1. Technical Field
This application relates to a vascular filter and more particularly to a vein filter for capturing blood clots within the vessel.
2. Background of Related Art
Passage of blood clots to the lungs is known as pulmonary embolism. These clots typically originate in the veins of the lower limbs and can migrate through the vascular system to the lungs where they can obstruct blood flow and therefore interfere with oxygenation of the blood. Pulmonary embolisms can also cause shock and even death.
In some instances, blood thinning medication, e.g. anticoagulants such as Heparin, or sodium warfare can be given to the patient. These medications, however, have limited use since they may not be able to be administered to patients after surgery or stroke or given to patients with high risk of internal bleeding. Also, this medication approach is not always effective in preventing recurring blood clots.
Therefore, surgical methods to reduce the likelihood of such pulmonary embolisms by actually blocking the blood clot from reaching the lungs have been developed. One surgical method of treatment involved major surgery where the size of the vessel lumen was restricted by placement of ligatures or clips around the vein, e.g. the inferior vena cava which transports blood from the lower portion of the body to the heart and lungs. This prevented passage of dangerously large blood clots through the vein to the lungs. However, this approach is an invasive surgical procedure, requiring an abdominal incision and general anesthesia and frequently causing vessel thrombosis and lower extremity swelling. Also, there is a lengthy patient recovery time and additional hospital and surgeon expenses associated with this major surgery. In fact, oftentimes, the patients requiring the surgery are unhealthy and the major surgery and general anesthesia poses a risk in and of itself.
To avoid such invasive surgery, less invasive surgical techniques have been developed. These involve the placement of a mechanical barrier in the inferior vena cava. These barriers are in the form of filters and are typically inserted through either the femoral vein in the patient's leg or the right jugular vein in the patient's neck or arm under local anesthesia. The filters are then advanced intravascularly to the inferior vena cava where they are expanded to block migration of the blood clots from the lower portion of the body to the heart and lungs.
These prior filters take various forms. One type of filter is composed of coiled wires such as disclosed in U.S. Pat. Nos. 5,893,869 and 6,059,825. Another type of filter consists of legs with free ends having anchors for embedding in the vessel wall to hold the filter. These filters are disclosed, for example, in U.S. Pat. Nos. 4,688,553, 4,781,173, 4,832,055, and 5,059,205, 5,984,947 and 6,007,558. Another type of filter is disclosed in U.S. Pat. No. 6,214,025 consisting of wires twisted together to form a cylindrical anchoring portion conforming to the inner vessel wall surface to exert a radial force and a conical filtering portion.
Several factors have to be considered in designing vein filters. One factor is that the filter needs to be securely anchored within the vessel wall, while avoiding traumatic engagement and damage to the wall as well as damage to the neighboring abdominal aorta. Another factor is that the filter must be collapsible to a sufficiently small size to be easily maneuvered and atraumatically advanced intravascularly to the inferior vena cava or other target vessel. Thirdly, the filter should direct the blood clots to the center of the vessel to improve dissolution of the clot within the vessel by the blood flow.
It would be advantageous to provide a vein filter that satisfies the foregoing parameters. Namely, such vein filter would advantageously have sufficient anchoring force to retain the filter within the vessel while providing atraumatic contact with the vessel wall, would have a minimized insertion (collapsed) profile to facilitate delivery through the vascular system to the surgical site, and would enable migration of the captured blood clots to the center of the vessel. Moreover, it would also be advantageous to provide a filter that could simplify insertion through the femoral or the right jugular vein or arm into the inferior vena cava.
Additionally, the need for a vein filter in many patients is temporary. In these instances it would be advantageous to provide a vein filter that satisfies the foregoing factors and in addition could be readily removed from the patient. It would further be advantageous if the filter could be removed minimally invasively, e.g. intravascularly.
The present invention overcomes the problems and deficiencies of the prior art. The present invention provides a vessel filter movable between a collapsed position for delivery to the vessel and an expanded position for placement within the vessel. The first region of the filter has a first set of struts forming a first mounting portion and a first filter portion opening in a first direction. The filter portion has a converging region at a first portion to direct particles toward the center of the filter and the mounting portion is flared in the expanded position to have a transverse dimension increasing toward a second portion opposite the first portion. The second region has a second set of struts forming a second mounting portion flared in the expanded position and opening in the first direction. A plurality of spaced apart struts extend between the first and second regions.
In one embodiment, one or more of the struts terminates in a vessel engaging hook. In one embodiment, the filter is formed from a laser cut tube and composed of shape memory material. In one embodiment, adjacent struts of the filter portion of the first set of struts are interconnected.
In one embodiment, the second region includes a retrieval region including a hook having a cutout exposing an internal annular surface dimensioned to receive a portion of a retrieval sheath.
The present invention also provides a vessel filter comprising a body, cut from a tube, having a first region and a second region and movable between a collapsed position for delivery to the vessel and an expanded position for placement within the vessel. The first region of the filter has a first set of spaced apart struts forming a first filter portion having a first converging region and a first mounting region for mounting the filter. The second region is formed by a second set of spaced apart struts forming a second mounting region for mounting the filter. The second set of struts are positioned distal of the first set of struts. The first and second set of struts are connected by at least one longitudinally extending strut and both sets of struts are oriented in a first direction.
One or more of the struts may include vessel engaging members to enhance retention of the filter. In one embodiment, adjacent struts are joined by a connecting strut.
The present invention also provides a vessel filter movable between a collapsed position for delivery to the vessel and an expanded position for placement within the vessel. The first region has a first set of struts having a first mounting portion and a first filter portion opening in a first direction and having a first converging region at a first portion to direct particles toward the center of the filter. The second region has a second set of struts having a second mounting portion. Adjacent struts of the first set of struts are interconnected by strut portions extending towards one another. In one embodiment, struts of the first set of struts terminate in vessel engaging members.
Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
Turning now to the drawings, wherein like reference numerals identify similar or like components throughout the several views, the vein filter of the present invention is described for placement within the inferior vena cava to capture blood clots or other particles which could otherwise pass to the lungs.
The filter is movable from a low profile collapsed configuration to facilitate insertion through the delivery sheath to a larger expanded placement configuration to enable atraumatic engagement with the vessel walls to secure (mount) the filter within the inferior vena cava. The filter has a substantially bell-shaped region having a filtering region (portion/section) and a flared mounting (anchoring) region (portion/section). As described in more detail below, the filtering portion has inwardly directed struts, terminating in a converging region, thereby directing particles toward the central axis of the filter. By directing the particles to the center and trapping them at the center, they will be exposed to greater blood flow than if trapped at the edges of the filter, thereby improving dissolution of the particles. The flared mounting portion provides less contact area than a straight region, resulting in less tissue ingrowth to facilitate removal of the filter if desired. The flare also reduces the chance of vessel distortion if inserted into a curved vena cava. To enhance mounting of the filter, a second mounting region is provided axially spaced from the bell-shaped region. This second region provides a stabilizing portion to help center the filter and limit tilting.
Turning now to details of the filter of a first embodiment of the present invention and with initial reference to
The collapsed configuration of filter 10 reduces the overall profile to facilitate delivery to the site. The diameter of filter 10 in the collapsed configuration is represented by reference D1 and preferably is about 2 mm and more preferably about 1.7 mm. Other dimensions are also contemplated. The filter is thus preferably dimensioned for insertion through a 6 French delivery system or 6 French catheter. The diameter or transverse dimensions of the filter in the expanded placement configurations is greater than the diameter or transverse dimension D1 in the collapsed (delivery) configuration.
Struts 30 are spaced apart as shown and extend at an angle away from the longitudinal axis L of filter 10 in region 35 to provide a flare. Preferably, this angle or taper is about 10 degrees, although other dimensions are contemplated. In the filtering region 32, beginning at an intermediate portion of the filter (the transition between the regions 35, 32) the struts 30 extend inwardly to the longitudinal axis at an angle to the respective tubular portion 19 thereby forming an angle with the longitudinal axis. That is, filtering section 32 extends from the flared region toward the central longitudinal axis L of the filter 10 and converges at portion 34 into tubular portion 19. For clarity, not all of these sections of each strut 30 are labeled in the drawings, it being understood that the non-labeled struts have the same configurations.
Struts 50 are spaced apart as shown and extend at an angle preferably about 60 degrees (other dimensions are contemplated) away from the longitudinal axis L of filter 10. The struts 50 extend outwardly from the longitudinal axis at an angle to the tubular portion 18, thereby forming an angle with the longitudinal axis, and then curve outwardly at a lesser angle to provide mounting portions. The struts 50 are preferably flared. The struts 50 can have an elongated mounting surface to engage the vessel wall.
In the embodiment of
In the illustrated embodiment, when expanded, the six struts 50 and the six struts 30 are shown spaced approximately 60 degrees apart. It is also contemplated that a fewer or greater number of struts could be provided and spacing other than 60 degrees be provided. The struts 50 can also be radially offset from the struts 30, e.g., by 30 degrees. It is also contemplated that struts 50 can have a larger transverse dimension than struts 30.
In the expanded placement configuration, a portion of each elongated strut 30 and 50 has an outer surface 31, 51 respectively, for engagement with the vessel wall to help retain the filter 10 in position in the vessel. This region is angled with respect to the longitudinal axis. The outer surface 31, 51 of struts 30, 50 could be roughened to enhance engagement. Alternatively, a plurality of cutouts, atraumatic tabs, barbs or other penetrating members (not shown) can extend from the outer surface of one or more of the struts to engage the vessel wall to retain the filter.
As can be appreciated, the tubular portion 11 connects the struts 30 and 50. As shown in
With continued reference to
In the illustrated embodiment, the hooks of filter 10 in region 17 are of two different sizes. More specifically, a first set of hooks 60a is larger than a second set of hooks 60b. Preferably, when formed in a laser cut tube, hooks 60a are formed so that they occupy a region equivalent to the transverse dimension of two adjacent struts. For example, in the collapsed configuration, hook 60a occupies a region (dimension) of two struts while smaller hook 60b would only occupy the region (dimension) of one strut. Smaller hooks 60b are spaced axially inwardly with respect to larger hooks 60a to minimize the collapsed profile (transverse dimension) of the filter when collapsed for insertion. Hooks 60b are also preferably spaced axially with respect to each other. In this preferred embodiment, smaller hooks 60b occupy the space created by the larger hooks 60a so they can be considered as nesting within larger hooks 60a (see
It should be appreciated that the hooks or other vessel engaging structure can be placed on both sets of struts 30, 50 or alternatively be placed only on struts 30 or only on struts 50 or placed on fewer than all the struts of the particular set of struts.
A recess or cutout can be provided at the tubular end portion 18 to receive a snare or other device for removal. In the preferred embodiment, a hook 92 at tubular portion 18 is illustrated and is configured to receive a snare.
Hook 90 has a curved hook 92 at the proximalmost end. Hook 92 is configured to receive a retrieval snare or other retrieval device. A portion of the wall of the hook 90 is cut out to expose the annular interior surface 94 (see
Filter 100 has a filtering region (portion/section) 119 and a flared anchoring (mounting) region (portion/section) 121 in first region 112, forming a bell shape. The mounting region 121 is of greater transverse dimension than the respective filtering region 119. Flared region 121 is preferably at an angle of about 10 degrees with respect to the longitudinal axis of the filter, although other angles are contemplated. In this flared region 121, the transverse dimension increases towards the anchoring end of the region 112 so that as in the other embodiments disclosed herein, the end of the filter at region 119 has a smaller transverse dimension than at the opposing end at the respective flared regions 121. The filtering region 119 extends from the flared region 121 toward the longitudinal axis of the filter 100 and converges at portion 132 into tubular portion 129. Longitudinally extending struts 130 connect the two sets of axially spaced struts 114, 154. Providing fewer longitudinal struts 130 is also contemplated.
Filtering region 119 preferably has six struts 114 curving outwardly from tubular portion 129. Each filter strut or strut portion 114 extends radially from tubular portion 129 and divides into two connecting filter struts or strut portions 114a, 114b (preferably of equal width) that angle away from each other (in different directions) to extend to the connecting strut portion of an adjacent strut 114. Thus, connecting strut portion 114a of one strut 114 interconnects with the connecting strut portion 114b of an adjacent strut at joining or connecting region 114d. This forms closed geometric shapes 125, preferably substantially diamond shaped in configuration. For clarity, not all of the identical parts are labeled in the drawing. In the illustrated embodiment, preferably six struts are provided forming twelve interconnecting struts, however a different number of struts and closed geometric shapes can be provided. Also, fewer than all of the struts could be interconnected. Also, although preferably the struts 114 divide into connecting struts 114a, 114b of half the width of the undivided strut 114, the struts can bifurcate to form connecting struts of other dimensions. It is also contemplated that fewer than all of the struts can be interconnected.
After convergence of strut portions 114a, 114b at joining region 114d, it transitions into elongated mounting strut portions 114c which form flared mounting or anchoring region 121. The length of the strut portions 114c in the anchoring region 121 can vary, with increased/decreased length increasing the flexibility/rigidity of the struts. The thickness of the strut portions can also vary to affect flexibility/rigidity.
Struts 154 of filter 100 are preferably identical to struts 50 of
Preferably, the strut portions 114c terminate in hooks 140a, 140b identical to hooks 60a, 60b of
Filter 100 can also preferably have a retrieval hook, such as hook 115 formed in tubular portion 118 which is identical to hook 92 of
The region 219 of filter 200 where the struts 214 interconnect (join) differs from filter 100. In filter 200, the struts 214 bifurcate into connecting strut portions 214a, 214b that angle away from each other. The connecting struts are joined to connecting struts of adjacent struts at joining region 223. Thus, closed geometric shapes 228 are formed as shown. Six such closed geometric shapes 228 are preferably formed, each connecting adjacent struts, although fewer closed shapes are contemplated if fewer than all the struts are interconnected. Thus, stated in other words, as in the embodiment of
Although shown divided into equally dimensioned struts, as with the other embodiments described herein, the struts can bifurcate into connecting struts of varying dimension.
In the alternate embodiment of
Note the designations of longitudinal, angled, connected, joined connecting strut, interconnected, etc. in the illustrated embodiments described herein refer to the same integral strut and are divided into such regions for ease of understanding.
In the placement (expanded) configuration, the filter of the present invention moves towards its memorized position and the extent it returns to its fully memorized position will be dependent on the size of the vessel in which the filter is inserted. (The larger the vessel, the closer the filter comes to returning to its fully memorized position.)
To enable movement between an expanded and collapsed configuration, the filter tube of the embodiments described herein is preferably made of shape memory metal material, such as Nitinol, a nickel titanium alloy, or elgiloy. The memorized configuration of the filter 10 is shown in
In alternate embodiments of the foregoing filters, the strut width can vary. For example, the struts can be wider at the flared region than at the filtering portion. This is preferably achieved by removing material to create the thinner portions. These thinner portions increase the flexibility of the filter for forming the angled and curved portions upon deployment. Alternatively, the filter can have struts which are thinner, rather than wider, at the flared region than at the angled and curved regions of the filtering portion. This would provide more stability at the curved regions. The adjustment of the widths is designed to strike a balance between stability and flexibility of the various regions of the filter. Thus, other width variations are contemplated such as making multiple width changes within each strut and/or in different struts.
The filter 10 (and other filters described herein) can be inserted through the jugular vein in the neck of the patient or through the femoral vein in the leg of the patient or the arm. The filters can also be placed in the superior vena cava. It can also be removed from access through the inferior vena cava or through the internal jugular vein.
To facilitate removal of the filter from the vessel, cold saline can be injected onto the implanted filter or within the retrieval sheath to change the temperature of the filter to move it to a relatively softer condition to facilitate the filter being drawn into the retrieval sheath. That is, injection of cold saline will cause the filter to approach its martensitic state, bringing the filter to a more flexible condition. The flexible condition facilitates the collapse and withdrawal of the filter into the retrieval sheath by decreasing the frictional contact between the filter and the inner surface of the retrieval sheath.
While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. For example, the filters can be inserted in other regions of the body. Also, any of the aforedescribed filters can have mounting sections of varying thickness. The foregoing filters can be made of materials other than shape memory material. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.
Number | Date | Country | |
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60613362 | Sep 2004 | US |
Number | Date | Country | |
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Parent | 13039471 | Mar 2011 | US |
Child | 14583637 | US | |
Parent | 11219433 | Sep 2005 | US |
Child | 13039471 | US |