FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
A BODY ACCESS TUBE WITH AN IMPROVED ADJUSTABLE
ANCHORING DEVICE
BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY REGISTERED UNDER THE COMPANIES ACT
WITH ADDRESS: SURVEY NO. 48, 3 & 48 7, PASHAN – SUS ROAD, SUS, PUNE,
MAHARASHTRA 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE SUBJECT MATTER.

FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of medical devices. More specifically, the present invention relates to external retention means to prevent inward migration of feeding tube within the body.
BACKGROUND
[0002] People suffering from stroke, Alzheimer's disease, cancer, inflammation or other infirmities, often cannot properly chew or swallow their food .The need to artificially introduce food into the digestive tract of patients who will or will not be able to eat must be delivered to the patient in another fashion if starvation and malnutrition are to be avoided and this has been known throughout the century and from the last century.Percutaneous Endoscopic Gastrostomy (PEG) is a medical procedure for placing a feeding tube through the abdominal wall and into the stomach of a patient, aided by endoscopy. PEG tubes are placed in a vast array of age-groups and disease-states to allow nutrition, fluids and/or medications
[0003] A common potential issue associated with percutaneous enteral feeding tubes is securing the tube in place. These tends to entangled and dislodged from the patient due to improper sizing and inadequate locking of the device to the patient. In some prior art devices, the exterior of the gastrostomy tube is taped to the wearer's body, and this can cause infection at the stoma entry, and along the taped area, as well as causing irritation due to the difficulty in maintaining these areas clean. An external bolster (i.e. a disc, linear bolster or like) is often used to prevent accidental dislodgement and to keep internally retained feeding tubes (by a balloon or bumper) in place. After placement of the percutaneous feeding tube, the internal retention device (i.e. balloon, or bumper) is pulled against the stomach wall and then the external bolster is pushed down to the skin. The only thing that keeps the external bolster in place is friction around the tube. When the external bolster remains close to the skin, there is no significant motion of the internal balloon or bumper, and any risk to the PEG tube is decreased. When the external bolster slides back, the gastrostomy or PEG tube is no longer held in place and there is an increasing "back and forth" motion of the balloon. This "back and forth" motion leads to an increased risk of complications, including peritube leakage, skin excoriation, infection, bleeding, inadequate feeding, and tube replacement/upsizing ultimately leading to tube dislodgment; possible need for antibiotic therapy; or even emergency department visits. In addition, the

forward dislodgement of the tube may lead to gastric or intestinal obstruction, with severe abdominal pain and inability to get needed nutrients. Moreover these problems can result in the tube being ingested into the stomach.
[0004] Currently, the available designs and methods for securing the location of an external bolster at a desired location along a tube lack the ability to secure them in a simplistic manner. A prior art teaches a more complex design using saw teeth on both the tube and the bolster and a compression element to secure the location of the bolster.This is a screw like securing means, which can be more expensive to manufacture. The saw teeth design can also cause increased discomfort when contacting the patient's skin. Furthermore other prior art devices employ a spring biased or threaded locking mechanism to secure a locking ring to the wearer's body, the locking ring being fastened on the gastrostomy tube. But these devices maintain a fixed pressure or position of the locking ring on the gastrostomy tube, and do not self adjust to peristaltic pressure of the stomach. This is of particular importance in the case of neonatal patients or other types of patients (e.g., incoherent or unconscious) who are unable to communicate the nature of their discomfort.
[0005] Other prior arts use methods like addition of a plastic ring, tightening a silk suture or tying a zip-tie around the neck external bolster. However, these methods restrict the lumen of the tube, which increases the risk of tube occlusion. Also,external bolsters do not additionally provide strain relief to dissipate the effect of an externally-directed pulling force applied to the PEG device. However, the application of a sufficiently great pulling force on the external end of an implanted PEG tube and the ill-advised removal of the PEG device from the patient can cause significant injury to the patient like tearing of sutures, damage to the stoma, and the like. Moreover, the use of tape or mechanical locking devices requires extra care which is usually provided by trained personnel such as nurses. Hence,there is a need for an adjustable anchoring device for the patients which they can handle themselves easily and which holds the tube in an effective manner against the skin .
[0006] This invention is therefore directed towards providing an improved retention device, which is relatively simple in design and structure, and is highly effective for its intended purpose.
SUMMARY

[0007] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.
[0008] An object of the present invention is to provide an improved assembly of a feeding tube with an external flexible adjustable anchoring device which can be locked in place efficiently on the feeding tube after being easily positioned by the physician.
[0009] Another object of the present invention is to provide an external flexible adjustable anchoring device which is maintained in its operational configuration by an easily installed flexible ring shaped seal ring.
[0010] Yet another object of the invention is to provide the external adjustable anchoring device, after locking it in place, become unitized on the feeding tube such that the tube cannot move inward inside the body.
[0011] It is still another object of the present invention to provide an external adjustable anchoring device that is adapted to relieve strain applied to an implanted medical feeding tube secured thereto.
[0012] It is yet still another object of the present invention to provide an external adjustable anchoring device that is inexpensive to manufacture and is easy to use.
[0013] In an aspect of the present disclosure, a feeding tube assembly 100 comprising a flexible external adjustable anchoring device 104 having a flexible seal ring 110 is disclosed. The flexible adjustable anchoring device 104 comprises of an annular base 202 having an upper surface 202(a) and a lower surface 202(b) wherein the upper surface 202(a) comprises of air gaps 210 which extends through the upper surface 202(a) to the lower surface 202(b) of the annular base 202 and helps in venting the air between the flexible external adjustable anchoring device 104 and stoma thereby reducing the risk of bacterial infection. The lower surface 202(b) of the annular base 202 comprises of raised, concentric plurality of legs 208 which are designed to rest on the skin of a patient in the area surrounding a stoma. In order to secure the feeding device to the skin of the patient, the feeding tube 102 is passed through the central cavity 206 of the

flexible external adjustable anchoring device 104 comprising a projection 204 extending away from the upper surface 202(a) of the annular base 202 and having a plurality of grooves 302 to accommodate the flexible seal ring 110. The flexible seal ring 110 is accommodated in the plurality of grooves 302 of the external adjustable anchoring device 104 according to the need to secure the feeding tube 102 as well as according to the comfort of the patient.
[0014] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiment.
[0015] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0016] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.
[0017] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0018] Fig 1. Illustrates an overall view of a feeding tube assembly comprising an improved flexible external adjustable anchoring device in accordance with an exemplary embodiment of the present disclosure;
[0019] Fig. 2(a) and 2(b) illustrates an upper and a lower surface of flexible external adjustable anchoring device with an exemplary embodiment of the present disclosure;

[0020] Fig. 3 illustrates an exploded view of the flexible external adjustable anchoring device in accordance with an exemplary embodiment of the present disclosure;
[0021] Fig. 4 illustrates a side view of a patient's stomach wall with a feeding tube inserted therein and secured via flexible external adjustable anchoring device and ring shaped seal ring.
[0022] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.
[0023] Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.
DETAILED DESCRIPTION OF EMBODIMENTS
[0024] The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. The words "comprising," "having," "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. As used herein, a “plurality” refers to two or more, for example, three or more, four or more, five or more, six or more. Each possibility represents a separate embodiment of the invention.
[0025] For purposes of the present specification and claims, various relational terms like “top,” “bottom,” “proximal,” “distal,” “upper,” “lower,” “front,” and “rear” are used to describe the present invention when said invention is positioned in or viewed from a given orientation. It is to be understood that, by altering the orientation of the invention, certain relational terms may need to be adjusted accordingly.

[0026] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.
[0027] Referring now to the drawings, Figures. 1-4 illustrates a body access tube for feeding/ medication having an improved flexible external adjustable anchoring device with a flexible ring shaped seal ring according to present invention. It should be noted that Figure 1-4 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure.
[0028] Referring now to the drawings, Fig. 1 illustrates a feeding device assembly 100 comprising a flexible feeding tube 102 and a flexible external adjustable anchoring device 104. The feeding tube 102 has a feeding inlet end 106 through which food and medication is fed via a connector (not shown), and an outlet end 108 which extends into the patient's stomach. Furthermore, the feeding tube 102 comprises a flexible external adjustable anchoring device 104 clearly visible outside the body and adapted to effectively secure the feeding tube 102 in its proper position via a flexible ring shaped seal ring 110 forming a seal at the interface when the feeding tube 102 is fed into stomach through the flexible external adjustable anchoring device 104 eventually preventing any dislodgement and migration of the device into the patient's stomach.
[0029] Now referring to Fig. 2(a), an improved external adjustable anchoring device is shown alone, apart from the standard gastrostomy/PEG/feeding tube with which it would otherwise be associated. The flexible external adjustable anchoring device comprises an annular base 202 having an upper surface 202(a) and a lower surface 202 (b). The annular base 202 also has a centrally located projection 204 (refer Fig 3) that extends in the direction opposite to the surface of the base 202 for the passage of the feeding tube 102 (not shown). The projection 204 and the annular base 202 jointly define a central cavity 206 which is of a uniform circular shape to accommodate the feeding tube securely. The lower surface 202(b) of the annular base 202 comprises of a plurality of raised, concentric legs 208 along its outer periphery in a spaced apart relationship. Each leg 208 is in the shape of a block which is generally rectangular in lateral cross-section. The concentric rectangular legs 208 are designed to rest on the skin of a patient

in the area surrounding a stoma when the adjustable anchoring device 104 is effectively and selectively positioned on the feeding tube by sliding along the surface of the tube 102. In this manner, concentric legs 208 serves the purpose of keeping flexible external adjustable anchoring device 104 out of contact with the stoma area and minimizes the surface area of flexible external adjustable anchoring 104 device that is in contact with the patient's skin, thereby limiting any irritation to the patient resulting from contact with the flexible external adjustable anchoring device 104.
[0030] Inbetween the concentric legs 208, a plurality of equidistantly arranged perforated air gaps 210 about the central cavity are provided in the annular base. Each air gap 210 is generally circular in lateral cross-section and extends through the annular base 202 from the upper surface 202(a) to the lower surface 202(b). Preferably, the flexible external adjustable anchoring device 104 comprises two or more circular air gaps. The air gaps 210 are provided to permit circulation of air between the flexible external adjustable anchoring device 104 and stoma area thereby reducing the risk of bacterial infection.
[0031] Fig. 2(a) and 2(b) are mere examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The present invention is not limited to the five air gaps and the number of air gaps can be more or less than five according to the requirement of the thickness of the adjustable anchoring device and the strength to secure the feeding tube to be achieved. The shape of the air gaps is not limited to circular and can be of any geometrical shape like triangle, elliptical, rectangle, square and the like according to the need of the design of the adjustable anchoring device.
[0032] Referring now to FIG. 3, the exploded view 300 of the flexible external adjustable anchoring device 104 is illustrated. A projection 204 is centrally located on annular base 202 extending upwardly from the central cavity 206 on the upper surface 202(a) of annular base 202. The Projection 204 comprises of a plurality of grooves 302 to accommodate the flexible ring shaped seal ring 110 in the grooves 302. The projection is sized and shaped to frictionally engage a conventional feeding tube 102 eventually securing the feeding tube 102 into the central cavity 206 according to the comfort of the patient. The flexible external adjustable anchoring device 104 prevents the feeding tube 102 from getting "pinched" when positioned within the central cavity 206. Therefore the central cavity 206 is appropriately dimensioned to have a strong interference fit between the flexible external adjustable anchoring device 104 and the feeding tube 102 when inserted into the central cavity 206.

[0033] Since the flexible external adjustable anchoring device 104 of the present invention can be manufactured in any number of different sizes according to the size of the associated feeding tube, the size of the central cavity will be such that the associated tube will fit adequately therein. As briefly discussed above, the adjustable anchoring device of the present invention may be slideably pushed or pulled manually over the surface of a conventional feeding tube, provided there is a certain tightness or resistance to prevent easy movement and dislodgement thereover. Furthermore, the adjustable anchoring device may also be formed as an integral element of the tube and immovably fastened thereto. The degree of resistance is established by the size of the central cavity which is also determined by the circumference of the feeding tube with which it becomes functionally associated.
[0034] Preferably, the flexible external adjustable anchoring device 104 and flexible ring shaped seal ring is made from the same flexible non-toxic materials as the gastrostomy/ feeding tubes such as biocompatible polymers, including silicone rubber, silicone elastomers, polyurethane, silicone copolymers, polypropylene and/or other similar materials or combinations thereof typically used in the art.
[0035] Fig. 3 is merely an example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The grooves in the projection are not limited to only two as per the embodiment of the present invention and can be added accordingly with respect to the need of the securement of the feeding tube and the comfort of the patient.
[0036] Referring now to FIG. 4a and 4b, the improved flexible external adjustable anchoring device 104 of the present invention is shown secured to the stomach wall 402 of a patient as a part of the feeding tube with which it is used. The external adjustable anchoring device 104 has a central cavity 206 so that the feeding tube 102 may pass therethrough held securely in its place with the help of a flexible ring shaped seal ring 110. A major advantage of the external adjustable anchoring device 104 of the present invention is the ability to hold feeding tube 102 efficiently without the need of any mechanical device to hold it like tie knot, screw like securing means, zip tie or the like thereby preventing injury to the surrounding delicate tissues and facilitates tube insertion, placement and removal.
[0037] Fig. 4(a) and 4(b) are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.

[0038] It is observed that the use of multiple mechanical fastening methods have been been completely eliminated.
[0039] It is further observed that along with the elimination of the mechanical fastening means, the flexible external adjustable anchoring device along with the flexible ring shaped seal ring has provided the much needed advantage of securing the feeding tube efficiently to the patient’s stomach wall which avoids any further discomfort to the patient. Along with these advantages , there is a cost reduction, as well as easy installation of external adjustable anchoring device described in the present invention
[0040] The present invention has both technical as well as economic significance with respect to the conventional bolsters.
[0041] While a particular embodiment of the invention has been illustrated and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiment, details and constructions of the flexible external adjustable anchoring device and their features described above and illustrated in the attached Figures may be interchanged among the various embodiment while remaining within the scope of the invention. Additionally, it is understood that various modifications could be made to any of the flexible external adjustable anchoring device and/or elements described herein above while remaining within the scope of the invention.

We claim:
1) A body access tube assembly for providing nutrition in the interior of a patient’s body comprising;
A flexible elongated body access tube 102 having a feeding inlet end 106 and an outlet end 108 wherein,
the said outlet end 108 is insertable within the patient’s body;
An anchoring device 104 slidably implanted on the said body access tube 102 wherein,
the said anchoring device 104 comprises an annular base 202 having an upper surface 202(a) and a lower surface 202(b), the said base 202 having a central cavity 206 through which the said body access tube 102 may be inserted in the body;
the said annular base 202 is designed to include a means 210 to enable the circulation of air under the said base 202 and patient’s body;
the said lower surface 202(b) of the said annular base 202 comprises a means 208 to elevate said base 202 relative to the patient’s body and is adapted to extend downwardly from the said lower surface 202(b) of the base 202; and
a projection 204 located centrally on the said upper surface 202(a) of the said base 202 and being aligned with the central cavity 206 on the base 202 wherein,
the said projection 204 comprises a plurality of grooves 302 adapted to accommodate a flexible seal ring 110 to prevent substantial "back and forth" movement of said access tube 104

within the body after frictionally engaging and selectively positioning the anchor device 104 on the body access tube 102.
2) The body access tube assembly as claimed in claim 1, wherein the shape of the said anchoring device 104 is spherical.
3) The body access tube assembly as claimed in claim 1, wherein the means for elevating the base 202 with respect to patient’s body comprises atleast 2 or more raised legs 208 designed in rectangular shape.
4) The body access tube assembly as claimed in claim 1, wherein the means for enable the circulation of air under the said base 202 and patient’s body comprises atleast 2 or more perforations.
5) The body access tube assembly as claimed in claim 1, wherein the seal ring on the said projection is an O-ring that is manually adjustable on the projection 204 according to the need of the patient. The O-Ring is made up of material such as silicone rubber.
6) The body access tube assembly as claimed in claim 1, wherein the projection 204 comprises atleast 2 or more grooves 302 to accommodate the seal ring 110.