Patent Application
20240157089
The present disclosure relates generally to devices to treat organs intravascularly. More specifically, the present disclosure relates to a micro balloon catheter device used to occlude a patient's blood vessel.
The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
In certain instances, a diseased patient organ can be treated intravascularly using targeted delivery of a treatment substance. For example, an organ having a tumor or cancerous growth may be treated by intravascular targeted delivery of a chemotherapeutic drug. In another example, a blood vessel within an organ can be permanently occluded to prevent blood flow into a tumor by targeted delivery of a thrombogenic agent. The intravascular treatment can utilize a dual balloon catheter infusion system that includes a micro balloon catheter to occlude the blood vessel distal of the treatment site and prevent flow of the treatment substance from the treatment site and a fluid infusion catheter having a balloon disposed over the micro balloon catheter.
Embodiments herein describe infusion catheter systems and methods to assist in targeted intravascular delivery of a treatment substance. The systems can be percutaneously inserted into a blood vessel of the organ or body area to be treated. In some embodiments within the scope of this disclosure, the infusion catheter systems include a catheter occlusion device that includes an elongate catheter or tube coupled to a connector having an inflation port. An inflation or expandable member (e.g., balloon) is disposed adjacent a distal end of the catheter. The balloon is in fluid communication with the inflation port through the catheter wherein the balloon can be inflated or expanded with a fluid. A vent port is coupled to the distal end of the catheter. A bore extends through the vent port and is in fluid communication with the balloon. The bore has a proximal portion and a distal portion. A diameter of the proximal portion is larger than a diameter of the distal portion. The bore has a distal opening.
A handle or actuator is couplable to the connector. The handle includes a slide actuator disposed within a housing. The slide actuator is displaceable between a distal position and a proximal position. A seal wire is coupled to the slide actuator and is displaced by the slide actuator. When the slide actuator is in the distal position, a distal end of the seal wire is sealingly disposed within the distal portion of the bore of the vent port to prevent fluid from flowing from the balloon and out the opening. This configuration allows the balloon to be inflated or expanded by the fluid delivered from the inflation port. When the slide actuator is in the proximal position, the distal end of the seal wire is disposed within the proximal portion of the bore of the vent port. This configuration allows fluid from the balloon to flow through the bore and out the opening resulting in self-deflation of the balloon within a short period of time.
In some embodiments within the scope of this disclosure the infusion catheter systems include an infusion catheter device that is coaxially disposable over the catheter occlusion device. The infusion catheter device includes an elongate catheter or tube coupled to a connector having an inflation port. An inflation or expandable member (e.g., balloon) is disposed adjacent a distal end of the catheter. The balloon is in fluid communication with the inflation port through an annular space of the catheter wherein the balloon can be inflated or expanded with a fluid. A backflow valve device is couplable to the connector and configured to prevent backflow of fluid, including blood, from the infusion catheter device.
In use, in embodiments within the scope of this disclosure, the catheter occlusion device and the infusion catheter device are percutaneously inserted into the blood vessel of the organ to be treated such that the distal end of the vessel occlusion device is positioned adjacent a desired treatment site. When inserted, the catheter occlusion device is in a ready state where the balloon is deflated, the slide actuator is in the distal position, and the distal end of the seal wire is sealingly disposed within the distal portion of the bore of the vent port. The balloon may be inflated or expanded to occlude the vessel distal of a treatment site by injection of a fluid from a fluid delivery device coupled to the inflation port. The fluid can flow through the inflation port, through an annular space within the catheter defined by the seal wire and the catheter wall, through a side port of the catheter, and into the balloon. The seal of the seal wire within the distal portion of the bore prevents fluid from flowing out the distal opening of the vent port.
The balloon of the infusion catheter device may be inflated or expanded to occlude the vessel proximal of the treatment site by injection of a fluid from a fluid delivery device coupled to the inflation port. The fluid can flow through the inflation port, through the annular space within the catheter, and into the balloon. A treatment medicament can be injected into the treatment site from a fluid delivery device through an infusion port of the backflow valve device and the catheter of the infusion catheter device. Treatment medicaments including drugs, solutions, and embolic particles are all within the scope of this disclosure.
The balloon of the catheter occlusion device may be deflated by displacement of the slide actuator to the proximal position resulting in proximal displacement of the seal wire from within the distal portion to the proximal portion of the bore of the vent port. This configuration allows fluid to flow from the balloon, through the side port, distally through the annular space, through the proximal portion around the seal wire, through the distal portion, and out the distal opening resulting in self-deflation of the balloon within a short time period of one to five seconds.
Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
As illustrated in
As depicted in
The catheter 114 extends distally from the connector 111. The catheter 114 may be formed of a shape memory metal alloy, such as nitinol, or any other suitable material that allows the catheter 114 to be maneuvered through a tortuous vessel path. An outer diameter of the catheter 114 may range from about 0.25 millimeters to about 0.5 millimeters, and may be about 0.27 millimeters. The lumen 115 extends through the catheter 114 in alignment with a longitudinal axis of the catheter 114. A diameter of the lumen 115 may range from about 0.18 millimeters to about 0.35 millimeters, and may be about 0.18 millimeters.
As shown in
The catheter 114 includes a side port 118 disposed through the wall of the catheter 114 and positioned within the occlusion member 117 to provide fluid communication between the lumen 115 and the occlusion member 117. When the occlusion member 117 is inflated or expanded, fluid flows through the inflation port 112, through the lumen 115, through the side port 118, and into the occlusion member 117.
The vent port 120 is coupled to a distal end of the catheter 114 and disposed distally of the occlusion member 117. The vent port 120 may be formed of any suitable polymeric material, such as pebax or nylon. In some embodiments, the vent port 120 may be flexible to permit passage of the catheter 114 through a tortuous vessel. In another embodiment, the vent port 120 and the catheter 114 may include a steering wire, such as a flat wire, extending from the vent port 120, along the catheter 114, and to a steering mechanism (e.g., wire tensioning mechanism) disposed at a proximal end of the catheter 114. The steering wire and the steering mechanism may be utilized to deflect the vent port 120 into an arcuate shape to allow steering of the catheter 114 through the tortuous vessel. Coupling of the vent port 120 to the catheter 114 can be accomplished using any suitable manufacturing technique, such as welding, bonding, gluing, overmolding, etc. An outer diameter of the vent port 120 may be substantially equivalent to the outer diameter of the catheter 114.
A bore 121 extends longitudinally through the vent port 120. The bore 121 is in axial alignment and fluid communication with the lumen 115. The bore 121 includes a first or proximal portion 122 having a diameter ranging from about 0.18 millimeters to about 0.35 millimeters and a second or distal portion 123 which may have a smaller diameter. The bore 121 includes an opening 124 disposed at a distal end of the vent port 120. When the occlusion member 117 is deflated, the fluid within the occlusion member 117 can flow through the side port 118, through the lumen 115, through the proximal portion 122, through the distal portion 123, and through the opening 124 into the environment surrounding the vent port 120, such as the blood within the blood vessel.
As illustrated in
The seal wire 137 is operably coupled to the slider 132 and extends distally from the slider 132 through the connector 111. The seal wire 137 may be formed of any suitable material, such as stainless steel, shape memory metal alloy (e.g., nitinol), etc. A diameter of the seal wire 137 may range between about 0.13 millimeters and about 0.3 millimeters. When the slider 132 is displaced a distance proximally from the distal position, the seal wire 137 is displaced proximally an equal distance, and when the slider 132 is displaced a distance distally from the proximal position, the seal wire 137 is displaced distally an equal distance. The seal wire 137 is coaxially disposed within the lumen 115 of the catheter 114 to define an annular space 116 between the seal wire 137 and the wall of the catheter 114, as shown in
As depicted in
The handle 130 is coupled to the connector 111 of the catheter occlusion device 110 with the slider 132 in the distal position wherein the tab 133 is disposed against the positive distal stop 136 of the housing 131 to position the distal portion 138 of the seal wire 137 within the distal portion 123 of the bore 121 of vent port 120. The vessel occlusion member 117 is in a deflated or non-expanded state wherein the outer diameter is substantially equivalent to the outer diameter of the catheter 114 and the vent port 120.
A fluid delivery device 108 (e.g., syringe) is coupled to the inflation port 112 of the connector 111. The fluid delivery device 108 may be at least partially filled with any suitable fluid configured to inflate or expand the occlusion member 117. For example, the fluid may be saline, contrast media, a saline and contrast media mixture, etc. The fluid is injected into the catheter occlusion device 110 by the fluid delivery device 108 wherein the fluid flows through the inflation port 112, the annular space 116, the side port 118, and into the occlusion member 117 resulting in inflation or expansion of the occlusion member 117. The occlusion member 117 may be inflated or expanded at a fluid pressure ranging from about 5 pounds per square inch to about 19 pounds per square inch.
As illustrated in
An expandable or inflatable vessel occlusion member 155 (shown in the expanded or inflated state in
As illustrated in
A fluid delivery device 108a (e.g., syringe) is coupled to the inflation port 112 of the connector 111. The fluid delivery device 108a may be at least partially filled with any suitable fluid configured to inflate or expand the first occlusion member 117. The fluid is injected into the catheter occlusion device 110 by the fluid delivery device 108a wherein the fluid flows through the inflation port 112, into an annular space defined by the catheter 114 and the seal wire, and into the first occlusion member 117 resulting in inflation or expansion of the first occlusion member 117.
A fluid delivery device 108b (e.g., syringe) is coupled to the inflation port 152 of the connector 151. The fluid delivery device 108b may be at least partially filled with any suitable fluid configured to inflate or expand the second occlusion member 155. The fluid is injected into the catheter infusion device 150 by the fluid delivery device 108b wherein the fluid flows through the inflation port 152, into an annular space of the catheter 154, and into the second occlusion member 155 resulting in inflation or expansion of the first occlusion member 155.
A fluid delivery device 108c (e.g., syringe) is coupled to the infusion port 172 of the body 171. The fluid delivery device 108c may be at least partially filled with any suitable medicament configured to occlude or treat the treatment site. For example, the medicament may include a thrombogenic agent or particles, a chemotherapeutic agent, etc. The medicament is injected into the catheter infusion device 150 by the fluid delivery device 108c wherein the medicament flows through the infusion port 172, the connector 151, and a lumen of the catheter 154, and into the treatment segment 109. In some embodiments, one or more branch vessels may extend from the defined or isolated treatment segment 109, which may facilitate treatment of the vessel 102 along the treatment segment 109 as well as branches downstream from the vessel 102 that intersect with the treatment segment. Embodiments within the scope of this disclosure wherein treatment is configured to be delivered only to an isolated treatment segment 109 (e.g. with no branch vessels and occlusion members on either side of the treatment segment) and embodiments wherein treatment is applied to a treatment segment 109 and portions of the vasculature downstream from the treatment segment are contemplated.
As illustrated in
A catheter fitting 225 is coupled to a proximal end of the catheter 214. The catheter fitting 225 is configured to selectively couple with a handle fitting 239 of the handle 230 wherein a fluid-tight seal is provided between the catheter fitting 225 and the handle fitting 239. In the depicted embodiment, the catheter fitting 225 includes external threads that are threadingly engageable with internal threads of the handle fitting 239. In other embodiments, the catheter fitting 225 and the handle fitting 239 may include any suitable coupling features to enable selective coupling and de-coupling of the catheter 214 to the handle 230. For example, the coupling features may include male and female tapered fittings, snap fit fittings, and bayonet fittings. Other types of coupling features are contemplated within the scope of this disclosure.
The selective coupling of the catheter 214 to the handle 230 allows a user to remove the handle 230 from the catheter 214 and dispose a catheter (e.g., infusion catheter) over the catheter 214 from the proximal end of the catheter 214. For example, in use, the catheter 214 may be inserted into a patient's vessel with the occlusion member positioned at a desired treatment site. The handle 230 can be de-coupled from the catheter 214 and the infusion catheter coaxially disposed over the catheter 214 from the proximal end toward the distal end of the catheter 214. The handle 230 can be re-coupled to the catheter 214, the occlusion member 217 expanded or inflated with a fluid injected through the inflation port 212, and a treatment medicament infused into the patient's vessel proximal to the occlusion member 217 through the infusion catheter.
Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. For example, a method of intravascular treatment may include one or more of the following steps: disposing a catheter occlusion device coaxially over a catheter infusion device; disposing an actuator of the catheter occlusion device in a first position, wherein a seal member seals a bore of an occlusion member evacuation port of the catheter occlusion device; inflating a first expandable occlusion member of the catheter occlusion device with a fluid to occlude a vessel; inflating a second expandable occlusion member of the catheter infusion device with a fluid to occlude the vessel; moving the actuator from the first position to a second position, wherein the seal member is displaced to open the bore; and deflating the first expandable occlusion member, wherein the fluid flows from the first expandable occlusion member into the bore and out a distal end of the occlusion member evacuation port. Other steps are also contemplated.
In the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
The phrases “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component.
The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest to the practitioner during use. As specifically applied to a vessel occluding device of this disclosure, the proximal end of the device refers to the end nearest to the handle and the distal end refers to the opposite end, the end nearest to the vent port.
“Fluiid” is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.
References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially equivalent” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely equivalent configuration.
The terms “a” and “an” can be described as one, but not limited to one. For example, although the disclosure may recite a housing having “a connector,” the disclosure also contemplates that the housing can have two or more connectors.
Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints.
Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element.
The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.
This application claims priority to U.S. Provisional Application No. 63/383,330, filed on Nov. 11, 2022 and titled, “Dual Balloon Catheter Infusion System,” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63383330 | Nov 2022 | US |
