Patent ID: 12201286

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

A first embodiment provides a sealing device having an expandable frame formed from a plurality of wires extending from a proximal end to a distal end of the frame with the wires forming a proximal and distal eyelet with a sealing member at least partially encapsulating the expandable wire frame.

FIG.1shows one embodiment of sealing device100. Sealing device100will be discussed in detail in a later section. Sealing device100may housed within third tube104. Third tube104contains sealing device100, first tube102, second tube108, retrieval cord110and locking loop111. Third tube104may be manufactured of Pebax® or any other material with suitable biocompatible and mechanical properties. A material choice with radiopacity may also be an option. The third tube104may be manufactured with or without a reinforcing braid to provide appropriate kink resistance and strength for the chosen application. Third tube104may also be designed with or without a radiopaque marker band. The design and materials of third tube104may be chosen for other properties such as torqueability, steerability and vascular trauma reduction. One of skill in the art can readily appreciate that there are a wide variety of potential materials that may be used to facilitate the present invention. The third tube104may be of any size but is preferably 10 fr. with an inner diameter of about 0.048 mm and an outer diameter of about 0.33 mm. Third tube104may be used with or without a guidewire and may include a rapid exchange port103. The tip of first tube104is preferably curved to aid in navigation and delivery of sealing device100from the access site to the defect with or without a guidewire.

Also shown inFIG.1is first tube102. As previously stated, first tube102may be housed within third tube104. The first tube102may be of any outer diameter size but is preferably sized to fit within the lumen of the third tube104. First tube102may be manufactured of Pebax® or any other material with suitable biocompatible and mechanical properties. First tube102is preferably a triple lumen catheter. The lumens may be of any geometric shape but are preferably round or oval or a combination of both. First tube102may be used to position and aid in the deployment of sealing device100. First tube102may be utilized in conjunction with second tube108to cause sealing device100to protrude from the distal tip of third tube104once sealing device100has reached the defect site. The first tube102may also have the function of retaining sealing device100onto the delivery system until final device deployment. First tube102has an opening109in the distal most end to allow the locking loop111to protrude during device deployment. The opening109and protruding locking loop111provide attachment to the device delivery system. Locking loop111is shown in its extended position prior to retaining its pre-set shape. The first tube102may be surface treated or coated to enhance the material's biocompatibility or alter or enhance the surface friction.

First tube102may house the second tube108. The second tube108is essentially tubular with an oval cross section and can have an outer diameter suitable to fit inside first tube102. A preferred outer diameter range would be from about 1.27×0.68 mm and would be flared at the distal end. The second tube108may be fabricated from any suitable biocompatible material including polymers or metals. A preferable material would be PEEK (polyetheretherketone). Second tube108can be used to aid in the delivery and deployment of sealing device100to a defect site. Second tube108is threaded through the eyelets of sealing device100to hold sealing device100on the delivery system and to provide stability while deploying the sealing device100. Sealing device eyelets will be discussed further.

Retrieval cord110is looped through two of the smaller lumens of the first tube102and through the proximal eyelet of the sealing device100to provide attachment to the delivery system and a method of retrieval once the sealing device has been deployed. Retrieval cord110extends through the length of first tube102with the ends terminating at the handle used for deploying sealing device100. Retrieval cord110may be manufactured of any biocompatible material of sufficient strength and size. A preferable material is ePTFE (expanded polytetrafluoroethylene).

As shown inFIG.2Asealing device100is formed of a wire frame200. When situated for delivery, wire frame200is at an extended position on second tube108and within third tube104. Wire frame200may be of any size appropriate for an application but is preferably sized with finished outer diameters of 15, 20, 25, or 30 mm. The wire frame200is formed of continuous wires. Any number of wires may be used to construct the wire frame200. A preferable number of wires is five. The wire frame200can be constructed of wires that have elastic properties that allow for wire frame200to be collapsed for catheter based delivery or thoracoscopic delivery, and self-expand to a “memory” induced configuration once positioned in a defect. The elastic wire may be a spring wire, or a shape memory NiTi (nitinol) alloy wire or a super-elastic NiTi alloy wire. The elastic wire may also be of a drawn-filled type of NiTi containing a different metal at the core. Preferably, wire frame200would be constructed of a drawn-filled type of NiTi wire containing a radiopaque metal at the center. Upon deployment, the wire structure resumes its deployed shape without permanent deformation.

Wire frame200and other wire frames shown are formed from elastic wire materials that have outer diameters between 0.12 and 0.4 mm. In a preferable embodiment, wire outer diameter size would be about 0.3 mm. When formed, wire frame200comprises a distal bumper208, distal eyelet204, locking loop206, an optional center eyelet203, and proximal eyelet202.FIG.2Bshows the position of elastic wires during the formation of eyelets202,203and204of wire frame200.

FIG.2Cshows a disk formed when wire frame200is deployed. The elastic wires that form wire frame200form petals212during deployment. The pre-set elastic wire configuration of wire frame200allows the frame to twist during deployment. This twist forms petals212. Deployed petals212form the outer diameter214of the wire frame200. Deployed petals212, when covered with sealing member106, form proximal and distal disks, to be discussed further. Petals212are optimally formed to have overlapping zones216to improve sealing qualities. The radius of petals212may be maximized to minimize sharp bend angles in the elastic wire and to minimize unsupported sections of petals212that improve sealing qualities of the device, reduce bending fatigue in the wire and aid in reducing device loading forces. Deployed petals212form a disk on either side of the center eyelet203. The deployed configuration will be discussed further.

Construction of wire frame200may be accomplished by a variety of means including machine winding with automatic wire tensioning or by hand winding with weights suspended from each wire during construction. Shown inFIGS.3A-Care keyed center pin300and button304, which may be used to aid in the construction of wire frame200. One commonly skilled in the art would recognize that there are many materials suitable for use as a manufacturing aid or tooling. A preferable material for use in forming a center pin300would be cobalt high strength steel. A preferable material for use in forming a button304and winding jig would be corrosion resistant tool steel. The winding jig will be discussed further. Shown in detail inFIG.3A, keyed center pin300may have groove302, which can be used to secure an elastic wire during device construction. Keyed center pin300can be used to guide an elastic wire through opening306in button304, the features of which are illustrated inFIGS.3B-C. Button304is preferably formed with an indention308in the bottom to fit securely in a winding jig. An elastic wire held in groove302and inserted through opening306in button304can form a bumper208and locking loop206. Keyed center pin300is also used in the formation of eyelets202,203and204. During device construction, after the formation of bumper208, elastic wires can be wound around keyed center pin300to form a distal eyelet202. Other eyelets,203and204can be formed in a similar manner. Once keyed center pin300is inserted in button304an elastic wire may be inserted into grooves in a winding jig.

A winding jig may be used to secure and form the elastic wires during construction and processing of the sealing device100. A typical winding jig may be constructed as commonly known in the arts. Materials used for construction of such a winding jig have been discussed previously. A preferable winding jig is shown inFIGS.4A and4B.FIG.4Aillustrates a side view of the winding jig400.FIG.4Bshows a view of the top of a preferable winding jig400. Winding jig400contains an aperture402that may be shaped and sized to hold keyed center pin300and button304during device construction. Grooves404in the jig surface are used to secure and form the elastic wires into petals212. Grooves404may be of any diameter but are preferably sized to accommodate an outer diameter of elastic wire. In one embodiment shown inFIG.5A, the winding jig assembly may be used to form a center eyelet203, a petal assembly and proximal eyelet204. The shaped wire may be constrained in the winding jig assembly, heated and processed to shape set as commonly known in the arts.

FIG.5Ashows an embodiment of sealing device100which is a composite assembly of wire frame200and sealing member106. Sealing member106may be attached to wire frame200by a bonding agent. Wire frame200may be coated with a bonding agent, for example fluorinated ethylene propylene (FEP) or other suitable adhesive. The adhesive may be applied through contact coating, powder coating, dip coating, spray coating, or any other appropriate means. In a preferred embodiment, the FEP adhesive is applied by electrostatic powder coating. Sealing member106may be constructed of a variety of materials, such as DACRON®, polyester, polyethylene, polypropylene, fluoropolymers, polyurethane, foamed films, silicone, nylon, silk, thin sheets of super-elastic materials, woven materials, polyethylene terephthalate (PET), collagen, pericardium tissue or any other biocompatible material. In one embodiment, sealing member106can be formed of a thin porous ePTFE (expanded polytetrafluoroethylene) substrate. Sealing member106is designed to enhance the defect closure characteristics of sealing device100by providing defect blockage and a medium for cellular in growth.

Also shown inFIG.5Aare proximal, distal and center eyelets (202,203and204) respectively covered with sealing member106and wrapped with a film. The eyelets202,203and204may be wrapped with a film to encourage adhesion of sealing member106to the device. The film used to wrap eyelets202,203, and204may be any biocompatible thin material but is a material preferably comprised of multiple layers of thin porous ePTFE that may be laminated with one or more layers of non-porous FEP.

FIG.5Billustrates an embodiment of sealing device100that includes a sealing member508that partially covers wire frame200. A partially covered device may have either the distal or proximal bulb covered in part or in entirely with a sealing member508.

Another embodiment of the device is a self centering device600. Shown inFIG.6, self centering device600comprises a wire frame602similar to that of wire frame200. Self centering device600is a composite assembly of wire frame602and sealing member604. Wire frame602may be constructed with the same techniques and a material as wire frame200but has no center eyelet. Wire frame602comprises distal bumper606, covered distal eyelet608, covered proximal eyelet610, and locking loop612. The pre-set elastic wire configuration of wire frame602allows the frame to twist upon deployment and create a centering region614of the device600during deployment. During deployment, region614may center itself in the defect forming a disk comprised of petals on either side of region614and the defect.

FIG.7shows a sealing device100fully deployed. During deployment, the constraint of the third tube104is removed from device100and the device returns to its pre-set shape. During deployment and locking, lock loop111is released from the constraint of first tube102and returns to its pre-set shape, curling from the proximal eyelet202. In this manner, the device is locked in a deployed state.FIG.7also illustrates the position of the proximal and distal disks, elements702and704, in relation to the proximal, center, and distal eyelets202,203, and204respectively.

FIG.8shows a perspective view of sealing device100attached to a delivery system including first tube102, third tube104, and a handle for deploying a sealing device100.FIG.8further illustrates a first linear actuator802, a flushing port804, the second linear actuator806, lock release actuator808, a housing810and a slot with a length in the housing812. First linear actuator802may have a variety of configurations which will be discussed further.

FIGS.9A-Dare flow charts which describe the movements of the various components of the delivery system and attached sealing device100during use. Loading sealing device100into the delivery system prior to use is described inFIG.9A. Components of the delivery system handle are shown inFIGS.8,10and11. A clinician may flush the delivery system by attaching a syringe or other suitable implement onto flushing port804and filling the system with saline or any other appropriate flushing material. The first linear actuator802may then be moved in slot812in housing810against a spring1100. Spring1100may be configured as shown or may be formed as a leaf spring, stepped spring or any form commonly known in the arts. This action rotates the mandrel control lever1000, shown inFIG.11, about a slider rod1102to the side of housing810. This same motion moves the first linear actuator802free of distal notch1104in the sizing insert1103and prevents the second tube108from translating either proximally or distally. Sizing insert1103may be of any material with suitable mechanical properties.

Typical handles, handle components, tools or catheters used to deliver medical devices can comprise commonly known materials such as Amorphous Commodity Thermoplastics that include Polymethyl Methacrylate (PMMA or Acrylic), Polystyrene (PS), Acrylonitrile Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), Modified Polyethylene Terephthalate Glycol (PETG), Cellulose Acetate Butyrate (CAB); Semi-Crystalline Commodity Plastics that include Polyethylene (PE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE or LLDPE), Polypropylene (PP), Polymethylpentene (PMP); Amorphous Engineering Thermoplastics that include Polycarbonate (PC), Polyphenylene Oxide (PPO), Modified Polyphenylene Oxide (Mod PPO), Polyphenelyne Ether (PPE), Modified Polyphenelyne Ether (Mod PPE), Thermoplastic Polyurethane (TPU); Semi-Crystalline Engineering Thermoplastics that include Polyamide (PA or Nylon), Polyoxymethylene (POM or Acetal), Polyethylene Terephthalate (PET, Thermoplastic Polyester), Polybutylene Terephthalate (PBT, Thermoplastic Polyester), Ultra High Molecular Weight Polyethylene (UHMW-PE); High Performance Thermoplastics that include Polyimide (PI, Imidized Plastic), Polyamide Imide (PAI, Imidized Plastic), Polybenzimidazole (PBI, Imidized Plastic); Amorphous High Performance Thermoplastics that include Polysulfone (PSU), Polyetherimide (PEI), Polyether Sulfone (PES), Polyaryl Sulfone (PAS); Semi-Crystalline High Performance Thermoplastics that include Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK); and Semi-Crystalline High Performance Thermoplastics, Fluoropolymers that include Fluorinated Ethylene Propylene (FEP), Ethylene Chlorotrifluroethylene (ECTFE), Ethylene, Ethylene Tetrafluoroethylene (ETFE), Polychlortrifluoroethylene (PCTFE), Polytetrafluoroethylene (PTFE), Polyvinylidene Fluoride (PVDF), Perfluoroalkoxy (PFA). Other commonly known medical grade materials include elastomeric organosilicon polymers, polyether block amide or thermoplastic copolyether (PEBAX) and metals such as stainless steel and nickel/titanium alloys.

A distal notch1104and proximal notch1106in sizing insert1103may be used to aid in the positioning of the first linear actuator802in housing slot812. The distance between the two notches,1104and1106respectively, may be the length of sealing device100when it is elongated over second tube108prior to loading onto the delivery system. Sizing insert1103may be sized to accommodate a variety of device lengths and is preferably from about 22.28 cm long with a distance between the proximal end of distal notch1104and proximal end of proximal notch1106from about 6.25-13.32 cm. Notches1104and1106may be of any shape but are preferably rectangular.

The first linear actuator802is then moved to a mid point in slot812toward the proximal end of the housing810. This action causes the first tube102to move proximally and the sealing device100proximal end to move proximally, thus elongating sealing device100. First linear actuator802may be any shape (lever, ball) but is preferably shaped to accommodate a clinician's thumb. First linear actuator802may be constructed of any material with suitable mechanical properties but is preferably a material similar to that of sizing insert1103. A feature of the first linear actuator802are recessed teeth formed in the top portion of the first linear actuator802for securing retrieval cord110. This feature is preferred but optional. The teeth could be made into any tortuous path or have any shape desired to create resistance for retrieval cord110during loading, deployment, or retrieval of sealing device100. Corresponding protruding teeth (not shown) may be formed in the bottom surface of retrieval cord lock803. These teeth may fit together and hold the retrieval cord firmly. Other methods commonly known in the art for securing a small diameter cord may also be used and will be discussed in detail in a following section.

The first linear actuator802is then moved further proximally until the device is loaded in third tube104. During this action, spring1100pushes the first linear actuator802and the mandrel control lever1000to the left of slot812and into the proximal notch1106in sizing insert1103. The second tube108is free to move proximally with sealing device100and first tube102. As the first linear actuator802is moved proximally, the second tube108, sealing device100and first tube102slide or translate into the third tube104. After the first linear actuator802is in its proximal most position, the system may again be flushed with saline in the manner described above.

Alternate embodiments of first linear actuator802are shown inFIGS.12A-D.FIG.12Ashows a perspective view of the alternate linear actuator1108in the locked retrieval cord position. Linear actuator1108is similar in construction to linear actuator802but features a retrieval cord locking ring1110and retrieval cord groove1112.FIG.12Bdepicts alternate embodiment1114, which is configured with a thumb wheel1116that extends beyond the sides of the linear actuator to facilitate easy manipulation. Thumb wheel1116is screwed onto a threaded post1118around which the retrieval cord is wound. Embodiment1114also contains a retrieval cord groove1120through which the retrieval cord is guided prior to securing it around threaded post1118.FIG.12Cillustrates yet another embodiment1122that utilizes a side fitted threaded thumb wheel1124around which the retrieval cord is wound and secured to the actuator1122by the act of inserting the threaded post1124into a threaded aperture (not shown) in the side of the actuator1122. Prior to threading the retrieval cord around the threaded post1124, the retrieval cord is inserted through the retrieval cord groove1126. Yet another embodiment1128is shown inFIG.12D. Embodiment1128shows a linear actuator with molded thumb wheel1130. The thumb wheel1130extends slightly beyond the edges of the linear actuator facilitating manipulation of the linear actuator. The retrieval cord is inserted through cord groove1132and wound around a threaded post (not shown). The molded thumb wheel1130is then secured on the threaded post securing the retrieval cord.

Deploying sealing device100into a defect is described inFIG.9B. The first linear actuator802is moved distally until a stop is reached. This movement causes the first tube102and second tube108to move distally within the third tube104. The linear actuator802must then be moved to the right in slot812, against spring1100. When the linear actuator802is moved to the right, mandrel control lever1000rotates on slider rod1102. This action causes the linear actuator802to be free of the proximal notch1106in sizing insert1103. After this action, the linear actuator802is further translated distally. This causes the first tube102and proximal eyelet202of sealing device100to move distally. Also affected by this action is the distal end of sealing device100which is prevented from moving. The first tube102guides the device out of the third tube104to deploy the device in a defect. Moving linear actuator802distally to the end of slot812results in the entire sealing device being deployed. One skilled in the art would recognize that the steps described above could be halted and reversed at certain points to allow optimal positioning of sealing device100.

Locking the device is described in the flowchart illustrated inFIG.9C. The retrieval cord lock803would be unsnapped from the first linear actuator802. A clinician would grasp the second linear actuator806by gripping attached lock release actuator808and press it toward the middle of housing810. The second linear actuator806may be of any size or shape but is preferably sized to fit within a slot1002in the longitudinal surface of housing810. Linear actuator806is fitted with lock release actuator808by means of a snap fitting. Any means of attachment would suffice to fasten lock release actuator808to linear actuator806such as glue or construction as a molded part. Materials appropriate for both the second linear actuator806and lock release actuator808may be any material of suitable mechanical properties but are preferably similar to that of the previously mentioned handle components. Lock release actuator808is designed to enable a user to grip the device securely. Gripping may be aided by protrusions on the lateral sides of the lock release actuator808. These protrusions may be made of a similar material as that of the lock release actuator808or may be made of a material with a high coefficient of friction or of a material more compliant than that of lock release actuator808. These protrusions may also be made with grating, a roughening, a raised design, or striations in the surface in conjunction with the material listed above to further aid in the gripping of the device. These features on the surface of lock release actuator808may also be used to aid in gripping without the use of gripping protrusions and may be applied directly to the lateral surface of the second linear actuator806. Slot1002may be configured to have a stop to hold the second linear actuator806in a distal most position until lock release of the sealing device. A preferred stop is shown inFIGS.10and11in the form of a corrugated area but may also be any manner of mechanical stop. Slot1002may be of any length but preferably has a length sufficient to translate motion proximally about the width of the second linear actuator806plus about 3.18 cm. Slot1002may be any shape that would accommodate the second linear actuator806.

An alternate embodiment of second linear actuator806is shown inFIGS.13A and13B. Instead of gripping lock release actuator808and activating second linear actuator806a rotatable lock release actuator1300is gripped and rotated to affect lock release. The rotatable lock release actuator1300may contain a window1302which would prevent forward movement of the first linear actuator802. When rotated, lock release actuator1300allows the same actions as lock release actuator806shown inFIG.10.

Once the second linear actuator808is gripped, a clinician may move the second linear actuator806proximally. This action results in proximal movement of third tube104, mandrel control lever1000, sizing insert1103and second tube108. Second tube108moves proximally from between eyelets of the device. An alternate method of achieving this action would be to provide a twist mechanism to the distal end of the handle instead of a second linear actuator806. This twist mechanism would be provided with a slot that allows for the same movement of the third tube104, mandrel control lever1000, sizing insert1103and second tube108as the second linear actuator806.

Once lock release has been achieved, the retrieval cord lock803is then twisted to remove it from the first linear actuator802and pulled until the retrieval cord110is free of the delivery system. Retrieval cord110is attached to the retrieval cord lock803at one end. Retrieval cord110may be constructed of any material with suitable mechanical properties such as Kevlar®, flexible metal wire, polymers and the like. A preferably material for retrieval cord110is an ePTFE fiber. Retrieval cord lock803may be configured in a variety of shapes and sizes. Possible retrieval cord locks may be designed to provide a slot in the linear actuator802through which the retrieval passes. In one configuration, the retrieval cord is secured by passing the cord through a slot or hole in the axis of the thumb wheel disposed in the linear actuator802and tightened by twisting the thumb wheel. An alternate configuration would provide a slide lock that binds the retrieval cord between the lock and the linear actuator802using friction. A preferred design would be to secure the retrieval cord between teeth formed in the retrieval cord lock as shown inFIG.11.

Materials suitable for constructing retrieval cord lock803are similar to that used to construct housing810and other handle components. As mentioned previously, retrieval cord lock803preferably has teeth or protrusions that correspond to indentations in linear actuator802for the purpose of gripping retrieval cord110. Retrieval cord lock803may be configured in a variety of shapes to enable retrieval cord110to be secured. A preferred configuration would include apertures through the retrieval cord lock803to allow retrieval cord110to be threaded therethrough and knotted. After twisting the retrieval cord lock803, it is pulled until the retrieval cord110is removed from the delivery system.

Prior to the step four described inFIG.9C, the sealing device100may be retrieved as described in the flowchart illustrated inFIG.9D. The retrieval cord lock803may be snapped into the first linear actuator802. This serves to lock the retrieval cord110in place. The clinician then moves the first linear actuator802to the right edge of slot812. The first linear actuator802moves in slot812to the right pressing on spring1100while the mandrel control lever1000rotates on the slider rod1102to the right of the handle. Slider rod1102is preferably of a round cross-section but one skilled in the art would recognize that a variety of cross-sectional shapes (e.g. square or triangular) would be acceptable. Slider rod1102could also be configured in the shape of a crown spring1400as shown inFIGS.14Aand B. The spring could be inserted in a slot1402through the linear actuator to allow fore and aft translation of the linear actuator. An alternate embodiment of spring1100may be a spring molded as an integral part1500of first linear actuator802as illustrated byFIG.15. Another embodiment of spring1100is shown inFIG.16. In this configuration, a spring1600is attached to housing810and pushes on the first linear actuator802in key positions. As stated above, one skilled in the art would recognize the appropriate materials for use as a spring or molded part. The first linear actuator802is free of distal notch1104and the second tube108is prevented from moving. The first linear actuator is moved proximally by the clinician causing first tube102to move proximally. This motion translates the proximal end of sealing device100proximally elongating the device100and allowing it to be pulled into the third tube104.

Alternately, the sealing device100may be retrieved in the following manner. The retrieval cord lock802may be snapped into the first linear actuator802. The retrieval luer814may be unscrewed which separates the delivery catheter104from the handle800. Device retrieval may be accomplished by then grasping the entire handle800and withdrawing it while holding the delivery catheter104in place. This action will force the device100to be withdrawn through the delivery catheter104.

EXAMPLES

Without intending to limit the scope of the invention, the following examples illustrate how various embodiments of the invention may be made and/or used.

Example 1

A sealing device similar toFIG.1was manufactured using the following components and assembly process.

An expanded polytetrafluoroethylene material was obtained with the following properties:Methanol bubble point of 1 psiMass/area of 2.2 grams/square meterLongitudinal maximum load of 1.6 kg/inchThickness of 0.0003 inchLongitudinal matrix tensile strength of 92000 psi

The following test methods and equipment were used to determine the above-mentioned properties: Methanol bubble point was measured using a custom built machine with a 1 inch diameter foot, a ramp rate of 0.2 psi/second and a liquid media of methanol. Length and width of the material were measured using a metal ruler. Mass/area was measured using a balance (Model GF-400 Top Loader Balance, ANG, San Jose CA.) with a 36×5 inch sample. Longitudinal maximum load was measured using a materials test machine (Model 5564, Instron, Grove City, PA) equipped with a 10 kg load cell. The gauge length was 1 inch and the cross head speed was 25 mm/minute. Sample width was 1 inch. Longitudinal tensile test measurements were taken in the length direction of the material. Thickness was measured using a thickness gauge (Mitutoyo Digital Indicator 547-400) with a foot diameter of ¼ inch. The longitudinal matrix tensile strengths (MTS) were calculated using the following equation: Density was calculated using the formula, density=mass/volume.

Matrix⁢Tensile⁢Strength=(σsample)⋆(ρPTFE)(ρsample)where:ρPTFE=2.2grams/ccσsample=(Maximum⁢Load/Width)/Thicknessρsample=(Mass/Area)/Thickness

An expanded polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene) material was obtained with the following properties:Mass/area of 36.1 grams/square meterMaximum Load, Longitudinal of 12.6 kg/inchMaximum Load, Transverse of 0.3 kg/inchThickness of 0.0012 inch

The following test methods and equipment were used to determine the above-mentioned properties: Material was weighed using a precision analytical balance (Model GF-400 Top Loader Balance, ANG, San Jose CA.) with a sample area of 36×1 inch sample. Length and width of the material were measured using a metal ruler. Material thickness was measured using a digital thickness gauge (Mitutoyo Digital Indicator 547-400) with a foot diameter of ¼ inch. Maximum transverse load was measured using a materials test machine (Model 5564, Instron, Grove City, PA) equipped with a 10 kg load cell. The sample width was 1 inch, the gauge length was 1 inch and the cross head speed was 25 mm/minute. Maximum longitudinal load was measured using a materials test machine (Model 5564, Instron, Grove City, PA) equipped with a 200 kg load cell. The sample width was 1 inch, the gauge length was 1 inch and the cross head speed was 25 mm/minute. Longitudinal tensile test measurements were taken in the length direction of the material and transverse tensile test measurements were taken in the direction orthogonal to the length direction.

A distal eyelet was formed by first obtaining a length of 10% platinum drawn filled nitinol wire (Fort Wayne Metals, Fort Wayne, IN.) with a diameter of about 0.23 mm. This wire was labeled “first wire”. A free end of the first wire was doubled on itself to create an open-ended loop and the open-ended loop was inserted into the button. The button was then inserted onto the keyed center pin. The button was shaped to have an opening through the center to accommodate the keyed center pin and to have features that allow it to rest securely in the winding jig. The keyed center pin (major axis of about 0.51 mm and minor axis of about 0.25 mm and length of about 10.16 mm) was then inserted in the center of a winding jig. The keyed center pin was fabricated from high strength steel (Super Cobalt HSS Tool Bit, MSC #56424278, Seco Fagersta). The steel was tempered per manufacture's instructions at 1475° F. for one hour. The winding jig and button were fabricated in house from corrosion resistant tool steel.

A second length of the same type of drawn filled nitinol wire was obtained and labeled “fifth wire”. The first, fifth and an additional three wires were tensioned by attaching weights to the wire ends. The first wire and the fifth wire were then wound around the free end of the first wire one full revolution. The three additional wires were introduced to the winding jig and all five wires were wound around the free end of the first wire to a height of about 1.98 mm.

A distal disk was then formed by separating the five wires and securing them in radial grooves around the circumferential edge of the winding jig. A radius was formed with the dimensions of 15 mm. Each wire formed one petal of the distal disk. The radius on the curvature of the petals was maximized in order to minimize sharp bend angles in the wire.

A center eyelet was formed by grouping the wires together and winding them around the free end of the first wire and the keyed center pin to a height of about 1.98 mm. The wires were then separated and secured in radial grooves around the circumferential edge of the winding jib creating a proximal disk with a radius of 15 mm.

A proximal eyelet was formed by again grouping the five wires and winding them around the free end of the first wire and the keyed center pin to a height of about 1.98 mm. The five wires were then separated and secured by placing a stainless steel plate on top of the wires and locking down the plate with screws. The free end of the first wire was then wound one revolution around a stainless steel pin with a diameter of about 3.18 mm and secured similarly to the other five wires.

The jig with sealing device was then removed from the stabilizing fixture and placed in an oven (BlueM SPX Electric Forced Air Convection Oven) and the wires were thermally shape set as commonly known in the arts. The device and jig were then water quenched. The secured wires were released from the securing plate and the device was chilled and removed from the jig and keyed center pin. The device was then placed on a piece of flattened PEEK (polyetherether ketone) and trimmed by hand to the outer diameter of the distal eyelet. The lock loop was trimmed by hand to a point just beyond one complete revolution and pulled through the proximal and center eyelets.

The device was pushed from the PEEK mandrel onto a keyed stainless steel process mandrel with an oval cross section. The mandrel was produced from flattened stainless steel wire (Ft. Wayne Metals, Fort Wayne, IN) with an oval cross-section to have a 45° clockwise twist between the proximal eyelet and the center eyelet and a second 45° clockwise twist between the center eyelet and the distal eyelet.

The process mandrel and device were then placed in a stabilizing fixture which was placed in a FEP powder coating machine (C-30, Electrostatic Technology, Inc., Bradford, CN) and processed until coated completely. Excess FEP powder was removed from the device. The FEP was vacuumed from the lock loop, process mandrel and bumper. The process mandrel and device were removed from the stabilizing fixture, placed into an oven and baked to set the FEP coating as commonly known in the arts.

A hollow core film mandrel (35.99 mm O.D. 76.2 cm long stainless steel) was obtained. Expanded polytetrafluoroethylene material with a slit width of 22.22 mm was obtained and loaded onto a spiral wrapping machine. The machine was manufactured in house to wrap PTFE (polytetrafluoroethylene) material at any desired angle, tension and rate. The mandrel was loaded onto the wrapping machine and the material was wrapped three times around the circumference of the hollow core mandrel. The material was then wrapped around the mandrel at an angle of about 8° for the length of the mandrel. The direction of wrapping was reversed and the material over wrapped at the same angle. The third and fourth layers were wrapped in the same manner with the seams offset. The mandrel was removed from the wrapping machine, inserted in an oven and baked at 370° C. for 45 minutes. The wrapped mandrel was removed from the oven and allowed to cool to room temperature. The resulting PTFE tube was removed from the mandrel.

The PTFE tube was then cut to about 140 mm and hand stretched to a desired length 155 mm. The PTFE tube was then pulled over the frame. The PTFE tube was then crimped onto the center eyelet and then crimped onto the distal and proximal eyelets.

An expanded polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene) material was then wrapped four times around the eyelets starting with the center eyelet. The wrapped eyelets were tacked into place a soldering iron. The PTFE tube was then heat set for 3 minutes at 320° C. and trimmed to the outer most points of the proximal and distal eyelets. The device was removed from the mandrel.

Example 2

A sealing device similar toFIG.6was manufactured using the following components and assembly process.

Expanded polytetrafluoroethylene and expanded polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene) materials similar to that described in Example 1 were obtained.

A distal eyelet was formed by first obtaining a length of 10% platinum drawn filled nitinol wire (Fort Wayne Metals, Fort Wayne, IN.) with a diameter of about 0.23 mm. This wire was labeled “first wire”. A free end of the first wire was doubled on itself to create an open-ended loop and the open-ended loop was inserted into the button. The button was then inserted onto the keyed center pin. The button was shaped to have an opening through the center to accommodate the keyed center pin and to have features that allow it to rest securely in the winding jig. The keyed center pin (major axis of about 5.79 mm and minor axis of about 0.25 mm and length of about 10.16 mm) was inserted in the center of a winding jig. The keyed center pin was fabricated from high strength steel (Super Cobalt HSS Tool Bit, MSC #56424278, Seco Fagersta). The winding jig and button were fabricated in house from corrosion resistant tool steel.

A second length of the same type of drawn filled nitinol wire was obtained and labeled “fifth wire”. The first, fifth and an additional three wires were tensioned by attaching weights to the wire ends. The first wire and the fifth wire were then wound around the free end of the first wire one full revolution. The three additional wires were introduced to the winding jig and all five wires were wound around the free end of the first wire to a height of about 1.98 mm.

A device was then formed by separating the five wires and securing them in radial grooves around the circumferential edge of the winding jig. A radius was formed with the dimensions of 15 mm. Each wire made an entire revolution around the winding jig.

A proximal eyelet was formed by grouping the five wires and winding them around the free end of the first wire and the keyed center pin to a height of about 1.981 mm. The five wires were then separated and secured by placing a stainless steel plate on top of the wires and locking down the plate with screws. The free end of the first wire was then wound one revolution around a stainless steel pin with a diameter of about 3.18 mm and secured similarly to the other five wires.

The jig with sealing device was removed from the stabilizing fixture and placed in an oven (Blue M SPX Electric Forced Air Convection Oven) where the wires were partially thermally shape set as commonly known in the arts. The device and jig were then water quenched. The secured wires were released from the securing plate and then the device was chilled and removed from the jig and keyed center pin. The lock loop was trimmed by hand to a point just beyond one complete revolution and pulled through the proximal and center eyelets.

The device was pushed from the PEEK mandrel onto a keyed stainless steel transfer mandrel with an oval cross section. The mandrel was produced from flattened stainless steel wire (Ft. Wayne Metals, Fort Wayne, IN) with an oval cross-section. The device was then partially removed from one end of the transfer mandrel. The removed device end was twisted approximately 180° clockwise and repositioned on the transfer mandrel. The device and transfer mandrel were placed in an oven (Blue M SPX Electric Forced Air Convection Oven) where the wires were thermally shape set as commonly known in the arts.

The transfer mandrel and device were then placed in a stabilizing fixture which was placed in a FEP powder coating machine (C-30, Electrostatic Technology, Inc., Bradford, CN) and processed until coated completely. Excess FEP powder was removed. FEP powder was vacuumed from the lock loop, process mandrel and bumper. The transfer mandrel and device were then removed from the stabilizing fixture, placed into an oven and baked to set the FEP coating as commonly known in the arts.

A hollow core film mandrel (35.99 mm O.D. 76.2 cm long stainless steel) was obtained. An ePTFE material with a slit width of 22.24 mm was obtained and loaded onto a spiral wrapping machine. The machine was manufactured in house to wrap ptfe film at any desired angle, tension and rate. The mandrel was loaded onto the wrapping machine and the film was wrapped three times around the circumference of the hollow core mandrel. The ePTFE material was then wrapped around the mandrel at an angle of about 8° for the length of the mandrel. The direction of wrapping was reversed and the material over wrapped at the same angle. The third and fourth layers were wrapped in the same manner with the seams offset. The mandrel was removed from the wrapping machine, inserted in an oven and baked at 370° C. for 45 minutes. The wrapped mandrel was removed from the oven and allowed to cool to room temperature. The resulting ePTFE tube was removed from the mandrel.

The ePTFE tube was then cut to about 140 mm and hand stretched to a desired length 155 mm. The ePTFE tube was then pulled over the frame. The ePTFE tube was then crimped onto the distal and proximal eyelets. An ePTFE with a thin layer of FEP (fluorinated ethylene propylene) material was then wrapped four times around the eyelets. The wrapped eyelets were tacked into place a soldering iron. The ePTFE tube was then heat set for 3 minutes at 320° C. and trimmed to the outer most points of the proximal and distal eyelets. The device was then removed from the mandrel.

Example 3

An handle assembly similar toFIG.8was manufactured using the following components and assembly process.

Components for the handle assembly were fabricated using an injection molding process. The parts were fabricated by Contour Plastics (Baldwin, WI) using Lustran® 348. This material was suitable for use in medical devices and has an advertised tensile strength of 48.2 MPa and a tensile modulus of 2.62 GPa. Nine parts were fabricated using this injection process and Lustran® 348. The parts included the second linear actuator, flushing gasket retainer, a first linear actuator, retrieval cord lock, mandrel control lever, left body housing, sizing insert, right body housing, and a lock release actuator.

Other materials required for the assembly of the handle were purchased items. A catheter tube formed with a layup process commonly known in the arts was ordered (Teleflex Medical, Jaffrey, NH) with an I.D. of 0.048 mm and an O.D. of 0.33 mm and a platinum iridium marker band placed near the end of the distal tip. The main body of the catheter tube was Pebax® 7233 tube with PTFE liner and stainless steel braid (65 PPI) and the distal most 20.32 mm of the catheter tube was comprised of 6333 Pebax® (0.027 mm I.D. and an 0.033 mm O.D.) and a curve in the distal end (39.98 mm radius). A guidewire port formed by a laser was placed in the catheter tube proximal of the marker band. A flushing gasket or u-cup type gasket made of silicone (22.99 mm depth, I.D. tapered from 2.89 mm to 1.85 mm I.D. tapered from 6.71 mm to 7.75 mm) was procured from Apple Rubber of Lancaster, NY A flushing port (Merit Medical, South Jordan, UT) having an about six inch flexible pvc (polyvinyl chloride) tube with a 3.18 mm O.D. female luer connector was obtained. A quick set cyanoacrylate adhesive was supplied from in-house stock. Stainless steel hypotubes were ordered from Small Parts, Inc. (1.45 mm O.D., 1.30 mm I.D., length of 30.48 cm.). Slider rods (PTFE coated stainless steel hypotubes, 3.18 mm O.D., 1.65 mm I.D., length of 33.02 cm) were procured from Applied Plastics. Control springs (PTFE-coated stainless steel leaf springs, thickness 0.10 mm, minor flange length 5.33 mm, major flange length 10.11 mm, overall length 15.88 mm) were ordered from Incodema of Ithaca, NY

The remainder of the components were supplied from in house stock or manufactured in house. All triple lumen tubes were manufactured of Pebax® 7233 with 20% barium sulfate. Both triple lumen tubes had an O.D. (outer diameter) of 0.25 mm. One triple lumen tube had round lumens with two I.D.s (inner diameters) of 0.035 mm and one I.D. of 0.15 mm. One triple lumen tube had one lumen with an oval cross-section with two I.D.s of 0.036 mm and one I.D of 0.127×0.07 mm. Stainless steel PTFE coated (polytetrafluoroethylene) process mandrels were manufactured in house. One process mandrel had a cross-sectional shape that transitioned from round (O.D. of 0.16 mm) to oval (O.D. of 0.14×0.07 mm). PTFE covered stainless steel wire was procured from in house stock (O.D. 0.03 mm). Standard luer fittings were obtained from in house stock. A PEEK (polyetheretherketone) second tube extrusion was obtained from in house stock with an oval cross-section of 1.27×0.69 mm O.D.

A first tube was made in the following manner. One triple lumen extruded tube with round lumens was obtained. Another triple lumen extruded tube was obtained with one lumen having an oval cross-section. A stainless steel processing mandrel was also obtained having a cross-sectional shape, which transitions from round (O.D. of 1.52 mm), to oval (O.D. of 1.39×0.81 mm). Both extruded tubes were loaded onto the mandrel with the mandrel being inserted through the larger lumen on both tubes. Two small PTFE covered stainless steel wires were inserted through the smaller lumens of both extruded tubes. The mandrel and tubes were inserted into a RF (radio frequency) die (2.51 mm I.D., 4.45 mm length, fabricated from D2 tool steel). The junction of the two catheters was positioned in the center of the RF die. The RF die and mandrel was placed in the middle of an RF coil on an RF welding machine (Hot Shot I, Ameritherm Inc., Scottsville, NY) and welded as commonly known in the art. When the components had reflowed, pressure was applied to each end of the extruded tubes to meld the junction of the tubes. The die was then sprayed with compressed air to cool the die and to set the Pebax®. The extruded tube and die were removed from the RF machine and the extruded tube was removed from the die. The process mandrel and wires were removed from the lumens of the extruded tube.

A lubricious coating may be applied to the second tube. A silicone mold release spray (Nix Stix X-9032A, Dwight Products, Inc., Lyndhurst NJ) may be sprayed onto about the distal 30 cm of the second tube and allowed to dry at ambient temperature under a fume hood.

A third tube sub-assembly was made in the following manner. A catheter tube was bisected with a straight razor at approximately 6.35 cm from the proximal end of the catheter tube. A male and female in-line luer connector (Qosina, Edgewood, NY) was obtained and drilled to an I.D. of 3.45 mm. U.V. (ultra-violet) cured adhesive (Loctite 3041) was applied to the bisected ends of the catheter tube and the drilled luer fittings were attached. The adhesive was cured per manufacture's instructions and the luer fittings were screwed together.

A the second linear actuator sub-assembly was made in the following manner. A the second linear actuator, flushing port, flushing gasket retainer and silicone flushing gasket were obtained. The flushing gasket was inserted into the back of the second linear actuator with the u portion of the flushing gasket facing distally. The flushing gasket retainer was fitted over the top inside the second linear actuator. Cyanoacrylate glue was applied around the gasket retainer to hold the gasket retainer in place. The flushing port was placed into an aperture in the second linear actuator and an U.V. cure adhesive was applied and cured according to manufactures instructions.

A first tube was obtained and cyanoacrylate was applied to the outside surface of the round I.D. section of the catheter in a 2.54 cm band from the end. The catheter was then inserted into the distal end of the control shuttle until the catheter became flush with the back of the control shuttle. The catheter was oriented so that the two small lumens were horizontal and on the top portion of the round lumen. The retrieval cord lock was snapped onto the control shuttle.

The second tube sub-assembly was manufactured in the following manner. A four inch piece of 0.033 mm diameter nitinol wire was inserted into the second tube extrusion. The second tube extrusion with wire insert was inserted into a hypotube. The distal end of the hypotube was crimped by hand three times.

The distal end of the first tube was threaded through the top of the mandrel control lever and through the top aperture on the distal end of the mandrel control lever. The distal end of the second tube was threaded into the proximal end of the control catheter. The second tube was pushed into the first tube until about 4 in. of hypotube were protruding from the end of the control catheter. A cyanoacrylate adhesive was applied to the proximal end of the hypotube over about a 12.7 mm section. This section was inserted into the top aperture in the proximal end of the mandrel control lever until flush with the back of the mandrel control lever. The distal end of the first tube was then threaded into the proximal end of the second linear actuator. The second linear actuator was moved to the back most position on the control catheter.

A sizing insert was then fitted into a left body shell. The sizing insert was oriented so that the groove in the sizing insert fit over the ridge in the left shell. The catheter sub assembly was placed into the left body shell so that the mandrel control lever fit into the sizing insert and the second linear actuator fit into the slot in the distal end of the left body shell. A slider rod was inserted through the openings in the sizing insert, mandrel control lever, control shuttle and the second linear actuator. The slider rod was made to rest on two supports in the left body shell. The control spring was inserted into the right body shell so that it fit into the opposing teeth. The right body shell was then placed onto the left body shell and the two were snapped together. Two screws (#4-24×½ in. thread-forming Pan Head) were inserted into the available apertures on the left body shell and tightened. The lock release actuator was snapped into place on the right tab of the second linear actuator with a drop of cyanoacrylate adhesive to ensure that it remained attached.

The second linear actuator, control shuttle, and the mandrel control lever were moved to their forward most positions. The second linear actuator was pulled back and then returned to its forward position. The distal end of the first tube was trimmed by hand with a razor blade to 1.27 mm measured from the tip of the third tube. The sizing insert was pushed forward. The second tube was trimmed by hand using a razor blade to a length of about 0.76 mm measured from the distal most end of the control catheter. An about 4 inch long piece of nitinol wire (0.30 mm diameter) was obtained. A cyanoacrylate adhesive was applied into the tip of the second tube with an elongated applicator tip. The nitinol wire was inserted into the tip of the locking and another piece of wire was used to insert the nitinol wire about 2 mm into the second tube. The cyanoacrylate adhesive was allowed to cure.

The second linear actuator was pulled back and a slot was punched out of the control catheter. The slot had a width that was about the same width as the small axis of the oval lumen of the catheter. A razor was used to skive the slot to a final length of about 19.05 mm. The second linear actuator and the sizing insert were then moved to a forward position.

A retrieval cord approximately 3.05 m long (PTFE fiber with a 0.25 mm O.D.) and a 1.52 m (0.15 mm O.D.) nitinol wire were obtained. The nitinol wire was inserted into one of the 0.04 mm lumens in the first tube and pushed through until it came out into the handle. Tweezers were used to grasp the wire and pull it out of the slot in the handle. About 76.2 mm of wire were made to protrude from the distal end of the control catheter. A loop was formed in the wire by inserting the loose end into the same lumen at the distal end of the control catheter. About 76.2 mm of retrieval cord was then threaded through the resulting loop. The nitinol wire was pulled through the catheter until the retrieval cord protruded into the handle.

A sealing device was obtained. A needle of a type commonly used for sewing was threaded with the retrieval cord and the needle was inserted through the PTFE bag opposite the lock loop and through the lumen of the proximal eyelet of the sealing device. The nitinol wire was then threaded through the remaining unoccupied 0.04 mm lumen in the first tube with the loop end of the wire pointing distally. The needle was removed from the retrieval cord and the cord was threaded through the loop on the nitinol wire. The retrieval cord was then pulled through the catheter in the manner described previously.

The control shuttle was retracted approximately 12.7 mm. The second tube was then threaded through the eyelets of the device. Tweezers were used to grasp the retrieval cord and pull in to the outside of the handle. A loop was formed in a portion of small diameter nitinol wire. The loop was inserted through an aperture in the distal portion of the top of the control shuttle. The retrieval cord was threaded through this loop and pulled through the aperture in the distal portion of the control shuttle. The retrieval cord lock was removed from the control shuttle and one free end of the retrieval cord was inserted through the aperture in the retrieval cord lock from the bottom. Four over hand knots were tied in the cord. Excess cord was trimmed by hand and the retrieval cord lock was returned to the control shuttle.

The remaining free retrieval cord was pulled until all slack was gone. The remaining free end of the retrieval cord was inserted into an aperture in the front of the top of the control shuttle. The retrieval cord was pulled until taught and the retrieval cord lock was snapped closed. The cord was trimmed by hand to about 20.32 cm.

The second tube was flared by obtaining a soldering iron with a sharp tip and heating it to about 500° F. The tip of the iron was inserted into the second tube until a flare was created that was approximately 1.39 mm in diameter. The locking loop on the device was chilled.