US 5,421,338 A · Acoustic imaging catheter and the like

Abstract

Acoustic imaging balloon catheters formed by a disposable liquid-confining sheath supporting a high fidelity, flexible drive shaft which carries on its end an ultrasound transducer and includes an inflatable dilatation balloon. The shaft and transducer rotate with sufficient speed and fidelity to produce real time images on a T.V. screen. In preferred embodiments, special features that contribute to the high fidelity of the drive shaft include the particular multifilar construction of concentric, oppositely wound, interfering coils, a preloaded torque condition on the coils enhancing their interfering contact, and dynamic loading of the distal end of the probe, preferably with viscous drag. The coil rotating in the presence of liquid in the sheath is used to produce a desirable pressure in the region of the transducer. Numerous selectable catheter sheaths are shown including a sheath with an integral acoustically-transparent window, sheaths with end extensions that aid in positioning, a liquid injection-producing sheath, a sheath having its window section under tension employing an axially loaded bearing, a sheath carrying a dilatation or positioning balloon over the transducer, a sheath carrying a distal rotating surgical tool and a sheath used in conjunction with a side-viewing trocar.

Claims91

Dependent claims

An acoustic imaging system, comprising:

a flexible, axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft arranged to direct ultrasonic signals toward a wall of a body lumen,
a catheter body in the form of an elongated, resinous, flexible member, and
an inflatable balloon disposed on said catheter body,
the material of said balloon, the portion of said catheter body carrying said balloon, and a portion of said catheter body axially spaced from said balloon being sonolucent,
a probe enclosing passage within said catheter body being constructed and arranged to enclose said elongated ultrasonic probe,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said catheter body and flexible ultrasonic probe being cooperatively constructed and arranged to enable axial sliding motion of said probe within said catheter body to position said ultrasound device mounted on said distal end of said drive shaft between at least two positions, one position being located in the portion of said catheter body axially spaced from said balloon, for providing an image of the wall of said body lumen when said acoustic imaging system is inserted in said body lumen, to locate a region of the body lumen wall requiring treatment or for viewing the body lumen wall after treatment, and the other position being located in the region of said catheter body corresponding to said balloon, enabling viewing of the body lumen wall while the balloon applies treatment conditions to the body lumen wall.

4 more elements

An acoustic imaging system, comprising:

a flexible, axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft arranged to direct ultrasonic signals toward a wall of a body lumen,
a catheter body in the form of an elongated, resinous, flexible member,
an inflatable balloon disposed on said catheter body,
the material of said balloon, the portion of said catheter body carrying said balloon, and a portion of said catheter body axially spaced from said balloon being sonolucent, and
a probe enclosing passage within said catheter body being constructed and arranged to enclose said elongated ultrasonic probe,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said catheter body and flexible ultrasonic probe being cooperatively constructed and arranged to enable axial sliding motion of said probe within said catheter body to position said ultrasound device mounted on said distal end of said drive shaft between at least two positions, one position being located in the portion of said catheter body axially spaced from said balloon, for providing an image of the wall of said body lumen when said acoustic imaging system is inserted in said body lumen, to locate a region of the body lumen wall requiring treatment or for viewing the body lumen wall after treatment, and the other position being located in the region of said catheter body corresponding to said balloon, enabling viewing of the body lumen wall while the balloon applies treatment conditions to the body lumen wall,
said acoustic imaging system further comprising position detector means adapted to detect the axial position within said catheter body of said ultrasound device mounted on said distal end of said drive shaft and processing means to provide an image of said body lumen as a function of said axial position and acoustic image information obtained during rotation of said ultrasound device mounted on said distal end of said drive shaft,
wherein said processing means comprises storage means to store acoustic image information from selected axial positions of said catheter body and image reconstruction means to provide therefrom a three-dimensional image of the body lumen.

6 more elements

An acoustic imaging system capable of treatment of a body lumen that is a blood vessel, comprising:

a flexible axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft, said ultrasound device being sized, constructed, and arranged to direct ultrasonic signals toward a wall of said blood vessel,
a catheter body in the form of an elongated, resinous, flexible member sized for insertion within said blood vessel, and
an inflatable treatment balloon constructed and arranged on said catheter body to apply a therapeutic treatment to a portion of said blood vessel which the balloon contacts,
the material of said balloon and the portion of said catheter body carrying said balloon being sonolucent,
a probe enclosing passage within said catheter body being constructed and arranged to enclose said elongated ultrasonic probe,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said ultrasound device mounted on said distal end of said drive shaft having a position within said sonolucent portion of said catheter body at the location of said balloon, and being arranged to form acoustic images of the portion of said blood vessel contacted by said treatment balloon during the progress of said treatment by directing said ultrasonic signals through said sonolucent portion of said catheter body and through said treatment balloon toward said wall of said blood vessel.

4 more elements

An acoustic imaging system capable of treatment of a body lumen, comprising:

a flexible axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft arranged to direct ultrasonic signals toward a wall of said body lumen,
a catheter body in the form of an elongated, resinous, flexible member, and
an inflatable treatment balloon constructed and arranged on said catheter body to apply a therapeutic treatment to a portion of the human body which the balloon contacts,
at least a portion of said catheter body being sonolucent,
a probe enclosing passage within said catheter body being constructed and arranged to enclose said elongated ultrasonic probe,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said ultrasound device mounted on said distal end of said drive shaft having a position within said sonolucent portion of said catheter body, and being arranged to form acoustic images of the portion of said body contacted by said treatment balloon during the progress of said treatment,
said acoustic imaging system further comprising a saddle member of limited axial extent fixed to the exterior of a portion of said catheter body corresponding to the location of said balloon, said saddle including a lumen enabling passage of a guidewire along the exterior of the catheter body through said balloon, with portions of said guidewire proximal and distal of said balloon being exposed to said body lumen.

5 more elements

A method for balloon dilatation, comprising the steps of

providing a balloon dilatation acoustic imaging system including
a flexible elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft arranged to direct ultrasonic signals toward a wall of a body lumen,
a catheter body in the form of an elongated, resinous, flexible member capable of withstanding dilatation pressures, and
an inflatable balloon disposed on said catheter body, the material of said balloon and a portion of said catheter body being sonolucent,
a passage within said catheter body being constructed and arranged to enclose said elongated ultrasonic probe,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said catheter body and flexible ultrasonic probe being cooperatively constructed to position said ultrasound device mounted on said distal end of said drive shaft in the sonolucent portion of said catheter body,
while viewing images produced by said ultrasound device mounted on said distal end of said drive shaft, introducing said catheter body to said body lumen, said body lumen having a region to be dilated,
advancing said catheter body in said body lumen to said region to be dilated and positioning said balloon about said region,
treatment said region by balloon dilatation,
deflating said balloon and observing the treated region to determine further treatment, and
removing said catheter body from said body lumen,
wherein said apparatus further includes a self-sealing septum and said method further comprises the step of preparing said apparatus by substantially removing air from said balloon and said catheter body.

10 more elements

An acoustic imaging system, comprising:

a flexible, axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on the distal end of said drive shaft arranged to direct ultrasonic signals toward an internal body structure, and
an elongated, flexible, tubular member on which an inflatable balloon is mounted, at least a portion of said tubular member being sonolucent,
said tubular member being constructed and arranged to enclose said elongated ultrasonic probe within a lumen extending axially through said tubular member, with said ultrasound device mounted on said distal end of said drive shaft being arranged to direct said ultrasonic signals through said sonolucent portion of said tubular member,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said tubular member and said axially elongated ultrasonic probe being constructed to permit a user to initiate, at will, relative axial sliding movement between said axially elongated ultrasonic probe and said tubular member carrying said inflatable balloon between a position in which said ultrasound device mounted on said distal end of said drive shaft is displaced axially from said balloon and at least one other position,
said lumen extending axially through said tubular member having a diameter sufficient to accommodate both said drive shaft and said ultrasound device mounted on said distal end of said drive shaft as said relative axial sliding movement between said tubular member carrying said inflatable balloon and said axially elongated ultrasonic probe occurs.

3 more elements

A method of producing acoustic images and treating an internal body structure, comprising the steps of:

providing a flexible, axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on the distal end of said drive shaft arranged to direct ultrasonic signals toward an internal body structure,
providing an elongated, flexible, tubular member, at least a portion of said tubular member being sonolucent, an inflatable balloon being mounted on said tubular member, said tubular member being constructed and arranged to enclose said elongated ultrasonic probe within a lumen extending axially through said tubular member,
initiating, at will, relative axial sliding movement between said axially elongated ultrasonic probe and said tubular member carrying said inflatable balloon between a position in which said ultrasound device mounted on said distal end of said drive shaft is displaced axially from said balloon and at least one other position, said lumen extending axially through said tubular member having a diameter sufficient to accommodate both said drive shaft and said ultrasound device mounted on said distal end of said drive shaft as said relative axial sliding movement between said tubular member carrying said inflatable balloon and said axially elongated ultrasonic probe occurs,
rotating said elongated ultrasonic probe while said ultrasound device mounted on said distal end of said drive shaft is arranged to direct said ultrasonic signals through said sonolucent portion of said tubular member,
viewing images produced by means of said ultrasound device mounted on said distal end of said drive shaft,
inflating said inflatable balloon to treat said internal body structure, and
deflating said inflatable balloon.

4 more elements

A method for balloon dilatation of a blood vessel, comprising the steps of:

providing a balloon dilatation acoustic imaging system including
a flexible elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on a distal end of said drive shaft arranged to direct ultrasonic signals toward a wall of said blood vessel,
a catheter body in the form of an elongated, resinous, flexible member capable of withstanding dilatation pressures, a passage within said catheter body enclosing said elongated ultrasonic probe, and
at least one inflatable dilatation balloon surrounding said catheter body and said ultrasonic probe in all radial directions, to permit dilatation of said blood vessel when said inflatable dilatation balloon surrounding said catheter body and said ultrasonic probe is inflated at said dilatation pressure,
said elongated ultrasonic probe being constructed to rotate with respect to said catheter body while generating acoustic images,
introducing said catheter body to said blood vessel, said blood vessel having a region to be dilated,
viewing images produced by means of said ultrasound device mounted on said distal end of said drive shaft,
positioning said dilatation balloon about said region to be dilated, and
treating said region by balloon dilatation.

6 more elements

An acoustic imaging system, comprising:

a flexible, axially elongated ultrasonic probe comprising a rotatable drive shaft and an ultrasound device mounted on the distal end of said drive shaft arranged to direct ultrasonic signals toward an internal body structure, and
an elongated, flexible, tubular member on which an inflatable balloon is mounted, at least a portion of said tubular member being sonolucent,
said tubular member being constructed and arranged to enclose said elongated ultrasonic probe within a first lumen extending axially through said tubular member, with said ultrasound device mounted on said distal end of said drive shaft being arranged to direct said ultrasonic signals through said sonolucent portion of said tubular member,
said elongated ultrasonic probe being constructed to rotate while generating acoustic images,
said tubular member and said axially elongated ultrasonic probe being constructed to permit a user to initiate, at will, relative axial sliding movement between said axially elongated ultrasonic probe and said tubular member carrying said inflatable balloon between a position in which said ultrasound device mounted on said distal end of said drive shaft is displaced axially from said balloon and at least one other position,
said first lumen extending axially through said tubular member having a diameter sufficient to accommodate both said drive shaft and said ultrasound device mounted on said distal end of said drive shaft as said relative axially sliding movement between said tubular member carrying said inflatable balloon and said axially elongated ultrasonic probe occurs,
said first lumen being parallel to a second axially extending lumen arranged to engage slidably a guide wire,
said tubular member including a distal extension at least a portion of which is sonolucent, said distal extension extending beyond the distal end of said second lumen,
said distal extension of said tubular member having a guide-wire entrance at the center of its distal tip,
said tubular member being constructed to be slid along said guide wire into position in the body, with said guide wire extending through said guide-wire entrance at the distal tip of said distal extension of said tubular member, through at least a portion of an extension of said first lumen within said distal extension of said tubular member, and through said second lumen,
said elongated ultrasonic probe being axially slidable to at least one position at which said ultrasound device is located within said first lumen at a location proximal to said portion of said extension of said first lumen through which said guide wire can extend.

8 more elements

Dependencies are inferred from the claim text.

Acoustic imaging catheter and the like

Life of this patent

Acoustic imaging catheter and the like

Life of this patent

Abstract

Claims91