Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/005—Flexible endoscopes
  • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
  • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
  • A61B8/445—Details of catheter construction
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/005—Flexible endoscopes
  • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
  • A61B1/0057—Constructional details of force transmission elements, e.g. control wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/00064—Constructional details of the endoscope body
  • A61B1/0011—Manufacturing of endoscope parts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0036—Multi-lumen catheters with stationary elements with more than four lumina
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0136—Handles therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires

Definitions

• This invention relates to the field of medical instruments, and in particular to a method and system for managing articulation pull-cables in a steerable catheter or other steerable instruments, such as endoscopes, gastroscopes, and transesophageal
• TEE echocardiography
• Catheters are commonly used for situating elements within passages in a patient's body, to monitor particular biometrics, perform surgical procedures, administer medication, and so on. To navigate through the passages, steerable catheters having an articulating distal end have been developed.
• FIGs. 1A-1C illustrate an example prior-art steerable catheter 100.
• the catheter 100 comprises a handle 110, an insertion tube 120, a flexible distal end 130, and a transducer 170.
• the transducer 170 acquires imaging data via ultrasound.
• Other devices may be substituted for transducer 170, these devices may receive biometrics of a patient and/or optical images of internal passages, or it may execute tasks such as making incisions, clearing blockages, administering medication, and so on.
• the handle 110 is coupled to a medical-instrument controller (not shown) and is coupled to the transducer 170 via one or more transducer cables 150 within the insertion tube 120.
• the steerable catheter 100 may be an ultrasound probe, such as a transesophageal echocardiography (TEE) ultrasound probe, a transvaginal ultrasound probe, for use with an ultrasound system.
• TEE transesophageal echocardiography
• FIG. IB illustrates the catheter 100 in a 'neutral' state wherein the flexible distal end 130 is not bent or twisted.
• the handle 110 includes an articulation controller 115 that is coupled to the flexible distal end 130 via articulation pull-cables 160a, 160b (collectively, articulation pull-cables 160) that extend through the insertion tube 120 to the flexible distal end 130.
• articulation pull-cables 160 are fixedly attached to a terminator 175 that is situated at the transducer-end of the flexible distal end 130, and can be selectively tensioned/pulled by the articulation controller 115.
• the articulation pull-cables 160a, 160b are situated opposite each other at an outer perimeter area of the terminator 175. This enables two degrees of freedom for adjusting the orientation of the flexible distal end 130.
• the flexible distal end 130 includes structural details that limit the bending of the flexible distal end 130 in the two opposite directions.
• a steerable catheter may include a larger plurality of cables situated on the perimeter of the terminator 175 to provide additional degrees of freedom of movement.
• four articulation pull-cables are provided to provide horizontal and vertical bending of the flexible distal end 130.
• pull-cable lumens 165 are provided through the flexible distal end 130 to provide a more uniform tension within the flexible distal end 130 as the articulation pull-cables 160 are tensioned/pulled.
• a single lumen 190 is provided for routing the transducer cables 150 and articulation pull -cables 160, as illustrated in the cross-section of FIG. 2B, so that the flexibility of the insertion tube 120 may be determined primarily by the dimensions and composition of the material forming the cylindrical insertion tube 120.
• the single lumen 190 also facilitates the insertion/routing of the cables 150, 160 within the insertion tube 120.
• this structure-less lumen 190 introduces issues that affect the reliability and longevity of the steerable catheter 100, as detailed below.
• An object of this invention is to provide a more robust catheter or similar elongated medical instrument device design by providing structure for cable routing within the insertion tube of a steerable catheter or (elongated) device without significantly affecting the flexibility of the insertion tube.
• the insertion tube may include a plurality of inserts that are spaced along the insertion tube from the handle to the distal end.
• Each insert of the plurality of inserts may include a plurality of lumens comprising one or more transducer-cable lumens and a plurality of pull-cable lumens, wherein the plurality of lumens isolate the transducer cable and each of the plurality of articulation pull-cables from each other.
• FIGs. 1A-1C illustrate an example prior art steerable catheter.
• FIGs. 2A-2B illustrate example cross-sections of the prior art steerable catheter.
• FIG. 3 illustrates an example prior art flexible distal end of a steerable catheter.
• FIG. 4 illustrates an example insert for placement within an insertion tube.
• FIG. 5 illustrates a plurality of inserts in an insertion tube.
• FIGs. 6 and 7 illustrate alternative insert structures.
• FIG. 8 illustrates a string of components for insertion into an insertion tube.
• FIG. 9 illustrates an alternative insert structure.
• Non limiting examples of other such medical devices falling within the scope of the invention are endoscopes, gastroscopes, transvaginal ultrasound probes, and transesophageal echocardiography (TEE) ultrasound probes.
• transducer 170 is of course an ultrasound transducer.
• the inventions as described below for use in the exemplary catheters may be readily implemented in these other elongated medical devices as well, and thus enjoy similar benefits and improvements over the prior art arrangements.
• the prior art catheter is prone to premature failure due to the structure-less lumen 190 of the insertion tube 120, illustrated in FIG. 2B.
• the cables 150, 160 often become entangled with each other, causing an increased resistance in the tensioning and slackening of the articulation pull-cables 160.
• This increased resistance can often lead to a premature failure of the catheter 100 due to an inability to pull or slacken one of the articulation pull-cables 160.
• each articulation pull -cable 160 can be lessened by encasing each articulation pull -cable 160 in a protective sleeve that is sized to enable the articulation pull-cable 160 to be pulled and slackened, and sufficiently rigid to withstand deformation by the other cables.
• a protective shield on each articulation pull- cable 160 would significantly affect the overall flexibility of the insertion tube 120.
• FIG. 4 illustrates an example insert 400 that provides structure within an insertion tube 420.
• the example insert 400 includes a transducer lumen 450 through which one or more transducer cables 150 transit, and a plurality of pull-cable lumens 460, through which a plurality of steering cables 160 transit.
• the pull-cable lumen 460 is C-shaped, and forms an enclosed volume when situated within the insertion tube 420.
• the transducer cables 150 are coupled to a transducer 170 at a flexible distal end 130 of the catheter, and to the handle 110 for coupling to a medical control device (not illustrated) in the handle 110 or external to the handle 110.
• the articulation pull-cables 160 are fixedly attached to a terminator 175 at the far end of the flexible distal end 130, and coupled to an articulation control element 115 in the handle 110.
• the articulation pull-cables 160 may be fixedly attached to the control element 115, or moveably attached to the control element 115, such as a pair of articulation pull-cables 160 comprising a continuous cable on a perimeter of a wheel that is rotated by the control element 115, exerting tension on one articulation pull -cable of the pair and slackening the other articulation pull-cable.
• the insertion tube 120 is attached to the handle 110 and the flexible distal end 130.
• Non limiting examples of the transducer 170 according to the present disclosure are an electromechanical transducer, an electroacoustic transducer such as an ultrasonic (or ultrasound) transducer.
• the lumens 450, 460 provide isolation of the articulation pull-cables 160 from the transducer cables 150, and from each other.
• the pull-cable lumens 460 are sized to enable free travel of the articulation pull -cables 160.
• the articulation pull-cables 160 or the pull-cable lumen 460, or both may be coated with a lubricous material that facilitates travel of the articulation pull-cable through the pull -cable lumen.
• the insert comprises lubricous material to facilitate insertion of the insert into the insertion tube 420.
• the insert comprises a high- temperature resilient material.
• the insert 400 may extend the entire length of the insertion tube 420, such a structure is likely to interfere with the flexibility of the insertion tube 420. Accordingly, in embodiments of this invention, a plurality of inserts 400 are situated along the length of the insertion tube, as illustrated in FIG. 5. To prevent displacement or rotation of each insert, the inserts 400 may be attached to the insertion tube 420 using heat staking, RF welding, or other attachment techniques.
• FIGs. 6 and 7 illustrate alternative structures for the insert 400.
• an enclosing pull-cable lumen 460 is provided for each articulation pull -cable 160, to facilitate assembly.
• the transducer cables 150, the articulation pull-cables 160, and the inserts 400 can be pre-assembled as a string of components that are subsequently enclosed by the insertion tube 420, as detailed further below.
• FIG. 7 illustrates an example embodiment wherein the transducer cables 150 are embedded in the insert 400. That is, each insert 400 is molded or otherwise formed around the transducer cables 150 such that the cables 150 are fixedly attached to each insert 400. In this embodiment, closed transducer-cable lumens 450 are formed by the cables 150 as each insert is formed.
• FIG. 8 illustrates an example string of components 800 comprising the transducer cables 150 embedded in each of a plurality of inserts 400. Also embedded in each insert 400 is a draw wire 850. The draw wire 850 may be used to pull the string 800 through the insertion tube 420 to create the assembly illustrated in FIG. 5.
• the articulation pull-cables 160 may be strung through the pull-cable lumens 460 of this string of components 800.
• the inserts 400 comprise open pull -cable lumens 460 as illustrated in FIG. 7, the articulation pull-cables 160 may be laid into each pull -cable lumen 460 of the inserts 400 as a string of components similar to the string of components 800 are drawn into the insertion tube 420.
• FIG. 9 illustrates an example insert that is structured to capture each articulation pull-cable 160 as it is laid into the pull -cable lumen 460.
• the insert 400 includes a trough that has an opening 960 that is slightly smaller than the diameter of the articulation pull-cable 160.
• the insert 400 comprises a resilient material that enables the larger articulation pull-cable 160 to be inserted through the smaller opening 960. Once inserted, the articulation pull-cable 160 is captured by the pull-cable lumen 460 within the pliable material as it returns to its original state of having a smaller opening 960 than the diameter of the articulation pull -cable 160.
• FIG. 10 illustrates an example flow diagram 1000 for assembling a steering catheter with articulation pull -cable support within the insertion tube.
• FIG. 10 illustrates an example flow diagram 1000 for assembling a steering catheter with articulation pull -cable support within the insertion tube.
• the illustrated order of steps is provided for ease of understanding, and the steps may be performed in different order, and/or some steps may be performed concurrently.
• the assembly of the steering catheter is consistent with known prior art techniques that do not require detailed descriptions in this specification.
• a plurality of inserts having pull -cable lumens are obtained. These may be pre-formed inserts, or created by extrusion or molding about a draw wire and/or transducer cables.
• a draw wire is attached to each insert, and at 1020, one or more transducer cables are routed through each insert. As noted above, steps 1010, 1015, and 1020 may be performed concurrently, as when the inserts are coextruded over the draw wire and the transducer cable(s).
• the articulation pull -cables are routed through the pull-cable lumens of each insert. If the pull-cable lumens are troughs, the articulation pull -cables may be temporarily held in place until the insert is about to be drawn into the insertion tube.
• the draw wire is passed through the insertion tube, and at 1035, the draw wire is drawn to draw the assembly of inserts, transducer cable(s), and articulation pull-cables into the insertion tube.
• the insertion tube may be extruded or otherwise formed over the assembly, eliminating the need for a draw wire.
• the inserts are attached to the insertion tube. This attachment is optional; if the inserts are sufficiently held in place by elastic pressure from the walls of the insertion tube, or by the formation of the insertion tube upon the assembly, further attachment may be unnecessary. As noted above, if attachment is necessary, heat staking, RF welding, or other attachment techniques may be used.
• the insertion tube may be a heat- shrink material that facilitates placement of the assembly in the insertion tube, and heat is subsequently applied to attach the insertion tube to each insert.
• the transducer cables are attached at each end to couple the transducer to the handle, and at 1050, the articulation pull-cables are attached at each end of the assembly so as to couple the flexible distal end to an articulation control in the handle.
• Final assembly of the catheter is performed by coupling the insertion tube to the handle and the flexible distal end, at 1055.
• a continuous insert is coextruded over the transducer cables, then selectively etched or otherwise reduced in diameter to create a plurality of full-size (unetched) inserts between these thinner (etched) segments.
• the material between the pull-cable lumens 460 along the perimeter of the continuously extruded insert can be selectively removed, leaving only the transducer cables embedded in the residual material between the unmodified inserts.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biophysics (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Radiology & Medical Imaging (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Physics & Mathematics (AREA)
• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Optics & Photonics (AREA)
• Mechanical Engineering (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Ultra Sonic Daignosis Equipment (AREA)
• Surgical Instruments (AREA)

Priority Applications (4)

Applications Claiming Priority (2)

Publications (1)

Family

ID=70921997

Family Applications (1)

Country Status (5)

Cited By (1)

Families Citing this family (4)

Citations (8)

Family Cites Families (14)

• 2020
  • 2020-05-20 JP JP2021568631A patent/JP7634157B2/ja active Active
  • 2020-05-20 WO PCT/EP2020/064017 patent/WO2020234328A1/en not_active Ceased
  • 2020-05-20 CN CN202080037226.2A patent/CN113840565A/zh active Pending
  • 2020-05-20 EP EP20729648.4A patent/EP3972476A1/en not_active Withdrawn
  • 2020-05-20 US US17/611,257 patent/US12295786B2/en active Active

Patent Citations (8)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events