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:
IMPLANTABLE MEMBRANE DEVICE

2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company, of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

3. The following specification particularly describes the invention and the manner in which it is to be performed:
FIELD OF INVENTION
[001] The present disclosure relates to an implant. More particularly, the present disclosure relates to an implantable membrane device.
BACKGROUND OF INVENTION
[002] Encapsulation implants have emerged as a great therapeutic intervention to manage chronic conditions. The encapsulation implants are capable of carrying biological entities inside them. The encapsulation implant along with the biological entity is implanted inside the body for treatment of various diseases.
[003] Conventional encapsulation implants suffer from various drawbacks such as they fail to maintain viability of the biological entities inside them. The biological entities perish due to improper and lack of nutrients and growth factors exchange across the membrane of the implants. Moreover, these device fails to improve viability, and maturation of the biological entities encapsulated in it.
[004] Further, the conventional encapsulation implants often have biocompatibility and aggregation issues. This causes interruption in the vascularization process inside the implant.
[005] Hence, there is a need for an improved implant that overcomes the problems associated with the conventional encapsulation implants.
SUMMARY OF INVENTION
[006] 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 structure.
[007] The present disclosure relates to a device including a lumen, at least one inner membrane, at least one outer membrane, at least one first ring, and at least one second ring. The lumen encapsulates one or more biological entities The inner membrane at least partially encloses the lumen. The inner membrane defines at least one intermediary surface. The inner membrane has a pore size. The outer membrane encloses the inner membrane. The outer membrane defines at least one outer surface adjacent to the at least one intermediary surface. The outer membrane has a pore size greater than the pore size of the inner membrane. The first ring defines a periphery of a device. The intermediary surface and the outer surface disposed between the periphery of the device. The second ring coupled to the outer membrane and the inner membrane to define one or more voids in the lumen of the device.
BRIEF DESCRIPTION OF DRAWINGS
[008] 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.
[009] Fig. 1 depicts a device 100, in accordance with one or more embodiment of the present disclosure.
[0010] Fig. 2 depicts a cross-section of the device 100, in accordance with one or more embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] The present disclosure discloses an implantable membrane device (or device). The device may be implanted inside the body to encapsulate one or more biological entities and deliver their products for managing chronic conditions. In an exemplary embodiment, the device is used to encapsulate pancreatic islet cells that produce insulin, for the treatment of diabetes.
[0016] The oval shape of the device of the present disclosure provides flexibility to the device at the time of implantation and/or after the implantation. A first ring defines a periphery of the device. The first ring provides strength and support to the device. An outer membrane is coupled to the first ring such that it creates at least one outer surface between the periphery defined by the first ring. The outer membrane helps in transportation of nutrients, glucose, and/or oxygen to and from the biological entities encapsulated in the lumen of the device. The outer membrane facilitates in-growth of vascularized connective tissues surrounding the device.
[0017] An inner membrane is disposed under the outer membrane such that the outer membrane encloses the inner membrane. The inner membrane defines at least one intermediary surface of the device. The inner membrane helps in transport of oxygen, glucose and/or other molecules essential for maintenance of the biological entities encapsulated in the device. The inner membrane also acts as an immune-protective barrier between the surrounding of the device and the encapsulated biological entities, i.e., the inner membrane does not allow the immune cells to enter the lumen of the device and the encapsulated biological entities to escape the lumen of the device.
[0018] Simultaneous vascularization of the device as well as prevention of immune response after implantation is achieved by controlling pore sizes of the outer membrane and the inner membrane. In an exemplary embodiment, the pore size of the outer membrane is larger than the pore size of the inner membrane.
[0019] A second ring is disposed in between the periphery defined by the first ring such that the second ring creates one or more voids in the lumen of the device. The formation of the one or more voids increases the surface area created by the outer membrane and the inner membrane. The increased surface area helps in better oxygen and nutrient exchange across the device. The one or more voids prohibits formation of aggregates in the encapsulated biological entities thus, maintaining the viability of the encapsulated biological entities.
[0020] Fig. 1 depicts an exemplary embodiment of a device 100 of the present disclosure. And, Fig. 2 depicts a cross-sectional view of the device 100 depicted in Fig. 1. The device 100 includes at least one first ring 101, at least one outer membrane 103, at least one inner membrane 105, at least one second ring 107, and one or more elongate members 109. The device 100 may have a pre-defined shape including but not limited to oval, cylindrical, rectangular, disk-shaped, patch shaped, spherical, etc. In an exemplary embodiment, as shown in Fig. 1, the device 100 has an elongated oval shape. The oval shape of the device 100 provides flexibility to the device 100 at the time of implantation and/or after the implantation.
[0021] The device 100 may define a lumen 100a (as shown in Fig. 2) to encapsulate one or more biological entities. The biological entities may include but not limited to cells, genetically modified cells, microspheres, drug eluting particles, antibiotics, biological active material, etc. In an exemplary embodiment, the device 100 encapsulates pancreatic islet cells in its lumen 100a.
[0022] In an exemplary embodiment, the device 100 has a length and a width ranging from 85 mm to 105 mm and from 20 mm to 40 mm, respectively. Accordingly, the lumen 100a may have a volume ranging from 350 µL to 550 µL.
[0023] In another exemplary embodiment, the device 100 has a length and a width ranging from 35 mm to 55 mm and from 10 mm to 30 mm, respectively. Accordingly, the lumen 100a may have a volume ranging from 5 µL to 35 µL.
[0024] The length and width of the device 100 may be scaled up or down depending upon the volume of the lumen 100a required for implantation as determined by a medical practitioner.
[0025] The first ring 101 may define a periphery of the device 100. The first ring 101 may be made of a material including, but not limited to, Polytetrafluoroethylene (PTFE), expandable PTFE (ePTFE), Polypropylene, Pebax, Nylon, Teflon, etc. In an exemplary embodiment, the first ring 101 is made of ePTFE. The first ring 101 may have a thickness ranging from 0.1 mm to 2 mm. The first ring 101 may have a length ranging from 10 mm to 60 mm. In an exemplary embodiment, the length and thickness of the first ring 101 are 11 mm and 0.6 mm, respectively. The first ring 101 provides strength and support to the device 100.
[0026] The outer membrane 103 is coupled to the first ring 101 such that it creates at least one outer surfaces between the periphery defined by the first ring 101. In an exemplary embodiment, the outer membrane 103 encloses the first ring 101 thereby creating two outer surfaces of the outer membrane 103. The outer membrane 103 may be coupled to the first ring 101 via at least one of stitching, welding, ultra sealing etc. In an exemplary embodiment, the outer membrane 103 is coupled to the first ring 101 by ultra sealing.
[0027] The outer membrane 103 may have a thickness ranging from 0.1 to 0.5mm. In an exemplary embodiment, the thickness of the outer membrane 103 is 0.34 mm. The outer membrane 103 may be made up of a biocompatible material such as but not limited to tetrafluoroethylene, polytetrafluoroethylene (PTFE), expandable PTFE (ePTFE), Polyester, polyurethane, collagen, etc. In an embodiment, the outer membrane 103 is made up of PTFE. The outer membrane 103 may have a pore size ranging from 90 µm to 100 µm. In an exemplary embodiment, the pore size of the outer membrane 103 is 95 µm. The outer membrane 103 further helps in transportation of nutrients, glucose, and/or oxygen to and from the biological entities encapsulated in the lumen 100a of the device 100. The outer membrane 103 facilitates in-growth of vascularized connective tissues surrounding the device 100.
[0028] The inner membrane 105 is disposed under the outer membrane 103 such that the outer membrane 103 encloses the inner membrane 105. Similar to the at least one outer surface defined by the outer membrane 103, the inner membrane 105 defines at least one intermediary surface of the device 100. The at least one intermediary surface defined by the inner membrane 105 is disposed beneath the outer membrane 103.
[0029] Similar to the outer membrane 103, the inner membrane 105 is coupled to the first ring 101. In an exemplary embodiment, the inner membrane 105 encloses the first ring 101 thereby creating the two intermediary surfaces of the inner membrane 105. The inner membrane 105 may be coupled to the first ring 101 via at least one of stitching, welding, ultra sealing, etc. In an exemplary embodiment, the inner membrane 105 is coupled to the first ring 101 by ultra sealing.
[0030] In an exemplary embodiment, the outer membrane 103 and the inner membrane 105 creates at least four layers at the periphery of the device 100. The periphery of the device 100 is used to suture the device 100 at the implantation site. The at least four layers at the periphery of the device 100 is sutured such that the stitch length of the suture is 5mm. The stitch length prevents leakage of the biological entities from the device 100.
[0031] The inner membrane 105 may be made up of a biocompatible material such as but not limited to tetrafluoroethylene, polytetrafluoroethylene (PTFE), expandable PTFE (ePTFE), Polyester, polyurethane, collagen, etc. In an exemplary embodiment, the inner membrane 105 is made up of ePTFE. The inner membrane 105 may have a pore size ranging from 0.1 µm to 1 µm. In an exemplary embodiment, the pore size of the inner membrane 105 is 0.45 microns. The inner membrane 105 may have a thickness ranging from 0.1 mm to 0.5 mm. In an exemplary embodiment, the thickness of the inner membrane 105 is 0.34 mm.
[0032] The inner membrane 105 defines the lumen 100a of the device 100, i.e., the inner membrane 105 encapsulates the biological entities disposed inside the device 100. The inner membrane 105 helps in transport of oxygen, glucose and other molecules essential for maintenance of the biological entities encapsulated in the device 100. The inner membrane 105 acts as an immune-protective barrier between the surrounding of the device 100 and the encapsulated biological entities, i.e., the inner membrane 105 does not allow the immune cells to enter the lumen 100a of the device 100 and the encapsulated biological entities to escape the lumen 100a of the device 100.
[0033] In an exemplary embodiment, the inner membrane 105 allows the passage of glucose and oxygen to the encapsulated pancreatic islet cells. In an exemplary case where a person suffers from diabetes, the encapsulated pancreatic islet cells release insulin.
[0034] Simultaneous vascularization of the device 100 as well as prevention of immune response after implantation is achieved by controlling the pore sizes of the outer membrane 103 and inner membrane 105. In an exemplary embodiment, the pore size of the outer membrane 103 is larger than the pore size of the inner membrane 105.
[0035] The second ring 107 is disposed in between the periphery defined by the first ring 101 such that the second ring 107 creates one or more voids 107a in the lumen 100a of the device 100. The second ring 107 may be coupled to the outer membrane 103 and the inner membrane 105 via stitching, welding, ultra sealing etc. In an exemplary embodiment, the second ring 107 is coupled to the outer membrane 103 and the inner membrane 105 via ultra sealing.
[0036] The formation of the one or more voids 107a increases the surface area created by the outer membrane 103 and the inner membrane 105. The increased surface area helps in better oxygen and nutrient exchange across the device 100. The one or more voids 107a prohibits formation of aggregates in the encapsulated biological entities thus, maintaining the viability of the encapsulated biological entities. The second ring 107 may have a length ranging from 5 mm to 55 mm. The second ring 107 may have a thickness ranging from 0.1 mm to 2 mm. In an exemplary embodiment, the length and thickness of the second ring 107 is 51 mm and 1 mm, respectively.
[0037] The elongate member 109 may be fluidically coupled to the lumen 100a of the device 100 via the first ring 101 such that the elongate member 109 creates a lumen 109a to access the lumen 100a of the device 100. The elongate member 109 may extend away from the device 100. The elongate member 109 may have a pre-defined shape including but not limited to cylindrical, square, spiral etc. In an exemplary embodiment, the elongate member 109 is a hollow cylinder. The elongate member 109 helps in filling the lumen 100a of the device 100 with the biological entities.
[0038] The elongate member 109 may have an outer diameter ranging from 1 mm to 5 mm. The elongate member 109 may have an inner diameter ranging from 0.5 mm to 4.5 mm. In an exemplary embodiment, the inner diameter and the outer diameter is 1.0 mm and 2.6 mm, respectively. The elongate member 109 may have a length ranging from 22 mm to 28 mm. In an exemplary embodiment, the length of the elongate member 109 is 25 mm.
[0039] 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. , C , C , Claims:WE CLAIM
1. A device (100) comprising:
a. a lumen (100a) encapsulating one or more biological entities;
b. at least one inner membrane (105) at least partially enclosing the lumen (100a), the inner membrane (105) defining at least one intermediary surface, the inner membrane (105) having a pore size;
c. at least one outer membrane (103) enclosing the inner membrane (105), the outer membrane (103) defining at least one outer surface adjacent to the at least one intermediary surface, the outer membrane (103) having a pore size greater than the pore size of the inner membrane (105);
d. at least one first ring (101) defining a periphery of a device (100), the at least one intermediary surface and the at least one outer surface disposed between the periphery of the device (100);
e. at least one second ring (107) coupled to the outer membrane (103) and the inner membrane (105) to define one or more voids (107a) in the lumen (100a) of the device (100).
2. The device (100) as claimed in claim 1, wherein the biological entities include at least one of cells, genetically modified cells, microspheres, drug eluting particles, antibiotics, and biological active materials.
3. The device (100) as claimed in claim 1, wherein the inner membrane (105) and the outer membrane (103) are coupled to the first ring (101) via at least one of stitching, welding, and ultra sealing.
4. The device (100) as claimed in claim 1, wherein the inner membrane (105) and the outer membrane (103) are coupled to the second ring (107) via at least one of stitching, welding, and ultra sealing.
5. The device (100) as claimed in claim 1, wherein the pore size of the outer membrane (103) ranges from 90 µm to 100 µm.
6. The device (100) as claimed in claim 1, wherein the pore size of the inner membrane (105) ranges from 0.1 µm to 1 µm.
7. The device (100) as claimed in claim 1, wherein a thickness of the outer membrane (103) ranges from 0.1 to 0.5mm.
8. The device (100) as claimed in claim 1, wherein a thickness of the inner membrane (105) ranges from 0.1 mm to 0.5mm.
9. The device (100) as claimed in claim 1, wherein the outer membrane (103) and the inner membrane (105) are made up of at least one of tetrafluoroethylene, polytetrafluoroethylene (PTEF), expandable PTFE (ePTFE), Polyester, polyurethane, and collagen.
10. The device (100) as claimed in claim 1, wherein an elongate member (109) is fluidically coupled to the lumen (100a) of the device (100) via the first ring (101).