US20150335415A1 - Intravenous filter with guidewire and catheter access guide - Google Patents
Intravenous filter with guidewire and catheter access guide Download PDFInfo
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- US20150335415A1 US20150335415A1 US14/819,258 US201514819258A US2015335415A1 US 20150335415 A1 US20150335415 A1 US 20150335415A1 US 201514819258 A US201514819258 A US 201514819258A US 2015335415 A1 US2015335415 A1 US 2015335415A1
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- filter
- wire
- filter wire
- dispenser
- vascular
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- 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
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
- A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
-
- A61F2002/011—
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- 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
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
-
- 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
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
-
- 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
- A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Surgical Instruments (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
A vascular filter system and method are disclosed. In one embodiment, the filter system comprises a dispensing needle, a guidewire and a catheter releasably attached to a filter dispenser which stores a length of filter wire. The filter wire dispenser has a guide tube which guides the filter wire into the catheter and then into a vein during surgical implantation. The filter wire is configured to form into a predetermined shape as it is deployed from the needle. The shape of the filter wire captures blood clots in the blood stream. The filter wire may be configured with a perforated section and a non-perforated section. Perforations are in fluid communication with an inner hollow lumen in the filter wire.
Description
- This application is a continuation in part of U.S. patent application Ser. No. 12/012,136 filed on Jan. 30, 2008 titled IMPROVED INTRAVENOUS DEEP VEIN THROMBOSIS FILTER AND METHOD OF FILTER PLACEMENT, which claims priority to U.S. Provisional Patent Application No. 60/898,939 filed on Jan. 31, 2007 titled IMPROVED INTRAVENOUS DEEP VEIN THROMBOSIS FILTER AND METHOD OF FILTER PLACEMENT.
- 1. Field
- The disclosed embodiments relate to vascular filters and, in particular to surgically implanted vascular filters which capture blood clots to prevent the clots from migrating to other regions of the circulatory system.
- 2. Related Art
- Deep vein thrombosis (DVT) is a common problem and causes significant morbidity and mortality in the United States and throughout the world. DVT is the formation of a blood clot within a deep vein, predominantly in the legs. These blood clots typically occur due to slow or reduced blood flow through the deep veins such as when the patient cannot ambulate or otherwise efficiently circulate their blood. Another cause of inefficient circulation may be due to structural damage to the veins resulting from general trauma or surgical procedures. Additionally, a blood clot may form in a deep vein due to a particular medical condition or a propensity for the patient to have a hypercoaguability state. For example, a woman on birth control who smokes has an increased risk of forming blood clots and is thus predisposed to DVT.
- The result and clinical significance of DVT is when the clot breaks free from its location in the deep vein of the leg. The clot travels through the circulatory system and may eventually lodge in a location that is adverse to the patient's health. For example, the clot may dislodge from a location in the deep vein of the patient's leg and migrate through the heart and come to rest in the patient's lung causing a pulmonary embolism (PE) resulting in the restricted circulation of blood in the lungs. PE may cause sudden death for the patient. As many as 600,000 cases of clinically significant Pulmonary Embolus occur and result in approximately 200,000 deaths annually in the United States.
- DVT & PE are currently prevented in several ways including anticoagulation therapy, thrombectomy, thrombolysis and inferior vena cava filter (IVC filter) placement. Anticoagulation therapy utilizes various medications that reduce the patient's propensity for forming blood clots. However, this form of therapy has the disadvantage that due to the patient's inability to form blood clots (due to the medication), there is an increased risk of excessive bleeding should the patient become injured, sustain surgical complications, or develop internal hemorrhaging.
- Thrombectomy is a procedure generally performed for treatment of a PE, in which a blood clot is extracted from the vein using a surgical procedure or by way of an intravenous catheter and a mechanical suction device. This form of treatment is risky and technically very difficult because the catheter has to be steered or navigated to a specific location in order to extract the clot. Additionally, during a thrombectomy there is an increased risk of causing vascular damage due to the surgical procedure and use of various mechanical devices.
- Thrombolysis is a medical technique that is performed for treatment of a PE, in which various medicines are infused into the region of the clot that subsequently causes the clot to dissolve. This form of treatment has the disadvantage that the medication may cause bleeding at other sites such as within the brain. For example, if a patient has previously had a minute non-clinical stroke, the medication used in a thrombolysis may cause a previously healed vessel to bleed within the patient's head.
- IVC filter placement is usually conducted by surgically installing a filter in a large bore vein (such as the inferior vena cava) in the patient's upper abdomen. The IVC filter is placed using a large bore catheter (Introducer Catheter) for delivery of the filter. Typically, a removable IVC filter is utilized based on FDA recommendations to remove the IVC filter once protection from PE is no longer needed. In the case where a removable filter is utilized, additional complications arise when the filter must be removed.
- The removable IVC filter is generally placed for a time period of a several weeks to a few months to prevent internal vascular scaring. However, removal of the IVC filter is technically challenging and requires large bore access. In practice, the removable IVC filter is captured by first accessing a large bore vein, using a large bore catheter to approach the filter, capturing the tip of the filter using a “snaring device” that is deployed through the large bore catheter, then pulling the filter into the catheter, and then the large bore catheter (with the filter therein) is removed from the patient. This procedure is very challenging, and requires increased patient recovery time.
- Current IVC filter placement has several disadvantages such as increased costs, requires the use of special surgical procedures such as fluoroscopy or cardiology labs, requires a team (lab technician, nurse, and physician) of medical professionals, and requires a second substantially difficult surgical procedure for filter removal. Additionally, the IVC filter placement procedure requires that the patient's coagulation status be sufficient to withstand the surgical procedure. For example, if the patient has medical condition (liver failure) or is on medications that prevents their blood from clotting (i.e., using anticoagulation therapy) there is a substantial risk of excessive bleeding during the procedure. Also, existing IVC filter placement procedures are of questionable practicality for preventative placement because of the intrusive surgical procedures that must be performed to place the filter. Correspondingly, the risks (particularly filter removal) must be balanced between the need for the filter and the patient's ability to endure the surgical procedure.
- Other complications may also arise from existing IVC filters. For example, despite FDA recommendations, the retrieval rate of IVC filters is very low given the complexity of the procedure to remove the filters. When the filters remain in the body, there is the possibility of filter fracturing and migrating into other parts of the body. Further, the filter may perforate the wall of the vein, and may even perforate into adjoining tissues or organs.
- As a result, there is a need in the art for a vascular filter that is inexpensive, facilitates placement by a physician at a convenient patient location (bedside), allows non-intrusive removal that can be performed at any location by either a physician or trained technician while having minimal recovery time and eliminating the need to determine the coagulation status of the patient. The method and vascular filter described herein enables a physician to place and remove the filter with minimal physical intrusion and at the same time reducing risk of procedural complications for the patient.
- To overcome the drawbacks of the prior art and provide additional benefits and features, a vascular filter and method of filter placement is disclosed. In one embodiment, the vascular filter includes a dispensing needle releasably attached to a syringe and a filter wire dispenser. Generally, the needle has two ends, a delivery end and a coupling end. The delivery end is placed within a vein and allows filter wire to be implanted into the vein. The coupling end allows the needle to be releasably connected to a filter wire dispenser or syringe.
- The filter wire dispenser stores a length of filter wire which is configured to coil upon deployment from the delivery end of the needle into a vein. The filter wire dispenser may store the filter wire as a spool or linearly, and includes a guide tube sized to insert into the needle. The guide tube is used to guide the filter wire from the dispenser into the needle.
- The filter wire may be configured to coil upon deployment in a number of ways. One way is to put residual stresses, surface tensions, or both into the filter wire such that, once deployed, the filter wire will coil into a predetermined shape as defined by the stresses and surface tensions in the filter wire. The filter wire may be configured to coil into a vortex type, nested, or tangled web shape as desired. In addition, the filter wire of some embodiments may have a flexible tip to better prevent damage to the interior walls of a vein.
- Once deployed a portion of the filter wire may be left protruding from the patient to allow the filter to be fixed in position. The protruding portion of the filter wire may be secured to a fixation device attached to the patient's skin. In one or more embodiments, the fixation device may have a portion configured to engage and secure the filter wire such as a protrusion.
- The vascular filter, in one embodiment, is implanted by accessing a vein with a needle, attaching a filter wire dispenser storing a length of filter wire to the needle, and advancing the filter wire through the needle such that the filter wire exits the delivery end of the needle. In one or more embodiments, the filter wire has two ends, a first end and a second end. In one embodiment the first end of the filter wire exits the dispenser first. As the filter wire exits the needle into the vein, it begins to coil, as described above, to form a vascular filter.
- Once the vascular filter is fully deployed the needle may be removed. In one or more embodiments, a portion of the filter wire is left protruding out of the patient so that it may be secured to a fixation device which generally covers the exist passage of the filter wire.
- In some embodiments, proper access to a vein may be verified prior to implanting the filter. One way to verify that the needle is accurately located in a vein is to attach a syringe to the needle and draw blood from the vein to confirm the needle is indeed properly within the vein. The needle is improperly placed if no blood can be drawn. Once verified, the syringe may be removed from the needle while leaving the needle in the vein. A filter wire dispenser may then be attached and the filter wire implanted subsequently.
- The vascular filter may be removed when desired or when no longer needed. In one embodiment, the vascular filter is removed by removing the filter wire from its associated fixation device and drawing the filter wire out of the patient. As the filter wire is drawn out of the patient, the filter wire unwinds itself so that it may be easily removed.
- In one embodiment a vascular filter system as described herein is provided with medication infusion capability. In such an embodiment the filter wire is configured to coil within or around the filter wire dispenser and further configured for coiled deployment from the filter wire dispenser to a patient, the filter wire comprising an open first end connected to a hub assembly. The filter wire includes an inner lumen within the filter wire in fluid communication with the open first end. The filter wire also includes a perforated section and a non-perforated section. Two or more infusion ports are in the perforated section such that the two or more infusion ports are in fluid communication with the inner lumen of the filter wire. A hub assembly is at the open first end such that the hub assembly is configured to surround at least a portion of the non-perforated section of the filter wire and selectively open and close the inner lumen to control the flow of medication into the perforated portion of the filter wire.
- In one configuration the infusion ports are holes in the perforated section of the filter wire which establish the inner lumen in fluid communication with the blood stream. The hub assembly may comprise a luer lock. In one embodiment the hub assembly is configured to mate with a syringe to accept an administration of medication into the inner lumen of the filter wire.
- Also disclosed is a vascular filter system that includes a length of filter wire having a first end and a second end. In this embodiment the length further includes a non-perforated section at the first end with an opening at the first end that is part of an inner passageway within the filter wire. A perforated section connects the non-perforated section and the second end such that the perforated section is configured to coil to form a filter upon deployment from the delivery end of the dispensing needle. Also part of this embodiment are two or more perforations in the perforated section that are in fluid communication with the inner lumen. A hub assembly is releasable connected near the first end of the filter wire and is configured to selective open and close the inner lumen.
- In one variation the vascular filter system further comprises an antithrombogenic on at least an outer surface of the perforated section. The portion of the filter wire that is within the hub assembly may be resilient.
- Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims.
- The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. In the figures, like reference numerals designate corresponding parts throughout the different views.
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FIG. 1 illustrates a typical blood clot lodged within a femoral vein. -
FIG. 2 illustrates an existing inferior vena cava filter and the proximate location of the filter in the upper abdomen. -
FIG. 3 illustrates the inferior vena cava and the two femoral veins. -
FIG. 4 illustrates a common femoral vein prior to access by a needle and syringe assembly. -
FIG. 5 illustrates actual needle and syringe assembly access into the common femoral vein. -
FIG. 6 illustrates removal of the syringe. -
FIG. 7 illustrates attachment of the filter dispenser to the needle. -
FIGS. 8 , 9, 10, and 11 illustrate deployment of the vascular filter. -
FIGS. 12 and 13 illustrate removal of the filter dispenser and needle. -
FIG. 14 illustrates retention of the filter wire to the patient's leg. -
FIG. 15 illustrates a blood clot approaching the deployed vascular filter. -
FIG. 16 illustrates the blood clot ofFIG. 15 trapped by the vascular filter. -
FIGS. 17 , 18A, 18B, 18C, 18D, and 19 illustrate removal of the vascular filter. -
FIG. 20 illustrates an infusible filter and associated hub assembly. -
FIG. 21A illustrates a more detailed view of the infusible filter and hub assembly including a close up of the filter wire with infusing mechanism. -
FIG. 21B illustrates the assembly ofFIG. 21A with the compression element compressed to close the inner lumen of the view of the filter. -
FIG. 22 illustrates a close up view of the perforated section of filter wire with medication outflow holes. -
FIGS. 23 and 24 illustrate the deployment of a guidewire into the common femoral vein. -
FIG. 25 illustrates the deployment of a catheter along the guidewire. -
FIG. 26 illustrates the removal of the guidewire. -
FIG. 27 illustrates the deployment of the vascular filter. -
FIG. 28 illustrates the retention of the filter wire in the patient's leg. -
FIG. 29 illustrates the removal of the vascular filter. -
FIG. 30 illustrates the removal of the catheter. -
FIG. 31 illustrates the deployment of a vascular filter according to a further exemplary embodiment. -
FIGS. 32 and 33 illustrate the removal of the vascular filter shown inFIG. 31 . - In the following description, numerous specific details are set forth in order to provide a more thorough description of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without these specific details. In other instances, well-known features have not been described in detail so as not to obscure the invention.
- One of the primary concerns regarding deep vein thrombosis (DVT) is that should the thrombosis (blood clot) dislodge from the original location, the clot may travel to another region of the circulatory system and cause injury and or death to the subject. For example, if a DVT dislodges it may migrate through the heart and eventually re-lodge in the lung of the subject, thus causing a pulmonary embolism (PE) which prevents adequate circulation and respiration, and can cause sudden death. By placing an intravenous filter in the common femoral vein, the blood clot is captured and prevented from migrating to vulnerable regions of the circulatory system. The filter may be placed in any vein or at any location such that the filter can capture a clot prior to causing damage to the patient. The term vein and vessel are used and defined interchangeably herein.
- Referring now to the drawings,
FIG. 1 illustrates a typical DVT where the commonfemoral vein 100 has ablood clot 102 lodged therein. As theblood clot 102 is formed there is reduced blood flow through the commonfemoral vein 100 because the blood clot begins to obstruct the fluid pathway. The reduced blood flow produces an environment that facilitates clot formation. In particular, as the blood flow is reduced, blood begins to coagulate in the chambers of thevascular valves 104, and, as a result, theblood clot 102 increases in size. -
FIG. 2 illustrates a known inferior vena cava vascular filter that is surgically implanted into the patient's upper abdomen. This inferior vena cava filter (IVC filter) 200 is commonly deployed using a large bore catheter and access to a large bore vein such as the inferior vena cava. TheIVC filter 200 has afirst end 202 and asecond end 204 where the second end comprises a plurality ofindividual wire components 206. In the proximity diagram ofFIG. 2 , anIVC filter 200 is shown within the inferior vena cava atlocation 208 in the upper abdomen of a patient. -
FIG. 3 illustrates theinferior vena cava 300 and two commonfemoral veins 302 branching off the inferior vena cava. In the known use of intravenous filters such as the IVC filter discussed above, it is common to place the IVC filter within theinferior vena cava 300 atlocation 304 in the upper abdomen. - As stated above, placement of an IVC filter within the
inferior vena cava 300 is expensive, requires special surgical procedures, requires imaging from a radiology or cardiology suite to ensure correct placement with the inferior vena cava, and is a substantially difficult and complicated surgery. In addition, known IVC filters must be placed in a large bore vein, and the placement surgery itself poses a significant risk in patients with conditions that prevent proper blood clotting. - The vascular filter in the disclosed embodiments has several advantages over known filters. In contrast to the above, the vascular filter of the disclosed embodiments may be placed within one of the common
femoral veins 302. In addition, the vascular filter may be placed at any other location in the body which is suited to capture or retain blood clots to prevent the clots from migrating to more critical areas. The vascular filter may be placed “blind” without imaging guidance from an expensive radiology or cardiology suite. Furthermore, the vascular filter may be placed in the commonfemoral vein 302 at hip level which is an area routinely used for catheter and other line access. Use of this common access area is another advantage in that such use of a commonly accessed area tends to reduce complexity and risk during placement as it is a well-known access area. - Though placement at hip level has advantages, placement at hip level may not be ideal in all patients and thus the vascular filter may also be placed in other areas. For example, in one embodiment, the filter may be placed in the
groin region 306 of the patient. It is contemplated that the vascular filter may be placed where it is best able to capture a dislodged blood clot and that more than one filter may be placed to ensure that any dislodged blood clots are captured. For example, in one embodiment the vascular filter may be placed in both of the commonfemoral veins 302 should the patient's medical condition require filtration of both legs. In other embodiments, additional vascular filters may be placed as well. - Placement of the vascular filter begins by accessing a common
femoral vein 302. Though the following description describes an embodiment of the present invention where the vascular filter is placed within a commonfemoral vein 302, the vascular filter may be similarly placed in other veins where dislodged blood clots may be captured as necessary. -
FIGS. 4 and 5 illustrate a commonfemoral vein 302 accessed by a dispensingneedle 400 andsyringe 402 assembly. In one or more embodiments, theneedle 400 has a first or delivery end through which a vascular filter is implanted in a patient, and a second or coupling end at which a syringe or filter dispenser may be attached. Notably, the coupling end in one or more embodiments may be configured to permit releasable attachment of theneedle 400 as described further below. - Generally, proper access to the common
femoral vein 302 may be verified by syringe aspiration (drawing blood from the vein into the body of the syringe) and is visually confirmed byblood return 500 into the syringe. In other embodiments, elements other than a syringe may be utilized including, but not limited to a single hollow large bore needle of which the blood can be seen flowing out of without syringe aspiration. - As illustrated in
FIG. 6 , thesyringe 402 may be disengaged or removed from theneedle 400 without removing the needle from the commonfemoral vein 302. In one or more embodiments, proper access to the commonfemoral vein 302 may be confirmed prior to disengaging thesyringe 402 by inspecting the syringe for blood return. Such blood return confirms that theneedle 400 is within a vein. - It is noted that disengagement or removal of the
syringe 402 from theneedle 400 may occur in various ways and that the syringe is releasably attached to the needle. For example, thesyringe 402 may be fitted with a bayonet type of locking mechanism that retains theneedle 400 within the end of the syringe. In addition, any other type of mechanism in addition to or other than a bayonet type locking mechanism may be utilized including but not limited to a manufactured threaded coupling system with “male and female” thread components. The locking mechanism may be any type of configuration that releasably retains the needle in the syringe and because these mechanisms are well known in the art they will not be described in detail so as not to obscure the present invention. - Attachment of the
vascular filter dispenser 700 to theneedle 400 is illustrated inFIG. 7 . In one embodiment, thevascular filter dispenser 700 is a spool device that is configured to house and dispense filter wire housed within the dispenser. Thevascular filter dispenser 700 is fitted with aguide tube 702 that facilitates the deployment of the filter wire from the dispenser through theneedle 400 and into the commonfemoral vein 302. It is contemplated that the end of theguide tube 702 be sized for operative insertion into the inner diameter of theneedle 400. Theguide tube 702 provides a smooth transition for the filter wire during the deployment process as the wire leaves thefilter dispenser 700 and enters theneedle 400. In some embodiments, filter means other than a wire may be utilized such as but not limited to monofilament strand or other materials with reformable properties. These structures may be pre-formed or shaped and/or configured at the time of use. - Reference is now made to
FIGS. 8 through 11 individually and in combination for illustrating the deployment of the vascular filter. As shown inFIG. 8 , aneedle 400 and avascular filter dispenser 700 are coupled together, and the filter dispenser is actuated such that thefilter wire 800 is fed from the dispenser through the needle and into the commonfemoral vein 302. In one embodiment, thefilter dispenser 700 is actuated by a rotational movement of the dispenser so that thefilter wire 800 is un-coiled and fed down theguide tube 702 and into theneedle 400. It is contemplated that thefilter dispenser 700 may comprise a user-rotatable wheel or knob in one or more embodiments. When rotated, the knob un-coils thefilter wire 800 and feeds thewire 800 down theguide tube 702. The knob may un-coil thefilter wire 800 through physical contact with the filter wire. However, it is contemplated that there may be an attached reel which is actuated by rotational movement of knob. Other embodiments of thefilter dispenser 700 are contemplated such as a linear dispenser by which the filter wire is translated down the length of the dispenser and into the needle. - As best illustrated in
FIG. 9 , as thefilter wire 800 traverses down theneedle 400 it remains substantially straight. However, when thefilter wire 800 exits theend 902 of theneedle 400, the filter wire begins to form acoil 900 within the commonfemoral vein 302. The filter wire coils due to residual stresses of the wire and the preformed shape memory imparted into the wire during the manufacturing process. - In one or more embodiments, the
filter wire 800 has a first and a second end and is preferably fabricated from a suitable material such as titanium, Nitinol, or monofilament strand, to name a few. Thefilter wire 800 may also be fabricated from a polymer as well. The wire may be similar to known wires commonly used in the medical industry and, in one or more embodiments, may range in diameter from 0.015-0.035 of an inch. Additionally, thefilter wire 800 may be treated with a compound that prevents clot formation on the wire such as a Heparin anticoagulation coating. The wire may comprise a mesh form or may be constructed of metal, plastic or a combination thereof or any other material. In addition, thefilter wire 800 may have a very flexible tip at its first end to reduce the possibility of damaging the inside wall of a vein when the filter wire is implanted. - In one embodiment, an important characteristic of the
filter wire 800 is that the wire be preformed to have residual stresses and/or surface tensions such that the wire will automatically coil once advanced beyond thedelivery needle end 902. For example, the filter wire may be fabricated so that the surface tension along the length of the wire causes the wire to naturally coil unless otherwise constrained. In this way, thefilter wire 800 may be housed or stored in one dispenser configuration and upon proper deployment; the filter wire would coil into a predetermined shape. In another embodiment, the filter wire may be preformed to take any various shapes that will achieve the goals set forth herein. For example, the filter wire may be preformed to have a vortex shape (coils of increasing/decreasing diameter) once deployed. Other embodiments may provide filter wire that is preformed to have a nesting or tangled web shape. - As illustrated in
FIGS. 10 and 11 , as thefilter wire 800 is advanced into the commonfemoral vein 302, thecoil 900 becomes larger and longer such that a substantial coil of wire is formed within the vein. As a result, thecoil 900 becomes a partial flow restriction within the commonfemoral vein 302 capable of capturing and retaining a blood clot therein. - In
FIG. 12 , thefilter wire 800 has been deployed and thefilter dispenser 700 anddelivery needle 400 are retracted from the subject's commonfemoral vein 302. As thedispenser 700 andneedle 400 are removed, aportion 1200 of thefilter wire 800 may be left protruding from the subject'sskin surface 1202 so that it may be secured to a fixation device 1300 (FIG. 13 ) to prevent thefilter wire 800 from moving within the vein. As illustrated inFIGS. 13 and 14 , aportion 1200 of thefilter wire 800 is intentionally left protruding from the subject'sskin surface 1202 so that it may be looped and subsequently attached to afixation device 1300. Thefixation device 1300 is then secured using a medical dressing to the subject'sskin 1202 and may cover the filter wire's exit. It is contemplated that types offixation devices 1300 other than those illustrated in the figures may be used, and that in other embodiments the protrudingportion 1200 of thefilter wire 800 may be attached in other ways such as by tying or adhering the filter wire to the fixation device. -
FIGS. 15 and 16 illustrate ablood clot 1500 approaching and being captured by the deployed vascular filter. As theblood clot 1500 migrates down the vein, it will encounter and preferably become trapped by thecoil 900 of the vascular filter. As illustrated inFIG. 16 , theblood clot 1500 will become lodged or entangled with the vascular filter's coils, and, in this way, the clot is prevented from entering other regions of the subject's circulatory system. - In the event that a
blood clot 1500 is captured by the vascular filter, the clot may be removed in one of several ways. First, theentangled blood clot 1500 may be verified using ultrasound or x-ray techniques. If there is ablood clot 1500, then the blood clot may be dissolved using anticoagulation therapy or any other means. If theblood clot 1500 does not dissolve in a timely manner, the attending physician may decide to perform additional procedures such as thrombectomy or thrombolysis to resolve the blood clot. In some cases, permanent placement of a standard IVC filter may be required where the blood clot does not dissolve. -
FIGS. 17 through 19 illustrate removal of the vascular filter. InFIG. 17 , thefixation device 1300 and associated dressing are removed from the patient'sskin surface 1202. Next, the protrudingportion 1200 of thefilter wire 800 is drawn away from the patient. As thefilter wire 800 is drawn out of the patient, thefilter coil 900 unwinds and/or unravels as illustrated inFIGS. 18A through 18D . A hydrophilic coating orhydrophilic filter wires 800 may be used, in one or more embodiments, to facilitate removal of thefilter coil 900. Once thefilter wire 800 is completely extracted from the patient as shown inFIG. 19 , the vascular filter has been successfully removed and may be discarded. - The vascular filter disclosed herein has several advantages over known IVC filters. The new vascular filter is inexpensive and easily deployed/removed with minimal intrusion to the patient. In contrast, existing vascular filters require a complex and potentially risky deployment procedure which is very expensive, requires a team of medical professionals and the use of an operating room or cardiology suite. Additionally, existing vascular filters require an even more complicated and risky procedure for removal.
- The new vascular filter is placed without the need for complex fluoroscopic guidance (i.e., the new filter may be placed blindly). For example, unlike existing filters that are placed within the inferior vena cava which requires x-ray fluoroscopic guidance for deployment, the new vascular filter may be placed without using any x-ray or imaging equipment.
- The new vascular filter is minimally invasive and can be deployed at the patient's bedside or in an emergency room setting. Correspondingly, removal of the new vascular filter may be performed at a convenient location such as bedside.
- The new vascular filter reduces the risk of complications because the filter is placed in a more conducive location within the patient's body. As disclosed herein, the new vascular filter may be placed in the pelvic or groin region of the patient unlike existing IVC filters which are generally placed in the upper abdomen or thoracic region. As a result, the new vascular filer is placed within one or both of the more accessible common femoral veins and is minimally intrusive for the patient. Another desirable aspect of the new vascular filter is a substantial reduction in recovery time for either deployment or removal of the new filter. In contrast, the existing filters require a substantial recovery time for both deployment and removal.
- As an improvement to the filter and method of use described above, also disclosed is the filter configured as a route for infusion of fluids, gels, or medications through the filter and into the blood stream. The infused material may medicate the entire body or vascular system, or just the area of the filter. As such treatment can be directed to a very direct and focused area of the body or arterial system. As discussed above, the filter may be used to retain clots and as such, while the clot is retained within the filter, medication may be applied or infused through the filter as disclosed below to target the retained clot. This provides the benefit of concentrating the medication to the clot which is particularly useful for application of clot dissolving medication such as, but not limited to, Tissue Pasminogen Activator (TPA—Alteplase). In addition, it is also contemplated that medication may be infused through the filter as described below to prevent clotting of the blood around or onto the filter, or any other type of build-up of material or growth on the filter. This extends the effective life of the filter within the body and increases the ease of removal.
-
FIG. 20 illustrates an infusible filter and associated hub assembly. As discussed above, thefilter 1600 is located within the vascular system, such asvein 1604 located below the surface of theskin 1608. Ahub attachment 1620 connects to the externally locatedend 1624 of thefilter 1600. The base function of thefilter 1600 operates as described above and in connection withFIGS. 1-19 . In this embodiment thefilter 1600 including the externally locatedend 1624 includes an inner passageway that is configured to conduct medication or other material such as a liquid or gel. The passageway may comprise a lumen. - The filter wire maybe categorized into a
perforated section 1630 which is contained within in the vascular system. The filter wire also includes anun-perforated section 1634 that connects theperforated section 1630 at a distal end and to the attachment hub at the proximal end. The perforated section has one or more openings (shown inFIG. 21 ) through which the medication or other material may exit the filter. The number and shape of the openings may be varied to meet the requirements of the filter, medication, and particular medical application. - The
filter sections hub attachment 1620 and the perforations (not shown inFIG. 20 ) for the movement of the medication or other material into the filter, through the filter, and out of the perforations. Thehub attachment 1620, the structure of which is discussed below in connection withFIG. 21 , serves several purposes and functions. The hub attachments provides an access port to the internal passage within thefilter sections hub attachment 1620 also provides a clamping or compression element to open and close the opening into the internal passage of the filter. This controls the flow of medication or other material into and output of the internal passage. Thehub attachment 1620 also provides an attachment point and structure to attach a syringe, drip line, medication storage/dispensing device infusion pump, or any other element configured to deliver medication or other material to the filter. -
FIG. 21A illustrates a more detailed view of the infusible filter and hub assembly including a close up of the filter wire with infusing mechanism. This is but one possible configuration of the filter and hub assembly. It is contemplated that in other embodiments other configurations may be realized without departing from the claims that follow. For example, different medical applications may require that the disclosed and claimed device interface with other medical devices and as such modifications may be made to the device shown without departing from the scope of the invention and claims. - As shown generally, the filter includes
hub attachment 1620 and thefilter wire 1600. A non-perforated section of the filter wire connects the perforated filter section to the hub assemble. The filter may be made from any type material that is configured to perform as described herein. - A
fluid chamber 1640 configured to connect to the hub assembly, which in this embodiment is aluer lock 1644. Thefluid chamber 1640 contains medication or other material which is provided to thefilter 1600 and ultimately to the patient. The fluid chamber may be part of a syringe, drip-line, infusion pump or medication administration device or any other element configured to store and connect to a hub assembly. Thefluid chamber 1640 may permanently connect to the filter or may be selectively connectable and removable to apply medication or other material to the filter. - Configured to mate with or connect to the
fluid chamber 1640 is aluer lock 1644 having afirst end 1648 with an opening configured to mate with the external shape of thefluid chamber 1640, in this embodiment a tapered end. Thehub attachment 1620 assembly is an addition to the prior art as it allows wire placement, such as for example, through a needle with the eventual needle removal. Once the entry needle is removed thehub assembly 1620 can be applied to the portion of the filter that is external to the body for infusion. - The
luer lock 1644 is generally known in the art and not describe in detail herein. As shown theluer lock 1644 has an internal passageway or lumen from thefirst end 1648 to asecond end 1652. In thesecond end 1652 is anopening 1656 configured in size and shape to accept aproximal end 1660 of thenon-perforated section 1644 filter wire. The opening extends toward the proximal end of theluer lock 1644 to a establish fluid (or there material state) passageway with thefluid chamber 1640. Through this fluid passageway medication or other material may be provided to thefilter wire 1600. The medication or other material may be pressurized in thefluid chamber 1640 to establish flow into the lower pressure filter wire. The pressure may be established by a syringe or gravity, or any other force to move the medication or other material from thechamber 1640 to the filter wire. - The
luer lock 1644 also includes anouter ring 1664 with internal threaded which rotationally interact with an externally threadedinner frame 1668 of the luer lock. Through rotational movement of theouter ring 1664 relative to theinner frame 1668 the outer ring moves in the linear direction between theproximal end 1648 and thedistal end 1652. - The movement of the
outer ring 1664 relative to theinner frame 1668 crushes ancompression element 1670 that when crushed closes the passage between thechamber 1640 and the internal passageway in thefilter 1600. Thecompression element 1670 may comprise any material capable of performing as described herein. Thecompression element 1670 is a known structure in the luer lock 1646 and it may also be known to pinch or otherwise close the flow of medication or other material into thefilter 1600. - In one configuration the
non-perforated section 1634 of the filter in contact with thecompression element 1670 may comprise a different material or configuration than the portion of the filter not in contact with the compression element. For example, thenon-perforated section 1634 of the filter in contact with thecompression element 1670 may be flexible and resilient to return to shape after opening, while theperforated section 1630 may comprise a more stiff material capable of functioning as described above as a filter in a vascular environment. -
FIG. 21B illustrates the assembly ofFIG. 21A with the compression element compressed to close the inner lumen of the view of the filter. As shown theouter ring 1664 is twisted relative to theinner frame 1668 to compress (shown at element 1671) thecompression element 1670, which in turn compresses the inner passageway or lumen to stop the flow of medication or other material. - Also shown in
FIG. 21A is a close upview 1631 of theperforated section 1630 of the filter. Each of the dots in the coiled filter wire comprise opening or holes through which the medication or other material may pass into the blood steam -
FIG. 22 illustrates a more detailed version of the filter. As shown theperforated section 1630 of the filter includes anouter wall 1680 which forms aninner passage 1678 or lumen through which medication or other material may flow or be placed. Perforating through thewall 1680 areopenings 1684 which provide passages for the medication or other material to exit theinner passageway 1678 or lumen and enter the bloodstream. Theopenings 1684, which may referred to herein as infusion pores or diffusion pores, may be of any various size and shape and such size and shape may depend on the medication or other material, dosing requirements, patient condition or numerous other factors. - This current improvement allows the place filter to be a route of infusion for fluids and/or medication. The enhanced filter with infusion capabilities can therefore aid in patient care as an extra source of venous access, provides an additional means to protect the filter itself from developing blood clots and potentially will provide a means of breaking up or dissolving the trapped clot via infusion of clot dissolving medications including but not limited to Tissue Plasminoge Activater (TPA) and any other medication now existing or develop in the future.
- In summary, once the filter has been placed medication can be infused directly into the blood stream via the inner lumen and multiple infusion pores (openings) located on the intravenous portion of the filter wire. In order to channel fluid through the inner lumen of the filter coil a custom coupling apparatus is provided to attach to a syringe or other device configured to present the medication into the inner passage of the filter wire. The coupler, such as hub assembly, allows for the filter wire with the open inner lumen to be put into fluid communication with a standard IV drip system or other medication administration mechanism via a luer lock connection (hub assembly). Within the coupler is a compression seal (4). When the two coupler bodies are threaded together the compression seal is deformed thus creating a fluid tight seal around the filter wire. Once a seal is made the coupler can be connected to an IV line allowing fluid to pass through the filter wire and infuse into the patient's blood stream.
- It is further contemplated that various coatings can be added to the surface of the filter to enhance its biocompatibility or prevent/inhibit growth or development of unwanted surface tissue by the body on the filter. An example is an antithrombogenic antiplatelet coating or material to prevent development thrombi in vitro. This may further prevent or reduce development of clots or scar tissue development on the vascular filter.
- The above-described vascular filters may also be inserted and removed by other methods. In
FIG. 23 , theneedle 400 is inserted into a patient's vein, such as the common femoral vein. Aguidewire 2310 is inserted through theneedle 400 into the vein. Theguidewire 2310 may have acurved tip 2312, such as a u-shaped or a j-shaped tip to facilitate navigation of theguidewire 2310 through the vein and to prevent catching of the guidewire on the vein. Theguidewire 2310 may be stored on a reel or other storage device, or inserted as a length of wire. When theguidewire 2310 is deployed in the vein, theneedle 400 may be removed as shown inFIG. 24 . - In addition and in reference to
FIG. 25 , the guidewire may also be used to establish a sheath orcatheter 2510 in a patient. As shown, a sheath orcatheter 2510 is utilized to deploy the vascular filter, as will be described in more detail below. Thecatheter 2510 has aproximal end 2512 and adistal end 2514. A proximal end of theguidewire 2310 outside of the patient is inserted into thedistal end 2514 of thecatheter 2510, and the catheter is guided over theguidewire 2310 to be inserted into the patient. In this manner, thecatheter 2510 is inserted into the patient's vein at a predetermined location along theguidewire 2310. Theguidewire 2310 acts as a guide for the catheter. Once thecatheter 2510 is properly placed within the vein, theguidewire 2310 is removed by pulling theguidewire 2310 out from theproximal end 2512 of thecatheter 2510 as shown inFIG. 26 . It is also contemplated that theguidewire 2510 may be left in place to facilitate filter removal, or for other medical procedures. - With the
catheter 2510 in place, the filter may be inserted in a manner similar as explained with reference toFIGS. 7-11 above. That is, as shown inFIG. 27 , afilter dispenser 700 may connect with and insert a distal end of thefilter 900 into theproximal end 2512 of thecatheter 2510. When thefilter 900 exits thedistal end 2514 of thecatheter 2510, residual stresses in thefilter 900 cause the filter wire to coil and form the filter within the patient's vein. In other embodiments deployment in a manner other than coiling may occur. - In
FIG. 28 , the proximal end of the catheter 2510 (or sheath) is configured with a valve or seal on or in the exposed end that allows the filter wire (or guide wire) to be placed and advanced/withdrawn without allowing air into the catheter or blood from escaping from the catheter. In this configuration a “plug” may be mainly used to prevent the wire from advancing further into thee vein. This plug may be referred to as a “wire fixation clamp or plug”. In another embodiment thecatheter 2510 is plugged by afixation plug 2810 or any other device or element such as tape, adhesive, ring/loop or the like. Thefixation plug 2810 holds thefilter 900 in position with respect to the insertedcatheter 2510 and may prevent infection while thefilter 900 is in place. Thecatheter 2510 may be plugged with thefixation plug 2810 or other element to prevent blood flow from the catheter. - Removal of the filter is shown in
FIGS. 29 and 30 . Here, thefilter 900 is removed by pulling thefilter 900 through thecatheter 2510 and out of theproximal end 2512 of the catheter. Once thefilter 900 is removed, thecatheter 2510 is then removed. In this embodiment, thefilter 900 may be safely and easily removed by way of thecatheter 2510 inserted in the patient. This is due to the pulling force on thefilter 900 to be substantially parallel to the vein with the filter is removed through thecatheter 2510. Thecatheter 2510 also protects the skin and vein by providing a protective wall between thefilter 900 and the skin and vein. It is contemplated that this system may be used with any type filter such as a filter having an interior passage and outlets for medication disbursement. Thefilter 900 may also be of any shape and having one or more barbs or rough surfaces to catch the edge of the vein. Thefilter 900 material may also be smooth to prevent adhesion to the veins. - Further modifications may be made within the scope of the invention. For example, as shown in
FIG. 31 , the filter may be configured to have an “umbrella”end 3100. That is, the end of the filter may be split into several different threads. The filter may deploy from the needle or catheter. The residual stresses within the threads of the umbrella end expand the threads into theumbrella shape 3100 once deployed from the needle 400 (a catheter such ascatheter 2510 may also be used). The threads of theumbrella filter 3100 are formed to be flexible such that when the filter is removed, as shown inFIG. 32 , the threads flex back and allow easy removal from the vein. It also contemplated that for removal, a flexible sheath may be inserted through a placement needle until the sheath contacts the umbrella portion of the filter causing the threads of the umbrella to collapse backwards and into the sheath for removal from the vessel. Although discussed for use in vein, it is contemplated that the filters may be used in any type or location of blood vessel. - While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention. In addition, the various features, elements, and embodiments described herein may be claimed or combined in any configuration or arrangement.
Claims (20)
1. A vascular filter system comprising:
a catheter having a proximal end and a distal end, the distal end configured to be inserted into a blood vessel of a patient, and the proximal end configured as a filter wire dispenser connection end to connect to a filter wire dispenser;
a filter wire; and
a filter wire dispenser for storing the filter wire, the filter wire dispenser including a guide tube configured to connect to the filter wire dispenser connection end of the catheter;
the filter wire having a filter portion configured to (i) coil within or around the filter wire dispenser (ii) deploy from the filter wire dispenser to the blood vessel of the patient, to form a vascular filter within the blood vessel, and (iii) completely retract percutaneously from the blood vessel after filtering within the blood vessel.
2. The vascular filter system of claim 1 , wherein the length of filter wire includes residual stresses, surface tensions, or both to shape the length of filter wire into a predetermined shape.
3. The vascular filter system of claim 1 , wherein the predetermined shape is a coil shape.
4. The vascular filter system of claim 1 , wherein the predetermined shape is an umbrella shape.
5. The vascular filter system of claim 1 , wherein the filter wire has a first end portion associated with the filter portion with a rounded tip that is more flexible than other portions of the filter wire.
6. The vascular filter system of claim 1 , further comprising a spool configured to store the filter wire.
7. The vascular filter system of claim 1 further comprising a fixation device configured to attach to a portion of the filter wire to thereby secure the filter wire to a patient.
8. A vascular filter system comprising:
a catheter having a proximal end and a distal end, the distal end configured to be inserted into a blood vessel of a patient, and the proximal end configured as a filter wire dispenser connection end to connect to a filter wire dispenser;
a filter wire configured to form a predetermined filter shape upon deployment from the distal end of the catheter;
a filter wire dispenser for storing the filter wire, the filter wire dispenser having:
a storage housing having a spool therein, the spool and storage housing configured to store the filter wire prior to dispensing in a patient;
a coupling end configured to releasably attach to the connection end of the catheter;
a guide between the storage housing and the coupling end configured to guide the filter wire from the storage housing to the coupling end,
the distal end of the catheter being configured to pass over a guide wire, the guide wire being maneuverable within the blood vessel to position the catheter at a predetermined location within the blood vessel of the patient, and the connection end of the catheter attaching to the coupling end of the filter wire dispenser while the catheter is deployed in the blood vessel of the patient.
9. The vascular filter system of claim 8 , further comprising a fixation device configured to attach to a portion of the filter wire which protrudes from the patient when in use.
10. The vascular filter system of claim 8 , wherein the filter wire includes residual stresses, surface tensions, or both configured to form the length of filter wire into a predetermined shape.
11. The vascular filter system of claim 10 , wherein the predetermined shape consists of one of the following shapes: a helix shape, a vortex shape, nested shape, an umbrella shape, and a tangled web shape.
12. The vascular filter system of claim 8 , wherein the filter wire is stored in a spool within the filter wire dispenser on the spool and the spool includes a user rotatable wheel or knob to rotate the spool, thereby dispensing the filter wire.
13. The vascular filter system of claim 8 , wherein the length of filter wire is stored linearly within the filter wire dispenser.
14. A method for installing a vascular filter comprising:
inserting a needle into a patient to access a blood vessel;
inserting a guide wire through the needle into the blood vessel;
removing the needle from the patient;
inserting a catheter into the patient, such that the guide wire is within the catheter;
removing the guide wire from the patient;
connecting a filter dispenser to the catheter, the filter dispenser including a spool storing filter wire within a cavity of the filter dispenser;
dispensing a portion of the filter wire into catheter and then into the blood vessel, the portion of the filter wire dispensed into the vessel configured to form a filter.
15. The method of claim 14 , wherein the filter wire includes residual stresses, surface tensions, or both configured to form the filter wire into a predetermined shape within the vessel.
16. The method of claim 15 , wherein the predetermined shape consists of one of the following shapes: a helix shape, a vortex shape, a nested shape, an umbrella shape, and a tangled web shape.
17. The vascular filter system of claim 14 , wherein the filter dispenser includes guide tube having a first end and a second end, the first end connected to the filter dispenser and the second end configured to releasably attach to the catheter.
18. The vascular filter system of claim 17 , further comprising a coupler at the second end of the guide tube to engage one or more replacement catheters.
19. The method of claim 14 , wherein the filter wire is stored in a spool within the filter dispenser.
20. The method of claim 14 , wherein the filter wire comprises a non-perforated section extending from a proximal end of the filter wire and a perforated section at a distal end of the filter wire, the perforated section being connected to the non-perforated section, and an inner passageway extending within the filter wire,
the proximal end of the filter wire includes an opening to the inner passageway, and
the inner passageway facilitates the flow of medication from the opening to the perforated section of the filter wire.
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/819,258 US20150335415A1 (en) | 2007-01-31 | 2015-08-05 | Intravenous filter with guidewire and catheter access guide |
US15/177,299 US20160346073A1 (en) | 2007-01-31 | 2016-06-08 | Method for using intravenous filter and method for filter placement |
US15/352,479 US20170119516A1 (en) | 2007-01-31 | 2016-11-15 | Intravenous Filter with Guidewire and Catheter Access Guide |
US15/463,991 US20170189161A1 (en) | 2007-01-31 | 2017-03-20 | Infusion filter and method for performing thrombolysis |
US15/486,199 US20170224461A1 (en) | 2007-01-31 | 2017-04-12 | Thrombectomy filter and method for performing a thrombectomy |
US16/512,155 US11547545B2 (en) | 2007-01-31 | 2019-07-15 | Infusion filter and method for performing thrombolysis |
US16/879,666 US11672640B2 (en) | 2007-01-31 | 2020-05-20 | Thrombectomy filter and method for performing a thrombectomy |
US18/094,944 US20230233310A1 (en) | 2015-08-05 | 2023-01-09 | Infusion filter and method for performing thrombolysis |
US18/208,787 US20230404736A1 (en) | 2007-01-31 | 2023-06-12 | Vibrating vascular filter with infusion capability |
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US89893907P | 2007-01-31 | 2007-01-31 | |
US12/012,136 US9387062B2 (en) | 2007-01-31 | 2008-01-30 | Intravenous deep vein thrombosis filter and method of filter placement |
US14/819,258 US20150335415A1 (en) | 2007-01-31 | 2015-08-05 | Intravenous filter with guidewire and catheter access guide |
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US12/012,136 Continuation-In-Part US9387062B2 (en) | 2007-01-31 | 2008-01-30 | Intravenous deep vein thrombosis filter and method of filter placement |
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US15/177,299 Continuation US20160346073A1 (en) | 2007-01-31 | 2016-06-08 | Method for using intravenous filter and method for filter placement |
US15/352,479 Continuation-In-Part US20170119516A1 (en) | 2007-01-31 | 2016-11-15 | Intravenous Filter with Guidewire and Catheter Access Guide |
US15/463,991 Continuation US20170189161A1 (en) | 2007-01-31 | 2017-03-20 | Infusion filter and method for performing thrombolysis |
US15/463,991 Continuation-In-Part US20170189161A1 (en) | 2007-01-31 | 2017-03-20 | Infusion filter and method for performing thrombolysis |
US15/486,199 Continuation US20170224461A1 (en) | 2007-01-31 | 2017-04-12 | Thrombectomy filter and method for performing a thrombectomy |
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US15/177,299 Abandoned US20160346073A1 (en) | 2007-01-31 | 2016-06-08 | Method for using intravenous filter and method for filter placement |
US15/463,991 Abandoned US20170189161A1 (en) | 2007-01-31 | 2017-03-20 | Infusion filter and method for performing thrombolysis |
US15/486,199 Abandoned US20170224461A1 (en) | 2007-01-31 | 2017-04-12 | Thrombectomy filter and method for performing a thrombectomy |
US16/512,155 Active 2029-07-04 US11547545B2 (en) | 2007-01-31 | 2019-07-15 | Infusion filter and method for performing thrombolysis |
US16/879,666 Active US11672640B2 (en) | 2007-01-31 | 2020-05-20 | Thrombectomy filter and method for performing a thrombectomy |
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US15/177,299 Abandoned US20160346073A1 (en) | 2007-01-31 | 2016-06-08 | Method for using intravenous filter and method for filter placement |
US15/463,991 Abandoned US20170189161A1 (en) | 2007-01-31 | 2017-03-20 | Infusion filter and method for performing thrombolysis |
US15/486,199 Abandoned US20170224461A1 (en) | 2007-01-31 | 2017-04-12 | Thrombectomy filter and method for performing a thrombectomy |
US16/512,155 Active 2029-07-04 US11547545B2 (en) | 2007-01-31 | 2019-07-15 | Infusion filter and method for performing thrombolysis |
US16/879,666 Active US11672640B2 (en) | 2007-01-31 | 2020-05-20 | Thrombectomy filter and method for performing a thrombectomy |
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Cited By (3)
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CN107374777A (en) * | 2017-08-25 | 2017-11-24 | 重庆医科大学附属第二医院 | It is a kind of be easily recycled and safety interim Vena cava filter |
CN109069140A (en) * | 2016-04-15 | 2018-12-21 | 英联邦高等教育系统天普大学 | Infusion catheter and method of use |
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Also Published As
Publication number | Publication date |
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US20170189161A1 (en) | 2017-07-06 |
US11672640B2 (en) | 2023-06-13 |
US20190336265A1 (en) | 2019-11-07 |
US20160346073A1 (en) | 2016-12-01 |
US20170224461A1 (en) | 2017-08-10 |
US20200375717A1 (en) | 2020-12-03 |
US11547545B2 (en) | 2023-01-10 |
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