Gastrostomy tube device and method of use

Abstract

A gastrostomy tube and systems and methods for implanting the same are provided. In one example, the gastrostomy tube comprises an elongated tubular member including a first end sized for introduction into a patient's mouth, a second end including an expandable member or other bumper, and a feeding lumen extending between the first and second ends. A bolster is connectable around the first end after the first end is directed from within the patient's stomach through intervening tissue to extend from the patient's skin and the bumper is placed against the stomach wall. An adapter is connectable to the bolster after the first end and excess material of the tubular member beyond the bolster are separated, and includes a connector for releasably connecting to a feeding tube.

Description

[Technical field]

[0001] The present invention relates to medical devices, and more particularly to gastrostomy tube devices, and systems and methods for implanting and using such devices.

[0002] Related Application Data This application claims the benefit of co-pending U.S. Provisional Application No. 63 / 213,060, filed June 21, 2021, the entire disclosure of which is expressly incorporated herein by reference. [Background technology]

[0003] A gastrostomy tube is a long tube that extends from the patient's abdomen. Gastrostomy tubes are implanted when a patient is unable to receive nutrition by mouth for, for example, at least 30 days. Low profile tubes that fit flush with the patient's abdomen are available, but cannot be safely placed until a pathway is created from the patient's stomach to the skin using a traditional long gastrostomy tube, as shown in Figure 1. These long gastrostomy tubes can cause multiple problems, including:

[0004] 1) Feeding tubes can be accidentally pulled out, for example by delirious patients in a critical condition in hospitals. Because accidental removal of the tube can lead to a fatal outcome requiring emergency surgery, patients are often placed in restraints, which entails great risks and costs.

[0005] 2) The tubes are unsightly and create psychological triggers for patients.

[0006] 3) Long tubes are prone to leaks and can be difficult for patients to handle.

[0007] 4) There is no way to convert the traditional long tube into a low profile supply tube.

[0008] Thus, there is a need for an improved gastrostomy tube that avoids the problems associated with conventional gastrostomy tubes. Summary of the Invention

[0009] The present invention is directed to medical devices, and more particularly to gastrostomy tube devices, and systems and methods for implanting and using such devices.

[0010] Described herein is a low profile gastrostomy tube that can be implanted during the initial procedure instead of waiting, for example, three months after implanting a traditional long gastrostomy tube. In an exemplary method, the gastrostomy tube can be implanted using the following procedure.

[0011] Step 1. Prepare a gastrostomy tube with a bumper. This can be done with the balloon inflated or with the bi-stable mechanism activated. The balloon can include a one-way valve to ensure that the balloon remains inflated after the tube is cut to size. Alternatively, the bumper can be a fixed shape that is always inflated.

[0012] Step 2. Under endoscopic visualization, for example after appropriate pneumoperitoneum of the stomach, a guidewire is introduced through the skin into the subject's stomach.

[0013] Step 3. The guide wire is pulled out of the mouth and attached to the gastrostomy tube. The tube is then pulled out of the mouth together with the guide wire and taken out of the stomach.

[0014] Step 4. Place a bolster around the tube and secure the exposed end of the tube to the abdomen. Secure the tube so that the abdominal wall is sandwiched between the intragastric bumper and the extragastric bolster.

[0015] Step 5. Cut the tube flush with the bolster.

[0016] Step 6. Secure the adapter to the bolster. In one example, this can be done using a flare fitting connection with a threaded connection between the bolster and the adapter. Other mechanisms for connecting the two parts to achieve a mechanical fit can also be used, including but not limited to snap attachments, adhesives, screws, pins, magnets, etc. The adapter can secure the bolster to allow manipulation of the bumper in the stomach. In the case of a balloon, there is a portal to deflate or deactivate the balloon. In the case of a bi-stable mechanism, there is a mechanism to change the shape of the bumper so that the tube can be removed. In the case of a fixed shape, the bumper in the stomach is not manipulated.

[0017] Step 7. When using a feeding tube to secure to the adapter, attach the feeding attachment to the adapter. The attachment is mechanically secured such that pulling on the tube will detach it from the adapter and will not pull the gastrostomy tube out of the abdomen. This can be accomplished using one or more of a secure fit, rotation, etc.

[0018] Step 8. When the tube is no longer needed, the bumper in the stomach is deactivated. If a balloon is used, it can be deflated or ruptured by applying suction through the adapter / bolster unit. If the bumper includes a bi-stable device, the device can be compressed, folded or otherwise adjusted through the adapter / bolster unit to remove the bumper from the skin.

[0019] Alternatively, the devices and methods herein can be used to convert a long gastrostomy feeding tube into a low profile tube. In this alternative, an annular bolster is placed around the long gastrostomy tube, for example against the patient's abdomen, thereby securing the tube firmly against the abdominal skin. The tube is then cut to remove excess material beyond the bolster, and an adapter is secured to the bolster, for example as described above.

[0020] The gastrostomy tube device herein may also be placed into an existing gastrostomy pathway or stoma, for example, for tube replacement. After removing the old tube, the patient may be left with a pathway from the skin to the stomach in the abdomen. In an exemplary method, a replacement gastrostomy tube including a bumper on a first end may be implanted using the following procedure.

[0021] Step 1. Manipulate the bumper, e.g., deflate if it is a balloon, compress if it is a bi-stable mechanism, so that the bumper in the stomach is flush with the outer surface of the tube.

[0022] Step 2. The first end of the tube (and bumper) is then inserted through the skin and into the stomach via the gastrostomy.

[0023] Step 3. Next, expand the intragastric bumper (e.g., via either a balloon or a bi-stable mechanism).

[0024] Step 4. A bolster is then placed around the tube and the exposed end of the tube is secured to the abdomen. The tube is secured so that the abdominal wall is sandwiched between the intragastric bumper and the extragastric bolster.

[0025] Step 5. Cut the tubing so that the exposed end is flush with the bolster.

[0026] Step 6. Secure the adapter to the bolster. In one example, this can be done using a flare fitting connection with a threaded connection between the bolster and the adapter. Other mechanisms for connecting the two parts to achieve a mechanical fit can also be used, including but not limited to snap attachments, adhesives, screws, pins, magnets, etc. The adapter can secure the bolster to allow for manipulation of the bumper within the stomach. In the case of a balloon, there is a portal to deflate or deactivate the balloon. In the case of a bi-stable mechanism, there is a mechanism to change the shape of the bumper to allow the tube to be removed.

[0027] According to one example, a gastrostomy tube device for implantation within a patient's abdomen is provided, the device comprising: an elongate tubular member including a first end sized for introduction into the patient's mouth, a second end including an expandable member or other bumper, and a supply lumen extending between the first and second ends; a bolster connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and extending through the patient's skin; and an adaptor connectable to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated, the adaptor including a connector for releasably connecting to a supply tube.

[0028] According to another example, a kit for implanting a gastrostomy tube within a patient's abdomen is provided, the kit comprising: an elongate tubular member including a first end sized for introduction into the patient's mouth, a second end including an expandable member or other bumper, and a supply lumen extending between the first and second ends; a bolster connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and extending through the patient's skin; and an adaptor connectable to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated, the adaptor including a connector for releasably connecting to a supply tube.

[0029] According to yet another example, a system for implanting a gastrostomy tube within a patient's abdomen is provided, the system comprising: an elongate tubular member including a first end sized for introduction into the patient's mouth, a second end including an expandable member, a supply lumen extending between the first and second ends, and an inflation lumen extending from the first end and in communication with an interior of the expandable member; a bolster connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and extending through the patient's skin; an adaptor connectable to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated, the adaptor including a connector for releasably connecting to a supply tube; and a source of inflation medium connectable to the inflation lumen for introducing inflation medium therein to expand the expandable member.

[0030] According to yet another example, a system for implanting a gastrostomy tube within a patient's abdomen is provided, the system comprising: an elongate tubular member having a first end sized for introduction into the patient's mouth, a second end including a bumper formed from a flexible extensible material, a supply lumen extending between the first and second ends; a bolster connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and out of the patient's skin; an adaptor connectable to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated, the adaptor including a connector for releasably connecting to a supply tube; and an instrument sized for introduction into the supply lumen to stretch the bumper to reduce its outer cross section and facilitate removal of the tubular member.

[0031] According to another example, a method is provided for implanting a gastrostomy tube within a patient's abdomen, the method including the steps of providing an elongated tubular member including a first end, a second end including an expandable member, and a lumen extending between the first and second ends; directing a first end of a guidewire through the patient's abdomen from the skin overlying the patient's stomach, through the intervening tissue, and into the stomach; directing the first end of the guidewire from the patient's stomach out of the patient's mouth and along the patient's upper gastrointestinal tract; expanding the expandable member at the second end of the tubular member; and, when the tubular member is positioned within the patient's stomach, the method includes the steps of: providing an elongated tubular member including a first end, a second end including an expandable member, and a lumen extending between the first and second ends; directing a first end of a guidewire through the patient's abdomen from the skin overlying the patient's stomach, through the intervening tissue, and into the stomach; directing the first end of the guidewire from the patient's stomach out of the patient's mouth and along the patient's upper gastrointestinal tract; the first end of the tubular member being inserted into the patient's mouth and upper gastrointestinal tract using a guidewire until the first end of the tubular member is exposed outside the patient's abdomen; guiding the first end through intervening tissue until the first end of the tubular member is exposed outside the patient's abdomen; securing a bolster to the first end adjacent the patient's skin such that the intervening tissue is sandwiched between the expandable member and the bolster within the stomach; separating the excess length of the tubular member exposed beyond the bolster; and securing an adapter to the bolster, the adapter including a connector for removably connecting a feeding tube to the adapter.

[0032] According to yet another example, a method is provided for implanting a gastrostomy tube within a patient's abdomen, the method including the steps of providing an elongated tubular member including a first end, a second end including a bumper, and a lumen extending between the first and second ends; directing a first end of a guidewire through the patient's abdomen from the skin overlying the patient's stomach, through the intervening tissue, and into the stomach; directing the first end of the guidewire from the patient's stomach out of the patient's mouth and along the patient's upper gastrointestinal tract; and using the guidewire to guide the first end of the tubular member until the tubular member is positioned within the patient's stomach. the expandable member into the patient's mouth and upper gastrointestinal tract; directing the first end of the tubular member through the intervening tissue until the first end is exposed outside the patient's abdomen with the bumper positioned against the stomach wall; securing a bolster to the first end flush with the patient's skin such that the intervening tissue is sandwiched between the expandable member and the bolster within the stomach; separating the excess length of the tubular member exposed beyond the bolster; and securing an adapter to the bolster, the adapter including a connector for releasably connecting a feeding tube to the adapter.

[0033] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0034] The invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference numbers identify the same elements, and in which: [Figure 1] FIG. 1 shows an example of a conventional gastrostomy tube implanted within a patient's abdomen. [Diagram 2] Figure 2A shows an example of a low profile gastrostomy tube device implanted within a patient's abdomen, while Figures 2B and 2C are side and cross-sectional views, respectively, of the gastrostomy tube device of Figure 2A. [Diagram 3]Figures 3A and 3B show an example of a tubular body for a gastrostomy tube device as shown in Figures 2A-2C including a first end and an annular balloon on the second end in an uninflated and inflated state, respectively. Figure 3C shows the tubular body of Figures 3A and 3B in an inflated state of the balloon and shows the inner lumen of the tubular body. Figure 3D is a cross-section of the tubular body of Figures 3A and 3B showing the central feeding lumen and the inflation lumen. [Figure 4] 4A and 4B are side and top views, respectively, of one example of a bolster for a gastrostomy tube device as shown in FIGS. 2A-2C including a connector for securing the bolster to the end of the tubular body shown in FIGS. 3A and 3B. [Diagram 5] 5A and 5B are side and top views, respectively, of one example of an adapter for a gastrostomy tube device such as that shown in FIGS. 2A-2C that may be connected to the bolster of FIGS. 4A and 4B. [Figure 6] 6A-6C illustrate an exemplary method for implanting a gastrostomy tube device, such as that shown in FIGS. 2A-2C, within a subject's abdomen. [Figure 7] 7A and 7B are cross-sectional views of an example of a tubular body for a gastrostomy tube device including a first end and a mechanically expandable bumper on a second end, the bumper shown in a collapsed and expanded state, respectively. [Figure 8] Figure 8A shows an alternative embodiment of a tubular member including an expandable bumper in a relaxed or expanded configuration, while Figures 8B and 8C show the tubular member of Figure 8A with an instrument advanced within the lumen of the tubular member to expand the bumper and reduce its outer cross section to facilitate removal. [Figure 9] Figure 9A is a perspective view of another example of a low profile gastrostomy tube device that can be implanted within a patient's abdomen, while Figures 9B and 9C are side and cross-sectional views, respectively, of the device of Figure 9A.

[0035] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be embodied in other various ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the detailed description, serve to explain the principles of the invention, although it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the art from the following description, which is an example of one of the best modes conceivable for carrying out the present invention. As will be understood, the present invention is also capable of various other obvious modes without departing from the present invention. For this reason, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0037] Before describing the embodiments, it is to be understood that the invention is not limited to particular embodiments described, as such may, of course, vary, and the scope of the present invention will be limited only by the appended claims. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0038] Where a range of values ​​is given, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, is also specifically disclosed unless the context clearly dictates otherwise. Each smaller range between any stated value or intervening value in a stated range and any other stated value or intervening value in a stated range is encompassed within the invention. The upper and lower limits of such smaller ranges may each be independently included or excluded within the range, and each range is encompassed within the invention, whether or not both or either are included in the smaller range, subject to the specifically excluded limit in the stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also intended to be included within the invention.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some possible exemplary methods and materials are described herein.

[0040] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "compound" includes a plurality of such compounds, and a reference to a "polymer" includes a reference to one or more polymers and equivalents thereof known to those skilled in the art.

[0041] In this specification, certain ranges are indicated by the term "about" before the numerical values. The term "about" is used in this specification to provide literal support for the exact numerical value following the term and for a numerical value close to or close to the numerical value following the term. In determining whether a numerical value is close to or close to a specifically stated numerical value, the close or close unstated numerical value may be a numerical value that provides a substantial equivalent to the specifically stated numerical value in the context in which it is presented.

[0042] 2A-2C illustrate an example of a gastrostomy tube device 10 implanted within the abdomen of a patient 90. As shown, device 10 generally includes an elongated tubular member or body 20, an expandable member or other bumper 28, a bolster 30, and an adapter 40. The components of device 10 may be provided individually to a medical professional, for example as a kit, which may be assembled during an implantation procedure as described elsewhere herein to provide a low profile gastrostomy tube that is implanted within the abdomen of a patient 90, i.e., between the skin 92 and the stomach 94, for example for a patient who is unable to receive nutrition by mouth for an extended period of time.

[0043] Additionally or alternatively, device 10 may be included in a system that includes one or more additional tools or instruments to facilitate implantation and / or removal of device 10, e.g., as further described elsewhere herein. For example, the system may include one or more guidewires, guide sheaths, pusher members and / or cutters (not shown) for introducing tubular member 20 into the patient's body 90 and / or for cutting tubular member 20 during implantation. Additionally, the system may include one or more inflation media sources and / or vacuum sources for inflating and / or collapsing bumper 28, e.g., if bumper 28 is a balloon, and / or one or more tools (also not shown) for otherwise collapsing bumper 28 for subsequent removal, as further described elsewhere herein.

[0044] 3A-3D , the tubular member 20 includes a first end 22 having a raw or tapered edge or other low profile cross-section, for example, below a major length of the tubular member 20 to facilitate introduction through abdominal tissue 96 between the stomach 94 and the skin 92, and a second end 24 including a bumper 28 and defining a longitudinal axis 21 therebetween. The tubular member 20 provided as a kit can have an original length between the first and second ends 22, 24 such that the first end extends from the patient's skin 92 when the second end 24 is positioned within the patient's stomach 94 with the bumper 28 against a wall 98 of the stomach 94 and the tubular member 20 extends through the intervening tissue 96 to the skin 92. In one example, the tubular member 20 can have a substantially uniform outer diameter between the first and second ends 22, 24, e.g., about four to eight millimeters (4.0 to 8.0 mm), and an original length between the ends 22, 24 of about twenty to one hundred centimeters (20 to 100 cm) or about seventy-five centimeters (75 cm) or more, which can facilitate introduction and / or manipulation of the tubular member 20 until the first end 22 is exposed from the patient's abdomen. After excess material is cut or otherwise removed, the final length of the tubular member 20 between the second end 24 and the cut first end can be about one to five centimeters (1.0 to 5.0 cm). Optionally, the original length, e.g., about twenty to one hundred centimeters (20 to 100 cm), can also be retained while the device is in use and / or for a period of time before excess material is cut or otherwise removed, e.g., for a period of hours to months or about one to two days. For example, the final length can be such that first end 22 extends approximately one-half to five centimeters (0.5-5 cm) from skin 92 after tubular member 20 has been introduced into stomach 94, bumper 28 has been placed against wall 98, and excess material has been removed, as further described elsewhere herein. Tubular member 20 can be formed from a flexible biocompatible material, e.g., a plastic such as polyurethane, silicone, etc., to facilitate introduction into stomach 94 while having sufficient stiffness to prevent collapse during use.

[0045] Additionally, tubular member 20 includes one or more lumens, e.g., primary or supply lumen 26a, and optionally one or more secondary lumens, e.g., inflation lumen 26b, extending between first and second ends 22, 24, as best seen in Figures 3C and 3D. In the example shown in Figures 3A-3D, bumper 28 is an annular balloon permanently or otherwise attached around second end 24 of tubular member 20 such that, e.g., supply lumen 26a extends between opening 27a of second end 24 and first end 22 of tubular member 20, i.e., through balloon 28. For example, as best seen in FIG. 2C, the balloon 28 can include a first end 28a attached to the tubular member 20, e.g., immediately adjacent the opening 25b, and a second end 28b attached to an outer wall of the tubular member 20 at a distance from the first end 28a, e.g., by one or more bonds, such as by adhesives, sonic welding, fusion, interference fitting, etc., so as to define an annular interior 28c.

[0046] In this example, the tubular member 20 includes an inflation lumen 26b extending at least partially between the first and second ends 22, 24, e.g., extending from the first end 22 adjacent the supply lumen 26a, and communicating with an interior 28c of the balloon 28 via one or more ports, e.g., port 27. The balloon 28 may be formed from a non-elastic material, such as PET, nylon, polyurethane, silicone, etc., such that when inflated, the balloon 28 expands to a preset size and / or shape, e.g., a relatively flat donut shape, to facilitate placement against the wall 98 of the stomach 94 and to prevent removal through the tissue 96. Alternatively, the balloon 28 may be formed from a resilient material, e.g., silicone or other elastomeric material, such that the size and / or shape of the balloon 28 may depend on the volume and / or pressure of the fluid introduced into the interior 28c.

[0047] Optionally, a valve 29 is provided within inflation lumen 26b, e.g., adjacent second end 24, spaced from first end 22 to remain when a portion of first end 22 is removed, or is otherwise in communication with inflation lumen 26b, so that an inflation medium, e.g., a gas such as carbon dioxide or a liquid such as saline, can be supplied, e.g., from a syringe, pump, or the like (not shown) and from inflation lumen 26a to interior 28c through valve 29 to inflate balloon 28. Valve 29 prevents the inflation medium from later leaking out, thereby allowing balloon 28 to remain inflated indefinitely (e.g., until device 10 is removed from the patient, as described elsewhere herein). For example, valve 29 may be a one-way valve, such as a flap valve or duckbill valve, that opens when inflation medium is introduced into inflation lumen 26b, i.e., under positive pressure from first end 22, and automatically closes when the pressure from the inflation medium is discontinued, thereby containing the inflation medium within interior 28c and preventing subsequent leakage.

[0048] Optionally, the valve 29 can be mechanically opened, for example by introducing a needle or other tool into the inflation lumen 26b from the first end 22, thereby allowing the inflation medium in the interior 28c to escape and deflate the balloon 28, for example for removal. Alternatively, the valve 29 can be configured to fail or otherwise open when a vacuum is applied to the inflation lumen 26b, i.e., under a negative pressure from the first end 22 that exceeds a preset threshold. For example, a syringe or vacuum line (not shown) can be connected to the inflation lumen 26b to apply a vacuum sufficient to open the valve 29 and evacuate the inflation medium from the balloon 28. In a further alternative, the balloon 28 can include one or more regions configured to break or otherwise open when additional positive pressure exceeding a preset threshold is applied to the interior 28c. For example, to facilitate removal of device 10, the wall of balloon 28 may be provided with a weakened region (not shown) that may break after balloon 28 is initially inflated, i.e., when sufficient additional positive pressure is applied, e.g., from a syringe or other source of additional inflation medium.

[0049] Alternatively, as shown in Figures 7A and 7B, for example, a tubular member 120 can be provided that includes first and second ends 122, 124 and a delivery lumen 126, generally similar to other examples herein, but that includes a bi-stable or other mechanically expandable device for a bumper 128. The bumper 128 can be oriented between a collapsed configuration, e.g., having a profile no larger than the second end 124, and an expanded configuration, e.g., in which one or more elements extend radially outward from the second end 124. For example, the bumper 128 can include a plurality of mechanically expandable elements 128a mounted or otherwise attached to the second end 124, which can be oriented between a collapsed configuration in which the elements 128a extend substantially axially relative to the longitudinal axis 121, as shown in Figure 7A, for example, and an expanded configuration in which at least a portion of the elements extend laterally, e.g., approximately perpendicular to the axis 121, as shown in Figure 7B, for example.

[0050] In the illustrated example, each of the elements 128a may include an intermediate region 128b that may be bent or folded outwardly relative to the axis 121 to define the expanded configuration. Alternatively, one or more flanges, wings, or other features may be provided that simply fold, bend, or otherwise redirect outwardly from the second end 124 toward the expanded configuration. The elements 128a may be biased toward the expanded configuration, and may be constrained in a collapsed configuration during introduction, for example, by one or more of an external sleeve, one or more filaments, and / or other constraining means (not shown). In this example, the elements 128a may automatically expand upon release from the one or more constraining means, for example, within the stomach, thereby pulling the elements 128a against the stomach wall to stabilize the second end 124. Alternatively, the elements 128a may be expanded by an actuator or a separate tool (not shown) that may plastically deform the elements 128a outwardly into the expanded configuration.

[0051] In a further alternative, the bumper may have a fixed shape, for example, defining an outer diameter or cross-section larger than the tubular member, but small enough to be guided through the subject's upper gastrointestinal tract and into the stomach. For example, as shown in FIG. 8A, a tubular member 220 may be provided including first and second ends 222, 224 and a delivery lumen 226 extending therebetween, generally similar to other examples herein, but with a stretchable bumper 228 at the second end 224. The bumper 228 may be formed from a flexible material, for example, silicone or other elastomeric material, such that the bumper 228 is biased into the expanded or relaxed shape shown in FIG. 8A. This material may allow the bumper 228 to be positioned against the stomach wall, for example, providing a shoulder that abuts the wall 98 of the patient's stomach 94 to stabilize the tubular member 220 after implantation and prevent removal through the abdominal tissue 96.

[0052] However, if desired, bumper 228 can be stretched to reduce its outer cross section. For example, as shown in FIGS. 8B and 8C, tool 280 can be provided that includes a rounded or otherwise atraumatic distal end 282 sized to be introduced into lumen 226. During removal of tubular member 220 (e.g., after removing the bolster and adapter (not shown) on first end 222), distal end 282 of tool 280 can be inserted into lumen 226 until it contacts bumper 228, and then advanced further to stretch bumper 228 along axis 221. Given the elasticity of the material, as bumper 228 stretches, its profile decreases, for example, toward the diameter of second end 224 of tubular member 220, thereby allowing for easy removal through abdominal tissue. In the illustrated example, bumper 228 includes one or more internal passages, e.g., outlet 228a, for supplying nutrients into the stomach via lumen 226, and a recess 228b for receiving distal end 282 of tool 280, e.g., to ensure that bumper 228 stretches substantially uniformly.

[0053] Optionally, the tool 280 can include one or more features to facilitate stretching the bumper 228 without applying excessive force that may cause the bumper 228 to tear or break. For example, the tool 280 can include an indicator (not shown), such as a light, speaker, or the like, at its proximal end, which can be coupled to a sensor that measures the distally directed force applied to the distal end 282. When the force applied to the bumper approaches or exceeds a maximum force, the indicator can provide an output to a user to notify the user not to apply additional force to prevent breakage of the bumper 228. Additionally or alternatively, a spring or other limiter can be provided at the proximal end such that when the maximum force is exceeded, the spring or limiter deforms or releases to prevent excessive force from being transmitted to the distal end 282.

[0054] 4A and 4B, the bolster 30 includes a ring or other annular housing that can be fitted around or otherwise connected to the tubular member 20, for example, after the first end 22 has been directed from within the patient's stomach 94 and through the intervening tissue 96 and has extended from the patient's skin 92, as shown in, for example, FIGS. 6A and 6B. Generally, as shown, the bolster 30 includes a first or lower end 32 for placement against the skin 92, a second or upper end 34, and a passageway 36 therebetween sized to receive the first end 22 of the tubular member 20. In one example, the bolster 30 can be attached to the tubular member 20 by one or more of crimping the bolster 30 onto the tubular member 20, adhesively adhering the bolster 30, one or more ratchet or detent elements that allow the bolster 30 to be advanced over the first end 22 but not removed, or the like. Additionally or alternatively, a zip tie or other clamp (not shown) may be applied around a portion of bolster 30 that can apply a radially inward force to secure bolster 30 to tubular member 20, for example, as described elsewhere herein with respect to Figures 8A-8C.

[0055] 5A and 5B, the adapter 40 can be connected to the bolster 30 and / or the tubular member 20, e.g., after excess material of the tubular member 20 over the bolster 30 has been separated, as further described elsewhere herein. In the illustrated example, the adapter 40 includes a first or lower end 42, a second or upper end 44, and one or more features for coupling to the tubular member 20. The bolster 30 and the adapter 40 can include cooperating connectors for permanently or removably securing the adapter 40 to the bolster 30. For example, as shown in FIGS. 2C, 4B, and 6B, the bolster 30 includes one or more male threads 38 and the adapter 40 includes a recess 46 including female threads 48, allowing the adapter 40 to be threaded around and / or onto the bolster 30, as shown. Alternatively, other mechanisms, such as connectors provided on device 310 described below, may be used to secure adapter 40 to bolster 30 and / or tubular member 20, including one or more of snap connectors, adhesives, screws, pins, cooperating magnets, and the like.

[0056] Optionally, as shown in FIG. 5A, the adapter 40 can include one or more features that engage with the tubular member 20, for example, after cutting or otherwise removing excess material from the first end 22. For example, as shown, the adapter 40 can include a first tubular hub 50a extending from the lower surface 42 that is sized to be inserted into the delivery lumen 26a at the cut end of the tubular member 20. Optionally, the hub 50a can include one or more connectors, such as annular ratchet elements 51a, that can allow the hub 50a to be inserted into the first end 22 while preventing removal. Optionally, a second hub 50b, also shown in FIG. 5A, can be provided that is similarly insertable into the inflation lumen 26b, for example, also including one or more ratchet elements 51b or other connectors.

[0057] The adapter 40 can include a connector for removably connecting to a feeding tube (not shown). For example, the adapter 40 can include a port or fitting for slidably and / or rotatably receiving an end of a feeding tube, and can further include a valve (not shown) that is biased in a closed position to prevent leakage from the feeding lumen 26a, for example, but can open when the feeding tube is coupled to the port. Alternatively, cooperating connectors can be provided that thread or otherwise couple together to provide a fluid-tight connection for delivery of nutrients through the feeding tube and feeding lumen 26a into the patient's stomach 94. Such connectors can include a release mechanism, such that, for example, when a preset force is applied to the feeding tube, the connector can automatically release or fail to prevent force from being transmitted to the gastrostomy tube device 10.

[0058] 9A-9C, another example of a device 310 is shown that includes a tubular member 320, a bumper 328, a bolster 330, and an adapter 340, generally similar to device 10. For example, similar to other examples herein, tubular member 320 can include a first end 322, a second end 324 that includes a bumper 328, and one or more lumens extending therebetween. For example, tubular member 320 can include a primary or supply lumen 326a that extends from first end 322, over bumper 328, to an outlet 327a at second end 324. As shown, bumper 328 is a balloon attached to second end 324, and tubular member 320 also includes a secondary or inflation lumen 326b that extends from first end 322 to a port 327b that communicates with an interior 328c of balloon 328.

[0059] The bolster 330 includes a base plate 332 configured to be placed against the patient's skin, e.g., includes a lower surface 332a including one or more spacers or other features configured to contact the skin, and a substantially flat or thinner upper surface 332b. A nipple or port 334 extends from the base plate 332 and includes an internal passageway 336 therein sized to receive the first end 322 of the tubular member 320. The nipple 334 can include a continuous annular wall that is sufficiently flexible such that the nipple 334 can be compressed inwardly around the first end 322. Alternatively, the nipple 334 can include a plurality of tabs (not shown) extending from the base plate 332 and spaced circumferentially from one another to surround the passageway 336. In this alternative, the tabs can be sufficiently flexible to be bent inwardly or otherwise compressed to secure the bolster 330 around the tubular member 320.

[0060] For example, as shown, a clamp or other fastening device 350 can be provided that is sized to be received around the nipple 334 and subsequently used to compress the nipple 334 inwardly to secure the bolster 330 to the first end 322 of the tubular member 320. For example, the clamp 350 can include a "C" shaped or flexible elongated member including two ends that include a ratchet or other mechanism (not shown) that allows the ends to engage one another after the clamp 350 is placed around the nipple 334 and to squeeze to compress the nipple 334 inwardly. For example, a zip tie device can be provided that includes a receptacle at a first end that can receive a second, opposite end after the zip tie is wrapped around the nipple 334. The ends can include cooperating ratchets, detents or other features that allow the ends to be tightened to prevent release in order to clamp the nipple 334 around the first end 320. Optionally, the second end can include one or more weakened areas where excess material can be separated by pulling or cutting, thereby providing a low-profile clamp 350 around the nipple 334.

[0061] The adapter 340 includes a housing 342 that can be secured to the bolster 330 to provide connectors for coupling a supply tube and / or a source of inflation media to the device 310. For example, as shown, the housing 342 has an elongated shape including first and second ends 342a, 342b defining a housing axis 341 therebetween. Each end 342a, 342b includes a connector 344a, 344b, respectively, for coupling to a supply tube and a source of inflation media (not shown). Each connector 344a, 344b communicates with a respective passageway 346a, 346b in the housing 342 that is configured to communicate with a respective lumen 326a, 326b of the tubular member 320.

[0062] Optionally, as shown in FIG. 9C, tubular extension 347a communicates with passageway 346a and is sized for insertion within supply lumen 326a and can extend from housing 342, e.g., approximately perpendicular to axis 341. For example, a portion of hypotube or other rigid tubular material inserted within supply lumen 326a can be attached to or extend from housing 342 to support lumen 326a, e.g., to prevent supply lumen 326a from collapsing when clamp 350 and nipple 334 are squeezed around first end 322 of tubular member 320. Additionally or alternatively, a tubular extension (not shown) can be provided in communication with passageway 346b and sized for insertion within inflation lumen 326b of tubular member 320, if desired.

[0063] Optionally, one or both of the passages 346a, 346b may include a valve 329a, 329b. For example, the passage 346a from the supply tube connector 342a may include a one-way valve 329a that is biased closed to prevent fluid from exiting the patient's stomach through the supply lumen 326a after implantation of the device 310. When a supply tube (not shown) is connected to the connector 344a to introduce nutrients into the patient's stomach, the valve 329a may open under positive pressure, for example, during delivery of nutrients, and close automatically when delivery ceases. Alternatively, the connector 342a may include a valve that opens when the connector from the supply tube is connected to the adapter 340 and automatically closes when the supply tube is removed. Similarly, for example, the inflation lumen 326b may include a valve 329b, rather than a valve in the tubular member 320, as described in other devices herein.

[0064] Additionally, the housing 342 includes one or more connectors 348 for securing the adapter 340 to the bolster 330, such as a pair of arms 348 extending from the housing 342 generally perpendicular to the housing axis 341. The arms 348 may include one or more detents or other features 348a configured to engage with corresponding features 338 on the nipple 334 of the bolster 330. For example, the detents 348a may snap engage over annular ridges 338 on the nipple 334 and / or over an edge of the clamp 350 to secure the adapter 350 to the bolster 340. With the arms 348 engaged with the nipple 334 and / or the clamp 350, the adapter 350 may be secured such that the housing axis 341 is substantially perpendicular to the longitudinal axis 321 of the tubular member 320. This allows the adapter 350 to be secured relatively close to the patient's skin in a low-profile orientation, thereby enhancing patient comfort and / or convenience and / or minimizing the risk of the adapter 350 being accidentally separated from the bolster 330.

[0065] 6A-6C, the devices herein can be implanted in a patient's abdomen to provide a low profile gastrostomy tube that can be used to provide nutrition directly into the patient's stomach. For example, the device 10 shown in Figures 2A-2C can be implanted intra-abdominally of a patient 90, i.e., extending from the patient's skin 92, through abdominal tissue 96 and into stomach 94, with the bolster 30 and adapter 40 providing a low profile that conforms to the patient's skin 92, while the bumper 28 is positioned within the stomach 94.

[0066] In an exemplary implantation method, for example, using conventional procedures, a first end of a guidewire (not shown) can be directed through the abdomen of the patient 90, through the skin 92 overlying the patient's stomach 94, through the intervening tissue 96 and into the stomach 94. For example, a needle (also not shown) can be directed directly through the skin 92 and intervening tissue 96 into the stomach 94, and the guidewire can be introduced through the lumen of the needle. The first end of the guidewire can then be directed from the patient's stomach 94, along the patient's upper gastrointestinal tract, and out the patient's mouth (not shown).

[0067] 3A and 3B, bumper 28 can be expanded or otherwise provided in an expanded configuration larger than the outer diameter of tubular member 20, and then a guidewire can be used to introduce first end 22 of tubular member 20 into the patient's mouth and upper gastrointestinal tract until tubular member 20 is disposed within the patient's stomach 94. For example, first end 22 of tubular member 20 can be connected to a first end of a guidewire outside the patient's mouth, and the guidewire can be pulled from a second, opposite side, e.g., outside the patient's abdomen, to guide tubular member 20 into stomach 94. Alternatively, tubular member 20 can be advanced over a guidewire, e.g., using a tubular pusher, guide, or other instrument (not shown).

[0068] 6A, the first end 22 of the tubular member 20 can then be guided through the intervening tissue 96 until the first end 22 is exposed outside the patient's abdomen, e.g., until the bumper 28 is positioned against the anterior wall 98 of the stomach 94. Optionally, one or more dilators and / or other tubular devices can be inserted through the tissue 96, e.g., over a guidewire, to widen the tissue 96 and / or accommodate the insertion of the first end 22 through the tissue 96 until positioned outside the abdomen. Alternatively, if the bumper 28 is a balloon or otherwise expandable, the tubular member 20 can be introduced and positioned through the intervening tissue 96 with the bumper collapsed. With the first end 22 exposed, a source of inflation media (not shown) can be connected to the inflation lumen 26b and inflation media can be introduced into the interior 28c of the balloon 28 to inflate the balloon 28 before the bumper 28 is positioned against the wall 98 of the stomach 94.

[0069] The bolster 30 can then be secured to the tubular member 20 against the patient's skin 92, e.g., advanced over the first end 22 such that the intervening tissue 96 is sandwiched between the bumper 28 and the bolster 30. The excess length of the tubular member 20 exposed beyond the bolster 30 can be cut or otherwise separated so that the tubular member 20 is flush with the bolster 30, e.g., as shown in FIG. 6B, and then an adapter 40 can be secured to the bolster 30, e.g., as shown in FIG. 6C. Similarly, a bolster 330, shown in FIGS. 9A-9C, can be advanced over the exposed first end 322 of the tubular member 320, the excess material removed, and then an adapter 340 secured to the bolster 330. Optionally, after the bolster 330 is first placed over the first end 322 of the tubular member 320, a clamp 350 can be placed around the nipple 334 and partially clamped. In this manner, clamp 350 can be used to initially stabilize tubular member 320 while excess material is removed. After adapter 340 is coupled to the bolster, clamp 350 can be further tightened to compress nipple 334 around tubular member 320. If adapter 340 is provided with tubular extension 347a, extension 347a can be inserted into supply lumen 326a before clamp 350 is further tightened to prevent supply lumen 326a from collapsing.

[0070] If desired, a feeding tube can be connected to the adapter 40, 342 to provide nutrition to the patient. When the patient no longer requires a gastrostomy tube, the device 10, 310 can be removed, for example, by collapsing the bumper 28, 328 and removing the tubular member 20, 320 from the patient's abdomen. For example, as shown in Figures 6A-6C, if the bumper 28 is a balloon, an instrument (not shown) can be introduced into the stomach 94 via the patient's upper gastrointestinal tract and used to puncture or otherwise disrupt the balloon 28. The tubular member 20 can then be withdrawn from the bolster 30 and / or adapter 40 (which are still secured to the first end 22 of the tubular member 20) so that the second end 24 can be directed from the stomach 94 and through the intervening tissue 96, or, if desired, one or both of the bolster 30 and / or adapter 40 can be removed from the tubular member 20 prior to withdrawal of the tubular member 20. Alternatively, if the balloon 28 includes a weakened region, additional inflation medium can be introduced into the interior 28c of the balloon 28 until the weakened region ruptures, thereby allowing the inflation medium to escape and collapsing the balloon 28.

[0071] In another alternative, if bumper 28 is a balloon in communication with inflation lumen 26b of tubular member 20, an instrument can be directed through valve 29 into inflation lumen 26b and the instrument can be used to remove the inflation media from the balloon or valve 29 can be opened to allow the inflation media to escape and collapse the balloon. Alternatively, a vacuum can be delivered into inflation lumen 26b, for example by applying suction from a syringe or vacuum line (not shown) above a preset threshold, to disable valve 29 and allow the inflation media to escape and collapse balloon 28. The remaining tissue passage can then be closed in a conventional manner.

[0072] While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail, It is to be understood, however, that the invention is not limited to the specific forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. A gastrostomy tube device for implantation into a patient's abdomen, comprising an elongated tubular member including a first end sized to be introduced into the patient's mouth, a second end including an expandable member, and a supply lumen extending between the first end and the second end; a bolster connectable around the first end after the first end has been guided through intervening tissue from the patient's stomach and extended from the patient's skin; an adapter connectable to the bolster after excess material of the first end and the tubular member beyond the bolster has been separated, the adapter including a connector for removably connecting to a supply tube.

2. A gastrostomy tube device for implantation into a patient's abdomen, comprising an elongated tubular member including a first end sized to be introduced into the patient's mouth, a second end including an expandable member, and a supply lumen extending between the first end and the second end; a bolster connectable around the first end after the first end has been guided through intervening tissue from the patient's stomach and extended from the patient's skin; an adapter connectable to the bolster after excess material of the first end and the tubular member beyond the bolster has been separated, the adapter including a connector for removably connecting to a supply tube, wherein the bolster and the adapter include cooperating connectors for securing the adapter to the bolster.

3. The device according to claim 1, wherein the length between the first end and the second end of the tubular member is such that when the first end is guided through intervening tissue from the patient's stomach and the expandable member is placed against the anterior wall of the stomach, the first end extends from the patient's skin.

4. The device according to claim 1 or 2, wherein the expandable member includes an annular balloon at the second end, and the tubular member further includes an inflation lumen extending from the first end and communicating with the interior of the balloon.

5. The device according to claim 4, further comprising a valve communicating with the inflation lumen to prevent leakage of inflation medium from the interior of the balloon after the balloon has inflated.

6. The device according to claim 5, The valve is a device characterized in that it enables expansion when a positive pressure is applied exceeding a preset threshold value and enables contraction when a negative pressure is applied. **Claim 7** In the device according to claim 4, a weakened area configured to break or permanently open when a positive pressure or a negative pressure exceeding a preset threshold value is applied, so that the balloon can be deflated to remove the device from the subject's abdomen, is further included in one of the balloon and the inflation lumen. The device is characterized by this. **Claim 8** In the device according to claim 1, the expandable member includes a bistable element that can expand radially outward from the second end of the tubular member. The device is characterized by this. **Claim 9** In the device according to claim 1, the bolster and the adapter include a cooperating connector for fixing the adapter to the bolster. The device is characterized by this. **Claim 10** In the device according to claim 2 or 9, the cooperating connector includes a fitting screw that enables screwing the adapter around the bolster. The device is characterized by this. **Claim 11** In the device according to claim 2 or 9, the cooperating connector includes one or more of a snap connector, an adhesive, a screw, a pin, and a cooperating magnet. The device is characterized by this. **Claim 12** In the device according to claim 2 or 9, the bolster includes a base plate configured to be placed against the patient's skin and a nipple extending from the base plate, and the cooperating connector includes a plurality of arms extending from the housing of the adapter and one or more elements on the nipple. The device is characterized by this. **Claim 13** In the device according to any one of claims 1 to 3 and 9, the bolster includes a base plate configured to be placed against the patient's skin and a nipple extending from the base plate, and the device further includes a clamp configured to be placed around the nipple to compress the nipple inwardly around the tubular member. The device is characterized by this. **Claim 14** In the device according to claim 13, the clamp includes a zip tie. The device is characterized by this. **Claim 15** A kit for implanting a gastrostomy tube into a patient's abdomen, An elongated tubular member including a first end portion sized to be introduced into a patient's mouth, a second end portion including an expandable member, and a supply lumen extending between the first end portion and the second end portion. A bolster connectable around the first end portion after the first end portion is guided through intervening tissue from within the patient's stomach and extends out from the patient's skin. An adapter connectable to the bolster after excess material of the first end portion and the tubular member beyond the bolster is separated, the adapter including a connector for removably connecting to a supply tube. A kit characterized by comprising the adapter.

16. In the kit according to claim 15, The kit further includes a cutter for separating the excess material from the remaining portion of the tubular member.

17. A system for implanting a gastrostomy tube into a patient's abdomen, An elongated tubular member including a first end portion sized to be introduced into a patient's mouth, a second end portion including an expandable member, a supply lumen extending between the first end portion and the second end portion, and an inflation lumen extending from the first end portion and communicating with the interior of the expandable member. A bolster connectable around the first end portion after the first end portion is guided through intervening tissue from within the patient's stomach and extends out from the patient's skin. An adapter connectable to the bolster after excess material of the first end portion and the tubular member beyond the bolster is separated, the adapter including a connector for removably connecting to a supply tube. A system characterized by comprising a source of inflation medium connectable to the inflation lumen for introducing an inflation medium into the interior to expand the expandable member.

18. In the system according to claim 17, The system further includes a valve communicating with the inflation lumen to prevent the inflation medium from leaking out of the interior of the balloon after the balloon expands.

19. In the system according to claim 18, The system further includes an instrument sized to be introduced into the inflation lumen for opening the valve to release the internal inflation medium to deflate the expandable member.

20. In the system according to claim 17, The system is characterized in that the expandable member includes an annular balloon at the second end portion.

21. A system for implanting a gastrostomy tube into a patient's abdomen, comprising an elongated tubular member including a first end sized to be introduced into the patient's mouth, a second end including a bumper formed of a flexible stretchable material, and a supply lumen extending between the first end and the second end; a bolster connectable around the first end after the first end is guided through intervening tissue from within the patient's stomach and extends out from the patient's skin; an adapter connectable to the bolster after excess material of the first end and the tubular member beyond the bolster is separated, the adapter including a connector for removably connecting to a supply tube; and an instrument sized to be introduced into the supply lumen for expanding the bumper to reduce its outer cross-section and facilitate removal of the tubular member.

22. In the system according to claim 21, the instrument includes an elongated tool sized to be introduced into the supply lumen and having a rounded or non-traumatic distal end for applying a force in the distal direction to the bumper to expand the bumper.

23. In the system according to claim 21, the instrument includes an indicator at its proximal end for providing an output when a force in the distal direction approaches or exceeds a maximum force to prevent breakage.

24. In the system according to claim 21, the instrument includes a limiter at its proximal end, the limiter being configured to deform or release when a maximum force is exceeded to prevent excessive force from being transmitted to the distal end.

25. In the system according to any one of claims 17 to 24, the bolster includes a base plate configured to be placed against the patient's skin and a nipple extending from the base plate, and the device further includes a clamp configured to be placed around the nipple for inwardly compressing the nipple around the tubular member.

26. In the system according to claim 25, The adapter comprises a tubular extension sized to be insertable into the supply lumen when the adapter is coupled to the bolster, the tubular extension having sufficient rigidity to prevent collapse of the supply lumen when the clamp is tightened around the nipple. A system characterized by this.

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