Catheter System
The catheter system addresses buckling and twisting issues by using a flexible outer tube, inner tube, and rotation restricting mechanism to ensure safe and effective treatment of occluded fallopian tubes.
Patent Information
- Application Number
- JP2021020748
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-02-12
- Publication Date
- 2024-12-20
- Estimated Expiration
- 2041-02-12
AI Technical Summary
Existing catheter systems require a large pushing force to spread occluded fallopian tube lesions, which can cause buckling and deformation of the balloon due to excessive compressive force, risking damage to the insertion portion.
A catheter system with a flexible outer tube, an inner tube, and a tubular balloon that inflates radially, supported by a linear insertion section, featuring a rotation restricting portion to prevent twisting and a rigid insertion base to suppress buckling, ensuring the balloon protrudes correctly without deformation.
The system effectively prevents buckling and twisting of the balloon, allowing safe and efficient treatment of occluded fallopian tubes by maintaining structural integrity during the application of large compressive forces.
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Abstract
Description
[Technical field]
[0001] The present invention ,mosquito Regarding catheter systems. [Background technology]
[0002] For example, Patent Document 1 discloses a catheter system including a balloon catheter for treating diseased parts (stenosis or obstruction) of fallopian tubes and a fallopian tube scope (endoscope). The balloon catheter includes a flexible outer tube, an inner tube disposed in the lumen of the outer tube so as to be movable in the axial direction relative to the outer tube, and a tubular balloon that connects the tip end of the outer tube with the tip end of the inner tube and expands radially inward of the outer tube.
[0003] Between the outer surface of the balloon and the inner surface of the outer tube, an outer space is formed through which a balloon expansion fluid flows for expanding the balloon radially inward. In fallopianoscopic salpingoplasty, the balloon is supported in an inflated state by the linear insertion part of the fallopianoscope inserted into the inner cavity of the balloon, and a pushing force toward the tip direction is transmitted from the inner tube to the balloon, causing the tip of the balloon to turn back and protrude from the tip opening of the outer tube and be inserted into the fallopian tube orifice. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Patent No. 3921108 Summary of the Invention [Problem to be solved by the invention]
[0005] In the above-mentioned fallopianoscopic salpingoplasty, in cases where the diseased part of the fallopian tube is completely blocked, a relatively large pushing force may be required to push open the diseased part with the balloon. If the pushing force is excessive, a large axial compressive force acts on the balloon, and there is a risk that the balloon and the insertion part will buckle and deform inside the outer tube (in the outer space).
[0006] The present invention has been made in consideration of such problems, and is capable of suppressing buckling deformation of the insertion part inside the outer tube while suppressing twisting of the balloon. Ruka The object of the present invention is to provide a catheter system. [Means for solving the problem]
[0009] The present invention oneAccording to one aspect, there is provided a catheter system including a balloon catheter having a flexible outer tube, an inner tube disposed in the inner cavity of the outer tube so as to be movable in an axial direction relative to the outer tube, a tubular balloon connecting a distal end of the outer tube with a distal end of the inner tube and expanding radially inwardly of the outer tube, and a medical device having a linear insertion portion to be inserted into the inner cavity of the balloon, wherein an outer space through which a balloon expansion fluid for expanding the balloon flows is formed between an outer surface of the balloon and an inner surface of the outer tube, and the balloon is inflated by the balloon expansion fluid and supported by the insertion portion, and a pushing force in the distal direction is transmitted from the inner tube to the balloon, thereby expanding the balloon. a tip end of the balloon protrudes in the tip direction from a tip opening of the outer tube while being turned over, the inner tube is provided with a rotation restricting portion that is formed so as to protrude radially outward from an outer surface of the balloon and that restricts circumferential rotation of the inner tube relative to the outer tube by contacting an inner surface of the outer tube, the rotation restricting portion slides in the lumen of the outer tube in the tip direction as the pushing force is transmitted from the inner tube to the balloon, the insertion portion includes an insertion base portion extending along the axial direction of the outer tube and an insertion tip portion extending in the tip direction from the tip of the insertion base, the rigidity of the insertion base portion is higher than the rigidity of the insertion tip portion, and the length of the insertion tip portion in the axial direction of the outer tube is shorter than the length of the balloon. The medical device is an endoscope, the outer diameter of the insertion base portion is larger than the outer diameter of the insertion tip portion, the outer tube has an outer tube base portion and an outer tube tip portion extending from the tip of the outer tube base toward the tip portion, the outer diameter of the outer tube tip portion is the same as the outer diameter of the outer tube base, and the wall thickness of the outer tube tip portion is thicker than the wall thickness of the outer tube base. It is a catheter system. Effect of the Invention
[0011] The present invention one According to this embodiment, the rigidity of the insertion base portion is higher than that of the insertion tip portion, and the length of the insertion tip portion in the axial direction of the outer tube is shorter than the length of the balloon. Therefore, even if a relatively large axial compressive force acts on the balloon, the insertion base portion can efficiently prevent the insertion portion from buckling. In addition, the rotation restriction portion provided on the inner tube restricts the rotation of the inner tube relative to the outer tube, thereby suppressing twisting of the balloon. [Brief description of the drawings]
[0012] [Figure 1] 1 is a schematic configuration diagram of a catheter system according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a longitudinal sectional view of the catheter system of FIG. 1, with a portion thereof omitted. [Diagram 3] FIG. 3 is an enlarged cross-sectional view of the distal end side of the catheter system of FIG. 2, with a portion thereof omitted. [Figure 4] 4A is a cross-sectional view taken along line IVA-IVA in FIG. 3, FIG. 4B is a cross-sectional view taken along line IVB-IVB in FIG. 3, and FIG. 4C is a cross-sectional view taken along line IVC-IVC in FIG. [Diagram 5] 5A is a partial cross-sectional explanatory view of an insertion portion of the endoscope in FIG. 1, and FIG. 5B is an enlarged cross-sectional explanatory view of a covering portion in FIG. 5A. [Figure 6] FIG. 2 is a first explanatory diagram of salpingoscopic salpingoplasty using the catheter system of FIG. 1. [Figure 7] FIG. 2 is a second explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 8] FIG. 3 is a third explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 9] FIG. 4 is a fourth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 10] FIG. 5 is a fifth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 11] FIG. 6 is a sixth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 12] FIG. 1 is an explanatory longitudinal sectional view showing an example of the configuration of a balloon catheter. [Figure 13] FIG. 2 is an explanatory longitudinal sectional view showing an example of the configuration of an endoscope. [Figure 14] FIG. 5 is a longitudinal sectional view of a catheter system according to a second embodiment of the present invention, with a portion thereof omitted. [Figure 15] FIG. 15A is a longitudinal sectional explanatory view showing another configuration example of an endoscope, and FIG. 15B is a longitudinal sectional explanatory view showing another configuration example of an endoscope. [Figure 16] FIG. 13 is an explanatory vertical cross-sectional view showing still another configuration example of the endoscope. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] The following relates to the present invention. Ruka A preferred embodiment of the catheter system will now be described with reference to the accompanying drawings.
[0014] (First embodiment) As shown in Fig. 1, a catheter system 10 according to the first embodiment of the present invention includes a balloon catheter 12 and an endoscope 14 (falling tube scope) which is a medical device. For convenience, Figs. 2 to 4C and 6 to 11 show a simplified cross section of the endoscope 14. As shown in Figs. 6 to 11, the catheter system 10 is used, for example, in fallopian tube endoscopic salpingoplasty for treating a lesion 204 (such as a stenosis or obstruction) of a fallopian tube 202. However, the catheter system 10 may be used to treat a lesion in a biological tube other than the fallopian tube 202, such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, a large intestine, or another organ.
[0015] In the following description of the catheter system 10, the left side in FIG. 1 (the direction of the arrow X1) is referred to as the "distal end," and the right side in FIG. 1 (the direction of the arrow X2) is referred to as the "proximal end."
[0016] As shown in FIGS. 1 and 2, the balloon catheter 12 includes an outer catheter 16, a slider 18 provided on the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a balloon 22.
[0017] The outer catheter 16 has a long, flexible outer tube 24, an outer tube hub 26 (outer tube operating portion) provided at the base end of the outer tube 24, and a fixing screw 28 provided on the outer tube hub 26. The overall length of the outer tube 24 is preferably set to be 100 mm or more and 1500 mm or less, and more preferably set to be 200 mm or more and 1000 mm or less.
[0018] 3, the outer tube 24 includes an outer tube main body 30 and a tip member 32 (tip tip) provided at the tip of the outer tube main body 30. Examples of materials constituting the outer tube main body 30 and the tip member 32 include polyolefin (e.g., polyethylene, polypropylene, polybutene, etc.), polyester (e.g., polyethylene terephthalate, etc.), elastomer resin (e.g., polyolefin elastomer, polyester elastomer, polyamide elastomer, fluororesin elastomer, polyurethane elastomer, etc.), flexible polymeric material (polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, etc.
[0019] As shown in Figs. 3 to 4B, the outer tube main body 30 is formed with a first lumen 34 penetrating from the tip to the base end. The outer tube main body 30 has an outer tube base 36 extending in the direction of the arrow X, and an outer tube tip portion 38 extending from the tip of the outer tube base 36 in the tip direction (arrow X1 direction). The first lumen 34 includes a base end side lumen 40 provided in the outer tube base 36, and a tip side lumen 42 provided in the outer tube tip portion 38. The tip side lumen 42 communicates with the base end side lumen 40 in the tip direction (arrow X1 direction). That is, the inner surface of the outer tube 24 includes a base end side inner surface 43 which is the inner surface of the outer tube base 36, and a tip side inner surface 44 which is the inner surface of the outer tube tip portion 38.
[0020] As shown in FIG. 3, the length L1 of the outer pipe tip portion 38 is shorter than the length L2 of the outer pipe base portion 36. The length L1 of the outer pipe tip portion 38 is preferably set to, for example, 30 mm or more and 80 mm or less, more preferably set to 40 mm or more and 70 mm or less, and even more preferably set to 50 mm or more and 60 mm or less. The outer pipe tip portion 38 is shaped so as to be curved in an arc shape in the axial direction. The outer diameter of the outer pipe tip portion 38 is the same as the outer diameter of the outer pipe base portion 36. In other words, the outer pipe main body 30 has a generally constant outer diameter over the entire length. The wall thickness T1 of the outer pipe tip portion 38 is thicker than the wall thickness T2 of the outer pipe base portion 36.
[0021] In FIG. 4A, the base end inner surface 43 has a curved surface 46 whose cross section is an arc, and a flat surface 48 connected to the curved surface 46. The curved surface 46 extends 180° or more in the circumferential direction of the balloon 22. In FIG. 4B, the tip end inner surface 42 is formed in a circular shape. That is, the tip end inner surface 44 has a circular cross section. The area of the tip end inner surface 42 as viewed from the direction of arrow X is smaller than the area of the base end inner surface 40 as viewed from the direction of arrow X. However, the cross-sectional shapes of the base end inner surface 40 and the tip end inner surface 42 can be changed as appropriate.
[0022] 3 and 4B, the tip side inner surface 44 is located radially inward of the outer tube 24 relative to the base side inner surface 43. In Fig. 3, an inclined inner surface 50 that is tapered and inclined radially inward of the outer tube 24 toward the tip side (arrow X1 direction) is formed at the connecting portion between the tip side inner surface 44 and the base side inner surface 43. However, a step surface extending in a direction perpendicular to the arrow X direction may be formed at the connecting portion between the tip side inner surface 44 and the base side inner surface 43.
[0023] The outer surface of the tip member 32 is curved to prevent damage to the balloon catheter 12 or living tissue. The tip member 32 is formed with a balloon outlet hole 52 for leading the balloon 22 in the distal direction (arrow X1 direction) from the tip member 32. The balloon outlet hole 52 communicates with a tip opening 54 of the outer tube 24.
[0024] 1 and 2, the outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, etc.
[0025] In FIG. 2, the outer tube hub 26 is formed hollow and has a size that makes it easy to operate by hand. The outer tube hub 26 is provided with a first space 53 communicating with the first lumen 34 of the outer tube 24, a first insertion hole 55 located on the base end side of the first space 53 and through which the inner catheter 20 is inserted, and a first introduction port portion 56 for introducing a balloon expansion fluid into the first space 53. The balloon expansion fluid is for inflating the balloon 22 shown in FIG. 2 radially inward of the outer tube 24. The balloon expansion fluid is, for example, physiological saline. The outer tube hub 26 is provided with a first seal member 57 for preventing the balloon expansion fluid in the first space 53 from leaking to the outside through the first insertion hole 55.
[0026] The fixing screw 28 is for fixing the inner catheter 20 to the outer tube hub 26. The fixing screw 28 may be made of the same material as the outer tube hub 26.
[0027] The slider 18 is provided in a state in which it can move (slide) in the axial direction of the outer tube 24 relative to the outer peripheral surface of the outer tube body 30. The overall length of the slider 18 is shorter than the overall length of the outer tube 24. The slider 18 has a long tubular slider body 58 and a slider hub 60 (slider operation portion) provided at the base end of the slider body 58. The slider body 58 and the slider hub 60 are each made of the same material as the outer tube hub 26 described above. The slider hub 60 is formed in an annular shape with a size that makes it easy to operate by hand.
[0028] When the slider 18 is moved to the most proximal side (arrow X2 direction) relative to the outer tube main body 30 (when the proximal end of the slider 18 is positioned at the tip of the outer tube hub 26), the tip side of the outer tube main body 30 is exposed further to the tip side than the slider 18 and curves in an arc. When the slider 18 is moved to the most distal side (arrow X1 direction) relative to the outer tube main body 30, the tip side of the outer tube main body 30 extends linearly along the shape of the slider main body 58.
[0029] 1 and 2, the inner catheter 20 includes a long inner tube 62 and an inner tube hub 64 (inner tube operating section) provided at the base end of the inner tube 62. The total length of the inner tube 62 is preferably set to 100 mm or more and 1500 mm or less, and more preferably set to 200 mm or more and 1000 mm or less.
[0030] 2, the inner tube 62 is made of a relatively hard resin (e.g., fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or metal (e.g., stainless steel, titanium, titanium alloy, etc.). The inner tube 62 is formed with a second lumen 66 that penetrates from the tip to the base end.
[0031] The inner tube 62 is inserted through the outer tube hub 26 and disposed in the first lumen 34 of the outer tube main body 30. The tip of the inner tube 62 is located in the proximal direction (the direction of arrow X2) from the tip of the outer tube main body 30. Between the outer surface of the inner tube 62 and the proximal side inner surface 43 of the outer tube base 36, an outer lumen Sa (expansion lumen) through which a balloon expansion fluid flows is provided.
[0032] A long, linear insertion section 90 of the endoscope 14, which also functions as a balloon support device, is inserted into the second lumen 66 of the inner tube 62. With the insertion section 90 inserted into the second lumen 66 of the inner tube 62, an inner lumen Sb (irrigation lumen) through which a perfusion fluid flows is formed between the inner tube 62 and the insertion section 90. The perfusion fluid is, for example, physiological saline.
[0033] In Fig. 1, the inner tube hub 64 is made of the same material as the outer tube hub 26. The inner tube hub 64 is formed to be hollow. The inner tube hub 64 is provided with a second space 68 communicating with the second lumen 66 of the inner tube 62, a second insertion hole 70 located on the proximal end side of the second space 68 and through which the insertion section 90 is inserted, and a second introduction port section 72 for introducing an irrigation fluid into the second space 68. The inner tube hub 64 is provided with a second seal member 73 for preventing the irrigation fluid in the second space 68 from leaking to the outside through the second insertion hole 70.
[0034] 3, the balloon 22 is a tubular member that connects the tip of the outer tube 24 and the tip of the inner tube 62. The balloon 22 is inflated radially inward of the outer tube 24 by a balloon expansion fluid. In other words, the balloon 22 is formed to be elastically deformable in the radial direction.
[0035] The balloon 22 is preferably made of a material such as polyolefin (e.g., polyethylene, polypropylene, polybutene, etc.), polyester (polyethylene terephthalate, etc.), elastomer resin (polyolefin elastomer, polyester elastomer, polyamide elastomer, fluororesin elastomer, polyurethane elastomer, etc.), flexible polymeric material (natural rubber, ethylene-propylene copolymer, polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, etc.
[0036] One end of the balloon 22 is adhered or fused to the tip end of the outer tube 24 (the base end of the tip member 32). In other words, one end of the balloon 22 is adhered or fused to the vicinity of the base end side of the balloon lead-out hole 52 of the outer tube 24. Specifically, one end of the balloon 22 is sandwiched between the tip of the outer tube main body 30 and the tip member 32. The other end of the balloon 22 is adhered or fused to the tip end of the outer surface of the inner tube 62. In addition, the other end of the balloon 22 is fixed to the tip end of the inner tube 62 by a balloon fixing member 74. The other end of the balloon 22 may be adhered or fused to the tip end of the inner surface of the inner tube 62. The balloon 22 has an inner cavity 76 into which the insertion part 90 of the endoscope 14 can be inserted. Between the outer surface of the balloon 22 and the inner surface of the outer tube main body 30, a bag-shaped outer space Sc with a closed tip is formed.
[0037] 7 and 8, when a pushing force (pushing force in the distal direction) is transmitted from the inner tube 62 to the balloon 22, the distal end 22a of the balloon 22 is turned back and protrudes in the distal direction from the distal end opening 54 of the outer tube 24. At this time, a radially double-folded portion is formed in the protruding portion 22b of the balloon 22 that protrudes in the direction of the arrow X1 beyond the distal end opening 54 of the outer tube 24.
[0038] As shown in FIG. 3, when the balloon 22 is not inflated radially inward of the outer tube 24, the distance L3 between the tip side inner surface 44 and the outer surface of the balloon 22 is narrower than the distance L4 between the base side inner surface 43 and the outer surface of the balloon 22.
[0039] 4C, the balloon catheter 12 has a rotation restricting portion 78 that is provided at the tip of the inner tube 62 and restricts circumferential rotation of the inner tube 62 relative to the outer tube 24. The rotation restricting portion 78 has an annular portion 80 and two protrusions 82a, 82b that protrude radially outward from the outer circumferential surface of the annular portion 80.
[0040] The inner peripheral surface of the annular portion 80 is fixed (adhered or fused) to the outer peripheral surface of the inner tube 62. That is, the inner tube 62 is inserted through the inner cavity of the annular portion 80. The outer peripheral surface of the annular portion 80 is in contact with the curved surface 46 and the flat surface 48. The two protrusions 82a, 82b are arranged offset toward the flat surface 48 from the center of the annular portion 80. The protrusion 82a is located on one side of a line segment La that is perpendicular to the flat surface 48 and passes through the center of the annular portion 80 (below the line segment La in FIG. 4C). The protrusion 82b is located on the other side of the line segment La (above the line segment La in FIG. 4C). The two protrusions 82a, 82b are close to the flat surface 48. Each of the protrusions 82a, 82b extends over the entire length of the annular portion 80 along the direction of the arrow X. Each of the protrusions 82a, 82b has an outer circumferential surface whose cross section is arc-shaped.
[0041] 4C relative to the outer tube 24, the convex portion 82a comes into contact with the flat surface 48, thereby suppressing twisting of the balloon 22 in the direction of the arrow R1. Also, when the inner tube 62 rotates in the direction of the arrow R2 in FIG. 4C relative to the outer tube 24, the convex portion 82b comes into contact with the flat surface 48, thereby suppressing twisting of the balloon 22 in the direction of the arrow R2.
[0042] 2 and 3, the endoscope 14 is an fallopian tube scope for observing the fallopian tube 202 (see FIG. 6). The endoscope 14 includes a flexible insertion section 90 inserted into the second lumen 66 of the inner tube 62 of the balloon catheter 12 and the lumen 76 of the balloon 22.
[0043] The insertion portion 90 includes an insertion base portion 92 extending in the axial direction (the direction of arrow X) of the outer tube 24, and an insertion tip portion 94 extending from the tip of the insertion base portion 92 in the tip direction (the direction of arrow X1).
[0044] The outer diameter D1 of the insertion base portion 92 is larger than the outer diameter D2 of the insertion tip portion 94. Specifically, the outer diameter D1 of the insertion base portion 92 is preferably set to be 140% or less of the outer diameter D2 of the insertion tip portion 94, and more preferably set to be 110% or more and 120% or less. The rigidity of the insertion base portion 92 is higher than the rigidity of the insertion tip portion 94.
[0045] 5A, specifically, the insertion section 90 includes a tube body 98, a lens unit 100, a light guide 102, an image guide 104, and a covering section 106. The tube body 98 is flexible. The tube body 98 is made of, but is not limited to, a resin material such as polyimide, polyurethane, polyethylene, polytetrafluoroethylene (PTFE), or a composite material of these resin materials.
[0046] The lens unit 100 is provided at the tip of the tube body 98. The lens unit 100 includes an objective lens. The lens unit 100 may include a plurality of lenses. The light guide 102 is a light guiding member that guides light from a light source (e.g., an LED) (not shown) provided on the base end side of the insertion portion 90 to the tip of the insertion portion 90. The number of light guides 102 is not particularly limited, and may be one or more.
[0047] The light guide 102 is formed, for example, by bundling a plurality of optical fibers. However, the light guide 102 may be formed from a single optical fiber. As the optical fiber, for example, a plastic optical fiber whose core and clad are made of plastic is used. However, the optical fiber may also be a glass optical fiber whose core and clad are made of glass (for example, quartz glass).
[0048] The image guide 104 is a transmission member that guides the image obtained by the lens unit 100 to the base end side of the insertion section 90. The image guide 104 is disposed coaxially with the lens unit 100. The image guide 104 is formed of an optical fiber similar to the light guide 102 described above.
[0049] 5B, the covering portion 106 covers the outer peripheral surface of the tube body 98 except for the tip portion. Here, the covering portion 106 is not provided at the tip portion of the tube body 98. The portion of the insertion portion 90 where the covering portion 106 is provided forms the insertion base portion 92. The portion of the insertion portion 90 where the covering portion 106 is not provided forms the insertion tip portion 94.
[0050] The covering portion 106 is formed, for example, by applying (coating) a plurality of layers of a resin member 108 to the outer circumferential surface of the tube body 98. The resin member 108 is made of the same material as that of the tube body 98 described above. The plurality of resin members 108 may be made of the same material or may be made of different materials. The tips of the plurality of resin members 108 are positioned more displaced toward the base end as they are positioned radially outward of the tube body 98. As a result, an inclined outer surface 96 is formed at the connection portion between the outer surface of the insertion tip portion 94 and the outer surface of the insertion base portion 92, the inclined outer surface 96 being tapered and inclined radially outward of the insertion portion 90 toward the base end direction of the insertion portion 90 (the direction of the arrow X2).
[0051] In order to reduce sliding resistance, a fluorine coating (not shown) is applied to the outer surface of the covering portion 106 and the outer surface of the tube body 98. The tube body 98 and the resin member 108 may be made of a resin material (composite material) containing a fluorine coating.
[0052] Of the multiple resin members 108, the resin member 108 in the innermost layer may extend to the tip of the tube body 98. In this case, the range in which the second layer of resin member 108 from the inside is provided forms the insertion base portion 92, and the portion distal to the insertion base portion 92 forms the insertion tip portion 94. In this way, when the resin member 108 is made of a material having higher slidability than the tube body 98, the resin member 108 in the innermost layer can increase the slidability of the insertion tip portion 94. The tip of the resin member 108 in the innermost layer may be located before the tip of the tube body 98 (in the base end direction).
[0053] Moreover, the outermost resin member 108 among the multiple resin members 108 may extend to the tip of the tube body 98. In this case, the range in which the innermost resin member 108 is provided forms the insertion base 92, and the tip side of the insertion base 92 forms the insertion tip portion 94. As a result, the tip portion of the resin member 108 located inside the outermost layer is covered by the outermost resin member 108, so that it is possible to prevent the resin member 108 from peeling off from the position of the inclined outer surface 96 during operation of the insertion portion 90. Furthermore, if the resin member 108 is made of a material having higher slidability than the tube body 98, the outermost resin member 108 can increase the slidability of the insertion tip portion 94. The tip of the outermost resin member 108 may be located before the tip of the tube body 98 (in the base end direction).
[0054] In this embodiment, the inclined outer surface 96 is formed by stacking a plurality of resin members 108 such that the tip positions are offset, but the inclined outer surface 96 may be formed by any suitable method.
[0055] The covering portion 106 may not have the inclined outer surface 96. That is, the covering portion 106 may have a tip surface (a tip surface oriented in the direction of the arrow X1) perpendicular to the axial direction of the tube body 98. In other words, a step surface extending in a direction perpendicular to the axial direction of the insertion portion 90 may be formed at the connection portion between the outer surface of the insertion tip portion 94 and the outer surface of the insertion base portion 92. The covering portion 106 may be formed by immersing (dipping) the tube body 98 in molten resin and baking it at a high temperature. The covering portion 106 may also be formed by spraying a solvent onto the outer peripheral surface of the tube body 98.
[0056] 3, in the axial direction of the outer tube 24, the length L5 of the insertion tip portion 94 is shorter than the length L6 of the insertion base portion 92. Specifically, the length L5 of the insertion tip portion 94 is preferably set to 20 mm or more and 50 mm or less, and more preferably set to 30 mm or more and 40 mm or less. The length L6 of the insertion base portion 92 is preferably set to, for example, 200 mm or more and 400 mm or less, and more preferably set to about 300 mm.
[0057] Such a catheter system 10 is set so that, in an initial state, the entire insertion tip section 94 is located in the tip side lumen 42 of the outer tube tip section 38 and the insertion base section 92 is located in the base side lumen 40 of the outer tube base section 36. However, in the initial state of the catheter system 10, a part of the tip side of the insertion base section 92 may be located in the tip side lumen 42 of the outer tube tip section 38. Also, in the initial state of the catheter system 10, the tip of the insertion tip section 94 is located on the base side of the tip opening 54 of the outer tube 24.
[0058] Furthermore, as shown in FIG. 7, when the balloon 22 is inflated radially inward of the outer tube 24, the inner diameter D3 of the outer tube tip portion 38 is set to be less than three times the outer diameter D4 of the portion of the balloon 22 that is in close contact with the outer surface of the insertion tip portion 94.
[0059] Next, a salpingoscopic salpingoplasty using the catheter system 10 configured as described above will be described.
[0060] In fallopianoscopic salpingoplasty, the above-mentioned catheter system 10 is prepared in a preparation step. The balloon catheter 12 and the endoscope 14 are in the initial positional relationship of the above-mentioned catheter system 10 (as shown in FIG. 3). At this time, the user fixes the inner tube 62 by using the fixing screw 28 in a state where the inner tube 62 is fully pulled toward the base end side (in the direction of the arrow X2). Furthermore, the slider 18 is slid relative to the outer tube 24 in the direction of the tip of the outer tube 24 to straighten the tip side of the outer tube main body 30.
[0061] Next, in the insertion step, the user inserts the balloon catheter 12 transcervically to the uterine fundus 200 (see FIG. 6). Then, in the sliding step, the slider 18 is pulled back relative to the outer tube 24 in the direction of the base end of the outer tube 24. As a result, as shown in FIG. 6, the tip side of the outer tube main body 30 is exposed from the slider 18 and assumes a curved shape. At this time, the user positions the tip of the insertion section 90 of the endoscope 14 at the tip opening 54 of the outer tube 24, and confirms the tubal orifice 202a on the image captured by the endoscope 14.
[0062] Then, the user tightens the fixing screw 28 while returning the insertion section 90 of the endoscope 14 to the initial position (the position shown in FIG. 6), and then performs the balloon extraction process. Specifically, as shown in FIG. 7, a balloon expansion fluid is supplied to the first introduction port section 56 (pressurization process). Then, the balloon expansion fluid is supplied from the first introduction port section 56 through the outer lumen Sa to the outer space Sc of the balloon 22. Then, the balloon 22 is pressed radially inward by the balloon expansion fluid supplied to the outer space Sc, and elastically deforms. That is, the portion of the balloon 22 located on the outer periphery side of the insertion section 90 is in close contact with the outer periphery surface of the insertion section 90. The inner surfaces of the portions of the balloon 22 located on the tip side of the tip of the insertion section 90 are in contact with each other.
[0063] Thereafter, with the fixing screw 28 loosened, the user operates the inner tube hub 64 to advance the inner tube 62 relative to the outer tube 24 (advancing step). Then, as shown in Fig. 8, the balloon 22, pushed in the distal direction by the inner tube 62, advances together with the insertion portion 90 relative to the outer tube 24. In other words, the pushing force is transmitted from the inner tube 62 to the balloon 22, so that the balloon 22 protrudes together with the insertion portion 90 in the distal direction (arrow X1 direction) from the distal opening 54 of the outer tube 24.
[0064] In the forward movement step, since one end of the balloon 22 is fixed to the tip of the outer tube 24, the balloon 22 advances while its tip 22a (protruding end) is turned up. That is, the balloon 22 is turned up at its tip 22a (protruding end) so that the inner surface faces outward. Therefore, the balloon 22 advances a distance equivalent to half the advancement distance of the insertion part 90. At this time, the insertion base part 92 is inserted into the tip side lumen 42 of the outer tube tip part 38.
[0065] Next, the user determines whether or not the balloon 22 has reached the lesion 204 based on the image captured by the endoscope 14. If the balloon 22 is located in front of the lesion 204, the balloon inflation fluid is depressurized and perfusion fluid (perfusion fluid) is supplied to the second introduction port 72 (depressurization step). This allows the perfusion fluid to flow between the balloon 22 and the insertion section 90 of the endoscope 14 via the inner lumen Sb. Next, the user moves the endoscope 14 backward a predetermined distance as shown in FIG. 9 (retraction step). Thereafter, the pressurization step and advancement step described above are performed again.
[0066] 10, when the distal end of the balloon 22 comes into contact with the lesion 204 during the forward movement process, a relatively large axial compressive force acts on the balloon 22 when the user pushes the inner tube 62 in the distal direction. Such a compressive force is likely to be large when the lesion 204 is completely occluded.
[0067] However, since the rigidity of the insertion base portion 92 is higher than the rigidity of the insertion tip portion 94, buckling deformation of the insertion base portion 92 is suppressed. Also, since the tip side inner surface 44 is located radially inward of the outer tube 24 relative to the base side inner surface 43, the outer surface of the balloon 22 comes into contact with the tip side inner surface 44 before the balloon 22 and the insertion tip portion 94 significantly deform in a direction intersecting the axial direction. Therefore, buckling deformation of the insertion tip portion 94 is suppressed.
[0068] 11, when the balloon 22 completely passes through the lesion 204, the lesion 204 is expanded by the balloon 22. That is, the stenosis or blockage of the fallopian tube 202 is improved.
[0069] After expanding the lesion 204, the user reduces the pressure of the balloon inflation fluid and then removes the balloon catheter 12 and the endoscope 14 (removal step). Note that before removing the balloon catheter 12, the user may inject irrigation fluid through the second introduction port 72 while pulling the inner tube 62 to retract the balloon 22, and at the same time operate the endoscope 14 to be positioned at the tip of the balloon 22, thereby removing the balloon catheter 12 while observing the inside of the fallopian tube 202 during the removal step. This completes the fallopianoscopic salpingoplasty.
[0070] This embodiment provides the following advantages.
[0071] According to the balloon catheter 12, the distal inner surface 44 is located radially inward of the outer tube 24 relative to the base inner surface 43, so that the gap (distance L3) between the outer surface of the balloon 22 and the distal inner surface 44 can be made relatively narrow. As a result, when a relatively large axial compressive force acts on the balloon 22, the outer surface of the balloon 22 can be brought into contact with the distal inner surface 44 before the balloon 22 and the insertion part 90 are significantly deformed in a direction intersecting the axial direction, so that buckling deformation of the insertion part 90 can be suppressed. In addition, the rotation of the inner tube 62 relative to the outer tube 24 is restricted by the rotation restricting part 78 provided on the inner tube 62, so that twisting of the balloon 22 can be suppressed.
[0072] The outer diameter of the outer tube tip portion 38 is the same as the outer diameter of the outer tube base portion 36 .
[0073] According to this configuration, no steps are formed on the outer surface of the outer tube body 30, so that the balloon catheter 12 can be smoothly inserted into the uterus.
[0074] The wall thickness T1 of the outer tube tip portion 38 is thicker than the wall thickness T2 of the outer tube base portion 36.
[0075] According to such a configuration, the distal end side inner surface 44 can be positioned radially inward of the proximal end side inner surface 43 of the outer tube 24 with a simple configuration.
[0076] In the catheter system 10, the insertion section 90 includes an insertion base section 92 extending along the axial direction of the outer tube 24, and an insertion tip section 94 extending in the distal direction from the tip of the insertion base section 92. The rigidity of the insertion base section 92 is higher than the rigidity of the insertion tip section 94.
[0077] According to this configuration, when a relatively large compressive force in the axial direction is applied to the balloon 22, the insertion base portion 92 can be prevented from buckling and deforming.
[0078] In the axial direction of the outer tube 24, the length L5 of the insertion tip portion 94 is shorter than the length L1 of the outer tube tip portion .
[0079] According to this configuration, in the initial state of the catheter system 10, the entire insertion tip portion 94 can be disposed in the tip side lumen 42 of the outer tube tip portion 38. Therefore, when a relatively large compressive force in the axial direction acts on the balloon 22, buckling deformation of the insertion tip portion 94 can be efficiently suppressed.
[0080] The outer diameter D 1 of the insertion base portion 92 is larger than the outer diameter D 2 of the insertion tip portion 94 .
[0081] According to this configuration, the rigidity of the insertion base portion 92 can be made higher than the rigidity of the insertion tip portion 94 with a simple configuration (for example, by providing the covering portion 106).
[0082] The catheter system 10 may include a balloon catheter 12a shown in Fig. 12 instead of the balloon catheter 12. In the balloon catheter 12a, the same components as those in the balloon catheter 12 described above are given the same reference numerals, and the description thereof will be omitted. In Fig. 12, a cross section of the endoscope 14 is shown in a simplified manner.
[0083] As shown in Fig. 12, the balloon catheter 12a includes an outer catheter 16a, a slider 18, an inner catheter 20, and a balloon 22. The outer tube 24a of the outer catheter 16a includes an outer tube main body 30a, a tip member 32, and a tube member 101 provided on the inner surface of the tip portion 99 of the outer tube main body 30a. The shape and size of the lumen of the outer tube main body 30a are generally constant over its entire length. The tip of the tube member 101 is located at the tip of the outer tube main body 30a. The outer peripheral surface of the tube member 101 is fixed to the inner peripheral surface of the outer tube main body 30a.
[0084] The outer tube main body 30a on the proximal side of the tube member 101 forms the outer tube base 36. The distal end 99 of the outer tube main body 30a (the part of the outer tube main body 30a overlapping with the tube member 101) and the tube member 101 form the outer tube distal end 38a. That is, the inner cavity of the tube member 101 forms the distal end inner cavity 42. The balloon 22 is inserted into the distal end inner cavity 42. The inner surface of the tube member 101 forms the distal end inner surface 44. An outer space Sc is formed between the distal end inner surface 44 and the outer surface of the balloon 22, through which a balloon expansion fluid for inflating the balloon 22 flows. In the axial direction of the outer tube 24a, the length of the outer tube distal end 38a is set to be the same as the length of the outer tube distal end 38 described above.
[0085] In this configuration example, the outer tube 24a has an outer tube main body 30a and a tube member 101 provided on the inner surface of the tip portion 99 of the outer tube main body 30a. The inner surface of the tube member 101 forms the tip side inner surface 44. The portion of the inner surface of the outer tube main body 30a that is closer to the base end than the tube member 101 forms the base side inner surface 43.
[0086] According to such a configuration, the distal end side inner surface 44 can be positioned radially inward of the proximal end side inner surface 43 of the outer tube 24a with a simple configuration.
[0087] The catheter system 10 may include an endoscope 14a shown in FIG. 13 instead of the endoscope 14 described above. As shown in FIG. 13, the insertion section 90a of the endoscope 14a is configured similarly to the above-described insertion section 90, except that it does not have a covering section 106. That is, the insertion section 90a has a generally constant outer diameter over its entire length. In other words, in the insertion section 90a, the outer diameter of the insertion base section 92a is the same as the outer diameter of the insertion tip section 94a. Even with such an endoscope 14a, buckling deformation of the insertion section 90a can be suppressed by combining it with the balloon catheters 12, 12a described above.
[0088] Second embodiment Next, a catheter system 10A according to a second embodiment of the present invention will be described with reference to Fig. 14. In the catheter system 10A, the same components as those in the above-mentioned catheter system 10 are given the same reference numerals, and the description thereof will be omitted. Fig. 14 shows a simplified cross section of the endoscope 14.
[0089] 14, a catheter system 10A according to this embodiment includes a balloon catheter 12b and an endoscope 14. The balloon catheter 12b has an outer catheter 16b, a slider 18, an inner catheter 20, and a balloon 22. The outer tube 24b of the outer catheter 16b includes an outer tube body 30a and a tip member 32. The shape and size of the lumen of the outer tube body 30a are generally constant over its entire length.
[0090] When the endoscope 14 is used in combination with such a balloon catheter 12b, the length L5 of the insertion tip 94 and the length L6 of the insertion base 92 of the endoscope 14 are preferably set as follows: That is, the length L5 of the insertion tip 94 of the endoscope 14 is preferably set to 20 mm or more and 150 mm or less, and more preferably set to 30 mm or more and 120 mm or less. The length L6 of the insertion base 92 is preferably set to, for example, 150 mm or more and 400 mm or less, and more preferably set to 180 mm or more and 300 mm or less.
[0091] According to this embodiment, the endoscope 14 (the endoscope 14 having the insertion base portion 92 and the insertion tip portion 94) is provided as described above. That is, the rigidity of the insertion base portion 92 is higher than that of the insertion tip portion 94, and the length L5 of the insertion tip portion 94 in the axial direction of the outer tube 24b is shorter than the length of the balloon 22. Therefore, even if a relatively large compressive force in the axial direction acts on the balloon 22, the insertion base portion 92 (insertion portion 90) can be efficiently prevented from buckling and deforming. In addition, the rotation of the inner tube 62 relative to the outer tube 24b is restricted by the rotation restricting portion 78 provided on the inner tube 62, so that twisting of the balloon 22 can be suppressed.
[0092] The catheter system 10A may include an endoscope 14b shown in Fig. 15A instead of the above-described endoscope 14. In the endoscope 14b, the same components as those in the above-described endoscope 14 are denoted by the same reference numerals, and the description thereof will be omitted.
[0093] 15A, the insertion section 90b of the endoscope 14b includes an insertion base portion 92b and an insertion tip portion 94. The insertion base portion 92b includes a tube body 98 and a reinforcing member 110 that is provided in the inner cavity of the tube body 98 and extends along the axial direction of the insertion section 90b.
[0094] The reinforcing member 110 is formed of a material having a higher strength than the tube body 98. Examples of the material of the reinforcing member 110 include metal and resin materials. The reinforcing member 110 extends over the entire length of the insertion base portion 92b. The outer diameter (thickness), length, arrangement, number, etc. of the reinforcing member 110 can be changed as appropriate.
[0095] In this configuration example, the insertion base portion 92b includes a tube body 98 and a reinforcing member 110 that is provided within the tube body 98 and extends along the axial direction of the insertion portion 90b.
[0096] According to this configuration, the rigidity of the insertion base portion 92b can be made higher than the rigidity of the insertion tip portion 94 with a simple configuration.
[0097] The endoscope 14b according to this configuration example may be used in combination with the balloon catheters 12, 12a described above.
[0098] The catheter system 10A may include an endoscope 14c shown in Fig. 15B instead of the above-described endoscope 14. In the endoscope 14c, the same components as those in the above-described endoscope 14 are denoted by the same reference numerals, and the description thereof will be omitted.
[0099] As shown in FIG. 15B, the insertion section 90c of the endoscope 14c has an insertion base section 92c, an insertion tip section 94a, and an insertion intermediate section 112. The insertion intermediate section 112 is located between the insertion base section 92c and the insertion tip section 94a. The rigidity of the insertion intermediate section 112 is lower than that of the insertion base section 92c and higher than that of the insertion tip section 94a. The sum of the length L7 of the insertion tip section 94a and the length L8 of the insertion intermediate section 112 is shorter than the length of the balloon 22 (see FIG. 14) and shorter than the length L9 of the insertion base section 92c. The length L8 of the insertion intermediate section 112 is shorter than the length L7 of the insertion tip section 94a.
[0100] Specifically, the insertion section 90c includes a tube body 98, a lens unit 100, a light guide 102, an image guide 104, and a covering section 106a. The covering section 106a covers the outer peripheral surface of the tube body 98 except for the tip portion. In other words, the covering section 106a is not provided at the tip portion of the tube body 98.
[0101] The coated portion 106a has a coated tip portion 114 and a coated base portion 116. A portion of the insertion portion 90c where the coated portion 106a is not provided forms the insertion tip portion 94a. A portion of the insertion portion 90c where the coated tip portion 114 is provided forms the insertion intermediate portion 112. A portion of the insertion portion 90c where the coated base portion 116 is provided forms the insertion base portion 92c.
[0102] The coated tip portion 114 is formed by connecting a first resin tube 118 and a second resin tube 120 provided on the outer circumferential surface of the tube body 98. The first resin tube 118 and the second resin tube 120 may be made of the same material as the tube body 98 described above. The outer diameter of the second resin tube 120 is larger than the outer diameter of the first resin tube 118. However, the outer diameter of the second resin tube 120 may be the same as the outer diameter of the first resin tube 118. The tip portion of the coated tip portion 114 (the tip portion of the first resin tube 118) is provided with an inclined outer surface 96a that is inclined radially inward toward the tip.
[0103] The rigidity of the coated base portion 116 is higher than the rigidity of the coated tip portion 114. Specifically, the coated base portion 116 is formed of a material having higher strength than the coated tip portion 114. The coated base portion 116 is formed, for example, by coating the outer peripheral surface of the tube body 98 with a resin material.
[0104] The covering portion 106a may be formed by molding the covered tip portion 114 with a first resin material, as in so-called two-color molding, and then molding the covered base portion 116 integrally with the covered tip portion 114 with a second resin material having a higher strength than the first resin material. Even in this case, the rigidity of the covered base portion 116 can be made higher than the rigidity of the covered tip portion 114.
[0105] In this configuration example, the insertion portion 90c has an insertion intermediate portion 112 between the insertion base portion 92c and the insertion tip portion 94a, and the rigidity of the insertion intermediate portion 112 is lower than the rigidity of the insertion base portion 92c and higher than the rigidity of the insertion tip portion 94a.
[0106] According to this configuration, the rigidity of the insertion portion 90c can be gradually increased from the insertion tip portion 94a, via the insertion intermediate portion 112, toward the insertion base portion 92c.
[0107] In the axial direction of the outer tube 24b, the sum of the length L7 of the insertion tip portion 94a and the length L8 of the insertion intermediate portion 112 is shorter than the length of the balloon 22.
[0108] With this configuration, the insertion tip portion 94 a, the insertion intermediate portion 112 and the insertion base portion 92 c can be disposed inside the balloon 22.
[0109] The endoscope 14c according to this configuration example may be used in combination with the balloon catheters 12, 12a described above.
[0110] The catheter system 10A may include an endoscope 14d shown in Fig. 16, instead of the endoscope 14 described above. Note that in the endoscope 14d, the same components as those in the endoscopes 14, 14a to 14c described above are denoted by the same reference numerals, and descriptions thereof will be omitted.
[0111] As shown in FIG. 16, the insertion section 90d of the endoscope 14d includes an insertion base 92d and an insertion tip 94. The insertion base 92d does not have the above-mentioned covering portion 106. That is, the insertion section 90d has a generally constant outer diameter over its entire length. In other words, the outer diameter of the insertion base 92d is the same as the outer diameter of the insertion tip 94. The above-mentioned reinforcing member 110 is provided inside the tube body 98 of the insertion base 92d. Therefore, the rigidity of the insertion base 92d is higher than the rigidity of the insertion tip 94. Such an endoscope 14d has the same effect as the endoscope 14 described above. The endoscope 14d according to this configuration example may be used in combination with the above-mentioned balloon catheters 12, 12a.
[0112] The present invention is not limited to the above-described embodiment, and various modifications are possible without departing from the gist of the present invention.
[0113] In the insertion sections 90, 90a of the endoscope 14, the insertion base sections 92, 92a may be made of a resin material having higher strength than the insertion tip section 94.
[0114] The above embodiments can be summarized as follows.
[0115] The above embodiment is a balloon catheter having a flexible outer tube, an inner tube disposed in the lumen of the outer tube so as to be movable in the axial direction relative to the outer tube, and a tubular balloon connecting the distal end of the outer tube and the distal end of the inner tube to each other and expanding radially inward of the outer tube, in which an outer space (Sc) through which a balloon expansion fluid for expanding the balloon flows is formed between the outer surface of the balloon and the inner surface of the outer tube, and the balloon in a state in which the balloon inflated by the balloon expansion fluid is supported by a linear insertion portion of a medical device, a pushing force in the distal direction is transmitted from the inner tube to the balloon, and the distal end of the balloon is rolled back. the inner tube has an outer tube base and an outer tube tip portion extending in the tip direction from the tip of the outer tube base, the inner tube is provided with a rotation regulating portion formed to protrude radially outward from the outer surface of the balloon and to regulate circumferential rotation of the inner tube relative to the outer tube by contacting a base-side inner surface that is the inner surface of the outer tube base, the rotation regulating portion slides in the tip direction within the lumen of the outer tube base as the pushing force is transmitted from the inner tube to the balloon, and the tip-side inner surface that is the inner surface of the outer tube tip portion is located radially inward of the outer tube relative to the base-side inner surface.
[0116] In the above balloon catheter, the outer diameter of the outer tube tip portion may be the same as the outer diameter of the outer tube base portion.
[0117] In the above balloon catheter, a wall thickness (T1) of the outer tube tip portion may be greater than a wall thickness (T2) of the outer tube base portion.
[0118] In the above-described balloon catheter, an inclined inner surface (50) that is tapered radially inwardly of the outer tube toward the tip end may be formed at the connecting portion between the tip end inner surface and the base end inner surface.
[0119] In the above-mentioned balloon catheter, the outer tube has an outer tube body and a tube member (101) provided on the inner surface of the tip portion of the outer tube body, the inner surface of the tube member forming the tip side inner surface, and a portion of the inner surface of the outer tube body that is on the base side of the tube member forms the base side inner surface.
[0120] In the above-mentioned balloon catheter, the outer tube tip portion may be shaped so as to be curved in an arc in the axial direction.
[0121] This embodiment discloses a catheter system (10) including the above-mentioned balloon catheter and the medical device.
[0122] In the above catheter system, the insertion section includes an insertion base section extending along the axial direction of the outer tube and an insertion tip section extending from the tip of the insertion base in the tip direction, and the rigidity of the insertion base section may be higher than the rigidity of the insertion tip section.
[0123] In the above catheter system, a length (L5, L7) of the insertion tip portion in the axial direction of the outer tube may be shorter than a length (L1) of the outer tube tip portion.
[0124] In the above catheter system, an outer diameter (D1) of the insertion base portion may be larger than an outer diameter (D2) of the insertion tip portion.
[0125] In the above-mentioned catheter system, a junction between the outer surface of the insertion tip portion and the outer surface of the insertion base portion may be formed with an inclined outer surface that tapers radially outwardly of the insertion portion toward the base end of the insertion portion.
[0126] In the above catheter system, the insertion base portion may be formed of a resin material having a higher strength than the insertion tip portion.
[0127] In the above catheter system, the insertion base portion may include a tubular body (98) and a reinforcing member provided within the tubular body and extending along the axial direction of the insertion portion.
[0128] In the above catheter system, the medical device may be an endoscope.
[0129] The present embodiment is a catheter system including a balloon catheter having a flexible outer tube, an inner tube disposed in the inner cavity of the outer tube so as to be movable in the axial direction relative to the outer tube, a tubular balloon connecting a distal end of the outer tube with a distal end of the inner tube and expanding radially inwardly of the outer tube, and a medical device having a linear insertion part inserted into the inner cavity of the balloon, in which an outer space through which a balloon expansion fluid for expanding the balloon flows is formed between the outer surface of the balloon and the inner surface of the outer tube, and the balloon is inflated by the balloon expansion fluid and supported by the insertion part, and a pushing force in the distal direction is transmitted from the inner tube to the balloon so that the distal end of the balloon is not rolled up. the insertion portion includes an insertion base portion extending along the axial direction of the outer tube and an insertion tip portion extending from the tip of the insertion base portion in the distal direction, and a length (L5, L7) of the insertion tip portion in the axial direction of the outer tube is shorter than the length of the balloon.
[0130] In the above catheter system, the insertion section may have an insertion intermediate section between the insertion base section and the insertion tip section, and the rigidity of the insertion intermediate section may be lower than the rigidity of the insertion base section and higher than the rigidity of the insertion tip section.
[0131] In the above catheter system, the sum of a length (L7) of the insertion tip portion and a length (L8) of the insertion intermediate portion in the axial direction of the outer tube may be shorter than a length of the balloon. [Explanation of symbols]
[0132] 10... Catheter system 12, 12a, 12b... Balloon catheter 14, 14a to 14d: Endoscope (medical device) 22... Balloon 24, 24a, 24b... Outer tube 34...First lumen 30, 30a...Outer tube body 36...Outer tube base 38, 38a...Outer tube tip 40…Proximal lumen 42…Distal lumen 43: Base end inner surface 50: Inclined inner surface 54...Tip opening 62...Inner tube 78...Rotation restriction portion 90, 90a to 90d...Insertion portion 92, 92a to 92d: Insertion base portion 94, 94a: Insertion tip portion 98... Tube body 101... Tube member 110: Reinforcing member 112: Insertion intermediate portion Sc…Outer space
Claims
[Claim 1] a balloon catheter including a flexible outer tube, an inner tube disposed in the lumen of the outer tube so as to be movable in an axial direction relative to the outer tube, and a tubular balloon connecting a distal end of the outer tube with a distal end of the inner tube and inflating radially inward of the outer tube; A catheter system comprising: a medical device having a linear insertion portion that is inserted into the inner cavity of the balloon, Between the outer surface of the balloon and the inner surface of the outer tube, an outer space is formed through which a balloon expansion fluid for inflating the balloon flows, a distal end of the balloon is turned up and protrudes from the distal end opening of the outer tube in the distal direction when a pushing force in the distal direction is transmitted from the inner tube to the balloon in a state in which the balloon is inflated by the balloon inflation fluid and supported by the insertion section; the inner tube is provided with a rotation restricting portion that is formed so as to protrude radially outward from an outer surface of the balloon and that restricts circumferential rotation of the inner tube relative to the outer tube by contacting an inner surface of the outer tube; the rotation restricting portion slides in the lumen of the outer tube toward the distal end when the pushing force is transmitted from the inner tube to the balloon, The insertion portion is an insertion base portion extending along the axial direction of the outer tube; an insertion tip portion extending in the tip direction from a tip of the insertion base portion, The rigidity of the insertion base portion is higher than the rigidity of the insertion tip portion, In the axial direction of the outer tube, the length of the insertion tip portion is shorter than the length of the balloon, The medical device is an endoscope, The outer diameter of the insertion base portion is larger than the outer diameter of the insertion tip portion, The outer tube is An outer pipe base; an outer tube tip portion extending in the tip direction from a tip of the outer tube base portion, A catheter system, wherein the outer diameter of the outer tube tip portion is the same as the outer diameter of the outer tube base portion, and the wall thickness of the outer tube tip portion is thicker than the wall thickness of the outer tube base portion.
Citation Information
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