Claims:WE CLAIM:
1. An implant system (100) comprising:
an implant (20);
a delivery tool (10) to deliver the implant (20) at an implantation site (30), the delivery tool (10) further comprising:
a handle (10a) having a lumen (L) and a locking mechanism (10e) embedded within the lumen (L), the locking mechanism (10e) including a first slot (10e1) and a second slot (10e2) placed below the first slot (10e1);
a cartridge (10c) being pre-loaded with the implant (20), the cartridge (10c) further defining a cavity (10c5) for housing the implant (20), the cartridge (10c) having at least two side walls (10c3), the side walls (10c3) including a plurality of extensions (10c3’) for locking the cartridge (10c) with the handle (10a); and
a pusher rod assembly (10b) having a rod (10b2), the rod (10b2) being configured to engage with one of the first slot (10e1) or the second slot (10e2) at a given time, the first slot (10e1) defining a first locking position (10e3) at a first predefined portion of the first slot (10e1) and in an axial direction, the second slot (10e2) defining a second locking position (10e5) at a second predefined portion of the second slot (10e2) and in an axial direction;
wherein the implant (20) is configured to be crimped on movement of the rod (10b2) to the first locking position (10e3);
wherein the implant (20) is deployed at the implantation site (30) on movement of the rod (10b2) to the second locking position (10e5).
2. The implant (20) as claimed in claim 1, wherein the implant (20) is a nasal implant.
3. The implant (20) as claimed in claim 1, wherein the implant (20) is coated with a coating of one or more of a polymer and/or a drug.
4. The implant (20) as claimed in claim 3, wherein the polymer includes one or more of polycaprolactone (PCL), poly-DL-lactide-co-glycolide (PDLG), poly-L-lactide (PLA), poly (L-lactide-co-D, L-lactide), poly DL-lactide (PDLLA) or combination thereof.
5. The implant (20) as claimed in claim 3, wherein the drug includes anti-bacterial drugs including one or more of tobramycin, kanamycin, gentamicin, neomycin, streptomycin, ansamycins, rifampin, cephalosporins, tyrothricin, bacitracin, vancomycin, polymyxins, triclosan or combination thereof.
6. The implant (20) as claimed in claim 3, wherein the drug includes anti-inflammatory drugs including one or more of ibuprofen, naproxen sodium, diclofenac sodium, celecoxib, rofecoxib, mometasone furoate, etoricoxib, indomethacin, naproxen or combination thereof.
7. The implant system (100) as claimed in claim 1, wherein the first slot (10e1) includes a length ranging between 15mm to 25mm.
8. The implant system (100) as claimed in claim 1, wherein the second slot (10e2) includes a length ranging between 10mm to 20mm.
9. The implant system (100) as claimed in claim 1, wherein the side walls (10c3) are flexible in nature having a thickness ranging between 0.8mm to 2.5mm.
10. The implant system (100) as claimed in claim 1, wherein the side walls (10c3) have a tapered configuration.
11. The implant system (100) as claimed in claim 1, wherein the cartridge (10c) includes an upper segment (10c1) and a lower segment (10c2) secured together by means of a plurality of locking projections (10c4).
12. The implant system (100) as claimed in claim 1, wherein the cavity (10c5) is in the form of a Y-shaped slot followed by a tapered section (10c5’).
13. The implant system (100) as claimed in claim 1, wherein the lumen (L) of the handle (10a) and the cavity (10c5) of the cartridge (10c) are provided with a frictionless coating.
14. The implant system (100) as claimed in claim 13, wherein the frictionless coating includes a base coat and a top coat.
15. The implant system (100) as claimed in claim 13, wherein the frictionless coating includes one or more of, silicone hybrid resin, polyurethane, polytetrafluoroethylene (PTFE), polyester, poly-N-vinylpyrrolidone (PVP), polyethylene oxide (PEO), polyethylene glycol (PEG), propylene glycol monomethyl ether acetate (PMA), sodium hyaluronate, hyaluronic acid and polyisocyanate or combination thereof.
16. The implant system (100) as claimed in claim 13, wherein the frictionless coating includes a cross-linker from one of aziridine, aliphatic diisocyanate, polyisocyanate and/or epoxy resin.
17. The implant system (100) as claimed in claim 14, wherein the base coat includes propylene glycol monomethyl ether acetate (PMA), hyaluronic acid, aziridine (cross-linker) and polyisocyanate in a weight ratio of 4.5:4.4:0.3:0.8.
18. The implant system (100) as claimed in claim 14, wherein the top coat includes sodium hyaluronate and hyaluronic acid in a weight ratio of 1:9.
19. The implant system (100) as claimed in claim 1, wherein the rod (10b2) is provided with a frictionless coating having a thickness ranging between 20µ to 150µ.
20. The implant system (100) as claimed in claim 19, wherein the frictionless coating includes one or more of, polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), and/or low density polyethylene (LDPE).
21. The implant system (100) as claimed in claim 1, wherein the delivery tool (10) includes a needle assembly (10d) having a needle (10d2) and a hub (10d1).
22. The implant system (100) as claimed in claim 1, wherein the needle (10d2) and the hub (10d1) are bonded using one of, UV bonding or adhesive bonding.
23. A method of operating an implant system (100), the method comprising:
providing a cartridge (10c) that is pre-loaded with an implant (20), the cartridge (10c) having a plurality of extensions (10c3’);
locking the pre-loaded cartridge (10c) with a handle (10a) via the plurality of extensions (10c3’), the handle (10a) including a first slot (10e1) defining a first locking position (10e3) and a second slot (10e2) defining a second locking position (10e5);
gradually pushing a rod (10b2) till the first locking position (10e3) to allow crimping of the implant (20); and
pushing the rod (10b2) further beginning with a twist till the second locking position (10e5) to deploy the implant (20). , Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION:
NASAL IMPLANT SYSTEM

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

The following specification particularly describes the invention and the manner in which it is to be performed:
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a delivery tool used to deploy a nasal implant.
BACKGROUND
[002] Nasal Valve Collapse (NVC) is a common cause for nasal airway obstruction. It is caused by muscular/cartilage/lateral wall weakness which leads to narrowing of a nasal valve. This narrowing obstructs the nasal airway, thus, creating difficulty in breathing.
[003] Conventionally, NVC is treated with the help of nasal dilators or through rhinoplasty. Nasal dilators are physical entities worn by a patient to expand the nasal passage. These dilators, having a questionable long term efficacy, may cause physical discomfort to the patient while using them. Further, due to its prominent physical presence around the nose, it is a sore sight to look at in day to day life.
[004] Rhinoplasty is a nasal reconstructive surgery which is an alternate option to treat NVC. A nasal implant is permanently placed at a treatment site through a surgical procedure to support the collapsed nasal valve. However, it has been observed that such implants are prone to cause infection and show signs of inflammation post-implantation. Further, being a surgical procedure, this may be a very expensive as well as complicated treatment strategy.
[005] Recently, bioresorbable implants have been utilized as a promising alternative available to treat NVC over other conventional treatment strategies. These implants degrade slowly in the body post-implantation, eventually to leave no trace post complete degradation. Unlike the sophisticated and complicated procedure followed in rhinoplasty, the implant is easily injected into the patient’s nose using a simple delivery system in an office like environment. However, as discussed in U.S. Pat. No. US20170079774A1, such implants are packaged separately from their delivery system. Due to such packaging, the physician has to physically/manually load the implant onto the delivery system prior to the implantation procedure with the help of forceps. During the loading process, there is a chance of damage of the implant if it is mishandled by the physician. Also, if the implant is placed onto the delivery system in an improper orientation, it might affect the loading mechanism of the implant. Moreover, the conventional delivery systems mostly include a fixed pusher rod due to which the physician may find the delivery system abnormally long and affect the handling of the delivery system during the implantation procedure. All these shortcomings of the conventional delivery system make the implantation procedure cumbersome for the physician.
[006] Moreover, the movement of the implant within the conventional delivery systems at the time of implantation mostly causes surface damage to the implant due to high frictional forces experienced by the implant.
[007] Therefore, there arises a requirement of an implant delivery system which overcomes the aforementioned challenges associated with the conventional delivery system for nasal implants.
SUMMARY
[008] The present invention corresponds to an implant system which includes an implant and a delivery tool. The delivery tool includes a handle, a cartridge and a pusher rod assembly. The handle includes a locking mechanism having a first slot and a second slot. The cartridge is pre-loaded with the implant and includes at least two side walls having extensions for locking the cartridge with the handle. The pusher rod assembly includes a rod which engages with one of the first slot or the second slot at a given time. The first slot defines a first locking position. The second slot defines a second locking position. The implant is configured to be crimped on movement of the rod to the first locking position and is deployed on movement of the rod to the second locking position. A lumen of the handle and the cavity (of the cartridge) are provided with a frictionless coating.
[009] The above disclosed implant system is operated via a pre-defined method. The method includes providing the cartridge that is pre-loaded with the implant, locking the pre-loaded cartridge with the handle via the plurality of extensions, gradually pushing the rod till the first locking position to allow crimping of the implant and pushing the rod further beginning with a twist till the second locking position to deploy the implant.
[0010] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0011] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0012] Fig. 1 depicts an implant system 100 in accordance with an embodiment of the present invention.
[0013] Fig. 2 depicts an implant 20 in accordance with an embodiment of the present invention.
[0014] Fig. 3 depicts a delivery tool 10 in accordance with an embodiment of the present invention.
[0015] Fig. 4 depicts a pusher rod assembly 10b in accordance with an embodiment of the present invention.
[0016] Fig. 5a and Fig. 5b depicts the longitudinal cross-section of a first section 10a4 of a handle 10a in accordance with an embodiment of the present invention.
[0017] Fig. 5c depicts the lateral cross-section of a first section 10a4 of a handle 10a in accordance with an embodiment of the present invention.
[0018] Fig. 6a depicts an implant cartridge 10c in accordance with an embodiment of the present invention.
[0019] Fig. 6b depicts a longitudinal cross section of the upper segment 10c1 of the implant cartridge 10c in accordance with an embodiment of the present invention.
[0020] Fig. 6c depicts a lower segment 10c2 of an implant cartridge 10c in accordance with an embodiment of the present invention.
[0021] Fig. 6d depicts a cartridge port 10a3 of a delivery tool 10 in accordance with an embodiment of the present invention.
[0022] Fig. 7 depicts a needle assembly 10d in accordance with an embodiment of the present invention.
[0023] Fig. 8 depicts a flowchart of steps involved in implantation of a nasal implant 20 in accordance with an embodiment of the present invention.
[0024] Fig. 8a-d depicts the crimping and loading of a nasal implant 20 using a delivery tool 10 in accordance with an embodiment of the present invention.
[0025] Fig. 8e-k depicts the deployment of the implant 20 at an implantation site 30 using the delivery tool 10 in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] In accordance with the present disclosure, a delivery tool used to deliver a medical implant (collectively referred to as an ‘implant system’) is disclosed. The delivery tool of the present invention may be used to deliver the medical implant at an implantation site through a minimal-invasive procedure. The implantation site in the present invention corresponds to for example, a collapsed lateral wall of a patient’s nose.
[0031] The implant system of the present invention includes a bioresorbable medical implant which is configured to be deployed by the delivery tool at the implantation site. The implant is pre-loaded onto the delivery tool and hence is integrated with the same. The delivery tool includes a needle assembly, one or more of implant cartridge, a handle and a pusher rod assembly. The needle assembly helps to puncture the tissue at the implantation site and makes way for the passage of the implant towards the implantation site. The implant cartridge of the implant system houses the implant to be deployed by the delivery tool. The pusher rod assembly helps to drive the implant from the cartridge to the implantation site. All these individual components of the delivery tool may be assembled within the handle of the delivery tool.
[0032] The cartridge arrangement of the delivery tool as mentioned above enables a physician to load implant(s) into the delivery tool by a simple locking and unlocking mechanism. The locking and/or unlocking mechanism includes a plurality of side walls which may be disposed on the cartridge. Moreover, a frictionless coating is applied on an internal cavity of the cartridge and a lumen of the handle. The said coating helps in easy and smooth loading as well as deployment of the implant. Further, the pusher rod assembly along with the handle of the delivery tool has a two-step locking which results in two positions of the pusher rod (i.e. a first locking position and a second locking position), which aid the physician in delivering the implant. The movement of the pusher rod assembly from a first end of the handle to the first locking position leads to crimping of the implant. Likewise, the movement of the pusher rod assembly from the first locking position to the second locking position translates into deployment of the implant at the implantation site. The pusher rod assembly may include a distal portion which may be covered with a lubricious material to reduce friction between the pusher rod and the lumen of the handle during the deployment procedure.
[0033] Now referring to figures, FIG. 1 shows the implant system 100 of the present invention. The delivery tool 10 may be employed to deploy the implant 20 to treat a collapsed lateral wall of the patient’s nose. In an embodiment, the delivery tool 10 is used to deliver a nasal implant 20 to treat nasal valve collapse and improve breathing pattern thereby quality of life of the patient. For ease of describing the present invention, the implant 20 is considered to be a nasal implant which is deployed with the help of the delivery tool 10 of the present invention. The implant 20 provides support to the upper and the lower lateral cartilages, the lateral wall or the nasal wall and improves breathing and reduces inflammation, pain, infection and ulcer.
[0034] The implant 20 may be made up of bioresorbable material including but are not limited to polycaprolactone (PCL), poly-DL-lactide-co-glycolide (PDLG), poly-L-lactide (PLA), poly (L-lactide-co-D, L-lactide), poly DL-lactide (PDLLA) or combinations thereof. The implant 20 made up of poly (L-lactide-co-D, L-lactide) may have different ratio of L-lactide and DL-lactide i.e., 90:10, 80:20, 70:30, 60:40, or 50:50. In an embodiment, the implant 20 is made up of bioresorbable, poly (L-lactide-co-D–L-lactide) (PDLLA) copolymer in ratio of 70:30 with an inherent viscosity ranging from 3.5 dl/g to 4.0 dl/g. Alternatively, the implant 20 may be made of one or more biocompatiable and/or bioresorbable metals. Biocompatible metals may include, but not limited to nitinol alloy, cobalt-chromium alloy, titanium alloy, etc. Bioresorbable metals may include, but not limited to magnesium, iron, zinc, their alloys, etc. Owing to its degradable nature, the implant 20 is gradually absorbed by the body over a period of time which may range from 12 to 18 months post implantation. Further, the implant 20 may have the desired characteristics like adequate strength and flexural rigidity.
[0035] The implant 20 may include pre-defined dimensions which may vary according to the anatomical dimension of the implantation site 30 of the patient. The length of the implant 20 may vary from 20mm to 25mm; more preferably from 21mm to 24 mm. In an embodiment, the implant 20 may be manufactured as having different lengths with an increment of around 0.5mm to 1.5mm. The diameter of the implant 20 may range from 0.5 mm to 2 mm; more preferably 1 mm to 1.5 mm.
[0036] In the present invention, the implant 20 has a distal portion 20a, a proximal portion 20b and a longitudinal central body 20c extending from the distal portion 20a to the proximal portion 20b as represented in FIG. 2. The distal portion 20a may include a predefined shape and structure. As a preferred embodiment, the distal portion 20a of the implant 20 is forked. The forked distal portion 20a of the implant 20 may be in the form of a “Y” shaped arm 20a1 as represented in FIG. 2. Such a shape helps to anchor the implant 20 against the lateral wall without any possible chance of migration while sneezing and further, reduces the risk of swelling and ulcer. The ‘Y’ shaped arm 20a1 may have a smooth or rough finish. The ‘Y’ shaped arm 20a1 may be symmetrical or asymmetrical in length. The ‘Y’ shaped arm 20a1 may have blunt edges. In an embodiment, the ‘Y’ shaped arm 20a1 is symmetrical having arms ‘a’ and ‘b’ of equal length as well as blunt edges with smooth finish. Such a structure of the ‘Y’ shaped arm 20a1 helps in atraumatic deployment of the implant 20 thereby reducing the risk of inflammation. The ‘Y’ shaped arm 20a1 at the distal forked portion 20a may be flexible. In an embodiment, such flexibility helps the implant 20 to contract and fit within a 16 gauge needle 10d2 of the delivery tool 10.
[0037] The angle between the arms ‘a’ and ‘b’ of the ‘Y’ shaped fork 20a1 ranges between 5° to 10°. The arms may be manufactured as having different lengths with an increment ranging from 0.5mm to 1.5mm. Such dimensional range helps the implant 20 in easy and smooth loading and deployment at the implantation site 30 to provide support to the nasal upper and lower cartilage.
[0038] In present invention, the distal portion 20a may be designed in such a way that the implant 20 can withstand the pushing force applied by the delivery tool 10 during deployment process of the implant 20.
[0039] The proximal portion 20b of the implant 20 may include a predefined shape and structure. In one embodiment, the proximal portion 20b of the implant 20 includes a rounded configuration. The rounded configuration helps to anchor the implant 20 and prevents its migration post implantation. Moreover, the rounded configuration may enable smooth pushing of the implant 20 due to even distribution of force throughout the implant 20 at the time of implantation.
[0040] The central body 20c of the implant 20 may have various shapes including, but not limited to, cylindrical, elliptical, etc. The central body 20c may have a uniform or a non-uniform diameter throughout the body. In an embodiment, the central body 20c includes a uniform diameter. The overall diameter of the central body 20c of the cylindrical implant 20 may be more than the proximal portion 20b of the implant 20. Such selection of dimensions provides increased flexibility to the implant 20 thereby allowing the implant 20 to withstand biomechanical force of the nose during routine activities.
[0041] The central body 20c may have various surface features along its length. The surface features may include but are not limited to, at least one ridge disposed over the central body 20c. The central body 20c may have 25 to 50 ridges. The axial length of each ridge may vary along the length of the central body 20c. The ridges may be disposed over the entire surface of the central body 20c or alternately, may partially extend over the central body 20c. The ridges may be in the form of concentric rings as shown in FIG. 2. Alternately, the ridges may form incomplete rings (not shown).
[0042] In an embodiment, the implant 20 is a nasal implant having 35 ridges in the form of concentric rings disposed over the surface of the cylindrical central body 20c. In an embodiment, all the ridges may include uniform dimensions. Alternatively, as represented in Fig. 2, one ridge 20c1 out of the ridges may include a longer axial length. The longer ridge provides structural strength to the proximal portion 20b of the implant 20. These ridges on implant 20 rest between the upper cartilage/ lower cartilage and the skin by providing support, gripping and strength to the lateral wall.
[0043] The central body 20c may alternately have other surface features including but not limited to oval or hemispherical ribs.
[0044] Additionally/optionally, a coating may be applied partially or completely over the implant 20. The coating on the implant 20 may be biocompatible and frictionless which improves the strength, reduces the possibility of formation of scar tissue and recovers the normal inhalation and exhalation breathing pattern of the patient. Further, the coating may also offer easy deployment of the implant 20 from the delivery tool 10 by reducing the friction. The coating may be hydrophilic, hydrophobic or a combination thereof. The composition of the coating may include a bioresorbable polymer which helps to improve the flexural strength of the implant 20. The polymers may include polycaprolactone (PCL), poly-DL-lactide-co-glycolide (PDLG), poly-L-lactide (PLA), poly (L-lactide-co-D, L-lactide), poly DL-lactide (PDLLA) or combinations thereof. In an embodiment, the bioresorbable polymer coating on the implant 20 degrades over a time period of 6 to 18 months; preferably 10 to 16 months post implantation.
[0045] Moreover, the coating prevents damage to the implant 20 from unnecessary pressure and force generated during loading, deployment process and post implantation. Furthermore, during loading and deployment of the implant 20, the coating remains intact due to well adhesion of the coating on implant surface. Also, coating achieved is smooth and uniform throughout the implant surface.
[0046] Further, a coating of a therapeutic agent may be provided over the implant 20 to prevent post-operative consequences like inflammation, swelling and ulcers. Therapeutic agents include but are not limited to antibacterial, anti-inflammatory, etc. A bioresorbable polymer may be provided to act as a carrier for release of drug from implant surface. In an embodiment, poly DL-lactide is used as a carrier polymer for drug release.
[0047] Anti-bacterial drugs may include but are not limited to tobramycin, kanamycin, gentamicin, neomycin, streptomycin; ansamycins, such as rifamycin, or rifampin; cephalosporins, tyrothricin, bacitracin, vancomycin, polymyxins, triclosan, etc. In an embodiment, the proportion of bioresorbable polymer and anti-bacterial drug ranges from 50:50, 60:40 and 70:30, more preferably ranging from 50:50. In an embodiment, triclosan is used as an anti-bacterial drug for coating the implant 20. The drug dosage of triclosan agent may range from 0.5µg/mm2 to 5.0µg/mm2, more preferably from 1.25µg/mm2 to 4µg/mm2. In-vitro study conducted in PBS solution showed that around 80% to 90% of the drug triclosan was released within 48hrs.
[0048] Similarly, the implant 20 may be coated with an anti-inflammatory drug to reduce post-implantation inflammation. Anti-inflammatory drug may include but are not limited to ibuprofen, naproxen sodium, diclofenac sodium, celecoxib, rofecoxib, mometasone furoate, etoricoxib, indomethacin and naproxen or their combinations. In an embodiment, the proportion of bioresorbable polymer and anti-inflammatory drug for coating ranges from 50:50, 60:40 and 70:30, more preferably 50:50. In an embodiment, mometasone furoate is used as an anti-inflammatory drug for coating the implant 20. The drug dosage of mometasone furoate agent may be in a range of 0.5µg/mm2 to 5.0µg/mm2, more preferably from 1.25µg/mm2 to 4µg/mm2. In-vitro study conducted in PBS solution showed that around 70% to 85% of the anti-inflammatory drug mometasone furoate was released within 72hrs.
[0049] FIG. 3 illustrates the delivery tool 10 of the present invention. The delivery tool 10 includes a plurality of components such as the handle 10a, the pusher rod assembly 10b, the implant cartridge 10c and a needle hub assembly 10d which operate in a synchronized manner to deploy the implant 20. The implant 20 is pre-loaded within the implant cartridge 10c which prevents human mishandling, human contact as well as protects the implant 20 from impurities present in the environment. This also helps the physician in easy handling of the delivery tool 10 to deploy the implant 20 directly at the implantation site 30.
[0050] The handle 10a of the delivery tool 10 includes a first end 10a1 and a second end 10a2. The first end 10a1 of the handle 10a may be coupled with the pusher rod assembly 10b. The second end 10a2 of the handle 10a may be coupled with the implant cartridge 10c through a cartridge port 10a3 present on the handle 10a. The first end 10a1 of the handle 10a includes a first section 10a4 having a lumen ‘L’ to allow the passage of the pusher rod assembly 10b. In an embodiment, the dimensions of the lumen ‘L’ of the first section 10a4 of the handle 10a correspond to the dimensions of the pusher rod assembly 10b. The first section 10a4 of the handle 10a may be equipped with a locking mechanism 10e. The lumen along with the locking mechanism 10e of the handle 10a allows the physician to operate the delivery tool 10 to deploy the implant 20 in a safe and controlled manner. The locking mechanism 10e offers a two-step locking procedure for crimping and deploying the implant 20. The locking mechanism 10e includes at least two slots which may be embedded in the lumen ‘L’ of the handle 10a. In an embodiment, the lumen ‘L’ of the handle 10a includes a first slot 10e1 and a second slot 10e2. The arrangement of the first and second slot 10e1, 10e2 may together resemble a lightning flash. The second slot 10e2 may be placed below the first slot 10e1. As shown in FIG. 5a and 5b, the first slot 10e1 extends from the first end 10a1 of the handle 10a to a first locking position 10e3. The first locking position 10e3 may be disposed at a first predefined portion of the first slot 10e1. The first predefined portion includes an end oppositely placed with respect to the first end 10a1. The first slot 10e1 includes a predefined length. The pre-defined length may range between 15mm to 25mm. In an embodiment, the pre-defined length of the first slot 10e1 is 20mm.
[0051] Likewise, the second slot 10e2 extends from a point below the first locking position 10e3 say, a first position 10e4 to a second locking position 10e5. The second locking position 10e5 may be disposed at a second predefined portion of the second slot 10e2. The second predefined portion includes an end oppositely placed with respect to the first position 10e4. The second slot 10e2 includes a predefined length. The pre-defined length may range between 10mm to 20mm. In an embodiment, the pre-defined length of the second slot 10e2 is 10mm.
[0052] The engagement of the pusher rod assembly 10b with the above disclosed first slot 10e1 and the second slot 10e2 allows crimping and deployment of the implant 20 respectively (described below).
[0053] The second end 10a2 of the handle 10a may include a second section 10a5. In an embodiment, the second section 10a5 corresponds to the cartridge port 10a3 as shown in FIG. 6d. The cartridge port 10a3 may be employed to accommodate one or more of the implant cartridges 10c.
[0054] As represented in FIG. 4, the pusher rod assembly 10b of the present invention includes a pusher pin 10b1 and a rod 10b2. The pusher pin 10b1 and the rod 10b2 may be manufactured as an integral unit. Alternately, the pusher pin 10b1 and the pusher rod 10b2 may be two separate units which may be easily assembled or dissembled as and when required. The pusher rod assembly 10b may also include an accompanying enclosure 10b3 which stays flush with the exterior of handle 10a. The enclosure 10b3 helps in keeping the pusher rod assembly 10b static during storage and transportation.
[0055] In an embodiment, the pusher pin 10b1 and the rod 10b2 are connected with each other via manually securing the pusher pin 10b1 to a circumferential groove present on the rod 10b2 with the help of epoxies and cyanoacrylate adhesives permanently. In order to increase the bonding strength, pre-defined textures or roughness may be provided over the rod 10b2 at one of its side. In an alternate embodiment, the bonding is through circumferential grooving having threads on the pusher pin 10b1 which facilitates efficient attachment between the rod 10b2 and the pusher pin 10b1. As represented in FIG. 4, the present invention has one circumferential groove. The rod 10b2 may be secured permanently to the groove with the help of adhesives.
[0056] As shown in FIG. 5b, the pusher pin 10b1 may be a T-shaped structure having a vertical portion and a horizontal portion. The vertical portion may be disposed along the longitudinal axis of the delivery tool 10 while the horizontal portion is disposed perpendicular to the vertical portion. The horizontal portion may be provided with a protrusion 10b4. As shown in Fig. 5c, the protrusion 10b4 may be configured to engage with the first and the second slots 10e1, 10e2 of the first section 10a4 of the handle 10a.
[0057] The rod 10b2 may be made of a pre-defined material having sufficient strength and durability. In an embodiment, the rod 10b2 is made of stainless steel. The diameter of the rod 10b2 may range from 0.8mm and 1.2mm, more preferably 0.9mm to 1mm. In an embodiment, the diameter is 1mm. The distal portion of the rod 10b2 may be made flat to prevent implant 20 damage during deployment procedure.
[0058] Optionally/additionally, the rod 10b2 of the pusher rod assembly 10b may be covered by a frictionless material such as PTFE, HDPE, and LDPE with ultrathin thickness ranging from 20µ to 150µ, more preferably ranges from 40µ to 100µ. This covering will help to prevent damage of the implant 20 during loading and deployment of the implant 20 with the help of pusher rod assembly 10b.
[0059] The cartridge 10c of the delivery tool 10 is illustrated in FIG. 6a. The cartridge 10c may include an upper and a lower segment 10c1, 10c2. The upper segment 10c1 may include a body ‘c’ having two side walls 10c3. The body ‘c’ of the upper segment 10c1 may include a plurality of locking projections 10c4 as represented in FIG. 6b. The locking projections 10c4 may be used to secure the upper segment 10c1 with the lower segment 10c2. The lower segment 10c2 may have appropriate locking holes 10c4’ to accommodate the locking projection 10c4. In an embodiment, four locking projections 10c4 disposed on either sides of the body ‘c’ are used to secure the upper segment 10c1 with the locking holes 10c4’ disposed respectively on the lower segment 10c2 via snap fit arrangement.
[0060] The side walls 10c3 in the upper segment 10c1 of the cartridge 10c may be employed for locking and/or unlocking the cartridge 10c from the handle 10a effortlessly. The side walls 10c3 may include one or more extensions 10c3’. The extensions 10c3’ may be disposed on a surface of the side walls 10c3 facing the body ‘c’. In an embodiment, there is one extension 10c3’ per side wall 10c3 which extend over the side walls 10c3 along the longitudinal direction. It should be noted that though the present invention explicitly defines the presence of “extensions”, other equivalent means may also be used in place of extensions for performing the same function.
[0061] The extensions 10c3’ may secure with the cartridge port 10a3 of the handle 10a to aid in locking the cartridge 10c to the cartridge port 10a3 of the delivery tool 10. The side walls 10c3 may include enough flexibility to retract in its initial position and lock with the handle 10a through a gentle push on the cartridge 10c upon the cartridge port 10a3. As a preferred embodiment, the flexibility of the side walls 10c3 in the present invention is attributed to their thickness. The thickness of the flexible side walls 10c3 may range from 0.8mm to 2.5mm. Each side wall 10c3 may include a tapered configuration having varying thickness. For example, the portion of side wall 10c3 attached to the body ‘c’ of the cartridge 10c may be thick relative to the opposite free end of the side wall thereby forming a tapered configuration. In an embodiment, the thickness of the side walls 10c3 is tapered from 1.35mm to 1mm. Alternately, the flexibility maybe conferred due to the material used for fabricating the side walls 10c3.
[0062] The upper segment 10c1 as well as the lower segment 10c2 may include respective cavities which form a cavity 10c5 together. The implant 20 may reside in the cavity 10c5 defined by the upper 10c1 and the lower segments 10c2 to enclose the implant 20 from bottom end as well top end. In an embodiment, after placing the implant 20 in the cavity of lower segment 10c2 of the cartridge 10c, the cavity of the upper segment 10c1 is placed over the implant 20 and locked in place. The locking of the upper and the lower segments 10c1, 10c2 may be mediated with the help of pre-defined locking means 10c4, 10c4’.
[0063] Furthermore, frictionless coating may be applied over the internal cavity 10c5 of cartridge 10c and the lumen ‘L’ of the handle 10a (surface to be coated) which helps in easy and smooth loading as well as deployment of the implant 20 even after longer period of storage. The frictionless coating may be provided as a single or multiple layers. In an embodiment, the frictionless coating includes two layers, i.e., a base coat and a top coat. The base coat may be disposed over the surface to be coated and the top coat may be disposed over the base coat. The base coat may act as a means of adherence of the top coat to the surface to be coated. The top coat may provide the required lubricity to prevent implant 20 damage due to the friction generated during the operation of the delivery tool 10. The coating material may include but are not limited to silicone hybrid resin, polyurethane, polytetrafluoroethylene (PTFE), polyester, poly-N-vinylpyrrolidone (PVP), polyethylene oxide (PEO), polyethylene glycol (PEG), propylene glycol monomethyl ether acetate (PMA), sodium hyaluronate, hyaluronic acid and polyisocyanate and or their combination. A cross-linker may also be incorporated within the coating material including but not limited to aziridine, aliphatic diisocyanate, polyisocyanate and epoxy resin. In an embodiment, the base coat is a mixture of propylene glycol monomethyl ether acetate (PMA), hyaluronic acid, aziridine (cross-linker) and polyisocyanate in a weight ratio of 4.5:4.4:0.3:0.8. In an embodiment, the top coat is sodium hyaluronate and hyaluronic acid in a weight ratio of 1:9. The lubricity of the top coat may not exceed 50g. In an embodiment, the lubricity of the top coat is 12g. After application, the coating may be heat cured at 60°C for a period of 120 minutes.
[0064] The cavities 10c5 of the upper segment 10c1 and the lower segment 10c2 may be exactly same in shape, structure and dimensions. The structure, shape and dimensions of the cavity 10c5 may be dependent upon the structure, shape and dimensions of the implant 20. In an embodiment, as represented in FIG. 6c, the cavity 10c5 is in the form of a Y-shaped slot followed by a tapered section 10c5’. The tapered section 10c5’ helps in crimping the forked distal portion 20a of the implant 20. The cavity 10c5 of the cartridge 10c is designed in such a way that it will crimp the “Y” shaped fork 20a1 of the implant 20 in the most efficient and uniform manner without damaging the “Y” shape fork 20a1 of the implant 20. The cartridge cavity 10c5 also helps to prevent the change in orientation of the implant 20 and guide it towards the needle 10d which is attached with a hub 10d1 and further assembled with the handle 10a, and make the delivery tool 10 ready for further deployment procedure.
[0065] In the present invention, the cartridge cavity 10c5 may be pre-loaded with the implant 20 in a static condition which reduces the chance of mishandling of the implant 20 during loading or placement.
[0066] The needle assembly 10d may be coupled to the handle 10a of the delivery tool 10. The needle assembly 10d may include a needle 10d2 and the hub 10d1 (collectively called needle assembly 10d) as shown in FIG. 7. The needle assembly 10d may be coupled with the handle 10a through a circumferential groove present on the hub 10d1. The groove may be provided with a plurality of threads for efficient attachment. Alternatively, the handle 10a may be manually secured in the circumferential groove of the hub 10d1 with the help of an adhesive.
[0067] The needle 10d2 and the hub 10d1 may be attached through various attachment techniques. In one embodiment, the needle 10d2 is manually secured to a circumferential groove present in the hub 10d1 with epoxies and cyanoacrylate adhesives permanently. To increase the bonding strength, some textures or roughness may be provided on the needle 10d2 at one side. In another embodiment, the attachment is provided by circumferential grooving having threads in the hub 10d1 which facilitates efficient attachment between the hub 10d1 and the needle 10d2. In an embodiment as shown in FIG. 7, the hub 10d1 includes one circumferential groove. The groove depth in the hub 10d1 may be provided in a range from 0.15mm to 0.35mm, more preferably 0.2mm to 0.3mm. The needle 10d2 may be manually secured in the circumferential groove of the handle 10a with the help of an adhesive.
[0068] The needle 10d2 may be protected by a cover 10d3 which may be removed at the time of implantation procedure. The needle 10d2 may include a sharp bevel tip so that it can easily puncture the tissue and make passage to deliver the implant 20 at implantation site 30 of the patient. The needle 10d2 may be selected in the ranges from 14G to 18G, more preferably 16G.
[0069] Different types of coating may be performed on the needle 10d2 to reduce the friction during creation of an open passage for the deployment procedure of the implant 20.
[0070] FIG. 8 represents the process of the implantation of the implant 20 using the delivery tool 10. In an embodiment, the implantation procedure using the implant system 100 is a two-stage process. It should be noted that the one or more cartridges 10c of the implant system 100 are packaged with the implant 20, i.e. the implant 20 is pre-loaded within the cavity 10c5 and hence, the physician is not required to manually place the implant 20 within the cavity 10c5 as opposed to the conventional systems. The cartridge 10c of the present invention makes it an easy process for replacing the cartridge 10c in the delivery tool 10 instead of manually placing and loading of implant 20.
[0071] At step 801, the cartridge 10c of the implant system 100 is locked with the handle 10a of the delivery tool 10 with the help of the extensions 10c3. The cartridge 10c of the implant system 100 is aligned over the handle 10a in such a manner that the extensions 10c3 are placed over the cartridge port 10c3 and thereby the cartridge 10c is firmly secured to the handle 10a.
[0072] At step 803, the pusher rod assembly 10b is pushed gradually from the first end 10a1 of the handle 10a to the first locking position 10e3 defined by the first slot 10e1. The said push corresponds to a first push. The pusher rod assembly 10b is pushed gently along the length of the first slot 10e1 of the handle 10a to prevent the damage of the implant 20. The gradual push provided to the pusher rod assembly 10b results in crimping of the implant 20 within the cavity 10c5 defined by the cartridge 10c as shown in FIGs. 8a-8d. Due to this first push, the implant 20 travels into the delivery tool 10 in a longitudinal direction from the cartridge 10c to the end of the needle 10d2. The distance travelled by the implant 20 may range between 50mm-70mm. Therefore, it is desirable that the implant 20 has adequate strength to withstand the axial force generated between delivery tool’s 10 needle 10d2 and implant 20 during the deployment process.
[0073] At step 805, the implantation site 30 is marked with the help of a marker strip 40 as shown in FIG. 8e and 8f. The marker strip 40 is used to mark an insertion point 30a and an end location 30b of the implant 20 on the exterior surface of the nose of the patient. This aids the physician in tracking the implant 20 and its location. The cover 10d3 of the needle 10d2 may be removed at this stage for further procedural steps.
[0074] At step 807, the needle 10d2 is pierced through the nose and a small opening is created in the underlying tissue to deliver the implant 20 to the patient as shown in FIG. 8g.
[0075] At step 809, the pusher rod assembly 10b is further pushed forward with a slight twist to move the pusher rod assembly 10b from the first slot 10e1 to the second slot 10e2 i.e., from the first position 10e3 to the second locking position 10e5 of the handle 10a. The said push corresponds to a second push. The second push results in deployment of the implant 20 at the implantation site 30 as shown in FIG. 8h.
[0076] At step 811, the needle 10d2 of the delivery tool 10 is retracted from the insertion point 30a manually by the physician as shown in FIGs. 8i-k. Alternately, the needle 10d2 may be retracted with the help of a lever arrangement present on the delivery tool 10.
[0077] In case, there is a requirement for deployment of a second implant 20, a second cartridge 10c already pre-loaded with the implant 20 is locked on the same delivery tool 10 and the implantation procedure is repeated as above.
[0078] The present invention as elaborated above is supported with the help of following examples:
[0079] Example-1: A nasal implant having a length of 23mm and an outer diameter of 1mm was implanted in an in-vitro simulation nasal model having a nasal height of around 43mm in order to treat nasal valve collapse. The nasal implant was deployed with the help of a delivery system. The nasal implant was loaded onto the delivery system at the time of procedure. The delivery system used for implanting the nasal implant included a handle with a port to load the implant manually with the help of forceps by the physician. The delivery system included a fixed pusher rod.
[0080] During placement of the implant into the port, 20% to 30% of deviation of the implant from its intended orientation was observed. It was found that the deviated orientation resulted in the damage of the ‘Y’ shaped end of the implant.
[0081] Moreover, owing to manual intervention, increased chance of surface damage due to mishandling of the miniature implant was observed. Further, owing to the fixed design of the pusher rod, the delivery system was found to be uncomfortably long and caused inconvenience to the physician in handling the delivery system while using the delivery system.
[0082] Example-2: A nasal implant having a length of 22mm and an outer diameter of 1mm was implanted in an in-vitro simulation nasal model having a nasal height of around 42mm in order to treat nasal valve collapse. The nasal implant was deployed with the help of a delivery tool. The nasal implant was pre-loaded onto the delivery tool.
[0083] The delivery system included a handle provided with a cartridge for housing the nasal implant. The cartridge loaded with the nasal implant was locked into the cartridge port of the handle. The cartridge included a pair of extensions to lock the cartridge with the handle effortlessly.
[0084] The internal cavity of the cartridge and the lumen of the handle were further provided with a frictionless coating. The coating included a base and top coat disposed in a layered fashion. The base coat was a mixture of propylene glycol monomethyl ether acetate (PMA), hyaluronic acid, aziridine (cross-linker) and polyisocyanate in the weight ratio of 4.5:4.4:0.3:0.8. The top coat disposed above the base coat was a mixture of sodium hyaluronate and hyaluronic acid in a weight ratio of 1:9. The delivery system included a pusher rod for implanting the nasal implant by way of pushing the implant. The pusher rod in combination with the handle of the delivery tool had an inbuilt locking system.
[0085] It was observed that the implant provided in a preloaded condition in the cartridge resulted in no deviation in implant orientation. Further, the proper orientation of the implant helps in smooth loading and prevents damage to implant surface. Owing to the fast and easy mechanism to lock and unlock the implant cartridge preloaded with the implant to the delivery tool, the surgery time was minimized. Moreover, the elimination of the need to handle the bare implant by the physician minimized the chances of implant damage due to mishandling and infection at the implantation site.
[0086] The frictionless coating helped to enable a smooth transition of implant form the implant cartridge to the distal end of delivery tool and hence, no damage to the implant was found on the surface of the implant.
[0087] Further, as the pusher rod assembly of the delivery tool was provided separately from the handle, an overall decrease in length of the delivery tool was observed. Such decrease in length provided convenience for the physician to comfortably handle the delivery tool while using the delivery system.
[0088] 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.