Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
ARTERIOVENOUS FISTULA IMPLANT
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present disclosure relates to a medical implant. More particularly, the present disclosure relates to an Arteriovenous (AV) fistula implant.
BACKGROUND OF INVENTION
[2] Chronic kidney disease results in the misfunctioning of the kidney. The consequences include increasingly weaker kidney functions, which ultimately results in kidney failure. Advanced chronic kidney disease may lead to dangerous levels of fluids, electrolytes and waste to build up in the body of an individual.
[3] Generally, people suffering from chronic kidney disease are treated with the process of hemodialysis, which includes filtering the blood by removing waste components such as creatine, urea and other impurities from the blood.
[4] Hemodialysis requires access to the vasculature system on a regular basis. Since veins are too fragile and arteries are too deep to provide regular access, arteriovenous (AV) fistula are typically created using a surgical procedure. During a dialysis session, a needle is placed into the AV fistula. However, this is extremely painful to the patients and may lead to traumatic experience for them, especially since the dialysis is performed regularly and frequently. Finding the AV fistula is also time consuming and therefore, increases the overall procedure time. Further, frequent insertion of the needle into the blood vessels leads to various other complications such as bleeding, local or disseminated intravascular infections (DIC), vessel (graft) occlusion.
[5] Some commercially available AV fistula implants are implanted in the patients and assist in accessing the AV fistula. However, these implants do not provide consistent and easy access to the AV fistula. This makes the process painful and dangerous, and consequently, increases the risk of long-term complications for the patients. Further, the conventional implants are made of metal alloys, for example, titanium. However, the metals lack chemical stability for long-term usage. Further, some people are intolerant to the metals. This may cause hyper-sensitization or an allergic reaction, placing additional burden on the patients.
[6] Thus, there arises a need for an implant that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed.
[8] The present disclosure relates to an arteriovenous (AV) fistula implant. In an embodiment, the AV fistula implant includes a guiding element having a first end and a second end. The guiding element is configured to provide an access to a vessel of an AV fistula. The guiding element includes a base and a sleeve. The base has a first face and a second face. The second face is configured to contact an outer surface of the vessel of the AV fistula. The sleeve extends upward from the first face and has a cavity sloping upward from the first end of the guiding element towards the second end of the guiding element. The cavity is configured to receive an instrument during a medical procedure. The AV fistula implant further includes a body having a first end and a second end. The body includes a central portion. The central portion includes a base and a first face sloping upwards from the base. A bottom face of the base is configured to contact the first face of the guiding element. The body includes an opening extending from the first face of the central portion in a longitudinal direction of the body towards the first end of the body, thereby defining a passage. The body further includes a channel extending from a bottom surface of the passage to the bottom face of the base. The inner surface of the channel contacts an outer surface of the sleeve. The guiding element is made of a self-sealing, flexible biocompatible polymeric material.
BRIEF DESCRIPTION OF DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1 depicts an isometric view of an AV fistula implant 100, according to an embodiment of the present disclosure.
[11] Fig. 1A depicts a front view of the AV fistula implant 100, according to an embodiment of the present disclosure.
[12] Fig. 1B depicts a side view of the AV fistula implant 100, according to an embodiment of the present disclosure.
[13] Fig. 1C depicts a top view of the AV fistula implant 100, according to an embodiment of the present disclosure.
[14] Fig. 1D depicts a bottom view of the AV fistula implant 100, according to an embodiment of the present disclosure.
[15] Fig. 2A depicts an isometric view of a body 103, according to an embodiment of the present disclosure.
[16] Fig. 2B depicts a bottom view of the body 103, according to an embodiment of the present disclosure.
[17] Fig. 3A depicts an isometric view of a guiding element 101, according to an embodiment of the present disclosure.
[18] Fig. 3B depicts a side view of the guiding element 101, according to an embodiment of the present disclosure.
[19] Fig. 4A depicts a side view a locking member 107, according to an embodiment of the present disclosure.
[20] Fig. 4B depicts a front view of the locking member 107, according to an embodiment of the present disclosure.
[21] Fig. 5 depicts the placement of the AV fistula implant 100 inside a patient’s body, according to an embodiment of the present disclosure.
[22] Fig. 6 depicts a method 600 of using the AV fistula implant 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[23] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[24] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[25] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[26] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[27] The present disclosure relates to an AV fistula implant (or implant). The implant is mainly used for individuals having kidney diseases and requiring regular hemodialysis procedures. In an embodiment, the implant includes a guiding element, a body and a locking member. The implant is implanted under the skin over a targeted blood vessel via a surgical procedure. The implant provides a long term and reliable access to the vasculature of the AV fistula. The implant prevents excessive bleeding, reduces trauma and pain of the patients. The implant makes the hemodialysis procedure easy to manage, thereby improving the quality of life of the patients.
[28] Figs. 1 – 1D depict various views of an AV fistula implant 100 (or implant 100), according to an embodiment. The implant 100 has a first end 100a, a second end 100b, a top end 100cand a bottom end 100d. In an embodiment, the implant 100 includes a guiding element 101, a body 103 and a locking member 107.
[29] Figs. 2A – 2B depict various views of the body 103, according to an element. The body 103 helps a user (a medical practitioner or a patient) to locate the implant 100. The body 103 has a first end 103a and a second end 103b. The body 103 includes a central portion 103d. The central portion 103d may have any suitable shape. In an embodiment, the central portion 103d generally resembles a triangular prism. The central portion 103d includes a base 103e. The base 103e has a substantially rectangular cross-section with rounded corners. The central portion 103d has a first face 103f1 and a second face 103f2 (shown in Fig. 1C) sloping upwards from the base 103e. Though the second face 103f2 is shown as sloping upwards in Fig. 1D, in another embodiment, the second face 103f2 may be substantially vertical. The body 103 has a top edge 103g and lateral edges 103h1 and 103h2. In an embodiment, the top edge 103g and the lateral edges 103h1 and 103h2 are blunt to prevent injury and/or infection post implantation. The central portion 103d is coupled to the guiding element 101 (described later).
[30] The body 103 has an opening provided in the central portion 103d at a suitable height from the base 103e. The opening extends from the first face 103f1 in a generally longitudinal direction of the body 103 towards the first end 103a, thereby defining a passage 103i as depicted in Fig. 2A. The passage 103i guides the user to locate the implant 100 and assists the user to access a vessel in the AV fistula. The body 103 is further provided with a channel 103j. The channel 103j is in the form of a through hole in a bottom surface 103k of the passage 103i. The channel 103j enables the coupling of the body 103 with the guiding element 101 as explained later. The channel 103j provides a passage to an instrument (e.g., a needle) to the vessel of the AV fistula. In an embodiment, the channel 103j slopes downward from the second end 103b towards the first end 103b.The channel 103j may have a pre-defined cross-section such as, without limitation, circular, square, rectangular, oval, etc. In an embodiment, the channel 103j has an oval cross-section. The cross-sectional width of the channel 103j is suitably designed based upon the size of the instrument.
[31] The body 103 is further provided with a pair of wings 105(hereinafter, interchangeably referred to as wings 105) with each wing 105 of the pair of wings 105 provided on each lateral side of the body 103. The pair of wings 105 extends laterally from the central portion 103d. The wings 105 are generally rectangular, though the wings 105 may have any other suitable shape. The wings 105 may have rounded corners which help in reducing the trauma to the target blood vessel as well as the neighboring blood vessels inside the body during implantation and post implantation. In an embodiment, the wings 105 have a radial curvature (as seen from Fig. 1A) on a bottom side of the wings 105. The radial curvature of the wings 105 corresponds to the curvature of the targeted blood vessel, thereby providing a proper accommodation and positioning of the implant 100 with the targeted blood vessel. It should be appreciated that the body 103 may have more than one pair of wings.
[32] The wings 105 includes a first set of cavities 105a and a second set of cavities 105b provided on either wing 105 of the pair of wings 105 (shown in Fig. 2A). The first set of cavities 105a and the second set of cavities 105b may have one or more cavities. In the depicted embodiment, the first set of cavities 105a and the second set of cavities 105b have two cavities each. A cavity of the first set of cavities 105a and a cavity of the second set of cavities 105b are coupled to the locking member 107, thereby coupling the implant 100 with the blood vessel. The first pair of cavities 105a and the second pair of cavities 105b along with the locking member 107 couple the implant 100 with the blood vessel as explained later. Having more than one cavity in the first pair of cavities 105a and the second pair of cavities 105b enable the user to adjust the locking member 107 according to the size of the vessel such that the implant 100 couples tightly with the vessel. The one or more cavities of the first pair of cavities 105a and the second pair of cavities 105b may have any suitable shape such as, without limitation, oval, circular, rectangular, square, etc. In an embodiment, the first pair of cavities 105a and the second pair of cavities 105b have oval shaped cavities.
[33] In an embodiment, the body 103 is an integrated component, though it is possible that the central portion 103d and the plurality of wings 105 are separate components coupled together using a suitable coupling technique to form the body 103. The body 103 may be made of any medical grade biocompatible polymeric material such as, without limitation, polytetrafluorethylene (PTEF), polyethylene, polyurethane, silicone, etc. In an embodiment, the body 103 is made up of a medical grade silicone of a pre-defined hardness. According to an embodiment, the body 103 is made of a medical grade silicone having the hardness between 50 shore A hardness and 90 shore A hardness. More specifically, the body 103 is made of a medical grade silicone having a hardness between 60 shore A hardness and 80 shore A hardness. In an example implementation, the body 103 is made of a medical grade silicone having 70 shore A hardness.
[34] Now referring to Figs. 3A and 3B, the guiding element 101 has a first end 101a and a second end 101b. The guiding element 101 includes a base 101g having a first face 101c and a second face 101d. The base 101g of the guiding element 101 has a substantially rectangular cross-section with rounded corners, though it may have any other suitable shape. The guiding element 101 includes a sleeve 101e. In an embodiment, the sleeve 101e extends from the first face 101c of the guiding element 101 towards the top end 100c. In an embodiment, the sleeve 101e slopes upwards from the first end 101a towards the second end 101b and defines an angle A° with the first face 101c. The slope of the sleeve 101e equals the slope of the channel 103j. The angle A° may range from 30° to 50°. In an embodiment, the angle A° is 40°. The sleeve 101e lines the channel 103j of the body 103. For example, outer surface of the sleeve 101e aligns with and contacts an inner surface of the channel 103j. The sleeve 101e has a cross-sectional shape and height matching that of the channel 103j. In an embodiment, the sleeve 101e has an oval cross-section. The sleeve 101e has a lip 101f provided at a top end of the sleeve 101e. The lip 101f protrudes outside a top end of the channel 103j and extends laterally around the perimeter of the channel 103j. In an embodiment, the lip 101f has cross-sectional dimensions greater than the corresponding cross-sectional dimensions of the channel 103j. This ensures that the sleeve 101e remains in position and the guiding element 101 does not slip out of the central portion 103d.
[35] The sleeve 101e has a cavity 101h. The cavity 101h slopes away from the first end 101a to the second end 101b. The cavity 101h has a cross-section corresponding to the cross-section of the channel 103j. In an embodiment, the cavity 101h has an oval cross-section. The cavity 101h is configured to accommodate the instrument (e.g., the needle) during the hemodialysis procedures. The slope of the cavity 101h helps in guiding the instrument more accurately and results in lesser trauma when accessing the vessel.
[36] The guiding element 101 prevents the backflow of the blood from the puncture site to the implant 100, which reduces the risk of bleeding. The guiding element 101 can be made of a self-sealing, flexible, biocompatible medical grade polymeric material. The self-sealing materials are materials that are penetrable and are capable of re-sealing or re-closing after the penetration is removed. The self-sealing characteristics of the guiding element 101 helps in sealing the puncture made by the needle prior to the subsequent needle insertion, thereby allowing the implant 100 to be used for a longer duration as compared to the conventional implants. The flexibility avoids the trauma to the blood vessels. Examples of self-sealing materials include, without limitation, polymers, silicone-based materials, soft thermoplastics, etc. According to an embodiment, the guiding element 101 is made of a medical grade silicone having a hardness between 20 shore A hardness and 70 shore A hardness. More specifically, the guiding element 101 is made of a medical grade silicone having a hardness between 30 shore A hardness and 60 shore A hardness. In an example implementation, the guiding element 101 is made of a medical grade silicone having 50 shore A hardness.
[37] The guiding element 101 prevents the backflow of the blood from the puncture site into the implant 100, which reduces the risk of bleeding. Further, in conventional implants the vessels are prone to being pulled out when the needle is removed from the patient’s body, which may lead to trauma and injury to the blood vessel and skin. In contrast, according to the teachings of the present disclosure, the guiding element 101 acts as a barrier and prevents such movement of the vessel, thereby preventing the blood vessel from coming out from the implant and less trauma to the blood vessel.
[38] The guiding element 101 is coupled to the body 103 via the sleeve 101e using techniques such as, without limitation, press-fit mechanism, friction-fit mechanism, etc. In an embodiment, the guiding element 101 is couped to the body 103 using the press-fit mechanism.
[39] The locking member 107 is removably coupled with the wings 105. The locking member 107 helps in better positioning of the implant 100 and prevents it from migrating. In an embodiment, the locking member 107 has a radial curvature. The radial curvature is designed according to the size and shape of the vessel at which the implant 100 is to be implanted. The locking member 107 may be made of a biocompatible, medical grade polymeric material such as, without limitation, polytetrafluorethylene (PTEF), polyethylene, polyurethane, silicone, etc. In an embodiment, the locking member 107 is made of silicone of a desired hardness. In an embodiment, the locking member 107 is a C-shaped shaft 107c (as shown in fig. 4A). The shaft 107c can be hollow or solid. In an embodiment, the shaft 107c is solid. The shaft 107c may have a suitable cross-sectional shape such as, without limitation, square, rectangular, circular, oval, etc. In an embodiment, the shaft 107c has a circular cross section. The curvature of the shaft 107c corresponds to the curvature of the targeted blood vessel, thereby providing a proper accommodation and positioning of the implant 100 with the targeted blood vessel.
[40] The locking member 107 includes a first pair of flaps 107a and a second pair of flaps 107b (as shown in fig. 4A and 4B). Each flap 107a of the first pair of flaps 107a and each flap 107b of the second pair of flaps 107b are provided on each side of the locking member 107. The first pair of flaps 107a are provided at the ends of the shaft 107c. In an embodiment, the first pair of flaps 107a and the second pair of flaps 107b are positioned at a pre-defined distance from each other such that the first pair of flaps 107a and the second pair of flaps 107b defines a gap between respective flaps.
[41] The first pair of flaps 107a and the second pair of flaps 107b have a cross-sectional shape and dimensions corresponding to the cross-sectional shape and dimensions of the one or more cavities of the first pair of cavities 105a and the second pair of cavities 105b. In an embodiment, the first pair of flaps 107a and the second pair of flaps 107b are oval shaped. In an embodiment, the first pair of flaps 107a are rotatably coupled to the shaft 107c and the second pair of flaps 107b are fixedly coupled to the shaft 107c.
[42] In an embodiment, the locking member 107 is removably coupled to the wings 105 using the first pair of flaps 107a and the first pair of cavities 105a and/or the second pair of cavities 105b. For example, during assembly of the implant 100, the first pair of flaps 107a is inserted into one cavity of the first pair of cavities 105a and one cavity of the second pair of cavities 105b until the second pair of flaps 107b contact the bottom surface of the wings 105. The first pair of flaps 107a are then rotated such that the longitudinal axis of the first pair of flaps 107a is perpendicular to the longitudinal axis of the cavities into which they are inserted (as shown in Fig. 1C). Further, the longitudinal axis of the second pair of flaps 107b is perpendicular to the longitudinal axis of the first pair of cavities 105a and the second pair of cavities 105b. This ensures that the locking member 107 does not come out the wings 105. The shaft 107c is configured to contact a portion of the circumference of the vessel. Consequently, the implant 100 is coupled to the target vessel and is locked into its place. A desired cavity of the first pair of cavities 105a and a desired cavity of the second pair of cavities 105b is selected depending upon the diameter of the targeted blood vessel.
[43] The implant 100 is surgically implanted inside the patient’s body. The hemodialysis procedure requires access to both an artery and a vein of the AV fistula. Therefore, two implants 100 are implanted in the patient with one implant 100 providing access to the artery and the other implant 100 providing access to the vein of the AV fistula. Fig. 5 illustrates the coupling of the implant 100 with a vein C of the AV fistula according to an embodiment. During the implantation procedure, the surgeon creates the AV fistula at a suitable location (e.g., in the forearm or the upper arm) of the patient. The surgeon places the implant 100 under the skin B and is coupled to the vein C. The implant 100 is placed on the C with the longitudinal axis of the implant 100 being parallel to the longitudinal axis of the vessel. The second face 101d of the guiding element 101 contacts an outer surface of the vein C. The implant 100 is oriented such that the passage 103i is generally parallel to the vein C, and the slopes of the channel 103j and the cavity 101h are in the same direction as the direction of blood flow in the vein C. Therefore, as depicted in Fig. 5, when the implant 100 is placed on the vein C, the first end 100a is distal and the second end 100b is proximal. As a result, when the instrument (e.g., a needle A) used during the hemodialysis procedure is inserted into the patient, it is also sloped in the same direction as the flow of the blood. Consequently, the cleaned blood from the dialyzer (not shown) can easily flow into the vein C via the needle A. Before inserting the implant 100 into the patient’s body, one flap of the first pair of flaps 107a of the locking member 107 is coupled with a cavity of the first pair of cavities 105a (or with a cavity of the second pair of cavities 105b) so that the locking member 107 is coupled with one side of the body 103. Once the implant 100 is placed as desired, the shaft 107c is wrapped around the vein C. Depending upon the diameter of the vein C, the other flap of the first pair of flaps 107a is then inserted into a suitable cavity of the second pair of cavities 105b (or a suitable cavity of the first pair of cavities 105a) so that the shaft 107c contacts an outer wall of the vein C. In the depicted embodiment, the first pair of flaps 107a are inserted into the lateral-most cavities of the first pair of cavities 105a and the second pair of cavities 105b. The first pair of flaps 107a are then rotated as described earlier such the vein C is disposed between the shaft 107c of the locking member 107 and the second face 101d of the guiding element 101. Thus, the implant 100 is coupled with the vessel C. The locking member 107 ensures that the implant 100 remains substantially fixed relative to the wall of the vein C. In an embodiment, the top edge 103g and/or a portion of the lateral edges 103h1 – 103h2 of the body 103 may result in creating a bump on the skin. Similarly, another implant 100 can be implanted and coupled to the artery (not shown) of the AV fistula. In this case, the implant 100 is oriented such that the passage 103i is generally parallel to the artery, and the slopes of the channel 103j and the cavity 101h are in the same direction as the direction of blood flow in the artery. Consequently, the blood from the artery (i.e., the arterial inflow) can easily enter the other needle coupled to the dialyzer. Thus, the implant 100 provides for more efficient venous outflow and the arterial inflow, thereby decreasing the procedure time and reducing patient trauma. Further, the orientation of the passage 103i allows the user to find the implant 100 more quickly and more easily. Moreover, in contrast to conventional AV fistula implants that are sutured with the AV fistula, the implant 100 is not sutured. Consequently, the implant 100 avoids challenges associated with the conventional implants that are sutured, such as suture breakage (and resultant implant dislocation), trauma to the blood vessel caused by sutures, swelling, allergic reactions, postoperative adhesion and irritation to patients, infection at the site of sutures, etc.
[44] Fig. 6 depicts a method 600 of using the implant 100 during the hemodialysis procedure. The use of the implant 100 is explained herein in the context of the implant 100 coupled to the vein C as depicted in Fig. 5. It will be apparent to a person skilled in the art that the other implant 100 (not shown) coupled to the artery can be similarly used.
[45] At step 601, the needle A is coupled to a dialysis tubing (not shown).
[46] At step 603, the dialysis tubing is coupled to the dialyzer.
[47] At step 605, the user locates the implant 100. For example, the user touches the skin at or around the area where the implant 100 is implanted and locates the implant 100 by finding the top edge 103g and/or the lateral edges 103h1 – 103h2 of the implant 100. The surgeon may provide a visual mark at the implantation site for easier location of the implant 100.
[48] At step 607, the user inserts the needle A into the vein C through the implant 100. The slope of the second face 103f2 and the lateral edges 103h1 – 103h2 enable the user to locate the passage 103i of the implant 100. Once the user finds the passage 103i, the user locates the cavity 101h and inserts the needle A through the cavity 101h into the vein C. The needle A pierces through the guiding element 101.
[49] At step 609, the dialyzer is switched on and the hemodialysis procedure begins. During the hemodialysis procedure, the dialysis tubing carries the arterial flow through another implant 100 (not shown) to the dialyzer and then carries the purified blood back into the vein C to the venous flow through the implant 100 as illustrated in Fig. 5.
[50] Once the hemodialysis procedure is completed, the dialyzer machine is switched off and the needle A is removed from the implant 100 and then from the patient’s body at step 611.
[51] The proposed implant presents several advantages. For example, the proposed implant enables the user (including patients themselves) to access the vasculature more accurately and easily. The button hole design of the implant makes it easy for the user to locate the implant as it can be felt over the skin and identify the cavity. This allows more patients to receive the dialysis at home, thereby minimizing hospitalization, decreasing risk of complications and reducing overall healthcare costs associated with the dialysis. The medical grade silicone used to make the proposed implant according to an embodiment, makes the implant more durable and can last for several years. Since it is a biocompatible material, it minimizes the chances of the rejection by the patient’s body unlike conventional implants made of metals. They are also relatively simpler to care. Further, the proposed implant made of a bio-compatible silicone resist tissue growth at the implantation site. Instead, the implant is surrounded by the natural skin tissues and adjusts to the environment inside the body which helps to maintain the position of the implant. Further, the use of self-sealing material helps to stabilize the fistula and prevents bleeding. In addition, the self-sealing material acts as a barrier to bacteria, which prevents infections. It also helps to maintain the patency of the AV fistula and reduces the risk of stenosis. Since the proposed implant can be implanted into the patient’s body for a long term, the overall patient experience is improved and leads to a better quality of life.
[52] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An arteriovenous (AV) fistula implant (100) comprising:
a. a guiding element (101) having a first end (101a) and a second end (101b), and configured to provide an access to a vessel of an AV fistula, the guiding element (101) comprising:
i. a base (101g) having a first face (101c) and a second face (101d) configured to contact an outer surface of the vessel of the AV fistula; and
ii. a sleeve (101e) extending upward from the first face (101c) and comprising a cavity (101h) sloping upward from the first end (101a) of the guiding element (101) towards the second end (101b) of the guiding element (101) and configured to receive an instrument during a medical procedure; and
b. a body (103), having a first end (103a) and a second end (103b), comprising:
i. a central portion (103d) comprising a base (103e) and a first face (103f1) sloping upwards from the base (103e), wherein a bottom face of the base (103e) is configured to contact the first face (101c) of the guiding element (101);
ii. an opening extending from the first face (103f1) of the central portion (103d) in a longitudinal direction of the body (103) towards the first end (103a) of the body (103), thereby defining a passage (103i); and
iii. a channel (103j) extending from a bottom surface (103k) of the passage (103i) to the bottom face of the base (103e), wherein an inner surface of the channel (103j) contacts an outer surface of the sleeve (101e);
c. wherein the guiding element (101) is made of a self-sealing, flexible biocompatible polymeric material.
2. The AV fistula implant (100) as claimed in claim 1, wherein the AV fistula implant (100) comprises a locking member (107) comprising a shaft (107c) removably coupled to the body (103), wherein the shaft (107c) is configured to encompass a portion of the circumference of the vessel.
3. The AV fistula implant (100) as claimed in claim 2, wherein:
a. the body (103) comprises a pair of wings (105) extending from the central portion (103d) with one wing (105) of the pair of wings (105) provided on each lateral side of the body (103); a first pair of cavities (105a) is provided on one wing (105) of the pair of wings (105) and a second pair of cavities (105b) is provided on the other wing (105) of the pair of wings (105); and
b. the locking member (107) comprises a first pair of flaps (107a) rotatably coupled to the shaft (107c), wherein one flap (107a) of the first pair of flaps (107a) is removably coupled to a cavity of the first pair of cavities (105a) and other flap (107a) of the first pair of flaps (107a) is removably coupled to a cavity of the second set of cavities (105b).
4. The AV fistula implant (100) as claimed in claim 3, wherein a bottom surface of the pair of wings (105) has a radial curvature.
5. The AV fistula implant (100) as claimed in claim 3, wherein the locking member (107) comprises a second pair of flaps (107b) positioned at a pre-defined distance from the first pair of flaps (107a) and fixedly coupled to the shaft (107c), the second pair of flaps (107b) are configured to contact a bottom surface of the pair of wings (105), wherein the longitudinal axis of the second pair of flaps (107b) is perpendicular to the longitudinal axis of the first set of cavities (105a) and the second set of cavities (105b).
6. The AV fistula implant (100) as claimed in claim 1, wherein the guiding element (101) comprises a lip (101f) provided on a top end of the sleeve (101e), the lip (101f) protrudes out of the channel (103j) at a top end of the channel (103j) and extends laterally around a perimeter of the channel (103j).
7. The AV fistula implant (100) as claimed in claim 1, wherein the guiding element (101) is made of a medical grade silicone having a hardness between 50 shore A hardness and 90 shore A hardness.
8. The AV fistula implant (100) as claimed in claim 1, wherein the sleeve (101e) slopes upwards from the first end (101a) of the guiding element (101) towards the second end (101b) of the guiding element (101) and wherein the channel (103j) slopes downward from the second end (103b) towards the first end (103a).
9. The AV fistula implant (100) as claimed in claim 1, wherein the body (103) is made of a biocompatible polymeric material.
10. The AV fistula implant (100) as claimed in claim 9, wherein the biocompatible polymeric material comprises a medical grade silicone of a pre-defined hardness.