Patent Application
20200297584
Physicians and other health care providers frequently use catheters to treat patients. Known catheters include a tube which is inserted into the human body. Certain catheters are inserted through the patient's nose or mouth for treating the gastrointestinal tract. These catheters, sometimes referred to as enteral catheters, typically include feeding tubes. The feeding tube lies in the stomach or intestines, and a feeding bag delivers liquid nutrient, liquid medicine or a combination of the two to the patient.
Other types of catheters are inserted into the patient's veins or arteries for treating the cardiovascular system. These catheters include, among others, the central venous catheter, peripheral venous catheter and the peripherally inserted central catheter (PICC). These catheters include a relatively small tube that passes through the patient's veins or arteries. The health care provider uses these catheters to provide patients with injections of medications, drugs, fluids, nutrients, or blood products over a period of time, typically several weeks or more.
When using these known catheters, it is important to place the end of the catheter at the proper location within the human body. Erroneous placement of the catheter tip may injure or harm the patient. For example, if the health care provider erroneously places an enteral catheter into the patient's lungs, liquid may be introduced into the lungs with harmful results. If the health care provider erroneously places a catheter into the wrong cavity of the cardiovascular system, the patient may experience infection or a harmful blockage.
While advancements have been made in the development of a signal generator placement control device for use in conjunction with electronic catheter guidance systems, there is still a risk of erroneous placement of a catheter by a health care provider, even when using a catheter guidance system. For instance, when a nasogastric (NG) tube is placed through the nasal cavity, the intent is for the NG tube to traverse through the esophagus, then down into the stomach, and into the small bowel, if desired. As the tube travels down the throat, the anatomy splits into the trachea and esophagus at the oropharynx. NG tubes can be misplaced into the trachea at this split, which can result in pneumonia, a pneumothorax, or even death. In addition, it is often challenging for health care providers to position the NG tube within the desired location in the gastrointestinal system, as the flexible nature of the NG tube makes manipulation of the tube into precise locations difficult.
Accordingly, there is a need for a system and method to overcome each of these disadvantages.
Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.
In one particular embodiment, the present invention is directed to a tubing assembly. The tubing assembly includes a catheter and a steering apparatus. The catheter has a proximal end and a distal end and extends in a longitudinal direction, where the proximal end and the distal end define a lumen therebetween. The steering apparatus includes an electrical connection having a distal end and a proximal end as well as a sheath having a proximal end and a distal end, where the sheath includes an electroactive polymer layer. The proximal end of the sheath is coupled to the distal end of the electrical connection, and the steering apparatus is located within the lumen of the catheter. Further, activation of the electroactive polymer layer results in a change in dimension of the sheath, where the change in dimension initiates a change in a direction in which the catheter travels within a body.
In one embodiment, the electroactive polymer layer can be an ionic electroactive polymer or an electric electroactive polymer.
In another embodiment, the sheath can include at least one insulating layer. For example, the sheath can include a first insulating layer and a second insulting layer, where the electroactive polymer layer can be disposed therebetween. Further, the insulating layer can include polyamide, polyethylene, polypropylene, poly-L-lysine, poly-D-lysine, polyethylene glycol, polyvinyl alcohol, polyvinyl acetate, polymethyl methacrylate, or a combination thereof.
In still another embodiment, the electrical connection can be configured to deliver an electrical signal from a power source to the electroactive polymer layer to initiate the change in dimension.
In yet another embodiment, the change in dimension of the sheath can result in the catheter changing in direction by an angle ranging from about 1° to about 180° relative to the longitudinal direction in which the catheter extends.
In one more embodiment, the proximal end of the electrical connection can be coupled to a controller coupler, where the controller coupler can be configured for connection to a power source.
In an additional embodiment, the electrical connection can include a wire.
In another embodiment, the tubing assembly can further include a signal generating assembly. The signal generating assembly can include an elongated wire assembly having a proximal end and a distal end and a signal generator, where the signal generator can be coupled to the distal end of the elongated wire assembly. Further, the elongated wire assembly can extend through a lumen of the sheath, and the signal generator can be positioned adjacent the distal end of the sheath towards the distal end of the catheter. In addition, the signal generator can be a magnetic field generator.
In another particular embodiment, the present invention is directed to a catheter guidance system. The system includes a controller, a power source, a tubing assembly, and a non-invasive movable receiver-transmitter or transceiver in communication with the tubing assembly, where the tubing assembly and the non-invasive movable receiver-transmitter or transceiver are electronically coupled to the controller. The tubing assembly includes a catheter and a signal generating assembly. The catheter includes a proximal end and a distal end and extends in a longitudinal direction, where the proximal end and the distal end define a lumen therebetween; and a steering apparatus, where the steering apparatus includes an electrical connection having a distal end and a proximal end and a sheath having a proximal end and a distal end and comprising an electroactive polymer layer, where the proximal end of the sheath is coupled to the distal end of the electrical connection, where the steering apparatus is located within the lumen of the catheter, where activation of the electroactive polymer layer from the power source via the electrical connection results in a change in dimension of the sheath, where the change in dimension initiates a change in direction in which the catheter travels within a body.
In one more embodiment of the present invention, a method for steering a catheter during placement of the catheter inside a body of a patient is provided. The method includes inserting a distal end of a tubing assembly into an orifice of the body, where the tubing assembly also has a proximal end and includes the catheter, where the catheter has a proximal end and a distal end and extends in a longitudinal direction, where the proximal end and the distal end define a lumen therebetween; and a steering apparatus, wherein the steering apparatus comprises an electrical connection having a distal end and a proximal end and a sheath having a proximal end and a distal end and comprising an electroactive polymer layer, where the proximal end of the sheath is coupled to the distal end of the electrical connection, where the steering apparatus is located within the lumen of the catheter. The method also includes connecting the tubing assembly to a power source; and delivering an electrical signal from the power source to the steering apparatus via the electrical connection to activate the electroactive polymer layer, where activating the electroactive polymer layer changes a dimension of the sheath, where the change in dimension changes a direction in which the catheter travels within the body.
In one embodiment, the orifice can be a nose or mouth.
In another embodiment, the change in dimension of the sheath can result in the catheter changing in direction by an angle ranging from about 1° to about 180° relative to the longitudinal direction in which the catheter extends.
In still another embodiment, the electroactive polymer layer can include an ionic electroactive polymer or an electric electroactive polymer.
In yet another embodiment, the method can include activating the electroactive polymer layer as the catheter reaches an area near the patient's epiglottis so that the catheter is steered towards the esophagus rather than the trachea.
In one more embodiment, the method can include activating the electroactive polymer layer as the catheter reaches an area near the patient's pylorus to facilitate duodenal or jejunal placement of the catheter.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:
Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.
Generally speaking, the present invention is directed to a tubing assembly for use in conjunction with electronic catheter guidance systems. The tubing assembly includes a catheter and a steering apparatus. The catheter has a proximal end and a distal end that define a lumen therebetween and extends in a longitudinal direction. The steering apparatus includes an electrical connection and a sheath. Further, the sheath includes an electroactive polymer layer, and the sheath's proximal end is coupled to the distal end of the electrical connection, where the steering apparatus is located within the lumen of the catheter. Activation of the electroactive polymer layer results in a change in dimension of the sheath, which initiates a change in a direction in which the catheter travels within a patient's body to assist in accurate placement of the catheter at a desired location. A catheter guidance system and a method for steering a catheter during its placement inside a body are also provided. Because of the specific components of the tubing assembly, catheter guidance system, and their methods of use, the present inventor has found that the placement of a catheter with a patient's gastrointestinal tract or any other anatomical location can be precisely controlled when the electroactive polymer layer is activated.
For instance, a health care provider can use the tubing assembly and catheter guidance system of the present invention to manipulate the placement of a catheter from outside the body. Such manipulation is facilitated by the electroactive polymer layer that forms at least a part of the sheath of the steering apparatus of the tubing assembly, where the polymer or polymers in the electroactive polymer layer can exhibit a change in dimension (e.g., a change in size, shape, and/or diameter) when exposed to an electric field, where the electric field can be applied from a power source in the form of a voltage or current via an electrical connection between the power source and the electroactive polymer layer. Because of the change in dimension of the steering apparatus due to the changes to the electroactive polymer layer, the catheter, which surrounds the steering apparatus (i.e., the steering apparatus is disposed within the lumen of the catheter), can bend in a desired direction such that the catheter can be accurately placed in a specific anatomical region.
For example, a catheter extending in a longitudinal direction L can change its direction of travel by an angle θ ranging from about 1° to about 180°, such as from about 5° to about 160°, such as from about 10° to about 90°, or any ranges therebetween, relative to the longitudinal direction L in which the catheter extends in response to the activation and resulting change in dimension of the electroactive polymer layer in the sheath of the steering apparatus, where the steering apparatus can be positioned or disposed within the catheter's lumen. Further, the length L1 of the sheath component of the steering apparatus relative to the overall length of the catheter can be relatively small, such as from about 0.5 inches (about 12.5 millimeters) to about 10 inches (about 250 millimeters), such as from about 1 inch (about 25 millimeters) to about 8 inches (about 200 millimeters), such as from about 2 inches (about 50 millimeters) to about 6 inches (about 150 millimeters), or any ranges therebetween. Nevertheless, despite the relatively short length of the sheath with respect to the overall catheter length, activation of the electroactive polymer layer is sufficient to adjust or alter the direction in which the catheter was traveling prior to activation.
The various components of the tubing assembly and catheter guidance system of the present invention are discussed in more detail below.
Referring now to the drawings, in an embodiment illustrated in
As best illustrated in
In one particular embodiment, the memory device 21 can store instructions which, when executed by the processor 20, cause the processor 20 to (i) interpret catheter 50 location and/or position information as determined and communicated by the signal generating assembly 16 and the non-invasive transceiver 32, and (ii) cause the processor 20 to then instruct the steering apparatus 79 to change direction based on such location and/or position information so that the catheter 50 is steered or guided via the system 2 to a desired anatomical region.
Health care providers can use the system 2 in a variety of catheter applications. In one example illustrated in
In another example illustrated in
Referring to
As best illustrated in
In one embodiment, the tubular insulator 40 includes a tube having: (a) a proximal end 100 attachable to an attachment member or neck 108 of the electronic catheter unit 12; (b) a distal end 102 receivable by the union device 42; (c) an internal diameter which is substantially equal to or greater than an external diameter of a wire assembly 38 (see
In one embodiment, the union device 42 includes: (a) a proximal end 116; (b) a distal end 118; (c) a position adjuster, extender or elongated neck 120 positioned between the proximal end 116 and the distal end 118; (d) a grasp or gripping member 122 positioned adjacent to the distal end 118 so as to assist users in grasping and manipulating the union device 42; and (e) an insert 124 positioned adjacent to the gripping member 122 which is received by the y-port connector 44. When assembled, the proximal end 116 of the union device 42 is coupled to the distal end 102 of the tubular insulator 40.
In one embodiment, the multi-port or y-port connector 44 includes: (a) a body 140; (b) a liquid delivery branch, medicine delivery branch or medicine branch 142 attached to the body 140 for distributing drugs, medicine or other medicinal liquids to the patient; (c) a nutrient delivery branch or feeding branch 144 attached to the body 140 and sized to receive the insert 124 of the union device 42; (d) a catheter or feeding tube connection branch 146 attached to the catheter 50; (e) a flexible or movable arm 148 attached to the body 140; and (f) a flexible or moveable arm 150 attached to the body 140. In an alternative embodiment, y-port connector 44 includes additional branches for administering various nutrients or medicines to the body 78. In another alternative embodiment, the y-port connector 44 includes only a feeding branch 144 and a connection branch 146. The arm 148 has a stopper 152, and the arm 150 has a stopper 154. The stoppers 152 and 154 are sized to prevent fluid from passing through the branches 142 and 144 after such branches 142 and 144 are plugged with stoppers 152 and 154, respectively. In addition, the arm 150 can include a fastener 155 which secures a tube-size adapter 156 to the arm 150. The tube-size adapter 156 enables fluid delivery tubes (not shown) having various diameters to connect to the feeding branch 144 of the y-port connector 44.
As illustrated in
The tubular connector 40, union device 42, y-port connector 44, catheter 50, and tip 60 can be made from any suitable polymer or plastic material including, but not limited to polyamide, polyethylene, polypropylene, polyurethane, silicone, polyacrylonitrile, poly-L-lysine, poly-D-lysine, polyethylene glycol, polyvinyl alcohol, polyvinyl acetate, polymethyl methacrylate, or a combination thereof.
Further, as illustrated in
Regardless of the particular arrangement of the steering apparatus 79, whether it be in the form of a sheath 80 as described above or as a coating, wrap, etc., the steering apparatus 79 contains an electroactive polymer layer 82 or other electroactive polymer component that can adjust the direction in which the catheter 50 travels upon activation of the electroactive polymer or polymers contained therein. Although any suitable electroactive polymer or combination thereof can be used in the steering apparatus 79 contemplated by the present invention, in some embodiments, the electroactive polymer can be an ionic electroactive polymer such as a conductive polymer, an ionomeric polymer-metal composite (IPMC), or carbon nanotubes (CNT). For example, the conductive polymer can include polypyrrole, poly(3,4-ethylenedioxythiophene), polythiophene, polyaniline, poly-p-phenylene-sulphide, polyacetylene, polyisoprene, polybutadiene, or a combination thereof. Meanwhile, the IPMC can include perfluorosulphonate, perfluorocarboxylate, or a combination thereof. In other embodiments, the electroactive polymer can be an electric electroactive polymer. For instance, in one embodiment, the electric electroactive polymer can be a piezoelectric polymer, such as polyvinylidene fluoride (PVDF) or a copolymer thereof. In another embodiment, the electric electroactive copolymer can be an electro-statically stricted polymer (ESSP), such as polyurethane, silicone, fluorosilicone, fluorodastomer, polybutadiene, isoprene natural rubber latex, polyacrylonitrile, or a combination thereof. In other embodiments, the electric electroactive polymer can be an electrorestrictive graft elastomer, an electro-viscoelastic elastomer, a liquid crystal elastomer, or a combination thereof.
Referring specifically to
As shown in
As shown in
Generally, the controller coupler 36 contains circuitry that enables it to transmit electrical signals (e.g., current and/or voltage) from the apparatus 10 (e.g., the processor or controller 20) through the electrical connection 84 of the steering apparatus 79 to activate the electroactive polymers in the sheath 80 to guide the movement of the catheter 50 within the tubing assembly 14 as it passes through various regions of the body 78. Various methods of steering the tubing assembly 14 to a desired location are discussed in more detail below with respect to
In one embodiment, the signal generator or magnetic field generator 58 is formed through a plurality of spirals or coils of wire. As the apparatus 10 transmits electrical current through the wires, the current travels in a circular path defined by the coils. This circular motion of current produces an electromagnetic field, B field or electromagnetic radiation. Further, it should be appreciated that the signal generator 58 can include any alternate suitable mechanism or device which generates or produces magnetic energy or a magnetic field. In one embodiment, the magnetic field generator 58 includes a magnet such as a permanent magnet, resistive magnet or superconducting magnet.
In operation, when the apparatus 10 sends electrical current to the coils, the coils transmit a signal or electromagnetic field capable of being detected by the non-invasive transceiver 32. The transceiver 32 then detects the electromagnetic field or signal generated by the signal generator 58 inside the body 78. The processor 20 then causes the display device 22 and/or the printer 28 to produce graphics 37 which assist the health care provider in catheter placement procedure.
Further, although not shown, in an alternative embodiment, it is to be understood that the invasive signal generating assembly 16 including the signal generator 58 can be incorporated directly into tubing assembly 14, for example, by embedding the coils of the signal generator 58 into a wall of the catheter 50.
Methods of using the various assemblies and components described above for accurately placing a catheter 50 in a desired anatomical region in, for example, a gastrointestinal tract of a of a patient are now described in detail with respect to
Generally, a method, such as a computer-implemented method, for steering a catheter 50 during placement of the catheter 50 inside a body 78 of a patient according the present invention, and referring to
Once the distal end 126 of the tubing assembly 14 is inserted into an orifice of the body 78, such as one of the nostrils 87 of the nose 72, various components of the tubing assembly 14 can be connected to the power source 25 such as via the controller coupler 36. For instance, the steering apparatus 79 can be connected to the power source 25 via the electrical extension 34 through the controller coupler 36 and through the electrical connection 84 of the steering apparatus 79. The electrical connection 84 can then be in contact with the electroactive polymer layer 82 of the sheath 80 so that the electroactive polymer layer 82 can be activated as needed via an electrical signal sent by the power source (e.g., current, voltage, etc.) to initiate a change in dimension (e.g., size, shape, diameter, etc.) of the sheath 80, which, in turn, results in the bending or angling of the catheter 50 in a desired direction to guide or steer the catheter 50 to a desired location. Further, although a physical electrical connection between the power source 25 and the steering apparatus 79 via the electrical extension 34 and the electrical connection 84 are described above, it is also to be understood that wireless connections are contemplated by the present invention.
Referring to
Referring to
Referring to
Meanwhile, referring to
Further, it should be understood that a method of guiding or steering the placement of the catheter 50 with the steering apparatus 79 as described above with respect to
In one example, the method of controlling the placement of the signal generator 58 includes first step of determining the length of the catheter 50. Next, prior to placing the catheter 50 into the human body 78 for enteral or parenteral feeding in conjunction with the steering apparatus 79, the health care provider or an assembler can place the signal generator 58 at a desired location within the catheter 50. In one particular embodiment, the sheath 80 of the steering apparatus 79 surrounds the wire assembly 38, while the signal generator 58 is located adjacent the steering apparatus 79 at a distal end 86 of the sheath 80, as shown in
Once the position of the steering apparatus 79 and signal generator 58 has been properly set, the health care provider places the transceiver 32 on the patient's chest area 76 and inserts the tubing assembly 14 of the electronic catheter unit 12 including the catheter 50 into the body 78. While doing so, the display device 22 displays graphics 37 that help the user in guiding the catheter tip 60 to a desired location within the human body 78. Once the catheter 50 is placed in the desired location via the aid of the steering apparatus 79 and the signal generating assembly 16 described in detail above, the health care provider can remove the steering apparatus 79 and signal generating assembly 16 including the wire assembly 38 and signal generator 58 while the position of the catheter 50 is maintained. The health care provider can then attach medicine and/or nutritional delivery tubes to the y-port connector 44 for introducing fluids into the body 78 for medical treatment.
It should be appreciated that the tubing assembly, electronic catheter unit and catheter position guidance system of the present invention can be used in a variety of catheter procedures and applications. These procedures may involve the treatment of the gastrointestinal tract, cardiovascular system or other portions of the human body. These procedures may involve treatment of humans by physicians, physician assistants, nurses or other health care providers. In addition, these procedures may involve treatment of other mammals and animals by veterinarians, researchers and others.
The present invention, in one embodiment, includes a tubing assembly and signal generator for an electronic catheter unit of a catheter position guidance system. The tubing assembly and signal generator are used in conjunction with other components of the system to assist the user in performing a catheter placement procedure. The tubing assembly has a position controller which enables the system to be used with catheters of variable lengths. Therefore, the tubing assembly and the position controller, used in conjunction with the catheter position guidance system of the present invention, provide an enhancement in medical treatment.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
