GASTROSTOMY TUBE REINSERTION DEVICE

Abstract

The invention disclosed herein is a method for progressive dilation of living tissue with a gastrostomy tube reinsertion device. In one aspect, the gastrostomy tube reinsertion device has multiple dilators to open collapsed soft tissue within the gastrostomy tube tract. Such device is useful for reinserting a gastrostomy tube into the previously defined tract in a human body, even after partial closure of the tract and gastrostomy tube insertion site. In another aspect, the present invention provides the method or steps for reinserting a gastrostomy tube into a patient.

Claims

1. A method for progressive dilation of a gastrostomy tube tract in living tissue of a mammalian body, comprising the steps of: inserting a first dilator into a collapsed soft tissue gastrostomy tube tract until a flange on the first dilator prevents further advancement of the first dilator; removing the first dilator from the collapsed soft tissue gastrostomy tube tract and immediately inserting a second dilator into the collapsed soft tissue gastrostomy tube tract until a flange on the second dilator prevents further advancement of the second dilator; removing the second dilator from the collapsed soft tissue gastrostomy tube tract and immediately inserting a third dilator into the collapsed soft tissue gastrostomy tube tract until a flange on the third dilator prevents further advancement of the third dilator, wherein the third dilator has a hollow interior; inserting a gastrostomy tube into and through the hollow interior of the third dilator and into a stomach of the mammalian body; and lifting, separating and removing the third dilator from the collapsed soft tissue gastrostomy tube tract.

2. The method of claim 1, further comprising: inflating a gastrostomy tube balloon before lifting, separating, and removing the third dilator from the collapsed soft tissue gastrostomy tube tract; and verifying placement of the gastrostomy tube balloon in the living tissue of the mammalian body.

3. The method of claim 1, further comprising a step of visualizing placement of the gastrostomy tube by radiography.

4. The method of claim 1, wherein an exterior surface of the second dilator has a periphery that is greater than a periphery of the first dilator.

5. The method of claim 4, wherein an exterior surface of the third dilator has a periphery that is greater than the periphery of the second dilator.

6. The method of claim 1, wherein each of the first dilator and the second dilator has a closed distal end with a rounded blunt tip.

7. The method of claim 1, wherein the third dilator has an open distal end with a rounded blunt tip with an opening sufficient to allow the gastrostomy tube to pass through the rounded blunt tip.

8. The method of claim 1, wherein the third dilator has serrated edges on two sides, the serrated edges extending from an open distal end of the flange to facilitate separating and removing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIGS. 1A, 1B and 1C are views of one embodiment of three differently sized dilators of a gastrostomy reinsertion device;

[0028] FIG. 2 is a side view of the dilator of a gastrostomy tube reinsertion device having serrated walls;

[0029] FIG. 3 is a top view of a dilator of the gastrostomy tube reinsertion device depicting the hollow interior and the flanges of the dilator;

[0030] FIG. 4 is a schematic illustration of a gastrostomy tube placed through the abdominal wall and into the gastric lumen of the stomach.

DRAWING ELEMENTS

[0031] 10a 3 mm diameter dilator

[0032] 10b 5 mm diameter dilator

[0033] 10c 8 mm diameter dilator

[0034] 11a hollow interior of 3 mm diameter dilator

[0035] 11b hollow interior of 5 mm diameter dilator

[0036] 11c hollow interior of 8 mm diameter dilator

[0037] 12a periphery of 3 mm diameter dilator

[0038] 12b periphery of 5 mm diameter dilator

[0039] 12c periphery of 8 mm diameter dilator

[0040] 14a exterior wall of 3 mm diameter dilator

[0041] 14b exterior wall of 5 mm diameter dilator

[0042] 14c exterior wall of 8 mm diameter dilator

[0043] 15a flange of 3 mm diameter dilator

[0044] 15b flange of 5 mm diameter dilator

[0045] 15c flange of 8 mm diameter dilator

[0046] 17a rounded blunt tip of 3 mm diameter dilator

[0047] 17b rounded blunt tip of 5 mm diameter dilator

[0048] 17c rounded blunt tip of 8 mm diameter dilator with open end

[0049] 20 opening in rounded blunt tip of 8 mm diameter dilator

[0050] 30 gastrostomy tube

[0051] 33 serrated sides of 8 mm diameter dilator

[0052] 35 gastrostomy tube insertion site

DETAILED DESCRIPTION OF THE EXAMPLE EMBODIMENTS

Overview

[0053] The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, methods and/or kits are disclosed and described, it is to be understood that this invention is not limited to the specific devices, methods and/or kits disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0054] The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.

[0055] As used herein, the singular forms “a,” “an,” and “the” comprise plural referents unless the context clearly dictates otherwise. Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect comprises from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0056] In simplest terms, disclosed herein are gastrostomy tube reinsertion devices. In one aspect, the gastrostomy tube reinsertion devices disclosed herein comprise multiple dilators to open collapsed soft tissue from and within the gastrostomy tube tract in a progressive and sequential manner. The present invention provides a dilation device for dilating the gastrostomy tube tract in living tissues. Such device is useful for reinserting a gastrostomy tube into the tract in a human body, even after partial closure of the tract. Although the dilation device may be used for other purposes, it is discussed in the context of reinsertion of a gastrostomy tube. The present invention also provides the steps for reinserting a gastrostomy tube into a patient in need thereof.

[0057] The method described for replacement of gastrostomy tubes may be performed by moderately-skilled medical personnel, such as by an emergency room physician, without the need for surgery or a hospital stay, which will reduce the costs to the patient and/or the patient's insurer.

[0058] Referring to FIGS. 1A, 1B and 1C, the dilators 10a, 10b, 10c are in incremental sizes. The first dilator 10a is hollow 11a with an outer surface 12a having a defined periphery of 3 mm and a length of 5 cm. The exterior wall 14a of the first dilator 10a is 1 mm thick and has a flange 15a at the top that is 3 cm in diameter and 2 mm in thickness. The function of the flange 15a is to prevent accidental insertion of the first dilator 10a completely into the stomach. The first dilator 10a has a rounded blunt tip 17a at the distal end of the dilator 10a. The function of the rounded blunt tip 17a is to gently ease apart the collapsed soft tissue of the gastrostomy tube insertion site 35 and the gastrostomy tube tract.

[0059] The second dilator 10b is hollow 11b with an outer surface 12b having a defined periphery of 5 mm and a length of 5 cm. The exterior wall 14b of the second dilator 10b is 1 mm thick and has a flange 15b at the top that is 3 cm in diameter and 2 mm in thickness. The function of the flange 15b is to prevent complete insertion of the second dilator 10b into the stomach. The second dilator 10b has a rounded blunt tip 17b at the distal end of the second dilator 10b. The function of the rounded blunt tip 17b of the second dilator 10b is to further gently ease apart the collapsed soft tissue of the gastrostomy tube insertion site 35 and the gastrostomy tube tract.

[0060] The third dilator 10c is hollow 11c with an outer surface 12c having a defined periphery of 8 mm and a length of 5 cm. The exterior wall 14c of the third dilator 10c is 1 mm thick and has a flange 15c at the top that is 3 cm in diameter and 2 mm in thickness. The function of the flange 15c is to prevent accidental insertion of the third dilator 10c completely into the stomach. The third dilator 10c has a rounded blunt tip 17c that includes an opening 20 in the bottom of the tip to permit insertion of the replacement gastrostomy tube 30. The third dilator 10c is serrated 33 on both sides to allow for separation and removal after the replacement gastrostomy tube 30 is placed through the third dilator 10c.

[0061] A view of one embodiment of the dilation device is illustrated. In one aspect, the dilation device comprises three differently sized dilators 10a, 10b, 10c. As one skilled in the art will appreciate, the dilators 10a, 10b, 10c can be of any size as long as adequate for the assigned task, that being the dilation of collapsed soft tissue of the gastrostomy tube site 35 and the gastrostomy tube tract.

[0062] In one aspect, the first and second dilators 10a, 10b are defined by an open end port on the top surface of the flange 15a, 15b and a closed end on the bottom rounded blunt tip 17a, 17b. The flange 15a, 15b is placed at the top of the dilator 10a, 10b for the purpose of preventing the dilator 10a, 10b from being inserted completely into the stomach. It is also contemplated that the third dilator 10c can be open at both ends and, in this aspect, the open ends of the dilator 10c are defined in the respective top and bottom surfaces of the dilator 10c.

[0063] Each dilator 10a, 10b, 10c is made of a firm, yet flexible material, such as silicone. Each dilator 10a, 10b, 10c defines a respective outer surface 12a, 12b, 12c having a respective periphery of differing sizes. Each dilator 10a, 10b, 10c also defines a tapering rounded blunt tip end 17a, 17b, 10c.

[0064] The plurality of dilators 10a, 10b, 10c have peripheries of various dimensions so that a set of dilators may be used as serial dilators. By using the plurality of dilators 10a, 10b, 10c in sequence from smaller to larger periphery, the gastrostomy tube tract is gradually dilated. For a dilator suitable for a gastrostomy tube reinsertion, the largest dilator should have a periphery approximately as large as the periphery of the gastrostomy tube and, preferably, approximately 1-2 mm larger than the gastrostomy tube. Each dilator is preferably about 3-7 cm in length and most preferably 5 cm in length.

[0065] The process of dilating the tract or passageway for the purpose of reinserting a replacement gastrostomy tube 30 is as follows. First, the exterior surfaces of each dilator 10a, 10b, 10c are lubricated with a water-soluble lubricant such as K-Y gel. The area of the gastrostomy tube site 35 should be cleaned with suitable cleansing products and dried prior to insertion of the replacement gastrostomy tube 30. The lubricated dilator 10a having the smallest periphery is inserted gently into the gastrostomy tube site 35 and advanced slowly and gently through the soft tissue of the tract until the flange 15a of the dilator 10a reaches the skin of the abdomen. The dilator 10a is then slowly and gently removed and the second dilator 10b having a larger periphery is immediately inserted into the partially dilated gastrostomy tube site 35 and advanced gently and slowly through the same soft tissue of the tract until the flange 15b of the dilator 10b reaches the abdominal skin. The dilator 10b is gently removed and the third and final dilator 10c having a periphery larger than the second dilator 10b is immediately inserted into the partially dilated tract and advanced slowly and gently through the same soft tissue of the tract until the flange 15c of the dilator 10c reaches the abdominal skin. The replacement gastrostomy tube 30 is lubricated with a lubricant such as K-Y gel and inserted into the hollow interior 11c of the third dilator 10c and through the bottom open end 17c of the dilator 10c. Once the replacement gastrostomy tube 30 has been placed sufficiently through the dilator 10c, the flange 15c of the dilator 10c is lifted up from the abdominal skin and the dilator 10c is separated along the serration 33 and removed from the gastrostomy tube tract. The gastrostomy tube 30 remains in the tract and into the stomach where the balloon at the end of the gastrostomy tube 30 is inflated and the placement inside the stomach is confirmed.

[0066] The placement of the gastrostomy tube 30 may be confirmed via radiography to visualize placement of the gastrostomy tube 30. Another means of confirming the placement of the gastrostomy tube 30 is by aspirating gastric contents via the gastrostomy tube 30 and measuring the pH of the aspirate.

[0067] Referring to FIG. 2, the serrated walls of the third dilator 10c are shown in a locked position outside the patient's body. After the third and final dilator 10c having a periphery larger than the second dilator 10b is inserted into the partially dilated tract and advanced slowly and gently through the same soft tissue of the tract until the flange 15c of the dilator 10c reaches the abdominal skin, the replacement gastrostomy tube 30 is then advanced through the opening at the top of the hollow dilator 10c and through the hollow dilator and out of the opening at the bottom of the dilator 10c into the stomach, then the flanges 15c of the third hollow dilator 10c are lifted up from the abdominal skin and gently pulled apart so as to separate along the serration 33 and removed from the gastrostomy tube tract.

[0068] Referring to FIG. 3, depicting a top view of the third hollow dilator 10c with its serrated sides 33, the removal of the third hollow dilator 10c does not occur until after the gastrostomy tube 30 has been inserted into the open end at the top of the dilator 10c and advanced through the hollow interior 11c of the dilator 10c and out through the bottom opening 20.

[0069] In another aspect of the invention, the balloon retention device of the gastrostomy tube 30 may be inflated prior to removal of the hollow dilator 10c in order to prevent the gastrostomy tube 30 from retracting back into the hollow dilator 10c. After inflation of the balloon retention means of the gastrostomy tube 30, the flanges 15c of the hollow dilator 10c are lifted up from the abdominal skin and gently pulled apart so as to separate along the serration 33 and removed from the gastrostomy tube tract. The gastrostomy tube 30 remains in the tract and into the stomach, and the placement of the gastrostomy tube inside the stomach is confirmed by radiology or other verification practice means.

[0070] The dilation device disclosed herein may have many uses known to those of skill in the art. For example, the disclosed dilation device can be used in any living tissue having a collapsed soft tissue site.

[0071] It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.