Patent Application
20160082230
1. Field of the Invention
The present disclosure generally relates to medical devices. More particularly, the disclosure relates to medical balloons comprising compliant sleeves.
2. Description of the Related Art
Balloon angioplasty is a widely used procedure for expanding constricted body passageways, such as arteries and other blood vessels, or various ducts (e.g., of the biliary system). In an angioplasty procedure, an uninflated angioplasty balloon attached to a catheter is delivered to a constricted region of a body passageway. Once the balloon is in position at the constricted region, fluid is injected through a lumen of the catheter and into the balloon. The balloon consequently inflates and exerts pressure against the constricted region to expand the passageway. After use, the balloon is collapsed, and the catheter is withdrawn.
Although treatment of constricted arteries in the vasculature is one common example where balloon catheters are used, this is only one example of how balloon catheters may be used and many other uses are possible. For example, balloon catheters may be used to deploy a stent to a target location in the body.
Regardless of the intended use of the balloon catheter, there are circumstances where it would be advantageous for only a portion of the balloon to expand or for the balloon to expand in a step-wise manner, for example. Conventional balloons, however, are generally incapable of this portion-wise or step-wise inflation.
In one embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system comprises a shaft having a distal end, a proximal end, and an expandable balloon mounted at the distal end of the shaft. The shaft has a lumen extending therethrough, in fluid communication with an interior region of the balloon, and the balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the balloon and a portion of the balloon remains uncovered by the sleeve. The sleeve is adhered to the balloon. In some embodiments, a thickness of a wall of the sleeve is varied along a length of the sleeve.
In another embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system comprises a shaft having a distal end, a proximal end, and an expandable balloon mounted at the distal end of the shaft. The shaft has a lumen extending therethrough, in fluid communication with an interior region of the balloon, and the balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the body portion of the balloon and the distal portion of the balloon and the proximal portion of the balloon remain uncovered by the sleeve.
In an additional embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system comprises a shaft having a distal end, a proximal end, and an expandable balloon mounted at the distal end of the shaft. The shaft has a lumen extending therethrough, in fluid communication with an interior region of the balloon, and the balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the proximal portion of the balloon and the distal portion of the balloon remains uncovered by the sleeve or a tubular sleeve is disposed around the distal portion of the balloon and the proximal portion of the balloon remains uncovered by the sleeve.
The foregoing has outlined rather broadly the features and technical advantages of the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter that form the subject of the claims of this application. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent embodiments do not depart from the spirit and scope of the disclosure as set forth in the appended claims.
A detailed description of the invention is hereafter described with specific reference being made to the drawings in which:
Various embodiments are described below with reference to the drawings in which like elements generally are referred to by like numerals. The relationship and functioning of the various elements of the embodiments may better be understood by reference to the following detailed description. However, embodiments are not limited to those illustrated in the drawings. It should be understood that the drawings are not necessarily to scale, and in certain instances details may have been omitted that are not necessary for an understanding of embodiments disclosed herein, such as—for example—conventional fabrication and assembly.
The present disclosure relates to vascular or medical balloon catheters comprising one or more sleeves disposed around at least a portion of the balloon. The balloon may be non-compliant or semi-compliant and its behavior may be modified by using the presently disclosed sleeve. Balloon compliance is meant to describe the degree to which a diameter of a balloon changes as a function of pressure. For example, the diameter of a compliant balloon may have greater than about 10% growth, the diameter of a semi-compliant balloon may have between about 5% growth and about 10% growth, and the diameter of a non-compliant balloon may have less than about 5% growth at the maximum rated pressure compared to a minimal or nominal pressure.
As illustrative examples, the behavior of the balloon may be modified by the sleeve in a manner such that the ends of the balloon expand (open) before a middle portion of the balloon, the middle portion of the balloon expands before the end portions, the proximal portion of the balloon expands before the distal portion, the distal portion of the balloon expands before the proximal portion, or any other configuration where one or more lengths of the balloon expand before the entire length of the balloon expands.
As used herein, the phrase “distal end portion of the balloon,” “distal portion of the balloon,” and the like, refers to the portion of the balloon extending distally from the body portion (mid-portion) of the balloon but excludes the leg/neck portion of the distal end of the balloon, which may be attached to the catheter. A distal portion is a portion located furthest from the handle of a catheter. The phrase “proximal end portion of the balloon,” “proximal portion of the balloon,” and the like, refers to the portion of the balloon extending proximally from the body portion (mid-portion) of the balloon but excludes the leg/neck portion of the proximal end of the balloon, which may be attached to a catheter. A proximal portion is a portion located closest to the handle of the catheter.
Thus, in some embodiments, if it is specified that a proximal portion of the balloon comprises a sleeve or is covered by a sleeve, this may refer to the portion of the balloon located proximally of the body portion, or partially overlapping a proximal section of the body portion of the balloon, including a proximal cone/transition portion but excluding a proximal neck/leg portion. However, the sleeve is not required to always cover, or fully cover, the proximal cone. In some embodiments, the sleeve may cover a proximal portion of the body portion, excluding the proximal cone, and in other embodiments, the sleeve may only cover the proximal cone.
Additionally, in some embodiments, if it is specified that a distal portion of the balloon comprises a sleeve or is covered by a sleeve, this refers to the portion of the balloon located distally of the body portion of the balloon, or partially overlapping a distal section of the body portion of the balloon, including the distal cone/transition portion but excluding the distal neck/leg portion. However, as noted above, the sleeve is not required to always cover, or fully cover, the distal cone. In some embodiments, the sleeve may cover a distal portion of the body portion, excluding the distal cone, and in other embodiments, the sleeve may only cover the distal cone.
The present disclosure also relates to systems for modifying the behavior of a vascular/medical balloon. Some of the systems may include a catheter having a catheter shaft with a distal end and a proximal end. The catheter may be any catheter commonly used to carry out medical procedures, such as angioplasty balloon catheters and balloon-expandable stent catheters.
With respect to
Any known medical balloon may be used in accordance with the present disclosure. Moreover, any known materials, such as elastic materials, may be used to manufacture the balloon. In some embodiments, the balloon comprises a material selected from the group consisting of silicone, polyethyleneterephthalate (PET), polyvinyl chloride, polypropylenes, polyolefins, polyethylenes, polyurethanes, nylons, polyamides, polyamide block copolymers, polyethers, polyesters, latex, natural rubber, synthetic rubbers, elastomers, and any combination thereof.
In some embodiments, such as shown in
In some embodiments, the sleeve may be disposed around the balloon such that all portions of the balloon are covered, including the neck portions of the balloon. In other embodiments, such as the embodiment depicted in
In some embodiments, a stent may be disposed on the sleeve and/or on the balloon. In other embodiments, a plurality of stents may be disposed on the sleeve and/or balloon, such as two stents, three stents, four stents, etc. In one particular embodiment, a stent may be disposed on the sleeve, a portion of the balloon may remain uncovered by the sleeve, and a second stent may be placed around that uncovered portion of the balloon. In the case of a balloon-expanding (BX) stent, the sleeve may be placed between the balloon and the stent.
As noted herein, the sleeve may be disposed around a portion of the balloon such that another portion (or portions) of the balloon remains uncovered. The presently disclosed sleeves may be distinguished from splittable sleeves in that the presently disclosed sleeves circumferentially surround the balloon both in the unexpanded and expanded states of the balloon. Additionally, more than one sleeve, such as two sleeves, may be disposed around the balloon such that portions of the balloon are covered by the sleeve and other portions are not covered by the sleeve. In some embodiments, the sleeve may be bonded or otherwise attached to one end, or both ends, of a catheter shaft. The sleeve may also be adhered to the balloon.
In accordance with the present disclosure, the terms “adhered,” “adhere,” and the like, refer to a configuration where the sleeve is disposed on a portion of the balloon and remains stationary on that portion of the balloon during expansion of the balloon such that the sleeve does not move longitudinally in the proximal or distal direction during expansion. In some embodiments, the sleeve may be adhered to the balloon by using friction forces, bonding, gluing, direct compression, or any combination thereof. In some embodiments, the sleeve may be adhered to the balloon primarily through friction forces but the sleeve may also be bonded to the balloon in one or more locations to further assist in the prevention of longitudinal movement during expansion. In the unexpanded state, the balloon may comprise folds, e.g. the body portion and the cone of the balloon may be folded. That is, in the unexpanded state, the balloon may be provided with a series of longitudinal creases where the balloon wall is folded over itself and wrapped around the shaft in order to achieve a reduced diameter. During expansion of the balloon, the balloon wall unfolds and unwraps in order to achieve a larger diameter with a smooth, unfolded circumference. Folding may be particularly useful for non-compliant and semi-compliant balloons where the wall of the balloon does not significantly stretch when inflation pressure is applied. Thus, in some embodiments, the sleeve may be adhered to the outer surfaces of the folds in the unexpanded state.
The length, thickness, durometer, and other properties of the sleeve may be selected to produce the desired resistance and opening pressure. The wall thickness of the sleeve is not particularly limited and may be selected by the user depending upon the application of the sleeve. In some embodiments, the wall thickness of the sleeve may be constant or uniform. In other embodiments, the wall thickness may vary along the length of the sleeve.
For example, a proximal portion of the sleeve may have a wall thickness that is thinner than the wall thickness of the distal portion of the sleeve. With such a configuration, upon expansion of the balloon comprising the sleeve, the proximal portion of the balloon may open/expand before the distal portion of the balloon. The wall of the sleeve may increase or decrease in thickness (gradually, step-wise, or a combination thereof) along the length of the sleeve. In general, a portion of the sleeve having a thinner wall thickness is less resistant to opening pressure than a portion of the sleeve having a thicker wall thickness. In some embodiments, the sleeve may be radially expandable, longitudinally expandable, or both radially and longitudinally expandable. In some embodiments, the balloon is less resistant to opening pressure than the sleeve.
In accordance with the present disclosure, the thickness of the wall of the sleeve may be, for example, from about 0.005 inches to about 0.015 inches. Thus, in one embodiment, a portion of the sleeve having a thinner wall thickness may comprise a thickness from about 0.005 to less than about 0.01 inches and a portion of the sleeve having a thicker wall thickness may comprise a thickness from greater than about 0.01 to about 0.015 inches. Of course, any desired wall thicknesses may be selected such that one or more portions of the wall of the sleeve are thinner or thicker than one or more other portions of the wall of the sleeve.
The sleeve may comprise an elastic material. In some embodiments, the sleeve comprises more than one material. While any elastic material may be used to manufacture the presently disclosed sleeve, certain illustrative examples of materials that may be used to manufacture the sleeve are as follows: silicone, latex, vulcanized latex, expanded polytetrafluoroethylene (ePTFE), polyolefins, fluoropolymers, noncompliant polyethylene terephthalate (PET), polyimides, nylons, polyamides, polyurethanes, polyesters, polyethylenes, PEBAX, polyesterether copolymers, polyetheresteramide terpolymers.
The sleeve may comprise any one of these materials or the sleeve may comprise any combination of two or more of these materials. In some embodiments, the sleeve may comprise a distal portion, a proximal portion, and a body portion, and each portion of the sleeve may comprise a different material or different combination of materials. Moreover, the distal portion of the sleeve and a distal section of the body portion may comprise one material or combination of materials and the proximal portion and proximal section of the body portion may comprise a different material or different combination of materials. Additionally, two portions of the sleeve may comprise the same material or same combination of materials and a third portion may comprise a different material or different combination of materials.
When different materials are used along the length of the sleeve, this may allow for multiple increments to open in a piece-wise manner because the materials may have different resistances to opening pressure. This is advantageous because it can reduce the number of balloons needing to be stocked at an institution or where the exact length of the balloon needed for a procedure may not be known until mid-way through the procedure.
With respect to
For example, if the sleeve had a uniform wall thickness but portion (222) was replaced with a material having a certain resistance to opening pressure and portion (221) was replaced with a material having a higher resistance to opening pressure than the material used for portion (222), the same piece-wise opening of the balloon could be achieved.
When a sleeve is disposed on a balloon in the folded state, the wall thickness (and resistance to opening) of the sleeve is relatively high. Once the pressure of the balloon expanding underneath the sleeve is great enough to cause the sleeve to start expanding, the wall thickness of the sleeve decreases, thereby further reducing the resistance to opening. If the material of the sleeve is selected to have a local minimum in its pressure-strain curve (see
Such an inflation routine could be used, for example, to rapidly deploy multiple overlapping stents or stent grafts on a single balloon. This would be useful in transjugular intrahepatic porto-systemic shunt (TIPS) procedures, where it is common to need an additional few centimiters of stent added to the proximal end of a shunt that proves to be longer than initially estimated. If it turns out that the additional length is not needed, this portion of the balloon and stent disposed thereon may be left uninflated, removed, and disposed of.
The foregoing routine is generally depicted in
The length of the balloon and the sleeve are not particularly limited and any length may be used. The length of the balloon and sleeve may be selected by the user depending upon the specific application. In some embodiments, the total length of the balloon and/or sleeve may be from about 4 mm to about 120 mm. In other embodiments, the length of the balloon and/or sleeve may be from about 60 mm to about 100 mm.
In one embodiment, as can be seen in
If a smaller portion of the body portion of the balloon is to be covered in addition to a proximal or distal cone, the length of the sleeve may be from about 15 mm to about 55 mm or from about 15 mm to about 30 mm. If two sleeves are used and a portion of the body portion of the balloon is to remain uncovered by the sleeves, the length of each sleeve can be independently selected from about 10 mm to about 40 mm, if the total length of the balloon is about 90 mm. Again, the foregoing lengths of the various components of the presently disclosed medical devices are for illustrative purposes only and any lengths may be selected depending upon the desired application.
While the presently disclosed balloon may comprise one or more sleeves on one or more portions of the balloon, and one or more portions of the balloon may remain uncovered by the one or more sleeves, specific configurations will now be disclosed. The following configurations are meant as illustrative examples and the present disclosure is not limited to the following configurations.
In one embodiment, the body portion of the balloon comprises a sleeve and the distal and proximal end portions of the balloon remain uncovered by the sleeve. In another embodiment, a distal end portion of the balloon comprises the sleeve and the body portion and proximal end portion of the balloon remain uncovered by the sleeve. In a further embodiment, the proximal end portion of the balloon comprises the sleeve and the body portion and distal end portion of the balloon remain uncovered by the sleeve. In an additional embodiment, the distal end portion of the balloon comprises the sleeve, the proximal end portion of the balloon comprises a second sleeve, and the body portion of the balloon remains uncovered. In another embodiment, the distal end portion of the balloon and at least a section of the body portion of the balloon comprise the sleeve and the proximal end portion of the balloon remains uncovered. In a further embodiment, the proximal end portion of the balloon and at least a section of the body portion of the balloon comprise the sleeve and the distal end portion of the balloon remains uncovered. In any of these configurations, a stent may be disposed on one or more of the sleeves and/or one or more uncovered portions of the balloon.
In one particular embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system incorporates a catheter comprising a shaft having a distal end and a proximal end. An expandable balloon is mounted at the distal end of the shaft. The shaft has a lumen extending therethrough and in fluid communication with an interior region of the balloon. The balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the balloon but at least a portion of the distal end portion, proximal end portion, or body portion of the balloon remains uncovered by the sleeve. The sleeve is adhered to the balloon. The distal end portion of the balloon and the proximal end portion of the balloon are portions that do not include the leg/neck portions of the balloon, which are attached to the catheter. In some aspects, a thickness of a wall of the sleeve is varied along its length.
In another specific embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system includes a catheter comprising a shaft having a distal end and a proximal end. An expandable balloon is mounted at the distal end of the shaft and the shaft has a lumen extending therethrough and in fluid communication with an interior region of the balloon. The balloon comprises a body portion, a distal end portion, and a proximal end portion. The distal end portion of the balloon and the proximal end portion of the balloon are portions that do not include the leg/neck portions of the balloon, which are attached to the catheter. A tubular sleeve is disposed around the distal end portion of the balloon and a second tubular sleeve is disposed around the proximal end portion of the balloon. In this configuration, the body portion of the balloon remains uncovered. Further, at least one of the tubular sleeve and the second tubular sleeve is adhered to the balloon. In some aspects, the first and second tubular sleeves are both adhered to the balloon. In some aspects, a thickness of a wall of at least one of the tubular sleeve and the second tubular sleeve is varied along its length.
In another specific embodiment, such as that shown in
In a further specific embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system includes a catheter having a shaft comprising a distal end and a proximal end. An expandable balloon is mounted at the distal end of the shaft and the shaft has a lumen extending therethrough and in fluid communication with an interior region of the balloon. The balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the proximal portion of the balloon, wherein the distal portion of the balloon remains uncovered by the sleeve. The distal end portion of the balloon and the proximal end portion of the balloon are portions that do not include the leg/neck portions of the balloon, which are attached to the catheter. In some aspects, a thickness of a wall of the sleeve is varied along a length of the sleeve. In some aspects, the sleeve is adhered to the balloon. Further, is some aspects, the body portion of the balloon is also covered by the sleeve. This embodiment may be useful, for example, if a user wishes to create a “sea anchor” to drift with blood flow into a position, or to allow tactile positioning at a point in the vessel where the diameter changes.
In another specific embodiment, a system for modifying the behavior of a vascular balloon is disclosed. The system comprises a catheter including a shaft having a distal end and a proximal end. An expandable balloon is mounted at the distal end of the shaft and the shaft has a lumen extending therethrough and in fluid communication with an interior region of the balloon. The balloon comprises a body portion, a distal end portion, and a proximal end portion. A tubular sleeve is disposed around the distal portion of the balloon, wherein the proximal portion of the balloon remains uncovered by the sleeve. In some aspects, the body portion of the balloon is also covered by the sleeve. The distal end portion of the balloon and the proximal end portion of the balloon are portions that do not include the leg/neck portions of the balloon, which are attached to the catheter. In some aspects, a thickness of a wall of the sleeve is varied along a length of the sleeve. In some aspects, the sleeve is adhered to the balloon. This embodiment may be useful, for example, if a user wishes to create a “sea anchor” to drift with blood flow into a position, or to allow tactile positioning at a point in the vessel where the diameter changes.
In addition to the foregoing benefits of the presently disclosed sleeve, if a balloon should burst during expansion or otherwise during a medical procedure, the content of the balloon may be held in place by the sleeve, thereby creating a safety feature.
All of the compositions, balloons, sleeves, and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. In addition, unless expressly stated to the contrary, use of the term “a” is intended to include “at least one” or “one or more.” For example, “a sleeve” is intended to include “at least one sleeve” or “one or more sleeves.”
Any ranges given either in absolute terms or in approximate terms are intended to encompass both, and any definitions used herein are intended to be clarifying and not limiting. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges (including all fractional and whole values) subsumed therein.
Furthermore, the invention encompasses any and all possible combinations of some or all of the various embodiments described herein. It should also be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| 62053373 | Sep 2014 | US |
