Tubing assembly and signal generator placement control device and method for use with catheter guidance systems

A tubing assembly having a signal generator placement control device for use in conjunction with electronic catheter guidance systems. The control device facilitates control of the position the guidance systems' signal generator relative to the end of the tubing assembly. The tubing assembly includes a tubular insulator coupled to one end of the control device, and the tubing assembly includes a tubular connector attached to the other end of control device. Also, the tubing assembly includes a catheter attached to the tubular connector and an end member attached to the catheter.

BACKGROUND OF THE INVENTION

Physicians and other health care providers frequently use catheters to treat patients. The known catheters include a tube which is inserted into the human body. Certain catheters are inserted into 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.

In some cases, health care providers use X-ray machines to gather information about the location of the catheters within the body. There are several of disadvantages with using X-ray machines. For example, these machines are relatively large and heavy, consume a relatively large amount of energy and may expose the patient to a relatively high degree of radiation. Also, these machines are typically not readily accessible for use because, due to their size, they are usually installed in a special X-ray room. This room can be relatively far away from the patient's room. Therefore, health care providers can find it inconvenient to use these machines for their catheter procedures. Furthermore, it can be inconvenient to transport these machines to a patient's home for home care catheter procedures.

Accordingly, there is a need to overcome each of these disadvantages.

SUMMARY OF THE INVENTION

The present invention generally relates to a tubing assembly for a catheter position guidance system. The catheter guidance system is used to help guide a catheter to a position located within the body. The system can be used during enteral, parenteral or other suitable catheter feeding applications.

In one embodiment, the catheter guidance system includes a signal generator attached to the end of a wire assembly or stylet. The tubing assembly of the present invention houses the signal generator and the stylet while the signal generator is in the body. The tubing assembly includes a tubular insulator, a mid-connector or union device which is connected to the tubular insulator, a y-port connector that attaches to the union device and a feeding tube or other catheter connected to the y-port connector.

The mid-connector or union device enables assemblers to conveniently set the position of the signal generator at the proper location within the catheter. This function of the union device enables a stylet of a set length to be used with catheters of variable lengths. Therefore, the tubing assembly, used in conjunction with the catheter position guidance system of the present invention, provides an enhancement in catheter placement during medical treatment.

It is therefore an advantage of the present invention to provide a tubing assembly and signal generator placement control device and method for use with catheter guidance systems.

Another advantage of the present invention is to assist the user in properly placing a catheter end within the body.

Still another advantage of the present invention is to reduce the amount of time necessary to properly guide a catheter to a desired cavity within the body.

Yet another advantage of the present invention is to reduce the amount of radiation exposure associated with machines that assist in catheter placement.

Another advantage of the present invention is to reduce the likelihood of harm caused by placing a catheter within the body.

Yet another advantage is to simplify the process of catheter placement procedures.

Still another advantage of the present invention is to increase the safety of catheter placement procedures.

Another advantage of the present invention is to adapt catheters of variable lengths to receive an electronic stylet of a pre-set length.

Yet another advantage of the present invention is to assist health care providers in guiding and locating catheters within the body at the patient's bedside.

Another advantage of the present invention is to increase the convenience of obtaining catheter placement information during and after placement of a catheter.

DETAILED DESCRIPTION OF THE INVENTION

I. Catheter Position Guidance System

Referring now to the drawings, in an embodiment illustrated inFIGS. 1 and 2, the catheter position guidance system or catheter guidance system2includes: (a) an apparatus10having a housing18which supports a controller or processor20and a display device22; (b) a non-invasive movable receiver-transmitter or transceiver32electronically coupled to the processor20by a wire, cable, signal data connection or signal carrier62; (c) a power chord27that couples the apparatus10to a power source25; (d) a printer28coupled to the apparatus10for printing out paper having graphics which indicate catheter location information; and (e) an invasive electronic catheter unit12in communication with the transceiver32and operatively coupled to the apparatus10by a wire, cable, chord or electrical extension34, which, in turn, is operatively coupled to the processor20. It should be appreciated that the transceiver32can include a device which has a separate signal receiver and signal transmitter. The transceiver32can also include a single device which functions so as to receive and transmit signals.

As best illustrated inFIG. 2, the system2, in one embodiment, includes: (a) a plurality of input devices17for providing input signals to the system2such as one or more control buttons29, a touch screen31and the transceiver32; (b) a signal generating assembly16which produces or generates electronic signals that are received by the transceiver32; (c) a memory device21including machine readable instructions and one or more computer programs (which, for example, may include a plurality of algorithms23) which are used by the processor20to process the signal data produced by the signal generating assembly16and transmitted by the transceiver32; and (d) a plurality of output devices19such as the display device22and the printer28which indicate the catheter information to the health care provider. The display device22may be any suitable display mechanism including, but not limited to, a liquid crystal display (LCD), light-emitting diode (LED) display, cathode-ray tube display (CRT) or plasma screen.

Health care providers can use the system2in a variety of catheter applications. In one example illustrated inFIG. 3, the system2is used in an enteral application. Here, a portion70of the electronic catheter unit12is placed through the patient's nose or mouth72. The distal end or tip60of the unit12is positioned in the stomach74. The health care provider places the transceiver32over the chest area76of a body78. The display device22and the printer28indicate information related to the location of the portion70of the electronic catheter unit12within the body78, as well as information related to the shape of the pathway taken by the catheter unit12. It should be appreciated that the system2need not indicate the exact location or path of the catheter unit12to provide assistance to the health care provider.

In another example illustrated inFIG. 4, a portion71of the electronic catheter unit12is introduced into the patient's body78through a vein or artery73leading to the heart75. Similar to the enteral example, the system2assists the health care provider in guiding the portion71of the unit12in the patient's vein or artery73to a desired cavity in the heart75in preparation for parenteral feeding.

II. Electronic Catheter Unit

Referring toFIG. 5, in one embodiment, the electronic catheter unit12includes a tubing assembly14which receives and houses the signal generating assembly16.

As best illustrated inFIGS. 6-7, in one embodiment, the tubing assembly14includes: (a) a tube or an electrical tubular insulator40; (b) a mid-connector or union device42which receives the tubular insulator40; (c) a multi-port connector or y-port connector44attachable to the union device42; (d) a catheter50, such as a feeding tube, connected to the y-port connector44; and (e) a catheter end, bolus or tip60attached to the distal end of the catheter50.

In one embodiment, the tubular insulator40includes a tube having: (a) a proximal end100attachable to an attachment member or neck108of the electronic catheter unit12; (b) a distal end102receivable by the union device42; (c) an internal diameter104which is substantially equal to or greater than an external diameter110of a wire assembly38described below so as to slide over the wire assembly38; and (d) an external diameter106. In another embodiment, the tubular insulator40may fit relatively tightly over the wire assembly38so as to be secured to the wire assembly38.

As best illustrated inFIGS. 8A,8B and9, in one embodiment, the union device42includes: (a) a proximal end116; (b) a distal end118; (c) a position adjuster, extender or elongated neck120positioned between the proximal end116and the distal end118; (d) a grasp or gripping member122positioned adjacent to the distal end118so as to assist users in grasping and manipulating the union device42; (e) an insert124positioned adjacent to the gripping member122which is received by the y-port connector44; and (f) an internal surface126having a blocking member or stop132which prevents the tubular insulator40from passing through the end118. The gripping member122includes a plurality of protruding walls or ribbed members136protruding from a surface123of the gripping member122assisting the user in grasping the union device42. In alternative embodiments, the surface123of the gripping member122may be rough or include other suitably shaped protrusions.

The proximal end116of the union device42has an internal diameter128and an external diameter130. When assembled, the proximal end116of the union device42is coupled to the distal end102of the tubular insulator40. In one embodiment, the internal diameter128of the proximal end116of the union device42is substantially equal to or larger than the external diameter106of the distal end102of the tubular insulator40. Referring back toFIG. 6, this enables a portion103of the distal end102of the tubular insulator40to be movably received by the elongated neck120of the union device42. As described above, the stop132(having a diameter133) of the union device42prevents the distal end102of the tubular insulator40from passing through the distal end118of the union device42.

Referring toFIGS. 10-11, in one embodiment, the multi-port or y-port connector44includes: (a) a body140; (b) a liquid delivery branch, medicine delivery branch or medicine branch142attached to the body140for distributing drugs, medicine or other medicinal liquids to the patient; (c) a nutrient delivery branch or feeding branch144attached to the body140and sized to receive the insert124of the union device42; (d) a catheter or feeding tube connection branch146attached to the catheter50; (e) a flexible or movable arm148attached to the body140; and (f) a flexible or moveable arm150attached to the body140. In an alternative embodiment, y-port connector44includes additional branches for administering various nutrients or medicines to the body78. In another alternative embodiment, the y-port connector44includes only a feeding branch144and a connection branch146. The arm148has a stopper152, and the arm150has a stopper154. The stoppers152and154are sized to prevent fluid from passing through the branches142and144after such branches142and144are plugged with stoppers152and154, respectively. In addition, the arm150includes a fastener155which secures a tube-size adapter156to the arm150. The tube-size adapter156enables fluid delivery tubes (not shown) having various diameters to connect to the feeding branch144of the y-port connector44.

As illustrated inFIGS. 12-13, in one embodiment, the catheter50includes a feeding tube with a body160having: (a) a proximal end162attached to the catheter connection branch146of the y-port connector44; (b) a distal end164; and (c) an external surface166. The proximal end162is insertable into the catheter connection branch146of the y-port connector44so as to bring the catheter50into fluid communication with the y-port connector44. In one embodiment, the external surface166has a plurality of volumetric, measurement or unit markings168uniformly spaced along the body160of the catheter. These markings168assist the user in measuring the flow or distribution of liquid to or from the patient. In an alternative embodiment, markings168function as placement markers which assist the user in assessing the depth that the catheter is placed within the human body.

As best illustrated inFIG. 13, in one embodiment, the end member, bolus or tip60is attached to the distal end164of the catheter50. The tip60includes a body172having a collar174and an end member176. The body172defines a passage178and an opening180. The opening180is positioned between the collar174and the end member176. A portion177of the end member176can have a rounded shape. The shape of the passage178and opening180of the tip60is configured to facilitate the flow of fluid from the catheter50into the patient's body while decreasing the likelihood that the opening180will become clogged.

The tubular connector40, union device42, y-port connector44, catheter and tip60can be made from any suitable polymer or plastic material including, but not limited to, polyamide, polyethylene, polypropylene, polyurethane, silicone and polyacrylonitrile.

B. Signal Generating Assembly

As best illustrated inFIGS. 14-21, in one embodiment, the invasive signal generating assembly16includes: (a) a controller coupler or an electrical connector36operatively connected to the electrical extension34; (b) an elongated wire assembly38operatively coupled to the connector36; (c) a wire or elongated stiffener39attached to the connector36and serving as a support for the wire assembly38; (d) a magnetic energy generator or magnetic field generator58operatively coupled to the distal end of the wire assembly38; and (e) a suitable fastener attaching the distal end of the elongated stiffener39to the magnetic field generator58. The tubular insulator40described above covers a portion41of the wire assembly38positioned adjacent to the connector36.

1. Electrical Connector

As best illustrated inFIGS. 16-18, in one embodiment, the electronic or electrical connector36includes: (a) a top wall or surface186; (b) a side wall or surface188attached to the top surface186; (c) a bottom wall or surface189attached to the side wall188; (d) an electronic lead assembly or electronic connector190, such as a circuit board191, positioned between the top surface186and the bottom surface189; and (e) fasteners192and194attaching the top surface186to the bottom surface189. It should be appreciated that various fasteners may be used to secure the top surface186to the bottom surface189. The fasteners192and194may be mechanical or chemical. Mechanical fasteners may, for example, include snaps, screws, rivets or other suitable fasteners. Chemical fasteners may include, for example, adhesives, chemical bonds, weld bonds or moldings suitable for securing the top surface186and the bottom surface189together. Although the embodiment illustrated inFIG. 16has multiple fasteners192and194passing through the circuit board191, it should be understood that, in other embodiments, a single fastener may securely position the circuit board191between the two surfaces186and189.

The circuit board191, in one embodiment, includes: (a) contact members196and198extending across a portion193of the circuit board190; and (b) a reserve contact member200extending across the circuit board190. The contact members196,198and200can be made from any conductive materials. When the electronic connector190is connected to the electrical extension34, the contact members196,198and200are operatively coupled to the apparatus10of the system2. Therefore, the contact members196and198transmit electrical current from the apparatus10to the magnetic energy generator or magnetic field generator58described below.

2. Wire Assembly

As best illustrated inFIGS. 16,18and21, in one embodiment, the wire assembly38includes: (a) an elongated flexible conductor such as a copper wire202having a proximal end206connected to the circuit board190and a distal end251connected to the magnetic field generator58; and (b) another elongated flexible conductor such as a copper wire204having a proximal end212connected to the circuit board190and a distal end253connected to the magnetic field generator58. In one embodiment, the copper wire202and copper wire204include a polymeric coating218. The proximal end206of the copper wire202is operatively coupled to an extension197of the contact member196of the circuit board191. Likewise, the proximal end212of the copper wire204is operatively coupled to an extension199of the contact member198of the circuit board191. The copper wires202and204can be soldered to the appropriate contact members196and198or attached by any suitable fastener.

In one embodiment described below, the distal ends251and253of the copper wires202and204have a coil configuration forming coils250thereby producing a magnetic field generator58as described below. The coil248is formed from a plurality of spirals252produced by wrapping a portion249of the copper wire204around the magnetic field generator58as described below.

Referring back toFIG. 16, the copper wire202and the copper wire204are twisted around each other along the lengths210and216to form a twisted configuration217. In one embodiment, the copper wires202and204are twisted a suitable number of times along the lengths210and216. The twisted configuration217reduces any electromagnetic field surrounding the wires202and204along the twisted lengths210and216. This reduction is caused by the counteraction of the electromagnetic forces of the electrical wires202and204. Accordingly, the hand-held transceiver32receives less, if any, signal interference arising from any electromagnetic fields generated by the wire assembly38.

As illustrated inFIG. 18, in one embodiment, the elongated stiffener39includes a bend or center portion228. The elongated stiffener39is preferably made of steel but can be made of any other suitable material. The center portion228of the elongated stiffener39is looped around the fastener192of the connector36forming a segment230and a segment232. The segments230and232are twisted around each other forming a twisted configuration234. The twisted configuration234increases the rigidity of the elongated stiffener39. In one embodiment, the wire assembly38is twisted into the grooves219of the twisted configuration234. This increases the space efficiency of the wire assembly38and the elongated stiffener39positioned within the tubing assembly14. The increase in space efficiency is a result of reducing the overall diameter110of the wire assembly38, as illustrated inFIG. 7.

3. Signal Generator

As best illustrated inFIG. 20, in one embodiment, the signal generator or magnetic field generator58is formed through a plurality of spirals or coils250of the wires202and204. As the apparatus10transmits electrical current through the wires202and204, the current travels in a circular path defined by the coils250. This circular motion of current produces an electromagnetic field, B field or electromagnetic radiation258. Although the embodiment illustrated includes the coils250as the magnetic field generator58, it should be appreciated that the magnetic field generator58can include any alternate suitable mechanism or device which generates or produces magnetic energy or a magnetic field. In one embodiment, the magnetic field generator58includes a magnet such as a permanent magnet, resistive magnet or superconducting magnet.

In operation, when the apparatus10sends electrical current to the coils250, and the coils250transmit a signal or electromagnetic field258capable of being detected by the non-invasive transceiver32. The transceiver32detects the electromagnetic field or signal258generated by the magnetic field generator58inside the human body. The processor20causes the display device22and the printer28to produce graphics which assist the health care provider in the catheter placement procedure.

C. Method of Controlling Placement of Signal Generator

As illustrated inFIGS. 21-25, several difficulties could arise if a catheter assembly300does not have the stop member132and position adjuster or controller120of the union member42of the present invention. For example, a catheter procedure may involve positioning the tip60of a catheter50to a desired location. During the manufacturing process for the catheters50, the catheters50may have length variations V1, V2and V3ranging up to one and one-fourth of an inch. In one embodiment, catheters50are constructed of a polyurethane material which provides the catheters50with a tendency to expand or contract during or after the manufacturing process thereby causing such variations. If one of the catheters50is too long, the magnetic field generator58could protrude through the tip60as illustrated inFIG. 21. If one of the catheters50is too short, the magnetic field generator58could substantially stop short of the tip60as illustrated inFIG. 22. This may result in a decrease in reliability of the information and graphics provided by the catheter position guidance system2of the present invention.

The system2is more helpful when the magnetic field generator58is positioned at or near the tip60of the catheter50. This positioning helps maintain an adequate level of reliability of guidance information provided by the system2. In the embodiments best illustrated inFIGS. 1-20and23-25, the union device42assists in maintaining the position of the magnetic field generator58at or near the tip60. The use of the union device42, in one such embodiment, reduces the likelihood that the magnetic field generator58might protrude through the tip60or stop substantially short of the tip60. Therefore, the union device42functions as a generator placement control device. In one embodiment, this placement and control function of the union device42is adjustable to conform to catheters50that have different lengths.

As best illustrated inFIGS. 24-25, the union device42has a proximal end116, a distal end118and a position controller, position adjuster or elongated neck120. The proximal end116is movably coupled to the distal end102of the tubular insulator40. The position adjuster or elongated neck120defines a passage134which provides the position adjustment function or adjustment device of the union device42. The user can adjustably position the second end102of the tubular insulator40to a plurality of different locations138(for example, L1-L3) along the passage134. Once the user determines the proper location138, the user fixes the tubular insulator40to the position adjuster120at that selected location. The position may be fixed using an adhesive, clip, clasp, tape or any other suitable fastener. Because the tubular insulator40is connected to the electrical connector36which, in turn, is connected to the magnetic field generator58, the fastening of the tubular insulator40to the proper location on the position adjuster120assists in the proper positioning of the magnetic field generator58relative to the tip60of the catheter50. This allows the user to position the magnetic field generators58at a desired or designated location relative to the end members or tips60of catheters50of various lengths. Thus, users can use the system2with manufactured catheters50having various lengths.

In one example, the method of controlling the placement of the generator58includes first step of determining the length of the catheter50. Next, prior to placing the catheter50into the human body for enteral or parenteral feeding, the user or assembler places the magnetic field generator58at a desired location within the catheter50. Finally, the assembler locks this placement by fastening the tubular insulator40to the union device42using a suitable adhesive.

Once the position of the generator58has been properly set, the health care provider places the transceiver32on the patient's chest and inserts the catheter50into the body. While doing so, the display device22displays graphics37that help the user in guiding the catheter tip60to a desired location within the human body. Once the catheter50is placed in the desired location, the user removes the signal generating assembly16while the position of the catheter50is maintained. The user then attaches medicine and nutritional delivery tubes to the y-port connector44for introducing fluids into the body for medical treatment.

It should also be understood that, in alternate embodiments, the electronic catheter unit of the present invention need not include the generator position control device described above. Here, the assemblers may measure each catheter and disregard each catheter that is too long or too short. It should be appreciated that other assembly processes and mechanisms may be used to control the proper location of the field generator58relative to the catheter tip60.

It should also 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.