Medical device with balloon and extraction member

Abstract

A medical device can include a tube, a sheath disposed about and coaxial with the tube, and an inflatable balloon at a distal end of the sheath. The balloon can receive fluid from a lumen of the sheath and can have a central opening along a longitudinal axis thereof and into which the tube extends, a proximal portion, an intermediate portion adjacent to and distal of the proximal portion, and a distal portion adjacent to and proximal of the intermediate portion. A maximum diameter of the intermediate portion can be less than a maximum diameter of the proximal portion and less than a maximum diameter of the distal portion when the balloon is inflated with the fluid. The medical device can also include an extraction member disposed at a distal end of the tube, distal of the balloon and axially movable relative to the balloon.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 006,793, filed April 8, 2020, which is incorporated by reference herein in its entirety. TECHNICAL FIELD

[0003] The present invention relates generally to a medical device having a balloon and an extraction member. In examples, the present invention relates to a medical device and related methods of using a dilation balloon and an extraction member to remove material from a subject. BACKGROUND

[0004] During endoscopic procedures for treating cholelithiasis, such as endoscopic sphincterotomy (ES) procedures, an operator can encounter problems when removing material, such as stones, from a subject’s bile duct. During such procedures, the operator often needs to use many different types of devices, particularly if the material proves difficult to remove. For example, extracting a relatively large stone from a bile duct can be problematic when the size of the stone exceeds the size of the ampulla, which can prevent extraction or cause complications during extraction. A biliary ES procedure can involve cutting the subject’s sphincter of Oddi and the intraduodenal segment of the common bile duct using high-frequency electrical current applied with a special knife or sphincterotome inserted through the papilla after selective cannulation. Thus, an ES procedure can require multiple devices and exchange of multiple devices throughout the ES procedure. Additionally, complications can arise during or as a result of the ES procedure, including damage to the subject’s sphincter mechanism. SUMMARY

[0005] Aspects of the present invention relate, among other things, to a medical device and related methods of using a dilation balloon and an extraction member to remove material from a subject. Each of the aspects disclosed herein can include one or more of the features described in connection with any of the other disclosed aspects.

[0006] According to one example, a medical device includes a tube, a sheath disposed about the tube and coaxial with the tube, and an inflatable balloon disposed at a distal end of the sheath. The balloon is configured to receive fluid from a lumen of the sheath and has a central opening along a longitudinal axis thereof and into which the tube extends, a proximal portion, an intermediate portion adjacent to and distal of the proximal portion, and a distal portion adjacent to and distal of the intermediate portion. In response to inflation, a maximum diameter of the intermediate portion is less than or equal to a maximum diameter of the proximal portion and less than a maximum diameter of the distal portion. The medical device further includes an extraction member disposed at a distal end of the tube, distal of the balloon and axially movable relative to the balloon.

[0007] Any of the medical devices described herein can also include one or more of the following features. The distal end of the sheath can be positioned within the central opening of the balloon. The extraction member can have a central opening along its longitudinal axis into which the tube extends. The extraction member can be one of a balloon and a mesh configured to receive fluid from the lumen of the tube. The proximal portion of the balloon can include a proximal tapered portion. The proximal portion of the balloon can include a spherical distal portion and a proximal tapered portion. The distal portion of the balloon can be cylindrical with respect to its longitudinal axis. The distal portion of the balloon can be spherical with respect to its longitudinal axis. A maximum diameter of the proximal portion can be equal to a maximum diameter of the middle portion of the balloon. A maximum diameter of the proximal portion can be less than a maximum diameter of the distal portion of the balloon. A length of the proximal portion of the balloon with respect to the longitudinal axis of the balloon can be greater than each of a length of the distal portion and a length of the middle portion of the balloon, and the length of the middle portion can be less than or equal to the length of the distal portion. The tube can include a distal opening, and the lumen of the tube can be configured to receive a guidewire that can extend beyond the distal opening of the tube. A distal-facing surface of the distal portion of the balloon can be concave. The distal-facing surface of the distal portion of the balloon can define a recess that extends radially inward and proximally toward the middle portion of the balloon. The recess can extend proximally to a depth that is less than or equal to half of a longitudinal length of the distal portion of the balloon.

[0008] According to another example, a medical device includes a tube, a sheath disposed about the tube and coaxial with the tube, and a balloon disposed at a distal end of the sheath. The balloon is configured to be inflated via a lumen of the sheath and has a distal-facing concave surface. In response to inflation, the balloon has an hourglass shape. The medical device also includes an extraction member disposed at a distal end of the tube, distally of the balloon.

[0009] Any of the medical devices described herein can also include one or more of the following features. The hourglass shape can be defined by a proximal bulb portion, a middle neck portion, and a distal bulb portion. A distal surface of the distal bulb portion of the balloon can define a recess that extends radially inward and proximally toward the proximal bulb portion of the balloon, the recess being configured to accommodate a gallstone.

[0010] According to yet another example, a method of removing material from a subject includes advancing a device into a cavity of a subject, the device including a tube, a sheath disposed about and coaxial with the tube, and a dilation balloon disposed at a distal end of the device. The dilation balloon has a central opening along its longitudinal axis that receives the tube, a proximal portion, a middle portion adjacent to and distal of the proximal portion, and a distal portion adjacent to and distal of the middle portion. The device also includes an extraction member disposed at a distal end of the tube and distal of the dilation balloon. The method also includes positioning the extraction member distal of the material, positioning the dilation balloon proximal of the material, inflating the dilation balloon such that a maximum diameter of the middle portion of the dilation balloon is less than or equal to a maximum diameter of the proximal portion of the dilation balloon and less than a maximum diameter of the distal portion of the balloon, and at least pulling the extraction member proximally to pull the material proximally.

[0011] Any of the methods described herein can also include one or more of the following features. The extraction member can include an extraction balloon. Additionally, the method can also include inflating the extraction balloon before or after inflating the dilation balloon.

[0012] It is to be understood that both the foregoing general description and the following detailed description are merely exemplary and explanatory and are not restrictive of the application, as claimed. BRIEF DESCRIPTION OF DRAWINGS

[0013] The accompanying drawings incorporated herein and forming a part of the specification, illustrate examples of the application and together with the description serve to explain the principles of the application.

[0014] Figure 1 A schematic view showing a portion of a medical device extending through the duodenum and into a bile duct of a subject.

[0015] Figure 2 A schematic view showing a portion of a medical device according to the present application extending through the duodenum and into a bile duct of a subject.

[0016] Figure 3 A schematic view showing a medical device according to the present application.

[0017] Figure 4 A cross-sectional view of a tube and sheath of a medical device according to the present application. Figure 3

[0018] Figures 5A to 5D A perspective view, a side view, a cross-sectional view, and a detailed cross-sectional view of a dilation balloon according to one embodiment of the present application are shown, respectively.

[0019] Figures 6A to 6C ​A side view, a cross-sectional view, and a detailed cross-sectional view of a dilation balloon according to another embodiment of the application are shown, respectively.

[0020] Figures 7A to 7C A side view, a cross-sectional view, and a detailed cross-sectional view of a dilation balloon according to another embodiment of the application are shown, respectively.

[0021] Figure 8 A method of removing material from a subject according to the application is shown.

[0022] Figure 9 A side view of a dilation balloon according to another embodiment of the application is shown.

[0023] Figure 10 A side view of a medical device having a dilation balloon and a mesh according to another embodiment of the application is shown.

[0024] Figures 11A to 11C A medical device having a dilation balloon with a recess according to another embodiment of the application is shown. DETAILED DESCRIPTION

[0025] It is to be understood that both the foregoing general description and the following detailed description are merely exemplary and explanatory and are not restrictive of the application, as claimed. As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes or contains a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used herein to mean "example" in the sense of "exemplar" or "model." As used herein, the terms "proximal" or "proximally" refer to a direction closer to an operator, and the terms "distal" or "distally" refer to a direction further from an operator. As used herein, the terms "about," "substantially," and "approximately" indicate a range of values within + / - 10% of the stated value. Although reference is made herein to endoscopes and endoscopic surgery, reference to endoscopes and endoscopic surgery should not be interpreted as limiting the possible applications of the disclosed medical devices and other aspects, and the disclosed medical devices and portions thereof can be used as portions of other types of medical devices, as well as in other types of endoscopic surgery.

[0026] As an alternative to the above-described ES procedure, an endoscopic papillary balloon dilation (EPBD) procedure can be performed, which can minimize complications and preserve sphincter mechanisms. For example, as described in Figure 1As shown, material 10, such as a stone, can be located within a bile duct 12 of a subject and can be removed in an EPBD procedure using a medical instrument 14. During the procedure, the medical instrument 14 is advanced distally through a duodenoscope 16 (or other scope, catheter, sheath, or tube) that is located within the gastrointestinal tract of the subject. More specifically, the duodenoscope 16 is located within a duodenum 18 of the subject and has a distal opening 20 that is positioned to face a papilla, here the ampulla of Vater 22. An elevator (not shown) can be within the opening 20 to lift and direct the medical instrument to a side of the duodenoscope 16. The medical instrument 14 extends from the distal opening 20 along a guide wire 24, through the ampulla of Vater 22 and into the bile duct 12. A portion of the medical instrument 14 that extends into the bile duct 12 is a treatment portion 26. The treatment portion 26 includes a lumen 28 and an extraction member 30. The extraction member 30 is disposed toward a distal end of the treatment portion 26. During the endoscopic procedure, the extraction member 30 is distal of the material 10 and can be expanded and / or inflated with fluid through an opening (not shown) in the lumen 28.

[0027] To remove the material 10 from the bile duct 12, the extraction member 30 is pulled proximally, i.e., dragged through the bile duct 12. During this process, the force required to pull the material 10 out of the bile duct 12 can cause the extraction balloon 30 to rupture in the case where the extraction member 30 is a balloon. Additionally, in the case where the bile duct 12 of the subject is "sigmoid", e.g., a curved or crescent-shaped bile duct, the medical instrument 14 can need to be twisted by the operator performing the procedure, which requires additional strength and endurance on the part of the operator and increases the risk of trauma to the bile duct 12 and other cavities of the subject.

[0028] To reduce the force required to pull the material 10 out of the bile duct 12, and thus the risk of rupture of the extraction balloon 30, the lumen proximal of the material 10 can be expanded. To do so, additional instruments can be required, including an additional lumen or sheath and an expansion balloon at a distal end thereof. The expansion balloon is located within the bile duct 12 proximal of the material 10. To remove the material 10 while preserving the sphincter mechanism, the extraction member 30 and the expansion balloon can be moved simultaneously in a proximal direction.

[0029] However, problems can arise when multiple devices or instruments are needed to both drag the bile duct 12 and dilate the ampulla of Vater 22. For example, the instruments can become entangled during their insertion or exchange. Further, as the instruments are exchanged or moved relative to one another, the guide wire 24 can move, and thus the operator can not access the bile duct 12, requiring re-cannulation. This process can cause further exacerbation of the subject's ampulla of Vater. Additionally, the use of multiple instruments increases the cost of the endoscopic procedure, as well as the time required to complete the endoscopic procedure. The increased time required to complete the endoscopic procedure can in turn increase the invasiveness of the procedure, the exacerbation of the subject's gastrointestinal tract, and the risk of infection or injury to the subject.

[0030] Figure 2 A schematic view of a portion of a medical instrument 32 according to an example of the present application is shown. During an endoscopic procedure, the medical instrument 32 is located within a duodenoscope 16 (or other scope, catheter, sheath, or tube) that is located within the duodenum 18 of a subject. The medical instrument 32 extends through the duodenoscope 16, out of the distal opening 20 of the duodenoscope 16, through the ampulla of Vater 22, and into the bile duct 12 of the subject. A treatment portion 38 of the medical instrument 32 extends into the bile duct 12 to a location that is around or near the material 10 to be extracted from the bile duct 12. The treatment portion 38 includes a tube 40 (shown in Figure 3 ) and a sheath 42 that extends coaxially around the tube 40 and is movable relative to the tube 40. The treatment portion 38 also includes a dilation balloon 44 and an extraction member 46, each of which is shown in an expanded state in Figure 2 . In the embodiment shown in Figure 1 and 2 , the extraction member 46 is a balloon. However, the extraction member 46 can be any suitable feature for capturing and moving objects for retrieval, such as a net as shown in Figure 10 . When the dilation balloon 44 is mounted to the sheath and the extraction member 46 is mounted to the tube 40, the dilation balloon 44 and the extraction member 46 can be expanded and moved independently of one another. The dilation balloon 44 can be moved by moving the sheath 42 distally or proximally, while the extraction member 46 can be moved by moving the tube 40 distally or proximally. Additionally, the dilation balloon 44 and the extraction member 46 can be expanded and moved simultaneously. As shown in Figure 2 , the dilation balloon 44 is located proximally of the material 10, while the extraction member 46 is located distally of the material 10. The treatment portion 38 can be advanced over a guide wire 48 to a location as shown in Figure 2 . Additionally, a distal tip 50 of the treatment portion 38 can form an atraumatic tip and include a distal opening 51 through which the guide wire 48 can pass.

[0031] Figure 3A schematic diagram of a medical device 32 according to an example of the invention is shown. At the proximal end 52 of the medical device 32, a tube 40, which may be a three-lumen squeeze tube, is connected to a handle 54. The handle 54 includes multiple ports, including a guidewire port 56, a contrast agent port 58, and an extraction member expansion port 60. The guidewire port 56 receives a guidewire 48, the contrast agent port 58 receives contrast agent material, such as dye, from a contrast agent material supply (not shown), or receives another desired fluid, and the extraction member expansion port 60 receives a mechanism for expanding the extraction member 46. For example, in the case where the extraction member 46 is a balloon, the extraction member expansion port 60 may receive fluid, such as air or saline, from a fluid supply, such as a pump or syringe (not shown). The handle 54 also provides coaxial movement of the expansion balloon 44 and the extraction member 46 relative to each other.

[0032] like Figure 3 As shown, on the distal side of the handle 54, a hypo tube 61 and an adapter 62, such as a Tuohy Borst adapter, can be positioned around the tube 40. A sheath 42 is attached to the adapter 62 and is coaxial with and extends around the tube 40 from the adapter 62 toward the treatment portion 38 of the medical device 32. The adapter 62 includes an inflation port 64 for the expansion balloon. Figure 3 As shown, the inflation port 64 of the dilator balloon receives fluid from a fluid supply, such as a pump or syringe 66, such as air or saline. The adapter 62 provides coaxial movement of the handle 54 and the hypo tube 61 and prevents fluid from leaking back through the handle 54.

[0033] refer to Figure 3 The tube 40 and sheath 42 extend coaxially from the proximal end 52 toward the distal tip 50 of the treatment portion 38 of the medical device 32. The sheath 42 extends through the proximal end 68 of the dilatation balloon 44, through the central opening 70 of the dilatation balloon 44, and terminates at or near the distal end 72 of the dilatation balloon 44. The sheath 42 has a circumferential opening 74 located between the proximal end 68 and the distal end 72 of the dilatation balloon 44.

[0034] For example, medical device 32 may have a length of approximately 220 cm from its proximal end 52 to its distal apex 50. However, the length of medical device 32 is not limited to this value and may vary within the range of approximately 200 cm to 240 cm. The tube 40 of medical device 32 may have a length of approximately 220 cm and a diameter of approximately 3.0 mm. However, the length and diameter of tube 40 are not limited to these values ​​and may vary within the range of approximately 200 cm to 240 cm and approximately 2.5 mm to 3.5 mm, respectively. For example, tube 40 may be formed of a material such as PEBAX. However, the material forming tube 40 is not limited to PEBAX. and can be any of low density polyethylene (LDPE), high density polyethylene (HDPE), polyether ether ketone (PEEK), nylon, Cristamid, Grilamid , polytetrafluoroethylene (PTFE), Zytel , Rilsan , or Vestamid . Additionally, semi-compliant materials can be used, including, for example, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylene, polyurethane, cross-linked low density polyethylene (PETs), high irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomeric resins. Examples of non-compliant materials include polyethylene terephthalate, polyacryl sulfide, and co-polyesters. Still further, other examples of the material include poly(styrene-isobutylene-styrene) tri-block polymers (SIBS), polyurethane, elastomeric polymers, woven fabrics, multi-walled membranes of polymers, and combinations thereof.

[0035] The sheath 42 of the medical device 32 can have a length of about 165 cm and a diameter of about 3.0 mm. However, the length and diameter of the sheath 42 are not limited to these values and can vary in the range of about 145 cm to 185 cm and in the range of about 2.5 mm to 3.5 mm, respectively. The sheath 42 can be formed of a material such as PEBAX . However, the material forming the sheath 42 is not limited to PEBAX and can be any of low density polyethylene (LDPE), high density polyethylene (HDPE), polyether ether ketone (PEEK), nylon, Cristamid, Grilamid , polytetrafluoroethylene (PTFE), Zytel , Rilsan , or Vestamid . Additionally, semi-compliant materials can be used, including, for example, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylene, polyurethane, cross-linked low density polyethylene (PETs), high irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomeric resins. Examples of non-compliant materials include polyethylene terephthalate, polyacryl sulfide, and co-polyesters. Still further, other examples of the material include poly(styrene-isobutylene-styrene) tri-block polymers (SIBS), polyurethane, elastomeric polymers, woven fabrics, multi-walled membranes of polymers, and combinations thereof.

[0036] In Figure 3In the illustrated embodiment, the dilation balloon 44 has an hourglass shape that allows for controlled dilation of the bile duct 12 and the ampulla of Vater 22 during endoscopic procedures, as discussed below. In particular, from the proximal end 68 to the distal end 72, the dilation balloon 44 includes a proximal neck 76, a proximal portion 78, an intermediate portion 80, a distal portion 82, and a distal neck 84. The dilation balloon 44 has a wall thickness of, for example, about 0.050 mm, which can be constant across the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84. In Figure 3 In the illustrated embodiment, the shapes and diameters of the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84 are different. The different shapes and diameters of these portions of the dilation balloon 44 will be described in more detail below with respect to Figures 5A to 7C In more detail.

[0037] The distal portion 82 of the dilation balloon has a distal-facing surface 86 into which the material 10 can move when the medical device 32 is in use. In Figure 3 In the illustrated embodiment, the distal-facing surface 86 is shown as a concave surface. The concavity of the distal-facing surface 86 defines a space into which the material 10 can be captured or fixed for removal, as discussed in more detail below. However, the distal-facing surface 86 is not limited to being a concave surface and can be planar or convex, or can have a recess, as discussed below with respect to Figures 11A to 11C The central opening 70 of the dilation balloon 44 extends through the entire length of the dilation balloon 44. In addition, one or more marker bands can be provided on the dilation balloon 44. In Figure 3 In the illustrated embodiment, two marker bands are provided, one marker band 88 between the proximal portion 78 and the intermediate portion 80, and another marker band 90 between the intermediate portion 80 and the distal portion 82 of the dilation balloon 44.

[0038] For example, the dilation balloon 44 can be formed from nylon. However, the material forming the dilation balloon 44 is not limited to nylon and can be other materials, such as polyethylene terephthalate (PET), PEBAX or another suitable material. As noted above, the dilation balloon 44 can have different shapes and diameters before the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84, and can be formed using free-form shaping. However, other techniques can be used to form the dilation balloon 44, such as stretch blow molding, extrusion blow molding. The dilation balloon 44 can be formed from a compliant material or a non-compliant material. The details of the different shapes and diameters of the dilation balloon 44 are described in more detail below with respect to Figures 5A to 7C The details of the different shapes and diameters of the dilation balloon 44 are described in more detail below.

[0039] Reference is made toFigure 3 Distal to the inflatable balloon 44, a tube 40 extends through the proximal end 92, through the central opening 94, and into the distal end 96 of the extraction member 46, which may terminate at the distal tip 50 of the treatment portion 38 and form the distal tip 50 of the treatment portion 38. In the case where the extraction member 46 is a balloon, as... Figure 3 As shown, the extraction member 46 has a proximal neck 98, a middle portion 100, and a distal neck 102. The tube 40 has a circumferential opening 104 located within the middle portion 100 of the extraction member 46. When in... Figure 3 In the inflated state shown, the middle portion 100 of the extraction member 46 has an oval profile. The diameter D46 of the middle portion of the extraction member 46 can be, for example, about 11 mm, and the length L46 of the extraction balloon 46 can be, for example, about 11 mm. However, the diameter D46 and length L46 of the extraction member 46 are not limited to these values, and can be in the range of about 5 mm to 13 mm and about 5 mm to 13 mm, respectively.

[0040] When the extraction component 46 is a balloon, it can be formed of, for example, nylon. However, the material forming the extraction component 46 is not limited to nylon and can be other materials such as polyethylene terephthalate (PET), PEBAX, etc. Or another suitable material. As described above, the extraction member 46 as a balloon can have an oval shape, and the specific diameters of the proximal neck 98, the middle portion 100, and the distal neck 102 can be formed using free forming. However, other techniques can be used to form the extraction member 46, such as stretch blow molding and extrusion blow molding. The extraction member 46 as a balloon can be formed from compliant or non-compliant materials.

[0041] Figure 4 It is along Figure 3 The cross-sectional view of pipe 40 and sheath 42 taken from section line 4-4. (See section line 4-4 for example.) Figure 4As shown, the tube 40 has at least three lumens, including a guidewire lumen 106, a contrast lumen 108, and an extraction member inflation lumen 110. The guidewire lumen 106 receives a guidewire 48 that extends from a guidewire port 56 of the handle 54 and can extend through a distal tip 50 of the treatment portion 38 of the medical instrument 32. The contrast lumen 108 receives contrast material (or other desired fluid) from a contrast material supply via a contrast port 58 in the handle 54. Additionally, in the case where the extraction member 46 is a balloon, the extraction member inflation lumen 110 receives fluid for inflating the extraction member 46 from a fluid supply via an extraction member inflation port 60. That is, when fluid is supplied through the extraction member inflation lumen 110 and the circumferential opening 104 in the tube 40, the extraction member 46 is inflated. Furthermore, an inflation balloon inflation lumen 112 is formed between an outer circumferential surface of the tube 40 and an inner circumferential surface of the sheath 42 and is connected to an inflation balloon inflation port 64. The inflation balloon inflation lumen 112 receives fluid for inflating the inflation balloon 44 from a syringe 66, as shown. Figure 3 That is, when fluid is supplied through the inflation balloon inflation lumen 112 and the circumferential opening 74 in the sheath 42, the inflation balloon 44 is inflated.

[0042] Reference is made to Figure 3 Additionally, in the case where the extraction member 46 is a balloon, the proximal neck 98 and the distal neck 102 of the extraction member 46 form a tight fit around the tube 40, thereby preventing fluid received from the extraction member inflation lumen 110 from leaking out of the extraction member 46. Similarly, in the case where the sheath 42 terminates beyond the distal end 72 of the inflation balloon 44, the proximal neck 76 and the distal neck 84 of the inflation balloon 44 form a tight fit around the sheath 42, thereby preventing fluid received from the inflation balloon inflation lumen 112 from leaking out of the inflation balloon 44. Also, in the case where the sheath 42 terminates proximal to the distal end 72 of the inflation balloon 44, the distal neck 84 of the inflation balloon 44 forms a tight fit around the tube 40, thereby preventing fluid received from the inflation balloon inflation lumen 112 from leaking out of the inflation balloon 44. Additionally, the proximal neck 98 of the extraction member 46 and the distal neck 84 of the inflation balloon 44 form a robust stop collar to prevent over-extraction of the extraction member 46 into the inflation balloon 44.

[0043] Figures 5A to 5D Additional details of the inflation balloon 44 according to embodiments of the present application are shown. Figure 5A A perspective view of the inflation balloon 44 having an hourglass shape defined by a proximal portion 78, an intermediate portion 80, and a distal portion 82 is shown. The distal portion 82 can be spherical or bulbous. Figure 5A A distally facing surface 86 of the inflation balloon 44 is also shown. Figure 5Bis a side view of the expansion balloon 44 and illustrates respective lengths of the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84. That is, the proximal neck 76 has a length L76, the proximal portion 78 has a length L78, the intermediate portion 80 has a length L80, the distal portion 82 has a length L82, and the distal neck 84 has a length L84. Relationships between the lengths of the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84 can be as follows: L76 < L84 < L80 = L82 < L78. However, the relationships between the lengths of the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84 are not limited to these relationships and can vary.

[0044] Figure 5C is a cross-sectional view of the expansion balloon 44 taken along line 5C-5C of Figure 5B In this embodiment, the proximal neck 76 and the distal neck 84 each have a generally constant diameter D76 and D84, respectively, while the proximal portion 78, the intermediate portion 80, and the distal portion 82 can have varying diameters across their respective lengths. That is, for example, the proximal portion 78 can have a proximal portion maximum diameter D78_MAX of about 20 mm and a proximal portion minimum diameter D78_MIN of about 10 mm, the intermediate portion 80 can have an intermediate portion maximum diameter D80_MAX of about 18 mm and an intermediate portion minimum diameter D80_MIN of about 8 mm, and the distal portion 82 can have a distal portion maximum diameter D82_MAX of about 20 mm and a distal portion minimum diameter D82_MIN of about 10 mm. However, the respective diameters of the proximal neck 76, the proximal portion 78, the intermediate portion 80, the distal portion 82, and the distal neck 84 of the expansion balloon 44 are not limited to these respective values and can vary.

[0045] As shown in Figure 5C the proximal portion 78 can have a tapered profile with the proximal portion minimum diameter D78_MIN at its proximal-most end and the proximal portion maximum diameter D78_MAX at its distal-most end nearest the intermediate portion 80. The intermediate portion 80 can have a curved, bi-concave profile forming a neck of the expansion balloon 44 with the intermediate portion minimum diameter D80_MIN at its center and the intermediate portion maximum diameter D80_MAX at each of its proximal and distal ends. Additionally, the distal portion 82 can be spherical or bulbous having a curved, bi-convex profile with the distal portion minimum diameter D82_MIN at its proximal end and the distal portion maximum diameter D82_MAX at its center. The outer circumferential surface of the expansion balloon 44 can be continuous and smooth across the proximal portion 78, the intermediate portion 80, and the distal portion 82.

[0046] In Figure 5C the illustrated embodiment, the relationship between the diameters of the proximal neck 76, proximal portion 78, intermediate portion 80, distal portion82, and distal neck84 can be as follows: D76 = D84 = D78_MIN < D80_MIN < D78_MAX = D80_MAX = D82_MIN < D82_MAX. That is, whenthe dilatation balloon44 is inflated, the maximum diameter D82_MAX of the distal portion is greater than the maximum diameter D80_MAX of the intermediate portion, and the maximum diameter D80_MAX of the intermediate portion is less than or equal to the maximum diameter D78_MAX of the proximal portion. However, the relationship between the diameters of the proximal neck 76, proximal portion 78, intermediate portion 80, distal portion82, and distal neck84 is not limited to these relationships and can vary. In the case where the maximum diameter D80_MAX of the intermediate portion is less than the maximum diameter D82_MAX of the distal portion and the maximum diameter D78_MAX of the proximal portion, the intermediate portion 80 of the dilatation balloon44 forms an anchor that reduces the likelihood of the dilatation balloon44 slipping into or out of the ampulla of Vater22 during an endoscopic procedure.

[0047] Figure 5D is a detailed view of the distally facing surface86 of the dilatation balloon44. In particular, Figure 5D shows the angle θ between the distal surface86 of the dilatation balloon44 and the distal neck84. For example, the angle θ can be an acute angle, and more specifically, can be between about 80° and 85°. That is, in Figures 5A to 5D the illustrated embodiment, the distal surface86 is concave with respect to the distal portion82 of the dilatation balloon44. However, the distal surface86 is not limited to being a concave surface and can be planar or convex, or can include recesses, as described below with reference to Figures 11A to 11C described.

[0048] Figures 6A to 6C shows a dilatation balloon114 according to an alternative embodiment of the present invention. Figure 6A is a side view of the dilatation balloon114, which includes a proximal neck116, a proximal portion118, an intermediate portion120, a distal portion122, and a distal neck124. Figure 6AThe respective lengths of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 are also shown. That is, the proximal neck 116 has a length L116, the proximal portion 118 has a length L118, the intermediate portion 120 has a length L120, the distal portion 122 has a length L122, and the distal neck 124 has a length L124. The relationships between the lengths of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 can be as follows: L116 < L124 < L118 = L120 = L122. However, the relationships between the diameters and lengths of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 are not limited to these relationships and can vary.

[0049] Figure 6B is a cross-sectional view of the dilation balloon 114 taken along the line 6B-6B of Figure 6A In this embodiment, the proximal neck 116 and the distal neck 124 have constant diameters D116 and D124, respectively, while the proximal portion 118, the intermediate portion 120, and the distal portion 122 can have varying diameters across their respective lengths. That is, for example, the proximal portion 118 can have a proximal portion maximum diameter D118_MAX of about 20 mm and a proximal portion minimum diameter D118_MIN of about 20 mm, the intermediate portion 120 can have an intermediate portion maximum diameter D120_MAX of about 18 mm and an intermediate portion minimum diameter D120_MIN of about 8 mm, and the distal portion 122 can have a distal portion maximum diameter D122_MAX of about 20 mm and a distal portion minimum diameter D122_MIN of about 10 mm. However, the respective diameters of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 of the dilation balloon 114 are not limited to these respective values and can vary.

[0050] Similar to the dilation balloon 44 of the embodiment shown in Figures 5A to 5D the proximal portion 118 of the dilation balloon 114 shown in Figures 6A to 6C may have a tapered profile, with the proximal portion minimum diameter D118_MIN at its proximal-most end nearest the proximal neck 116 and the proximal portion maximum diameter D118_MAX at its distal-most end nearest the intermediate portion 120. The intermediate portion 120 can have a curved, double-concave profile, thereby forming a neck of the dilation balloon 114, with the intermediate portion minimum diameter D120_MIN at its center and the intermediate portion maximum diameter D120_MAX at each of its proximal and distal ends.

[0051] In contrast to the embodiment shown in Figures 5A to 5D the proximal portion 118 of the dilation balloon 114 shown inFigures 6A to 6C The distal portion 122 of the illustrated expansion balloon 114 can include a hemi-spherical portion 126 having a curved profile at its proximal end, and a cylindrical portion 128 having a straight profile at its distal end. A distal portion minimum diameter D122_MIN is located at the proximal end of the hemi-spherical portion 126 of the distal portion 122, and a distal portion maximum diameter D122_MAX is constant along the cylindrical portion 128 of the distal portion 122. The distal portion 122 also has a distal facing surface 130, which in this embodiment is a concave surface relative to the distal portion 122. The outer circumferential surface of the expansion balloon 114 can be continuous and smooth across the proximal portion 118, the intermediate portion 120, and the distal portion 122.

[0052] In Figures 6A to 6C In the illustrated embodiment, the relationship between the diameters of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 can be as follows: D116 = D124 = D118_MIN < D120_MIN < D118_MAX = D120_MAX = D122_MIN < D122_MAX. However, the relationship between the diameters of the proximal neck 116, the proximal portion 118, the intermediate portion 120, the distal portion 122, and the distal neck 124 is not limited to these relationships, and can vary.

[0053] Figure 6C is a detailed view of the distal facing surface 130 of the expansion balloon 114. In particular, Figure 6C An angle Δ is shown between the distal surface 130 of the expansion balloon 114 and the distal neck 124. For example, the angle Δ can be an acute angle, and more particularly, can be between about 80° to 85°. That is, in Figures 6A to 6C In the illustrated embodiment, the distal surface 130 is concave relative to the distal portion 122 of the expansion balloon 114. However, the distal surface 130 is not limited to being a concave surface, and can be planar or convex, or can include a concave portion, as described below with reference to Figures 11A to 11C

[0054] Figures 7A to 7C An expansion balloon 132 according to yet another embodiment of the present application is shown. Figure 7A is a side view of the expansion balloon 132, which includes a proximal neck 134, a proximal conical portion 136, a proximal biconvex portion 138, an intermediate portion 140, a distal portion 142, and a distal neck 144. The proximal biconvex portion 138 can be spherical or bulbous, and the intermediate portion 140 can form a curved neck of the expansion balloon 132. Additionally, the distal portion 142 can be spherical or bulbous. Figure 7A ​The respective lengths of the proximal neck 134, proximal tapered portion 136, proximal biconvex portion 138, intermediate portion 140, distal portion 142, and distal neck 144 are also shown. That is, the proximal neck 134 has a length L134, the proximal tapered portion 136 has a length L136, the proximal biconvex portion 138 has a length L138, the intermediate portion 140 has a length L140, the distal portion 142 has a length L142, and the distal neck 144 has a length L144. The relationships between the lengths of the proximal neck 134, proximal tapered portion 136, proximal biconvex portion 138, intermediate portion 140, distal portion 142, and distal neck 144 can be as follows: L134 < L140 < L144 < L136 < L142 < L138. However, the relationships between the lengths of the proximal neck 134, proximal tapered portion 136, proximal biconvex portion 138, intermediate portion 140, distal portion 142, and distal neck 144 are not limited to these relationships and can vary.

[0055] Figure 7B is a cross-sectional view of the inflated balloon 132 taken along Figure 7A line 7B-7B. In this embodiment, the proximal neck 134 and the distal neck 144 have constant diameters D134 and D144, respectively, while the proximal tapered portion 136, proximal biconvex portion 138, intermediate portion 140, and distal portion 142 can have varying diameters across their respective lengths. That is, for example, the proximal tapered portion 136 can have a proximal tapered portion maximum diameter D136_MAX of approximately 8 mm and a proximal tapered portion minimum diameter D136_MIN of approximately 6 mm, the proximal biconvex portion 138 can have a proximal biconvex portion maximum diameter D138_MAX of approximately 20 mm and a proximal biconvex portion minimum diameter D138_MIN of approximately 10 mm, the intermediate portion 140 can have an intermediate portion maximum diameter D140_MAX of approximately 18 mm and an intermediate portion minimum diameter D140_MIN of approximately 8 mm, and the distal portion 142 can have a distal portion maximum diameter D142_MAX of approximately 20 mm and a distal portion minimum diameter D142_MIN of approximately 10 mm. However, the diameters of the proximal neck 134, proximal tapered portion 136, proximal biconvex portion 138, intermediate portion 140, distal portion 142, and distal neck 144 of the inflated balloon 132 are not limited to these respective values and can vary.

[0056] are respectively similar to Figures 5A to 5D and Figures 6A to 6CThe proximal tapered portion 136 of the illustrated embodiment of the expansion balloon 44 and the expansion balloon 114, the expansion balloon 132 can have a tapered profile, with the proximal tapered portion minimum diameter D136_MIN at its proximal end nearest the proximal neck 134, and the proximal tapered portion maximum diameter D136_MAX at its distal end nearest the proximal biconvex portion 138. However, in contrast to the expansion balloons 44 and 114 of the preceding embodiments, the expansion balloon 132 has a proximal biconvex portion 138 between the proximal tapered portion 136 and the intermediate portion 140. The proximal biconvex portion 138 can have a spherical shape with a biconvex profile. Each of the proximal and distal ends of the proximal biconvex portion 138 can have a proximal biconvex portion minimum diameter D138_MIN, and the center of the proximal biconvex portion 138 can have a proximal biconvex portion maximum diameter D138_MAX, as Figure 7B illustrated. The intermediate portion 140 can have a curved tapered profile, with the intermediate portion maximum diameter D140_MAX at its proximal end nearest the proximal tapered portion 136, and the intermediate portion minimum diameter D140_MIN at its distal end nearest the distal portion 142.

[0057] Additionally, similar to Figures 5A to 5D the illustrated embodiment of the expansion balloon 44 and the expansion balloon 114, the distal portion 142 of the expansion balloon 132 can have a curved biconvex profile. As Figure 7B illustrated, the distal portion minimum diameter D142_MIN is at each of its proximal and distal ends, and the distal portion maximum diameter D142_MAX is at its center, as Figure 7B illustrated. The distal portion 142 also has a distal-facing surface 146, which in this embodiment is a planar surface. The outer circumferential surface of the expansion balloon 132 can be continuous and smooth across the proximal tapered portion 136, the proximal biconvex portion 138, the intermediate portion 140, and the distal portion 142.

[0058] In Figure 7B the illustrated embodiment, the relationship between the diameters of the proximal neck 134, the proximal tapered portion 136, the proximal biconvex portion 138, the intermediate portion 140, the distal portion 142, and the distal neck 144 can be as follows: D134 = D144 = D136_MIN < D136_MAX = D138_MIN = D140_MIN = D142_MIN < D142_MAX < D138_MIN = D140_MAX < D138_MAX. That is, in contrast to Figures 5A to 5D and Figures 6A to 6CIn contrast to the embodiment shown, the portion of the inflatable balloon 132 with the largest diameter is the proximal biconvex portion 138, rather than the distal portion 142. However, the relationship between the diameters of the proximal neck 134, the proximal conical portion 136, the proximal biconvex portion 138, the intermediate portion 140, the distal portion 142, and the distal neck 144 is not limited to these relationships and can vary.

[0059] Figure 7C This is a detailed view of the distal surface 146 of the inflatable balloon 132. Specifically, Figure 7C This illustrates the right angle formed between the distal surface 146 and the distal neck 144 of the inflatable balloon 132. That is, in Figures 7A to 7C In the illustrated embodiment, the distal surface 146 is perpendicular to the outer circumferential surface of the distal neck 144 of the inflatable balloon 132. Although the distal surface 146 is shown as a planar surface, it is not limited thereto and may be curved, concave, or convex, and may include recesses.

[0060] Figure 8 A method 800 for using a medical device 32 during endoscopic surgery is illustrated. In step 802, the medical device 32 is advanced into a lumen of a subject, such as the duodenum 18. In this step, the medical device 32 can be advanced within a duodenoscope 16, positioned within the duodenum 18 of the subject's gastrointestinal tract. The distal opening 20 of the duodenoscope 16 can be positioned facing the ampulla of Fatter 22. A guidewire 48 can be advanced through the medical device 32, the distal opening 20, and the ampulla of Fatter 22, and into the bile duct 12. The treatment portion 38 of the medical device 32 (in a contracted, expanded state) can be advanced over the guidewire 48 to be positioned within the bile duct 12, such as... Figure 2 As shown.

[0061] Subsequently, in step 804, the extraction component 46 of the balloon is positioned distally beyond the material 10, as... Figure 2 As shown. In step 806, the dilating balloon 44 is positioned proximally to the material 10, as... Figure 2The extraction member 46 is pulled proximally (i.e., in a direction back toward the duodenum 18) to extract the material 10 from the bile duct 12. In this step, the material 10 can be pinched between the extraction member 46 and the distally-facing surface 86 of the dilation balloon 44. That is, as the extraction member 46 is pulled proximally, the dilation balloon 44 can remain stationary for a period of time, with the material 10 being pressed into the space defined by the concave distally-facing surface 86 until the material 10 is pinched and secured between the extraction member 46 and the dilation balloon 44. Because the dilation balloon 44 is mounted to the sheath 42 and the extraction member 46 is mounted on the tube 40, the dilation balloon 44 and the extraction member 46 are movable separately from one another, with the sheath 42 movable relative to the tube 40. Additionally, because of the circumferential opening 74 of the sheath 42 through which fluid passes to inflate the dilation balloon 44 and the circumferential opening 104 of the tube 40 through which fluid passes to inflate the extraction member 46, the dilation balloon 44 and the extraction member 46 are inflatable separately from one another.

[0062] The treatment portion 38 (including the extraction member 46 and the dilation balloon 44) can then be withdrawn from the bile duct 12. In one embodiment, the duodenoscope 16 and the instrument 32 can then be removed from the subject together. In another embodiment, all or a portion of the instrument 32 can be pulled back into the duodenoscope 16 through the distal opening 20 and the medical instrument 32, including the removed material 10, can then be removed from the subject.

[0063] Although the method 800 is described as including the steps 802-810, the method 800 can also include additional steps. For example, the method 800 can include the steps of cannulating the bile duct 12 and positioning the guidewire 48 therein, advancing the medical instrument 32 into the duodenum 18 until the distal tip 50 of the medical instrument 32 is positioned against the ampulla 22, and advancing the treatment portion 38 over the guidewire 48 into the bile duct prior to performing the step 804 of positioning the extraction member 46 distally of the material 10.

[0064] Additionally, in the case where the extraction member 46 is a balloon, the method 800 can also include the additional step of inflating the extraction member 46. The step of inflating the extraction member 46 can be performed after the step 804, with the extraction member 46 positioned distally of the material, prior to, concurrently with, or after the step 808 of inflating the dilation balloon 44. The method 800 can also include the step of withdrawing the material pinched between the inflated extraction member 46 and the inflated dilation balloon 44 from the bile duct 12 and into the duodenum 18. The method 800 can also include the step of deflating the extraction member 46 and the dilation balloon 44 prior to withdrawing the material 10 into the duodenum 18.

[0065] Additionally, in cases where the material 10 is particularly difficult to move using the steps of the method 800 described above, in alternative embodiments, the method 800 can further include a step of deflating the dilation balloon 44, a step of moving the dilation balloon 44 proximally within the bile duct 12, and a subsequent step of re-inflating the dilation balloon 44. Subsequently, the extraction member 46 can be pulled proximally to move the material 10 toward the dilation balloon 44. These steps can be repeated until the material 10 becomes freely movable or has been removed from the bile duct 12.

[0066] In alternative embodiments, the dilation balloon 44 and the extraction member 46 can be simultaneously dilated or inflated and moved.

[0067] In another alternative embodiment, the method 800 further includes a step of injecting a contrast agent into the bile duct 12 via the contrast agent port 58 and the contrast agent lumen 108 to provide a fluoroscopic image of the material 10 and the size and complexity of the duct. In this alternative embodiment, the contrast agent can be injected prior to or after the step 804, with the extraction member 46 positioned distally of the material 10.

[0068] In yet another alternative embodiment, the method 800 can include a step of using the marker bands 88 and 90 to confirm the position of the dilation balloon 44 within the bile duct 12. That is, the marker bands 88 and 90 can be used to confirm that the middle portion 80 of the dilation balloon 44 is at least within the ampulla 22 and the distal portion 82 of the dilation balloon 44 is at least within the bile duct 12. The step of confirming the position of at least the middle portion 80 and the distal portion 82 of the dilation balloon 44 can be performed prior to the step 808 of inflating the dilation balloon 44.

[0069] In yet another alternative embodiment, after inflating the dilation balloon 148 to a first or initial inflated diameter D148_1 in the step 808, the method 800 can include an additional step of inflating the dilation balloon 148 to a second or subsequent inflated diameter D148_2, as shown in Figure 9 In this alternative embodiment, if the material 10, for example, is a larger stone located in the bile duct, it can be necessary to further dilate the ampulla 22 in order to extract the stone from the bile duct 12. Accordingly, the dilation balloon 148 can be inflated to the first inflated diameter D148_1 in the step 808, and the dilation balloon 148 can be further inflated to the second inflated diameter D148_2 prior to the step 810 in which the extraction member 46 is pulled proximally. The dilation balloon 148 of this embodiment can have a shape similar to the dilation balloon 44 shown in Figures 5A to 5D the dilation balloon 114 shown in Figures 6A to 6C or the dilation balloon 126 shown in Figures 7A to 7CThe illustrated expansion balloon 132 is of the same construction. The expansion balloon 148 includes at least a distal portion 150 having a distal portion maximum diameter D150_MAX. The first inflated diameter D148_1 and the second inflated diameter D148_2 can be defined relative to the distal portion maximum diameter D150_MAX of the expansion balloon 148, i.e., across the center of the distal portion 150, as Figure 9 As illustrated, relative to the longitudinal axis A-A of the expansion balloon 148.

[0070] Additionally, in another alternative embodiment, the extraction member 46 can be an extraction net 152, as Figure 10 The medical instrument 32 can otherwise be the same or similar to that illustrated in Figure 3 According to this alternative embodiment, after positioning the extraction net 152 distally of the material 10, the method 800 can further include the step of deploying the extraction net 152.

[0071] In yet another alternative embodiment, the expansion balloon can be formed of a sponge material, i.e., can be an expansion sponge. In this alternative embodiment, the expansion sponge can be contained within the sheath 40 until the medical instrument 32 is positioned within the bile duct 12. The expansion sponge can then be deployed, i.e., extended, outside of the sheath 40 and can expand and dilate the bile duct 12. The expansion sponge can function in the same manner as the expansion balloon 44 described above in that the expansion sponge expands the bile duct 12 and the ampulla of Vater 22 during extraction of the material 10 from the bile duct 12.

[0072] Additionally, in another alternative embodiment, the expansion balloon 154 can be provided with a recess 156 in a distally facing surface 158 of the expansion balloon 154, as Figures 11A to 11C The recess 156 can extend proximally from the distally facing surface 158 to a depth D156 within a distal portion 160 of the expansion balloon 154 that is less than or equal to the length of the distal portion 160. More particularly, the recess can have a depth D156 that is less than or equal to one-half the length of the distal portion 160. In this alternative embodiment, the extraction member 46 is a balloon and is positioned distally of the material 10 and inflated within the bile duct 12, and the expansion balloon 154 is positioned proximally of the material 10 and inflated, as Figure 11A As the extraction member 46 is pulled proximally in step 810, the expansion balloon 154 remains stationary and the extraction member 46 moves the material 10 in the bile duct 12 into the recess 156 of the inflated expansion balloon 154, as Figure 11B Subsequently, in a subsequent step, the extraction member 46 and the expansion balloon 154 can be scaled, as Figure 11CAs shown, this traps or encloses the material 10 within the recess 156. The treatment portion 38 can then be withdrawn from the bile duct 12 to safely and reliably remove the material 10 from the bile duct 12.

[0073] In relation to Figures 11A to 11C In a modification of the described embodiment, in addition to the recess 156, the dilating balloon 154 may have a fluid injection channel. The fluid injection channel may be connected to the fluid injection chamber of the tube 50. In this alternative embodiment, after positioning the extraction member 46 distal to the material 10 and before step 810 of pulling the extraction member 46 proximally, method 800 may include a step of breaking down the material 10. The step of breaking down the material 10 includes, for example, supplying fluid (e.g., water) to the fluid injection channel under high pressure. As the water exits the water injection channel, it targets the material and breaks down the material 10 into pieces of relatively small size. The dilated extraction member 46 prevents small fragments of the material 10 from moving distally within the bile duct. Subsequently, in step 810, the extraction member 46 may be pulled proximally, thereby moving the pieces of material 10 into the recess 156 of the dilating balloon 154. In subsequent steps, the extraction member 46 and the dilating balloon 154 may be scaled to capture the material 10 within the recess 156. Then, the treatment portion 38 can be withdrawn from the bile duct 12 to safely and reliably remove the material 10 from the bile duct 12.

[0074] Although medical device 32 is described as being used during endoscopic surgery, it can also be used in other medical procedures, such as for the removal of, for example, kidney stones.

[0075] With the medical device 32 of the present invention, material 10 can be safely and securely removed from the bile duct 12 of the subject while preventing damage to the wall of the bile duct 12. The extraction member 46 and the dilation balloon 44 are used to capture material 10 therebetween, thereby preventing the material 10 from scraping or tearing the wall of the bile duct 12.

[0076] Figures 5A to 5C The dilatation balloon 44 of the illustrated embodiment provides widening of the bile duct 12 directly proximal to the material 10, which reduces potential trauma to the bile duct 12 caused by the material 10 and improves the maneuverability of the medical device 32. Additionally, the tapered proximal portion 78 of the dilatation balloon 44 allows for gradual dilation of the ampulla of Fatter 22 at the entrance to the duodenum 18 (i.e., the opening between the bile duct 12 and the duodenum 18). Furthermore, as described above, the intermediate portion 80 of the dilatation balloon 44 acts as an "anchor," reducing the likelihood of the dilatation balloon slipping into or out of the ampulla of Fatter 22 during endoscopic procedures.

[0077] Figures 6A to 6CThe expansion balloon 114 of the illustrated embodiment similarly provides widening of the bile duct 12 directly proximal of the material, which reduces potential trauma to the bile duct 12 by the material 10 and improves maneuverability of the medical device 32. The shape of the distally facing surface 130, including its concavity, provides relatively more secure entrapment of the material 10 during the procedure. Similar to the tapered proximal portion 78 of the expansion balloon 44, the tapered proximal portion 118 of the expansion balloon 114 allows for gradual expansion of the ampulla 22 at the entrance to the duodenum 18. Additionally, similar to the intermediate portion 80 of the expansion balloon 44, the intermediate portion 120 of the expansion balloon 114 serves as an "anchor" that reduces the likelihood of the expansion balloon slipping into or out of the ampulla 22 during the endoscopic procedure.

[0078] Additionally, Figures 7A to 7C The expansion balloon 132 of the illustrated embodiment similarly provides widening of the bile duct 12 directly proximal of the material 10, which reduces potential trauma to the bile duct 12 by the material 10 and improves maneuverability of the medical device 32. Similar to the tapered proximal portion 78 of the expansion balloon 44, the tapered proximal portion 136 of the expansion balloon 132 allows for gradual expansion of the ampulla 22 at the entrance to the duodenum. Additionally, similar to the intermediate portion 80 of the expansion balloon 44, the intermediate portion 140 of the expansion balloon 132 serves as an "anchor" that reduces the likelihood of the expansion balloon slipping into or out of the ampulla 22 during the endoscopic procedure. The expansion balloon 132 of this embodiment, and in particular the proximal biconvex portion 138 of the expansion balloon 132, accounts for variations in anatomy that can require a larger portion of the expansion balloon 132 proximal of the treatment portion 38 nearest the duodenum 18 during the endoscopic procedure.

[0079] Additionally, by positioning and inflating the expansion balloon 44 of the medical device 32, as described herein, the lumen on the proximal side of the material 10 can be increased or expanded in a controlled manner, thereby reducing the force required to pull the material 10 out of the bile duct 12 and, in turn, reducing the risk of the extraction member 46 breaking if the extraction member 46 is a balloon. The hourglass shape of the expansion balloon 44 provides for smooth stretching of the bile duct 12 and / or the ampulla 22 during the endoscopic procedure, and in particular during extraction of the material 10. Additionally, in the event that the bile duct 12 of the subject is a "sigmoid" bile duct, e.g., curved or crescent shaped, the expansion balloon 44 enlarges the bile duct 12, thereby reducing the need for twisting by the operator performing the procedure.

[0080] Further, with the medical device 32 and related methods 800 described herein, a single device is provided for use in endoscopic procedures, such as during EPBD. Thus, problems associated with use of multiple devices can be eliminated and / or reduced, including tangling of the devices during their insertion or exchange, loss of positioning of the guide wire, increased cost associated with the procedure, increased time required to complete the procedure, increased invasiveness and morbidity of the subject’s gastrointestinal tract, and increased risk of infection or injury to the subject.

[0081] While the principles of the application have been described herein with reference to illustrative examples for particular applications, it is to be understood that the application is not limited to the examples described herein. Additional modifications, applications and equivalents of the described examples will occur to one skilled in the art having the benefit of the teachings provided herein. Therefore, the present application should not be considered limited to the foregoing description.

Claims

1. A medical device comprising: Tube; A sheath, the sheath being disposed around the tube and coaxial with the tube; An inflatable balloon disposed at the distal end of the sheath, the balloon being configured to receive fluid from a cavity in the sheath, and the balloon having: The tube extends into the central opening along the longitudinal axis of the balloon; Proximal portion; The middle portion adjacent to the proximal portion and distal to the proximal portion; A distal portion adjacent to and far from the intermediate portion, wherein the distal portion includes a surface facing the distal side; as well as The neck extends distally from the distally facing surface; In response to inflation, the maximum diameter of the middle portion is less than or equal to the maximum diameter of the proximal portion, and less than the maximum diameter of the distal portion; Wherein, in the inflated state of the balloon, the neck and the distally facing surface form an acute or right angle therebetween, and An extraction member is disposed at the distal end of the tube, distal to the balloon, and is axially movable relative to the balloon.

2. The medical device of claim 1, wherein the distal end of the sheath is positioned within the central opening of the balloon.

3. The medical device of claim 1, wherein the extraction member has a central opening along the longitudinal axis of the extraction member, and the tube extends into the central opening.

4. The medical device according to claim 1, wherein the extraction component is one of the following: A balloon, the balloon being configured to receive fluid from the lumen of the tube; and net.

5. The medical device of claim 1, wherein the proximal portion of the balloon includes a proximal conical portion.

6. The medical device of claim 1, wherein the proximal portion of the balloon comprises a spherical distal portion and a proximal conical portion.

7. The medical device of claim 1, wherein the distal portion of the balloon is cylindrical.

8. The medical device of claim 1, wherein the distal portion of the balloon is spherical.

9. The medical device according to any of the preceding claims, wherein the maximum diameter of the proximal portion is equal to the maximum diameter of the intermediate portion of the balloon.

10. The medical device according to any one of claims 1 to 8, wherein the maximum diameter of the proximal portion is smaller than the maximum diameter of the distal portion of the balloon.

11. The medical device according to any one of claims 1-8, wherein, with respect to the longitudinal axis of the balloon, the length of the proximal portion of the balloon is greater than each of the length of the distal portion and the length of the intermediate portion, and the length of the intermediate portion is less than or equal to the length of the distal portion.

12. The medical device according to any one of claims 1-8, wherein the tube includes a distal opening, and the lumen of the tube is configured to receive a guidewire capable of extending beyond the distal opening of the tube.

13. The medical device according to any one of claims 1-8, wherein the distal surface of the distal portion of the balloon is concave, and the neck is fixed to the tube.

14. The medical device according to any one of claims 1-8, wherein the distal surface of the distal portion of the balloon defines a radially inward recess extending proximally toward the intermediate portion of the balloon.

15. The medical device of claim 14, wherein the recess extends proximally to a depth less than or equal to half the longitudinal length of the distal portion of the balloon.

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