Arterial occlusion implant and delivery catheter and methods
Inventors
Gupta, Ajay • Torres, Enio Perez • Shafer, Joshua Dean • Sundin, Camden Schneider • Awes, Samuel Benjamin • Urbanski, Kenneth Patrick
Assignees
Boston Scientific Scimed Inc • University of Minnesota System
Publication Number
US-12364485-B2
Publication Date
2025-07-22
Expiration Date
2042-12-01
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Abstract
An artery can be occluded by implanting an occlusion implant within a subintimal space within a wall of the artery. As an example, a catheter having a side port just proximal of an inflatable balloon disposed near a distal end of the catheter can be advanced through the artery to a site at which an occlusion is desired. The inflatable balloon can be inflated and a guidewire can be advanced through a lumen of the catheter, out of the side port and into a subintimal space of the artery, with the inflated inflatable balloon guiding the guidewire towards the artery wall. An occlusion implant can be advanced over the guidewire into the subintimal space and the guidewire can be withdrawn, leaving the occlusion implant positioned within the subintimal space.
Core Innovation
The invention provides a method and assembly for occluding an artery by implanting an occlusion implant within a subintimal space of the artery wall. This is achieved by advancing a catheter through the artery to a target site, wherein the catheter includes a side port located just proximal to an inflatable balloon near its distal end. The balloon is inflated to guide a puncture guidewire through a lumen and out the side port into the subintimal space. An occlusion implant is then advanced over the puncture guidewire into this space, and the guidewire is withdrawn, leaving the implant in place to occlude the artery.
The catheter design includes features such as a central guidewire lumen allowing advance over a guidewire, an inflatable balloon to assist in guiding the puncture guidewire into the subintimal space, and a side port for guidewire and implant deployment. The occlusion implant is designed to be rod-shaped with a lumen extending through it to facilitate delivery over the puncture guidewire, and may be made from hydrophilic or biosorbable materials that can swell after absorbing fluid to produce temporary or permanent occlusion.
A further embodiment includes a first catheter with an inflatable balloon on one side and a trap door on the opposite side, which, upon inflating the balloon and withdrawing an initial guidewire, exposes a lumen through which a second guidewire can be advanced into the subintimal space. Over this second guidewire a second catheter and then an occlusion implant can be advanced into the subintimal space. This assembly and method are adapted for precise placement and controlled occlusion of the artery.
The problem addressed by this invention is the need for safe, controlled, and effective techniques to occlude arteries either temporarily or permanently. Prior art devices and methods for arterial access and intervention have limitations regarding selective occlusion within the artery wall, especially in cases requiring minimization of thrombus formation and control over occlusion duration and degree. The invention seeks to provide improved tools and methods for interventional therapy where artery occlusion is desired for treating various medical conditions.
Claims Coverage
The patent includes two independent methods of occluding an artery and a method of an assembly adapted for delivering an occlusion implant to a subintimal space. The main inventive features revolve around catheter design, guidewire usage, delivery mechanisms, and occlusion implant characteristics.
Method for artery occlusion using a catheter with a side port and inflatable balloon
Advancing a catheter with a side port proximal to an inflatable balloon to a targeted artery site; inflating the balloon to guide a puncture guidewire through the side port into the subintimal space; advancing an occlusion implant over this guidewire into the subintimal space; and withdrawing the guidewire leaving the implant positioned to occlude the artery.
Sequential method of occlusion using a first catheter with trap door and second catheter with occlusion implant
Advancing a first guidewire beyond the occlusion site; advancing a first catheter with a device lumen, inflation lumen, an inflatable balloon on one side, and a hinged trap door on the opposite side; inflating the balloon to push the catheter towards the artery wall; withdrawing the first guidewire to allow the trap door to drop into the lumen; advancing a second guidewire through the trap door into the subintimal space; advancing a second catheter over the second guidewire through the trap door into the subintimal space; withdrawing the second guidewire; and advancing an occlusion implant through the second catheter to permanently occlude the artery.
The claims cover inventive methods involving specialized catheter systems with inflatable balloons and side ports or trap doors for accessing the subintimal space, using puncture guidewires and delivery catheters to accurately place occlusion implants made of materials capable of expanding or being bioabsorbed to achieve temporary or permanent artery occlusion.
Stated Advantages
Allows controlled and precise implantation of occlusion devices within a subintimal space to achieve artery occlusion.
Use of inflatable balloons facilitates guiding the puncture guidewire and positioning the occlusion implant effectively.
Occlusion implants made from hydrophilic and/or bioabsorbable materials can provide temporary or permanent occlusion with reduced thrombus formation risk.
The assembly allows gradual constriction of blood flow, reducing harmful acute side effects.
Designs enable minimally invasive delivery via guidewire lumens and catheter systems suited for tortuous vasculature.
The approach can be used to redirect blood flow or reduce flow to treat various medical conditions with fewer off-target effects.
Documented Applications
Reducing blood flow to the spleen for conditions such as splenomegaly or thrombocytopenia.
Reducing blood flow to allow healing of gastro-intestinal ulcers and to stop bleeds in trauma.
Bariatric artery embolization for weight loss.
Gastric artery embolization prior to radioembolization procedures using yttrium Y-90.
Prostate artery embolization to reduce prostate size.
Geniculate artery embolization for pain reduction.
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