Flexible Catheters and Related Methods

Abstract

Various embodiments of a flexible catheter including one or more flexible regions are described herein. In one embodiment, a catheter includes an elongate body having a proximal segment and a distal segment; a first lumen defined by the elongate body and configured to drain fluid from a body region; and a plurality of flexible regions located over or within the distal segment of the elongate body. The plurality of flexible regions are collectively configured to bend forward passively. Additionally, a percentage of cut depth of at least one of the plurality of flexible regions is from about 50% to about 75% of a wall thickness of the elongate body. The characteristics and arrangement of the flexible regions described herein result in a reduced force required during insertion of the catheter into a body cavity.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This international application under the Patent Cooperation Treaty claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 193,228, filed on May 26, 2021, the contents of which are incorporated herein by reference in their entirety.

[0003] Incorporation by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference in its entirety. Technical Field

[0005] The present disclosure relates generally to the field of catheterization, and more particularly to the field of urology. Flexible catheters and related methods for improving catheterization in body cavities such as the urinary tract, nasopharynx, gastrointestinal tract, neurovascular, etc. are described herein. Background Art

[0006] Practitioners use a variety of different catheters to perform different functions in both acute and chronic care settings. Common indications for placing a urinary catheter in a patient include: 1) acute or chronic urinary retention (e.g., benign prostatic hypertrophy, atonic bladder, neurogenic bladder, etc.); 2) urine output measurement; 3) incontinence; and 4) patient status following bladder or prostate surgery. Available catheters include Foley catheters, Robinson catheters, Catheter, etc.

[0007] For example, an indwelling catheter (also known as a Foley catheter) is configured to be placed in the urethra for an extended period of time. The tip of a Foley catheter is provided with an inflatable balloon that secures the catheter in place within the bladder, thereby reducing the likelihood of expulsion from the bladder. In other cases, a Robinson catheter or intermittent catheter may be used to drain urine from the bladder on a short-term basis. Unlike a Foley catheter, it does not have a balloon at the tip and therefore cannot be self-anchored. Alternatively, a Foley catheter may be used. A catheter having a curved tip with or without a balloon (as described above) is intended to facilitate catheter insertion into a urethral stricture or prostatic urethral obstruction, such as in the case of benign prostatic hypertrophy. Additionally or alternatively, the catheter may include a temperature probe or may include one or more flushing lumens to deliver flushing fluids (e.g., chemotherapy fluids, saline, cleaning fluids, etc.) into the bladder. It is primarily used to flush the bladder in the presence or absence of blood clots in the bladder.

[0008] Not only are there many different types of adult catheters, which can make it difficult for hospital staff to determine when to use which catheter, but the most common adult urinary catheters come in a variety of diameters, such as 12F (4 mm) to 30F (10 mm).

[0009] If the catheter is not placed properly, various complications may occur. For example, complications from catheter-related trauma include bleeding (gross hematuria), urethral injury (eg, urethral stricture, false passage formation, difficulty in future catheterization, etc.), potential sexual side effects such as the proximity and parallelism of the erectile bodies (ie, corpora cavernosa) to the urethra, Peyronie's disease (ie, abnormal curvature of the penis due to scarring of the tunica albuginea of ​​the erectile bodies), urinary tract infection, and urinary retention.

[0010] Additionally, the wide variety of catheters and their associated different sizes often leads to confusion and / or placement of multiple catheters for one patient or one indication, resulting in excessive medical waste, redundancy, and workflow disruption.

[0011] Therefore, there is a need for a universal catheter that is safe, efficient, and non-confusional while also minimizing medical waste and workflow disruption. Summary of the invention

[0012] One aspect of the present disclosure relates to a catheter, comprising: an elongated body having a proximal segment and a distal segment; a first lumen defined by the elongated body and configured to drain a fluid from a body region; and a plurality of flexible zones located on or in the distal segment of the elongated body. In any of the foregoing embodiments, the plurality of flexible zones are collectively configured to passively bend forward when advanced through a tortuous path.

[0013] In any of the foregoing embodiments, at least one of the plurality of flexible zones has a cutout depth percentage of about 50% to about 75% of a wall thickness of the elongated body.

[0014] In any of the foregoing embodiments, the volume percentage removed from at least one of the plurality of flexible zones is about 15% to about 20%.

[0015] In any of the foregoing embodiments, the force to bend the flexible zone is less than the force to bend a portion of the elongated body that does not include any of the plurality of flexible zones. In any of the foregoing embodiments, the force to bend the distal segment forward is less than the force to bend the distal segment backward.

[0016] In any of the foregoing embodiments, the volume percentage removed from at least one of the plurality of flexible zones is about 15% to about 20%. In any of the foregoing embodiments, the volume percentage removed from at least one of the plurality of flexible zones is about 25% to about 35%.

[0017] In any of the foregoing embodiments, at least a subset of the plurality of flexible zones has a combined bend angle of about 30 degrees to about 200 degrees.

[0018] In any of the preceding embodiments, the catheter is a urinary catheter. In any of the preceding embodiments, the body region comprises one of: a tissue, an organ, a blood vessel, or a cavity.

[0019] In any of the foregoing embodiments, at least a subset of the plurality of flexible zones extend into the first lumen and further serve as a drainage port. In any of the foregoing embodiments, the catheter further comprises a retaining balloon disposed around at least a portion of the distal segment of the elongated body. In any of the foregoing embodiments, the catheter further comprises a second lumen configured to inflate the retaining balloon.

[0020] In any of the foregoing embodiments, the cut depth percentage of one or more of the plurality of flexible zones is about 40% to about 50% of the outer diameter of the elongated body. In any of the foregoing embodiments, the cut depth percentage of one or more of the plurality of flexible zones is about 51% to about 67% of the outer diameter of the elongated body.

[0021] In any of the foregoing embodiments, the cut length percentage of at least a subset of the plurality of flexible zones is about 10% to about 90%. In any of the foregoing embodiments, the cut length percentage is about 70% to about 80%.

[0022] In any of the preceding embodiments, the plurality of flexible zones includes more than two flexible zones. In any of the preceding embodiments, the plurality of flexible zones includes three to five flexible zones.

[0023] In any of the foregoing embodiments, the hardness of the elongated body is between about 20 Shore A and about 80 Shore A. In any of the foregoing embodiments, the hardness of the elongated body is between about 40 Shore A and about 70 Shore A.

[0024] In any of the preceding embodiments, the length of the distal segment is about 1 cm to about 10 cm.

[0025] In any of the aforementioned embodiments, the length of the distal segment is about 3 cm to about 5 cm.

[0026] In any of the foregoing embodiments, a ratio of an outer diameter of the elongated body to an outer protrusion thickness of a distal tip of the distal section is about 1.0:0.8 to about 1.0:0.2.

[0027] In any of the foregoing embodiments, one or more of the plurality of flexible zones extends through the anterior sidewall of the elongated body, through the first lumen, and into the luminal surface of the posterior sidewall of the elongated body.

[0028] In any of the foregoing embodiments, one or more of the plurality of flexible zones extends through the anterior sidewall of the elongated body, circumferentially around at least a portion of the first lumen, and into the luminal surface of the posterior sidewall of the elongated body.

[0029] In any of the foregoing embodiments, the distal-most flexible zone of the plurality of flexible zones has a greater percentage of incision depth than the subset of the plurality of flexible zones.

[0030] In any of the foregoing embodiments, the cutout depth percentage of the distal-most flexible zone is about 80% to about 95% of the outer diameter of the elongated body.

[0031] In any of the foregoing embodiments, at least a portion of the elongated body has a polygonal shape. In any of the foregoing embodiments, the polygonal shape is a trapezoidal prism.

[0032] In any of the preceding embodiments, the plurality of flexible zones comprises a plurality of anterior flexible zones. In any of the preceding embodiments, the catheter further comprises a plurality of posterior flexible zones.

[0033] In any of the foregoing embodiments, the plurality of rear flexible zones each comprise a groove in the inner sidewall of the first lumen of the elongated body. In any of the foregoing embodiments, the groove in the inner sidewall of the first lumen has a cut depth percentage of 5% to about 20% of the wall thickness.

[0034] Another aspect of the present disclosure relates to a catheter comprising: an elongated body having a proximal segment and a distal segment; a first lumen defined by the elongated body and configured to drain fluid from a body region; and at least one flexible region located on or in the distal segment of the elongated body.

[0035] In any of the foregoing embodiments, the at least one flexible zone is configured to bend forward at an absolute bend angle of about 20 degrees to about 200 degrees.

[0036] In any of the foregoing embodiments, the at least one flexible zone has a cutout depth percentage of about 30% to about 70% of the outer diameter of the elongated body.

[0037] In any of the preceding embodiments, the catheter is a urinary catheter. In any of the preceding embodiments, the body region comprises one of: a tissue, an organ, a blood vessel, or a cavity.

[0038] In any of the aforementioned embodiments, the at least one flexible zone extends into the first lumen and further serves as a drainage port.

[0039] In any of the foregoing embodiments, the catheter further comprises a retention balloon disposed around at least a portion of the distal section of the elongated body. In any of the foregoing embodiments, the catheter further comprises a second lumen configured for inflating the retention balloon.

[0040] In any of the foregoing embodiments, the cut depth percentage is about 40% to about 50% of the outer diameter of the elongated body. In any of the foregoing embodiments, the cut depth percentage is about 58% to about 67% of the outer diameter of the elongated body. In any of the foregoing embodiments, the cut depth percentage is about 50% to about 60% of the outer diameter of the elongated body.

[0041] In any of the foregoing embodiments, the cut length percentage of at least a subset of the plurality of flexible zones is about 10% to about 90%. In any of the foregoing embodiments, the cut length percentage is about 70% to about 80%.

[0042] In any of the foregoing embodiments, the hardness of the elongated body is between about 20 Shore A and about 80 Shore A. In any of the foregoing embodiments, the hardness of the elongated body is between about 40 Shore A and about 70 Shore A.

[0043] In any of the preceding embodiments, the length of the distal segment is about 1 cm to about 10 cm. In any of the preceding embodiments, the length of the distal segment is about 3 cm to about 5 cm.

[0044] In any of the foregoing embodiments, a ratio of an outer diameter of the elongated body to an outer protrusion thickness of a distal tip of the distal section is about 1.0:0.8 to about 1.0:0.2.

[0045] In any of the foregoing embodiments, the at least one flexible zone extends through the anterior sidewall of the elongated body, through the first lumen, and into the luminal surface of the posterior sidewall of the elongated body.

[0046] In any of the foregoing embodiments, at least a portion of the elongate portion has a polygonal shape. In any of the foregoing embodiments, the polygonal shape is a trapezoidal prism.

[0047] In any of the preceding embodiments, the plurality of flexible zones comprises a plurality of anterior flexible zones. In any of the preceding embodiments, the catheter further comprises a plurality of posterior flexible zones.

[0048] In any of the foregoing embodiments, the plurality of rear flexible zones each comprise a groove in an inner wall of the first lumen of the elongated body. In any of the foregoing embodiments, the groove in the inner wall of the first lumen has a cut depth percentage of 5% to about 90%.

[0049] Another aspect of the present disclosure relates to a urinary catheter comprising: an elongated body having a proximal segment and a distal segment, such that the distal segment defines at least one port configured to drain fluid from an organ; a retention balloon disposed around at least a portion of the distal segment of the elongated body; two or more lumens defined by the elongated body; and one or more flexible regions disposed on or in the distal segment of the elongated body.

[0050] In any of the aforementioned embodiments, the first lumen is configured for draining the fluid from the organ and the second lumen is configured for inflating the retention balloon.

[0051] In any of the aforementioned embodiments, the one or more flexible zones are configured to promote unidirectional deflection of at least a portion of the distal section during guidance of the elongated body.

[0052] In any of the foregoing embodiments, there are two flexible zones on the anterior distal zone and two flexible zones on the posterior distal zone.

[0053] In any of the foregoing embodiments, the two front flexible zones and the two rear flexible zones are each generally laterally aligned.

[0054] In any of the foregoing embodiments, there are at least two flexible zones having a combined bend angle of about 20 degrees to about 70 degrees.

[0055] In any of the foregoing embodiments, there are at least two flexible zones having a combined bend angle of about 60 degrees to about 200 degrees.

[0056] In any of the foregoing embodiments, there are at least two flexible zones, a first, more proximal flexible zone having a bend angle of about 50 degrees to about 70 degrees, and a second, more distal flexible zone having a bend angle of about 40 degrees to about 80 degrees.

[0057] In any of the foregoing embodiments, one or more flexible zones include through holes.

[0058] In any of the preceding embodiments, the one or more flexible zones include blind holes.

[0059] In any of the aforementioned embodiments, the one or more flexible zones comprise a material that is less stiff than the distal section surrounding the one or more flexible zones.

[0060] In any of the foregoing embodiments, the one or more flexible zones comprise a material having a stiffness less than that of a material comprising the elongated body.

[0061] In any of the preceding embodiments, the one or more flexible zones extend semi-circumferentially around the elongated body.

[0062] In any of the aforementioned embodiments, the one or more flexible zones include less material than the distal section surrounding the one or more flexible zones.

[0063] In any of the foregoing embodiments, the elongated body further defines a third lumen and the distal section further defines a flushing port, such that the third lumen is configured to deliver a fluid to an organ through the flushing port.

[0064] In any of the aforementioned embodiments, the distal segment further defines an aperture configured to pass a guide wire therethrough.

[0065] In any of the preceding embodiments, the organ is a bladder.

[0066] Another aspect of the present disclosure relates to a method for guiding or positioning a urinary catheter. In some embodiments, the method comprises: guiding an elongated body through a patient's urethra; optionally, temporarily and / or optionally during guiding, unidirectionally passively deflecting at least a portion of a distal segment of the elongated body such that the deflection occurs near one or more of the following: the bulbar urethra, the membranous urethra, or the prostatic urethra, and the temporary and unidirectional deflection occurs at a region including one or more flexible regions; inflating a retaining balloon disposed around the distal segment of the elongated body to retain at least one region of the distal segment in the patient's bladder, such that inflation occurs through an inflation lumen defined by the elongated body and fluidly connected to a volume defined by the retaining balloon; and aspirating fluid from the patient's bladder through at least one port defined by the distal segment and fluidly connected to a lumen defined by the elongated body.

[0067] In any of the preceding embodiments, the method further comprises deflation of the retention balloon.

[0068] In any of the aforementioned embodiments, the method further comprises removing the elongate body from the bladder and urethra of the patient.

[0069] In any of the foregoing embodiments, introducing further comprises inserting the elongated body into the urethra of the patient.

[0070] In any of the preceding embodiments, the method further comprises flushing at least a portion of the bladder.

[0071] In any of the foregoing embodiments, flushing occurs through at least one flush port fluidly connected to an flushing lumen defined by the elongated body.

[0072] In any of the foregoing embodiments, the method further comprises removing the particle from the patient's bladder such that the distal tip of the elongated body defines an aperture therein.

[0073] Another aspect of the present disclosure relates to a urinary catheter comprising: an elongated body having a proximal segment and a distal segment; a retaining balloon disposed around at least a portion of the distal segment of the elongated body; two or more lumens defined by the elongated body; and at least one port defined by the distal segment.

[0074] In any of the aforementioned embodiments, the first lumen is configured for draining fluid from the organ and the second lumen is configured for inflating the retention balloon.

[0075] In any of the aforementioned embodiments, the at least one port is configured to drain the fluid from the organ or to pass a guide wire therethrough.

[0076] In any of the aforementioned embodiments, the at least one port is further configured to facilitate temporary unidirectional deflection of at least a portion of the distal section during navigation of the elongated body. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The foregoing is an overview and therefore is necessarily limited in detail. The above aspects and other aspects, features and advantages of the present invention are described below in conjunction with various embodiments and with reference to the accompanying drawings.

[0078] Figure 1 Illustrate the male urinary tract.

[0079] Figure 2 Illustration of a typical two-way catheter.

[0080] Figure 3 Illustration of a typical three-way catheter.

[0081] Figure 4A A cross-sectional view of a typical two-way conduit is shown.

[0082] Figure 4B A cross-sectional view of a typical three-way conduit is shown.

[0083] Figure 5 Various planes and sides of the catheter are shown.

[0084] Fig. 6A A front view of one embodiment of a flexible conduit is shown.

[0085] Figure 6B Show Fig. 6A A side view of an embodiment of the present invention.

[0086] Figure 6C Shown in a bent configuration Figure 6B A side view of an embodiment of the present invention.

[0087] Fig. 7A A front view of another embodiment of a flexible conduit is shown.

[0088] Figure 7B Show Fig. 7A A cross-sectional view of an embodiment along section AA.

[0089] Fig. 8A A front view of another embodiment of a flexible conduit is shown.

[0090] Figure 8B Show Fig. 8A A cross-sectional view of an embodiment along section AA.

[0091] Fig. 9A A front view of another embodiment of a flexible conduit is shown.

[0092] Fig. 9B Show Fig. 9A A cross-sectional view of an embodiment along section AA.

[0093] Fig. 10A A front view of another embodiment of a flexible conduit is shown.

[0094] Fig. 10B Show Fig. 10A A cross-sectional view of an embodiment along section AA.

[0095] Fig.11A A front view of another embodiment of a flexible conduit is shown.

[0096] Fig. 11B Show Fig.11A A cross-sectional view of an embodiment along section AA.

[0097] Fig. 12A A front view of another embodiment of a flexible conduit is shown.

[0098] Fig. 12B Show Fig. 12A A cross-sectional view of an embodiment along section AA.

[0099] Fig. 12C Shown in a bent configuration Fig. 12A A side view of an embodiment of the present invention.

[0100] Fig.12D Shown in a bent configuration Fig. 12A A side view of an embodiment of the present invention.

[0101] Fig.13A A front view of another embodiment of a flexible conduit is shown.

[0102] Fig. 13B Show Fig.13A A cross-sectional view of an embodiment along section AA.

[0103] Fig. 13C Shown in a bent configuration Fig.13A A side view of an embodiment of the present invention.

[0104] Fig.14A A front view of another embodiment of a flexible conduit is shown.

[0105] Fig. 14B Show Fig.14A Cross-sectional view of an embodiment along section DD.

[0106] Fig.15A A front or front view of another embodiment of a flexible conduit is shown.

[0107] Fig. 15B Show Fig.15A A side view of an embodiment of the present invention.

[0108] Fig. 15C Show Fig.15A A rear view of an embodiment of the present invention.

[0109] Fig.15D Show Fig.15A Cross-sectional view of an embodiment along section DD.

[0110] Fig.16A A side view of another embodiment of a flexible conduit is shown.

[0111] Fig. 16B Show Fig.16A Front cross-sectional view of an embodiment along section AA.

[0112] Fig. 16C Show Fig.16A Rear cross-sectional view of an embodiment along section BB.

[0113] Fig.16D Show Fig. 16B A transverse cross-sectional view of an embodiment along section CC.

[0114] Fig.16E Show Fig.16D Cross-sectional view of an embodiment along section DD.

[0115] Fig.16F Show Fig.16D A cross-sectional view of an embodiment along section EE.

[0116] Figure 16G Show Fig.16D An enlarged view of a portion of.

[0117] Fig.16H Shown is a three-dimensional perspective view of two flexible zones removed from the tube to show the volume of each zone.

[0118] Fig.17A A front view of another embodiment of a flexible conduit is shown.

[0119] Fig. 17B A front view of another embodiment of a flexible conduit is shown.

[0120] Fig. 17C A front view of another embodiment of a flexible conduit is shown.

[0121] Fig.18A A side view of another embodiment of a flexible catheter is shown in a bent configuration.

[0122] Fig.18B Show Fig.18A A front view of an embodiment of the present invention.

[0123] Fig.19A A front view of another embodiment of a flexible conduit is shown.

[0124] Fig.19B Show Fig.19A A side view of an embodiment of the present invention.

[0125] Fig.19C Show Fig.19B Front cross-sectional view of an embodiment along section AA.

[0126] Fig.19D Show Fig.19B Rear cross-sectional view along section BB of an embodiment.

[0127] Fig.19E Show Fig.19C A transverse cross-sectional view of an embodiment along section CC.

[0128] Fig.19F Show Fig.19E Cross-sectional view of an embodiment along section DD.

[0129] Figure 19G Show Fig.19E A cross-sectional view of an embodiment along section EE.

[0130] Fig. 20AA front view of another embodiment of a flexible conduit is shown.

[0131] Fig. 20B Show Fig. 20A A cross-sectional view of an embodiment along section AA.

[0132] Fig. 20C A cross-sectional view of another embodiment of a flexible conduit is shown.

[0133] Fig.20D Show Fig. 20C A cross-sectional view of an embodiment along section BB.

[0134] Fig.20E Shown is the flexible zone in the tube used for volume calculation.

[0135] Fig.20F Shown from Fig.20E The material removed from the flexible zone.

[0136] Figure 20G Show Fig. 20C A magnified view of a subset of the flexible zone.

[0137] Fig.21A A front view of another embodiment of a flexible conduit is shown.

[0138] Fig. 21B Show Fig.21A A cross-sectional view of an embodiment along section BB.

[0139] Fig.22A A front view of another embodiment of a flexible conduit is shown.

[0140] Fig. 22B Show Fig.22A A side view of an embodiment of the present invention.

[0141] Fig. 22C Show Fig. 22B Front cross-sectional view of an embodiment along section AA.

[0142] Fig.22D Show Fig. 22B Rear cross-sectional view of an embodiment along section BB.

[0143] Fig.22E Show Fig. 22C A side cross-sectional view of an embodiment along section CC.

[0144] Fig.22F Show Fig.22E Cross-sectional view of an embodiment along section DD.

[0145] Figure 22G Show Fig.22ECross-sectional view along section E-E of an embodiment.

[0146] Fig.23 Side cross-sectional view showing another embodiment of a flexible catheter having an offset lumen.

[0147] Fig.24A Side view showing an embodiment of a flexible catheter having one or more proximally located flexible regions.

[0148] Fig. 24B Showing Fig.24A Cross-sectional view along section A-A of an embodiment.

[0149] Fig.24C Showing Fig.24A Cross-sectional view along section B-B of an embodiment.

[0150] Fig.24D Showing Fig.24A Cross-sectional view along section C-C of an embodiment.

[0151] Fig.24E Showing Fig.24A Side cross-sectional view of an embodiment.

[0152] Fig.24F Showing in a deflected state Fig.24A Side view of an embodiment.

[0153] Fig.25A Top view showing another embodiment of a flexible catheter having a tapered distal tip.

[0154] Fig.25B Showing Fig.25A Side view of an embodiment.

[0155] Fig.25C Showing Fig.25A Side cross-sectional view of an embodiment.

[0156] Fig.25D Showing Fig.25C Magnified view of a portion.

[0157] Fig.25E Showing Fig.25B Three-dimensional perspective view of the most distal flexible region of an embodiment.

[0158] Fig.25F Showing Fig.25C Magnified view of the most distal flexible region.

[0159] Figure 25G Showing Fig.25A Three-dimensional perspective view of the flexible region of an embodiment.

[0160] Fig.25H Shown from Figure 25G The two flexible zones with the tube removed to show the volume of each zone.

[0161] Fig.25I Show Fig.25A A three-dimensional perspective view of the distal-most flexible zone (the front flexible zone connected to the rear flexible zone) of an embodiment.

[0162] Fig.25J Shown from Fig.25I The distal-most flexible zone with the tube removed to show the volume of each zone.

[0163] Fig.26A A side cross-sectional view of another embodiment of a flexible conduit having one or more polygonal apertures is shown.

[0164] Fig.26B Show Fig.26A Cross section BB.

[0165] Fig.27A A top view of another embodiment of a flexible catheter having an elongated flexible curved section is shown.

[0166] Fig.27B Show Fig.27A A cross-sectional view of an embodiment of the present invention.

[0167] Fig.28A A top view of another embodiment of a flexible conduit is shown.

[0168] Fig.28B Show Fig.28A A side view of an embodiment of the present invention.

[0169] Fig.28C Show Fig.28A A cross-sectional view of an embodiment of the present invention.

[0170] Fig.29A A perspective view of an elongated body is shown with various measurable parameters marked thereon.

[0171] Fig.29B An enlarged cross-sectional view of one embodiment showing the cut depth of the flexible zone.

[0172] Fig.29C An enlarged cross-sectional view showing another embodiment of the cut depth of the flexible zone.

[0173] Fig.29D An enlarged cross-sectional view showing one embodiment of the shape of the flexible zone.

[0174] Fig.29E An enlarged cross-sectional view showing another embodiment of the shape of the flexible zone.

[0175] Fig.29F An enlarged cross-sectional view showing another embodiment of the shape of the flexible zone.

[0176] Figure 29G An enlarged cross-sectional view showing another embodiment of the shape of the flexible zone.

[0177] Fig. 30A Shown including from Graph of data from a computational analysis in which the effects of various catheter characteristics on wall pressure and column strength were analyzed.

[0178] Fig. 30B Shown including from Graph of data from a computational analysis comparing various standard of care catheters to the catheter embodiments described herein.

[0179] Fig.31A An image showing a test fixture used to test insertion force relative to insertion depth into a test lumen.

[0180] Fig.31B Shown is a graph including data from physical testing comparing various standard of care catheter analogs to various catheter embodiments described herein.

[0181] Fig.32 A schematic diagram of a test fixture for testing the force required to deflect the distal tip portion of an exemplary flexible catheter is shown.

[0182] Fig.33 Shown including the use of Fig.32 A graph of deflection force versus deflection on a fixed curved surface of a catheter including a flexible region extending from an exterior surface to an interior region obtained using a test fixture.

[0183] Fig.34 Shown including the use of Fig.32 Graph of deflection force data for a catheter including an internal (non-destructive external surface) flexible zone obtained using a test fixture of FIG.

[0184] Fig.35 Show the use Fig.33 The test fixture data is normalized Fig. 30B of simulated data.

[0185] The illustrated embodiments are examples only and are not intended to limit the present disclosure. Schematic diagrams are drawn to illustrate features and concepts and are not necessarily drawn to scale. DETAILED DESCRIPTION

[0186] The foregoing is an overview and, therefore, is necessarily limited in detail. The above aspects and other aspects, features and advantages of the technology of the present invention will now be described in conjunction with various embodiments. The inclusion of the following embodiments is not intended to limit the present disclosure to these embodiments, but rather to allow those skilled in the art to make and use the contemplated invention. Other embodiments may be utilized and modifications may be made without departing from the spirit or scope of the subject matter presented herein. The aspects of the present disclosure as described and illustrated herein may be arranged, combined, modified and designed in a variety of different conceived forms, all of which are clearly contemplated and form part of the present disclosure.

[0187] As described herein, various flexible catheters are described. It will be appreciated by those skilled in the art that, although described with reference to the urinary system or urinary tract, the catheters described herein can certainly be used in other peripheral, vascular or organ systems. For example, the catheters described herein can be configured for use in the nasopharynx, larynx / trachea / bronchus, gastrointestinal tract, neurovascular system, peripheral vascular system or any other suitable body cavity or organ system.

[0188] The various flexible catheters described herein are intended to cause less trauma to the transport tissue (tissue in the blood vessel) and the target organ. The flexible catheters achieve this by increasing flexibility, increasing bendability, reducing stiffness, and increasing trackability (e.g., reducing insertion force), thereby bringing one or more of the following advantages: reducing the risk of perforation, reducing stenosis or scarring (e.g., urethral stenosis, esophageal stenosis), reducing spasm (e.g., bladder spasm, laryngospasm, vasospasm, etc.), reducing the risk of infection due to reduced trauma, reducing the risk of stripping of each tissue layer, and reducing the risk of forming a false passage (e.g., a false urethra, a false peripheral aneurysm).

[0189] As used herein, "proximal" means close to or toward the operator of the device, and "distal" means away from the operator and toward the patient or target tissue or organ into which the catheter is inserted. For clarity, the distal end 21 and the proximal end 23 are shown in FIG. Figure 2 , but are understood to apply to all embodiments described herein.

[0190] As used herein and as Figure 5As shown, the "front side" is the inner radius of the curved configuration of the catheter on the top or front side of the longitudinal anterior-posterior (AP) plane, and the "rear side" is the outer radius of the curved configuration of the catheter on the bottom or rear side of the longitudinal AP plane. The inner (M) and outer (L) longitudinal cross-sections of the catheter are also shown. In addition, in some embodiments described herein, the flexible zones may be aligned laterally or in a transverse plane. For example, a first flexible zone may be positioned on the front side and a second flexible zone may be positioned on the rear side, but the first flexible zone and the second flexible zone may be aligned laterally or in a transverse plane with each other. In some embodiments, the flexible zones may be aligned longitudinally or in a longitudinal plane, such as Figure 5 shown.

[0191] As used herein, "passive" deflection includes deflection due to anatomical and physiological bending, which does not necessarily require an active mechanism, such as puller wires, concentric tubes, etc. Such "active" deflection mechanisms (puller wires, concentric tubes, etc.) require an additional actuation mechanism to achieve deflection.

[0192] As used herein and as Fig.29A As shown, "incision length percentage" is defined as incision length 5700 (i.e., flexible zone length or zone length that has been modified to change zone flexibility) divided by (incision length plus incision (i.e., flexible zone) inter-length 5710). The incision length percentage may vary depending on the size of the catheter used.

[0193] In some embodiments, as used herein and as Fig.29A As shown, the “cut depth percentage” is defined as Figure 5 The depth 5720 of a transverse cut or flexible zone or zone that has been modified to change the flexibility of the zone (lower durometer material, material removal, etc.) in the elongated body shown perpendicular to the longitudinal axis of the elongated body is divided by the outer diameter 5730 of the elongated body, multiplied by 100. The cut extends from the outer surface of the elongated body to a laterally offset interior zone of the elongated body. In some embodiments, as Fig.29B As shown, the flexible zone includes circumferentially removed material from the inner wall of the lumen, so that the lateral offset zone includes a cut depth corresponding to the location where the material is removed from the inner wall. Fig.29C As shown, the laterally offset inner zone passes through the lumen and the opposing inner sidewall of the lumen such that the cut depth percentage includes the inner diameter of the lumen and the depth of the cut into the opposing inner sidewall (e.g., the posterior sidewall when the flexible zone is in the anterior sidewall). From the cross-sectional views of the various embodiments of the flexible zone, it should be appreciated that material can be removed in a variety of different ways to form the flexible zone. The perimeter 358 of the flexible zone 350 can have a convex section 354 near the outer surface 356 of the catheter, which transitions to a concave section 352, such as Fig.29D The perimeter 368 of the flexible zone 360 ​​may have a convex shape 362, such as Fig.29E The perimeter 378 of the flexible zone 370 may have a concave shape 372, such as Fig.29F The perimeter 388 of the flexible zone 380 may be inclined 382 (eg, angled relative to the transverse axis) or perpendicular (parallel to the transverse axis), such as Figure 29G This list is not exhaustive, but is intended to illustrate various shapes of material that are removed to form the flexible zone. The cut depth 5720 can be measured from the back side of the elongated body to the laterally offset inner zone or from the front side of the elongated body to the laterally offset inner zone.

[0194] In other embodiments, as used herein, the cut depth percentage is defined relative to the wall thickness (rather than the outer diameter) of the elongated body. Figure 16G As shown, the percentage of the cut depth relative to the sidewall thickness is about 10% to about 80%, about 20% to about 80%, about 20% to about 30%, about 30% to about 70%, about 70% to about 80%, etc. When describing the corresponding embodiments, the embodiments relative to the sidewall thickness will be indicated.

[0195] As used herein, "percent volume removed" or "percent volume" is defined as the volume of material that has been removed to create an incision in the catheter sidewall (inner or outer sidewall), or the volume of material that has been replaced by a higher or lower durometer material in the catheter sidewall (inner or outer sidewall). The volume removed does not necessarily penetrate the lumen of the catheter, but may be superficial. In some embodiments, the volume percentage removed from the flexible zone is a good indication of the actual material removed because it takes into account the material removed circumferentially from the front zone, the rear zone, and / or the sidewall in the lumen.

[0196] The boundary of the planar tube used for the volume percentage calculation is defined above as the cut-out length of the flexible zone. Therefore, the volume percentage of the flexible zone is calculated by determining the volume of the removed material relative to the volume of a plain tube (i.e., without modification). It should be noted that the volume will take into account the material removed from the front wall, outer side wall, inner side wall, and rear wall, where applicable.

[0197] In general, the overall length of any urinary catheter embodiment described herein may be about 40 cm to about 60 cm, such as about 45 cm to about 50 cm; specialized catheters for other indications may have different lengths (depending on the clinical situation). In addition, in any embodiment described herein, a person skilled in the art may modify the distal tip of the catheter or elongated body to have a bulbous tip (along the transverse plane). In any embodiment described herein, the distal tip of the catheter or elongated body may be modified to have a tapered tip, such as Figures 25A-25BAs shown and further described elsewhere herein. In any of the embodiments described herein, the distal tip of the catheter or elongated body can be modified to have an offset tip (offset from the longitudinal axis of the elongated body), e.g. Figures 22A-22G As shown and further described elsewhere herein. In any of the embodiments described herein, the distal tip of the catheter or elongated body can be modified to include a ridge, e.g. Figures 19A-19G As shown and further described elsewhere herein.

[0198] As used herein, a "flexible zone" may include any one or more or more of the following features or characteristics: a through hole; a blind hole; an aperture; a cutout on the outer diameter of the catheter; a cutout on the inner diameter of the catheter; a cutout through the sidewall of the catheter and allowing fluid communication between the lumen and the external environment; a material having a different hardness than the rest of the catheter body; a concave surface; a convex surface; etc. In addition, the flexible zone may be elongated, circular, elliptical, rectangular, square, dot-shaped, non-cylindrical, bulbous, tapered cylindrical, hollow cone-shaped, polygonal, etc. In yet another embodiment, one or more flexible zones may be arranged in a pattern to impart flexibility to the zone, for example, the flexible zone includes the following features or characteristics: radially arranged features or characteristics; linearly arranged features or characteristics; features or characteristics located in the front half of the catheter; features or characteristics located in the back half of the catheter; features or characteristics located distal to the irrigation / drainage port; features or characteristics located proximal to the irrigation / drainage port; features or characteristics located both distally and proximally to the irrigation / drainage port; etc.

[0199] In some embodiments, a flexible zone is formed by removing a certain volume of material to increase the flexibility of the zone or by replacing a certain volume of material with a material of different hardness to increase the flexibility of the zone. The volume can be removed or replaced from the following: the external surface of the catheter, the external surface of the lumen leading to the catheter, at least part of the circumferential position of the lumen of the catheter, the rear inner wall of the lumen, the inner zone of the side wall, so that the external surface of the catheter or the lumen surface of the catheter is not damaged, or other situations. The range of the volume removed or replaced can be about 0.1% to about 95%, for example, about 0.1% to about 2%, about 1% to about 5%, 5% to about 10%, about 10% to about 20%, about 20% to about 30%, about 30% to about 40%, about 40% to about 50%, about 50% to about 60%, about 60% to about 70%, about 70% to about 80%, about 80% to about 90%, or more than 90%. When the material is replaced with a material of a different hardness, 100% of the volume percentage of the flexible zone may be composed of the material of the different hardness.

[0200] In some embodiments, one or more flexible zones are configured, individually or collectively, to apply the following degrees of curvature to the distal segment of the catheter: about 5 degrees to about 180 degrees; about 15 degrees to about 85 degrees, about 20 degrees to about 80 degrees; about 20 degrees to about 60 degrees, about 20 degrees to about 40 degrees, about 15 degrees to about 30 degrees, etc. For example, the first flexible zone may apply a bend of about 15 degrees to about 25 degrees to the proximal portion of the distal segment of the catheter body, and the second flexible zone may apply a bend of about 50 degrees to about 80 degrees to the distal portion of the distal segment of the catheter body. The bend angle measurements (in degrees) described herein are absolute and measured relative to the initial "flat and horizontal" axis, rather than relative to the curvature or curvature of the more proximal segment of the catheter body. If the angle depends on the position or orientation of the more proximal portion of the elongated body, the angle will be relative. In other words, if the catheter is in a linear non-bending configuration, all angle measurements herein are measured relative to the longitudinal axis of the catheter in the linear non-bending configuration. To show the degree of curvature of the various sections of the catheter, Fig.12D and 13C As shown, some relative degrees of bending are shown, but the starting point is the absolute bending starting point (measured relative to the initial "flat and horizontal" axis).

[0201] As shown and described herein, any flexible zone may be structured, shaped and / or otherwise positioned to promote forward deflection, such as unidirectional deflection in the forward direction. However, unidirectional deflection rearward or in a lateral plane is also contemplated.

[0202] Generally speaking, any device herein can be coated. For example, the coating can be hydrophilic, lubricious, have antibacterial properties, etc. The coating can include: silicone, polytetrafluoroethylene (PTFE), silver, etc.

[0203] In general, any device herein may include no balloon, one balloon, or two balloons on the elongated body. For example, a dual balloon embodiment may be used for induction of labor in obstetrics or for retrograde urethrography. A dual balloon catheter embodiment includes one or more holes between the balloons and / or to cushion the tip to reduce suction from the holes.

[0204] Generally speaking, any device described herein may at least partially include or be formed from the following materials: natural latex, silicone, latex, polyisoprene, silicone rubber latex (e.g., latex with a silicone coating), vinyl, urethane, TPE, etc. The hardness of the material may be about 20 Shore A to about 80 Shore A, about 30A to about 70A, about 25A to about 75A, about 35A to about 53A, or about 45A to about 55A, preferably about 40A to about 70A.

[0205] In general, any device herein may have a variety of sizes: about 12 to about 30 French; about 14 to about 16 French; about 12 French; about 14 French; about 16 French; about 18 French; about 20 French; about 22 French; about 24 French; about 26 French; about 28 French; about 30 French, etc. A unique feature of the present disclosure is to provide devices that are sized to be more accessible to the user, such as using language such as small, medium, large, and / or extra large. For example, a small size may include a 14 French catheter; a medium size may include a 17 French catheter; a large size may include a 22 French catheter; and an extra large size may include a 25 French catheter.

[0206] In some embodiments, any catheter described herein may include one or more indicators or markings to distinguish the front side and the back side of the catheter, the front side being the curved side (the inner radius side when in a curved configuration). For example, the indicators or markings may include different shading or coloring of the front and back sides, printed directional lines, dashes, dots or stripes, text, symbols, etc.

[0207] In some embodiments, as described herein, the bend or deflection of the distal tip or distal portion of the catheter can be temporary, such that the distal tip or distal portion deflects only when encountering resistance in the body cavity, but is otherwise substantially unbent or substantially unpre-bent. For example, temporary deflection can include bending only during passage through the prostate apex or after passage or cleaning of the prostate, such that the distal tip or distal portion then presents a substantially straight profile.

[0208] In general, any device described herein can be packaged, sold, manufactured or otherwise distributed as a kit. For example, the kit may include a lubricant, such as KY jelly, a jelly including an anesthetic (e.g., lidocaine), etc. The kit of some embodiments may include a drainage bag with a tube (e.g., a spiral tube). In certain embodiments, the kit may include one or more catheters, such as any combination of small, medium, large and / or extra-large catheters may be included in the kit. The kit may optionally include an antibacterial solution for cleaning the urethral opening before insertion and / or a syringe equipped with sterile water for filling a catheter balloon. In addition, the kit may optionally include a catheter retaining device that fixes the catheter to the body (e.g., bonded to a catheter rotating device to fix it to a thigh).

[0209] In addition, for example, many of the embodiments described herein show distal apertures for draining fluid from an organ; however, it is similarly contemplated and not departing from the scope of the present disclosure that the distal tip may not include an aperture. Alternatively, an aperture may be present but used to pass a wire through it for tracking.

[0210] In addition, for example, many embodiments described herein illustrate a lumen for draining liquid from an organ defined by a catheter body; however, it is similarly conceivable and not departing from the scope of the present disclosure that at least part of the catheter body does not define a lumen. For example, the distal end portion of the catheter body may not include a lumen. In such embodiments, the lumen extends to one or more apertures, but terminates at these apertures so that drainage, flushing and / or balloon flushing may still occur, but the stiffness profile of the catheter remains after the lumen terminates. For example, in some embodiments, the distal end of about 1.5 cm to about 2.5 cm may not include a lumen, or the distal end of about 5 cm to about 6 cm may not include a lumen.

[0211] In embodiments comprising two or more apertures, those skilled in the art will appreciate that the apertures may be located on opposite sides of the catheter body (offset laterally), may be axially or longitudinally aligned, may be positioned forwardly, may be positioned rearwardly, etc., without departing from the scope of the present disclosure.

[0212] In addition, although the attached catheter diagrams only show the distal end portion or segment of each embodiment, it will be appreciated by those skilled in the art that any proximal end feature may be used, or a proximal end zone control mechanism may be used. For example, without departing from the scope and intent of the present disclosure, an anchoring balloon, a valve, a connector, a rapid exchange segment, a drainage bag, a syringe for liquid injection, an actuating mechanism, etc. may be included on the proximal end of each catheter described herein. In some variants, the proximal end portion or segment may optionally be used as a temperature probe and to flush the lumen.

[0213] In addition, although one or more flexible zones are shown as being distal, such as distal to the retaining balloon, it will be appreciated by those skilled in the art that one or more flexible zones may be further proximal or near the retaining balloon. For example, there may be one or more flexible zones located about 1 cm to about 12 cm, about 1 cm to about 5 cm, about 5 cm to about 15 cm, about 8 cm to about 12 cm, about 10 cm proximal to the retaining balloon. In one embodiment, the one or more flexible zones may include any of the disclosed embodiments described herein and be spaced apart, for example, about 2.5 cm proximal to the retaining balloon. In some embodiments, the proximal flexible zones may be symmetrical so that the promotion of bending does not differ in two directions. Such proximal flexible zones will be combined with Figures 24A-24F This is described in further detail below.

[0214] In any of the embodiments described herein, there are various optional features that may be included, such as a temporary occluder during insertion or a vacuum source to facilitate adequate drainage of the catheter (eg, in those embodiments having an internal flexible zone).

[0215] In any of the embodiments described herein, the various features may also be used in a urethral dilator. Thus, any of the features of the following embodiments may be used in a urethral dilator without departing from the scope of the invention disclosed herein.

[0216] In any of the embodiments described herein, one or more portions of the catheter can be radiopaque. In one embodiment, the entire length of the catheter is radiopaque.

[0217] In general, the dimensions shown and described herein relate to an 18 Fr device. As will be appreciated by those skilled in the art, the dimensions may be scaled up or down linearly based on the size of the device.

[0218] Figure 1 The male urinary tract is shown. When inserting a catheter into the male urinary tract, it is pushed through the penile urethra 10 into the prostatic urethra 14, past the prostate 12 and through the bladder neck 18 of the bladder 16. Figure 1 As shown, the male anatomy has significant tortuosity through which the catheter must navigate to reach the bladder. For women, the path to the bladder is less tortuous. The catheter is inserted through the external urethral opening, through the urethra, through the bladder neck, and into the bladder. Regardless of the anatomy, inserting a catheter into the urethra can be difficult; tissue sensitivity, tortuosity of the anatomy, and the potential for various organs (e.g., the prostate) to impinge on the urethra can make passage difficult. Currently available catheters are difficult to use and difficult to select. For example, pre-catheterization imaging is not routinely performed, and Foley catheters, A catheter or guidewire with a Councill tip may not be able to enter. Additionally, insertion may become more difficult after the first attempt due to tissue trauma or damage from the first failed attempt. There may be significant bleeding, and each failed attempt will escalate the patient's anxiety / discomfort / pain. In some cases, the practitioner may need to resort to flexible cystoscopy or suprapubic tube insertion. Additionally, for example, adult catheter sizes range from 12 French to 30 French, which is a measurement of the outer diameter of the catheter. However, given the large size range, it may be difficult to determine which catheter size is appropriate for the patient. Additionally, some catheters only have selected features, resulting in the need to switch to a different catheter to achieve the intended function. For example, with the help of Figure 2 As shown in the exemplary catheter 28 in FIG. 1 , some catheters include a distal aperture 20 for passive removal of particles or urine; two-way channels 24, 26 for drainage from the distal aperture 20 and balloon inflation, respectively; and / or an inflatable balloon 22 for retention in the bladder; etc. In addition, for example, as with the aid of Figure 3As shown in the exemplary catheter 30 in FIG. 1 , some catheters include a three-way channel (e.g., a lumen 32 for filling and retaining a balloon, a lumen 36 for irrigation, and a lumen 34 for drainage); an inflatable balloon 38 for retention in the bladder; multiple apertures for particle removal and / or irrigation; etc. In other embodiments, irrigation and drainage are both performed through the same lumen. Figure 4A Further shown is a cross-sectional view of a catheter body 40 defining a lumen 44 for drainage and a lumen 42 for filling and retaining a balloon or for irrigation.

[0219] Figure 4B Further shown is a cross-sectional view of a catheter body 50 defining a lumen 54 for drainage, a lumen 52 for filling and retaining a balloon, and a lumen 56 for flushing. Any catheter described herein may include a combination of Figure 2-5 One or more of the features described renders the catheter multifunctional, thereby reducing the need to use multiple catheters to achieve a desired outcome for a patient.

[0220] Now turn to see Figures 6A-6C , shows an embodiment of a flexible conduit. Figure 6A-6B As shown in the unbent configuration, the elongated body 60 of the catheter defines one or more flexible regions shown as a plurality of blind holes or through holes 62 proximal to the distal tip 64. Figure 6C As shown, the distal tip 66 is bent at the flexible zone 62 . Figures 6A-6C The embodiment further includes a retention balloon 68 , which is shown in an uninflated state, positioned proximally relative to the flexible zone 62 .

[0221] Figure 7A-7B Show Figures 6A-6C The embodiment is similar to the embodiment of FIG. 1 , except that in this embodiment, the elongated body 70 defines a single aperture 72 as a flexible region where the elongated body 70 bends unidirectionally. Figure 7A-7B As shown and will Figure 7A-7B Compared to other embodiments herein, the flexible zone 72 comprises material removed from the front sidewall, the material removal extending circumferentially around the outer diameter of the catheter so that the flexible zone has a U-shaped cross-section, such as Figure 7B The material removal extends to a plane that lies along the longitudinal axis of the conduit. Figure 7BIn the embodiment shown, the plane exists between about 40% to about 60% of the outer diameter, for example, at about 50%. The incision depth percentage 75 of the flexible zone 72 is about 40% to about 60%. As described above, the catheter body 70 defines a lumen 71 through which it passes, contains but does not need to maintain a balloon 78 (in an uninflated state), and includes a distal tip 74. The distal tip 74 defines a pore 73 for passing a guide wire therethrough, draining liquid from an organ, or flushing tissue in an organ. In any embodiment described herein, the distal tip pore 73 can be centered along the axial or longitudinal centerline axis of the catheter body or offset relative to the centerline axis of the catheter body.

[0222] Figures 8A-8B ( Figure 8B is along section AA Fig. 8A The cross-sectional view of Figure 7A-7B The embodiment of the present invention further comprises a second flexible zone 85, which comprises a decreasing wall thickness (from the distal side to the proximal side) at the distal end of the front. For example, at the distal side of the aperture 82, the second flexible zone 85 comprises a first inner wall thickness 85a that transitions to a second inner wall thickness 85b, and the second thickness 85b is thinner than the first thickness 85a. The transition between the first thickness and the second thickness can be graded, stepped, gradual, etc. For example, the transition can be about 0.25 to about 0.5mm, or about 1mm to about 2mm. The volume percentage of the material removed to form the second flexible zone 85 can be about 5% to about 30%. As described above, the catheter body 80 defines a lumen 81 through which it passes, contains but does not need to maintain a balloon 88 (in an uninflated state), and includes a distal tip 84. The distal tip 84 defines a pore 83 for passing a guide wire therethrough, draining liquid from an organ, or flushing tissue in the organ.

[0223] Figures 9A-9B Show Figures 8A-8B The embodiment further comprises a second flexible zone 95, wherein the second flexible zone comprises an inner wall cutout with a depth increasing from the distal side to the proximal side. Fig. 9B The decreasing inner wall thickness shown is aligned, Fig. 9B is along section AA Fig. 9A. In addition, distal to the aperture 92, the second flexible zone 95 includes a series of internal grooves having a sawtooth profile. The distance between the ridges and valleys of the sawteeth 95a, 95b and the internal heights of the ridges and valleys may be graded, stepped, gradual, etc. Alternatively or in addition, the depth of the incision may gradually increase as one moves proximally, or the depth may suddenly change as one moves proximally toward the first flexible zone 92. The depth may range from about 0.25-0.5 mm to about 1-2 mm. The volume percentage of material removed to form the second flexible zone 85 may be about 10% to about 90%. The incision may be generally triangular (the bottom of the triangular incision is located on the rear side of the catheter body), generally rectangular, generally slit, etc. In some embodiments, the incision in the inner wall thickness does not have a bonded Figures 8A-8B As described above, the catheter body 90 defines a lumen 91 therethrough, contains but need not hold a balloon 98 (in an uninflated state), and contains a distal tip 94. The distal tip 94 defines an aperture 93 for passing a guide wire therethrough, draining fluid from an organ, or flushing tissue in the organ.

[0224] Figures 10A-10B Show Figure 7A-7B The embodiment further includes a second flexible zone, which includes a front portion 105a of the catheter body 100, and the hardness or material of the front portion is different from the following: the rear portion 105b of the catheter body 100 and / or the proximal portion of the catheter body 100 (for example, proximal to the balloon 108 or proximal to the pore 102). The front portion 105a can be generally the front half, the front surface, the front quarter, etc. The hardness of the second flexible zone may be lower (softer) than the hardness of the rest of the catheter body 100. Alternatively or in addition, the material of the front portion 105a may be different from that of the rear portion, so that the material properties of the front portion 105a are softer than the rear portion. Fig. 10B As shown, it is along section AA Fig. 10A In a cross-sectional view of the catheter body 100, the second flexible zone 105a extends proximally from the distal tip 104 beyond or beyond the distal aperture 102. The flexibility of the second flexible zone 105a may increase from the distal to the proximal side, so that the lowest flexibility is at the distal tip 104 and the highest flexibility is at the proximal end of the second flexible zone. Alternatively, the second flexible zone 105a may include two low-flexibility zones located on the sides of the central high-flexibility zone, and the high-flexibility zone is centered on the distal aperture 102, surrounds the distal aperture or at least proximal to the distal aperture. As described above, the catheter body 100 defines a lumen 101 through which it passes, contains but does not need to hold a balloon 108 (in an uninflated state), and contains a distal tip 104. The distal tip 104 defines an aperture 103 for passing a guide wire therethrough, draining liquid from an organ, or flushing tissue in the organ.

[0225] Figures 11A-11B Show Figures 10A-10B , but wherein the second flexible zone 115a extends only to the distal or end of the distal aperture 112. The second flexible zone includes a front portion 115a of the catheter body 110, which has a different hardness or material than a rear portion 115b of the catheter body 110. The front portion 115a may be generally the front half, the front surface, the front quarter, etc. The hardness of the second flexible zone 115a may be lower (softer) than the rest of the catheter body 110. Alternatively or in addition, the material of the front portion 115a may be different from that of the rear portion 115b, such that the material properties of the front portion 115a are softer than those of the rear portion. Fig. 11B As shown, it is along section AA Fig.11A , the second flexible zone 115a extends from the distal tip 114 to the distal end of the distal aperture 112. The second flexible zone 115a may be adjacent to the distal aperture 112, or may be just proximal to the distal aperture 112 but not adjacent to the distal aperture. The flexibility of the second flexible zone 115a may increase from the distal side to the proximal side, so that the lowest flexibility is at the distal tip 114 and the highest flexibility is at the proximal end of the second flexible zone. Alternatively, the second flexible zone 115a may include two low-flexibility zones located on the sides of the central high-flexibility zone. As described above, the catheter body 110 defines a lumen 111 through which it passes, contains but does not need to hold a balloon 118 (in an uninflated state), and includes a distal tip 114. The distal tip 114 defines an aperture 113 for passing a guide wire therethrough, draining liquid from an organ, or flushing tissue in the organ.

[0226] Figures 12A-12D Another embodiment of a flexible conduit is shown. Figures 12A-12B As shown, the elongated body 120 defines a lumen 121 therethrough, defines one or more apertures 123 (e.g., for irrigating tissue, draining fluids, etc.), and includes a distal tip or distal end 124. The elongated body 120 further includes one or more flexible zones 122a on the front portion of the catheter 120. For example, the flexible zone 122a may include a low durometer filler material having one or more relief apertures 127 defined by the zone 122a. The relief apertures 127 may relieve stress at the zone 122a and / or enhance flexibility. Fig. 12B As shown, it is along section AA Fig. 12A In the cross-sectional view of FIG. 1 , the release aperture 127 passes through the front side wall, but it should be understood by those skilled in the art that the release aperture does not have to pass through the side wall to increase the flexibility at the area. The cut depth percentage 125 of the flexible zone 122a can be about 30% to about 70% of the outer diameter 5800. The volume percentage occupied by the low-hardness filler material in the flexible zone 122a can be about 5% to about 50% of the outer diameter 5800. Fig. 12AAs shown and as applied to any flexible zone described elsewhere herein, each flexible zone 122a can include a unique shape, structure and / or filler material. In this example, one flexible zone has a more rounded appearance or shape, while the other flexible zone has a more oval appearance or shape.

[0227] In addition, if Fig. 12B As best shown in FIG. 1 , the elongated body 120 further includes one or more flexible zones 122b on the rear portion of the catheter 120. The flexible zone 122b may include a low durometer filler material, one or more release apertures, a convex surface, a concave surface, etc. The cut depth percentage 129 of the flexible zone 122b may be about 5% to about 30%. The volume percentage occupied by the low durometer filler material in the flexible zone 122a may be about 5% to about 40%. In some embodiments, one or more front flexible zones are substantially the same as the rear flexible zone; in other embodiments, one or more front flexible zones are substantially different from one or more rear flexible zones. As described above, the catheter body 120 includes but is not required to retain the balloon 128 (shown in an uninflated state).

[0228] The flexibility characteristics of the catheter 120 are shown in Figures 12C-12D In the flexible region 122a, the catheter 120 has increased bendability. For example, at the flexible region 122a, the catheter 120 can be bent at angles A1, A2, A3, or A4, each of which is about 10 degrees to about 90 degrees; about 20 degrees to about 80 degrees; about 20 degrees to about 60 degrees; about 15 degrees to about 50 degrees; about 50 degrees to about 90 degrees; about 10 degrees to about 40 degrees; about 20 degrees to about 40 degrees; about 5 degrees to about 50 degrees; about 5 degrees to about 30 degrees; about 10 degrees to about 30 degrees; about 15 degrees to about 25 degrees; and so on. In some embodiments, the cumulative curvature of A1 and A2 or A3 and A4 is about 20 degrees to about 200 degrees; about 30 degrees to about 90 degrees; about 75 degrees to about 85 degrees; about 80 degrees to about 180 degrees; substantially 80 degrees; and so on. The flexible zone of the catheter 120 may include a farthest or distal portion of a length from the distal tip 124 of about 15 mm to about 60 mm; about 30 mm to about 55 mm; about 50 mm to about 70 mm; about 40 mm to about 80 mm; about 50 mm to about 60 mm; and the like. In some embodiments, angle A2 is greater than angle A1. In other embodiments, A1 is greater than A2. Additionally, in some embodiments, angle A4 is greater than angle A3. In other embodiments, A3 is greater than A3. In yet other embodiments, A2 may be substantially equal to A1, or A3 may be substantially equal to A4. As described above, the catheter body 120 defines a lumen 121 therethrough, and one or more apertures 123 for drainage / flushing, etc. Additionally, the catheter 120 includes, but need not retain, a balloon 128 (in an uninflated state), and includes a distal tip 124.

[0229] Figures 13A-13C Similar to Figures 12A-12D The embodiment shown is different in that in this embodiment, the catheter or slender body 130 includes multiple front flexible zones 132a and multiple rear flexible zones 132b. In this exemplary non-limiting embodiment, there are four front flexible zones and four rear flexible zones; however, it should be understood by those skilled in the art that the number, spacing, shape and / or composition of the flexible zones can be changed without departing from the original scope of the present disclosure. In some embodiments, the rear and / or front flexible zones 132a, 132b contain or include a low durometer filler material having one or more release pores 137 defined by the zones 132a or 132b. The release pores 137 can relieve stress at the zone 132a and / or enhance flexibility. As Fig.13A As shown and as applied to any flexible zone described elsewhere herein, each flexible zone 132a may include a unique shape, structure and / or filler material. In this example, the front flexible zone 132a has a generally elliptical appearance or shape, while the rear flexible zone 132b has a more rounded appearance or shape. In some embodiments, there may be equal spacing between adjacent flexible zones 132a; in other embodiments, there may be irregular spacing between adjacent flexible zones 132a. For example, there may be about 5mm to about 20mm between adjacent flexible zones 132a; about 10mm to about 15mm; about 8mm to about 18mm; about 12mm to about 15mm; and so on. The distal-most flexible zone may be spaced apart from the distal tip 134 by about 1mm to about 10mm; about 3mm to about 8mm; generally 5mm; about 5mm to about 15mm; and so on. Additionally, in some embodiments, flexible zone 132b is offset laterally but not axially relative to flexible zone 132a; in other embodiments, flexible zone 132b is offset laterally and axially relative to flexible zone 132a. In still other embodiments, flexible zone 132b is offset axially but not laterally relative to flexible zone 132a, thereby obtaining more anterior flexible zone.

[0230] The flexibility characteristics of the catheter 130 are shown in Fig. 13C The catheter 130 is bent at the flexible regions 132a, 132b. For example, at the flexible region 132a, the catheter 130 may be bent at an angle A5, A6, A7, or A8 of about 1 degree to about 50 degrees; about 10 degrees to about 40 degrees; about 15 degrees to about 25 degrees; about 10 degrees to about 30 degrees; about 18 degrees to about 23 degrees; and so on. In some embodiments, the cumulative curvature of A5, A6, A7, and A8 is about 15 degrees to about 200 degrees; about 60 degrees to about 90 degrees; about 75 degrees to about 85 degrees; generally 80 degrees; and so on. In some embodiments, the angle A3 ( Fig.12D), A5, etc. can help facilitate guidance during insertion. The flexible region of the catheter 130 can include a distal-most or distal portion that is about 15 mm to about 60 mm from the distal tip 134; about 30 mm to about 55 mm; about 50 mm to about 70 mm; about 40 mm to about 80 mm; about 50 mm to about 60 mm; etc. As described above, the catheter body 130 (when it is along section AA) Fig.13A Cross-sectional view of Fig. 13B The catheter 130 defines a lumen 131 for passing a guide wire therethrough, draining fluid from an organ, or flushing tissue in the organ, and one or more apertures 133 for drainage / flushing, etc. In addition, the catheter 130 includes, but need not retain, a balloon 138 (in an uninflated state), and includes a distal tip 134.

[0231] Figures 14A-14B ( Fig. 14B is along section DD Fig.14A The cross-sectional view is similar to Figures 13A-13B The difference is that in Figures 14A-14B In the embodiment of the present invention, there are multiple front flexible zones 142a and multiple rear flexible zones 142b, which can be blind holes, concave sections in the outer diameter of the catheter, convex sections in the outer diameter of the catheter, sections of a different material than the rest of the catheter body, etc. In this exemplary non-limiting embodiment, there are nine front flexible zones and nine rear flexible zones; however, it should be understood by those skilled in the art that the number, spacing, shape and / or composition of the flexible zones can be changed without departing from the original scope of the present disclosure. The catheter 140 can be similar to Figures 12A-13C The catheter body 140 is curved like a catheter of the present invention, for example, wherein the cumulative curvature is about 15 degrees to about 200 degrees; about 60 degrees to about 90 degrees; about 75 degrees to about 85 degrees; generally 80 degrees; etc. As described above, the catheter body 140 defines a lumen 141 for passing a guidewire therethrough, draining fluid from an organ, or flushing tissue in the organ, and one or more apertures 143 for drainage / flushing, etc. In addition, the catheter 140 includes a distal tip 144 and, optionally, a retaining balloon 148 (shown in an uninflated state).

[0232] Figures 15A-15D Another embodiment of a flexible conduit 150 is shown that includes one or more front flexible zones 152a and / or one or more rear flexible zones 152b. For example, one or more flexible zones 152a may include a series or multiple slits, apertures, etc. separated by one or more flanges 152f, such as Fig.15D As shown. For example, the depth of each slit may be about 25% to about 75% of the catheter diameter, and the width of each slit may be about 0.25 to about 2 mm. The length of region 152a may be about 10 mm to about 50 mm. In addition, as Fig. 15BAs shown, one or more slits or apertures and therefore the flanges may be at an angle A9 of about 0 to about 90 degrees; about 20 to about 70 degrees; about 30 to about 60 degrees; about 40 to about 70 degrees; etc., so that the slits or apertures are angled in the desired bending direction, further facilitating unidirectional bending. Fig. 15C , which shows the rear flexible zone 152b. The rear flexible zone 152b includes an axial positioning ridge 152c of a material that may be different from the catheter body, etc., and one or more laterally extending apertures 152d, 152e. The axial positioning ridge 152c is configured to provide a substantially continuous surface between the apertures 152d, 152e to avoid deep transitions and edges. For example, the axial positioning ridge 152c can prevent squeezing and / or abrupt transitions to reduce patient discomfort during insertion and / or removal. The flexible zone 152a may similarly (optionally) include an axial positioning ridge.

[0233] The size (e.g., depth, amplitude, circumference, radius, diameter, etc.) of the laterally extending pores may vary, such as being extended 152d or shortened 152e. The diameter of each pore 152d, 152e in terms of the long dimension may range from about 20% to about 80% of the diameter of the catheter. The diameter of each pore 152d, 152e in terms of the short dimension may range from about 0.25 mm to about 5 mm. In addition, one or more laterally extending pores (from the ridge) may be in a pattern (e.g., one every other; all extended; all shortened; two shortened and one extended; two extended and one shortened; etc.). The extended pores may be blind holes, through holes, include materials of different hardness, etc. In addition, as Fig.15D As shown and described above, the catheter body 150 defines a lumen 151 for passing a guidewire therethrough, draining fluid from an organ, or flushing tissue in an organ, and one or more apertures 153 for drainage / flushing, etc. In addition, the catheter 150 includes, but need not retain, a balloon 158 (in an uninflated state), and includes a distal tip 154.

[0234] In some embodiments, Figures 16A-16D As shown, at least a portion of the inner wall along the inner diameter or lumen of the elongated body 160 may be removed to provide one or more flexible zones 162a, 162b. The flexible zone may be a forwardly positioned flexible zone 162a or a rearwardly positioned flexible zone 162b or both, such as Figures 16B-16C In this particular embodiment, there are two front flexible zones and one rear flexible zone, but one or more front flexible zones and one or more rear flexible zones are contemplated herein. Fig. 16B As shown, it is along section AA Fig.16A In a cross-sectional view of FIG. 1 , there may be two flexible zones spaced apart and positioned distally relative to one or more apertures 163. In addition, as Fig.16AAs shown, since the flexible regions 162a, 162b are disposed internally, they may not be visible from an external view of the elongated body 160. Fig.16D As shown, in some embodiments, flexible zone 162b is offset laterally but not longitudinally relative to flexible zone 162a; in other embodiments, flexible zone 162b is offset laterally and longitudinally relative to flexible zone 162a. In still other embodiments, flexible zone 162b is offset longitudinally but not laterally relative to flexible zone 162a, thereby obtaining more front flexible zone. Figures 16E-16H Show Fig.16D sectional views (along sections DD and EE, respectively) to show how at least a portion of the sidewall 167 of the inner diameter of the elongated body 160 is removed to form the flexible zones 162a, 162b. In some embodiments, the wall thickness 162c and length 162d of the front flexible zone 162a may be thinner than the wall thickness 162e and length 162f of the rear flexible zone 162b to facilitate bending in the forward direction. For example, Figure 16G 165d, and a rear wall cut depth 165b and a front wall cut depth 165c are shown. The front wall cut depth 165c can be about 5% to about 95%, about 20% to about 80%, or about 70% to about 80%. The rear wall cut depth 165b can be about 5% to about 95%, about 5% to about 50%, or about 25% to about 35%. In other embodiments, the area or volume of the front and rear flexible zones is the same, or the area or volume of the front flexible zone is larger than the rear flexible zone to facilitate forward bending. Fig.16H The volumes of material removed from the front flexible zone 162 and the rear flexible zone 162b are shown relative to the tube 169. The volume percentage 515 of material removed from the front flexible zone 162a is about 20% to about 30%, and the volume percentage 516 of material removed from the rear flexible zone 162b is about 1% to about 10% or about 2% to about 5%, relative to the tube 169 encapsulating the zones.

[0235] In addition, if Figures 16E-16G As shown and described above, the catheter body 160 defines a lumen 161 therethrough, and one or more apertures 163 for drainage / irrigation, etc. Additionally, the catheter 160 includes, but need not retain, a balloon 168 (in an uninflated state), and includes a distal tip 164 .

[0236] Now turn to see Figures 17A-17C , which shows various pore locations relative to one or more flexible zones. Fig.17AAs shown, the catheter 170 defines a lumen 171 for passing a guide wire therethrough, draining fluid from an organ, or flushing tissue in the organ, and an aperture 173 positioned laterally offset from the flexible zone 172c relative to the longitudinal axis of the catheter body 170 but longitudinally aligned with the flexible zone 172c. In such embodiments, the aperture 173 outside the flexible zone 172c can further enhance the flexibility at this location on the catheter body 170. Fig.17A As shown, the catheter body 170 may further include a second flexible zone 172a positioned more distally relative to the flexible zone 172c on the distal tip of the catheter.

[0237] In addition, if Fig. 17B As shown, the bulbous end 176a of the flexible zone 172c can be positioned more proximally than the end 176b of the flexible zone 172c positioned between the apertures 173 defined by the catheter body 170. This configuration of the flexible zone 172c can cause or promote the forward bending of the distal tip 174 of the catheter body 170. As described above, the catheter 170 can further define a lumen 171 for passing a guide wire therethrough, draining fluid from an organ, or irrigating tissue in the organ, and a second flexible zone 172a positioned more distally than the flexible zone 172c.

[0238] In yet another variation, Fig. 17C As shown, the catheter body 170 includes a flexible zone 172c disposed between a plurality of apertures 173. For example, two apertures may be positioned more proximally than the zone 172c, and one aperture may be positioned more distally than the zone 172c. In other embodiments, any number of apertures may be positioned more proximally and / or more distally relative to the zone 172c. In addition, the flexible zone 172c may have any shape, configuration, or other condition that facilitates bending. The elongated body 170 may further include a second flexible zone 172a positioned more distally than the flexible zone 172c. As Fig. 17C An alternative embodiment of Figures 18A-18B As shown, the aperture 183 may include a plurality of mesh holes or outlets defined by the elongated body 180. Figures 18A-18B As shown, the aperture 183 is positioned between the flexible zones 182a and 182c and proximal to the flexible zone 182c. Such apertures 183 may enhance the bendability in the zone and / or simply serve as irrigation apertures, drainage apertures, etc. Alternatively, the apertures 183 may not be apertures at all, but rather zones with different hardness, materials, flexibility, blind holes, etc.

[0239] Now turn to see Figures 19A-19G , which shows that Figures 16A-16FA similar embodiment, except that the elongated body 190 further includes a distal end portion 194, which includes a terminal region 194a that narrows when viewed from a side perspective to maintain a substantially constant circumference between the elongated body and a raised portion 194b at the distal end. The diameter 194e of the narrowed terminal region 194a is smaller than the diameter 190d of the catheter body 190, so that the transverse circumference of the raised portion 194b is substantially equal to the transverse circumference of the elongated body (e.g., at 190d). This relationship between the transverse circumference of the raised portion and the transverse circumference of the elongated body can be used to avoid stretching of the inner circumference of the blood vessel into which the catheter is inserted. The raised portion 194b can be positioned or extended forward or backward to facilitate deflection of the distal end in a direction opposite to the raised portion 194b. The raised portion 194b can be defined as a distal end portion in which the longitudinal cross-sectional length 194c is less than the transverse cross-sectional length 194d. In addition, as described above in Figures 16A-16F As shown in Figures 19A-19G As shown, at least a portion of the sidewall along the inner diameter of the elongated body 190 may be removed to provide one or more flexible zones 192a, 192b. The flexible zone may be a forwardly positioned flexible zone 192a or a rearwardly positioned flexible zone 192b or both, such as Figures 19C-19G In addition, Fig.19C As shown, it is along section AA Fig.19B In a cross-sectional view of FIG. 1 , there may be two flexible zones spaced apart and positioned distally relative to one or more apertures 193. In addition, as Figures 19A-19B As shown, since the flexible regions 192a, 192b are disposed internally, they may not be visible from an external view of the elongated body 190. Fig.19D As shown, it is along section BB Fig.19B In a cross-sectional view of the embodiment of the present invention, in some embodiments, flexible zone 192b is offset laterally but not longitudinally relative to flexible zone 192a; in other embodiments, flexible zone 192b is offset laterally and longitudinally relative to flexible zone 192a. In still other embodiments, flexible zone 192b is offset longitudinally but not laterally relative to flexible zone 192a, thereby obtaining more front flexible zone. Figures 19F-19G Show Fig.19E A cross-sectional view of the embodiment of the present invention is provided to show how to remove the side wall 197 of the inner diameter of the elongated body 190 (at Fig.19E It is shown in FIG. 1 , which is along section CC. Fig.19C ) to form at least a portion of the flexible regions 192a, 192b. In addition, in this embodiment, Figures 19F-19G ( Fig.19F is along section DD Fig.19E A lateral view of Figure 19G is along section EE Fig.19EBoth views (a lateral view of the figure) show a rearwardly extending ridge 194b. In some embodiments, the wall thickness and length of the wall covering the interior cavity of the front flexible zone 192a can be greater than the wall thickness, area, and length of the wall covering the interior cavity of the rear flexible zone 192b to facilitate bending in the forward direction. In other embodiments, the wall thickness, area, and length of the rear flexible zone are the same as the front flexible zone, or the wall thickness, area, and length of the rear flexible zone are greater than the wall thickness, area, and length of the front flexible zone.

[0240] In addition, if Fig.19A As shown, the area proximal to the balloon 198 may include an orientation marker 199, shown as a stripe, for example. The marker may be positioned on the front side of the elongated body 190 so that the user can determine the orientation of the catheter after insertion. Thus, the user can then know in which direction the distal deflection occurs, since the deflection is unidirectional in the forward direction. Alternatively, the marker may be positioned on the rear side of the elongated body 190 or otherwise positioned to communicate the orientation of the catheter during or after insertion.

[0241] In addition, if Fig.19A 19F-19G and as described above, the catheter body 190 defines a lumen 191 therethrough and one or more apertures 193 for guidewire passage / drainage / flushing, etc. In addition, the catheter 190 includes but need not retain a balloon 198 (in an uninflated state), and includes a distal tip region 194.

[0242] Figures 22A-22G Shown with Figures 16A-16F Another embodiment of a similar flexible catheter, except that this embodiment includes an asymmetric tip. Figures 22A-22C ( Fig. 22C is along section AA Fig. 22B As shown in a cross-sectional view of FIG. 2 , an elongated body 220 defining a pore 223 and a lumen 221 and including (but not requiring) a balloon 228 includes a distal end region 224 and optionally a marker 229,

[0243] As described elsewhere herein. The distal end region is longitudinally offset 224b, such as Fig. 22B and 22E 16 and 19 . The distal end region has a circumference or diameter similar to the rest of the catheter body 220, but extends rearwardly (or alternatively, forwardly). For example, the longitudinal offset 224b may be about 0.5 mm to about 5 mm. The elongated body 220 further includes one or more front flexible regions 222a and / or rear flexible regions 222b, as described elsewhere herein at least with respect to FIGS. 16 and 19 . A cross-sectional view is also shown in FIG. Figures 22F-22G , flexible regions 222a, 222b, longitudinally offset distal tip 224b and lumen 221 are illustrated.

[0244] In addition, if Fig.23 As shown but also as applied to any embodiments shown and / or described herein, the slender body 230 may define a lumen 231 that is offset relative to the centerline axis of the slender body 230. For example, the front inner wall 231a may be thinner than the rear inner wall 231b or in other words, material may be added to the rear inner wall of the lumen of the slender body 230 and / or material may be removed from the front inner wall of the lumen of the slender body 230 (e.g., to maintain a desired French size of the catheter). This thinner inner wall 231a may promote unidirectional bending in the forward direction. As will be appreciated by those skilled in the art, the rear wall may also be thinner than the front wall to promote backward bending. In addition, as described above, the catheter body 230 may include one or more flexible regions 232a, 232b and define one or more pores 233. The slender body 230, such as Fig.23 As shown, a distal tip 234 is included that includes a rear protrusion or bump 234 b such that the diameter of the distal tip 234 is greater than the diameter of the elongated body 230 .

[0245] Figures 20A-20B Another embodiment of a flexible conduit is shown. Fig. 20B As shown, it is along section AA Fig. 20A 202n only extends distally of the balloon 208 to near the distal end 204 of the elongated body 200. Each flexible zone 202 includes an inner wall cutout or corrugation. Each cutout is defined by a cutout depth 205 and a corrugation length 203. For example, Fig. 20B As shown, the plurality of flexible zones 202 look similar to waves or in other words look like sinusoids, but other types of cuts are also contemplated (e.g., square, zigzag, etc.). As non-limiting examples, the amplitude may be about 0.2 mm to about 0.6 mm, or about 0.4 mm; and the wave length may be about 2 mm to about 4 mm, or about 3 mm. An optional balloon 208 is also shown, and the lumen 201 defined by the elongated body 200 is also shown.

[0246] Figures 20C-20G Show Figures 20A-20B An embodiment similar to the embodiment of the present invention is different in that the slender body 5200 defining a lumen 5201 and including a distal tip 5204 includes a plurality of flexible zones, each flexible zone 5202a, 5202b, 5202c, ..., 5202n extending along a circumferential surface shape of the lumen (i.e., material is removed from the lumen without passing through the outer surface of the elongated body). Fig. 20C is a cross-sectional view. Fig.20D The flexible region 5202a is shown along Fig. 20CThe volume percentage 5220 removed from the tube 5210, as shown in FIG. Figures 20E-20F As shown, for the flexible zone 5202a, it is about 10% to about 30% or about 15% to about 20%. Figure 20G The cut depth of the flexible zone is shown relative to the wall thickness. The wall thickness 5810 of the catheter 5200 is 100%, and the cut depth percentage 5820 is shown as about 50% to about 75% of the wall thickness into the wall.

[0247] Figures 21A-21B ( Fig. 21B Along section BB Fig.21A A cross-sectional view of Figures 20A-20B The embodiment of the embodiment of the present invention is similar to the embodiment of the present invention, except that this embodiment includes a plurality of rear flexible zones 216a, 216b, 216c, ..., 216n plus a plurality of front flexible zones 212a, 212b, 212c, ..., 212n, as described above in conjunction with Figures 20A-20B as described. However, the wave length 217 is greater than the wave length 219, and the posterior incision depth 215 is shallower than the anterior incision depth 213. As a non-limiting example, the amplitude 213 may be about 0.2 mm to about 0.6 mm or about 0.4 mm, and the amplitude 215 may be about 0.1 mm to about 0.5 mm or about 0.3 mm. In addition, the wave length 219 may be about 2 mm to about 4 mm or about 3 mm, and the wave length 217 may be about 4 mm to about 8 mm or about 6 mm. Alternatively, the wave lengths 219, 217 may be substantially similar, and the amplitudes 213, 215 may be substantially similar. Also alternatively, in some embodiments, the wave length 217 may be smaller than the wave length 219, and the amplitude 215 may be larger than the amplitude 213. Consistent with the relationship between amplitude and wave length, in some embodiments, as Fig. 21B As shown, the rear portion may have less corrugation than the front portion, but it is also contemplated that the front portion may have substantially the same amount of variation as the rear portion or may have less variation than the rear portion.An optional balloon 218 is also shown, and a lumen 211 defined by the elongated body 210 is also shown.

[0248] In any of the foregoing embodiments described herein that include one or more flexible zones in the distal segment of the elongated body, the proximal segment of the elongated body may include one or more proximal flexible zones. Fig.23 The various features of the elongated body 230 (flexible regions disposed in the inner wall of the lumen defined by the elongated body) may be combined with one or more proximal flexible regions of the elongated body 240, such as Fig.24E As shown, it includes one or more distal flexible zones 242a, 242b plus one or more proximal flexible zones 245a, 245b. The cross-sectional view of each of the flexible zones is shown in FIG. Figures 24B-24D middle, Fig. 24Bis a cross-sectional view along section AA, Fig.24C is a cross-sectional view along section BB, and Fig.24D 247a, 247b, to prevent tissue from being squeezed between the grooves 247a and / or the grooves 247b. In some embodiments, each front proximal flexible zone 245a is laterally aligned with each rear flexible zone 245b. This lateral alignment causes at least the more proximal zone (or, in the case of the distal zone, the distal zone) to be flexible in the forward and rearward directions. Figures 24B-24D Also shown is an inflation lumen 242 defined by the elongated body 240 for inflating a balloon 248, as shown in FIG. Fig.24F As shown. The flexible regions 245a, 245b facilitate bending of the proximal segment, for example, up to about 180 degrees, about 10 degrees to about 90 degrees; about 20 degrees to about 60 degrees; etc. As will be appreciated by those skilled in the art, although shown on the proximal segment of the elongated body, Figures 24A-24F The flexible zone shown may be similarly positioned on the distal segment.

[0249] Additionally, any of the foregoing embodiments described herein may include a distal tip having a tapered profile as viewed from the side, with Figures 25A-25C Similar as shown. Figures 25A-25C ( Fig.25C It is along Fig.25A 2 (a cross-sectional view of section AA) shows an elongated body 250 including a plurality of front flexible zones 252a, 252b, 252c, 252d and a plurality of rear flexible zones 252e, 252f, 252g and 252h. The outer diameter 256d of the elongated body 250 may be larger than the protrusion thickness 256b of the distal tip 254, so that the outer diameter 256d of the elongated body 250 gradually narrows toward the outer protrusion thickness 256b of the distal tip 254 in the distal segment. For example, the ratio of the outer diameter 256d to the outer protrusion thickness 256b may be about 1.0:0.8 to about 1.0:0.2. The gradually narrowing range between the outer diameter 256d and the protrusion thickness 256b may be about 1.0:0.8 to about 1.0:0.2. The tip width 256c and thickness 256b are appropriately sized to maintain a constant lateral circumference of the tip equal to or less than the circumference of the circular body (i.e., at 256d) to avoid stretching the inner circumference of the anatomical lumen; the tip width 256c may also be equal to or less than the outer diameter 256d to further avoid stretching the anatomical lumen.

[0250] Figures 25D-25F ( Fig.25F yes Fig.25A) show a cross-sectional enlarged view, a cross-sectional three-dimensional view, and another cross-sectional enlarged view of various incision depth percentages of the flexible zone of the slender body 250, respectively. The incision depth percentages 253a and 253b defined by the incision depth relative to the outer diameter 256d of the multiple front flexible zones 252b, 252c, 252d are about 10% to about 70%. The incision depth percentage of the farthest front flexible zone 252a may be greater than the incision depth percentages 252b, 252c, 252d to facilitate bending at the first zone 252a. For example, the incision depth percentage 253a of the farthest front flexible zone may be about 25% to about 75%. The total incision depth percentage 255 of the farthest flexible zone 252a is about 60% to about 95% or about 80% to about 95% or about 90% to about 95%. In addition, as Fig.25C and 25D As shown, the optional plurality of rear flexible zones 252e, 252f, 252g and 252h each include grooves in the inner sidewall and rear wall 281b of the lumen 281a of the elongated body 250. The cut depth percentage 257 (relative to the outer diameter of the elongated body) of the rear grooves 252e, 252f, 252g in the inner sidewall 281b can be 5% to about 20%, wherein the cut depth percentage 251 (relative to the outer diameter of the elongated body) of 252h is equal to or greater than the cut depth percentage of 252e, 252f or 252g, in the range of about 5% to about 60%. The cut depth percentage 251 of the flexible zone 252h relative to the thickness 259 of the rear sidewall 281b is about 60% to about 70%.

[0251] In some embodiments, Figures 25I-25J As shown, the front flexible zone 252a is continuous with the rear flexible zone 252h, so that at least a portion of the inner wall 410 of the lumen is removed between the front flexible zone 252a and the rear flexible zone 252h. In such embodiments, the volume percentage is expressed relative to the combination of the material removed from the two zones of the tube 400 (the front material 440 removed from the zone 252a, the rear material 430 removed from the zone 252h) and the lumen wall material 420 removed from the zone 410 between the front zone 252a and the rear zone 252h, as shown in FIG. Figures 25I-25J shown.

[0252] like Fig.25J As shown, the volume percentage of the distal-most flexible zone, which includes the anterior material removal portion 440 on the anterior side, the posterior material removal portion 430 on the inner posterior side, and the at least partial circumferential removal portion 420 in the lumen between the anterior and posterior sides, is about 20% to about 40%, preferably about 25% to about 35%.

[0253] In some embodiments, Figures 25G-25HAs shown, the front flexible zone 252b is separated from the rear flexible zone 252e, but the zones collectively facilitate bending of the catheter in the forward direction. In such embodiments, the volume percentage is expressed relative to the combination of the material removed from the two zones (the front material 540 removed from the zone 252b and the rear material 530 removed from the zone 252e) of the tube 500, as shown in FIG. Figures 25G-25H The combined volume percentage is about 20% to about 40%, preferably about 25% to about 35%.

[0254] like Fig.25H As shown, for example, the volume percentage of the front flexible zone 252b including the front material removal portion 540 and some circumferential material removal portions of the lumen is about 20% to about 40% or about 25% to about 30%. In addition, for example, the volume percentage of the rear flexible zone 252e including the rear material removal portion 530 is about 0.1% to about 2% or about 0.5% to about 10%.

[0255] Still further, any of the foregoing embodiments described herein may include an elongated body having a polygonal cross-section, Figures 26A-26B Similar as shown. Figures 26A-26B An elongated body 260 is shown defining a lumen 261 therethrough and including a distal tip 264. In this embodiment, as shown along Fig.26A Cross-section of BB Fig.26B As shown, the polygonal shape of the body (having a narrower front width 263a and a wider rear width 263b) tends to bend forward more easily when subjected to axial force. For example, the width 263b of the rear side may be 2mm to about 5mm, while the width 263a of the front side may be 1mm to about 3mm. In one embodiment, material is added to the rear side of the catheter so that the rear side or rear inner wall of the lumen of the slender body 260 makes the width of the rear side greater than the front side. In another embodiment, material is added to the rear side of the outer surface of the slender body 260 to form a polygonal shape that preferably bends forward. In addition, although the trapezoidal polygon (i.e., a trapezoidal prism or a three-dimensional trapezoid) is shown in Figures 26A-26B However, those skilled in the art should understand that any polygonal shape is within the scope of the present disclosure, including but not limited to: rectangles (i.e., rectangular prisms, rectangular cuboids, rectangular parallelepipeds), triangles (i.e., triangular prisms, elongated rectangular prisms), and any flat or straight surface can be replaced with a curved surface, etc.

[0256] In some embodiments, the flexible region may include elongated pores, e.g. Figures 27A-27B shown. Figures 27A-27BAn elongated body 270 is shown defining a lumen 271 therethrough and including an elongated flexible zone 272. The cutout length percentage 276 of the flexible zone 272 may be about 5% to about 90% of the length of the elongated body 270, or about 15% to about 30% of the length of the elongated body 270. The flexible zone 272 may be such that it extends into the lumen 271 such that the lumen 271 has an elongated slot opening as the flexible zone 272. Fig.27B As shown, it is along section AA Fig.27A In cross-section, the flexible zone 276 may be generally "U" shaped, for example, such that the inner angles 277a, 277b of the ends of the flexible zone are curved. Although a "U" shaped curvature is shown, it should be understood by those skilled in the art that sharp or oblique angles, etc. are also contemplated herein. The features of the flexible zone 272 may be applicable to any flexible zone described elsewhere herein.

[0257] In another embodiment, if Figures 28A-28C ( Fig.28C Along Fig.28A As shown in section AA of FIG. 1 , the elongated body 280 may include a plurality of flexible zones 282 (e.g., 282a, 282b, 282c, 282d, 282e). One or more flexible zones may include apertures such that the flexible zone extends through the front side wall 288a, through the lumen 281, and through the lumen surface 287 of the rear side wall 288b (without damaging the outer surface of the rear side wall), such that the one or more flexible zones 282 include an incision depth percentage of about 30% to about 70% (excluding the deep incision in the rear wall). The incision depth percentage 285a of the one or more flexible zones is about 50% to about 95%. For example, the incision depth of a 6 mm outer diameter catheter may be about 2.5 mm to about 3.5 mm. In addition, each of the flexible zones 282 includes an incision depth percentage 285a of about 5% to about 55%. The volume percentage of the one or more flexible zones is about 10% to about 40% or about 25% to about 35% (the material 530, 540 removed from the tube 500 is shown in FIG. Figures 25G-25H As shown in Fig.28C As shown, the flexible zone 282 extends from the front side and through the lumen such that material is removed circumferentially around the lumen and includes some material removal on the back side of the lumen.

[0258] exist Figures 28A-28C In the illustrated embodiment, the plurality of flexible regions 282 also include drainage or flushing apertures because the plurality of flexible regions extend into the lumen 281. The elongated body 280 may further include a retaining balloon (not shown), one or more proximal indicators (not shown), one or more additional apertures (shown as 282a-d, 282e) for drainage / flushing, etc. Additionally or alternatively, the elongated body 280 may include the invention as described elsewhere herein, for example with reference to Figures 19A-19C, any of the distal tip 284 configurations described in 22A-22C, 23, and 25A-25C.

[0259] exist Figures 28A-28C In some embodiments, the distal-most flexible zone may have a greater percentage of incision depth than other flexible zones located more proximally, for example, similar to the combination of Fig.25C Additionally or alternatively, Figures 28A-28C Embodiments of the invention may also include a rear flexible zone comprising a groove in the inner side wall of the lumen of the elongated body, such as in combination with Fig.25C Additionally or alternatively, Figures 28A-28C Embodiments may also include a tapered distal tip, such as in combination with Fig.25B As described.

[0260] like Fig.28C As shown, the distal tip 284 may define an aperture 283 for passing a guidewire or other instrument therethrough and / or for drainage / irrigation. Figures 28A-28C In other embodiments, the distal tip 284 does not define a pore. Figures 28A-28C The flexible zone in FIG. 2 is shown on the front side of the elongated body, but it should be understood by those skilled in the art that the flexible zone may also exist on the rear side of the elongated body. In addition, the elongated body 280 may include any of the inner flexible zone and / or rear flexible zone described elsewhere herein, such as Figure 8B , 9B , 16E-16F, 19F-19G, 20B, 21B, 25C. In addition, the elongated body 280 may include one or more proximal flexible zones described elsewhere herein, such as Figures 24A-24D Those proximal flexible zones.

[0261] for Figure 6A-28C In all of the above embodiments, there is a balance between maintaining column strength along the length of the catheter (for controlled and predictable pushability) and limiting the amount of pressure (described herein as wall pressure) applied to the anatomical structure when the catheter is advanced or retracted. In other words, the wall pressure is the local maximum pressure applied by the catheter on the wall. Local high pressure can cause deformation of the catheter lumen, which may cause the catheter to get stuck. The catheter lumen may have a complex stiffness behavior, so one way to reduce significant deformation is to minimize wall pressure.

[0262] The effects of various parameters on column strength and wall pressure as well as their effect on the insertion force or pressure required to deflect the distal segment of the catheter were investigated using mechanical testing fixtures and computer simulations. Fig.29A As shown, the incision length, incision depth, incision location, and number of segments were varied to determine the effects on column strength, wall pressure, and insertion force.

[0263] For example, using computer software-based simulations ( Various catheter designs were analyzed using a mechanical software package. Exemplary data from these analyses are shown in Figures 30A-30B Computer simulation analysis measures the internal forces of the catheter surrounding the flexible zone (force per distance of insertion) as well as the interaction between the catheter and the anatomical pathway (wall pressure, as described elsewhere herein).

[0264] To accurately analyze wall pressure, a simplified 3D CAD model of each catheter was created along with a tube representing the anatomical path the catheter must pass through. A nonlinear contact model with friction was used to simulate the interaction between the catheter and the tube. Depending on the material of the catheter and the desired simulation accuracy, either a linear or hyperelastic material was used. The tube was modeled as a rigid material to evaluate the flexibility and column strength of the catheter.

[0265] To evaluate the column strength, an eigenvalue buckling analysis was performed by applying a unit compressive load to the conduit in a linear analysis.

[0266] A simplified 3D CAD model of the catheter was created as fully parametric. Fig. 30A As shown, the key input parameters studied are the material properties of the catheter, the percentage of the cut length in the flexible zone, and the percentage of the cut depth in the flexible zone. Fig. 30B As shown, the insertion pressure is analyzed and determined.

[0267] Fig. 30A Normalized values ​​of catheter material properties (Young's modulus), percent incision depth, and percent incision length measured in a sensitivity study are shown (shown as local sensitivity percentage on the y-axis). A sensitivity study calculates the slope of an output variable with respect to an input variable. Local sensitivity means that the slope is calculated at a point on a multidimensional surface. Fig. 30A The slope of the wall pressure and column strength is shown as a function of Young's modulus, notch depth, and notch percentage. The output of the analysis shown on the x-axis is the wall pressure, column strength (first buckling mode), and column strength (second buckling mode). Since columns typically buckle in two directions perpendicular to the column axis, two buckling modes are evaluated. For example, if the column axis is Z, buckling can occur in either the X or Y axis. Fig. 30A As shown, the cut depth percentage has the greatest impact on wall stress and column strength. The cut length percentage also has an impact, but less than the cut depth percentage. The material properties, while still important to the overall design, have less impact on the output parameters than the cut depth or cut length.

[0268] Fig. 30B Data from a computer simulation are shown, in which a Foley catheter, Catheters and test catheters (e.g. Figures 28A-28C). The test catheter included a plurality of flexible zones, each flexible zone having a cut length percentage of about 70% to about 80% and a cut depth percentage of about 50% to about 70%. Fig. 30B The data in represent the pressure (MPa) that a patient may experience when a catheter is inserted, advanced or otherwise pushed into a patient's body cavity (expressed as an insertion ratio; the ratio of catheter inserted into the bend region to the total catheter length).

[0269] like Fig. 30B As shown, with standard care Foley or Compared with catheter analogs, The catheter applies significantly less pressure to the surrounding tissue during insertion. The maximum pressure exerted by the catheter during insertion is approximately 39% of the maximum pressure of the Foley catheter and 43% of maximum catheter pressure.

[0270] In addition to computer simulation tests, a mechanical test fixture was developed, e.g. Fig.31A As shown, the fixture will mimic the anatomical path of a human patient in terms of size, feel and tortuosity. The mechanical test fixture includes a digital dynamometer and a cast gel block 312 with a curved cylindrical lumen 314 to simulate the urethral bend. In order to form the curved urethral lumen of the test fixture, the cast gel is poured into a mold and hardened. The hardness of the cast gel is about 10 Shore 00. The catheter insertion path is cast into an inner diameter 316 of 0.25 inches (0.635cm), 0.375 inches (0.9525cm), 0.5 inches (1.27cm), 0.5625 inches (1.42875cm) and 0.625 inches (1.5875cm). The bending radius R is about 32mm. The catheter enters the gel about 1 inch along a straight path 318, transitions to a 180-degree bend, and exits straight up and leaves the gel about 1 inch. Each catheter is attached to a motorized test bench 320 (MARK- Model ESM 301), the test station fed each catheter straight down into the artificial urethra of the cast gel block at a speed of 330mm / min while recording the insertion force. Each catheter and path was fully lubricated with KY jelly to minimize friction. The force differences caused by mechanical bending and the passage of tortuous paths for each test catheter were measured and compared. All samples were tested at least three times; the running values ​​were averaged to compare each design. The test results of insertion force and insertion depth for each design were compared, as shown in Figure 2. Fig.31B The tests were conducted using 2x scale devices (test and control) that were 3D printed using a rubber-like material with similar hardness and flexibility.

[0271] Fig.31BThe data in represents the force (compression force) experienced by a user (e.g., a physician, nurse, medical practitioner, etc.) when inserting, advancing, or otherwise pushing the proximal tip of a catheter into a patient's body cavity. In other words, the force measurement is made on the proximal tip of the catheter being advanced. Fig.31B As shown, the standard of care Foley and has the highest insertion force. The Test 1 catheter is shown in Figures 25A-25B The catheter in Fig.31B Marked as "duckbill"), test 2 catheters combined Figures 28A-28C Describe (in Fig.31B marked as "OG Folde" in the video above.

[0272] like Fig.31B As shown, compared with standard care Foley and Compared to the standard of care example, the insertion force required for the test example to pass through the curve in the model (entering the curve at about 50 mm of insertion and exiting the curve at about 110 mm of insertion) was significantly improved. The peak value for test catheter 1 was about 0.65 N, the peak value for test catheter 2 was about 0.50 N, and the peak value for the Foley catheter was about 1.57 N, The peak value of the catheter is about 0.88 N. Given these data and in general, the catheter described herein includes one or more flexible regions (e.g., Figure 6A-27B Any embodiments of the flexible zones (such as those shown) can be configured such that a maximum insertion force of less than about 0.75 N is required to insert the catheter into a body cavity. In some embodiments, the maximum insertion force can be less than about 0.70 N, less than about 0.60 N, less than about 0.55 N, or between about 0.40 N and about 0.80 N, between about 0.45 N and about 0.75 N, between about 0.5 N and about 0.80 N, etc.

[0273] Figure 32-34 Another exemplary test fixture and resulting data are shown to determine the deflection force required for various flexible catheters, as described elsewhere herein. In other words, Fig.32 The test fixture shown is configured to measure bending forces on a radius. Although some exemplary embodiments were tested, those skilled in the art will appreciate that other catheters described herein and including similar flexible regions may behave similarly as shown. Fig.32As shown, each catheter 320 is restrained proximally by a block 360, while a vertical load (indenter) 340 is pressed against the catheter 320 (applying a force F to the catheter). The distal end 362 of the block 360 is positioned at a first distance D1 of about 3.5 inches (88.9 mm) from the distal tip 322 of the catheter 320, and the vertical load 340 is positioned at a second distance D2 of about 2.5 inches (63.5 mm) from the distal end 362 of the block 360, the second distance being measured relative to the central axis 342 of the vertical load 340. The catheter 320 is bent along a curved surface 380 having a radius 382 of about 1 inch (25.4 mm). The speed of the vertical load 340 is 100 mm per minute and is measured by a motorized test bench (MARK- Model ESM 301). The force F is applied by MARK- Measured by dynamometer (model M3-2).

[0274] Fig.33 A graphical representation of the force (in N) versus the amount of deflection (in mm) for deflection 0 to 15 mm for various catheters is shown, where higher numbers indicate greater resistance to bending. For the standard of care Foley catheter, the deflection force increases roughly linearly with time, requiring a maximum force of about 0.16 N to deflect 15 mm. In contrast, catheters with either a posterior flexible zone or an anterior flexible zone (shown herein as five zones, also in combination with Figures 28A-28C Describe or show as Figures 15A-15D The catheter in zone 152a) requires a maximum force of approximately 0.069N (upper "cut" groove) and .052N (lower "cut" groove) to deflect 15mm.

[0275] Fig.34 A graphical representation of the force (in N) required to deflect the catheter shown (in mm) by 15 mm is shown. Fig.34 As shown, a standard of care Foley catheter was tested and compared to two test catheters, one with multiple internal rear flexible zones and the other with multiple internal front flexible zones. An exemplary embodiment of a catheter with internal flexible zones is shown in Figures 20A-20G as well as Figures 21A-21B For a standard of care Foley catheter, the deflection force required to deflect the catheter 15 mm was 0.159 N. In comparison, the maximum force required for catheters with either a posterior internal flexible zone or an anterior internal flexible zone was 0.145 N for an anteriorly positioned internal flexible zone and 0.136 N for a posteriorly positioned internal flexible zone.

[0276] To illustrate the rigor of the simulation and test fixture data and to compare the data from the simulation and test fixtures, e.g. Fig.35As shown, the data is normalized for insertion force (y-axis) and insertion distance (x-axis). The y-axis is normalized using the maximum insertion force from the test fixture data and the simulation data. The x-axis is normalized by the length of the catheter. The maximum value of 0.6 means that 60% of the catheter has been inserted. Fig.35 As shown, whether testing in a simulated test fixture or a physical test fixture, standard care Foley and The catheters all require a high force to be inserted into the fixture (real and modeled). In comparison, the test catheter (labeled Folde, Figures 28A-28C On average, the force required to insert the test catheter was less than that of the Foley or There were approximately 58% fewer catheters.

[0277] As used in the specification and claims, the singular forms "a," "an," and "the" include singular and plural references unless the context clearly dictates otherwise. For example, the term "flexible zone" may include and is intended to include a plurality of flexible zones. At times, the claims and disclosure may include terms such as "plurality," "one or more," or "at least one"; however, the absence of such terms does not mean and should not be interpreted to mean that a plurality is not contemplated.

[0278] When the term "about" or "approximately" is used before a numerical designation or range (e.g., to define a length or pressure), the term indicates an approximate value that can vary by ±5%, ±1%, or ±0.1%. All numerical ranges provided herein include the stated starting and ending numbers. The term "substantially" indicates a majority (i.e., greater than 50%) or substantially all of a device, substance, or composition.

[0279] As used herein, the terms "comprising" or "comprises" are intended to mean that devices, systems and methods include the listed elements and may additionally include any other elements. "Consisting essentially of shall mean that devices, systems and methods include the listed elements and exclude other elements that are significant to the combination for the stated purpose. Thus, a system or method consisting essentially of the elements as defined herein will not exclude other materials, features or steps that do not materially affect the basic and novel characteristics of the claimed disclosure. "Consisting of" will mean that devices, systems and methods include the listed elements and exclude anything other than insignificant or insignificant elements or steps. Embodiments defined by each of these transition terms are within the scope of the present disclosure.

[0280] The examples and descriptions contained herein show specific embodiments in which the subject matter can be practiced in an illustrative and non-limiting manner. Other embodiments may be utilized and derived from this article, so that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to individually or collectively by the term "the present invention" herein, which is merely for convenience, and if more than one invention or inventive concept is actually disclosed, it is not intended to intentionally limit the scope of the present application to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement intended to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or changes of various embodiments. After reviewing the above description, the combination of the above-mentioned embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A catheter, include: an elongated body having a proximal segment and a distal segment; a first lumen defined by the elongated body; as well as at least one anterior flexible zone located on said distal segment of said elongated body, wherein the at least one front flexible zone extends from the front outer surface of the elongated body to the first lumen and extends at least partially circumferentially from the front outer surface along the outer side wall of the elongated body without passing through the first lumen along the outer side wall, the at least one front flexible zone having a cut depth percentage of 40% to 50% of the outer diameter of the elongated body, and the volume percentage of material removed from the at least one front flexible zone is 20% to 40%.

2. The catheter of claim 1, wherein a force to bend the at least one front flexible zone is less than a force to bend a portion of the elongated body that does not include the at least one front flexible zone. 3 . The catheter of claim 1 , wherein a force that causes the distal segment to bend forward is less than a force that causes the distal segment to bend backward.

4. The catheter according to claim 1, wherein the catheter is a urinary catheter, include: a retention balloon disposed about at least a portion of the distal section of the elongated body, and A second lumen is defined by the elongated body and is configured to inflate the retention balloon.

5. The catheter of claim 1, wherein the at least one front flexible zone has a cut length percentage of 10% to 90%.

6. The catheter of claim 1, wherein the distal tip of the distal segment is tapered such that a ratio of an outer diameter of the elongated body to an outer protrusion thickness of the distal tip of the distal segment is 1.0:0.8 to 1.0:0.

2.

7. The catheter of claim 1, wherein the at least one anterior flexible zone comprises a plurality of anterior flexible zones located above the distal segment; in, at least one of the plurality of anterior flexible zones extending from a first zone of the anterior exterior surface of the elongated body to the first lumen and extending at least partially circumferentially from the first zone of the anterior exterior surface along the exterior sidewall of the elongated body without passing through the first lumen along the exterior sidewall; And wherein a distal-most anterior flexible zone of the plurality of anterior flexible zones extends from a second zone of the anterior exterior surface of the elongated body, circumferentially around an inner sidewall of the first lumen, and into a luminal surface of a posterior sidewall of the elongated body.

8. A catheter according to claim 1, wherein the at least one front flexible zone includes a plurality of front flexible zones located above the distal segment, so that the most distal front flexible zone of the plurality of front flexible zones has a second incision depth percentage, and the second incision depth percentage is greater than the incision depth percentage of the at least one front flexible zone.

9. The catheter of claim 8, wherein the second cutout depth percentage of the distal-most anterior flexible zone is between 60% and 95% of the outer diameter of the elongated body.

10. The catheter of claim 1, further comprising at least one rear flexible zone located above the distal section.

11. The catheter of claim 10, wherein the at least one rear flexible zone comprises a groove in a rear portion of an inner sidewall of the first lumen of the elongated body.

12. The catheter of claim 11, wherein the recess in the rear portion of the inner sidewall of the first lumen has a rear cut depth percentage of 5% to 20% of the wall thickness of the elongated body.

13. A catheter, include: an elongated body having a proximal segment and a distal segment; a lumen defined by the elongated body; as well as at least one anterior flexible zone located on said distal segment of said elongated body, wherein the at least one front flexible zone extends through the front outer side wall of the slender body, circumferentially around the inner wall of the lumen, and into the lumen surface of the rear side wall of the slender body, the at least one front flexible zone having a cut depth percentage of 80% to 95% of the outer diameter of the slender body, and the volume percentage of material removed from the at least one front flexible zone is 20% to 40%, wherein the removed material comes from the front outer side wall, the inner wall of the lumen, and the lumen surface of the rear side wall.

14. The catheter of claim 13, wherein the at least one front flexible zone has a cutout length percentage of 10% to 90%.

15. The catheter of claim 13, wherein the distal tip of the distal segment is tapered such that a ratio of an outer diameter of the elongated body to an outer protrusion thickness of the distal tip of the distal segment is 1.0:0.8 to 1.0:0.

2.

16. A catheter, include: an elongated body having a proximal segment and a distal segment, wherein a distal tip of the distal segment is tapered such that a ratio of an outer diameter of the elongated body to an outer projection thickness of the distal tip of the distal segment is 1.0:0.8 to 1.0:0.2; a lumen defined by the elongated body; as well as A plurality of anterior flexible zones located above the distal segment of the elongated body, wherein at least one of the plurality of anterior flexible zones extends from a first zone of the anterior external surface of the elongated body to the lumen and extends at least partially circumferentially from the first zone of the anterior external surface along a first external side wall of the elongated body, and the volume percentage of material removed from the at least one anterior flexible zone is 20% to 40%.

17. A catheter according to claim 16, wherein a second front flexible zone among the multiple front flexible zones extends through a second zone of the front outer surface of the slender body, circumferentially around the inner wall of the lumen, and into the lumen surface of the rear wall of the slender body, the second front flexible zone having a cut depth percentage of 80% to 95% of the outer diameter of the slender body, and a second volume percentage of material removed from the second front flexible zone of 20% to 40%.

18. The catheter of claim 16, further comprising a plurality of posterior flexible zones located above the distal segment, wherein each of the plurality of posterior flexible zones is laterally aligned with a corresponding anterior flexible zone of the plurality of anterior flexible zones.

19. The catheter of claim 18, wherein each of the plurality of rear flexible zones comprises a rear groove in the inner sidewall of the lumen and each of the plurality of rear flexible zones has a cutout depth percentage of 5% to 20% relative to the outer diameter of the elongated body.

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