The invention relates generally to catheters and more particularly to intravascular ultrasound catheters.
Ultrasound can be useful in a variety of medical procedures. Intravascular ultrasound, in which an ultrasound transducer is advanced into a patient's body through the patient's vasculature, has particular uses and advantages.
An ultrasound transducer can be advanced through a patient's vasculature within an ultrasound catheter. While ultrasound catheters are known, a need remains for improved ultrasound catheters. A need remains as well for ultrasound catheters exhibiting improved flexibility.
The present invention pertains to catheters such as intravascular ultrasound catheters. An intravascular ultrasound catheter may include a central lumen adapted to receive a drive shaft bearing an ultrasound transducer. The intravascular ultrasound catheter may, in some instances, exhibit improved flexibility.
Accordingly, an example embodiment of the present invention can be found in an intravascular ultrasound catheter that has a distal portion and a proximal portion. The catheter can include an inner polymeric layer, an outer polymeric layer and a spiral-cut hypotube that is positioned between the inner polymeric layer and the outer polymeric layer and that extends from the distal portion of the catheter to the proximal portion.
The spiral-cut hypotube has a pitch having a rate of change, i.e., a first derivative, that is a function of distance from a distal end of the spiral-cut hypotube. In other words, the pitch, or inches per turn, changes at a rate that depends upon relative position along the hypotube. At one point on the hypotube, the pitch can change slowly with respect to position while at a point positioned elsewhere on the hypotube, the pitch can change more rapidly with respect to position.
Another example embodiment of the present invention can be found in an intravascular ultrasound assembly that includes an intravascular ultrasound drive shaft having a distal end and an ultrasound transducer positioned near the distal end of the intravascular ultrasound drive shaft. The assembly also includes a catheter that is adapted to receive the intravascular ultrasound drive shaft.
The catheter has an inner polymeric layer that defines a lumen that is adapted to accommodate the intravascular ultrasound drive shaft. The catheter includes an outer polymeric layer and a spiral-cut hypotube that extends between the inner polymeric layer and the outer polymeric layer from a distal portion to a proximal portion of the catheter.
The above summary of the present invention is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, Detailed Description and Examples which follow more particularly exemplify these embodiments.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value, i.e., having the same function or result. In many instances, the term “about” may include numbers that are rounded to the nearest significant figure.
As used in this specification and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and in the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. Although examples of construction, dimensions, and materials are illustrated for the various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that may be utilized.
Several of these components can include elements known in the art. For example, the motor 14 can be any suitable electrically driven motor having an appropriate speed and load rating. The drive shaft 16 can be formed from any suitable material or materials. The ultrasound transducer 18 may be any suitable transducer crystal made from any suitable material such as a barium titanate, a lead zirconate titanate, a lead metaniobate, and others. The monitor 22 can simply be a display unit such as a cathode ray tube or an LCD display. In some instances, the monitor 22 can represent a computer system including data processing systems as well as a display unit.
The intravascular ultrasound catheter 12 can be discussed in greater detail with respect to
In some embodiments, the inner polymer layer 34 can be formed of or include a coating of a material having a suitably low coefficient of friction. Examples of suitable materials include polytetrafluoroethylene (PTFE), better known as TEFLON®. The inner polymer layer 34 can be dimensioned to define a lumen 38 having an appropriate inner diameter to accommodate its intended use. In some embodiments, the inner polymer layer 34 can define a lumen 38 having a diameter of about 0.020 inches and can have a wall thickness of about 0.001 inches.
The outer polymer layer 32 can be formed from any suitable polymer that will provide the desired strength, flexibility or other desired characteristics. Polymers with low durometer or hardness can provide increased flexibility, while polymers with high durometer or hardness can provide increased stiffness. In some embodiments, the polymer material used is a thermoplastic polymer material. Some examples of some suitable materials include polyurethane, elastomeric polyamides, block polyamide/ethers (such as PEBAX®), silicones, and co-polymers. The outer polymer layer 32 can be a single polymer, multiple longitudinal sections or layers, or a blend of polymers. By employing careful selection of materials and processing techniques, thermoplastic, solvent soluble, and thermosetting variants of these materials can be employed to achieve the desired results.
While not expressly illustrated, it is contemplated that the elongate shaft 24 may include several different sections that can vary in flexibility. In some instances, for example, the inner polymer layer 34 and perhaps the intermediate metallic layer 36 may extend continuously at least substantially the entire length of the elongate shaft 12. The outer polymer layer 32, however, may have several sections formed of differing polymers to provide additional flexibility. For example, the outer polymer layer 32 may include (not illustrated) a proximal section, a middle section and a distal section. The distal section may be formed of a polymer having a lower durometer than that of the middle section, which may itself be formed of a polymer having a lower durometer than that of the proximal section.
In particular embodiments, a thermoplastic polymer such as a co-polyester thermoplastic elastomer, for example, that available commercially under the ARNITEL® name, can be used. The outer polymer layer 32 can have an inner diameter that is about equal to the outer diameter of the inner polymer layer 34. The outer layer 32 can have an inner diameter that is slightly greater than the outer diameter of the inner polymer layer 34 to accommodate the thickness of the intermediate metallic layer 36. In some embodiments, the outer polymer layer 32 of the shaft can have an inner diameter in the range of about 0.025 inches to about 0.100 inches and an outer diameter in the range of about 0.028 inches to about 0.150 inches.
The outer polymer layer 32 may in, some instances, provide a compressive force to the intermediate metallic layer 36 in order to help retain a desired tubular shape for the intermediate metallic layer 36. In some cases, the outer polymer layer 32 may have a compression fit over the intermediate metallic layer 36. In some instances, the outer polymer layer 32 may have an interference fit or a slip fit with the intermediate metallic layer 36.
In some instances, it may be useful to be able to provide fluid from an interior of the catheter 12 to the exterior of the catheter 12.
As discussed above, catheter section 44 includes an outer polymer layer 32, an inner polymer layer 34 and an intermediate metallic layer 36, much as discussed with respect to
The elongate shaft 24 includes a second portion 56 having (as illustrated) four spiral-cuts 58 as an example and corresponds to an intermediate portion. It can be seen that adjacent spiral-cuts 58 are spaced a distance d2 apart, and that d2 is less than d1. The elongate shaft 24 also includes a third portion 60 having (as illustrated) seven spiral-cuts 62 as an example. It can be seen that adjacent spiral-cuts 62 are spaced a distance d3 apart, and that d3 is less than d2. The third portion 60 corresponds to a (relatively) distal portion 66. The number of cuts and distance apart can, however, be varied within the scope of the present invention.
In some embodiments, the pitch, or the spacing between adjacent turnings or windings, may decrease considerably when moving from the proximal end 26 of the elongate shaft 24 to the distal end 28 of the elongate shaft 24. In some embodiments, the intermediate metallic layer 36 may be spiral-cut from the proximal end 26 to the distal end 28. In some instances, the intermediate metallic layer 36 may be spiral-cut from a position distal of the proximal end 26 to the distal end 28. In particular, the intermediate metallic layer 36 may be spiral-cut from about a midpoint of the elongate shaft 24 to the distal end 28, although other points along the shaft may be selected.
In some instances, the intermediate metallic layer 36 may be spiral-cut such that adjacent windings or kerfs are very close together near the distal end 28 of the elongate shaft and are substantially less close together as distance from the distal end 28 increases. To illustrate, adjacent windings or kerfs may be spaced apart from 0.005 to about 0.25 inches at the distal end 28 while being spaced about 0.2 to about 1.0 inches at an opposite, more proximal, end of the spiral cutting. As noted above, the spiral-cutting need not extend all the way to the proximal end 26 of the elongate shaft 24.
By cutting the intermediate metallic layer 36 in this fashion, the intravascular ultrasound catheter 12 may have a flexibility that is much greater near the distal end 28 than at positions proximal to the distal end 28. The intermediate metallic layer 36 may be cut in any suitable fashion. In a particular embodiment, the intermediate metallic layer 36 is spiral-cut by a computer-guided laser.
In particular embodiments, the pitch may be given by an equation defining the pitch in terms of a distance to the distal end 28 of the elongate shaft 24. The pitch may have a rate of change, or first derivative in calculus terms, that is itself a function of relative position. As a result, the rate at which the pitch changes will itself vary as one moves from the proximal end 26 to the distal end 28.
In some instances, the pitch may decrease exponentially when moving toward the distal end 28. In some embodiments, the pitch may be given by the formula y=A(Bx)+C, where y is the pitch, x is the distance from the distal end of the elongate shaft 24, A is in a range of about 5 to about 100, B is in a range of about 0.01 to about 1, and C is in a range of about 0 to about 25.
In some embodiments, the pitch may decrease logarithmically when moving toward the distal end 28. In some embodiments, the pitch may be given by the formula y=A+B ln Cx, where y is the pitch, x is the distance from the distal end of the elongate shaft 24, A is in a range of about 0 to about 25, B is in a range of about 0.5 to about 25, and C is in a range of about 0.5 to about 100.
In some embodiments, the pitch may be given by the formula y=A+B log Cx, where y is the pitch, x is the distance from the distal end of the elongate shaft 24, A is in a range of about 0 to about 100, B is in a range of about 20 to about 200, and C is in a range of about 0.01 to about 100.
In some instances, the pitch may be a second power pitch, a third power pitch or a fourth power pitch, and may be given by the formula y=Ax2+Bx+C, where y is the pitch, x is the distance from the distal end of the elongate shaft 24, A is in the range of about 0.001 to about 0.5, B is in the range of about 0 to about 0.001, C is in the range of about 0 to about 100.
One of skill will recognize that a number of other equations may also be used to determine pitch as a function of distance from a distal end. In each of the illustrative but non-limiting examples provided herein it should be noted that the pitch is a function of distance from the distal end. Moreover, in each of these examples, the rate at which the pitch changes, or the first derivative of the pitch, is also a function of relative position.
Returning now to
In
In some embodiments, part or all of the catheter 12 may include a lubricious coating. Lubricious coatings can improve steerability and improve lesion crossing capability. Examples of suitable lubricious polymers include hydrophilic polymers such as polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers can be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding and solubility. In some embodiments, a distal portion of the catheter can be coated with a hydrophilic polymer, while the more proximal portions can be coated with a fluoropolymer.
The invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention as set out in the attached claims. Various modifications, equivalent processes, as well as numerous structures to which the invention can be applicable will be readily apparent to those of skill in the art upon review of the instant specification.
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25 39 191 | Mar 1976 | DE |
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WO 9204072 | Mar 1992 | WO |
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WO 9304722 | Mar 1993 | WO |
WO 9524236 | Sep 1995 | WO |
WO 9619255 | Jun 1996 | WO |
WO 9743949 | Nov 1997 | WO |
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WO 9744086 | Nov 1997 | WO |
WO 9810694 | Mar 1998 | WO |
WO 9911313 | Mar 1999 | WO |
WO 0027303 | May 2000 | WO |
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WO 0048645 | Aug 2000 | WO |
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WO 0066199 | Nov 2000 | WO |
WO 0067845 | Nov 2000 | WO |
WO 0072907 | Dec 2000 | WO |
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Entry |
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