All of the material in this patent document is subject to copyright protection under the copyright laws of the United States and other countries. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in official governmental records but, otherwise, all other copyright rights whatsoever are reserved.
1. Field of the Invention
Embodiments of the present invention relate to a vascular filter for protection during surgery. In certain embodiments, the present invention relates specifically to systems and methods involving angioplasty and/or stenting to protect against loose embolic material or other debris.
2. Description of the Related Art
Angioplasty and stenting are performed to remove obstructions or blockages in arteries and thereby alleviate life-threatening conditions. The procedures may result in a fracturing or disintegration of the obstructing material and if the resulting particles, or debris, were permitted to flow downstream within the circulatory system, they can cause blockages in smaller arteries, or their microscopic branches termed the microcirculation, downstream of the treatment site. The result can be new life-threatening conditions, including stroke.
Various systems and techniques exist to remove debris from the circulatory system, including temporarily obstructing the artery by means such as a balloon and then suctioning debris and blood from the treatment site. While such techniques can effectively solve the problem stated above, they require that blood flow through the artery be obstructed, causing complete cessation or at least a substantial reduction in blood flow volume, during a time period which can be significant for organ or cell survival.
Filters have also been used to collect debris in the vascular system. The filters are generally inserted before the procedure to trap debris and then closed and removed with the trapped debris after the procedure. Multiple problems exist for filters in use today. One problem is that debris can escape a filter from the proximal end (opening) when the filter is closed for removal.
Another issue that arises focuses on debris that may be squeezed through the holes of the filter when the filter is closed. Another problem is that the size and/or inflexibility of the filter prevent the filters from being used in distal sections or peripheral arteries of the body. For example, a filter used in the carotid artery is unable to be used in a peripheral artery located in the foot. Another problem is that filters are fixed as to make it impossible for an additional device to enter the filter for additional treatment such as flushing or suction. Another problem is that the length and/or rigidity of the filters cause the filter poorly fit in strong bent arteries and thus be deformed or have gaps between the wall of the artery and the filter.
Another problem is that the length of filters cause the filters to be placed further away from the lesion. Another problem is that unwanted movement by the person holding the guideline for the filter may cause an unwanted influence in orientation or geometry of the filter. Another problem is that the membrane of the filter is thin and fragile and may tear during use, thus preventing from a sufficient number of holes being made in the membrane for filtering.
The instant apparatus and system, as illustrated herein, is clearly not anticipated, rendered obvious, or even present in any of the prior art mechanisms, either alone or in any combination thereof. A versatile system, method and series of apparatuses for creating and utilizing a vascular filter for protection during surgery. Thus the several embodiments of the instant apparatus are illustrated herein.
It is an object of the instant system to introduce a series of systems and methods involving angioplasty and/or stenting which protect against loose embolic material and other debris.
It is an object of the instant system to introduce a system including a filter with a membrane, a frame and a rod and the filter includes a self-expanding cylindrical nitinol stent.
It is an object of the instant system to introduce a system utilizing a distally disposed ring that slides on the rod at a distal end.
It is an object of the instant system to introduce a system utilizing a vascular filter for protection during surgery.
There has thus been outlined, rather broadly, the more important features of the versatile vascular filter for protection during surgery embodiments in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto.
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
These together with other objects of the invention, along with the various features of novelty, which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention.
Advantages of the present invention and better understanding will be apparent from the following detailed description of exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings, in which:
a is an example membrane of the filter in
b is an example membrane in
a is an example strut connectors of the frame in
b shows a front view of the strut connector in
c shows a side view of the strut connector in
d shows a top view of the strut connector in
a is an example of the frame in
b is an example of the frame in
Embodiments of the present series of apparatuses, systems and interrelated methods pertain to a vascular filter for protection during surgery. In certain embodiments, the present series of apparatuses, systems and interrelated methods relate specifically to systems and methods involving angioplasty and/or stenting to protect against loose embolic material or other debris. Throughout the description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without some of these specific details. In other instances, well-known structures and devices are shown in generic form to avoid obscuring the underlying principles of the present invention.
The rod 103 may have a flexible, radio opaque distal tip to allow maneuverability within a blood vessel. In one embodiment, the rod is 0.35 mm in diameter and a guidewire for the person inserting the filter 100. In another embodiment, the rod diameter ranges from 0.01 mm to 15 mm or any range within this range. The filter 100 may be housed by a sheath 104 (e.g., a tube) during insertion. In one embodiment, the tube 104 is used during the procedure as a suction or flushing device in order to remove debris from the filter 100. Furthermore, in one embodiment the system may utilize a 0.018 mm guidewire.
a and 2b are photographs of an example membrane of the filter in
In one embodiment, the free moving fibers 302 are fine ultra high molecular weight polyethylene fibers with high flexibility and extreme tensile strength and a thickness of approximately 50 microns. When expanded, the strut section 301 fits to the artery wall and leave the proximal entrance of the filter 100 open. In one embodiment, the struts are a shape memory alloy, such as nitinol, and the frame 102 is opaque to radio signals. Radio opacity of the frame 102 may be enhanced by a coating. For example, a gold-coating of 3 microns thickness may be applied to the frame 102 so that the status of deployment of the filter 100 is well visible on X-ray.
In one embodiment, the dimensions of the frame are a length of 7 mm and an external diameter of 0.7 mm collapsed and 7 mm expanded. In another embodiment, the external diameter may range from 0.1 mm collapsed to 20 mm expanded or any range within this range. The rod 103 may include a mechanical stop 306 to engage the guide ring 304 of the frame 102 or the distal ring (307 of
In one embodiment, the guide ring 304 allows inclusion of an additional device, such as a suction tube, into the filter 100 in order to suction it empty and thus prevent a pile-up of debris. In another embodiment, the free moving fibers 302 allow the insertion of such device.
One embodiment of attaching the struts 301 to free moving fibers 302 is the strut connectors 303.
As previously stated, in one embodiment, the frame 102 includes reinforcement fibers 305 connected to the membrane 101. Since the membrane may be thin and pliable, reinforcement fibers 305 are connected to the membrane 101 in order to prevent cracking or separation of the membrane 101 from the frame 102. In one embodiment, the fibers 305 are wrapped around the frame struts 301 and then embedded into the membrane 101 to prevent accidental detachment from the frame 102. An example connection of the reinforcement fiber 305 to the strut 301 is illustrated in
The reinforcement fibers 305 may be from a multitude of materials, but one example reinforcement fiber is a fine multifilament fiber of high molecular weight polyethylene. In one embodiment, the tensile strength of the fiber exceeds 3000 mega Pascal (MPa) and flexible. In one embodiment, the flexibility of the fiber is limited in the length direction such that the maximum increase in length is approximately 3%. The fibers retain the properties of flexibility and tensile strength after thousands of cycles of use. The reinforcement fibers 305 also allow the membrane 101 to wrap around debris without squeezing during closure of the filter 100. The reinforcement fibers 305 also receive the tensile stress from the rod 103 when removing the filter 100 from a sheath 104 and pull the membrane 101 into place.
The size, flexibility, and expandability of the filter 100 allow for the filter 100 to be used in multiple size blood vessels, including large arteries, such as the carotid artery or aorta, to peripheral arteries, such as those found in distal limbs of the body (e.g., the foot or hand).
a illustrates the struts 301 of the frame while in the sheath 104. The frame 104 is compressed into a small diameter for easy insertion into the blood vessel.
In one embodiment, the strut section of frame 102 of the filter 100 may be collapsed without changing the shape of the membrane 101.
Embodiments of the invention may include various processes or components as set forth above. It will be apparent to one skilled in the art that not all components or processes are required, and the processes described for insertion and extraction of the filter may be in different order. In addition, while the filter has been described in terms of being used in the vascular system, other uses of the filter exist.
For example, the filter may be used in various piping not associated with the human body, the gastrointestinal system, the respiratory system, and/or other fluid conduits. In another example, while the reinforcement fibers are shown as lying longitudinally and approximately parallel to the rod, the reinforcement fibers may be any network or pattern, including a randomly oriented network. In another example, while the membrane is described as being stretched like an umbrella, reinforcement fibers may be fused with or be a shape memory alloy (e.g., nitinol) so as to control the shape the membrane. In another example, expandable or deformable frames are used.
In another example, while the filter is described as being attached, other devices may be attached to the sheath or rod. In an embodiment, additional proximal fibers are attached to such devices. Examples include removable temporary stents, occlusion devices, grafts, valves, clips, retrieval bags, inflatable members, devices for body tissue replacement and delivery platforms for drugs, radiation or gene therapy.
In another example, while a sheath is described as a tube, a sheath may include, but is not limited to, a ring to compress the frame, a latch attached to the struts to lock the frame in a compressed state, an at least one Micro Electrical Mechanical (MEM) motor or other motor to open and close the frame, or the frame being a piezoelectric material in order to compress when an electric current is introduced. In another example, while the frame is described as including a stent structure, the frame may alternatively include a plurality of crossbeams attached to the rod in order to open the membrane for filtering. In another example, while the strut connector is described as including an anchor shape structure, many shapes may be utilized, including a loop or a hook.
In another example, while a mechanical means is described for inserting, opening and removing the filter, the filter may be opened by other means including, but not limited to, fluid pressure to open the membrane for filtering or pressure from the artery wall to trigger opening of the filter. In a further example, while a radio opaque material is described for coating the frame for tracking the location of the filter, other materials may coat or be embedded in the material of the frame or filter including, but not limited to, a slight radioactive material that emits energy (e.g., through doping of the metal or coating) or a photo luminescent material to reflect light shined on the filter. In another example, while fibers are described as being polyethylene, other materials including metal, textiles, glass, or plastics may be used. In addition, while fibers are described, other means including threads or rope may be used. In another embodiment, while debris is described as embolic material, debris may be any material unwanted (e.g., foreign object) and thus to be removed.
In another example, removing the filter while the membrane is open is described, other removal means may occur including the membrane being closed and/or compressed to wrap around trapped debris during removal. In another example, while rings are described for engaging a stop, other engagement means may exist including, but not limited to, a hook, nub, protrusion, or friction surface.
In additional embodiments, much like
For purposes of summarizing the invention and the advantages achieved over the prior art, certain objects and advantages of the invention have been described herein above. Of course, it is to be understood that not necessarily all such objects or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. All of the herein described embodiments are intended to be within the scope of the invention herein disclosed.
This applications takes priority from and claims the benefit of U.S. Provisional Patent application Ser. No. 61/930,667 filed on Jan. 23, 2014, the contents of which are herein incorporated by reference.
Number | Date | Country | |
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61930667 | Jan 2014 | US |