1. Field of the Invention
The present invention relates to providing tight seals along shafts by means of laser energy and more particularly to laser bonding of medical device shaft geometries.
2. Description of Related Art
Balloon catheters are well known for their utility in treating certain types of obstructions in blood vessels. In a Percutaneous Transluminal Coronary Angioplasty (PTCA or balloon angioplasty) procedure, catheters are inserted into the cardiovascular system. A pre-shaped guiding catheter is positioned in the coronary artery and then a dilatation catheter having a distensible balloon portion is advanced through the branches of the coronary artery until the balloon portion traverses or crosses a stenotic lesion. The balloon portion is then inflated with a fluid to compress the atherosclerosis in a direction generally perpendicular to the wall of the artery, thus dilating the lumen of the artery.
In the manufacture of balloon catheters and stent delivery systems, it is essential that the bonds between the catheter shaft and the balloon material be fluid tight and of sufficient strength to withstand the inflation fluid pressure. Typically, the balloon is mounted along the distal end region of the catheter body. In a multi-lumen balloon having a plurality of outer lumens disposed around a central lumen, the balloon outer lumens have tapered distal and proximal seal ends forming a fluted shaped balloon configuration. The balloon's proximal and distal seal ends are bonded to the catheter shaft via a proximal seal arrangement and a distal seal arrangement.
In some applications, including medical-related applications, two or more irregular shaped lumens or shafts must be bonded together so as to form a multi-lumen or multi-shaft assembly. Other applications may require that a material be bonded to a lumen or shaft that has an irregular shaped geometry.
There are several ways to bond a balloon to a catheter shaft, bond two or more lumens or shafts together into a multi-lumen or multi-shaft sub-assembly, or bond a material to an irregular shaped geometry.
One method to bond two or more lumens together into a multi-lumen sub-assembly or bond a material to an irregular shaped geometry is by using resistance heating of copper jaws. While the resistance jaws press the respective multi-lumens in the sub-assembly against each other the resistance jaws are heated until the lumens fuse. This method is particularly useful when bonding together shafts or lumens constructed of similar materials or of materials having similar material characteristics. However, this method provides unacceptable seals for when bonding components having multiple lumens, multiple shafts, or irregular geometries, for example, the non-circular geometry of the proximal and distal balloon seals of a multi-lumen balloon radiation centering catheter.
Another approach to bonding is to use adhesives or chemicals (i.e., solvent bonding). This approach is useful for multiple-lumen sub-assemblies being constructed of dissimilar materials. However, the adhesive layers add to the thickness of the area being bonded and increase its rigidity at the region of the bonds.
Yet another method for bonding is using a laser beam to target and heat up the region of interest until a seal is achieved. The laser seal configuration currently being used in most medical device applications has a helical or “rings” laser seal pattern. A laser beam is used to trace out a conventional “rings” pattern around the circumference of an area to be bonded such as where a balloon is being bonded to a catheter shaft. The helical laser seal pattern is achieved by directing a laser beam onto the balloon and catheter shaft while balloon and catheter shaft are rotated together about their longitudinal axis.
This prior art helical laser seal pattern has a number of disadvantages. For example, when laser sealing an multi-lumen, multi-shaft, or irregular geometry, the helical laser sealing pattern is unable to fully achieve a fluid tight seal. In other words, where the configuration to be sealed is not circular, oval or has another simple geometry, the helical sealing pattern may not seal all the areas along such geometries properly. For example, a multi-lumen balloon has an irregular shape and has grooves (or flutes) between the lumens for providing perfusion when in use. The helical laser sealing pattern may not form a fluid tight seal within these grooves.
Thus, what is desired is a method and apparatus for forming a seal (or bond) in multiple lumen, multiple shaft, and/or irregular geometry configurations.
The present invention provides a square-wave laser seal pattern made by first directing a laser beam onto a shaft bundle while the shaft is moving in a horizontal direction relative to a laser device so as to create a horizontal laser seal bond segment. With the shaft rotating about a shaft longitudinal axis, the laser beam is directed onto the shaft so as to create a vertical laser seal bond segment. By alternately creating and coupling together a plurality of horizontal and vertical laser seal bond segments, a square-wave laser seal is formed around a circumference of the shaft.
The present invention is illustrated by way of example and not limitation in the accompanying figures:
a-5e illustrate an example of the variable horizontal translation speed of the holder fixture while performing the square-wave laser seal around a multi-lumen component.
A square-wave laser seal pattern and seal performed around the circumference of a shaft to bond materials and method for providing the same is described. The present invention improves the bonding and sealing of multiple lumen, multiple shaft, and irregular geometric components. For example, the present invention may be used to bond a material to a catheter shaft, where the conventional helical or rings laser seal pattern is unable to target and seal the material in the groove of a multiple lumen balloon.
The square-wave laser seal pattern of the present invention may be used in bonding components together, and is especially useful for bonding components of non-circular geometries such as multiple lumens and multiple shaft components as well as components with other irregular geometries. The square-wave laser seal pattern is also well suited to be used for performing the proximal and distal balloon seals for a single or multi-lumen balloon catheters, such as a multi-lumen balloon or radiation centering catheter. Furthermore, the square-wave laser seal pattern is well suited for use in other emerging products that have irregular shaft geometries that would make conventional laser sealing difficult.
In the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. However, it will be apparent to those skilled in the art to which this invention pertains that the present invention may be practiced without these specific details. In other instances, well-known devices, methods, procedures, and individual components have not been described in detail so as not to unnecessarily obscure aspects of the present invention.
Shaft 10 may be a conventional circular or oval shaft or may be a non-circular shaft such as a multi-lumen or multi-shaft bundle, or a shaft having other irregular geometries. For example, shaft 10 may be a catheter shaft having multiple lumens or a multiple lumen balloon that has an irregular geometry.
With reference to
As shown on
It should be noted that shaft 10, which is being held by a shaft holder fixture 30, is rotated along its longitudinal axis 12 in a circular direction 16 that may be in either a clockwise or counter-clockwise direction. Furthermore, to achieve the square-wave laser seal pattern 2 shown in
It is also important to note that for the embodiment shown in
In the example of a catheter shaft and a multi-lumen balloon, the lengths of the horizontal laser seal bond segments (22, 24) define a “width” 26 of the square-wave laser seal pattern shown in
It should further be noted that shaft 10 being held by the shaft holder fixture 30, is generally incrementally rotated along its longitudinal axis 12 based on a preset degree of rotation 31 of the shaft holder fixture 30. Therefore, the lengths of the vertical laser seal bond segments (23, 25) are based on the preset degree of rotation 31 as well as the diameter of the shaft 10. The preset degree of rotation 31 represents the predetermined number of degrees of circular rotation for the shaft holder fixture 30 if these were measured around the circumference 11 of the shaft 10 (where one degree of circular rotation equals 1/360 of the circumference 11 of the shaft 10). The larger the preset degree of rotation 31 is, the larger the lengths of the vertical laser seal bond segments (23, 25) will be. For the square-wave laser seal pattern embodiment shown in
With reference to
The square-wave laser seal shown in
As shown in
As shown in
In the multi-lumen irregular shaped shaft embodiment, the lengths of the horizontal laser seal bond segments (22, 24) define a “width” 26 of the square-wave laser seal pattern shown in
For the embodiment shown in
The shaft holder fixture 30 with the multi-lumen irregular shaped shaft bundle 10b is generally incrementally rotated along its longitudinal axis 12 based on a preset degree of rotation 31 of the shaft holder fixture 30. For the square-wave laser seal pattern embodiment shown in
One significant feature differentiating the process used to achieve the square-wave laser seal shown in
Changing the horizontal translation speed rate is dependent on such variables as: (a) how far the multi-lumen shaft bundle 10b is from a focal point 27 of the laser beam 21, (b) whether the laser beam 21 passes any “thin walled” regions 28 within the multi-lumen shaft bundle 10b, and (c) whether the laser beam 21 passes any grooves 15 within the multi-lumen shaft bundle 10b.
With reference to
With reference to
Referring to
Referring to
Using an approach similar to the seal approach shown in
Referring to
A square-wave laser seal pattern and seal around the circumference of a shaft to bond materials and method for providing the same has been described. Although specific embodiments, including specific parameters, methods, and materials have been described, various modifications to the disclosed embodiments will be apparent to one of ordinary skill in the art upon reading this disclosure. Therefore, it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention and that this invention is not limited to the specific embodiments shown and described.
This application is a continuation of application Ser. No. 10/328,794 filed Dec. 23, 2002 now abandoned which is a continuation of parent application Ser. No. 09/505,335 filed Feb. 16, 2000 now abandoned.
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Number | Date | Country | |
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Parent | 10328794 | Dec 2002 | US |
Child | 11137869 | US | |
Parent | 09505335 | Feb 2000 | US |
Child | 10328794 | US |