Patent Application
20140243843
Embodiments of the present invention relate to methods and apparatuses inflating a balloon catheter, and more particularly to a balloon that inflates rapidly.
Balloon catheters are used in a wide variety of medical procedures. For example, they may be used to dilate vessels, expand stents, block fluid flow in a vessel, and anchor a medical device, among other uses.
A balloon catheter typically has at least one lumen extending the length of the balloon catheter. The lumen allows fluid communication between a distal location and the balloon disposed at a proximal end of the balloon catheter. The balloon is inflated by pressurizing a fluid within the lumen causing the balloon to inflate. As the balloon inflates, additional fluid must fill in the increased volume of the inflated balloon. Because the balloon is located at a proximal end of the catheter and a surgeon typically only has access to the distal end of the balloon catheter, the fluid is pressurized at the distal end, and the fluid flows through the lumen to inflate the balloon.
In balloon catheters having a relatively large diameter lumen, the fluid flows relatively easily through the lumen. However, there is a need to expand treatment options to smaller vessels requiring balloon catheters having relatively small diameter lumens. In such balloon catheters the smaller lumen results in increased fluid resistance and the fluid does not flow easily through the lumen. This increased fluid resistance results in a balloon that takes longer to inflate and deflate relative to a larger lumen balloon catheter.
Embodiments of the invention include a balloon catheter assembly comprising a catheter, a sleeve, and a balloon. The catheter has a catheter body, an exterior surface, a lumen, a port providing fluid communication between the lumen and the exterior surface, and a coupling mechanism to couple the lumen to an inflation source. The sleeve has an interior surface facing the exterior surface, the sleeve being coaxial with the catheter and configured to move longitudinally about the catheter. The balloon is disposed about the catheter and has a middle segment covering the port, a distal segment coupled to the sleeve, and a proximal segment coupled to the catheter. The middle segment has a middle longitudinal stiffness, the distal segment has a distal longitudinal stiffness, and the proximal segment has a proximal longitudinal stiffness. The middle longitudinal stiffness is greater than the proximal longitudinal stiffness and the middle longitudinal stiffness is greater than the distal longitudinal stiffness. The balloon catheter assembly of claim 1 wherein the middle segment has at least one lateral reinforcement.
Another embodiment is directed to a method for deploying a balloon catheter. The method comprises a series of steps. A balloon catheter assembly is provided comprising a catheter having a catheter body and a proximal end, an exterior surface, a lumen, a port providing fluid communication between the lumen and the exterior surface, a sleeve having an interior surface facing the exterior surface, the sleeve being coaxial with the catheter and configured to move longitudinally about the catheter, a balloon disposed about the catheter and having a middle segment covering the port, a distal segment coupled to the sleeve, and a proximal segment coupled to the catheter, wherein the middle segment has a middle longitudinal stiffness, the distal segment has a distal longitudinal stiffness, and the proximal segment has a proximal longitudinal stiffness, wherein the middle longitudinal stiffness is greater than the proximal longitudinal stiffness and the middle longitudinal stiffness is greater than the distal longitudinal stiffness, and an inflation source in fluid communication with the lumen. The proximal end of the catheter is advanced into a body lumen to a treatment site. The balloon is inflated with the inflation source by providing an inflation fluid to the balloon through the lumen and the port. The sleeve is then advanced proximally over the catheter to move the distal segment towards the proximal segment thereby expanding the middle segment radially and folding the distal segment and the proximal segment under the middle segment.
Another embodiment includes a balloon catheter assembly comprising a catheter, a balloon, and a trigger wire. The catheter has a catheter body, an exterior surface, a lumen, a proximal end, and a mechanism adapted to couple the lumen to an inflation source. The balloon is disposed at the proximal end of the catheter, the balloon having an inner volume in fluid communication with the lumen, a distal segment coupled to the catheter, a middle segment, and a proximal segment, wherein the middle segment has a middle longitudinal stiffness, the distal segment has a distal longitudinal stiffness, and the proximal segment has a proximal longitudinal stiffness, wherein the middle longitudinal stiffness is greater than the proximal longitudinal stiffness and the middle longitudinal stiffness is greater than the distal longitudinal stiffness. The trigger wire is coupled to the proximal segment, the trigger wire extending distally along the catheter.
To further clarify the above and other advantages and features of the one or more present inventions, reference to specific embodiments thereof are illustrated in the appended drawings. The drawings depict only typical embodiments and are therefore not to be considered limiting. One or more embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
As used herein, “at least one,” “one or more,” and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
Various embodiments of the present inventions are set forth in the attached figures and in the Detailed Description as provided herein and as embodied by the claims. It should be understood, however, that this Detailed Description does not contain all of the aspects and embodiments of the one or more present inventions, is not meant to be limiting or restrictive in any manner, and that the invention(s) as disclosed herein is/are and will be understood by those of ordinary skill in the art to encompass obvious improvements and modifications thereto.
Additional advantages of the present invention will become readily apparent from the following discussion, particularly when taken together with the accompanying drawings.
In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the inventive balloon catheter, as well as the axial ends of various component features. The term “proximal” is used in its conventional sense to refer to the end of the apparatus (or component thereof) that is closest to the heart during use of the apparatus. The term “distal” is used in its conventional sense to refer to the end of the apparatus (or component thereof) that is furthest from the heart during use. For example, a catheter may have a proximal end and a distal end, with the distal end designating the end furthest from the heart during an operation, such as a handle, and the proximal end designating an opposite end of the catheter closer to the heart. Similarly, the term “proximally” refers to a direction that is generally away from the heart along the apparatus during use and the term “distally” refers to a direction that is generally away from the heart along the apparatus.
The catheter 106 has at least one lumen 118 extending from the proximal end 102 of the rapid expansion balloon catheter 100 to an inflation source (not shown). The lumen 118 provides fluid communication from the inflation source to the proximal end 102. The proximal end 102 of the lumen 118 is typically sealed such that a fluid within the lumen 118 is inhibited from flowing out the proximal end 102. Near the proximal end 102, the catheter 106 has at least one port 120 passing from the lumen 118 to the exterior surface 116 of the catheter 106. The at least one port 120 provides fluid communication from the lumen 118 to the exterior surface 116 of the catheter 106.
The balloon segment 108 is formed of a flexible material 122 suitable for inflation. The catheter 106 extends beyond a proximal end 128 of the sleeve 104 such that a portion 130 of the exterior surface 116 of the catheter 106 is not disposed within the lumen 110 of the sleeve 104. The flexible material 122 wraps around the portion 130 of the exterior surface 116 of the catheter 106 and a proximal segment 126 of the flexible material 122 is adhered to the proximal end 102 of the catheter 106. A distal segment 132 of the flexible material 122 is adhered to the sleeve 104 at its proximal end 128.
A close fit between the exterior surface 116 of the catheter 106 and the inner surface 114 of the sleeve 104 effectively forms a seal that inhibits fluid from traveling between the outer surface 116 and the inner surface 114. In some instances when a close fit is not possible, an actual sealing element may be disposed between the exterior surface 116 and the inner surface 114 to inhibit fluid passing between the two surfaces 116, 114. With the flexible material 122 adhered at its proximal end 102 to the catheter 106 and at its distal end 132 to the sleeve 104, a balloon 124 is formed with the only means of fluid communication into the balloon 134 being through the at least one port 120.
The second lumen 118 is typically filled with a liquid for inflating the balloon. Because a liquid is not readily compressible, any increase in pressure and volume is readily transmitted to the balloon 124 through the at least one port 120.
In one embodiment, the reinforcements 406, 408, are made by heat setting the balloon 400 to create folds in the balloon 400, similar to using an iron to create a crease or fold in fabric. In another embodiment, a fiber matrix is incorporated in the balloon with the fiber matrix having the desired shape. In a circumferential reinforcement region the fibers would run around the circumference of the balloon 400 and in the longitudinal reinforcement region, they would run longitudinally along the balloon 400.
Other configurations of reinforcements are possible. For example,
The described rapid expansion balloon catheter allows for the balloon to be inflated rapidly in vascular systems requiring the use of a small balloon catheter. The use of the rapid balloon expansion catheter will now be described in relation to
A surgeon initially guides the proximal end 102 of the rapid expansion balloon catheter 100 to a treatment site. The proximal end 102 is typically guided in a deflated state to minimize the cross section of the proximal end 102. In some embodiments, the proximal end 102 may be guided to the treatment site in a partially inflated state. Once the proximal end 102 is at the treatment site, a fluid is delivered through the second lumen 118 of the catheter 106 to partially inflate the balloon 124.
After the balloon 124 is inflated to a desired size, the fluid delivery path is closed inhibiting the fluid from traveling back distally through the second lumen 118. Because the balloon 124 is only partially inflated and does not occlude the entire vessel at the treatment site, continued proximal perfusion past the balloon 124 is possible.
To rapidly inflate the balloon 124 to occlude the entire vessel at the treatment site, the surgeon advances the sleeve 104 over the catheter 106 bringing the proximal end 128 of the sleeve 104 toward the proximal end 118 of the catheter 106. In one embodiment, the sleeve 104 is advanced by placing the catheter 106 under traction and then pushing the sleeve 104 forward. In another embodiment, the catheter 106 and the sleeve 104 have a threaded engagement which causes the sleeve 104 to advance over the catheter 106 when rotated relative to the catheter 106. In yet another embodiment, the rapid inflation balloon catheter has a sleeve 104 and is advanced through a cannula. A threaded engagement between the cannula and the sleeve 104 causes the cannula to push the sleeve 104 proximally in response to a rotation of the sleeve 104 relative to the cannula.
| Number | Date | Country | |
|---|---|---|---|
| 61746933 | Dec 2012 | US |
