Therapeutic ultrasound system

• US 5,989,208 A
• Filed: 05/16/1997
• Issued: 11/23/1999
• Est. Priority Date: 05/16/1997
• Status: Expired due to Term

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Henry Nita
• Inventors: Nita, Henry
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): KENNEDY, SHARON E
• Application Number:
  US08/857,416
• Time in Patent Office: 921 Days
• Field of Search: 604/19-22, 604/96, 604/102, 604/113, 604/282, 604/283, 604/905, 604/912, 604/915, 604/916, 600/437, 600/459, 600/462, 600/466, 600/467, 600/470, 600/471, 601/2, 128/200.16, 433/86
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation

Abstract

An ultrasound system is disclosed having a catheter including an elongate flexible catheter body having at least one lumen extending longitudinally therethrough. The catheter further includes an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end connectable to an ultrasound transducer. The catheter also includes a distal head positioned on the distal end of the ultrasound transmission member. The catheter also has a coil with a proximal end connected to the distal end of the catheter body, and a distal end connected to the distal head. The coil defines a lumen communicating with the lumen of the catheter body. The ultrasound system also includes a sonic connector for coupling the ultrasound transmission member to the transducer. Different configurations are disclosed for the distal head and the ultrasound transmission member.

Claims

1. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a distal end, and a proximal end connectable to a separate ultrasound generating device;

a distal head positioned on the distal end of the ultrasound transmission member; and

a coil having a proximal end connected to the distal end of the catheter body, and a distal end connected to the distal head, the coil defining a lumen communicating with the lumen of the catheter body.

2. The ultrasound catheter of claim 1, further comprising an inner tube extending inside the lumens of the catheter body and the coil, the inner tube having a proximal end connected to the catheter body and a free distal end, and defining a spacing between the distal end of the inner tube and the distal head.

3. The ultrasound catheter of claim 2, wherein the distal head has a fluid outflow channel provided therethrough and communicating with the lumens of the catheter body and the coil, and wherein drugs may be aspirated through the spacing and the fluid outflow channel.

4. The ultrasound catheter of claim 1, further comprising an inner tube extending inside the lumens of the catheter body and the coil, the inner tube having a proximal end connected to the catheter body and a distal end connected to the distal head.

5. The ultrasound catheter of claim 1, wherein the distal head has a generally cylindrical proximal portion with a bore for receiving the distal end of the ultrasound transmission member.

6. The ultrasound catheter of claim 1, further comprising a non-symmetrical balloon positioned adjacent the distal end of the catheter body such that inflation of the balloon will position the catheter body in an off-centered manner in a vessel.

7. The ultrasound catheter of claim 6, wherein the catheter body is positioned at another off-centered position by rotating the catheter body by ninety degrees.

8. The ultrasound catheter of claim 1, wherein the catheter body has a proximal region adjacent the proximal end, a distal region adjacent the distal end, and an intermediate region between the proximal region and the distal region, and wherein the flexibility of the catheter body increases from the proximal region to the intermediate region, and from the intermediate region to the distal region.

9. The ultrasound catheter of claim 1, wherein the ultrasound transmission member has a proximal region adjacent the proximal end and an intermediate region between the proximal region and the distal end, and wherein the intermediate region has a plurality of progressively tapered sections having dimensions that progressively decrease from adjacent the proximal region to the distal end.

10. The ultrasound catheter of claim 1, wherein the ultrasound transmission member has a proximal region adjacent the proximal end and a distal region adjacent the distal end, wherein the distal region is continuously tapered until it reaches a conical distal tip.

11. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a distal end, and a proximal end connectable to a separate ultrasound generating device;

a distal head positioned at the distal end of the ultrasound transmission member and having a generally cylindrical proximal portion with a bore for receiving the distal end of the ultrasound transmission member, wherein the distal head further includes a rounded distal portion having a narrowed tip extending distally therefrom; and

a coil having a proximal end connected to the distal end of the catheter body, and a distal end connected to the distal head, the coil defining a lumen communicating with the lumen of the catheter body.

12. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a distal end, and a proximal end connectable to a separate ultrasound generating device;

a distal head positioned at the distal end of the ultrasound transmission member and having a generally cylindrical proximal portion with a bore for receiving the distal end of the ultrasound transmission member, wherein the distal head further includes a central narrowed tip, an annular ridge, and a concave region separating the central narrowed tip and annular ridge; and

a coil having a proximal end connected to the distal end of the catheter body, and a distal end connected to the distal head, the coil defining a lumen communicating with the lumen of the catheter body.

13. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device, a proximal region adjacent the proximal end, a distal end, and an intermediate region between the proximal region and the distal end; and

a distal head positioned at the distal end of the ultrasound transmission member;

wherein the intermediate region of the ultrasound transmission member has a plurality of progressively tapered sections having diameters that progressively decrease from adjacent the proximal region to the distal end, and wherein the distal end of the ultrasound transmission member has a diameter which is larger than the diameter of the distal-most part of the intermediate region.

14. The ultrasound catheter of claim 13, wherein the distal end of the ultrasound transmission member comprises a ball having a diameter which is larger than the diameter of the distal-most part of the intermediate region.

15. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device, a proximal region adjacent the proximal end, a distal end, and an intermediate region between the proximal region and the distal end; and

a distal head positioned at the distal end of the ultrasound transmission member;

wherein the intermediate region of the ultrasound transmission member has a dimension which is smaller than the dimension of the proximal region, and wherein the distal end of the ultrasound transmission member has a dimension which is larger than the dimension of the distal-most part of the intermediate region; and

wherein the distal end of the ultrasound transmission member has a configuration with two opposing straight sides connected by two curved sides, and wherein the distal head includes a cylindrical bore for receiving the distal end of the ultrasound transmission member, and a filler material for filling the space in the cylindrical bore between the distal end of the ultrasound transmission member and the cylindrical bore.

16. An ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end and a distal end;

a distal head positioned on the distal end of the ultrasound transmission member;

a sonic connector positioned on the proximal end of the ultrasound transmission member for connecting the ultrasound transmission member to a separate ultrasound generating device, the sonic connector comprising a proximal section for connection to a separate ultrasound generating device, a central portion, and a tapered portion extending distally from the central portion, the tapered portion having a stem which couples the proximal end of the ultrasound transmission member; and

a housing for housing the sonic connector, the housing including a distal bore for retaining the stem and the proximal ends of the catheter body and the ultrasound transmission member, the housing further including an O-ring positioned around the stem inside the distal bore in a position proximal to the proximal ends of the catheter body and the ultrasound transmission member.

17. The ultrasound catheter of claim 16, further comprising:

a connector housing for housing the sonic connector, the connector housing having an open proximal end;

an ultrasound transducer for generating ultrasound energy, the transducer having a distal end;

a transducer housing having a bore for housing the transducer, an internal housing wall and an external housing wall, the transducer housing further including an annular recess provided on the external housing wall, the annular recess having a beveled channel extending through the housing wall having an opening at the internal housing wall which is smaller than an opening at the external housing wall, the transducer housing further including a ball positioned inside the beveled channel, and a sliding collar positioned in a part of the annular recess;

wherein the connector housing is received inside the bore of the transducer housing with the proximal section of the sonic connector coupled to the distal end of the transducer; and

wherein the sliding collar is advanced inside the annular recess to depress the ball inside the beveled channel and to cause a portion of the ball to protrude out of the opening at the internal housing wall to engage the connector housing.

18. The ultrasound catheter of claim 17, wherein the sliding collar includes an annular bevel which covers, but does not depress, the ball before the sliding collar is advanced.

19. An ultrasound system comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end and a distal end; and

a distal head positioned on the distal end of the ultrasound transmission member;

an ultrasound transducer for generating ultrasound energy, the transducer having a distal end;

a sonic connector positioned on the proximal end of the ultrasound transmission member for connecting the ultrasound transmission member to the transducer;

a connector housing for housing the sonic connector, the connector housing having an open proximal end; and

a transducer housing having a bore for housing the transducer, an internal housing wall and an external housing wall, the transducer housing further including an annular recess provided on the external housing wall, the annular recess having a beveled channel extending through the housing wall having an opening at the internal housing wall which is smaller than an opening at the external housing wall, the transducer housing further including a ball positioned inside the beveled channel, and a sliding collar positioned in a part of the annular recess;

wherein the connector housing is received inside the bore of the transducer housing with the proximal section of the sonic connector coupled to the distal end of the transducer; and

wherein the sliding collar is advanced inside the annular recess to depress the ball inside the beveled channel and to cause a portion of the ball to protrude out of the opening at the internal housing wall to engage the connector housing.

20. The ultrasound system of claim 19, wherein the sliding collar includes an annular bevel which covers, but does not depress, the ball before the sliding collar is advanced.

21. An ultrasound system comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end and a distal end;

a distal head positioned at the distal end of the ultrasound transmission member;

an ultrasound transducer having a transducer horn; and

a sonic connector positioned on the proximal end of the ultrasound transmission member for connecting the ultrasound transmission member to the transducer horn, the sonic connector comprising a proximal section for connection to the transducer horn, a central portion, and a tapered portion extending distally from the central portion, the tapered portion having a stem which couples the proximal end of the ultrasound transmission member.