FIELD OF THE INVENTION
- DISCUSSION OF RELATED ART
The present invention relates, in general, to transducer mountings for ultrasound catheter assemblies used in diagnostic or therapeutic applications.
Mechanically scanned ultrasound catheter assemblies employ a single transducer mounted inside a rotating housing. In particular, the transducer transmits and receives ultrasonic waves while the transducer housing rotates about a fixed axis in an acoustic window located at a distal tip of the catheter. The rotational motion of the transducer housing is accomplished by a flexible drive-shaft that extends through an axially disposed lumen of the catheter, wherein the drive-shaft has one end connected to the transducer housing. Once the distal end of the catheter is positioned, for example, in a patient's vascular system, a cross-sectional image of the tissue surrounding the distal catheter tip is produced by using imaging and control circuitry that are electrically coupled to the transducer via an electrical conductor extending through the drive shaft.
With respect to FIG. 1, a conventional prior art ultrasound catheter assembly 100, which appears in U.S. Pat. No. 5,842,994, is depicted. U.S. Pat. No. 5,842,994 is hereby incorporated by reference. The catheter assembly 100 comprises a first elongate tubular element 120, which forms an axially disposed lumen 130. An acoustic imaging window 140 is attached to a distal end of the first tubular element 120, thereby forming an enclosed tip of the catheter assembly 110. A flexible drive-shaft 150 extends through the lumen 130 and is connected at a distal end to a transducer housing 60 disposed in the acoustic imaging window 140. The transducer housing 60 has a generally cylindrical transducer 170 mounted therein, exposing a circular active surface area, or aperture. A second elongate tubular element 180 forms an additional lumen 190 used for other catheter functions such as housing pullwires or delivering liquid to a distally disposed balloon during angioplasty.
- SUMMARY OF THE INVENTION
With further reference to FIG. 1, the transducer housing 60 is an expensive, high-precision part that requires a particular joining operation to attach it to the drive-shaft 150. In addition, the joint created between the drive-shaft 150 and the transducer housing 60 may potentially fail. Therefore, it would be advantageous to eliminate the transducer housing 60 from catheter assembly 110. FIG. 1A depicts an alternative conventional prior art ultrasound catheter, which includes opening 65 adapted to permit flushing from the proximal end of catheter assembly 100 and dimensioned for the passage of guide wires. This alternative catheter does not include first elongate tubular element 120 or second elongate tubular element 180.
An aspect of the invention involves a method of making a transducer mounting to a driveshaft by providing an elongate tubular element including a lumen, providing a rotatable imaging core adapted to pass through the lumen, the imaging core including a flexible driveshaft and a transducer. The method optionally contemplates treating and machining the distal tip of the drive-shaft, and then attaching the transducer to the distal tip.
Another separate aspect of the invention involves a method of making a transducer mounting to a driveshaft comprising a step of treating the distal tip of the drive-shaft by hardening the distal tip with a welding process, wherein the drive-shaft is initially made of flexible wound wires and the welding process joins the wound wires of the distal tip together such that a rigid distal tip is formed. This method optionally contemplates the use of electrical welding by applying electrodes at two locations on the drive shaft for electrical conductivity therebetween.
A further separate aspect of the invention involves a method of making a transducer mounting to a driveshaft comprising a step of treating the distal tip of the drive-shaft by hardening the distal tip with a soldering process, wherein the drive-shaft is made of flexible wound wires having interstices therebetween and the soldering process fills the interstitial spaces such that a rigid distal tip is formed. This method optionally contemplates the use of a cold clamp having a high specific heat to dissipate excess heat during soldering. In addition, this method may incorporate the use of a ceramic or fiber-optic plug for keeping the central lumen open during soldering.
An additional separate aspect of the invention involves a method of making a transducer mounting to a driveshaft comprising a step of machining the distal tip of the drive-shaft by grinding or drilling the distal tip to form an arcuate recession with opposing tapered side walls. This method optionally contemplates attaching the transducer to the distal tip of the drive-shaft by crimping the tapered side walls about the perimeter of the transducer so that the transducer is held in place therebetween. In addition, a clamping member or an adhesive may be used to secure the transducer to the distal tip of the drive shaft.
Yet another separate aspect of the invention involves an ultrasonic imaging catheter assembly comprising an elongate tubular element including a lumen, a rotatable imaging core adapted to pass through the lumen, the rotatable imaging core including a flexible drive-shaft attached to a transducer, wherein the driveshaft has a rigid distal tip adapted to be mounted to the transducer.
An additional separate aspect of the invention involves an ultrasonic imaging catheter assembly having a drive-shaft with a rigid distal tip which includes an arcuate recession with opposing tapered side walls, wherein the transducer is attached to the distal tip of the drive-shaft by crimping the tapered side walls about the perimeter of the transducer so that the transducer is held in place therebetween. Alternatively, a clamping member or an adhesive may be used to secure the transducer to the distal tip of the drive shaft.
The invention may include any one of these separate aspects individually, or any combination of these separate aspects.
BRIEF DESCRIPTION OF THE DRAWINGS
Other features and advantages of the invention will be evident from reading the following detailed description, which is intended to illustrate, but not limit, the invention.
The drawings illustrate the design and utility of preferred embodiments of the present invention, in which similar elements are referred to by common reference numerals.
FIG. 1 is a cut-away partial side view of a prior art ultrasound catheter assembly.
FIG. 1 A is a cut-away partial side view of a prior art ultrasound catheter assembly.
FIG. 2 is a cut-away partial side view of an ultrasound catheter assembly according to an example embodiment of the present invention.
FIG. 2A is a cross-sectional view taken along line 2A-2A of FIG. 2.
FIG. 3 is a cut-away partial side view of the ultrasound catheter assembly of FIG. 2.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 3A is a cross-sectional view taken along line 3A-3A of FIG. 3.
With respect to FIGS. 2 and 3 , a preferred ultrasound catheter assembly 100 includes an elongate tubular element 115 having tubular section 120, which forms an axially disposed lumen 130. A dome-shaped acoustic imaging window 140 is attached to a distal end of the elongate tubular element 115, thereby forming an enclosed tip of the catheter assembly 100. Alternatively, the shape of the acoustic imaging window 140 may be virtually any shape or combination of shapes. An imaging core 145 comprising a flexible drive-shaft 150 having a rigid distal tip 160 and a generally cylindrical transducer 170 is disposed within lumen 130. The imaging core 145 is capable of translation along its center axis 185.
As best seen in FIG. 2A, axially disposed lumen 130 has a substantially “D-shaped” cross-section wherein the inner dimensions of lumen 130 are sufficient for transducer 170 to be translated therein. With further reference to FIG. 2A, a solid section 180 of elongate tubular element 115 forms an additional lumen 190 used for other catheter functions such as, by way of non-limiting examples, housing pullwires, drug delivery, balloon angioplasty, laser ablation, or for housing a stiffening member to help prevent the collapsing of the catheter assembly.
A cover tube 200 formed of a suitable material, such as a heat shrinkable nylon, urethane, polyethylene or other plastic, is disposed around tubular element 115, wherein cover tube 200 provides both structural integrity to the catheter assembly 100, as well as a smooth outer surface for ease in axial movement in a patient's body passage with minimal friction. Preferably, the acoustic imaging window 140 has its proximal end open and its distal end rounded and is attached to a distal outer circumferential portion of the tubular element 115 to form an enclosed catheter tip 210, with respective ends of the cover tube 200 and acoustic imaging window 140 bonded together at a common joint 220. The outer diameter of the proximal end of window 140 is preferably substantially equal to that of the installed cover tube 200, so that a smooth outer surface is provided at joint 220.
Referring to FIGS. 2 and 3, the transducer 170 is attached to the flexible drive-shaft 150 at a cut-away portion 165 of rigid distal tip 160 such that its active surface 175 slopes at a slight angle with respect to the center axis 185 of drive-shaft 150. This tilting of transducer 170 helps to minimize internal reflections inside of catheter tip 210. The transducer 170 can be fixedly attached in a number of ways including by an adhesive such as a UV (ultraviolet light) cure epoxy, by crimping of opposing tapered side walls 195 surrounding cut-away portion 165, by a clamp 205, any other known method of affixing, or any combination of these methods.
As best seen in FIGS. 3 and 3A, drive-shaft 150 has a central lumen 225 adapted for the passage of transducer wires or coaxial cable, which extend through relieved area 163. The driveshaft 150 is made of wound wire such as a superalloy or stainless steel in order to be flexible inside of a patient's blood vessel, for example. However, distal tip 160 of drive-shaft 150 preferably should be hardened and machined in order to mount transducer 170. Hardening of distal tip 160 can be accomplished by a number of means including welding and soldering.
Welding of the distal tip 160 is preferably accomplished electrically, by applying electrodes at two locations along distal tip 160 for conductivity therebetween. The two locations can be the end of distal tip 160 and, for example, location 230 along the drive-shaft 150. By running sufficient electricity between these two locations, the wound wires of drive-shaft 150 will heat up, begin to liquefy, and bond together, eliminating some of the interstitial spaces between the wound wires. Although electrical welding of the distal tip 160 should be continued until the wires have fused together, it should be terminated before unwanted deformation of the distal tip 160 has occurred. After welding and a brief cool-down period, the distal tip 160 will be more rigid than the rest of the drive-shaft 150 due to the fusing between the wound wires.
Alternatively, the hardening of the distal tip 160 can be accomplished by a soldering process wherein the interstitial spaces between the wound wires are filled with softened metal. Although many different solders can be used, the solder is preferably a 5% silver solder mixed with 95% tin. During the soldering process, the silver solder should be heated to approximately 850-900 degrees Fahrenheit and melted into the interstitial spaces in the distal tip 160 of driveshaft 150. Alternatively, a brazing process can be used, which requires greater temperatures to melt solder having a higher percentage of silver.
During soldering, a cold clamp can be utilized to dissipate excess heat and to limit unnecessary fusion of the wound wires of the rest of the flexible drive-shaft 150. Ideally, the cold clamp is made of metal such as aluminum or copper having a high specific heat. Also, the cold clamp is circular so that it can encircle the perimeter of drive shaft 150 at location 230. Before soldering, a plug should be inserted within central lumen 225 so that it is not stopped up by melted metal. Preferably, the plug is made of a material having a high melting point such as a ceramic rod or a piece of fiber optic. In addition, the plug can have an outer coating to prevent adherence to the solder.
The hardening of the distal tip may also be accomplished using an adhesive such as an epoxy wherein an adhesive is used to fill the interstitial spaces of the wound wire of distal tip 160. After the distal tip 160 has been hardened so that it is rigid, it can be machined to create an effective mount for transducer 170.
During machining, a cut-away portion 165 in the form of an arcuate recession with opposing tapered side walls 195 is formed on the rigid distal tip 160 using a milling or grinding process. In addition, relieved area 163 is formed within cut-away portion 165 using a similar milling or grinding process. Cut-away portion 165 is adapted to receive the cylindrical transducer 170. The opposing tapered walls 195 of machined distal tip 160 can be crimped inwardly about the perimeter of the transducer 170 to hold it fixedly in place. Additionally, an epoxy or other adhesive such as a UV cure epoxy can be used to further secure transducer 170 to distal tip 160. Alternatively, clamping member 205 can be used to secure the transducer 170 to the distal tip 160 of the drive-shaft 150. The clamping member is fixedly attached to the driveshaft 150 and removably attached to the transducer 170.
Any one or more of the features depicted in FIGS. 1-3, or described in the accompanying text, may be interchanged with that of another figure to form still other embodiments.
While preferred embodiments and methods have been shown and described, it will be apparent to one of ordinary skill in the art that numerous alterations may be made without departing from the spirit or scope of the invention. Therefore, the invention is not limited except in accordance with the following claims.