Patent ID: 12208064

DETAILED DESCRIPTION

Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, 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. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.

As used herein, the terms “about,” “approximately,” or “generally,” when used to modify a value, indicates that the value can be raised or lowered by 5% and remain within the disclosed embodiment. Further, when a plurality of ranges are provided, any combination of a minimum value and a maximum value described in the plurality of ranges are contemplated by the present invention. For example, if ranges of “from about 20% to about 80%” and “from about 30% to about 70%” are described, a range of “from about 20% to about 70%” or a range of “from about 30% to about 80%” are also contemplated by the present invention.

Generally speaking, the present invention is directed to a feeding tube port for use in connection with an enteral feeding system. The feeding tube port includes an inner core made of a first material and an over-layer made of a second material. The over-layer at least partially encloses the inner core, such that the inner core is configured to resist separation from the over-layer. In some aspects, the inner core may be formed from a rigid plastic material and the over-layer may be formed from a pliable material. The inner core may include one or more ribs, slots and/or apertures configured to enhance adherence between the inner core first material and the over-layer second material. The inner core may further include one or more contact points configured for attachment of a feeding tube valve to the feeding tube port. The present inventors have found that the formation of the feeding tube port from a rigid inner core and a pliable over-layer having mechanical bonding between the inner core and the over-layer enhances adherence between the inner core and the over-layer. When the inner core provides additional contact points for components that are made from a similar material as the inner core such as a feeding tube valve, the inner core acts as an anchor for such other components, thereby reducing the likelihood of delamination or detachment between the feeding tube valve and the pliable port. The specific features of the feeding tube port of the present invention may be better understood with reference toFIGS.1-11.

FIGS.1and2illustrate one or more embodiments of a feeding tube port100of the present invention. For instance, the feeding tube port100may be a low-profile gastrointestinal feeding tube port for use with an enteral or gastrointestinal feeding system. The feeding tube port100includes an inner core110and an over-layer150that at least partially encloses the inner core110. The feeding tube port100is connected to a feeding tube10. For instance, the inner core110may include an aperture114and the over-layer150may include an opening156which are aligned and configured to be in communication with the feeding tube10. The over-layer150includes an over-molded portion152defined by the surface area of contact between the inner core110and the over-layer150.

As best shown inFIGS.1-2and4-5, the inner core110defines the internal skeleton of the feeding tube port100. The inner core110is made from a first material that is more rigid than the material of the over-layer150. In some aspects, the inner core110may be formed as a unitary structure, i.e., manufactured, e.g., by molding, as a single unitary piece. The inner core110has an upper surface112, a lower surface118, and a side surface116extending between the upper surface112and the lower surface118. Additionally, the inner core110can include an aperture114extending therethrough from the upper surface112to the lower surface118. The aperture114can provide a channel or lumen for delivering food or other fluid through the feeding tube port100to the patient. The aperture114can also provide a channel or lumen for extracting fluids through the feeding tube port100from the patient, as is the case in instances such as gastric decompression. The upper surface112may further include a valve seat130, shown as a round or generally circular indentation in the upper surface112inFIG.2, in which a valve200or other component can be seated as will described in more detail below. The upper surface112may also include one or more contact points132at which the upper surface112can receive and retain the valve200or other component(s) to be attached to the upper surface112of the inner core110. The contact points132may include one or more of a snap, twist, or locking feature for securely attaching the valve200or other component(s) to the inner core110. As shown inFIG.2, the upper surface112of the inner core110may be exposed. However, the present inventors also contemplate configurations in which at least a portion of the upper surface112is encapsulated by the over-molded portion152of the over-layer150.

In some embodiments, the inner core110can have a generally cylindrical shape having a diameter that is generally larger than the height H. For instance, the inner core110can have a generally circular shaped upper surface112having a diameter D1. The lower surface118may also have a generally circular shape having a diameter D2that is approximately equal to the diameter D1. Additionally, the aperture114through the inner core110has a diameter D4that is smaller than the diameter D1and D2of the upper surface112and lower surface118, respectively.

Portions of the inner core110, such as the lower surface118, may further include one or more structures which are configured to prevent separation between the inner core110and the over-layer150. For instance, the inner core110includes one or more ribs120, slots122, holes/openings124, and/or cut-outs126that increase the surface area for contact between the inner core110and the over-layer150. The ribs120, slots122, openings124and/or cut-outs or indented portions126may be formed in or on the side surface116, the lower surface118and/or the upper surface112of the inner core110. For instance, as shown inFIG.4, the upper surface112may include one or more slots122formed in the upper surface112. Additionally, as shown inFIG.4, the upper surface112may include one or more cut-out or indented portions126around the perimeter of the upper surface112. Further, the side surface116of the inner core110shown inFIG.4can include one or more ribs120interposed with slots122in between the ribs120. Additionally, the lower surface118of the inner core110shown inFIG.4can include one or more holes or openings124through the lower surface118into the adjacent slots122. The lower surface118may also include one or more cut-out or indented portions126along the perimeter of the lower surface118. The lower surface118may have a diameter D3extending across the cut-out or indented portions126that is smaller than the diameter D2of the lower surface118yet larger than the diameter D4of the aperture114through the inner core110. However, any arrangement or combination of ribs120, slots122, holes/openings124and/or cut-out or indented portions126may be formed in the inner core110as contemplated by the present invention. The one or more ribs120, slots122, holes/openings124, and/or cut-outs or indented portions126provide openings or voids through which the material of the over-layer150can fill in to form the over-molded portion152so that the inner core110is mechanically bonded in place within the over-layer150.

Additionally, the inner core110can have a smooth surface texture and/or a rough, uneven textured surface. For instance, at least a portion of the inner core110can have a textured surface having ridges, dimples, rounded protrusions such as hemispheres, pyramids, or any other three-dimensional texture in or on the surface of the inner core110. By providing a three-dimensional surface texture on the inner core110, the bonding surface area of the inner core110is expanded compared to a smooth surface texture in order to provide increased area for bonding between the over-layer150and the inner core110. The over-layer150can fill in voids within the textured surface of the inner core110in order to further increase the surface area of the overmolded portion152to bond the inner core110in place with the over-layer150.

The over-layer150forms the outer structure of the feeding tube port150as shown inFIGS.1-3. The over-layer150is made of a second, pliable material such as a thermoplastic elastomer in some embodiments. When such an elastomer is used, it can be a medical-compliant over-mold that adheres to various substrates, including the types of more rigid material used in the inner core110, noted above. This type of material has a rubber feel and soft touch and is typically clear or translucent. For instance, the second material can be used in injection molding fabrication, as will be discussed in greater detail. Over-layer150also can be made of an opaque material, including materials that can possess preselected color characteristics. Over-layer150provides a good gripping material for individuals who are handling and manipulating the feed valve port100(e.g., nurse, clinician, caregiver, patient, etc.) and also provides a resilient enclosure that permits the use of a more rigid first material for the inner core110while protecting the inner core110from breakage, damage, slipperiness and other undesirable characteristics. Moreover, the soft, flexible material of over-layer150allows the feed valve port100to be comfortably placed in close proximity to a patient's exposed skin. The combination of the inner core110and the over-layer150permits an organic, smooth shape that allows for ergonomic gripping of the feed valve port100during use and reduces discomfort between the port100and the patient's skin.

In one aspect of the present invention, the inner core110can be made of polycarbonate and the over-layer150can be made of polyurethane. Polyurethane generally has better abrasion and tear resistance than rubber materials, and additionally a higher load bearing capacity, making it a suitable choice of material for the over-layer150of the present invention. Polyurethane is also more resistant to many oils, solvents, and weak acids/bases than rubbers. Moreover, polyurethane is a lubricious material, i.e., it seeps lubricant over time. However, these same beneficial characteristics can make polyurethane a difficult material to adhere or bond components that are made from other materials. Thus, over-molding polyurethane over or around a component, such as the inner core110, is often a preferred method to bond the components together, in addition to using one or more adhesives and/or solvents to bond the components. The present inventors have found that polycarbonate is a material that adheres well to polyurethane, especially when the polyurethane material is overmolded onto a polycarbonate skeleton. Thus, when the inner core110is made of polycarbonate and the over-layer150made of polyurethane is molded over the inner core110, desirable bonding characteristics are achieved.

Moreover, as described above, the surface features of the inner core110such as the ribs120, slots122, openings124and/or cut-outs or indented portions126increase the surface area of the inner core110that can be overmolded with the over-layer150to form a greater over-molded portion152. By enabling the polyurethane to fill in the slots122, apertures124and/or cut-out or indented portions126while the ribs120stick out or protrude from the inner core110, the inner core110and the over-layer150are effectively stitched together by the polyurethane overmolded portion152. Thus, the inner core110can be retained within the over-layer150without requiring the use of other adhesive and/or solvent bonding. Instead, the over-molding of the over-layer150over the inner core110may replace the need for adhesive or solvent bonding between the pliable material(s) and rigid material(s) of the feeding tube port. However, adhesive and/or solvent bonding may be used in addition to the overmolding of the inner core110and the over-layer150. For instance, as will be described in greater detail below, adhesive bonding and/or solvent bonding may be used to bond one or more additional components to the inner core110in order to form the feeding tube port100.

The over-layer150is formed by over-molding a pliable material, e.g., polyurethane, around the inner core110. The over-layer150includes a recess156for holding or receiving the inner core110within the over-layer150. The recess156extends through the over-layer150from an upper surface160to a lower surface162. The over-layer150is configured to receive a feeding tube10within an opening154at the lower surface162. The opening154for the feeding tube10is in fluid communication with the opening156for the inner core110, and particularly, the opening154is in fluid communication with the aperture114of the inner core110for allowing fluid to pass through the feeding tube port100into the feeding tube10. Moreover, the over-layer150can have a rounded, e.g., generally circular, oval or elliptical, shape surrounding the inner core110and generally conforming to the outer shape of the inner core110.

In some aspects, the over-layer150of the port100can include one or more side ports170, as shown inFIGS.1-3and9-11. Each side port170may include an opening172facing generally perpendicular to the opening156and feeding tube10. Each of the side ports170can accommodate one or more components that are part of or can be used in conjunction with the feeding tube port100. For instance, one of the side ports170may form a balloon port or other similar port intended to access the feeding tube's internal retention bolster. The balloon port is configured to allow fluid, e.g., air, water, saline, etc., into the balloon20of the port100. The balloon20is disposed surrounding the feeding tube10and configured to hold the feeding tube10in place relative to the patient's body. Thus, after the feeding tube10is inserted into the patient's body, the balloon20can be inflated via the balloon port170.

The inner core110can be formed, e.g., by a molding process or an extrusion process. For instance, the inner core110can be formed by injection molding. The inner core110may be manufactured independently prior to over-molding the over-layer150onto the inner core110. In one aspect of the present invention, the inner core110can be molded as an integrated step of a single manufacturing process in which the inner core110is molded and then the over-layer150is overmolded onto the inner core110, for instance, by injection molding. When the over-layer150is overmolded onto the inner core110, one or more portions of the inner core110may be blocked so that they remain free of the over-layer150. For instance, the upper surface112of the inner core110may be covered or blocked during the fabrication of the over-layer150so that the valve seat130and the aperture114remain exposed and are not covered by the over-layer150.

In some aspects, the inner core110and/or the over-layer150may each have pre-selected color characteristics. For instance, the inner core110may have an opaque color such that the inner core110can be easily visible or identifiable within the over-layer150when the over-layer150is clear or translucent. In such an embodiment, the contact points132or other component attachments of the inner core110may be more easily identifiable when the feeding tube port100is observed. Additionally, the inner core110can include printed and/or molded text on the upper surface112, side surface116or lower surface118that is configured to be visible through the over-layer150when the over-layer is clear or translucent. The over-layer150may also have an opaque material having preselected color characteristics. For instance, the inner core110may have a first color and the over-layer may be formed from at least a second color that is different from the first color. Optionally, the first color and/or second color may be selected to match a color of a subcomponent configured to be bonded with the inner core110and/or over-layer150in order to enable a user to easily match the colors for properly aligning and attaching the subcomponents. For instance, the balloon port170of the over-layer150may be formed from a particular color, and an attached balloon valve may be formed from a matching color.

As illustrated inFIGS.6-8, one of the additional components of the feeding tube port100may further include a feeding tube valve200. The feeding tube valve200includes an aperture218extending therethrough from an upper surface212to a lower surface222. A valve202is seated within the aperture218. The valve202may be, for instance, a one-way valve or a two-way valve. For instance, the valve202may be formed of an elastomeric material having one or more flaps for opening and closing the valve. As shown inFIG.6, the valve202may include one or more slits within the elastomeric material to form the flaps, such as four flaps formed from a cross-shaped slit illustrated inFIGS.6and7.

The feeding tube valve200may also contain a connection portion210that may be configured to connect the feeding tube valve200with a tube, connector, port or other source of enteral feeding, fluid, medicine, or other substance to be delivered through the feeding tube port100. The connection portion210includes an upper surface212which forms an upper surface of the valve200. The connection portion210further includes an inner lip214sitting beneath the upper surface212and an inner cylinder216sitting below the upper surface212such that the upper surface210sits generally on the inner cylinder210. Such configuration enables a connector, tube or port that is configured to interface with the connection portion210to surround the upper surface212and interface with the inner lip214formed around the inner cylinder216.

As illustrated inFIGS.8-9and11, the feeding tube valve200is configured to fit within the valve seat130of the inner core110using the attachment portion220of the valve200. The attachment portion220can include a seat222configured to fit within the valve seat130of the inner core110, and one or more contact points224configured to engage with the contact points132of the inner core110. By placing the seat222of the in feeding tube valve200within the valve seat130of the inner core and aligning the contact points224with the contact points132of the inner core110, the feeding tube valve200can be securely fit and held in place within the inner core110. In addition to mechanically fitting the feeding tube valve200with the inner core110, the feeding tube valve200can be bonded to the inner core110such as by an adhesive or solvent bonding. For instance, the bonding between the inner core110and the feeding tube valve200can use an adhesive such as cyanoacrylate, an ultraviolet-cured adhesive, a solvent such as dimethyl chlorine, or any other adhesive or solvent suitable for bonding the materials of the inner core110and the feeding tube valve200. In some aspects, the inner core110and the feeding tube valve200may be made from the same or similar materials. When the inner core110and feeding tube valve are formed from the same or similar materials, they may bond together easily. For instance, when both the inner core110and the feeding tube valve200are formed from polycarbonate, cyanoacrylate adhesive or dimethyl chloride solvent may be used to bond the inner core110and feeding tube valve200components together.

In addition to or supplemented with adhesive or solvent bonding, the feeding tube valve200can also be connected to the inner core110via a variety of mechanical attachments. Examples of these types of mechanical attachments include features such as ribs, slots, and other general protrusions that create physical interference between the two components. Additionally, helical features, or the like, may be incorporated into inner core110such that the tube valve200is assembled and retained via a “twist and lock” type of feature.

As mentioned above, the feeding tube port100may additionally include one or more side ports, such as two side ports170as shown inFIGS.1-2and9-11. For instance, one of the side ports may be a balloon port for filling an inflatable balloon20configured to hold the feeding tube10in place. When the balloon20is inflated, it serves to hold the feeding tube port100and feeding tube10in place and prevent leakage of gastric contents via the patient's stoma.

In additional embodiments (not shown), the inner core110is configured to form an inner skeleton for a feeding tube port100that defines not only the skeleton for the feeding tube valve200but also the balloon port170and/or any other side port or valve. For instance, the shape of the inner core110may include one or more side openings oriented at an angle to the axis of the aperture114, e.g., generally perpendicular to the axis of the aperture114, in order to form a skeleton for the balloon port170. Similarly, the present inventors contemplate the formation of a dual port such as a gastric-jejunal feeding port formed having an inner core and an overmolded layer as described by the present invention. Moreover, any other catheter or port configured to sit in contact with the patient's skin, such as an intravenous line, chemotherapy drug delivery port, ostomy port or stoma, or other suitable medical device port.

This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.