CA2208345A1 - Vena caval filter - Google Patents
Vena caval filterInfo
- Publication number
- CA2208345A1 CA2208345A1 CA002208345A CA2208345A CA2208345A1 CA 2208345 A1 CA2208345 A1 CA 2208345A1 CA 002208345 A CA002208345 A CA 002208345A CA 2208345 A CA2208345 A CA 2208345A CA 2208345 A1 CA2208345 A1 CA 2208345A1
- Authority
- CA
- Canada
- Prior art keywords
- filter
- catheter
- blood vessel
- outer catheter
- distal end
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/011—Instruments for their placement or removal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
Abstract
A coaxial filtering device (10) for removing particles from arteries and veins comprises an outer catheter (14) that can be inserted into a blood vessel, and an inner catheter (17) with a filter at its distal end. The filter (13) is a radially expandable receptacle made of an elastic mesh structure of spring wires or plastic mono-filaments. The filter (13) expands into engagement with the walls of the blood vessel when it is pushed from the distal end of the outer catheter. A syringe (22) is attached to the proximal end (19) of the inner catheter (17), and particles entrapped within the filter (13) are aspirated through the inner catheter (17) into the syringe (22). When filtering is no longer necessary, the filter (13) can easily be removed by pulling the elastic material through the outer catheter (14).
Description
CA 02208345 l997-06-l9 WO 96/19941 PCT/US9~/16792 VENA CAVAL ~ILTER
Field of the Invention This invention relates gene~lly to a device for filtPring blood in a blood vessel, and more particularly, to a radially-Pxp~nd~hle filtering device for temporary use in the vena cava, for example during orthopedic surgery and after long bone fractures.
Back~round of the Invention During joint replacement :jUl~l,y such as total hip arthroplasty, emboli in the form of lllallOW fat, m~ ry bony debris and cement are released into the patient's bloodstream. These emboli may be released into the inferior vena cava (IVC) in large qll~ntities during the relocation of the prosthetic femoral head into the acetabular component, which sends a shower of embolic debris into the cardiopulmonary circulation.
The emboli have detrimental effects due to both mech~nic~l pulmonary arterial blockage and potentially cardiosuppressive activity, thus requiring the emboli to be filtered.
Conventional blood filte.ring devices are designed primarily to filter relatively large blood clots and to be perm~nPntly placed within the blood vessel. The majority of these filters include an anchoring device to prevent migr~rion of the filter after placement. Once the filtering device is positioned within the blood vessel, the device is perrn~3nP,nt An example of such a blood clot filtering device is disclosed in U.S. Pat.
No. 4,619,246 issued October 28, 1986 to Molgaard-Nielsen et al. This reference Y discloses a collapsible filter receptacle adapted to be introduced into a blood vessel for the purpose of ellLld~illg thrombi and emboli in the patient's blood. The Molgaard-Nielsen device has a plurality of anchoring legs secured to the filter receptacle. The free end of each anchoring leg is bent outwardly tO ~orm a hook. When the filter receptacle is CA 0220834~ 1997-06-19 WO 96119941 PCT/US95~16792 positioned within the blood vessel, each hook penetrates into the wall of the vessel to hold the filter receptacle in position, thus ~l~m~ing the vessel wall. Similar examples are shown in U.S. Pat. No. 5,242,462 issued September 7, 1993 to El-Nounou et al. and more recently U.S. Pat. No. 5,324,304 issued June 28, 1994 to l~m~ en There are several disadvantages to a perm~n~ntly placed filter. First, some types, if not correctly seated in the IVC, have a m~rk~lly decreased filtt-rin~ ab~lity, thus neces~it~ting placement of a second filter. Second, the filter may ~ccllm~ te so much clot as to occlude the entire vena cava, a circumstance which occurs in up to 19% of cases.
Third, the rate of rupture of the IVC may be as high as 15 % due to erosion of l:he vessel wall by the anchoring hooks of the filter. Fourth, if removal becomes n~cesc~ry, it almost always must be done surgically; moreover. removal may greatly damage the vessel because over time the filter's struts become endoth( li~li7ecl by the interior wall oi the vena cava. Fifth, a patient with a permanent filter must take anticoagulant me lic~tiott for life.
These disadvantages are regrettable since the placement of the filter in the vein is usually only nPces~ry for a limited ti~ne, corresponding to the period during which there is a real risk of embolism.
A technique has been developed for temporarily placing a removable vena caval filter so that it can be withdrawn at a later time. For this, a c~thPt~r remains inserted in the vein after the filter is deployed and projects from the body at the introduction site. Unlike the prior art, this f~ter is capable of being flushed while positioned within the blood vessel. Rec~llse the catheter projects from the skin, it conctitllt~s a potential source of infection.
Another technique is disclosed in U.S. Pat No. 5,300,086 issued April 5, 1994 to Gory et al. In the Gory reference, the ç~theter is cut outside the jugular vein, crimped to seal the proximal end and sutured just below the surface of the skin. This technique significantly reduces the risk of infection. UnfiJlLun~Lely, the catheter, which is relatively rigid is uncomfortable for the patient. Moreover, as with the prior art, the filter is incapable of being flushed while positioned within the blood vessel.
Another technique is disclosed in U.S. Pat. No. 5,102,415 issued April 7, 1992 to Guenther et al. This reference discloses a triple c~theter having a rec~ptacle at t the distal end of an intermediate catheter and a suction device at the proximal end for ting in the removal of debris during placement of the receptacle within the blood vessel. However, the receptacle is covered with an elastic coating or membrane and thus is in~p~hle of filtPring blood in the conventional sense. Thus, the receptacle is not a f~ter for emboli but only a receptacle for relatively large blood clots. Furthermore, the Guenther reference requires the use of an inflatable balloon attached to the distal end of the inner c~thPtPr, which forces the clot into the receptacle. l~e intçrm~1i~t~ and inner S c~th~ters must then be completely removed from the outer c~theter to remove the blood clot. The receptacle of the Guenther reference does not filter the blood and must be completely removed from the patient's body to remove the blood clot.
Sun~nary of the Invention Accordingly, it is an object of the present invention to provide a temporary vena caval filter for filt~Prin~ emboli and thrombi.
Another object of the present invention is to provide an improved vena caval filter capable of being flushed while positioned within the blood vessel.
Still another object of the present învention is ~o provide a vena caval filtering device which does not become endothPl;~li7ecl and thus ~tt~hP~ to the interior vena cava wall.
A still further object of the invention is to provide a vena caval f~ter which requires no hooks or the like that may tend to injure the vessel wall.
Yet another object is to provide a vena caval filter which is autom~ti~lly seated correctly after it has been deployed.
In carrying out the above and other objects of the present invention, there is provided a filtering device preferably comprising inner and outer catheters each having proximal and distal ends, and a self-çxp~n-1in~ filter ~tt~chç~l at the distal end of the inner catheter. The filter is made of a mesh-like m~t.ori~l through which blood can flow when it is deployed and which can be collapsed by pressure so that it can be pulled through the outer catheter when the filter is no longer n~edecl.
Brief Description of the Draw;n~
A FIG. 1 is a diagr~mm~tic view of a human body illustrating use of a vena caval filter device in accordance with the preferred embodiment of the invention.
FIG. 2 is an enlarged view, partially in section, of the filter device in its retracted state.
FIG. 3 is a view, partially in section. of the filter device in its exp~n~led state.
CA oi20s34~ 1997-06-lg wo 96/19941 PCT/US95/l6792 FIG. 4 is a view, partially in section, of the filter device in its exr~n~1e~
state showing particles being aspirated through the inner c~thPtPr into the SUCtiOIl device.
Detailed Description of the Preferred Embodiment Referring to the drawings, a ~l~re;lrt;d venal caval filter device 10 is shown in accordance with the present invention in its deployed condition wherein emboli and/or thrombi 11 (Fig. 4) are filtered from the inferior venal caval 12 using a f~ter 13. The filter device 10 comprises a sheath or outer c~thP.ter 14 having proximal and distal ends 15 and 16, respectively, and a coaxial inner c~thP.ter 17 which is slidable axially within a through lumen 18 of the outer C~ rlP.I 14. The inner c~tl~P.ter 17, having proximal and distal ends 19 and 20, respectively, in~ludes a through lumen 21 and is connec~P~ at its proximal end 19 to a suction device, preferably a syringe 22, for reasons explained below.
The filter 13 comprises a mesh-like, collapsible basket connected to the distal end 20 of the inner catheter 17 in such a way that when it is deployed (opened), the patient's blood can flow past the open filter 13 to the patient's heart (see arrow 29). After deployment, the m~teri~l 11 to be filtered is aspirated through the lumen 21 of lhe inner catheter 17 by means of the syringe 22, which is connPctçd to a port 24 at the proximal end 19 of the inner c~thPter 17.
The construction of the filter 13 is not critical and various dirrelclll constructions may be used in accordance with the invention. What is necessary is that the filter be self-exr~ntling so that when it is released from the outer ç~thPtP.r 14, it expands into contact with the vena cava and, of course, that it be made of a m~teri~l which when exr~ncle-l will block the particles of concern. The filter must also be capable of being compressed by contact with the outer c~thPt~Pr so that it can be withdrawn after the need for filtering no longer exists.
M~tP.ri~l~s which are suitable for use as a filter in accordance with this invention have been proposed for use as self-exr~n~ing stents. One such construction is shown in U.S. Patent No. 4,655,771 which is incorporated herein by reference. The stent A
disclosed in that patent is a radially and axially flexible, elastic tubular body made of a multiplicity of thread elements defining a radially self-Pxr~n~ing helix. The thread elements may be metallic or plastic as described in the patent. When radial pressure is applied to such a self-expanding helix, the diameter is decreased which, in the case of the WO 96119941 PCTJ~JS9SJ16792 s invention, means that the ~i~meter of the filter can be decreased sllfficiently so that it will fit within the outer c~ ler 14 when co~ t;ssed.
The proximal end 15 of the outer c~theter 14 is connPcted to a hub 30 which inclndes a side port 32 and a locking diaphram 34 through which the inner c~theter 5 17 extends. This type of hub is collve-~ n~l The proximal end of inner c~lllrlPI 17 may be attached to a syringe 22 by a luer lock (not numbered) so that a negative pressure can be applied to c~thPter 17 as descrihe(l below. When locking diaphram 34 is loosened, the inner catheter 17 can be moved axially relative to the outer c~thPter 14. When diaphram 34 is locked, the inner ç~th~ter 17 is held in position within a fluid tight seal. The side 10 port 32 can be connected to a syr;nge 36 co.~ E a hepr~ni7~1 saline solution which can be forced under pressure through the outer c~thPtPr 14 after the filter 13 has been e~cr~n~1e~ ~1tPrn~tively, a pres~llri7eA IV bag may be conn~ctP~l to side port 32 to provide a continuous flow of h~~ ed saline solution between the c~thPtPrs. This prevents clots from acc~lm~ tin~ in the space between the two ç~thPters 17 and 14.
Preferably, the filter 13 and the inner c~thPtPr 17 are loaded into the outer catheter 14 during m~mlf~c*lre so that the entire assembly can be positioned in the patient's blood vessel. Referring to FIGS. 1 and 2, to position the f~ter 13 properly within the blood vessel 12, the distal end 16 of the outer c~thPter 14 is inserted within the right internal jugular vein of the patient preferably using a Seldinger needle and guidewire 20 as is well known in the art. The outer c~ll.rLe~ 14 may include a suitable marker (not shown) at its distal end 16 to enable its position to be ~let~rminpd fluoroscopically so that the operator knows when the distal end 16 of ç~thPter 14 has been advanced to the i~lfld~ al portion of the inferior vena cava 12.
When the device is properly positioned, as detPrminPd fluoroscopically, the 25 diaphram 34 is released and the inner catheter 17 advanced. As the inner catheter 17 is advanced, the filter 13 starts to exit from the distal end of the outer c~tllpter 14, causing the filter to deploy autom~ti~lly as the ~ E pressure of the outer catheter is removed. When the filter is fully deployed as shown in Figs. 3 and 4, the distal portion 27 of the filter expands into light contact with the inner surface 25 of the Vena Cava 12.
30 This self-exp~n~inE action causes the filter to be seated correctly and retains the filter in position within the blood vessel without resort to hooks or the like which might tend to injure the vessel. Once exr~n~lpd~ particles 11 in the blood which flows through the filter 13 will be entrapped by the filter.
CA 0220834~ 1997-06-19 WO 96/19941 PCT/US95l16792 Although, in the ~lt;r~ ed embo-liment7 the physician will receive the device with the inner cAthPtPr 17 and filter 13 loaded within the outer cAthPter 14, it is possible to provide the cAthPter~ as separate components in which case the inner cAth~ter 17 and filter 13 would be threaded through the outer cAthPter 14 after the outer çAt~Pter 5 has been positioned within the patient's blood vessel.
The filter may be deployed by pushing the inner CAI1-~'lPI 17 so as to expel the filter from the stationary outer c~thPt~Pr 14 or it may be deployed by pulling the outer catheter 14 while holding the inner catheter 17 stationary. In either case, once the filter braid is free of the constraint of the outer cAthPter 14, it will expand into a funnel-like 10 shape, expansion of the proximal portion of the filter being prevented by its ~ttAchment to the distal end of the inner catheter 17. In this condition, the filter 13 will prevent the undesired emboli and thrombi from passing into the aorta.
If the filter is made by the braiding process described in Patent No.
4,655,771, particularly using metal filAment~, the distal end of the filter may be enclosed 15 in a protective rim to prevent injury to the walls of the blood vessel, and re~uce the possibility of snagging as the filter is moved relative to the outer c~thPter 14.
Referring to FIG. 4, as the filter 13 collects emboli and thrombi 11, the syringe 22 may be used to provide a suction force that aspirates the particles 11 from the filter 13 through the lumen 21 of the inner catheter 17 and into the syringe 22, where they 20 may be safely disposed.
The suction provided by the syringe 22 within the lumen 21 has a greater force than the force from the rate of blood flow. Thus, the blood is directed into the lumen 21 with sufficient force to flush the particles 11 from the mesh of the filter 13 into the lumen 21 and into the syringe 22. This process can be performed repeatedly during 25 the surgery when the buL~ of the particles 11 will be dislodged into the vena cava 12.
Thus, the filter 13 may be flushed repeatedly without the need to remove the filter 13 from the blood vessel 12 since the flllshing or suction force is provided by the syringe 22 located outside the patient.
The shape of the filter 13 is important. In the plerell~d embo-lirnent7 the 30 funnel-like or inverted umbrella shape enables the filter 13 to be compressed by pulling on the inner catheter 17 causing the mesh-like material of the filter 13 to contact the distal end 16 of the outer catheter 14. Continued pressure causes the filter 13 to collapse or CA 02208345 l997-06-l9 WO 96/19941 PCT/US9~i~16792 compress to the condition shown in Figure 2. In this condition, the filter 13 can easily be removed after there is no longer a need for the filter 13.
While the embodiment of the invention shown and described is fully capable of achieving the results desired, it is to be understood that this embodiment has been 5 shown and described for purposes of illllstr~ti~n only and not for purposes of limit~ticn.
Therefore, the invention is limited only by the appended claims.
Field of the Invention This invention relates gene~lly to a device for filtPring blood in a blood vessel, and more particularly, to a radially-Pxp~nd~hle filtering device for temporary use in the vena cava, for example during orthopedic surgery and after long bone fractures.
Back~round of the Invention During joint replacement :jUl~l,y such as total hip arthroplasty, emboli in the form of lllallOW fat, m~ ry bony debris and cement are released into the patient's bloodstream. These emboli may be released into the inferior vena cava (IVC) in large qll~ntities during the relocation of the prosthetic femoral head into the acetabular component, which sends a shower of embolic debris into the cardiopulmonary circulation.
The emboli have detrimental effects due to both mech~nic~l pulmonary arterial blockage and potentially cardiosuppressive activity, thus requiring the emboli to be filtered.
Conventional blood filte.ring devices are designed primarily to filter relatively large blood clots and to be perm~nPntly placed within the blood vessel. The majority of these filters include an anchoring device to prevent migr~rion of the filter after placement. Once the filtering device is positioned within the blood vessel, the device is perrn~3nP,nt An example of such a blood clot filtering device is disclosed in U.S. Pat.
No. 4,619,246 issued October 28, 1986 to Molgaard-Nielsen et al. This reference Y discloses a collapsible filter receptacle adapted to be introduced into a blood vessel for the purpose of ellLld~illg thrombi and emboli in the patient's blood. The Molgaard-Nielsen device has a plurality of anchoring legs secured to the filter receptacle. The free end of each anchoring leg is bent outwardly tO ~orm a hook. When the filter receptacle is CA 0220834~ 1997-06-19 WO 96119941 PCT/US95~16792 positioned within the blood vessel, each hook penetrates into the wall of the vessel to hold the filter receptacle in position, thus ~l~m~ing the vessel wall. Similar examples are shown in U.S. Pat. No. 5,242,462 issued September 7, 1993 to El-Nounou et al. and more recently U.S. Pat. No. 5,324,304 issued June 28, 1994 to l~m~ en There are several disadvantages to a perm~n~ntly placed filter. First, some types, if not correctly seated in the IVC, have a m~rk~lly decreased filtt-rin~ ab~lity, thus neces~it~ting placement of a second filter. Second, the filter may ~ccllm~ te so much clot as to occlude the entire vena cava, a circumstance which occurs in up to 19% of cases.
Third, the rate of rupture of the IVC may be as high as 15 % due to erosion of l:he vessel wall by the anchoring hooks of the filter. Fourth, if removal becomes n~cesc~ry, it almost always must be done surgically; moreover. removal may greatly damage the vessel because over time the filter's struts become endoth( li~li7ecl by the interior wall oi the vena cava. Fifth, a patient with a permanent filter must take anticoagulant me lic~tiott for life.
These disadvantages are regrettable since the placement of the filter in the vein is usually only nPces~ry for a limited ti~ne, corresponding to the period during which there is a real risk of embolism.
A technique has been developed for temporarily placing a removable vena caval filter so that it can be withdrawn at a later time. For this, a c~thPt~r remains inserted in the vein after the filter is deployed and projects from the body at the introduction site. Unlike the prior art, this f~ter is capable of being flushed while positioned within the blood vessel. Rec~llse the catheter projects from the skin, it conctitllt~s a potential source of infection.
Another technique is disclosed in U.S. Pat No. 5,300,086 issued April 5, 1994 to Gory et al. In the Gory reference, the ç~theter is cut outside the jugular vein, crimped to seal the proximal end and sutured just below the surface of the skin. This technique significantly reduces the risk of infection. UnfiJlLun~Lely, the catheter, which is relatively rigid is uncomfortable for the patient. Moreover, as with the prior art, the filter is incapable of being flushed while positioned within the blood vessel.
Another technique is disclosed in U.S. Pat. No. 5,102,415 issued April 7, 1992 to Guenther et al. This reference discloses a triple c~theter having a rec~ptacle at t the distal end of an intermediate catheter and a suction device at the proximal end for ting in the removal of debris during placement of the receptacle within the blood vessel. However, the receptacle is covered with an elastic coating or membrane and thus is in~p~hle of filtPring blood in the conventional sense. Thus, the receptacle is not a f~ter for emboli but only a receptacle for relatively large blood clots. Furthermore, the Guenther reference requires the use of an inflatable balloon attached to the distal end of the inner c~thPtPr, which forces the clot into the receptacle. l~e intçrm~1i~t~ and inner S c~th~ters must then be completely removed from the outer c~theter to remove the blood clot. The receptacle of the Guenther reference does not filter the blood and must be completely removed from the patient's body to remove the blood clot.
Sun~nary of the Invention Accordingly, it is an object of the present invention to provide a temporary vena caval filter for filt~Prin~ emboli and thrombi.
Another object of the present invention is to provide an improved vena caval filter capable of being flushed while positioned within the blood vessel.
Still another object of the present învention is ~o provide a vena caval filtering device which does not become endothPl;~li7ecl and thus ~tt~hP~ to the interior vena cava wall.
A still further object of the invention is to provide a vena caval f~ter which requires no hooks or the like that may tend to injure the vessel wall.
Yet another object is to provide a vena caval filter which is autom~ti~lly seated correctly after it has been deployed.
In carrying out the above and other objects of the present invention, there is provided a filtering device preferably comprising inner and outer catheters each having proximal and distal ends, and a self-çxp~n-1in~ filter ~tt~chç~l at the distal end of the inner catheter. The filter is made of a mesh-like m~t.ori~l through which blood can flow when it is deployed and which can be collapsed by pressure so that it can be pulled through the outer catheter when the filter is no longer n~edecl.
Brief Description of the Draw;n~
A FIG. 1 is a diagr~mm~tic view of a human body illustrating use of a vena caval filter device in accordance with the preferred embodiment of the invention.
FIG. 2 is an enlarged view, partially in section, of the filter device in its retracted state.
FIG. 3 is a view, partially in section. of the filter device in its exp~n~led state.
CA oi20s34~ 1997-06-lg wo 96/19941 PCT/US95/l6792 FIG. 4 is a view, partially in section, of the filter device in its exr~n~1e~
state showing particles being aspirated through the inner c~thPtPr into the SUCtiOIl device.
Detailed Description of the Preferred Embodiment Referring to the drawings, a ~l~re;lrt;d venal caval filter device 10 is shown in accordance with the present invention in its deployed condition wherein emboli and/or thrombi 11 (Fig. 4) are filtered from the inferior venal caval 12 using a f~ter 13. The filter device 10 comprises a sheath or outer c~thP.ter 14 having proximal and distal ends 15 and 16, respectively, and a coaxial inner c~thP.ter 17 which is slidable axially within a through lumen 18 of the outer C~ rlP.I 14. The inner c~tl~P.ter 17, having proximal and distal ends 19 and 20, respectively, in~ludes a through lumen 21 and is connec~P~ at its proximal end 19 to a suction device, preferably a syringe 22, for reasons explained below.
The filter 13 comprises a mesh-like, collapsible basket connected to the distal end 20 of the inner catheter 17 in such a way that when it is deployed (opened), the patient's blood can flow past the open filter 13 to the patient's heart (see arrow 29). After deployment, the m~teri~l 11 to be filtered is aspirated through the lumen 21 of lhe inner catheter 17 by means of the syringe 22, which is connPctçd to a port 24 at the proximal end 19 of the inner c~thPter 17.
The construction of the filter 13 is not critical and various dirrelclll constructions may be used in accordance with the invention. What is necessary is that the filter be self-exr~ntling so that when it is released from the outer ç~thPtP.r 14, it expands into contact with the vena cava and, of course, that it be made of a m~teri~l which when exr~ncle-l will block the particles of concern. The filter must also be capable of being compressed by contact with the outer c~thPt~Pr so that it can be withdrawn after the need for filtering no longer exists.
M~tP.ri~l~s which are suitable for use as a filter in accordance with this invention have been proposed for use as self-exr~n~ing stents. One such construction is shown in U.S. Patent No. 4,655,771 which is incorporated herein by reference. The stent A
disclosed in that patent is a radially and axially flexible, elastic tubular body made of a multiplicity of thread elements defining a radially self-Pxr~n~ing helix. The thread elements may be metallic or plastic as described in the patent. When radial pressure is applied to such a self-expanding helix, the diameter is decreased which, in the case of the WO 96119941 PCTJ~JS9SJ16792 s invention, means that the ~i~meter of the filter can be decreased sllfficiently so that it will fit within the outer c~ ler 14 when co~ t;ssed.
The proximal end 15 of the outer c~theter 14 is connPcted to a hub 30 which inclndes a side port 32 and a locking diaphram 34 through which the inner c~theter 5 17 extends. This type of hub is collve-~ n~l The proximal end of inner c~lllrlPI 17 may be attached to a syringe 22 by a luer lock (not numbered) so that a negative pressure can be applied to c~thPter 17 as descrihe(l below. When locking diaphram 34 is loosened, the inner catheter 17 can be moved axially relative to the outer c~thPter 14. When diaphram 34 is locked, the inner ç~th~ter 17 is held in position within a fluid tight seal. The side 10 port 32 can be connected to a syr;nge 36 co.~ E a hepr~ni7~1 saline solution which can be forced under pressure through the outer c~thPtPr 14 after the filter 13 has been e~cr~n~1e~ ~1tPrn~tively, a pres~llri7eA IV bag may be conn~ctP~l to side port 32 to provide a continuous flow of h~~ ed saline solution between the c~thPtPrs. This prevents clots from acc~lm~ tin~ in the space between the two ç~thPters 17 and 14.
Preferably, the filter 13 and the inner c~thPtPr 17 are loaded into the outer catheter 14 during m~mlf~c*lre so that the entire assembly can be positioned in the patient's blood vessel. Referring to FIGS. 1 and 2, to position the f~ter 13 properly within the blood vessel 12, the distal end 16 of the outer c~thPter 14 is inserted within the right internal jugular vein of the patient preferably using a Seldinger needle and guidewire 20 as is well known in the art. The outer c~ll.rLe~ 14 may include a suitable marker (not shown) at its distal end 16 to enable its position to be ~let~rminpd fluoroscopically so that the operator knows when the distal end 16 of ç~thPter 14 has been advanced to the i~lfld~ al portion of the inferior vena cava 12.
When the device is properly positioned, as detPrminPd fluoroscopically, the 25 diaphram 34 is released and the inner catheter 17 advanced. As the inner catheter 17 is advanced, the filter 13 starts to exit from the distal end of the outer c~tllpter 14, causing the filter to deploy autom~ti~lly as the ~ E pressure of the outer catheter is removed. When the filter is fully deployed as shown in Figs. 3 and 4, the distal portion 27 of the filter expands into light contact with the inner surface 25 of the Vena Cava 12.
30 This self-exp~n~inE action causes the filter to be seated correctly and retains the filter in position within the blood vessel without resort to hooks or the like which might tend to injure the vessel. Once exr~n~lpd~ particles 11 in the blood which flows through the filter 13 will be entrapped by the filter.
CA 0220834~ 1997-06-19 WO 96/19941 PCT/US95l16792 Although, in the ~lt;r~ ed embo-liment7 the physician will receive the device with the inner cAthPtPr 17 and filter 13 loaded within the outer cAthPter 14, it is possible to provide the cAthPter~ as separate components in which case the inner cAth~ter 17 and filter 13 would be threaded through the outer cAthPter 14 after the outer çAt~Pter 5 has been positioned within the patient's blood vessel.
The filter may be deployed by pushing the inner CAI1-~'lPI 17 so as to expel the filter from the stationary outer c~thPt~Pr 14 or it may be deployed by pulling the outer catheter 14 while holding the inner catheter 17 stationary. In either case, once the filter braid is free of the constraint of the outer cAthPter 14, it will expand into a funnel-like 10 shape, expansion of the proximal portion of the filter being prevented by its ~ttAchment to the distal end of the inner catheter 17. In this condition, the filter 13 will prevent the undesired emboli and thrombi from passing into the aorta.
If the filter is made by the braiding process described in Patent No.
4,655,771, particularly using metal filAment~, the distal end of the filter may be enclosed 15 in a protective rim to prevent injury to the walls of the blood vessel, and re~uce the possibility of snagging as the filter is moved relative to the outer c~thPter 14.
Referring to FIG. 4, as the filter 13 collects emboli and thrombi 11, the syringe 22 may be used to provide a suction force that aspirates the particles 11 from the filter 13 through the lumen 21 of the inner catheter 17 and into the syringe 22, where they 20 may be safely disposed.
The suction provided by the syringe 22 within the lumen 21 has a greater force than the force from the rate of blood flow. Thus, the blood is directed into the lumen 21 with sufficient force to flush the particles 11 from the mesh of the filter 13 into the lumen 21 and into the syringe 22. This process can be performed repeatedly during 25 the surgery when the buL~ of the particles 11 will be dislodged into the vena cava 12.
Thus, the filter 13 may be flushed repeatedly without the need to remove the filter 13 from the blood vessel 12 since the flllshing or suction force is provided by the syringe 22 located outside the patient.
The shape of the filter 13 is important. In the plerell~d embo-lirnent7 the 30 funnel-like or inverted umbrella shape enables the filter 13 to be compressed by pulling on the inner catheter 17 causing the mesh-like material of the filter 13 to contact the distal end 16 of the outer catheter 14. Continued pressure causes the filter 13 to collapse or CA 02208345 l997-06-l9 WO 96/19941 PCT/US9~i~16792 compress to the condition shown in Figure 2. In this condition, the filter 13 can easily be removed after there is no longer a need for the filter 13.
While the embodiment of the invention shown and described is fully capable of achieving the results desired, it is to be understood that this embodiment has been 5 shown and described for purposes of illllstr~ti~n only and not for purposes of limit~ticn.
Therefore, the invention is limited only by the appended claims.
Claims (3)
1. A filtering device for removing particles from a blood vessel, comprising:
an outer catheter having distal and proximal ends;
an inner catheter for insertion through said outer catheter, said inner catheter having distal and proximal ends and a through lumen, and being movable relative to said outer catheter;
a filter attached to said distal end of said inner catheter, said filter being made of a radially expandable material which can be compressed by said outer catheter, whereby said filter will expand into contact with the blood vessel when said filter extends from said distal end of said outer catheter; and
an outer catheter having distal and proximal ends;
an inner catheter for insertion through said outer catheter, said inner catheter having distal and proximal ends and a through lumen, and being movable relative to said outer catheter;
a filter attached to said distal end of said inner catheter, said filter being made of a radially expandable material which can be compressed by said outer catheter, whereby said filter will expand into contact with the blood vessel when said filter extends from said distal end of said outer catheter; and
2. The filtering device of claim 1. further comprising clamping means arranged at said proximal end of said inner and outer catheters for locking said inner and outer catheters together to prevent an unintended axial displacement of said inner and outer catheters relative to each other.
3. A method for filtering particles from blood in a blood vessel of a patient comprising the steps of:
introducing an outer catheter into the blood vessel;
advancing said outer catheter to a desired location within the blood vessel;
guiding an inner catheter having a contracted filter distally attached to said inner catheter to said desired location within said outer catheter, said inner catheter having a suction means proximally attached;
positioning said filter at a desired location beyond said distal end of said outer catheter whereby said filter expands radially within the blood vessel;
aspirating the particles from within said filter by applying suction to said inner catheter; and withdrawing the filter from the blood vessel by pulling it through said outer catheter.
introducing an outer catheter into the blood vessel;
advancing said outer catheter to a desired location within the blood vessel;
guiding an inner catheter having a contracted filter distally attached to said inner catheter to said desired location within said outer catheter, said inner catheter having a suction means proximally attached;
positioning said filter at a desired location beyond said distal end of said outer catheter whereby said filter expands radially within the blood vessel;
aspirating the particles from within said filter by applying suction to said inner catheter; and withdrawing the filter from the blood vessel by pulling it through said outer catheter.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/362,835 US5549626A (en) | 1994-12-23 | 1994-12-23 | Vena caval filter |
US08/362,835 | 1994-12-23 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2208345A1 true CA2208345A1 (en) | 1996-07-04 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002208345A Abandoned CA2208345A1 (en) | 1994-12-23 | 1995-12-26 | Vena caval filter |
Country Status (5)
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US (1) | US5549626A (en) |
EP (1) | EP0798983A4 (en) |
JP (1) | JPH11501227A (en) |
CA (1) | CA2208345A1 (en) |
WO (1) | WO1996019941A1 (en) |
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-
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- 1994-12-23 US US08/362,835 patent/US5549626A/en not_active Expired - Fee Related
-
1995
- 1995-12-26 CA CA002208345A patent/CA2208345A1/en not_active Abandoned
- 1995-12-26 EP EP95944382A patent/EP0798983A4/en not_active Withdrawn
- 1995-12-26 JP JP8520553A patent/JPH11501227A/en active Pending
- 1995-12-26 WO PCT/US1995/016792 patent/WO1996019941A1/en not_active Application Discontinuation
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EP0798983A1 (en) | 1997-10-08 |
US5549626A (en) | 1996-08-27 |
WO1996019941A1 (en) | 1996-07-04 |
JPH11501227A (en) | 1999-02-02 |
EP0798983A4 (en) | 1999-01-13 |
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Legal Events
Date | Code | Title | Description |
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FZDE | Discontinued |