Patent Application
20150173710
Catheters are used to access patients and diagnose and treat diseases. They are typically used in medical practice to reach locations inside the body otherwise unreachable without surgery. For example, patients suffering from coronary artery disease may receive percutaneous coronary interventions for treatment of the disease. An intravascular catheter may be used to evaluate the coronary artery disease as well as guide the selection of treatment devices. Catheters typically have a long and tubular sheath that defines an inner lumen. Catheters also have a distal end which enters the patient as well as a proximal end that is controlled by a system user.
The catheter sheath defines an inner lumen through which a medical device can be inserted during a medical procedure. Often times, as the medical device inserts into and moves through the inner lumen, air or gas bubbles form within the inner lumen. These bubbles can cause a variety of problems. As such, system users often insert fluid into the sheath in order to flush out these bubbles. However, flushing is time consuming. Also, in some cases, bubbles can remain trapped even after flushing is performed.
In some medical procedures, catheters are used as a part of an intra-vascular ultrasound (IVUS) system. A standard IVUS system includes a control module, an imaging catheter and a transducer positioned within an inner lumen of the catheter. As the transducer moves through the inner lumen, the transducer produces images of the inside walls of the blood vessel. However, bubbles trapped within the inner lumen can interfere with the IVUS system and cause problems with ultrasound image quality.
It would be advantageous to provide a catheter that resists air or gas bubble formation. It would also be advantageous to provide a catheter that allows for easier flushing of bubbles. It would further be advantageous to provide an imaging catheter and IVUS system that has enhanced image quality.
The following drawings are illustrative of particular examples of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Examples of the present invention will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing examples of the present invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of ordinary skill in the field of the invention. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives. For example, each time the term “comprising” is used, in alternative embodiments, “comprising” can be replaced with “consisting essentially of” or “consisting of.”
The sheath 12 also includes an inner surface 16 and an outer surface 18. The inner surface 16 defines the inner lumen 14 and is in contact with the fluid within the inner lumen 14. As a medical device inserts into and moves through the sheath 12, air bubbles can form along the inner surface 16 of the inner lumen 14. Operators commonly insert fluid into the inner lumen 14 in order to flush these air bubbles out. However, flushing is time consuming and often times, air bubbles remain trapped along the inner surface 16 even after flushing.
The present catheter 10 includes a sheath portion 24 that comprises a hydrophilic material that is in direct contact with the fluid in the inner lumen 14. The hydrophilic material in the sheath portion 24 helps reduce the number of air bubbles trapped along the inner surface 16 of the inner lumen 14. The hydrophilic material also helps to dislodge trapped air bubbles. In some cases, the sheath portion 24 has an inner surface 16 that includes hydrophilic material that is in direct contact with the fluid. In other cases, the entire sheath portion 24, including the inner surface 16 and the outer surface 18, includes hydrophilic material.
The sheath portion 24 that includes the hydrophilic material can be located at a desired location on the catheter 10.
In some embodiments, the sheath portion 24 is located on the distal end 22 of the catheter 10. In some cases, the sheath portion 24 is the entire distal end 22, as shown in
The hydrophilic material can be any hydrophilic material that is substantially transparent to ultrasound energy. In some cases, the hydrophilic material comprises an amphiphile. The inclusion of a hydrophilic material increases the surface energy of the sheath portion 24. In some cases, the sheath portion 24 has a surface energy of at least about 35 dynes, at least about 40 dynes, at least about 45 dynes or at least about 50 dynes. In other cases, the sheath portion 24 has a surface energy that is greater than or equal to the surface energy of fluid in the inner lumen 14. In certain cases, the inner lumen receives saline solution as the fluid and the sheath portion has a surface energy of greater than or equal to the surface energy of saline solution.
In some embodiments, the sheath portion 24 includes both a biocompatible material and a hydrophilic material. The biocompatible materials can be materials such as nylon, polyurethane and polyethylene. In some cases, the sheath portion 24 includes both a polyethylene and a hydrophilic material. In certain cases, the sheath portion 24 is a hydrophilic polyethylene material disclosed in U.S. Pat. No. 4,728,694, U.S. Pat. No. 5,240,985, or WO2002053632, the entire contents of each which are incorporated herein by reference.
In some embodiments, the catheter 10 is an imaging catheter. In other cases, the catheter 10 is an ultrasound imaging catheter. In yet other cases, the catheter 10 is an IVUS imaging catheter.
As the imaging core 30 moves through the inner lumen 14, the transducer 34 produces images of the inside walls of the blood vessel. However, the movement of the imaging core 30 through the inner lumen 14 can also generate air bubbles. However, since the sheath portion 24 comprises a hydrophilic material in contact with the fluid, the air bubbles resist formation along the inner lumen 14 and/or are more easily flushed with a flushing fluid.
In some embodiments, the catheter 10 is an IVUS imaging catheter that is part of an IVUS imaging system.
Some embodiments provide methods of manufacturing catheters having sheath portions 24 comprising a hydrophilic material. In some cases, a hydrophilic material can be added as a resin to a polymer extrusion that is used to manufacture a catheter sheath. Here, any known method of manufacturing a catheter can be used, wherein a hydrophilic material is added to the polymer extrusion.
Various examples of the invention have been described. Although the present invention has been described in considerable detail with reference to certain disclosed embodiments, the embodiments are presented for purposes of illustration and not limitation. Other embodiments incorporating the invention are possible. One skilled in the art will appreciate that various changes, adaptations, and modifications may be made without departing from the spirit of the invention and the scope of the appended claims.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/918,361 filed Dec. 19, 2013, the contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61918361 | Dec 2013 | US |
