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NZ778423B2 - Dual-lumen ultrasonic catheters, systems, and methods - Google Patents
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NZ778423B2 - Dual-lumen ultrasonic catheters, systems, and methods - Google Patents

Dual-lumen ultrasonic catheters, systems, and methods Download PDF

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Publication number
NZ778423B2
NZ778423B2 NZ778423A NZ77842317A NZ778423B2 NZ 778423 B2 NZ778423 B2 NZ 778423B2 NZ 778423 A NZ778423 A NZ 778423A NZ 77842317 A NZ77842317 A NZ 77842317A NZ 778423 B2 NZ778423 B2 NZ 778423B2
Authority
NZ
New Zealand
Prior art keywords
lumen
tube
dual
extrusion
catheter assembly
Prior art date
Application number
NZ778423A
Other versions
NZ778423A (en
Inventor
Jessica Lynn Roll Hoye
William E Parmentier
Amanda Young
Original Assignee
Cr Bard Inc
Filing date
Publication date
Application filed by Cr Bard Inc filed Critical Cr Bard Inc
Priority to NZ778423A priority Critical patent/NZ778423B2/en
Priority claimed from PCT/US2017/030266 external-priority patent/WO2018200004A1/en
Publication of NZ778423A publication Critical patent/NZ778423A/en
Publication of NZ778423B2 publication Critical patent/NZ778423B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00973—Surgical instruments, devices or methods pedal-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22039—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0013—Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0014—Connecting a tube to a hub
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
    • 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
    • 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
    • A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/09—Guide wires

Abstract

catheter assembly is provided which is configured for modifying intravascular lesions. The catheter assembly includes a core wire including a proximal end configured to vibrationally couple to an ultrasound transducer and a dual-lumen catheter including a first lumen and a second lumen. The core wire is disposed within the first lumen, and the second lumen is configured to accommodate a guidewire. A manifold is disposed around at least a skived proximal-end portion of the dual-lumen extrusion, wherein the skived portion includes the second lumen without the first lumen. A distal end of the dual-lumen extrusion includes a flared portion of the dual lumen extrusion, and a size-matched pieced of guidewire tubing is disposed in the flared portion, extending the second lumen of the dual-lumen extrusion through a tip member. Such a catheter assembly configuration improves structural integrity of the catheter assembly and aims to avoid device complications such as twisting of portions of the guidewire tube able to move independently from the dual-lumen extrusion. A system configured for modifying intravascular lesions is also provided which includes the catheter assembly described above and an ultrasonic energy-producing mechanism including an ultrasound generator and an ultrasound transducer. A method for manufacturing the catheter assembly is further provided.

Claims (21)

1. A catheter assembly configured for modifying intravascular lesions, comprising: a core wire including a proximal end configured to vibrationally couple to an ultrasound transducer; a dual-lumen extrusion including a first lumen and a second lumen, wherein: the core wire is disposed within the first lumen, and the second lumen is configured to accommodate a guidewire; and a manifold disposed around at least a skived proximal-end portion of the dual-lumen extrusion, wherein the skived portion includes the second lumen without the first lumen, wherein a distal end of the dual-lumen includes a flared portion of the dual-lumen extrusion, and wherein a size-matched piece of guidewire tubing is disposed in the flared portion extending the second lumen of the dual-lumen extrusion through a tip member.
2. The catheter assembly of claim 1, wherein the dual lumen extrusion comprises a first tube including the first lumen and a second tube including the second lumen, and the second tube is disposed within the first lumen in the dual-lumen extrusion.
3. The catheter assembly of either claim 1 or claim 2, wherein the skived portion of the dual-lumen extrusion is less than or equal to about 35 mm long.
4. The catheter assembly of any one of claims 1 to 3, wherein: the skived portion of the dual-lumen extrusion is disposed in a support tube, and the manifold is disposed around the support tube and an adjoining portion of the dual-lumen extrusion including the first lumen and the second lumen.
5. The catheter assembly of any one of claims 1 to 4, wherein: 20930126_1 (GHMatters) P45558NZ01 the tip member is seated in a distal end of the dual-lumen extrusion, and wherein the second lumen of the dual-lumen extrusion extends through the tip member enabling a guidewire to pass through the tip member.
6. The catheter assembly of any one of claims 1-5, further comprising an ultrasound transducer at the proximal end of the core wire.
7. A system configured for modifying intravascular lesions, comprising: a) a catheter assembly, including: a core wire; a dual-tube extrusion including a first tube with a first lumen and a second tube with a second lumen, wherein: the core wire is disposed within the first lumen, and the second lumen is configured to accommodate a guidewire; and a manifold disposed around at least a skived proximal-end portion of the dual-tube extrusion, wherein the skived portion includes the second lumen without the first lumen, wherein a distal end of the dual-lumen extrusion includes a flared portion of the dual-lumen extrusion, and wherein a size-matched piece of guidewire tubing is disposed in the flared portion extending the second lumen of the dual-lumen extrusion through a tip member; and b) an ultrasonic energy-producing mechanism, including: an ultrasound generator; and an ultrasound transducer, wherein a proximal end of the core wire is configured to vibrationally couple to the ultrasound transducer.
8. The system of claim 7, wherein the second tube is disposed within the first tube of the dual-tube extrusion. 20930126_1 (GHMatters) P45558NZ01
9. The system of claim 8, wherein the second tube shares at least a portion of a tube wall with the first tube.
10. The system of any one of claims 7 to 9, wherein: the second tube of the skived portion of the dual-tube extrusion is disposed in a support tube, and the manifold is disposed around the support tube and an adjoining portion of the dual-tube extrusion including the first tube and the second tube.
11. The system of any one of claims 7 to 10, wherein the tip member is seated in a distal end of the dual-tube extrusion, and wherein the second lumen of the dual-tube extrusion extends through the tip member enabling a guidewire to pass through the tip member.
12. The system of any one of claims 7 to 11, further comprising: c) a console including a foot switch and the ultrasonic energy-producing mechanism including the ultrasound generator and the ultrasound transducer, wherein the foot switch is configured to activate and deactivate the ultrasonic energy-producing mechanism.
13. The system of any one of claims 7 to 11, further comprising: c) a console including a foot switch and the ultrasound generator of the ultrasonic energy- producing mechanism, wherein: the catheter assembly further includes the ultrasound transducer of the ultrasonic energy- producing mechanism, and the foot switch is configured to activate and deactivate the ultrasonic energy- producing mechanism.
14. A method for manufacturing a catheter assembly configured for modifying intravascular lesions, comprising: extruding a dual-tube extrusion including a first tube with a first lumen and a second tube with a second lumen, wherein: the first lumen is configured for disposing a core wire therein and 20930126_1 (GHMatters) P45558NZ01 the second lumen is configured to accommodate a guidewire; skiving off the first tube in a proximal-end portion of the dual-tube extrusion to provide a skived portion of the dual-tube extrusion including the second lumen without the first lumen; flaring the second tube in a distal-end portion of the dual-tube extrusion to provide a flared portion of the second tube; disposing at least the skived portion of the dual-tube extrusion in a manifold; disposing a size-matched piece of guidewire tubing in the flared portion which extends the second lumen of the dual-tube extrusion; and seating a lesion-modifying tip member in a distal end of the dual-tube extrusion.
15. The method of claim 14, wherein: the second is disposed within the first tube in the dual-tube extrusion, and the second tube and the first tube share a wall.
16. The method of either claim 14 or claim 15, further comprising disposing the second tube of the skived portion of the dual-tube extrusion in a support tube, and subsequently disposing the skived portion in the manifold with an adjoining portion of the dual -tube extrusion including the first tube and the second tube.
17. The method of claim 16, further comprising attaching a guidewire hub to the support tube.
18. The method of any one of claims 14 to 17, further comprising disposing a core wire in the first lumen.
19. The catheter assembly as claimed in claim 1 and substantially herein described with reference to the drawings.
20. The system as claimed in claim 7 and substantially herein described with reference to the drawings. 20930126_1 (GHMatters) P45558NZ01
21. The method as claimed in claim 14 and substantially herein described with reference to the drawings. 20930126_1 (GHMatters) P45558NZ01
NZ778423A 2017-04-28 Dual-lumen ultrasonic catheters, systems, and methods NZ778423B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
NZ778423A NZ778423B2 (en) 2017-04-28 Dual-lumen ultrasonic catheters, systems, and methods

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NZ758189A NZ758189B2 (en) 2017-04-28 Dual-lumen ultrasonic catheters, systems, and methods
PCT/US2017/030266 WO2018200004A1 (en) 2017-04-28 2017-04-28 Dual-lumen ultrasonic catheters, systems, and methods
NZ778423A NZ778423B2 (en) 2017-04-28 Dual-lumen ultrasonic catheters, systems, and methods

Publications (2)

Publication Number Publication Date
NZ778423A NZ778423A (en) 2024-07-26
NZ778423B2 true NZ778423B2 (en) 2024-10-30

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