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Neurovascular intervention device

Info

Publication number
CA2605382C
CA2605382C CA 2605382 CA2605382A CA2605382C CA 2605382 C CA2605382 C CA 2605382C CA 2605382 CA2605382 CA 2605382 CA 2605382 A CA2605382 A CA 2605382A CA 2605382 C CA2605382 C CA 2605382C
Authority
CA
Grant status
Grant
Patent type
Prior art keywords
imaging
device
wire
treatment
microcatheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA 2605382
Other languages
French (fr)
Other versions
CA2605382A1 (en )
Inventor
Nickola Lewis
Scott Harshman
Charles Wells
Daniel O'keefe
Robert Zelenka
Richard Romley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd
Original Assignee
Boston Scientific Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Grant date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445Details of catheter construction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

In one embodiment, an intravascular intervention device includes a microcatheter (100) configured for intravascular delivery, an imaging wire (120) received within the microcatheter, and a treatment device (150) received within the microcatheter, wherein the imaging wire and the treatment device may be simultaneously advanced. The treatment device is configured to perform intravascular intervention. For example, the treatment device may be configured to deliver a stent, an embolic coil and/or a thrombolytic agent. I
this embodiment, the intravascular intervention device may image the area of interest while performing the intravascular intervention, thus allowing imaging to take place in real time .

Description

NEUROVASCULAR IN _____________________ lERVENTION DEVICE
FIELD OF THE INVENTION
The field of the invention relates to medical devices, and more particularly to an BACKGROUND OF THE INVENTION
Intraluminal, intracavity, intravascular, and intracardiac treatments and diagnosis of medical conditions utilizing minimally invasive procedures are effective tools in many areas of Currently, there exists no indicated intravascular imaging method for the neurovasculature. When evaluating a proposed intravascular imaging device for the neurovasculature, the procedure steps for coronary interventions serve as baseline. Typically, In the case of a stroke caused by embolus, it may be beneficial for the clinician to determine the nature of the embolus in order to plan necessary intervention.
The embolus may come in two forms, hard plaque or soft thrombus, and different treatments may be used for In the case of an aneurysm, the ability to characterize the aneurysm accurately is very aneurysm, the diameter of the aneurysm itself, the density of the sac thrombus, and the patency of the parent artery are all important items of data when planning intervention. The ability to determine and/or confirm these items of data real time may provide a factor of safety when planning the required intervention. For example, the embolic coils originally chosen for treatment based on angiograms may have to be modified based on findings that the aneurysm neck is larger or smaller than anticipated. Accordingly, an improved intravascular intervention device would be desirable.
SUMMARY OF THE INVENTION
The present invention generally relates to medical devices, and more particularly to an improved intravascular intervention device. In one embodiment, an intravascular intervention device includes a microcatheter configured for intravascular delivery, an imaging wire received within the microcatheter, and a treatment device received within the microcatheter, wherein the imaging wire and the treatment device may be simultaneously advanced. The treatment device is configured to perform intravascular intervention. For example, the treatment device may be configured to deliver a stent, an embolic coil and/or a thrombolytic agent. In this embodiment, the intravascular intervention device may image the area of interest while performing the intravascular intervention, thus allowing imaging to take place in real time.
According to an aspect, there is provided an intravascular intervention device comprising: a microcatheter configured to fit in a patient's neurovasculature and comprising a sheath; an imaging wire received within the sheath of the microcatheter, the imaging wire comprising an imaging transducer assembly configured to image the neurovasculature; and a treatment device received within the sheath of the microcatheter, the treatment device being adapted to apply treatment to the neurovasculature, the sheath of the microcatheter being configured to receive both the imaging wire and the treatment device simultaneously and both the imaging wire and the treatment device being capable of being advanced with respect to the sheath.
Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to better appreciate how the above-recited and other advantages and objects of the present inventions are objected, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the Fig. la is a cross-sectional side view of a microcatheter in accordance with a preferred embodiment of the present invention.
2a Fig. lb is a cross-sectional view of a microcatheter in accordance with a preferred embodiment of the present invention.
Fig. lc is a cross-sectional view of a microcatheter in accordance with a preferred embodiment of the present invention.
Fig. 2a is a cross-sectional side view of an imaging wire in accordance with a preferred embodiment of the present invention.
Fig. 2b is a cross-sectional view of an imaging wire in accordance with a preferred embodiment of the present invention.
Fig. 3 is a cross-sectional view of an imaging wire in accordance with a preferred embodiment of the present invention.
Fig. 4 is a diagram of a medical imaging system in accordance with a preferred embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREIIERRED EMBODIMENTS
As described above, an intravascular intervention device that allows the simultaneous delivery of an imaging device and a treatment device may be desirable. Turning to Fig. la, a microcatheter 100 is shown. The microcatheter 100 is constructed to allow navigation into cerebral arteries. Such a microcatheter 100 has a size range of up to 0.027 inches. An example -of such a microcatheter is described in U.S. Patent No. 4,739,768 to Engelson.
The microcatheter 100 includes an outer sheath 110 having a lumen that is capable of receiving an imaging wire 120 and a treatment device 150.
The microcatheter 100 may utilize a guidewire (not shown) to facilitate in advancing the microcatheter 100 to the area of interest One of ordinary skill in the art will appreciate that both the imaging wire 120 and the treatment device 150 may be capable of being advanced beyond the distal end of the sheath 110 of the microcatheter 100.
Turning to Fig. lb, which shows a cross-section of a rnicrocatheter 100, the microcatheter 100 may receive the imaging wire 120 and the treatment device 150 via a single lumen 103. Alternatively, turning to Fig. lc, which shows a cross-section of an alternative microcatheter 100, the microcatheter 100 may receive the imaging wire 120 and the treatment device 150 through a first lumen 102 and a second lumen 104 respectively.
Turning to back to Fig. la, the imaging wire 120 includes a sheath 121, preferably braided polymer, that is coupled with a floppy tip 124 at the distal end of the sheath 121. The sheath 121 includes a lumen that receives an imaging transducer assembly 130 shown in Fig.
2a. The imaging wire sheath 121 may be coated with a lubricious coating that enables improved movement within a vessel. The imaging sheath 121 preferably includes a puncture hole- 122 tOwards the 'Cligraffortion of the imaging wire 120, which allows blood pressure to fill the cavity around the imaging element 130 to improve imaging. The sheath braid may discontinue for a particular amount of length, thus allowing the imaging transducer to acquire an image with reduced interference. The sheath 121 may be withdrawn completely after reaching the desired position, thus leaving the imaging transducer assembly 130 and the floppy tip 124 exposed to the area of interest. In such a configuration, it may be desirable to coat the assembly 130 with a lubricious and/or thrombolytic agent, such as heparin.
In an alternative configuration, the sheath 121 may be a thick walled hypotube or partially hollowed rod to allow attachment of the floppy tip 124 and passage of the imaging transducer assembly 130. In addition, the sheath 121 may include conductive traces that allow the imaging transducer assembly 130 to be electrically coupled with a proximal connector 200 (shown in Fig. 3). A thin coating of insulating material may protect the conductive traces.
The floppy tip 124 may be composed of a layered coil atop a cylindrical wire that is flattened into a ribbon under the coil. Further, the floppy tip 124 may have a proximally extended axial section over which the imaging transducer 130 may translate (not shown).
Turning to Fig. 2a, an example of an imaging transducer assembly 130 is shown within the sheath 121 of the imaging wire 120. The imaging transducer 130 includes a coaxial cable 132, having a center conductor wire 136 and an outer shield wire 134, shown in Fig. 2b. A
conductive wire, having a diameter of approximately 500 microns, is wrapped around the coaxial cable 132, forming a coil, which functions as a drive shaft 138. The wire may be a laser cut Nitinol tube, which allows for torquability and flexibility.
Alternatively, the drive shaft 138 may be composed of coaxial cables wound such that the cables are kept separated, via individual shielding or additional wire, while surrounding a neutral core.
Further, the drive shaft 138 may be pre-tensioned.
Connected to the distal end of the drive shaft 138 is a stainless steel housing 140, which serves to reinforce the structure of the imaging transducer assembly 130.
Surrounding the coaxial cable 132, within the housing 140 is a silver epoxy 142, a conductive material. Thus, the housing 140 is electrically coupled to the shield wire 134 of the coaxial cable 132 via the epoxy 142. On the distal end of the silver epoxy 142 is an insulating substance, e.g., a non-conductive epoxy 144.
Alternatively, or in addition to the configuration above, the drive shaft 138 may be printed with one or more conductive traces that allow communication between the imaging transducer 130 and a proximal connector 200 (shown in Fig. 3), which allows the imaging transducer 130 to connect to external circuitry 300 that processes signals, such as imaging and navigational signals, from the imaging transducer 130, such circuits being well known (shown m Fig. 4). in yet another alternative configuration, the drive shaft 138 may be composed of an extruded polymer reinforced with a polymer/fiber/metal braid with the coaxial cable 132 extruded within the walls (not shown).
On the distal end of the non-conductive epoxy 144 is a layer of piezoelectric crystal During operation, the PZT layer 147 is electrically excited by both the backing material 148 and the acoustic lens 146. The backing material 148 receives its charge from the shield In an alternative embodiment, transducer 130 is replaced by a phased array as disclosed Further, other imaging devices may be used, instead of, or in addition to imaging transducers, such as light based apparatuses for obtaining images through optical coherence tomography (OCT). Image acquisition using OCT is described in Huang et al., "Optical Coherence Tomography," Science, 254, Nov. 22, 1991, pp 1178-1181.
coherence domain reflectorneter (OCDR) is disclosed in Swanson U.S. Pat. No.

5,321,501.
The OCDR is capable of electronically performing two- and three-dimensional image scans over an extended longitudinal or depth range with sharp focus and high resolution and sensitivity over the range.

Turning to the treatment device 150 shown in Fig. la, the treatment device 150 delivers treatment to an intravascular area, such as an area with an aneurysm or an embolism. One of ordinary skill in the art may appreciate that the treatment device 150 may deliver drugs, agents, or medical devices such as embolic coils or stents. U.S. Patent No. 4,994,069 to Ritchart, describes a treatment device that delivers one or more vaso-occlusive coils.
In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the scope of the of process actions described herein is merely illustrative, and the invention can be performed using different or additional process actions, or a different combination or ordering of process actions. As a further example, each feature of one embodiment can be mixed and matched with other features shown in other embodiments. Additionally and obviously, features may be

Claims (16)

1. An intravascular intervention device comprising:
a microcatheter configured to fit in a patient's neurovasculature and comprising a sheath;
an imaging wire received within the sheath of the microcatheter, the imaging wire comprising an imaging transducer assembly configured to image the neurovasculature;
and a treatment device received within the sheath of the microcatheter, the treatment device being adapted to apply treatment to the neurovasculature, the sheath of the microcatheter being configured to receive both the imaging wire and the treatment device simultaneously and both the imaging wire and the treatment device being capable of being advanced with respect to the sheath.
2. The device of claim 1 further comprising a processor coupled to the imaging wire and configured to process signals generated by the imaging wire.
3. The device of claim 1 or claim 2, wherein the sheath of the microcatheter has a single lumen configured to receive the imaging wire and the treatment device.
4. The device of claim 1 or claim 2, wherein the sheath of the microcatheter has a first lumen configured to receive the imaging wire and a second lumen configured to receive the treatment device.
5. The device of claim 1 or claim 2, wherein the imaging wire includes a sheath and a floppy tip coupled to a distal end of the sheath.
6. The device of claim 5, wherein the sheath defines a vent hole towards the distal end of the sheath.
7. The device of claim 5, wherein the imaging wire includes the imaging transducer assembly received within the sheath of the imaging wire.
8. The device of claim 7, wherein the imaging transducer assembly is translatable within the sheath of the imaging wire.
9. The device of claim 8, wherein the imaging wire further includes a drive shaft proximally coupled to the imaging transducer assembly.
10. The device of claim 9, wherein the drive shaft comprises of a wound coil.
11. The device of claim 9, wherein the drive shaft comprises of a laser cut Nitinol tube.
12. The device of claim 9, wherein the drive shaft comprises of a counterwound coaxial cable.
13. The device of claim 1 or claim 2, wherein the treatment device is configured to deliver a treatment drug.
14. The device of claim 1 or claim 2, wherein the treatment device is configured to deliver a stent.
15. The device of claim 1, wherein the treatment device is configured to deliver an embolic coil.
16. The device of claim 2, wherein the treatment device is configured to deliver a vasoocclusive coil.
CA 2605382 2005-04-20 2006-04-19 Neurovascular intervention device Expired - Fee Related CA2605382C (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US11111254 US8467854B2 (en) 2005-04-20 2005-04-20 Neurovascular intervention device
US11/111,254 2005-04-20
PCT/US2006/014850 WO2006113856A1 (en) 2005-04-20 2006-04-19 Neurovascular intervention device

Publications (2)

Publication Number Publication Date
CA2605382A1 true CA2605382A1 (en) 2006-10-26
CA2605382C true CA2605382C (en) 2013-07-16

Family

ID=36754258

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2605382 Expired - Fee Related CA2605382C (en) 2005-04-20 2006-04-19 Neurovascular intervention device

Country Status (7)

Country Link
US (1) US8467854B2 (en)
JP (1) JP2008538521A (en)
CA (1) CA2605382C (en)
DE (1) DE602006007456D1 (en)
EP (1) EP1877124B1 (en)
ES (1) ES2326915T3 (en)
WO (1) WO2006113856A1 (en)

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Also Published As

Publication number Publication date Type
EP1877124B1 (en) 2009-06-24 grant
ES2326915T3 (en) 2009-10-21 grant
DE602006007456D1 (en) 2009-08-06 grant
US8467854B2 (en) 2013-06-18 grant
WO2006113856A1 (en) 2006-10-26 application
JP2008538521A (en) 2008-10-30 application
CA2605382A1 (en) 2006-10-26 application
EP1877124A1 (en) 2008-01-16 application
US20060253023A1 (en) 2006-11-09 application

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