Patent Application
20230190328
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Balloon dilatation catheters are used to treat lesions in vessels. However, difficulties are encountered in navigating tortuous anatomy and safely crossing very tight lesions. Moreover, some lesions are difficult to dilate using just a balloon, and require a focused force to dilate the lesion at safe inflation pressures.
U.S. Pat. No. 6,394,995 to Solar et al. describes a system used to provide enhanced force to treat a lesion. This system has a flexible advancement member with a tracking member slidable over a guidewire, and a balloon having a distal end attached to the tracking member. This type of system fixes the location of the scoring wires, which can limit flexibility in certain applications.
An object of the disclosure is a balloon catheter that can be used either as a conventional, non-scoring balloon catheter or for providing scoring functionality, when such is desired.
In one aspect, the disclosure relates to a scoring balloon catheter comprising a shaft having a proximal end portion and a distal end portion. An inflatable balloon is mounted on the distal end portion of the shaft. At least one scoring wire includes a portion extending alongside the inflatable balloon. The shaft and the at least one scoring wire are adapted to form a magnetic coupling.
In one embodiment, the at least one scoring wire comprises a magnet for magnetically coupling with the shaft. The magnet may comprise a magnetic band attached to a distal end portion of the at least one scoring wire. Alternatively or additionally, the shaft may comprise a magnet for magnetically coupling with the at least one scoring wire. The magnet of the shaft may be associated with a tip portion thereof, and may comprise a magnetic band attached to the shaft.
In some embodiments, the balloon catheter includes a plurality of scoring wires, each magnetically coupled to the shaft. A proximal end of the scoring wire(s) may be adapted to move longitudinally relative to the shaft, and may also extend at least partially within the shaft.
According to a further aspect of the disclosure, a scoring balloon catheter comprises a shaft having a proximal end portion and a distal end portion , and an inflatable balloon mounted on the distal end portion of the shaft. At least one scoring wire includes a portion extending alongside the inflatable balloon. A magnetic coupling connects the at least one scoring wire to the shaft.
In one embodiment, the magnetic coupling is formed between a tip portion of the shaft and a distal end portion of the at least one scoring wire. The at least one scoring wire may comprise a magnet for forming the magnetic coupling. The shaft may comprise a magnet for forming the magnetic coupling, which magnet may be associated with a tip portion of the shaft, and/or may comprise a magnetic band attached to the shaft.
In some embodiments, a plurality of scoring wires each magnetically couple to the shaft. A proximal end of the at least one scoring wire may be adapted to move longitudinally relative to the shaft. The at least one scoring wire may also extend at least partially within the shaft.
According to a further aspect of the disclosure, a scoring balloon catheter includes an inflatable balloon for selective use in connection with at least one scoring wire including a portion extending alongside the inflatable balloon. A shaft includes a proximal end portion and a distal end portion supporting the balloon. The distal end portion of the shaft includes a magnet for forming a magnetic coupling with the at least one scoring wire. The magnet may be associated with a tip of the shaft, and may comprise a magnetic band attached to the shaft.
Still a further aspect of the disclosure relates to a scoring balloon catheter. The scoring balloon catheter comprises a shaft having a proximal end portion and a distal end portion . An inflatable balloon is mounted on the distal end portion of the shaft. At least one scoring wire includes a portion extending alongside the inflatable balloon and a magnet.
Yet another aspect of the disclosure pertains to a method of forming a scoring balloon catheter. The method comprises magnetically coupling a scoring wire running alongside an inflatable balloon to a shaft. The method may further comprise the step of locating a portion of the scoring wire within the shaft.
The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:
The dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, sometimes reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.
In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the present invention. The disclosed embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, or structures may not have been described in detail so as not to obscure the present invention.
The present disclosure is directed to systems and methods for treatment of a vessel. The principles and operation of systems and methods of the present invention may be better understood with reference to the drawings and accompanying descriptions.
The invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
Certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.
With reference to
The catheter shaft 14 also includes an elongated, tubular shaft 24 forming a guidewire lumen 23 that directs the guidewire 26 through the catheter 10, and along the distal end portion of which the balloon 12 may be located. As illustrated in
Inflatable balloon 12 may include a single or multi-layered balloon wall 28 forming the interior for receiving the inflation fluid. The balloon 12 may be a non-compliant balloon having a balloon wall 28 that maintains its size and shape in one or more directions when the balloon is inflated. The balloon 12 in such case also has a pre-determined surface area that remains constant during and after inflation, also has a pre-determined length and pre-determined diameter that each, or together, remain constant during and after inflation. However, the balloon 12 could be semi-compliant or compliant instead, depending on the particular use. The balloon 12 can have any of a variety of diameters ranging from 1.25-40 mm or 2.0-8.0 mm. In any of the embodiments set out herein, inflatable balloon 12 can have any of a variety of lengths such as 10-300 mm or 20-300 mm. Longer balloons may be particularly useful for treating peripheral lesions, which often have long diseased portions.
According to a first aspect of the disclosure, and with reference to
As illustrated in
As can be appreciated, the selective attachment achieved via magnetic coupling allows for the scoring wire 30 to be selectively used in connection with the catheter 10 or not (such as for completing percutaneous transluminal angioplasty (PTA) without a scoring function, in which case a scoring wire would not be used). In other words, the catheter 10 may be useful as a standard PTA catheter, or associated with one or more scoring wires, as desired to achieve a particular treatment effect.
In the situation where the band 32a comprises a magnet, a magnetic field external to the shaft 14 is created to form the magnetic coupling with the scoring wire 30.
In some embodiments the diameter of scoring wire 30 is between 0.003 inches and 0.040 inches, or 0.005 inches and 0.015 inches, 0.008 inches and 0.012 inches. In some embodiments, scoring wire 135 is 0.10 inches. Scoring wire 30 need not have a uniform diameter, and may have a larger diameter at a distal end as compared to a proximal end, or visa-versa. In some embodiments, scoring wire 30 comprises metal, metal alloy, polymer, and/or a shape memory material.
As can be understood from
With the scoring wire(s) in place and connected to catheter 10, the physician maneuvers the catheter 10 along the guidewire until inflatable balloon 12 reaches the desired position near the site of a lesion L. Typically, this position will allow at least one scoring wire to effectively engage the lesion. After that, the physician inflates inflatable balloon 12 until scoring wire(s) 30 firmly press into or crack the lesion L. Once lesion treatment with catheter 10 is complete, the physician deflates inflatable balloon 12, which allows scoring wire(s) 30 to relax away from the lesion L and from the wall of the vessel V.
Scoring wire(s) 30 may contacts the lesion as long as inflatable balloon 12 remains inflated. The inflation time corresponds to the times the physician chooses for scoring wire to contact the lesion. Inflation times may range from 5 seconds to 5 minutes. The nature of the lesion may determine the appropriate inflation time and inflation speed. Once the catheter 10 is removed from the vessel V, the scoring wire(s) 30 may be optionally removed for reuse.
In the above version, the scoring wires 30 extend entirely external to the catheter 10, but could also be partially located within shaft 14. Specifically, with reference to
Summarizing, this disclosure may be considered to relate to the following items:
a shaft having a proximal end portion and a distal end portion;
an inflatable balloon mounted on the distal end portion of the shaft; and
at least one scoring wire including a portion extending alongside the inflatable balloon;
wherein the scoring balloon catheter, particularly the shaft and the at least one scoring wire, is/are configured to form a magnetic coupling (between the shaft and the at least one scoring wire).
a shaft having a proximal end portion and a distal end portion;
an inflatable balloon mounted on the distal end portion of the shaft;
at least one scoring wire including a portion extending alongside the inflatable balloon; and
a magnetic coupling (optionally detachably) connecting (configured to connect) the at least one scoring wire to the shaft. (The at least one scoring wire and/or the shaft may comprise a magnetic coupling, the magnetic coupling configured to, optionally detachably, connect the least one scoring wire to the shaft.)
an inflatable balloon; and
a shaft having a proximal end portion and a distal end portion supporting the balloon, the distal end portion including a magnet for producing a magnetic field external to the shaft for forming a magnetic coupling with the at least one scoring wire.
a shaft having a proximal end portion and a distal end portion;
an inflatable balloon mounted on the distal end portion of the shaft; and
at least one scoring wire including a portion extending alongside the inflatable balloon and a magnet.
magnetically coupling a scoring wire running alongside an inflatable balloon to a shaft.
Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it embraces all such alternatives, modifications, and variations that fall within the appended claims' spirit and scope. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/037402 | 6/12/2020 | WO |
