The disclosure herein relates to devices used to clear obstructions and objects in veins, arteries and any other tubular structure within the body. Obstructions can form in arteries and veins when a catheter is inserted for permanent or semi-permanent treatments. Specifically, fibrin sheaths or thrombus can form around the outer surface of a hemodialysis catheter, reducing or even completely blocking flow through either lumen of the catheter. The disclosed device relates to a catheter for removing fibrin sheaths, embolisms, or any other objects inside of an artery, vein, or other structure with a lumen. The disclosed device relates to devices that expand within a vein, artery, or bodily structure with lumen while still allowing flow through said passage and capturing the material being removed.
Systems known in the art allow a surgeon to remove objects from a passage within a body. These systems can include netting made of wires, the netting expanding and contracting to form different shapes. The netting can be made of materials that expand, contract, and bend in ways that allow the net to form different shapes within a passage. Such devices require more than one hand to open and close to capture objects, limiting the tasks a user can perform while actuating the device.
It is important for devices in the field to be uniquely suited for the passage or body they are used in due to the delicate nature of the tissues these devices are used near and within. Devices also must be simple to use with one hand. There is a wide variety of procedures that are carried out in veins and arteries, each with their own requirement for stiffness of the wire net, controllability of the expansion and contraction of the wire net, visibility of the wire net on imaging machines, the device's ability to remove or install an object, and to effectively handle and manipulate the size, shape, and consistency of the object in the passage. Applicant addresses problems with devices in the prior art by providing a device that can be actuated with one hand while a user's other hand is used to guide the device through a passage, or perform other functions simultaneously with actuation.
The needs set forth herein as well as further and other needs and advantages are addressed by the present embodiments, which illustrate solutions and advantages described below.
There is a need for a device that can be inserted into a vein, artery, or other passage in a body and be expanded in an umbrella shape to capture an object in the body passage and allow a surgeon to withdraw the object with the device.
There is a need for a catheter device that is small enough in cross sectional diameter to be inserted into a body passage and long enough to reach an object or obstruction. There is also a need for the device to have a linkage extending from a proximal end of the device to the distal end of the device that allows a user to expand a distal end of the catheter in an umbrella shape. There is a need for the device's umbrella shaped end to allow fluid flow through the body passage when expanded. There is also a need for the umbrella shape to be retracted such that an object is secured to the distal end of the device while the device is withdrawn from the body passage.
One embodiment of the catheter device has a tube with a proximal end and a distal end. The device also has a linkage inside the tube extending between the proximal end and the distal end of the tube and a plurality of ribs connected to a first connection point at the distal end of the tube. The ribs have a first end at the first connection point and a second end opposite the first end and a mesh connecting to each of the plurality of ribs. The device also has a first handle at the proximal end of the tube and a second handle adjacent to the first handle and attached to the linkage where the second handle actuates the plurality of ribs from a retracted position to generally an extended position from the tube.
Another embodiment of the catheter device has a second handle where the second handle actuates the plurality of ribs by longitudinal movement of the linkage.
Another embodiment of the catheter device has a spring between the first handle and the second handle where the spring is in a loaded condition when the ribs are in the extended position and the spring is in an unloaded condition when the ribs are in the retracted position.
Another embodiment of the catheter device has ribs where at least one rib of the plurality of ribs extends from the tube in an arc.
Another embodiment of the catheter device has a second connection point on the tube proximal to the first connection point where at least one rib of the plurality of ribs extends from the first connection point in the arc to the second connection point on the tube.
Another embodiment of the catheter device has a plurality of ribs where each rib of the plurality of ribs has an atraumatic tip at the second end of each rib.
Another embodiment of the catheter device has an atraumatic tip wherein the atraumatic tip includes a polymer.
Another embodiment of the catheter device has a mesh where the mesh includes a plurality of filaments.
Another embodiment of the catheter device has filaments where the filaments are woven.
Another embodiment of the catheter device has an end cone at the distal end of the tube.
Another embodiment of the catheter device has ribs where each rib has at least one filament connected to the second end of the rib and to the second end of another rib of the plurality of ribs.
Another embodiment of the catheter device has a plurality of ribs where at least one rib of the plurality of ribs includes a shape-memory alloy.
Another embodiment of the catheter device has a plurality of ribs where each rib of the plurality of ribs has a stretcher wire connected at a first end of the stretcher wire to a point on the rib between the first end and second end of the rib and a second end of the stretcher wire connected to the linkage.
Another embodiment of the catheter device has stretcher wires where when the catheter device is in the extended position, at least one stretcher wire presses on at least one rib causing the arc.
Another embodiment of the catheter device has a fluid coupling fitting at the proximal end of the catheter device.
Another embodiment of the catheter device has a tube and linkage where the tube and the linkage are flexible.
An embodiment of the catheter device has a linkage having a proximal end and a distal end and a plurality of ribs connected to a first connection point at the distal end of the linkage. The device has ribs that have a first end at the first connection point and a second end opposite the first end and a mesh connecting to each of the plurality of ribs. The device also has a first handle at the proximal end of the linkage and a second handle adjacent to the first handle and attached to the linkage. The second handle actuates the plurality of ribs from a retracted position to generally an extended position from the linkage.
Another embodiment of the catheter device has linkage where the linkage is flexible.
An embodiment of the catheter device has a tube having a proximal end and a distal end and a linkage inside the tube extending between the proximal end and the distal end of the tube. The device also has a plurality of ribs connected to a first connection point at the distal end of the tube, the ribs have a first end at the first connection point and a second end opposite the first end and a mesh connecting to each of the plurality of ribs. The device also has a first handle at the proximal end of the tube and a second handle adjacent to the first handle and attached to the linkage where the second handle actuates the plurality of ribs from a retracted position to generally an extended position from the tube by longitudinal movement of the linkage. The device also has a spring between the first handle and the second handle, where the spring is in a loaded condition when the ribs are in the extended position and the spring is in an unloaded condition when the ribs are in the retracted position. Each rib of the plurality of ribs has a stretcher wire connected at a first end of the stretcher wire to a point on the rib between the first end and second end of the rib and a second end of the stretcher wire connected to the linkage. At least one rib of the plurality of ribs extends from the shaft in an arc and when the catheter device is in the extended position, at least one stretcher wire presses on at least one rib causing the arc.
An embodiment of the catheter device has a tube having a proximal end and a distal end and a linkage inside the tube extending between the proximal end and the distal end of the tube. The device also has a plurality of ribs connected to a first connection point at the distal end of the tube, the ribs having a first end at the first connection point and a second end opposite the first end and a mesh connecting to each of the plurality of ribs. The device also has an actuator at the proximal end of the tube and connected to the linkage, where the actuator accepts a signal and actuates the plurality of ribs from a retracted position to generally an extended position from the tube.
Another embodiment of the catheter device has an input device connected to the actuator that interacts with and provides a signal to the actuator.
Another embodiment of the catheter device has an input where the input device includes a button.
The present teachings are described more fully hereinafter with reference to the accompanying drawings, in which the present embodiments are shown. The following description is presented for illustrative purposes only and the present teachings should not be limited to these embodiments.
In compliance with the statute, the present teachings have been described in language more or less specific as to structural and mechanical features. It is to be understood, however, that the present teachings are not limited to the specific features shown and described, since the apparatus, systems, and methods herein disclosed comprise preferred forms of putting the present teachings into effect.
For purposes of explanation and not limitation, specific details are set forth such as particular structures, architectures, interfaces, techniques, etc. in order to provide a thorough understanding. In other instances, detailed descriptions of well-known devices and methods are omitted so as not to obscure the description with unnecessary detail.
Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, component, means, step, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, step, etc., unless explicitly stated otherwise. The steps of any method disclosed herein do not have to be performed in the exact order disclosed, unless explicitly stated. The use of “first”, “second,” etc. for different features/components of the present disclosure are only intended to distinguish the features/components from other similar features/components and not to impart any order or hierarchy to the features/components.
To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto, Applicant does not intend any of the appended claims or claim elements to invoke 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.
A notable advantage to the disclosed device is the ability to securely capture an object within a body passage and withdraw the object with the device while only minimally restricting fluid flow through the body passage. Another notable advantage to the disclosed device includes the ability to retrieve obstructive objects while maintaining venous or arterial access via an intraluminal wire extending within the central lumen or flush port of the device. Another notable advantage to the disclosed device includes the variability in potential diameter of the basket portion of the device to adequately oppose large vessel walls or small vessel walls depending on designed and created size of the device. Additionally, a notable advantage to the disclosed device is a self-centering nature of the catheter within a passage lumen due to radial force from the ribs of the device against interior walls of the passage.
Referring to
The tube 107 is shaped such that it can be inserted into a body passage including, but not limited to, a vein, artery, urethra, lymph duct, airway, vessel, duct, or any other body passage known in the art. The tube can be flexible, rigid, or have sections of the tube 107 that are rigid and others that are flexible. The diameter and length of the catheter can vary depending on the passage the tube 107 will be inserted into and how far it must be inserted to reach an object. The tube 107 can be manufactured from materials including, but not limited to, polymer, plastic, rubber, metal, composite, or any other material known in the art for constructing medical instruments. Further examples of materials that can be used to construct the tube 107 include, but are not limited to, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, and any other material known in the art for producing medical instruments and devices.
Further referring to
The catheter 100 can have multiple ribs 109 that connect to the tube 107 at a connection area 112. The ribs 109 can move in a hinging motion towards and away from the tube 107. The ribs 109 can form an umbrella shape when in the position generally away from the tube 107. This position can also be called an “extended position.” The hinging motion can be about the connection area 112. The ribs 109 can be rigid, flexible, or have joints connecting lengths of rib 109 and, in the case of a flexible rib 109, it can have a shape memory wherein when a bending force is applied to the rib 109, the rib 109 returns to its unbent shape when the force is removed.
The ribs 109 can be made from materials including, but not limited to, polymer, plastic, rubber, metal, composite, or any other material known in the art for constructing medical instruments. Further examples of materials that can be used to construct the ribs 109 include, but are not limited to, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, Nitinol®, other shape-memory alloys, and any other material known in the art for producing medical instruments and devices.
In other embodiments, the ribs 109 can also connect to a second connection point, 121. Actuation of the catheter 100 causes the ribs 109 to form a basket shape as shown in
The ribs 109 can each have an atraumatic tip 113 on the ends opposite those connected to the tube 107 at connection point 112. The atraumatic tips 113 can be rounded in shape so as to not snag or cut tissue when the device 100 is in use. The atraumatic tips 113 can be made from the same material as the ribs 109 or they can be made from a different material bonded to or otherwise secured to the ends of the ribs 109.
The atraumatic tips 113 can be made from materials including, but not limited to polymer, plastic, rubber, metal, composite, or any other material known in the art for constructing medical instruments. Further examples of materials that can be used to construct the atraumatic tips 113 include, but are not limited to, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, Nitinol®, and any other material known in the art for producing medical instruments and devices. The atraumatic tips 113 can be bonded using adhesive, epoxy, welding, over molding, molding, pressing, crimping, threading, screws, rivets, pins or any other method known in the art for joining materials together.
The catheter 100 can have an atraumatic end cone 110 at the distal end of the tube 107. The end cone 110 can be a shape including, but not limited to, a cone, truncated cone, pyramid, angled chisel, perpendicular chisel, sphere, elliptic paraboloid, bullet, elliptic hyperparaboloid, or any other shape known in the art for shaping the tip of an instrument for insertion into a body. The atraumatic end cone 110 can be made from materials including, but not limited to, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, Nitinol®, and any other material known in the art for producing medical instruments and devices. The atraumatic end cone 110 can be bonded to the tube 107 using adhesive, epoxy, welding, over molding, molding, pressing, crimping, threading, screws, rivets, pins or any other method known in the art for joining materials together.
The catheter 100 can have stretchers 108 each connected at one end to the linkage 106, or fixation point 111 and the other end to one rib 109. The stretchers 108 can act on the ribs 109 to move and fix the ribs 109 in relation to the tube 107. The stretchers 108 can be connected to the linkage 106 or the fixation point 111 and the ribs 109 such that they are movable in a hinging motion in relation to the linkage 106 and the ribs 109. The stretchers 108 can be connected to the linkage 106 and the ribs 109 by use of connections including, but not limited to, hinges, flexible joints, adhesives, sealants, moldings, pins, slots, soldering, welding, or any other method known in the art for joining materials. The stretchers 108 can be flexibly or rigidly connected to the linkage 106 or the fixation point 111, and the ribs 109. In the case of a rigid connection, the stretchers 108 can rely on a flexibility of the stretchers 108 for the hinging motion between the stretchers 108 and the linkage 106 and ribs 109.
The stretchers 108 can be made from materials including, but not limited to, Nitinol®, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, other shape-memory alloys, and any other material known in the art for producing medical instruments and devices.
The linkage 106 can be inside of the hollow passage of the tube 107 or, as in the embodiment of
The linkage 106 can also move in directions including, but not limited to, rotating clockwise or counter clockwise, or translationally in a direction perpendicular to the long direction of the tube 107, to transition the catheter 100 between the extended and retracted positions. The linkage can be made from materials including, but not limited to, Nitinol®, silicone rubber, polyurethane, polycarbonate, polypropylene, polyethylene, polyester, polystyrene, PVC, polyethersulfone, thermoplastic elastomers, fluoropolymers, Makolon®, Bayfol®, peek, acrylic, stainless steel, titanium, polylactic acid, other shape-memory alloys, and any other material known in the art for producing medical instruments and devices.
When the catheter 100 is in the retracted position, the stretchers 108 can hold the ribs 109 adjacent to the tube 107. The stretchers 108 can hold the ribs 109 in a position by tension, compression, or bending forces.
The catheter 100 can have a plunger 115 at the proximal end of the device 100 that is connected to the linkage 106. The plunger 115 can be shaped such that when the plunger 115 is pressed in the distal direction of the catheter 100, the ribs 109 are actuated away from the catheter 100. The catheter 100 can have a spring 104 that acts to resist movement of the plunger 115 and, upon the removal of distal-direction force on the plunger 115, the spring 104 moving the plunger 115 to a proximal resting position. The proximal resting position of the plunger 115 can correspond with the retracted position of the catheter 100 depicted in
Other embodiments of the catheter 100 can have a plunger 115 shaped such that when the plunger 115 is pressed in the proximal direction of the catheter 100, the ribs 109 are actuated towards the catheter 100. The catheter 100 can have a spring 104 that acts to resist movement of the plunger 115 and, upon removal of the proximal-direction force on the plunger 115, the spring 104 moving the plunger 115 to a distal resting position.
The catheter 100 can have a first handle 102 at the proximal end of the catheter 100. The first handle 102 can be connected to the proximal end of the tube 107. The first handle 102 can have loops through which a user's fingers can pass to gain a secure grip on the catheter 100. The loops can be made of materials including, but not limited to, plastic, rubber, silicone rubber, metal, stainless steel, titanium, polymer, or any other material known in the art for producing medical instruments.
Instead of loops, the first handle 102 can have one or two bars that protrude perpendicular to the tube 107. As a further alternative, the first handle 102 can have a circular or ovular disk through which the tube 107 passes or protrudes from.
The catheter 100 can have a second handle 105 attached to the linkage 106 such that a user grips both the first handle 102 and the second handle 105 and moves the two grips in relation to each other to actuate the catheter 100 from the retracted position to the extended position and vice versa. The second handle 105 can be of the same design or a different design as the first handle 102. The second handle 105 can be any of the designs listed above as options for the first handle 102.
The handles 102 and 105 can be positioned such that a user only needs to use one hand to actuate the catheter 100. For example, a user may hold the handles 102 and 105 such that the user's index finger and middle finger rest on the handle 102 and the user's thumb rests on the handle 105. To actuate the catheter 100, the user presses on the handles 102 and 105 with the above referenced fingers, bringing their fingers together in a grasping motion. This motion brings the handles 102 and 105 together and actuates the catheter 100.
Alternatively, the first handle 102 can be attached to the proximal end of the linkage 106 and operate as the plunger 115 is described above. The second handle 105 can be attached to the tube 107. This embodiment is described in
The tube 107 or linkage 106 can have a fluid fitting 103 at or near the proximal end. The fluid fitting 103 can be connectable to a fluid conduit that allows fluid flow to or from a body cavity or passage. The fluid fitting 103 can be connectable to a fluid conduit that supplies fluid flow for injection into or suction from a body cavity. The fluid flow can be supplied to flush material from the tube 107 or the distal end of the catheter 100. The fluid fitting 103 can include, but is not limited to, a luer lock fitting, threaded fitting, quick connect fitting, tapered fitting, barb fitting, bayonet fitting, or any other fitting known in the art for making a connection with a fluid conduit.
The fluid fitting 103 or the tube 107 can include a valve for controlling fluid through the fluid fitting 103. The valve can be a design including, ball valve, poppet valve, spool valve, gate valve, tube clamp, or any other valve known in the art for control of fluid flow through a fluid conduit.
Referring to
The mesh 114 can be made up of filaments that contract or bend when the catheter 100 is transitioned into the retracted position. The mesh 114 can contract to be adjacent to the tube 107 or can contract to be inside of the tube 107. The mesh 114 can be partially made up of rigid filaments and partially of flexible filaments. The ratio of rigid to flexible filaments can change based upon the desired retracted and extended shapes of the rib 109 and mesh 114 assembly.
Referring to
The catheter 100 shape can have a diameter across an outer perimeter of the extended ribs 109. This diameter can vary to adequately oppose the inner surfaces of a variety of sizes of vessels including large vessel walls and small vessel walls. The diameter of the catheter 100 shape can vary based upon the structure of the ribs 109 as designed for manufacture. The diameter, length, cross section, and material of each rib 109 can be selected to provide a specific catheter 100 shape.
When in the extended position, the catheter 100 can be centered within a passage by the extension of the ribs 109 and their contact with an interior surface of the passage. The ribs 109 can extend in way such that the catheter has a self-centering characteristic by which each of the ribs 109 extend equally from the tube 107.
The handles 102 and 105 are shown in their actuated positions and the spring 104 in a loaded condition. In the embodiment shown, the resting position of the catheter 100 is the retracted position. The handles 102 and 105 have been pressed so they are closer together, in effect, moving the linkage 106 in the distal direction and actuating the ribs of the catheter 100. In other embodiments, the handles 102 and 105 could be rotated in relation to each other to actuate the catheter 100, or the handles 102 and 105 could be separated from each other to actuate the catheter 100. In other embodiments, the spring 104 could be put into an unloaded position when the catheter 100 is actuated to an extended position making it so the catheter 100 tends towards the extended position.
Referring to
Additionally, the mesh 114 can be made from planar material having perforations or holes such that fluid can pass through the mesh while an object is captured. The mesh can be made without elongated elements.
An intraluminal wire can extend within the tube 107, the tube 107 providing access to a passage including a vein or an artery. The intraluminal wire can be used within the tube 107 or the flush port 101 to retrieve obstructive objects within the passage.
Referring to
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Referring to
An exemplary embodiment of the disclosed apparatus is described below.
The catheter 100 is made of a tube 107, linkage 106, ribs 109, stretchers 108, a mesh 114 between the ribs 109, and handles 102 and 105. A guidewire or similar device is inserted in to a vein in a patient to a location of an object. The catheter 100 is inserted into the vein and past an object in the vein in a human patient over the guidewire. The handles 102 and 105 are shaped such that a surgeon can hold them between their thumb, first (index), and second (middle) fingers. The surgeon's thumb rests on the handle 102 that is attached to the linkage 106 and the surgeons first and second fingers rest on the second handle which is attached to the tube 107. In some cases, a guide wire is not necessary to guide the catheter 100 and not used. In those cases, the catheter 100 is inserted directly into a passage without the guidewire.
The surgeon actuates the catheter 100 inside of the vein by pressing their thumb against the handle 102, moving the handle 102 towards the handle 105, in effect moving the linkage 106. The linkage 106 has ends of stretchers 108 connected to it. The linkage 106 moves the ends of the stretchers 108 in relation to the tube 107 in effect moving the rest of the stretchers 108 away from the tube 107 in a spreading motion. Each stretcher wire 108 acts on a rib 109 and spreads the ribs 109 from the tube 107 forming the frame of an umbrella shape.
The ribs 109 have elongated elements 116 connected between them forming a mesh 114. The mesh 114 is made taunt by the extension of the ribs 109. The surgeon uses the extended ribs 109 and the mesh 114 to capture the object in the vein by holding the catheter 100 in the extended position and partially withdrawing the catheter 100 from the vein. The surgeon can then release one of the handles 102 or 105, to allow the catheter 100 to transition to the retracted position. In the retracted position, the handles 102 and 105 separate from each other and the linkage 106 moves in relation to the tube 107. The stretchers 108 and ribs 109 are retracted towards the tube 107 and the ribs 109 are retracted towards the tube 107. The mesh 114 is closed around the object, securing the object to the distal end of the catheter 100. The surgeon then fully withdraws the catheter 100 from the vein with the object securely attached to the catheter 100.
Atraumatic tips on the distal tips of the ribs 109 and the distal tip of the tube 107 prevent damage to the walls of the vein. The atraumatic tips also allow the catheter 100 to move more freely through the vein and past an object in the vein.
Once withdrawn from the vein, the catheter 100 can be transitioned to the extended position to release the object for disposal or examination. The catheter 100 can then be disposed of or sterilized for reuse.