Patent Application
20090149834
1. Field of the Invention
This invention relates to catheters.
2. Description of the Related Art
Catheters, such as feeding and aspirating tubes, are generally inserted into a person's gastrointestinal tract through his or her nasal passage. Some examples of feeding and aspiration tubes are disclosed in U.S. Pat. Nos. 3,618,613, 4,543,089, 4,642,092, 4,705,511, 4,806,182, 5,334,169, 5,599,325, 5,676,659, 5,947,940 and 6,508,804. Some catheters are dual lumen devices which include feeding and aspiration tubes. Examples of dual lumen devices are disclosed in U.S. Pat. Nos. 5,807,311, 6,881,211 and 6,921,396.
The feeding tube is used to provide a patient with food internally and is often referred to as an enteral feeding catheter. Food is provided to nourish the patient, help him or her heal faster and resist infection, which decreases the patient recovery time. The aspirating tube is used to reduce abdominal distention, which occurs when swallowed air accumulates, and too much food is provided internally relative to its rate of absorption. Abdominal distention can impair the ability of the patient to breathe deeply and adequately cough to clear secretions. Abdominal distention can also cause discomfort and slow down the rate of bowel absorption. A slower rate of bowel absorption causes undernourishment and slows down the healing process, which increases the patient recovery time. Hence, it is desirable to reduce abdominal distention while providing the patient with sufficient nourishment to facilitate his or her recovery.
These feeding and aspirating tubes generally contact sensitive tissue, such as tissue in the nasal passage, or must penetrate healthy tissue to enter the stomach or intestine. Further, these feeding and aspirating tubes often have to reside within the nasal passage and gastrointestinal tract for a prolonged period of time. Hence, it is desirable to provide feeding and aspirating tubes which have a reduced wall thickness and still restrict the ability of the tube to kink. This allows more material to flow through the tube, without increasing patient discomfort.
The present invention employs a catheter which includes a spring positioned between inner and outer layers of resilient material. In one embodiment, the inner and outer layers of resilient material are in the form of inner and outer tubes, respectively, and the spring is a helical coil of wire. The inner and outer tubes are coupled together so that the spring is held between them. The spring restricts the ability of the inner and outer tubes to kink, and the combined thickness of the inner and outer layers is less than or equal to the diameter of the wire. In this way, the catheter is less bulky and is less likely to kink. The thinner walled catheter is more comfortable when it is used as an enteral feeding catheter. Catheters, in accordance with the invention, can be fabricated with a thickness less than about one-quarter the thickness of catheters currently available.
In one embodiment, the catheter includes first and second springs positioned between the inner and outer layers of resilient material. The first spring extends along a proximal portion of the catheter and the second spring extends along the distal portion. When the catheter is inserted into the patient, the proximal portion is within the nasal passage, and the distal portion extends into the stomach or beyond. The first and second springs can have a different number of turns per unit length. In some embodiments, the first spring has a larger number of turns per unit length then the second spring so that the catheter is less likely to kink when making the obligatory sharp bend in the patient's nasal passage. The distal portion of the catheter is not subjected to as severe bending forces, and the greater distance between turns of wire allow for easier cutting of orifices.
The present invention provides a method of manufacturing a catheter which includes providing inner and outer layers of resilient material and positioning a spring between them. The inner and outer layers of resilient material are in the form of inner and outer tubes, respectively, and the spring is a helical coil of wire. The inner and outer tubes are coupled together so that the spring is held between them. The inner and outer tubes can be coupled together in many different ways, such as by applying heat to them so they fuse together. In one embodiment of manufacturing the catheter, first and second springs are positioned between the inner and outer tubes, wherein the first spring extends along a proximal portion of the catheter and the second spring extends along the distal portion.
The present invention provides a method of using the catheter which includes inserting it through patient's nasal passage so it extends to the gastrointestinal tract. Alternatively, the catheter can be inserted through healthy tissue directly into the gastrointestinal tract.
These and other features, aspects, and advantages of the present invention will become better understood with reference to the following drawings and description.
a is a side view of the catheter of
b is a cut-away side view of a portion of the catheter of
a is a partial cut-away view of the inner and outer tubes of
b is a partial cut-away view of the inner and outer tubes of
a is a side view of a catheter, in accordance with the invention, which includes two springs.
b is a cut-away side view of a portion of the catheter of
c is a cut-away side view of the proximal and distal portions of the catheter of
a is a perspective view of a dual lumen device which includes the catheter of
b is a close-up perspective view of the dual lumen device of
a is a perspective view of another dual lumen device which includes the catheter of
b is a close-up perspective view of the dual lumen device of
a,
10
b,
10
c and 10d are flow diagrams of methods of manufacturing a catheter, in accordance with the invention.
a and 11b are flow diagrams of methods of using a catheter, in accordance with the invention.
a is a side view of catheter 101, in accordance with the invention. In this embodiment, catheter 101 includes a connector 101c connected to proximal portion 101a and a tip 105. Connector 101c allows catheter 101 to be connected to a machine (not shown), such as a feeding or suction machine, and tip 105 retains distal portion 101b in the gastrointestinal tract.
b is a cut-away side view of a portion of catheter 101, in accordance with the invention, as shown in a region 108 of
In this embodiment, spring 104 extends through both proximal and distal portions 101a and 101b. In this way, catheter 101 includes one spring. Examples of springs which can be used in catheter 101 are disclosed in some of the patents referenced in the background of this application. The spring is generally helical in shape and includes a helical wire with multiple coils, wherein the helical wire is typically a round wire or a flat wire. When the helical wire is a round wire, it has a thickness that corresponds to its diameter because it has a circular cross-section. When the helical wire is a flat wire, it has a thickness that corresponds to its width because it has a rectangular cross-section. One example of spring 104 when it includes a flat wire is indicated by an indication arrow 129. The width of the flat wire extends radially outward from catheter 101, and the length of the flat wire extends transversely. It should be noted that, in this embodiment, the width of the flat wire is greater than its length.
Inner and outer tubes 102 and 103 can include many different types of resilient materials, but here they include biocompatible material that is flexible and elastic. The material can be of many different types, such as polyurethane, polysiloxane, and polyfluorohydrocarbons (“Teflon”). It should be noted that resilient materials are often referred to as elastomers. Examples of materials which can be used in catheter 101 are disclosed in some of the patents referenced in the background of this application. It should be noted that inner and outer tubes 102 and 103 generally include single layers of resilient material in the shape of a tube.
Inner and outer tubes 102 and 103 generally include the same materials. However, catheter 101 can be manufactured so that inner and outer tubes 102 and 103 include different materials. When inner and outer tubes 102 and 103 include the same material, they are more likely to be coupled together and to remain coupled together. When inner and outer tubes 102 and 103 include different materials, they are more likely to decouple from each other. The coupling and decoupling of materials is often referred to as lamination and delamination, respectively. More information regarding lamination and delamination is provided in U.S. Pat. No. 4,806,182.
One reason inner and outer tubes 102 and 103 are used in catheter 101 is because they have a predetermined thickness, which is generally uniform along their lengths. Hence, the thickness of them combined together can be better controlled, so that the thickness of catheter 101 is better controlled. Further, inner and outer tubes 102 and 103 with desired thicknesses can be chosen before they are coupled together. In this way, the thickness of the combination of inner and outer tubes 102 and 103 can be chosen and better controlled. Other embodiments of catheters, such as those disclosed in U.S. Pat. No. 3,618,613, include a coating. However, it is difficult to control the thickness and uniformity of the coating.
Catheter 101 has a wall thickness t5, which can have many different values. In accordance with the invention, thickness t5 is less than about 0.008 inches. In one embodiment, thickness t5 is between about 0.008 inches and 0.001 inches. In another embodiment, thickness t5 is between about 0.001 inches and 0.004 inches. In some embodiments, thickness t5 is between about the thickness of spring 104 to about three times the thickness of spring 104. It should be noted that thickness t5 generally varies along the length of catheter 101. For example, thickness t5 is generally smaller between adjacent coils of spring 104 and larger proximate to the coils of spring 104.
Inner tube 102 has a diameter d1 that is smaller than a diameter d2 of outer tube 103 so that inner tube 102 will fit inside of outer tube 103. Further, spring 104 has a diameter d3 that it larger than diameter d1 of inner tube 102. Inner tube 102 is positioned within an opening 104a of spring 104, and inner tube 102 and spring 104 are positioned within an opening 103a of outer tube 103. Inner and outer tubes 102 and 103 are coupled together so that spring 104 is positioned between them, as shown in
Inner and outer tubes 102 and 103, as well as spring 104, can be manufactured in many different ways. For example, inner and outer tubes 102 and 103 can be manufactured by rolling flat pieces of resilient material into tubes. Inner and outer tubes 102 and 103 can also be extruded. Inner and outer tubes 102 and 103 can be extruded in many different ways, such as those disclosed in U.S. Pat. Nos. 4,791,965, 4,888,146, 5,102,325, 5,542,937, 6,045,547, 6,165,166, 6,434,430, 6,692,804, 6,773,804 and 6,776,945. Spring 104 can be made in many different ways, such as those disclosed in U.S. Pat. Nos. 4,302,959, 5,363,681, 6,006,572, 6,923,034 and 7,198,187.
a and 6b are partial cut-away side views of catheter 101 showing one way it can be manufactured.
a is a side view of a catheter 110, in accordance with the invention. In this embodiment, proximal portion 101a extends a length L1 along catheter 111 and distal portion 101b extends a length L2 along catheter 111. Length L1 can have many different length values, but it is generally between about six inches to about eighteen inches. Length L2 can also have many different length values, but it is generally greater than length L1. It should be noted that the length values of L1 and L2 typically depend on the size of patient 100. For example, lengths L1 and L2 are typically chosen so that it terminates within the gastrointestinal tract of person 100. In accordance with the invention, catheter 110 includes two springs, wherein one spring extends through proximal portion 101a and the other spring extends through distal portion 101b.
b is a cut-away side view of a portion of catheter 101 included in proximal portion 101a. It should be noted that the portion of catheter 101 shown in
As indicated by an indication arrow 125,
Thicknesses t1, t2 and t3 can have many different values relative to each other. In accordance with the invention, thickness t3 is greater than thickness t1. Further, thickness t3 is greater than thickness t2. In the embodiment indicated by indication arrow 125, thickness t3 is greater than the combination of thicknesses t1 and t2.
However, in other embodiments, such as the one indicated by an indication arrow 126 in
c is a cut-away side view of proximal and distal portions 101a and 101b in a transition region 109 of
In accordance with the invention, the helical wire of spring 104b includes a number of turns per unit length that is different from the number of turns per unit length of the helical wire of spring 104c. In this embodiment, the number of turns per unit length L of spring 104b is greater than the number of turns per unit length L of spring 104c. It should be noted that springs 104b and 104c can be the same or similar to spring 104, which is discussed in more detail above.
As indicated by an indication arrow 127,
As indicated by an indication arrow 128,
Catheter 101 can be inserted into patient 100 in many different ways. In this embodiment, length L1 (
a is a perspective view of a dual lumen device 113, in accordance with the invention. More information regarding dual lumen devices can be found in U.S. patent application Ser. No. 11/838,657, entitled “DUAL LUMEN GASTROINTESTINAL FEEDING AND ASPIRATING DEVICE”, filed on Aug. 14, 2007 by Kurt W. Grathwohl, the contents of which are incorporated herein by reference. In this embodiment, dual lumen device 113 includes an aspiration tube 111 and catheter 101, wherein catheter 101 extends through aspiration tube 111. Hence, aspiration tube 111 extends around catheter 101.
In accordance with the invention, catheter 101 includes inner and outer tubes 102 and 103 with a spring positioned between them, as discussed in more detail above. In some embodiments, the inner periphery of aspiration tube 111 is attached to outer tube 103 and, other embodiments, catheter 101 extends through aspiration tube 111, but it is not attached to it. In some embodiments, aspiration tube 111 is thicker than the combination of inner and outer tubes 102 and 103 so that it protects them from being damaged.
b is a close-up perspective view of dual lumen device 113, wherein aspiration tube 111 includes spring 104 and inner and outer tubes 102 and 103, wherein spring 104 is positioned between inner and outer tubes 102 and 103. Aspiration tube 111 can be of many different types, such as those disclosed in U.S. patent application Ser. No. 11/838,657. However, in some embodiment, aspiration tube 111 can have the same or a similar configuration as catheter 101. For example, aspiration tube 111 can include inner and outer tubes with a spring positioned therebetween, as shown in
a is a perspective view of a dual lumen device 114, in accordance with the invention. It should be noted that dual lumen device 114 can include the same features of dual lumen device 113. In this embodiment, dual lumen device 114 includes catheter 101 attached to and carried by an aspiration tube 111, wherein catheter 101 operates as a feeding tube. In accordance with the invention, catheter 101 includes inner and outer tubes 102 and 103 with a spring positioned therebetween, as discussed in more detail above, wherein the outer periphery of aspiration tube 111 is attached to outer tube 103.
It should be noted that dual lumen devices 113 and 114 are shown here as being a single integrated piece, but they can be separate pieces in other embodiments. For example, catheter 101 and aspiration tube 111 can be separate pieces coupled together. In other embodiments, dual lumen device 114 is a single tube having separate feeding and aspiration channels extending through it. More information regarding feeding and aspiration tubes can be found in U.S. Pat. Nos. 4,543,089 and 4,642,092 by Moss, both of which are incorporated herein by reference.
In accordance with the invention, aspiration tube 111 also operates as a stent for the insertion of an instrument into a patient, as discussed in more detail in U.S. patent application Ser. No. 11/838,657. The instrument can be of many different types, but it is generally a medical instrument, such as a gastroscope. The instrument is elongated so its distal end can be moved through aspiration tube 111 between locations internal and external to the patient.
b is a close-up perspective view of dual lumen device 114, wherein aspiration tube 111 includes spring 104 and inner and outer tubes 102 and 103, wherein spring 104 is positioned between inner and outer tubes 102 and 103. Aspiration device 111 generally includes opposed orifices and/or windows, as described in more detail in U.S. patent application Ser. No. 11/838,657. In this embodiment, dual lumen device 114 includes orifices 112, wherein orifices 112 extend through aspiration tube 111 between adjacent coils of spring 104.
a is a flow diagram of a method 200 of manufacturing a catheter, in accordance with the invention. In this embodiment, method 200 includes a step 201 of providing a spring having a coil of wire. It should be noted that the coil of wire can be in many different forms, but here it is a helical coil of wire. Method 200 includes a step 202 of providing inner and outer layers of resilient material. The inner tube has a smaller diameter than the outer tube so that the inner tube will fit within the outer tube. In accordance with the invention, the first and second layers of resilient material each have a combined thickness that is less than the thickness of the wire included with the spring.
The inner and outer layers of material are generally in the form of inner and outer tubes, respectively. The inner and outer layers of resilient material can be provided to the user in the form of tubes (i.e. preformed), or they can be formed into tubes by the user, such as by extrusion. Further, the spring can be provided to the user preformed or it can be formed by the user. In some embodiments, the inner and outer tubes include the same material, but, in other embodiments, the inner and outer tubes include different materials. In some embodiments, the inner and outer tubes include single layers of material, but, in other embodiments, the inner and outer tubes include multiple layers or materials.
Method 200 includes a step 203 of positioning the spring between the inner and outer layers of resilient material. Method 200 includes a step 204 of coupling the inner and outer layers of resilient material together so the spring is held therebetween. Portions of the inner and outer layers of resilient material between the coils of the helical wire are typically coupled together. The inner and outer layers of resilient material can be coupled together in many different ways, such as by applying heat to them so they fuse together.
b is a flow diagram of a method 205, in accordance with the invention, of manufacturing a feeding tube. In this embodiment, method 205 includes a step 206 of providing first and second springs, which can be of many different types. In this embodiment, the first and second springs include helical coils of wire. In some embodiments, the number of turns per unit length of the first and second springs are different. For example, the first spring can have a number of turns per unit length that is greater than the number of turns per unit length of the second spring. In some embodiments, the distance between each adjacent coil in the first spring is driven to equal the diameter of the wire of the first spring.
Method 205 includes a step 207 of providing inner and outer layers of resilient material. The inner and outer layers of resilient material are generally in the form of inner and outer tubes, respectively, wherein the diameter of the inner tube is less than the diameter of the outer tube. Method 205 includes a step 208 of positioning the first and second springs between the inner and outer layers of resilient material, and a step 209 of coupling the inner and outer layers of resilient material together so the first and second springs are held between them. In this embodiment, the first spring extends along a proximal portion of the feeding tube and the second spring extends along the distal portion.
c is a flow diagram of a method 210 of manufacturing a catheter, in accordance with the invention. In this embodiment, method 210 includes a step 211 of extruding an inner tube and a step 212 of winding a wire around the inner tube, wherein the wire forms a helical coil that operates as a spring. Method 210 includes a step 213 of extruding an outer tube so that it is over the wire and inner tube. While portions of the inner and outer tubes are being extruded, the portions of the inner and outer tubes that have been extruded are fused together so that the spring is held between them. It should be noted that the spring is typically wound around the inner tube in a controlled manner so that the number of turns per unit length is controlled. For example, the number of turns per unit length can be adjusted as the inner tube is extruded. The number of turns per unit length can be adjusted by increasing or decreasing its value.
d is a flow diagram of a method 215 of manufacturing a catheter, in accordance with the invention. In this embodiment, method 215 includes a step 216 of extruding an inner tube having first and second layers of resilient material. In one embodiment, the first layer of material includes Teflon and the second layer of material includes another material, such as polyurethane. In general, the first layer of material has less friction than the second layer of material so that an instrument can slide through the catheter easier. Method 215 includes a step 217 of winding a wire around the inner tube, wherein the wire forms a helical coil that operates as a spring. In this embodiment, the wire is adjacent to the second layer of material. Method 215 includes a step 218 of extruding an outer tube so that it is over the wire and inner tube. While portions of the inner and outer tubes are being extruded, the portions of the inner and outer tubes that have been extruded are fused together so that the spring is held between them.
a is a flow diagram of a method 220 of using a catheter, in accordance with the invention. In this embodiment, method 220 includes a step 221 of providing a catheter which includes inner and outer layers of resilient material and a spring positioned between them. The inner and outer layers of resilient material are generally in the form of inner and outer tubes, respectively, wherein the inner tube can fit inside the outer tube. It should be noted that the catheter generally includes one or more lumens. Further, in some embodiments, the catheter can be included in a dual lumen device. Method 220 includes a step 222 of inserting the catheter into a patient through his or her nasal passage, so it extends to the gastrointestinal tract.
b is a flow diagram of a method 230 of using a catheter, in accordance with the invention. In this embodiment, method 230 includes a step 231 of providing a catheter which includes inner and outer layers of resilient material and first and second springs positioned between them. The first and second springs can be of many different types, such as helical coils of wire. In some embodiments, the number of turns per unit length of the first and second springs are different. For example, the first spring can have a number of turns per unit length that is greater than the number of turns per unit length of the second spring. In some embodiments, the distance between each adjacent coil in the first spring is driven to equal the diameter of the wire of the first spring. In this embodiment, the first spring extends along a proximal portion of the feeding tube and the second spring extends along the distal portion.
Method 230 includes a step 232 of inserting the catheter into a patient through his or her nasal passage, so it extends to the gastrointestinal tract. The catheter is positioned so that its proximal portion is adjacent to the patient's nasal passage and the distal portion extends through the patient's gastrointestinal tract. In this way, the first spring is adjacent to the patient's nasal passage and the second spring is not. The length of the catheter is chosen so that the proximal portion extends through the patient's nasal passage and the distal portion extends into the patient's gastrointestinal tract.
It should be noted that the steps in the methods disclosed herein can be carried out in many different orders. It should also be noted that the catheters of the methods disclosed herein generally include one or more lumens. Further, in some embodiments, the catheters can be included in a dual lumen device. For example, the catheter can be attached to and carried by an aspiration tube, wherein the aspiration tube can include inner and outer layers of resilient material with a spring positioned between them. The methods disclosed herein can include one or more of the steps disclosed in the methods described in U.S. patent application Ser. No. 11/838,657.
The embodiments of the invention described herein are exemplary and numerous modifications, variations and rearrangements can be readily envisioned to achieve substantially equivalent results, all of which are intended to be embraced within the spirit and scope of the invention.
