiment ofFIG.4, contrast dye port425may be coupled to a second lumen420in a manner that permits contrast dye from second lumen420to be dispensed through contrast dye port425, located at a proximal end portion of the multi-lumen shaft. Likewise, contrast dye port435may be coupled to third lumen430in a manner that permits contrast dye from third lumen430to be dispensed via contrast dye port435. Multi-lumen shaft440may also comprise guide wire lumen460in a manner that permits multi-lumen shaft440to slide along guide wire450.

Returning briefly toFIG.2B, polycarbonate manifold260may comprise a polycarbonate structure suitable for use with, for example, medical equipment. Polycarbonate materials suitable for construction of a manifold may be purchased from suppliers such as Westlake Plastics Company, PO Box 127, Lenni, PA 19052 (www.Westlakepastics.com). However, alternative materials other than polycarbonate structures, for example, may comprise polycarbonate manifold260. Considerations for selection of a material may include, for example, materials comprising a suitable flexural modulus, flexural strength, hardness (Rockwell) impact strength, tensile elongation, tensile strength, coefficient of thermal expansion, heat deflection temperature, and specific gravity.

Expandable vessels, such as described herein may comprise a thermoplastic polyurethane elastomer that may be partially or fully thermoplastic. In embodiments, an expandable vessel may comprise a linear segment block copolymer comprising “hard” and “soft” segments. A hard segment may comprise an aromatic or aliphatic material. Aromatic thermoplastic polyurethanes may be based on isocyanates such as methylene diphenyl diisocyanate and/or related compounds. Aliphatic thermoplastic polyurethanes may be based on isocyanates such as methylene dicyclohexyl diisocyanate (H12MDI). Isocyanates may be combined with short-chain diols to form a “hard” segment. It should be noted that these are merely examples of engineered thermoplastic polyurethanes that may be used to form an expandable vessel, however claimed subject matter is not limited in this regard.

FIG.5is a flow diagram of a process for using an embodiment of a multi-lumen shaft in association with an endoscopic procedure. The arrangement of components inFIG.1may be suitable for performing the method of embodiment50. However, claimed subject matter is not limited to the particular implementation of any particular figure shown and described herein and alternate arrangements of components in other implementations may be used. Example embodiments, such as embodiment50shown inFIG.5, may include blocks in addition to those shown and described, fewer blocks, blocks occurring in an order different than may be identified, or any combination thereof.

At510, a multi-lumen shaft may be inserted into a location distal to an object for removal.510may be preceded by inserting a guide wire into an orifice, such as a bile duct, and dispensing fluoroscopic contrast dye in a manner that permits an endoscopic surgeon, for example, to observe a position of an object to be removed. At520, and expandable vessel may be inflated until the expandable vessel forms a temporary seal which may, for example. At530, contrast dye may be dispensed so as to permit radioimaging of additional structures, such as biliary tree, which may be coupled to a patient's bile duct. It should be noted, however, that530may be employed to enable radioimaging of other structures, and claimed subject matter is not limited in this respect. At540, a multi-lumen shaft, which may be fused to an expandable vessel, be drawn toward an ostium or other opening in a manner that permits a stone or other object to empty into a patient's alimentary canal. Again, embodiments may permit the removal of other objects, which may be lodged at locations other than ducts coupled to the elementary canal, and claimed subject matter is not limited in this regard.

While there has been illustrated and/or described what are presently considered to be example features, it will be understood by those skilled in the relevant art that various other modifications may be made and/or equivalents may be substituted, without departing from claimed subject matter. Additionally, many modifications may be made to adapt a particular situation to teachings of claimed subject matter without departing from one or more central concept(s) described herein. Therefore, it is intended that claimed subject matter not be limited to particular examples disclosed, but that claimed subject matter may also include all aspects falling within appended claims and/or equivalents thereof.