MXPA01005810A - Polyurethane feeding tube and associated adaptors - Google Patents

Abstract

Feeding tube assembly includes a feeding tube made of a polyurethane, preferably Carbothane, and a feeding tube adaptor including at least an inlet conduit and an outlet conduit. In one aspect, the feeding tube adaptor is made of a substantially rigid material, and the exterior surface of the outlet conduit defines a retention member to engage an interior surface at a first end portion of the feeding tube when the outlet end of the outlet conduit is inserted within a lumen defined in the feeding tube. In accordance with another aspect, the tube adaptor is provided with a removable cap to close selectively the inlet conduit, and both the inlet conduit and the cap are made of polyurethane. The cap has an engagement surface to engage a corresponding surface of the first inlet conduit, wherein the engagement surface of the cap has a surface configuration different than that of the corresponding surface of the first inlet conduit. This difference in surface configurations can be established by providing one or both of the surfaces with a series of protuberances, a series of indentations, a different cross-sectional shape, or a combination thereof.

Description

RETURNED POLYU FEED PIPE AND ASSOCIATED ADAPTERS This is a request from continuation of the previous application Serial No. 09 / 010,41 1, filed on January 21, 1998.

BACKGROUND OF THE I NVENC ION CAM PO OF THE INVENTION This invention refers to an apparatus useful in the placement of a percutaneous endoscopic gastronomic tube. In particular, the present invention is directed to an introducer attached to a receptacle around which a positioning wire is placed. Following insertion of the introducer into a selected portion of a patient's gastrointestinal tract, the placement wire is inserted into a patient through the introducer by turning the receptacle, whereby the wire advances through the introducer. The present invention also relates to a feeding tube assembly for placement in the gastrointestinal tract of a patient. Particularly, the feed tube assembly includes a feed tube made of polyurethane, and most preferably Cabothane, and a feed tube adapter provided in a first end portion thereof. In accordance with one aspect of this invention, the connector of the feeding tube is made of a substantially rigid material and includes a retaining member for frictional engagement with the feeding tube. According to another aspect of the invention, the feed tube connector is provided with a cover, both of which are made of a polyurethane, wherein the cover has a coupling surface with a surface configuration different from that of a corresponding surface of the feed tube connector.

DESCRIPTION OF THE RELATIVE TECHNIQUE Gastrostomy and jejunostomy tubes are used to deliver nutritional products to the gastrointestinal tract of a patient who has difficulty in ingesting food. The gastrostomy tubes deliver the products nutritionally percutaneously from an external source, through the patient's abdominal wall, and directly to the patient's stomach, while the jejunostomy tubes deliver the nutritional products percutaneously to the jejunum. small intestine of the patient. In addition to primary placement percutaneously through the patient's abdominal wall, the gastrostomy and jejunostomy tubes can be placed in the patient's gastrointestinal tract through a mature stoma formed in the abdominal wall, or through the nasal passage using nasogastric or nasojejunal tube, respectively. The gastrostomy, jejunostomy, nasogastric and nasojejunal tubes are collectively referred to herein as "feeding tubes", unless otherwise indicated. The first step for primary percutaneous placement of a feeding tube in a patient typically involves the passage of an endoscope through the patient's esophagus in order to see the esophagus and determine whether or not there are any obstructions or lesions in the esophagus that will inhibit or prevent the passage of the feeding tube through the esophagus. The endoscope is also used to examine the inside of the stomach and / or the small intestine. Next, the doctor visually selects the site through which the feeding tube to the stomach will be introduced and transilluminates the selected site by directing light out from the endoscope so that the light shines through the patient's abdominal wall so that The doctor is allowed to identify the entry site from a point outside the patient's body. The doctor then inserts a catheter or introducer through the patient's abdominal wall and into the stomach at the selected entry site. A first end of a positioning wire is then passed through the introducer and into the stomach. The first end of the wire is clamped using a clamping tool associated with the endoscope, and the endoscope and placement wire are pulled out of the patient's stomach and esophagus through the patient's mouth. Upon completion of this step of the procedure, a second end of the wire remains external to the abdominal wall of the patient while the first end of the wire extends out of the patient's mouth. The laying wires can have a variety of shapes. In a commercially available embodiment, the laying wire is a double wire coated with a biocompatible plastic material. However, other forms of laying wires are well known. These placement wires are typically provided in a sterile package for use by a medical professional. For example, the placement wire can be rolled up and placed in a sealed bag. The wire is removed from the bag immediately before placement in a patient. This packing methodology has certain disadvantages because the wire is prone to becoming entangled during insertion into the patient. Thus, the wire must be carefully manipulated in order to ensure that it is fed properly through the introducer and the patient. Such handling can result in contamination by touching the wire as it is handled. In addition, in order to ensure that the wire is properly fed to the patient's stomach, it is sometimes necessary to have a person handle the wire while a second person feeds the wire into the patient. This need for additional medical personnel increases the cost of placing the feeding tube in the patient. In a different commercially available embodiment, the wire is a "silk" type yarn that is loosely wound in a provided fastener. The yarn extends through a hole in the fastener and can be pulled out from the fastener through the hole. As the endoscope is removed through the patient's esophagus, an insulator should carefully pull the fastener thread and allow it to be fed through the catheter. This embodiment also has certain disadvantages due to the fact that an assistant is required in order to manipulate and feed the thread into the catheter. In addition, it is typically necessary to create a knot at the end of the thread before attaching it to a feeding tube. In some cases, the creation of this knot can be difficult due to the physical characteristics of the silk thread after it has been pulled through the stomach, esophagus and mouth of the patient. In another commercially available embodiment, the positioning wire is retained in a rigid pipe spool. The wire can be difficult to handle and therefore may require the presence of an assistant to remove the wire from the rolled pipe. However, this method tends to reduce the entanglement of the placement wire during the placement of the wire in the patient. Another modality still commercially available includes a positioning wire provided in a circular spout. Although this embodiment tends to minimize the entanglement of the laying wire, the wire may still be difficult to supply from the circular spout and therefore requires the presence of an assistant.

It is preferable to provide a positioning wire in such a way that (a) the possibility of entangling the wire is minimized; (b) the possibility of contamination by touch of the wire is minimized; and (c) removal of the wire from its packaging does not require additional personnel. The present invention is directed to each of these. With the wire inserted properly, initial or primary placement of a feeding tube can be performed percutaneously in the patient's gastrointestinal tract. In another technique for primary placement of the feeding tube, the first end of the positioning wire is attached to a first end of a feeding tube. The connection of the feeding tube to the first end of the laying wire is facilitated by a curl at the first end of the laying wire and by means of a complementary curl at the first end of the feeding tube. Pulling the second end of the wire placed external to the patient's abdominal wall, the feeding tube is pulled through the mouth and esophagus of the patient, and into the stomach. The additional pulling of the second end of the wire causes the first end of the feeding tube to exit percutaneously from the stomach through a tract in the abdominal wall formed by the introducer. The feeding tube is pulled out through the tract until a retaining member mounted on the second end of the feeding tube engages with the inside of the stomach. This technique is referred to as a "shot" technique.

In an alternative technique for primary placement of feeding tube, a defined channel through the feeding tube is placed on the wire so that the feeding tube can be pushed along the length of the wire. As the feeding tube is pushed over the wire, it passes through the mouth, esophagus and stomach of the patient until the first end of the feeding tube exits through the incision in the abdominal wall. The feeding tube is then pulled out through the abdominal tract until a retention member at the second or inner end of the feeding tube engages with the interior of the stomach. The wire is then removed from the patient through the channel of the feeding tube. This technique is referred to as a "push" technique. Still another method can be used for percutaneous placement of the feeding tube, particularly when passage through the esophagus is excluded. This method, which is commonly referred to as the "knock" technique, is most frequently used to place a feeding tube having an internal balloon-type retention member. Once a secure site in the stomach is identified, the blow technique requires that the stomach wall be retracted and secured against the patient's abdominal wall using a known anchoring device, such as T-Fasteners °. One or more dilators are then used in sequence to form a suitable tract of sufficient size through which the feeding tube and retention member can be inserted in a deflated state. The retaining member is then inflated in its proper position to ensure the placement of the feeding tube. After a stoma tract has been completely formed through the abdominal wall of the patient using any of the techniques outlined above, the initial feeding tube may be removed if desired or secondary placement of a different feeding tube is necessary. In this way, a new feeding tube can be inserted directly into the developed stoma tract that is formed through the abdominal wall of the patient and is retained in a conventional manner. A variety of feeding tube configurations made of different materials are well known and are each suitable for their intended purpose. However, there remains a continuing need for feed tube assemblies with improved operational characteristics and cost-effective construction.

BRIEF DESCRIPTION OF THE INVENTION The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practicing the invention. Additional advantages of the invention will be noted and obtained by the methods and systems set forth particularly in the description and written claims thereof, as well as from the accompanying drawings. In order to achieve these and other advantages and in accordance with the purpose of the invention, as described and incorporated broadly, the invention includes a method for placing a wire feeding tube into a patient. The method includes the step of providing a placement wire spout. The dispenser includes a rotating positioning wire receptacle that defines a placement wire exit. The spout further includes a tube extending outwardly from the placement wire receptacle. The tube defines a placement wire entry that is in communication with the placement wire outlet of the receptacle. A positioning wire is wound around the receptacle, and is in mechanical engagement with the receptacle, so that rotation of the positioning wire receptacle causes a first end of the positioning wire to advance through the positioning wire outlet, through the wire entry of the tube placement, and through the tube. A first end of the tube is constructed for insertion through an abdominal wall of the patient and into a patient's stomach. The method further includes the step of placing the first end of the tube through an abdominal wall of the patient and the stomach of the patient. The rotational movement is imparted to the receptacle to advance the positioning wire through the positioning wire outlet, through the placement wire entry, through the tube and into the patient's stomach. The present invention also includes a placement wire spout. The dispenser includes a rotating positioning wire receptacle that defines a placement wire exit. The spout further includes a tube extending outward from the positioning wire receptacle. The tube defines a placement wire entry that is in communication with the placement wire outlet of the receptacle. A positioning wire is wound around the receptacle, and is in mechanical engagement with the receptacle, so that rotation of the positioning wire receptacle causes a first end of the positioning wire to advance through the positioning wire outlet, through the wire entry, tube placement, and through the tube. A first end of the tube is constructed for insertion through an abdominal wall of the patient and into a patient's stomach. The present invention is furthermore directed to a feeding tube placement package. The package includes a placement wire spout. The dispenser includes a rotating positioning wire receptacle that defines a placement wire exit. The spout further includes a tube extending outward from the positioning wire receptacle. The bo defines a placement wire entry that is in communication with the receptacle positioning wire outlet. A positioning wire is wound around the receptacle, and is in mechanical engagement with the receptacle, so that rotation of the positioning wire receptacle causes a first end of the positioning wire to advance through the positioning wire outlet, through the wire entry of the tube placement, and through the tube. A first end of the tube is constructed for insertion through an abdominal wall of the patient and into a patient's stomach. Package includes in addition a feeding tube having a first terminal portion and a second terminal portion. The feeding tube defines a feeding lumen therethrough. A retaining member is disposed in the second terminal portion of the feed tube. The present invention is also directed to a feed tube adapter having an outlet duct and an inlet duct. An outer surface of the outlet duct is configured to have a first section having a circumferential dimension increasing from an outlet end of the adapter to an inlet end of the adapter. The outer surface of the outlet conduit is further configured to have a second section having a decreasing circumferential dimension from an outlet end of the adapter to an inlet end of the adapter. The first and second sections of the outer surface of the outlet duct define a tube retention member, and preferably they are placed adjacent to each other. Additionally, the present invention is directed to a feed tube assembly that includes a feed tube made of a polyurethane, preferably Carbothane. The feeding tube has a first terminal portion, a second terminal portion and at least one lumen defined therein. The feed tube assembly further includes a feed tube adapter having an inlet duct and an outlet duct, preferably made of a substantially rigid material, wherein the outlet duct has an outlet end to be inserted into the outlet duct. a lumen in the first terminal portion of the feeding tube for fluid communication therebetween. The outer surface of the outlet conduit defines a retaining member for coupling with an inner surface at the first terminal portion of the feed tube when the outlet end of the outlet conduit is inserted into the lumen of the feed tube. The retaining member includes a first section having an outer peripheral dimension that increases with increasing distance from the exit end of the exit passage, and a second section having an outer peripheral dimension that decreases with the distance dimension from the outlet end of the outlet duct. According to another aspect, the present invention is directed to a feed tube assembly that includes a feed tube, a feed tube adapter having a first feed pipe, and a removable lid made of polyurethane to selectively close a feed pipe. entrance hole of the first inlet duct. The lid has a mating surface for coupling with a corresponding surface of the first inlet conduit, wherein the mating surface of the lid has a surface configuration different from that of the corresponding surface of the first inlet conduit. For example, the inlet conduit may include a hole defined by an inner surface and the cap may include a plug to be inserted into the hole, wherein the mating surface of the cap is an outer surface of the cap and the corresponding surface of the cap. Inlet duct is an interior surface of the inlet duct. Alternatively, the cap may include a peripheral eyebrow, so that the mating surface of the cap is an inner surface of the peripheral eyebrow that couples with a corresponding surface of the outer surface of the entry conduit. The difference in surface configurations can be established by providing one or both of the surfaces with a series of protuberances, a series of indentations, a different cross-sectional shape, or a combination thereof. It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide additional explanation of the claimed invention. The accompanying drawing, which is incorporated and constitutes part of this specification, is included to illustrate and provide a further understanding of the method and system of the invention. Along with the description, the drawing serves to explain the principles of the invention.

BRIEF DESCRIPTION OF THE DIAGRAMS In the accompanying drawings that form part of the specification, and in which similar numbers are used to designate similar parts therein: Figure 1 is a perspective view of a wire spout; positioning constructed in accordance with the present invention; Figure 2 is an exploded view of a positioning wire spout constructed in accordance with the present invention; Figure 3 is a second perspective view of a positioning wire spout constructed in accordance with the present invention; Figure 4 is a perspective view of a feeding tube constructed in accordance with the present invention; Figure 5 is a perspective view of an adapter constructed in accordance with the present invention; Figure 6 is a plan view of a feeding tube assembly according to a further aspect of the invention; Figure 7 is a cross-sectional view of the feed tube assembly of Figure 6, taken along line 7-7; Figure 8 is an enlarged perspective view of the feed tube adapter of the feed tube assembly of Figure 6; Figure 8A is an enlarged cross-sectional view showing a possible surface configuration between the coupling surface of the lid and the corresponding surface of the inlet conduit of the supply tube adapter of Figure 8; Figure 8B is an enlarged cross-sectional view showing another possible surface configuration between the mating surface of the lid and the corresponding surface of the inlet conduit of the feed tube adapter of Figure 8; Figure 8C is an enlarged cross-sectional view showing an additional surface configuration between the mating surface of the lid and the corresponding surface of the inlet conduit of the feed tube adapter of Figure 8; Figure 9 is an enlarged perspective view of an alternate embodiment of the feed tube adapter of the feed tube assembly of Figure 6.

DETAILED DESCRIPTION OF THE INVENTION Reference will now be made in detail to the present preferred embodiments of the invention, an example of which is illustrated in the accompanying drawings. The method and the corresponding steps of the invention will be described in conjunction with the detailed description of the system. Although this invention is susceptible to incorporation in many different forms, this specification and the accompanying drawings describe specific embodiments as examples of the invention.

The invention is not intended to be limited to the embodiments described or shown. The scope of the invention is set forth in and defined by the appended claims. The figures that illustrate the apparatus show some elements that are known and will be recognized by one skilled in the art. Detailed descriptions of such elements are not necessary for an understanding of the invention, and accordingly, are presented herein only to the extent necessary to facilitate an understanding of the novel aspects of the present invention. The present invention is practiced with certain conventional components whose details, although not fully illustrated or described, will be apparent to those skilled in the art and an understanding of the necessary functions of such components. A method of the invention will be described herein in the context of the appended figures which represent a method for placing a feeding tube percutaneously in a patient's stomach. However, it will be appreciated by one of ordinary skill in the art that this method of the present invention can be employed for the purposes of placing feeding tubes in other preselected sections of a patient's gastrointestinal tract., v. g. , small intestine. Accordingly, the detailed description set forth herein is intended to cover methods for placing feeding tubes in any preselected section of a patient's gastrointestinal tract, including, but not limited to, the stomach and small intestine. The spout 10 constructed in accordance with the present invention is generally shown in Figure 1. The spout 10 is constructed substantially in accordance with the teachings set forth in the U.S. Patent. No. 4, 342, 313 which is incorporated herein by reference. The Patent of E. U. No. 4,342,313 is assigned to Abbott Laboratories, the assignee of the invention described and claimed herein. Applicants also hereby incorporate by reference the teachings of the Application of E. U. Serial No. 08/733, 900 filed on October 18, 1996, which was a continuation of E. OR . Serial No. 08/365, 398 filed on December 28, 1994. These requests are also assigned to Abbott Laboratories. The dispenser 10 includes a positioning wire 12 wrapped around a receptacle 14. The positioning wire 12 can be constructed from a variety of known biocompatible materials and can have a variety of known configurations useful in the placement of percutaneous gastrostomy endoscopic tubes. and jejunostomy. In a preferred embodiment, the wire 12 includes a pair of wires coated with a biocompatible plastic material. The receptacle 14 preferably contains the positioning wire 12 therein so that the positioning wire 12 is not exposed to an environment external to the receptacle 14 until it is dispensed therefrom, as described in detail herein. The receptacle 14 defines the wire outlet 16 therethrough. The wire outlet 16 is configured. so that the positioning wire 12 can pass through it, as explained in detail herein. The positioning wire 12 is in mechanical engagement with the receptacle 14 so that rotation of the receptacle 14 causes the positioning wire 12 to rotate and advance out of the receptacle 14. Anyone of ordinary skill in the art will appreciate that a A variety of methods for mechanically engaging the positioning wire 12 with the receptacle 14 so that rotation of the receptacle 14 will cause the wire 12 to be dispensed therefrom. The present invention is intended to encompass all methodologies. A shaft or handle 1 8 can be mechanically connected to the receptacle 14 in order to facilitate manual rotation of the receptacle 14. A tubular portion 20 is mounted in the receptacle 14 as shown in Figure 1. The tubular portion 20 defines the wire inlet 22 therethrough. The wire inlet 22 is configured so that the positioning wire 12 can be passed through it. The wire inlet 22 and the wire outlet 20 are disposed so as to be in communication with each other, i.e., so that the positioning wire 12 will pass through the wire outlet 16, through the inlet 22 of the wire. wire, and to the tubular portion 20 when the receptacle 14 is rotated. The tubular portion 20 has a first terminal portion 24 and a second terminal portion 26. In the embodiment of the present invention shown in Figure 1, both the first terminal portion 24 and the second terminal portion 26 are open such that the channel 28 defined by the tubular portion 20 is open to an external environment of the tubular portion 20. in the first terminal portion 24 and the second terminal portion 26. However, it will be appreciated that the second terminal portion 26 can be closed so that the channel 28 does not open to an external environment of the tubular portion 20 without departing from the spirit of the present invention. This will be explained in more detail later. The first terminal portion 24 of the tubular portion 20 can be constructed so that it has a clear terminal end 30, as shown in Figure 1. In the embodiment shown in Figure 1, the piercing member 32 is provided and is constructed so that it can be inserted through the channel 28 of the tubular portion 20 of the second portion 26 terminal to the first terminal portion 24. It will be appreciated that the second terminal portion 26 of the tubular portion 20 must be open to an external environment of the tubular portion 20 in this embodiment of the present invention in order to allow the piercing member 32 to be inserted therein. The piercing member 32 is constructed so that the piercing tip 34 thereof is disposed outwardly of the terminal end 30 when the piercing member 32 is properly positioned within the tubular portion 20. The piercing member 32 can be solid. However, in the embodiment of the present invention shown in the appended Figures, the piercing member 32 defines the channel 36 therethrough. The piercing member 36 has a hub end 38 opposite the piercing tip 34. The hub member 40 is mounted on the hub end 38. The hub member 40 is configured so that selected instruments can be attached thereto. For example, the hub member 40 can be constructed so that it can be fluidly connected to a source of pressurized air so that the pressurized air can be directed through the channel 36 after the piercing tip 34 has been placed in the stomach of a patient, which facilitates the insufflation of a patient's stomach. The hub member 40 may be configured to provide a variety of known connections, including, but not limited to, threaded connections, luer connections, and luer lock connections. It will be appreciated that the piercing member 32 may be omitted from the present invention in certain embodiments. For example, the first end portion 24 of the tubular portion 20 can be constructed so that it can be inserted directly through an abdominal wall of the patient and into the stomach of the patient, whereby the need for the piercing member 32 is obviated. That is, a piercing tip 34a may be provided in the first terminal portion 24 of the tubular portion 20 where the piercing tip is constructed so as to penetrate through the abdominal wall of a patient and into the patient's stomach. In another alternate embodiment, the first terminal portion 24 is substantially planar, as shown in the accompanying figures. It will be appreciated that the first end portion 24 of the tubular portion 20 can be inserted through a dilator, introducer or catheter of known construction that has been inserted through the abdominal wall of a patient and into the patient's stomach. In this way the terminal end 30 of the tubular portion 20 can be placed in the stomach of a patient without the use of the piercing member 32 and without the presence of a piercing tip in the tubular portion 20. It will be appreciated that in some cases it may be possible to insert the first terminal portion 24 of the tubular portion 20 through an abdominal wall of the patient and into the patient's stomach without the use of a piercing member, a piercing tip, a dilator, an introducer and / or a catheter. If the piercing member 32 is not used, it is not necessary for the second terminal portion 26 of the tubular portion 20 to provide communication between the channel 28 and an environment external to the tubular portion 20. If the piercing member 32 is used, or if the first terminal portion 24 of the tubular portion 20 includes a piercing tip 34a, the protective sheath 42 can be provided in order to prevent the piercing tip 34, 34a from inadvertently piercing. the skin of a medical professional and / or a patient. In the embodiment shown in the appended figures, the sleeve 42 is a substantially tubular member configured to surround the tip 34., 34a drilling. However, it will be appreciated that the sleeve 42 may have a variety of known configurations without departing from the scope of the present invention. In a preferred embodiment of the present invention, a valve 25 for fluid flow of one direction is disposed in the channel 28 of the tubular portion 20. The valve 25 for fluid flow in one direction is constituted to prevent fluid flow, v. g. , air, out of the patient through the tubular portion 20. The valve 25 for fluid flow in one direction is configured to allow movement of the positioning wire 12 therethrough as the wire 12 advances from the receptacle 14 through the tubular portion 20 and toward a patient. The valve 25 for fluid flow in one direction can have a variety of known configurations without departing from the scope of the present invention set forth in the appended claims. In another embodiment of the present invention, the valve 25 for fluid flow in one direction is a flat valve of known construction. The placement of a feeding tube is facilitated by the use of the dispenser 10 of the present invention. In use, the dispenser 10 is provided as described herein. A medical professional introduces the first terminal portion 24 of the tubular portion 20 inward through the abdominal wall of a patient and into a patient's stomach. In one embodiment of the method of the present invention, the first terminal portion 24 does not include the piercing tip 34a and the piercing member 32 is not used. In this embodiment, the first terminal portion 24 of the tubular portion 20 is inserted through the abdominal wall of a patient and into the stomach of a patient with or without the use of a dilator, introducer or catheter, subject to the discretion of the patient. medical professional. In a second embodiment, the first terminal portion 24 has a piercing tip 34a associated therewith. In a third embodiment, the piercing member 32 is provided and inserted through the channel 28 so that the piercing tip 34 extends outwardly from the terminal end 30 of the tubular portion. In each case, the first terminal portion 24 is pushed through the abdominal wall of the patient and into the patient's stomach. If desired, the medical professional can insufflate the patient's stomach by directing pressurized air through channel 28 and into a patient's stomach. If the piercing member 32 is used, the pressurized air can be directed through the channel 36 of the piercing member 32 and into the stomach of the patient. In particular, the pressurized air source may be connected to the hub member 40 of the piercing member 32. If the piercing member 32 is not used, and if the second terminal portion 26 of the tubular portion 20 provides open communication between the channel 28 and an external environment of the tubular portion 20, the pressurized air may be directed through the second portion. terminal portion 26 of the tubular portion 20 and toward the stomach of the patient through the channel 28 of the tubular portion 20. If the piercing member 32 is used, it is removed after the channel 28 by pulling the terminal portion 38 of the hub thereof until the piercing tip 34 is removed from the second terminal portion 26 of the tubular portion. Rotating motion is then imparted to the receptacle 14 so that the positioning wire 12 advances through the wire outlet 16, through the wire inlet 22, through the channel 28 and into the stomach of the patient. The rotation movement can be imparted manually or by the use of a mechanical means, v. g. , an electric motor. After the positioning wire 12 has been placed in the patient's stomach, it is held using a holding tool and removed through the patient's esophagus and mouth according to known methodologies. The first terminal portion 24 of the tubular portion 20 can then be removed from the patient's stomach. A supply pipe 44 of known construction can be connected to the laying wire 12, and the positioning wire 12 and the feeding tube 44 are pushed through the esophagus and stomach of the patient until the feeding tube 44 passes percutaneously through the abdominal wall of the patient. In a preferred embodiment, the feeding tube 44 is constructed of a polyurethane material; particularly Carbothane. The feeding tube 44 may include a known radiopaque material that allows it to be visualized via X-rays or other image creation systems. A retainer member 46 is mounted on a second terminal portion of the feed tube 44. The retention member 46 is constructed to prevent the second end portion of the feeding tube 44 from passing through the abdominal wall of the patient. The retention member 46 may have a variety of known configurations and may be constructed from a variety of known materials, including, but not limited to, silicone and polyurethane. For example, but not limitation, flexible element type retention member configurations are described in U.S. Patent No. 5,080,650 and U.S. Patent No. 5,391, 159, each of which is incorporated in its entirety by reference to the I presented. It has been found that, under certain adverse conditions, these flexible element type retention members may inadvertently detach from the feed tube 44 when the feed tube 44 is constructed of a polyurethane material. It has been found that this potential problem occurs particularly when the feeding tube 44 is constructed of a polyurethane material and the retaining member 46 is constructed of a silicone material. This potential problem can be obviated by sliding molding of the molding retention member 46 in the feed tube 44. Slip molding techniques are well known in the art and will not be described in detail herein. Alternatively, it may be desirable to provide a balloon-like retention member configuration. Examples of various balloon type retention member configurations are described in the U.S. Patent. No. 5,098,378 and Patent of E. U. No. 5, 840,065, which are also incorporated in their entirety by reference herein. It is noted that these balloon-type retention members are generally configured for use with a multi-lumen feeding tube, wherein at least one lumen is used for selectively inflating and deflating the retention member in a known manner. A multi-lumen feeding tube is represented in the representative embodiment of Figure 7, as will be described in detail below by proper primary placement of the feeding tube 44 through the abdominal wall of the patient, a first portion can be cut. terminal of the feeding tube 44 to an appropriate length. An external retention disc 48 may be placed on the first end portion of the feeding tube 44 in order to prevent unwanted inward movement of the delivery tube 44 through the abdominal wall of the patient. The external retention disc 48 may have a variety of known configurations. An adapter 50 may be provided in order to interconnect the feed tube 44 and another in-line feed element, v. g. , a tube that extends from a source of enteral nutritional product. In one embodiment, the adapter 50 includes the outlet duct 52 having an exterior surface 54. The adapter 48 further includes one or more inlet ducts 56. An example of a suitable adapter 50 is described in the U.S. Patent. No. 5,057,093 which is incorporated herein by reference. In the event that the feed tube 44 is constructed of a polyurethane material and in accordance with another aspect of the present invention, it is preferable that the outer surface 54 d of the outlet conduit 52 define a retainer member 58 thereon. which prevents the feed tube 44 from sliding out of the outer surface 54 during use. In a preferred embodiment, the retaining member 58 includes a first section 60 on the outer surface 54. The first section 60 has an increasing circumferential dimension seen from the outlet conduit 52 to the inlet conduits 56 as shown in Figure 5 The retaining member 58 further includes a second section 62. The second section 62 has a decreasing circumferential dimension seen from the exit conduit 52 to the inlet conduits 56. The first section 60 and the second section 62 can be placed adjacent to one another as shown in the accompanying figures, or they may be separated from one another by an intermediate section that has a variety of configurations, v. g. , a surface of substantially constant circumferential dimension, without departing from the spirit of the present invention. Preferably, the adapter of the feeding tube of this embodiment, or at least the retaining member, is made of an acrylonitrile-butadiene-styrene resin (ABS) or similar rigid material, such as nylon. In another aspect of the present invention, a package for the placement of a feeding tube is provided. The package includes the dispenser 10 and the feeding tube 44 constructed in accordance with the modalities discussed above. The package may further include the adapter 50 constructed in accordance with the modalities discussed above.

Once a stoma tract is formed or fully matured through the patient's abdominal wall, the feeding tube can be removed for secondary placement of a different feeding tube if necessary or if desired. That is, a new feed tube assembly can be inserted through the mature stoma tract in a conventional manner without the need for a placement wire or placement wire spout. A variety of feed tube assemblies capable of secondary placement are known and widely available. Figure 6, however, shows a representative embodiment of a feed tube assembly, generally designated by the reference character 100, in accordance with a further aspect of the present invention. The feed tube assembly 100 includes a feed tube 140 having a first end portion 141 and a second end portion 142 opposite the first end portion 141. At least one lumen 143 is defined within the feeding tube 140, and extends between the first terminal portion 141 and the second terminal portion 142 thereof. The axial length and cross sectional dimensions of the feed tube 140 are appropriate for their intended purpose. For example, a feeding tube 140 for adult use will have larger overall dimensions than those of a feeding tube 140 for pediatric use. Feed tube 140 can be constructed of any of a variety of known biocompatible materials. However, the evidence indicates that the use of a polyurethane known as Carbothane PC (3575A-B20), which is available from Thermedics, or an equivalent material thereof, provides superior performance and durability. The assembled tube assembly 100 herein further includes a feeding tube adapter 150 made of polyurethane mounted on the first terminal portion 141 of the feeding tube 140. The adapter 150 of the feed tube includes at least a first inlet duct 1 56 having an inlet orifice 154, and an outlet duct 152 in fluid communication with the first inlet duct 156. Additional inlet ducts 156 'may be provided, as desired or necessary, to allow secondary introduction of beneficial agents or additives similar to lumen 143 feeding the feeding tube 140. In addition, one or more additional inlet ducts 157 may be provided to accommodate the operation of a balloon type retention member, if provided, as further described below. The outlet conduit 152 is connected in fluid communication with the first terminal portion 141 of the supply tube 140. This connection between the adapter and the feeding tube can be made by a variety of known construction techniques. For example, insert molding is preferred to establish a relatively permanent connection, particularly when using a multi-lumen feeding tube, as previously described in conjunction with a balloon-type retaining member. Alternatively, the feed tube adapter 150 may be provided with an insert member (not shown) in the outlet conduit 152, wherein the insert member is made of an acrylonitrile-butadiene-styrene resin (ABS) or the like and has an external surface configuration similar to that of the outlet duct 152 shown in Figure 5. As such, a polyurethane feed tube adapter 150 can be connected to a polyurethane feed tube 140 in a manner similar to previously described with respect to the power tube adapter 150 of Figure 5. A removable lid 160 is also provided to selectively close each inlet orifice 154 of the first inlet duct 1 56. In this way, the feeding tube 140, and thus the direct access to the gastrointestinal tract can be sealed from the external environment when it is not in use. The cap 160 thus has a mating surface for coupling with a corresponding surface of the first inlet conduit 156 when the cap 160 is positioned to seal the inlet orifice 154. To avoid the lack of positioning of the lid 160, it is preferred that the lid 160 be permanently connected to the feeding tube adapter 1 50, such as by a tie-down member 162 or similar connector element Although a separate element can be provided for such. connection, it is preferred that the cap 160 be formed integrally with at least a portion of the feed tube adapter 150 to reduce the construction cost. As noted, the power tube adapter 150 is made of polyurethane for its performance characteristics. In the preferred embodiment, a polyurethane known as Tecoflex (EG80A-B20) available from Thermedics, or an equivalent material thereof, is used for construction of the feed tube adapter 150. If the lid 160 is integrally formed with the feed tube adapter 150, as preferred, the lid 160 will similarly be formed of the same material or a compatible construction material for the feed tube adapter 150. Such polyurethane materials are susceptible to hydrogen bonds and similar self-adhesion phenomena. As such, and in accordance with a further aspect of the present invention, the coupling surface of the lid 160 is provided with a surface configuration different from that of the corresponding surface of the first inlet duct 156. For example, as shown in Figure 8, the inlet hole 154 of the inlet duct 156 is defined by an inner surface 1 55 and the lid 160 includes a plug 164 to be inserted into the inlet orifice 154, the surface The coupling of the lid 160 is therefore defined, at least in part, by the outer surface 165 of the plug 164 and the corresponding surface is defined, at least in part, by the inner surface 155 of the inlet duct 156. Alternatively or additionally, as shown in Figure 9, the lid 160 can be provided with a peripheral eyebrow 168, such that the mating surface of the lid 160 is defined by an interior surface 169 of the peripheral eyebrow 168 and the surface The corresponding one of the inlet duct 156 is defined by an outer surface 1 59 thereof. Figures 8A to 8C show three possible surface configurations between the mating surface of the lid and the corresponding surface of an inlet conduit of the feed tube adapter of Figure 8. Each of these three views is taken in cross section facing the inlet port 154 toward the outlet conduit 152, with the cap 160 positioned against the end of the inlet conduit 156 opposite the outlet conduit 152 to seal the inlet orifice 154. Particularly, Figure 8A shows that at least one of any of the mating surface or corresponding surface is provided with a series, ie, one or more, of protuberances 161 to define a different surface configuration therebetween. Although Figure 8A shows the protuberances 161 in the cap 164 of the lid 160, such protuberances 161 can be similarly provided on the corresponding surface of the first inlet conduit 1 56. The protuberances 161 can be provided in any of a variety of shapes, including buttons, ribs, loins, rings, etc. Similarly, the difference in surface configurations between the mating surface and the corresponding surface can be defined by a series of marks 163 provided on at least one of the two surfaces as shown by the exemplary embodiment of Figure 8B. further, the difference in surface configurations between the mating surface and the corresponding surface can be defined by providing one of the two surfaces with a cross-sectional shape that is different from that of the other surface. For example, but not as limitation, Figure 8C shows that the inlet hole 154 of the inlet duct 156 can be defined by a circular cross section, while the lid 160 can be provided with a plug 164 having a generally cross section square or rectangular dimensioned so that not only the corners of the plug 164 engage with the inner surface 155 of the inlet hole 54. The feeding tube assembly 100 according to this embodiment of the invention, as described, can be used not only for gastrostomy and jejunostomy applications, but also for nasoenteric applications. That is, and as long as the imitation tube 140 has a suitable length and transverse dimension, the feed tube assembly 100 as described can be inserted via the nasal passage into the gastrointestinal tract of a patient in a known manner. According to a further aspect of the invention, however, the feeding tube assembly 100 can also be provided with a retaining member 146 attached to the second terminal portion 142 of the feeding tube 140 when applications for gastrostomy and jejunostomy are intended. . Any of a variety of known retention members can be used, including flexible element type retention members as previously described. In a preferred embodiment, a balloon-like retention member 146 is attached to the second terminal portion 142 of the supply tube 140. Although the balloon-type retention member can be constructed and attached to the feeding tube 140 in a variety of configurations, the preferred embodiment uses a configuration similar to that of the balloon catheter construction described in the U.S. Patent. No. 5,522,961, which is incorporated by reference herein. This preferred configuration defines an energy absorbing end to reduce the risk of trauma to the patient during the placement of the feeding tube 140. Preferably, however, and unlike the disclosure of the U.S. Patent No. 5,522,961, the balloon-type retention member for the feeding tube 140 is attached using a conventional heat-melting technique. Solvents and epoxy materials are not required. In the preferred embodiment, the balloon member itself has a nominal thickness of approximately 0.0508 mm, and is made of Tin 58309 available from BF Goodrich, or an equivalent material thereof. If a balloon-type retention member is provided, it is preferred that the feeder tube 140 define at least two lumens therethrough.; a lumen defining a feeding lumen 143 for the introduction of enteral nutritional products and the like, and another lumen defining a filling lumen 145 for inflating and deflating the retaining member 146, as shown in Figure 7. The lumen 143 feed therefore extends through the length of the feed tube 140, while the filling lumen 145 extends at least from the first end portion 141 of the feed tube 140 to an opening for accessing the chamber of the balloon type retention member 146. Figure 7 shows the feed lumen 143 having a substantially D-shaped cross section, with the filling lumen 145 disposed proximate the flat inner edge of the feed lumen 143. In this embodiment, the filling lumen 145 may have a circular or elliptical cross section, and preferably the feeding tube 140 has a generally circular external cross-sectional configuration. Alternative configurations and multi-lumen feeding tube constructions can also be used. Although not necessary, it is preferred that the feeding tube assembly 1 00 of the present invention also include a radiopaque rod or member provided to assist in the proper placement of the feeding tube 140 using X-rays or similar imaging techniques. . For example, as embodied herein the filling lumen 145 may extend entirely from the first terminal portion 141 to the second terminal portion 142 of the supply tube 140. A rod 170 of known radiopaque material can thus be inserted into the filling lumen 145 in the second terminal portion of the feeding tube 140 to extend it to the access opening of the retaining member 140. Alternatively, the feeding tube itself can be made from a known radiopaque material or formed with a stripe of opaque material extending all or a portion of the length thereof. The secondary placement of the feed tube assembly 100 of the present invention can be performed in a conventional manner. For example, if nasoenteric access is desired, the feeding tube assembly 100 may or may not be provided with a retaining member, as well as a weighted tip (not shown) in the second terminal portion 142 of the feeding tube 140 as is well known. . The second terminal portion 142 is thus inserted into the nostril of the patient and guided to the desired position in the gastrointestinal tract. The balloon-type retention member, if provided, is then inflated to ensure placement of the feeding tube.

If secondary placement through a mature stoma is desired, retaining members are provided as previously described. When a balloon-like retention member is used, for example, the retention member 146 is deflated for the initial insertion of the second terminal portion 142 of the feeding tube 140 into the stoma. Once properly positioned, the retention member 146 is filled with an appropriate fluid via the appropriate inlet conduit 157 and filling lumen 145 to expand the retention member 146 and engage an internal wall of the patient proximal to the stoma. The feeding tube 140 of the present invention may also include an external retention disc, also known as a skin disc 1 72, as described above. The skin disc 172 is mounted for movement along the feeder tube 140, to be placed against the patient's abdominal exterior wall to ensure placement of the feeder tube assembly 100. The removable lid 160 can thus be removed selectively, with limited risk of self-adhesion or attachment to the inlet duct 156, to allow enteral nutritional feeding or the like. It will be apparent to those skilled in the art that various modifications and variations may be made to the method and system of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims (10)

1. R EIVI N D ICACTIONS 1. A power tube adapter comprising: a first inlet duct; and an outlet conduit in fluid communication with the first inlet conduit, the outlet conduit constructed for fluid connection with a first terminal portion of a supply pipe, the outlet conduit having an exterior surface and an outlet end.; the outer surface of the outlet duct defining a retaining member, the retaining member including a first section having an increasing outer peripheral dimension with increasing distance from the outlet end of the outlet duct, the retaining member including in addition a second section having an outer peripheral dimension that decreases with decreasing distance from the outlet end of the outlet conduit. A power tube adapter according to claim 1, further including a second inlet conduit in fluid communication with the first inlet duct and the outlet duct. 3. A feeding tube adapter according to claim 1, wherein the second section of the retaining member is positioned adjacent to the first section of the retaining member. 4. A feeding tube assembly comprising: a feeding tube made of polyurethane, the feeding tube having a first terminal portion, a second terminal portion opposite the first terminal portion, and at least one lumen defined therein. extending between the first terminal portion and the second terminal portion; and a feed tube adapter including a first inlet duct and an outlet duct in fluid communication with the first inlet duct, the outlet duct having an outlet end for insertion into the at least one lumen in the first terminal portion of the feed tube for fluid communication therebetween, the outlet conduit further having an outer surface defining a retainer member for coupling with an inner surface in the first terminal portion of the feed tube when the The outlet end of the outlet duct is inserted into the at least one lumen of the feeding tube. A feed tube assembly according to claim 4, wherein the retaining member defined by the outer surface of the outlet conduit includes a first section having an outer peripheral dimension increasing with increasing distance from the outlet end. of the outlet duct, the retaining member further including a second section further from the outlet end than the first section and having a decreasing outer peripheral dimension with the decreasing distance from the outlet end of the outlet duct. 6. A feed tube assembly according to claim 5, wherein the second section of the retaining member is positioned adjacent to the first section of the retaining member. 7. A feed tube assembly according to claim 4, wherein the feed tube adapter is made of a substantially rigid material. A feed tube assembly according to claim 4, wherein the feed tube adapter further includes a second inlet conduit in fluid communication with the first inlet conduit and the outlet conduit. 9. A feeding tube assembly according to claim 4, wherein the feeding tube is made of a material similar to Carbothane. 10. A feeding tube assembly comprising: a feeding tube adapter made of polyurethane, the feeding tube adapter including a first intake duct having an inlet orifice, the feeding tube adapter also including an outlet duct for fluid communication with an inlet duct of a feeding tube; and a lid made of polyurethane removably attached to selectively close the inlet orifice of the first inlet duct, the lid having a mating surface for coupling with a corresponding surface of the first inlet duct, the mating surface of the cover having a surface configuration different from that of the corresponding surface of the first inlet duct. eleven . A feed tube assembly according to claim 10, wherein the lid is permanently connected to the feed tube adapter. 12. A feed tube assembly according to claim 10, wherein the inlet orifice is defined by an inner surface and the cap includes a plug to be inserted in the hole, the mating surface of the cap that it is an outer surface of the plug and the corresponding surface which is the inner surface of the inlet duct. 3. A feeding tube assembly according to claim 10, wherein the lid includes a peripheral eyebrow, the mating surface of the lid which is an inner surface of the peripheral eyebrow and the corresponding surface which is an outer surface. of the inlet duct. 14. A feed tube assembly according to claim 1, wherein at least one of the coupling surfaces and the corresponding surface is provided with a series of protuberances. 5. A feed tube assembly according to claim 10, wherein at least one of the coupling surface and the corresponding surface is provided with a series of markings. 16. A feed tube assembly according to claim 10, wherein the mating surface of the lid defines a cross-sectional shape different from that of the corresponding surface of the first input conduit. 7. A feed tube assembly according to claim 10, further comprising a feed tube having a first end portion, a second end portion opposite the first end portion, and at least one lumen defined in the end portion. same that extends between the first terminal portion and the second terminal portion; the outlet conduit of the feeding tube adapter connected in fluid communication with the first terminal portion of the feeding tube. 1 8. A feed tube assembly according to claim 17. wherein the feeding tube is made of a material such as Carbothane. 9. A feed tube assembly according to claim 18, further comprising a retaining member attached to the second end portion of the feed tube. 20. A feed tube assembly according to claim 1, wherein the retaining member is made of a material such as Tin.