Patent Application
20200164185
This disclosure generally relates to a catheter having an inflatable balloon for performing a dilatation procedure within a patient's vascular system and more particularly to a tool and method for returning a balloon that has been inflated to a wrapped profile.
Catheter systems are used in a variety of therapeutic applications, including many vascular treatments due to the desire to provide minimally invasive procedures. Notably, a catheter may be provided with an inflatable balloon at the distal end for performing angioplasty, such as percutaneous transluminal coronary angioplasty (PTCA). Patency may be restored by inflating a balloon positioned in a blood vessel that is blocked or narrowed by a lesion or stenosis. It will be appreciated that a number of other procedures also employ a catheter having an inflatable balloon. The balloons used in such catheters are formed from relatively inelastic materials in order to positively control the outer diameter of the balloon once expanded. Accordingly, the balloon typically has wings or flaps of excess material when uninflated. During manufacture, the flaps are tightly wound around the catheter shaft to minimize the insertion profile to facilitate advancing the distal end of the catheter through a catheter sheath introducer (CSI) to gain access to the patient's vasculature.
In some situations, it would be desirable to utilize a dilatation catheter multiple times. Typically, the CSI is chosen to have the minimum diameter that will accommodate the dilatation catheter being employed. As such, there may be relatively little clearance between the inner diameter of the CSI and the balloon profile when wrapped. After the balloon has been inflated once, it may prove challenging to return the balloon to its wrapped profile. Correspondingly, re-inserting the dilatation catheter through the CSI may be considerably more difficult.
Conventional attempts to address this problem have involved the use of rewrapping tool that is shaped in the form of a tube having a lumen that is sized to compress the deflated balloon to a wrapped profile. The rewrapping tool may be provided separately from the dilatation catheter or it may be preloaded on a proximal portion of the shaft. By drawing the balloon through the lumen, the operator may rewrap the flaps around the catheter shaft, ideally returning the balloon to a profile that is close to its manufactured state. However, a number of deficiencies are associated with these techniques. If the rewrapping tool is provided as a separate device, the operator must thread the distal end of the catheter through the lumen and advance the balloon into the lumen. This operation involves a pushing force and the catheter shaft may not have sufficient column strength successfully pass the balloon through the lumen without buckling. Additionally, since the lumen of the rewrapping tool typically has a diameter close to that of the CSI, it is of comparable difficulty to simply re-introduce the dilatation catheter, obviating the motivation for employing the rewrapping tool.
Implementations in which the rewrapping tool is preloaded on the proximal catheter shaft insertion initially avoid these drawbacks, as the user rewraps the balloon by pulling the distal end of the catheter with the balloon through the lumen without the need to push the balloon through the lumen. Unfortunately, the benefit is only available once. A single pass of the balloon through the lumen of the rewrapping tool may not be sufficient to achieve the desired insertion profile. Further, it may be desirable to use the catheter more than twice. In either situation, the operator must now push the balloon through the lumen, which presents the difficulties discussed above.
Accordingly, the present inventor has recognized that there is a need in the art for a tool for rewrapping the balloon of a catheter mapping. Similarly, the inventor has recognized a need in the art for a tool that allows an operator to pull a deflated balloon through a lumen sized to return the balloon to a wrapped profile that may be employed multiple times without pushing the balloon through the lumen. Still further, the inventor has recognized a need in the art for a method of using such a tool that facilitates introduction of a balloon catheter through an introducer multiple times. The techniques of this disclosure as described in the following materials satisfy these and other needs.
The present disclosure is directed to a rewrapping tool for returning a balloon of a dilatation catheter to a wrapped profile following inflation having a body extending along a longitudinal axis, a first lumen defined by the body and having a length that extends between opposing ends of the body, and a channel communicating along the length of the first lumen, wherein the channel has a width and a depth matched to an inner diameter of the first lumen. The channel may be defined by opposing surfaces of a guide that projects from the body. The opposing surfaces of the guide may be formed from material thinner than a remainder of the body. The channel may have a width in the range of approximately 0.001″ to 0.005″ less than the inner diameter of the first lumen and the channel may have a depth greater than the inner diameter of the first lumen.
In one aspect, the rewrapping tool may have a second lumen defined by the body and having a length that extends between opposing ends of the body, wherein the channel communicates along the length of the second lumen and wherein the second lumen has an inner diameter greater than the inner diameter of the first lumen. The inner diameter of the second lumen may accommodate a deflated balloon of a dilatation catheter having a catheter shaft with an outer diameter that corresponds to the inner diameter of the first lumen.
In one aspect, the rewrapping tool may also have at least one intermediate lumen defined by the body and having a length that extends between opposing ends of the body, wherein the channel communicates along two lengths of the intermediate lumen and wherein the intermediate lumen has an inner diameter greater than the inner diameter of the first lumen and less than the inner diameter of the second lumen.
This disclosure also includes a kit for retuning a balloon of a dilatation catheter that has been inflated to a wrapped profile including a dilatation catheter having a catheter shaft extending along a longitudinal axis with an outer diameter and an inflatable balloon disposed around a distal portion of the catheter shaft and a rewrapping tool having a body extending along a longitudinal axis, a first lumen defined by the body and having a length that extends between opposing ends of the body, and a channel communicating along the length of the first lumen, wherein the channel has a width and a depth matched to an inner diameter of the first lumen and wherein the inner diameter of the first lumen accommodates the catheter shaft and compresses the balloon to a wrapped profile.
This disclosure also includes a method for rewrapping a balloon of a dilatation catheter involving providing a rewrapping tool having a body extending along a longitudinal axis, a first lumen defined by the body and having a length that extends between opposing ends of the body, and a channel communicating along the length of the first lumen, wherein the channel has a width and a depth matched to an inner diameter of the first lumen, sliding the channel over a catheter shaft of the dilatation catheter at a position proximal to the balloon so that the catheter shaft is coaxial with the first lumen and pulling the catheter shaft in a proximal direction so that the balloon is drawn through the first lumen to return the balloon to a wrapped profile. Sliding of the channel over the catheter shaft at a position proximal to the balloon and drawing the balloon through the first lumen may be repeated until a desired wrapped profile is obtained. As desired, the first lumen may be compressed as the balloon is drawn through. In addition, the rewrapping tool may be rotated slightly as the balloon is drawn through to assist in rewrapping the balloon to the desired wrapped profile.
In one aspect, the rewrapping tool has a second lumen defined by the body with an inner diameter greater than the inner diameter of the first lumen and a length that extends between opposing ends of the body and the channel communicates along the length of the second lumen and the method may include introducing the balloon through the second lumen and advancing the catheter shaft distally until the rewrapping tool is at the position proximal to the balloon. Sliding the channel over the catheter shaft may move the catheter shaft from being coaxial with the second lumen to being coaxial with the first lumen.
In one aspect, the rewrapping tool also has at least one intermediate lumen defined by the body with an inner diameter greater than the inner diameter of the first lumen and a length that extends between opposing ends of the body and the channel communicates along two lengths of the second lumen and the method may include sliding the channel over the catheter shaft of the dilatation catheter at a position proximal to the balloon so that the catheter shaft is coaxial with the intermediate lumen and pulling the catheter shaft in a proximal direction so that the balloon is drawn through the intermediate lumen prior to drawing the balloon through the first lumen.
Further features and advantages will become apparent from the following and more particular description of the preferred embodiments of the disclosure, as illustrated in the accompanying drawings, and in which like referenced characters generally refer to the same parts or elements throughout the views, and in which:
At the outset, it is to be understood that this disclosure is not limited to particularly exemplified materials, architectures, routines, methods or structures as such may vary. Thus, although a number of such options, similar or equivalent to those described herein, can be used in the practice or embodiments of this disclosure, the preferred materials and methods are described herein.
It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of this disclosure only and is not intended to be limiting.
The detailed description set forth below in connection with the appended drawings is intended as a description of exemplary embodiments of the present disclosure and is not intended to represent the only exemplary embodiments in which the present disclosure can be practiced. The term “exemplary” used throughout this description means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other exemplary embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the exemplary embodiments of the specification. It will be apparent to those skilled in the art that the exemplary embodiments of the specification may be practiced without these specific details. In some instances, well known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the exemplary embodiments presented herein.
For purposes of convenience and clarity only, directional terms, such as top, bottom, left, right, up, down, over, above, below, beneath, rear, back, and front, may be used with respect to the accompanying drawings. These and similar directional terms should not be construed to limit the scope of the disclosure in any manner.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one skilled in the art to which the disclosure pertains.
Finally, as used in this specification and the appended claims, the singular forms “a, “an” and “the” include plural referents unless the content clearly dictates otherwise.
As noted above, this disclosure is directed to catheters having an inflatable balloon, such as dilatation catheters. More particularly, tools and methods are described for facilitating the rewrapping of the balloon multiple times. For context, an exemplary balloon dilatation catheter is illustrated in
Balloon 16 is shown in
In one embodiment shown in
The dimensions of channel 28 and first lumen 24 are matched to correspond to the characteristics of the given catheter with which rewrapping tool 20 will be used. For example, channel 28 may have a width equal to or less than the diameter of first lumen 24. In one aspect, channel 28 may have a width in the range of approximately 0.001″ to 0.005″ less than the diameter of lumen 24. As such, the width of channel 28 may be approximately the same or somewhat narrower than the outer diameter of the catheter shaft it is being used with, which is less than the diameter of balloon 16 in its wrapped profile. When the channel width is narrower, rewrapping tool 20 may be deflected slightly to accommodate introduction of the catheter shaft, creating a snap fit connection when the catheter shaft is fully inserted and coaxially aligned with first lumen 24.
Accordingly, rewrapping tool 20 may be formed of a suitable material, such a polymeric material, having a desired compliance with a relatively low durometer. Further, rewrapping material 20 may also be compressed as the balloon is being pulled through first lumen 24 to impart an enhanced rewrapping force. Exemplary materials include, without limitation, polyethylenes such as high density polyethylene (HDPE) and fluoropolymers such as polytetrafluoroethylene (PTFE). Suitable materials may be relatively lubricious to facilitate pulling the balloon through the first lumen. The length of body 22 may be long enough to allow ready manipulation by the operator and it may also be desirable to minimize the length of body 22 to reduce friction with the balloon as it is being drawn through, while maintaining sufficient length to be manipulated by the operator. As an example and without limitation, body 22 may have a length in the range of approximately 2 cm to 5 cm.
One suitable technique for employing rewrapping tool 20 is schematically illustrated in
Another embodiment is schematically depicted in
To illustrate the use of rewrapping tool 40,
Yet another embodiment is schematically depicted in
Use of rewrapping tool 50 may be similar to that of rewrapping tool 40, in that balloon 16 may be pushed through second lumen 56 in a distal direction so that catheter shaft may be slid through channel 60 until it is coaxial with first lumen 54, allowing balloon 16 to be drawn through and rewrapped. However, one or more intermediate rewrapping operations may be performed as desired by positioning catheter shaft 14 so that it is coaxial with third lumen 58. Accordingly, balloon 16 may be drawn through third lumen 58 to begin the rewrapping process. Since the inner diameter of third lumen 58 is greater than the inner diameter of first lumen 54, it may be easier to first draw balloon through third lumen 58 one or more times to provide a partially wrapped configuration that has a reduced profile as compared to the deflated but unwrapped balloon. This intermediate stage may facilitate the subsequent drawing of balloon 16 through first lumen 54. In other embodiments, any suitable number of intermediate lumens may be provided so that the rewrapping tool has four or more lumens, all connected by a continuous channel. Further, the lumens may be offset as shown in
The preceding description has been presented with reference to presently disclosed embodiments of this disclosure. Workers skilled in the art and technology to which this disclosure pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this disclosure. As understood by one of skilled in the art, the drawings are not necessarily to scale. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2016/000538 | 3/29/2016 | WO | 00 |
