MXPA01008366A - External retaining device for a catheter and catheter assembly and method using same - Google Patents

Abstract

Preferably, pivotal movement is accomplished by forming the side walls of elastic material and affixing each clip element to a corresponding side wall, such that flexure of the side walls toward each other moves the clip elements to the open position. The elongate tube of the catheter is thereby directed through the passage and positioned within the channel to form a smooth 90°bend, and secured in place at the second section of the channel with the clip assembly moved to the closed position. An internal retaining device also can be used in combination with the external retaining device.

Description

EXTERNAL RETENTION DEVICE FOR CATHETER AND ASSEMBLY OF CATHETER AND METHOD USED THEREOF BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a device for retaining a catheter, such as a gastrostomy feeding tube or jejunostomy, in place with respect to a patient's skin. The present invention also relates to a catheter assembly and a method using the same.

Description of the Related Art It is common practice in health care or similar facilities that an elongated flexible tube, generally known as a catheter, be inserted percutaneously into a patient to aid in medical treatment. Such catheters are used in a variety of applications to inject fluids into or withdraw fluids from a patient's channels, vessels, passages or body cavities. Catheters can also be used to maintain a similar orifice or passage in an open condition. For example, many patients receiving medical treatment are unable to eat orally due to conditions, such as facial injuries, esophageal injuries or unconsciousness. Consequently, liquid nutritional products have been developed for a process known as enteral feeding. Enteral feeding typically involves inserting a feeding tube percutaneously into the gastrointestinal tract of a patient, such as the feeding assembly, it is advantageous to retain the placement of the feeding tube relative to the patient's skin. A variety of retention devices have been developed for this purpose FIG 1 demonstrates, for purposes of illustration only, a known catheter or feeding tube assembly including a gastrostomy tube 10 inserted percutaneously into a patient for the introduction of a liquid nutrient product. The gastrostomy tube 10 IO extends through the epidermis 11, the fat layer 12, the muscle layer 13, the peritoneum 14, the stomach lining 15 and the gastric mucosa 16 A 17 end of the gastrostomy tube is located inside the stomach A member Internal retainer 18 is fastened next to one end of the gastrostomy tube and is located inside the stomach, I5 adjacent the mucosal wall 16 The internal retention member 18 thereby reduces the possibility of inadvertent removal of the patient's gastrostomy tube. As shown in FIG. 1, the internal retention member may be an inflatable or expandable membrane, although it is also known to use a flange-type internal retention member, if Additionally, it is noted that catheter assemblies used for other applications, such as for jejunostomy or intravenous applications, may not require an internal restraint device. The known supply tube assembly of FIG. 1 also includes an external holding device 19 located externally D of the person adjacent to the epidermis 11. This particular external holding device is generally a disc-shaped member having a cylindrical opening formed therethrough to maintain the feeding tube substantially perpendicular to the patient's skin Similar external retention devices are available for use with inert feed tubes distributed by Sandoz Nutriton Corporation, 5320 West Twenty Third Street, PO Box 370, Mmneapolis, Minn 55440, US, under the trade names, such as, CALUSO® PEG and SUPER PEGMR Although the Sandoz external retention device has a circular base portion, other shapes may be used, as demonstrated by US Pat. No. 5,071,405. Because the feeding tube extends perpendicularly from the patient, this known feeding tube assembly may be susceptible to entanglement. To minimize such entanglement, it is recommended that the tube of this tube assembly food is wrapped or rolled in | 5 a loop However, care must be taken to ensure that pulling and pulling does not entangle the loop and thus occludes the flow through the tube. Various concepts for external holding devices, which are also known in the industry. Medical devices such as 0 skin discs have been developed in an attempt to minimize or eliminate the disadvantages of the prior art design. In particular, US Pat. No. 5,267,969 describes an external holding device configured to receive a feeding tube. which extends substantially perpendicularly from a patient and then guides the feeding tube through a 90 ° bend without being entangled. The external holding device of US Pat. No. 5,267,969 includes a first hole for receiving. the feeding tube and a larger diameter tube having a central axis arranged in a copel- Anar but perpendicular to the central axis of the first hole Although effective for the intended purpose, it has been found that this external retention device may be difficult to adjust in position once it is properly positioned against the patient with the feeding tube extending. through it In view of the above, there remains a need for an easily adjustable external holding device capable of bending and holding a catheter in position against a patient without becoming entangled or occlused. Additionally, there is a need for a tube mount of the im entation that includes this improved external retention device and a method that uses the same BRIEF DESCRIPTION OF THE INVENTION The purpose and advantages of the present invention will be set forth in, and will be evident from, the following description, as will be learned in the practice of the invention. Further advantages of the invention will be realized and achieved. by the apparatus and method particularly pointed out in the written description and claims of the same, as well as the accompanying drawings. In order to achieve these and other advantages and in accordance with the purpose of the invention, as encompassed and amply described, the invention includes an external holding device for use with a catheter having an elongated tube The present invention also includes the catheter assembly incorporating the external holding device and the method for using the same. has a lower surface and a higher surface A step that has a central axis is defined The lower and upper surfaces of the base member preferably have a tube length of tube extending from the upper surface of the base member. The tube guide portion has a longitudinal flange with a longitudinal axis defined in the I presented A first section of the channel is located next to the passage with the longitudinal axis in the first section of the channel aligned substantially with the central axis of the passage. The second section of the channel is separated from the first section of the channel with the longitudinal axis in the second section of the second wing relative to the central axis of the passage In this manner, the elongated tube can be directed through the passage and placed inside the channel to form approximately a 90 ° bend in the tube at length of a smooth transition without entangling or pinching the tube A manually operable safety assembly is provided on the base member to ensure the positioning of the external retaining device 0 relative to the elongated tube and, thus, the positioning of the tube to be released in relation to the base portion of the external retention device The secure assembly is selectively movable between a closed position and a position. With this, the elongated tube can be received by the lock assembly when the lock assembly is in the open position and is secured in place, without occlusion, when the lock assembly is in the closed position. In the preferred embodiment of the present invention, the lock assembly is located in the pipe guide portion next to the second channel section. Additionally, the lock assembly includes , preferably, opposed safety elements mounted to the tube guide portion close to the second section of the channel. The pivotal movement is achieved by forming the side walls of the tube guide portion with an elastic material and fixing each securing element. to a corresponding side wall, so that the flexing of each side wall towards the other moves the lock element to the open position A digital grip can provide on each side wall to enhance flexure The base member and the tube guide portion they are preferably formed together as a one-piece polyurethane member, with the safety elements made of relatively rigid plastic. and embedded in the corresponding side walls It will be understood that both the above general description and the following detailed description are exemplary and are intended to provide a further explanation of the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in, and constitute a part of, this specification, are included to illustrate and provide further understanding of the apparatus and method of the invention. Along with the description, the drawings serve to explain the Principles of the Invention FIG 1 is a schematic representation of a gastrostomy tube using a known external retention device, FIG 2 is a perspective view of a representative embodiment of the external retention device of the present invention FIG 3 is a top view of the external retention device of FIG. 2, FIG. 4 is a cross-sectional side view of the external retention device of FIG. 2, taken along line 4-4 in FIG. 3, FIG. 5 is a rear view of the external holding device of FIG 2, FIG 6 is a schematic rear view of the holding device external of FIG 2, showing the flexure of a side wall to move an insurance element corresponding to an open position, FIG 7 is a schematic representation of a catheter assembly including a gastrostomy tube and an external holding device according to the present invention, FIG 8 is a schematic representation of another catheter tube assembly including a tube of gastrostomy and an external holding device according to the present invention; and FIG 9 is a schematic representation of an additional catheter assembly including a jejunostomy tube and an external holding device according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION Reference will now be made in detail to the preferred embodiments of the present invention, an example of which is illustrated in the accompanying drawings. The method and corresponding steps of the invention will be described in conjunction with the detailed description. of the device and mounting The external retention device of the present invention, as appropriately modified for size and its intended application, can be used in conjunction with any of a variety of catheters. The external retention device of this invention is particularly suitable for use with either gastrostomy or jejunostomy feeding tube assembly, having an elongated tube to be placed percutaneously in a patient. For purposes of illustration and not limitation, reference will be made accordingly to the construction and use of an external holding device for a tube assembly However, it is recognized that modifications can be made to alternative catheter applications. As such, the term "rim tube" or "tube", as used herein, is meant to represent all reasonable catheter applications, unless Note that an exemplary embodiment of the retention device of the present invention is shown in FIGS 2-5 and is generally designated by reference character 100 according to the present invention, and as it is encompassed in FIG. present, the external holding device 100 includes a base member 110 having a lower surface 112 and an upper surface 114. As used herein and in the claims, such terms as "upper", "upward" and "lower" ", are intended to define a spatial relationship in relation to the lower surface 112 of the base member 110, when resting on a surface Horizontal IO as shown in FIG 2 The lower surface 112, as shown in FIGS 4 and 5, is configured so as to be placed with direct discharge or surface discharge on the patient's skin Although shown as a flat surface , the lower surface 112 can be contoured for the purpose to be convex or concave, or both, if desired for a particular application or can be corrugated to allow air access to the underlying skin.FIGS. 2 and 5 show the upper surface 114 as having a planar configuration, although such alternative surface configurations may be provided if desired. In the preferred embodiment, and as shown in FIGS. 4 and 5, the upper surfaces and lower are both flat and parallel to each other. FIG 3 shows the base member 110 of the preferred embodiment as having a generally triangular shape with rounded corners although similar alternative shapes such as circular, rectangular or irregular geometric shapes may be used. base member 110 of the external retainer device 100 encompassed herein also has a passage 116 with a central shaft 118 defined herein. The passage 116 extends between the lower surface 112 and the upper surface 114 of the base member 110, and is dimensioned and shaped to receive a tube of a known cross section therethrough. Preferably, step e s dimensioned and shaped in order to create a friction or interference fit with the elongated tube, but still allows sliding or longitudinal movement of the elongated tube through the passage when an appropriate force is applied as desired. For example, and not by limitation step 116 would preferably be a circular opening having a diameter of 523 centimeters to be used in combination with a tube made of polyurethane having an outside diameter of 053 centimeters (16 French) In this manner, an elongated tube extending percutaneously from a patient , can be directed through the passage 116 and be supported by friction therein FIGS 3 and 4 show the passage 116 as a circular opening extending through the base member 110, so that the tube would be inserted axially along of the central axis 118 of step 116 Alternatively the step can be defined as an open depression, such as a depression in Horseshoe or omega shape, formed along a peripheral edge of the base member 110 In this manner, and with the base member 110 formed of a soft elastic material, the elongated tube can be inserted transverse in the passage from the peripheral edge of base member 110, instead of being axially directed therein However, as described above, the pitch would preferably be sized to create a frictional fit with the elongated tube directed therein As covered herein , the base member 110 of the external holding device 100 is provided with a tube guiding portion. FIGS. 2 to 5 show the tube guiding portion 120 extending from the upper surface 114 of the base member 110, and having a channel. elongate 130 with a longitudinal axis 138 defined therein A first section of channel 130 is located proximal to passage 116 with longitudinal axis 118 with first section 131 of channel 130, substantially aligned with the central axis 118 of the passage 116 As such, the elongated tube extending from the patient and directed through the passage 116, can be easily positioned in the channel 130 of the guide portion of the tube 120 I-. The elongated channel 130 of the preferred embodiment has a second opposed section 132 separated from the first section 131 of the channel 130. As best shown in FIG 4, the longitudinal axis 138 in the second section 132 of the channel 130 is preferably angled, with In relation to the central axis 118 of the passage 116 In particular, and as it is encompassed in the present 0, the longitudinal axis 138 in the second section 132 of the channel 130, is coplanar with and angled approximately 90 ° in relation both to the central axis 118 of the passage 116 as the longitudinal axis 138 in the first section 131 of the channel 130 FIG 4 further shows that the channel 130 is configured to provide a substantially smooth transition from the first section 131 of the channel 130 to the second section 132 for an elongated tube positioned in the same This smooth transition minimizes the risk of entanglement or pinching the elongated tube within the channel 130 to further retain the elongated tube, and as best shown in FIGS. 2 and 5, the channel 130 of the preferred embodiment also has a concave surface 134 along with its length that is complementary to the outer surface of the elongated tube and of sufficient depth to inhibit lateral movement of the tube. tube once it is placed within the channel 130 To support the desired channel configuration, the tube guide portion 120 encompassed herein includes two side walls 122 extending upwardly from the base member 110 FIGS 3 and 5 show the two walls as being substantially planar and parallel to each other, although alternative shapes may be used. The side profile formed by the upper edge area 124 of each side wall 122 may have an angular ramp configuration, as shown in FIG. FIG 4 Alternatively, the upper edge area 124 can generally follow the outline of the channel 130 along its length from the first section of the channel. ion 131 to the second section 132, or may be provided with any other acceptable geometric configuration. As covered herein, the channel 130 is located between the side walls 122 proximate an upper edge area 124 of each side wall 122, for a Easier positioning of the elongated tube therein Below the channel 130 and between the side walls 122, the tube guide portion 120 may be made of a solid construction or, as shown in FIGS 4 and 5, and as described in detail later, the two side walls 122 can define a hollow space 125 therebetween. In addition, according to the invention, a manually operable safety assembly is provided on the base member 110 .5 to ensure placement of the external holding device along the elongated tube directed through the passage. The lock assembly is selectively movable between a closed position and an open position. In particular, the latch assembly is configured and located in the base member 110, so that an elongated tube directed through the step 116 can be received by the latch assembly when the latch assembly is in the open position and is secured in place without occlusion thereof, when the lock assembly is in the closed position Because the lock assembly is easily movable between the closed and open position, the positioning of the lock device i? external 100 relative to the elongate tube and, thus, the placement of the elongated tube relative to the base member 110 of the external holding device 100 can be adjusted and secured more easily. A variety of insurance mounting configurations may be used in accordance with the present invention. As encompassed herein, the manually operable lock assembly 140 includes at least one lock element 142 mounted on the base member 110 for pivotal movement between the open position and the closed position. Although only one insurance element 142 needs to be provided, if it is properly dimensioned to ensure the placement of the elongated tube relative to the base portion, it is preferable to provide two or more such insurance elements 142. Securing assembly 140 of the device External retainer 100 covered herein includes opposing securing elements 142 mounted to the base member 1 1 0. The opposing securing elements 142 are sufficiently spaced apart to allow the elongated tube to be received therebetween, when the securement assembly 140 is in the open position, and is captured or secured in place by the secluded elements 1 42 s in occlusion of the tube, when the lock assembly 140 is in the closed position. Preferably, the insurance elements 142 are coplanar with one another as shown in FIGS. 2, 3 and 5, although they may be de-aligned from one another if desired. At least one of these securing elements 142 is mounted for pivotal movement between the open position and the closed position according to the invention. Nevertheless, it is preferred that both insurance elements 142 are capable of such pivotally intensified operation of the securing assembly 1 40. The securing element 142 encompassed herein includes a rod 144 having a hook-shaped, open end. 146. In this way, the safety element 142 can be mounted on this rod 144, so that the distal end of the hook 146 can move in and out of position to capture or trap the elongated tube without occlusion thereof. For example, and as encompassed herein, FIGS. 2-6 show opposite safety elements 142, mounted along the second section of the channel 1 30 defined in the tube guiding portion 120, with at least one securing element 142 mounted on each side of the channel 1. Each latch element 142 is mounted with the rod 144 located close to the upper edge area 124 of the corresponding side wall 122 and the distal end 5 in the shape of a hook 145 extending transversely through at least a portion of the catheter. 1 30, when the insurance element 142 is in the closed position If more than one insurance element 142 is used, as shown, then the insurance elements 1 42 are preferably substantially identical Although it is possible to form the secure elements 142 integrally with the corresponding side wall 1 22 as a single piece, each securing element 142 is preferably made as a separate piece using a relatively rigid plastic material, such as or polycarbonate or similar alternating materials that can be used include acrylic cirolite or a ream of ! > acp lonitplo-butadiene-styrene ("ABS") The pivotal movement of the securing element can be achieved by using a spring hinge connection to deflect the latch element toward the closed position Such a pivotal configuration would preferably include a latch which engages the fingers, which extends from the safety element to allow the safety element to be engaged and manually moved by the operator to the open position Upon release of the tongue, the safety element would return to the closed position due to deflection of the spring hinge The spring hinge connection can be provided as a separate element 5 which connects the securing element to the base member, or can be integrally formed as a live hinge if the The element of insurance and the base member are made together as one piece. Alternatively, the pivotal movement of the securing element 142 can be achieved by bending the tube guide portion 120 by itself. For example, and with the lock assembly 140 located in the tube guide portion 120 of the base member 1 10 as encompassed herein, at least one side wall 122 of the tube guide portion 120 is made resilient to flexure towards the other side wall l 122. With at least one securing element 142 mounted proximate the second section 132 of the channel 1 30 in the upper edge area 124 of the elastic side wall 1 22, the securing element 142 can moving in a pivotal manner from the closed position to the open position, by bending the elastic side wall 1 22 as shown by the arrow A in the FI G. 6. The securing element 142 can be fixed to an exposed surface of the side wall 122 or, in accordance with the preferred embodiment of the present invention, can be directly embedded in the elastic side wall 122, using known construction or molding techniques. Preferably, the lock element 1 42 includes a cushion formed at the proximal end 142 of the rod 144, which is embedded in the upper edge area 1 24 of the side wall 1 22. In the preferred embodiment of the present invention, both side walls 122 are elastic for bending one towards the other. Each side wall 1 22 has at least one latch element 142 of the latch assembly 140 mounted to be pivotally moved from the closed position to the open position by bending the corresponding side wall 122 FIG. 6 shows the flexing of only one side wall for purposes of comparison with the opposite side wall in the non-flexed state. To further facilitate the pivotal movement of the securing elements 142, each side wall 122 is provided with a finger grip l 1 25, such as a rib or retainer, which identifies the best location to apply pressure for bending of the side wall corresponding to The pressure is applied generally to the side walls 1 22, although not necessarily, using the flea fingers of the operator. Upon release of the applied pressure, the elastic side walls 122 automatically return to the condition without flexing. original, as shown in FIG. 5, in order to move the lock elements 142 to the closed position due to the memory of the elastic material used. As noted previously, and as shown in FIGS. 4-6, the two lateral walls 122 preferably define a hollow space 125 therebetween. In particular, FIG. 5 shows a hollow space 1 25 having a generally rectangular lower cross-section, defined by the interior surface 127 of FIG. the flat side walls 122 and a generally triangular upper cross section, defined by tapered surfaces 129 formed below the channel 1 30 in the upper edge area portion 1 24 of the side walls 122. In this manner, a "live hinge" "is defined in the appendix of the surfaces ah used 1 29 to further facilitate the bending of the side walls 1 22 and, thus, the movement of the securing elements 142 from the closed position to the open position.

The tube guide portion 120 can be constructed separately from the base member 110, either of the same material or different material, and then joined together. However, in the preferred embodiment, the base member 110 and the tube guide portion 120 are formed together as a single piece Elastic, soft, and durable material such as polyurethane, silicone rubber or any other suitable elastomer material may be used, although polyurethane is preferred. Alternatively, it is possible to form the guide portion of tube 120, either individually or together with the base member 110, as a solid structure without hollow space using a conventional foam material encased in a skin or film of vinyl, plastic or a durable material in a similar manner. of known construction or molding, such as insert molding, injection molding or rotational molding. Preferred dimensions of the base member, including the portion The tube guide, if provided, will depend on the size and type of elongated tube used for catheter assembly, as well as its intended application. For purposes of examples, but not by limitation, the base member with a generally triangular shape, as shown in FIG. FIGS 2-5, if sized for use with a French gastrostomy feeding tube 16 would, preferably but not necessarily, have an overall length of approximately 381 centimeters, an overall width of approximately 3302 centimeters and an overall height of approximately 0177. centimeters If desired, the base member 1 1 0 may be provided with one or more carriers (not shown), defined herein to attach the external retention device 1 00 to the patient. These holes thus allow the use of sutures. Staples or similar fasteners for attaching the external retention device 1 00 to the patient's skin Alternatively, the retention device The external device 100 may be joined using known adhesives or bands, if desired. However, in the preferred embodiment, an internal retaining device is provided at the end located internally of the elongated tube, as shown 10 for purposes of examples in FIG. FIGS. 7 and 8, which would effectively assist in maintaining the positioning of the external holding device in operation, and making reference to the external holding device 1 00 previously described in detail, as well as to FIGS 2-76 for purposes For example, the method for retaining a catheter assembly in a patient according to the present invention involves directing the elongate tube 70 of the catheter assembly through the passage 1 1 6 of the base member 1 1 0 of the catheter assembly. external retention device 1 00, and placing the elongated tube into the channel 130 of the tube guide portion 120 These steps can be performed either before the elongated tube has been 0 placed in percutaneously in the patient or, as in the preferred embodiment of the invention, performed after such percutaneous placement. The method of the present invention further includes moving the securing molding 140 to the open position and inserting the elongated tube 70. in the insurance mode 140 According to the above preferred embodiment, this is accomplished by applying pressure to each elastic side wall 122 of the tube guide portion 1 20 to move the latch element 142 pivotally from the closed position to the open position by bending the elastic side wall 122 In particular, when both side walls 122 are elastic, this step involves tightening the side plates 122 towards each other to move each latch element 142 pivotally from the closed position to the position open by bending the corresponding side wall 122 U once properly positioned, such as with the bottom surface 122 of the base member 1 1 0 at a desired location along the length of the i or pipe to start, the latch assembly 140 is closed to secure the elongated tube in the second section 132 of the channel 1 With the preferred embodiment of the invention, this is achieved simply by releasing the elastic side walls 122 to return the latch elements 142 to the closed position | As noted previously, an internal retention device 1 00 may be used in combination with the external retention device 100 of the present invention. This is particularly likely when the catheter assembly is a gastrostomy feeding tube assembly. Among other things , the interaction of the internal retention device 1 00 and 0 the external retention device 1 00 generally help to retain the proper placement of the rimmed tube. Additionally, the external retention device 100 can be attached to the patient by secondary means, if desired, so that the placement of the catheter assembly is additionally retained. This can be achieved by using a known adhesive or, if the holes are provided in the base member 1 1 0 of the external holding device 100, using sutures, staples. or similar known bras. It is noted that an advantage of the present invention is the ease with which the external retention device 1 00 can be adjusted or moved along the length of the elongated tube. For example, if the treatment or cleaning of the stoma or skin below the external holding device 100 is required, the securing elements 142 can be easily moved to the open position to allow the external retaining device 1 00 to be slid or moved out of the way. another way to an alternate or adjusted position. Once the treatment is completed, the external retention device 1 00 is repositioned and secured in place as previously described. The application of the apparatus and method of the present invention can be better understood by reference to FIG. 7, in conjunction with FIGS. 2-5. That is, FIG. 7 shows one embodiment of a catheter assembly as properly retained in accordance with the present invention. A gastrostomy tube 70 extends percutaneously via a stoma through several layers of body tissue, as previously described with respect to FIG. 1 and in the stomach 75 of a patient. An internal retention member 78, which in this embodiment is an expandable membrane as is well known in the art, is disposed adjacent to the stomach mucosa 75. The lower surface 1 1 2 of the external retention device 1 00 is placed with discharge against the skin of the patient 71. Step 1 16 defined in the base member 1 10 extends It is usually perpendicular to the skin of the patient 71 and is aligned close to the stoma, so that the gastrostomy tube 70 can be directed through it. The external or exposed portion of the gastrostomy tube 70 is then positioned within the channel 130, in order to bend 90 ° along a smooth transition to a substantially parallel alignment with the skin of patient 71 Gastrostomy tube 70 proximate to second section of channel 130 is releasably secured in the assembly of secure 140 with the safety elements 142 in the closed position as previously described With reference to FIG. 8 below, an alternative gastrostomy tube 80 is shown passing percutaneously via a stoma through several layers of body tissue, as described previously with respect to FIG 1, and in the stomach 85 of a patient The external holding device 100 of the present invention it is applied in the same manner as described with respect to the embodiment of FIG. 7 However, unlike the catheter assembly of FIG. 7, this embodiment has a tab 88 internal retaining member similar to that of the U.S. Pat. No. 5,080,650, which is incorporated herein by reference. In addition, the gastrostomy tube assembly of FIG 8 preferably includes a connector 82 to allow the feed tube 80 to be connected to a source of fluid tai as for the introduction of a product or liquid nutritional supplement Examples of such connectors include a Y port, as described in U.S. Design Patent No. 308,576 and U.S. Patent No. 5,057,093, which are incorporated herein by reference Yet another application of the apparatus and method of the present invention is shown in FIG. 9. In particular, FIG. 9 is directed to a jejunostomy tube molding The external retention device 1 00 is threaded. The jejunostomy tube 90 passes through the abdominal wall 91 and the intestinal wall 93 to be located in the patient's jejunum 96. During the placement of the tube assembly, the intestine 93 is secured adjacent to the patient. to the abdominal wall using fastener mounts 94, of the type shown in US Patent RE 34,021 and incorporated herein by reference. Preferably, such bras need to be used only temporarily until the stoma has been adequately formed. The jejunostomy normally has a much smaller diameter than a gastrostomy tube and, therefore, the dimensions of the external retention device 1 00 must be modified accordingly. In addition, it is noted from FIG 9 that no internal restraint device is attached to the jejunostomy tube 90 by itself Although the peristaltic action of the intestines can exert forces on the jejunostomy tube 90 capable of causing a portion of the tube to be withdrawn from the body into the stoma, the interference fit created between the jejunostomy tube 90 and the external retention device 100 minimizes such movement. is, if properly dimensioned, an interference fit will be created between jejunostomy tube 90 and step 1 16 and will be further intensified by the resultant resistance of the fold configuration of channel 130 and the forces exerted by the assembly of sure 140. It will be apparent to those skilled in the art, that various modifications and variations may be made in the apparatus and method 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 modifications that are within the scope of the appended claims and their equivalents.

Claims (24)

1. CLAIMS 1 . An external holding device for use with a catheter, the holding device comprising: a base member having a lower surface and an upper surface, the base member defining a passage therethrough from the lower surface to the surface upper, the passage having a central axis and being configured by an elongated tube of a catheter to be directed through it; and IO a manually operable lock assembly located in the base member, the lock assembly movable selectively entering a closed position and an open position, the lock assembly being capable of receiving an elongated tube directed through the passage when the mounting Safe is in the open position and ensure tube placement I5 elongated in relation to the base member when the lock assembly is in the closed position. An external retainer device according to claim 1, wherein the base member has a tube guide portion extending from the top surface, the tube guide portion 0 having an elongate channel with a defined longitudinal axis in the present, with the channel having a first section located next to the passage, the longitudinal axis in the first section of the channel is aligned substantially with the central axis of the passage, the channel having a second section separated from the first section of the channel with the longitudinal axis in the second section of the channel angled in relation to the central axis of passage; and further, wherein the lock assembly is located in the tube guide portion proximate the second section of the channel, so as to secure the elongated tube within the channel when the lock assembly is in the closed position. 3. An external retention device according to claim 2, wherein the lock assembly includes at least one lock element mounted on the pipe guide portion proximate to the second channel section, the lock element being mounted. for pivotal movement between the open position and the closed position. An external retainer device according to claim 2, wherein the lock assembly includes opposing lock elements mounted on the pipe guide portion proximate the second channel section with a lock element mounted on each side of the rail. channel, at least one of the securing elements being mounted for pivotal movement between the open position and the closed position. 5. An external holding device according to claim 2, wherein the tube guide portion includes two side walls extending upwardly from the base member, the channel being located between the side walls proximate to an area. of top edge of each side wall, with at least one side wall being elastic for bending towards the other side wall l; and further, wherein the lock assembly includes at least one lock element mounted next to the second section of the channel in the upper edge area of the elastic side wall, the lock member being pivotally moved from the closed position to the open position by bending the elastic side wall. 6 An external retention device according to claim 5, wherein the securing element includes a rod having a distal end with a gauge shape, the securing element being mounted with the rod attached to the upper edge area of the retention member. the corresponding side wall and the distal end forms a hook that extends transversely through at least a portion of the channel, when the safety element is in the closed position. An external holding device according to claim 6, wherein the securing element further includes a cushion formed at the proximal end of the rod and is embedded in the upper edge area of the corresponding side wall 8 An external holding device according to claim 6, wherein the securing element is made of a rigid material 9 An external holding device, according to claim 5, wherein the two side walls are elastic for bending towards each other, each side wall having at least one element of the insurance mechanism mounted in the upper edge area thereof, to be moved pivotally from the closed position to the open position by bending the corresponding side wall 1 0 An external holding device according to claim 9, wherein each side wall has a digital grip for bending the side wall 1 1 An external holding device according to claim 9 wherein the two side walls of the tube guide portion define a hollow space therebetween 12 A device of external retention according to claim 9, wherein the tube guide portion and the base member are formed of polyester. iuretane 1 3 An external holding device according to claim 9, wherein the tube guide portion and the base member are formed together as a single piece. 14 An external holding device according to claim 2, wherein the The longitudinal axis l in the second section of the channel is coplanar with and angled approximately 90% with respect to the central axis of the passage and the longitudinal axis l in the first section of the canal 1 5 A catheter assembly comprising a catheter which includes an elongated tube, and an external holding device, including a base member having a lower surface and an upper surface, the base member defining a passage therethrough from the lower surface to the upper surface, the passage having a central axis and being configured so that the elongated tube is directed through the same, and a manually operable safety assembly located in the basemix, being movib selectively mounting the lock between a closed position and an open position, the rear mounting being capable of receiving the elongated tube directed through the passage, when the lock assembly is in the open position and securing the positioning of the elongate tube in relation to the base member when the lock assembly is in the closed position 1 6. A catheter assembly according to claim 1, wherein the base member of the external holding device has a portion of a guidewire. of tube extending from the upper surface, the tube guide portion having an elongate channel with a defined longitudinal axis 5 in the present, the channel having a first section located next to the passage, the longitudinal axis being aligned in the first section of the channel substantially with the central axis of the passage, the channel having a second section separated from the first section of the channel with the longitudinal axis in the second section of the angled channel in relation to the axis centers it of the passage; and further, wherein the lock assembly is located in the pipe guiding portion proximate the second section of the channel, in order to secure the elongated pipe within the channel when the lock assembly is in the closed position. 7. A catheter assembly according to claim 16, wherein the tube guide portion of the external retainer includes two side walls extending upward from the base member, this located the channel between the side walls proximate an upper edge area of each side wall, with at least one side wall being elastic for bending toward the other side wall, and further, where 0 the secure assembly of the external retainer includes at least a securing element mounted next to the second section of the channel in the upper edge area of the elastic side wall, the securing element being pivotably moved from the closed position to the open position by bending the elastic side wall. 1 8. A catheter assembly according to claim 1, wherein the two side walls are elastic for bending towards one another, each side wall having at least one securing element of the safety assembly mounted on the edge area. top thereof, to be moved pivotally from the closed position to the open position half of the flexure of the corresponding side wall, and additionally, wherein the lock element includes a rod having a distal hook-shaped end, being mounted the securing element with the rod fixed to the upper edge area of the corresponding side wall and the hook-shaped distal end extending transversely through at least a portion of the channel when the securing element is in the closed position. 1 9. A catheter assembly according to claim 1, wherein the catheter is an enteral feeding tube; the catheter assembly further comprising a retaining device attached to a first section of the feeding tube to be located within a patient. 20. A method for retaining a catheter assembly to a patient, the method comprising the steps of: placing a catheter having a bore in a percutaneous manner in a patient; providing an external holding device that includes a base member having a lower surface and an upper surface, the base member defining a passage therethrough from the lower surface to the upper surface, the passage having a central axis and being configured so that the outlet pipe is directed through it, and a manually operable lock assembly located on the base member, the lock assembly being selectively movable between a closed position and an open position, the assembly being capable sure to receive the elongated tube directed through the passage when the lock assembly is in the open position and to ensure the placement of the elongated tube relative to the base member when the lock assembly is in the closed position; direct the elongated tube of the catheter through the passage of the base member of the external retention device; move the lock assembly to the open position; Insert the elongated tube of the catheter into the secure assembly; and closing the lock assembly to ensure placement of the elongated catheter tube relative to the base member of the external retainer. twenty-one . A method according to claim 20, wherein the base member of the external retention device provided during the proportion stage includes a tube guide portion extending from the top surface, the tube guide portion having an elongate channel with a longitudinal axis defined in the same, the channel having a first section located next to the passage, the longitudinal axis l being aligned in the first section substantially with the central axis of the passage, the channel having a second section separated from the first section of the channel with the longitudinal axis in the second section of the angled channel relative to the central axis of the passage, the segregation assembly being located in the tube guide portion close to the second section of the channel;; and further, wherein the method includes placing the catheter end tube into the channel of the tube guide portion prior to the insertion step. 22. A method according to claim 21, wherein the tube guide portion of the external retention device provided during the proportion stage includes two side walls extending upward from the base member, being located the channel between the side walls close to an upper edge area of each side wall, with at least one side wall for bending elastic to the other side wall, and wherein additionally the safety assembly of the external retaining device includes at least an insurance element mounted next to the second section of the channel in the upper edge area of the elastic side wall to be moved pivotally from the closed position to the open position by bending the elastic side wall; the movement step including applying pressure to the elastic side wall l to move the safety element pivotally from the closed position to the open position by bending the elastic side wall. 23. A method according to claim 22, wherein the two side walls are resilient for flexing towards each other, each side wall having at least one securing element of the secure mounting in the upper edge area of the body. same to be moved pivotally from the closed position to the open position by bending the corresponding side wall, and further wherein the securing element includes a rod having a distal end with a hook shape, the securing element being mounted with the rod fixed to the upper edge area of the corresponding side wall and the hook-shaped distal end extending transversely through at least a portion of the channel when the safety element is in the closed position; the movement step includes tightening the two side walls towards each other to move each latch member pivotally from the closed position to the open position by bending the corresponding side wall. 24. A method according to claim 20, wherein the catheter col ocated percutaneously in a patient during the placement step is an enteral feeding tube; the method further comprising the step of fastening an internal retaining device to a first section of the feeding tube within the patient.