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
CRIMPER

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 crimper. More particularly, the present disclosure relates to a sinus implant crimper.
BACKGROUND OF INVENTION
[2] Sinusitis is a medical condition in which the sinus cavities get inflamed, that requires frequent medical attention. A stent like sinus implant is used to treat such conditions. The sinus implant is a self-expandable stent which is radially crimped before it is inserted within the body for implantation. The sinus implant may be made of one or more biodegradable materials with one or more drug coatings on its outer surface.
[3] Conventionally, a medical practitioner manually crimps the sinus implant using their hands, which causes damage to the sinus implant. Particularly, the drug coatings may be irreversibly deformed or the drug-based coatings may be lost. Further, the extent of expandability of the sinus implants may be affected while it is crimped manually using hands.
[4] Hence, there arises a need for a crimper that overcomes the drawbacks associated with conventional crimping techniques.
SUMMARY OF INVENTION
[5] 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.
[6] In an embodiment, the present disclosure relates to a crimper to radially collapse an implant. The crimper includes a first end, a second end, a first plate and at least one second plate. The first plate has a first slot disposed close to the second end and a first aperture disposed between the first slot and the first end. The second plate has a second aperture being an inverted mirror image of the first aperture of the first plate. The second plate is configured to move relative to the first plate upon coupling with the first plate. The second aperture is configured to at least partially align with the first aperture to at least partially receive an implant. In a non-crimped configuration, the first plate and the second plate are arranged such that the first aperture and the second aperture are configured to receive the implant in its radially expanded state. In a crimped configuration, the first plate and the second plate are arranged such that the implant is disposed completely within the first aperture and the second aperture in its radially crimped state.
[7] In another embodiment, the present disclosure relates to a method to crimp an implant using a crimper. The method commences by positioning at least a portion of a second plate beneath a first plate. The second plate is advanced beneath the first plate to at least partially align the second aperture of the second plate with the first aperture of the first plate. An implant is inserted within the at least partially aligned first aperture and the second aperture. The first end of the second plate is gradually brought towards the first end of the first plate, thereby at least partially crimping the implant.
BRIEF DESCRIPTION OF DRAWINGS
[8] 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.
[9] Fig. 1 depicts a crimper 100, according to an embodiment of the present disclosure.
[10] Fig. 2 depicts a first plate 110 of the crimper 100, according to an embodiment of the present disclosure.
[11] Figs. 2a-2e depict the first plate 110, according to various embodiments of the present disclosure.
[12] Fig. 3 depicts a second plate 130 of the crimper 100, according to an embodiment of the present disclosure.
[13] Fig. 3a depicts the second plate 130 of the crimper 100, according to another embodiment of the present disclosure.
[14] Fig. 4 depicts an exemplary method 200 to crimp an implant 10 using the crimper 100, according to an embodiment of the present disclosure.
[15] Fig. 4a depicts the crimper 100 in its expanded configuration, according to an embodiment of the present disclosure.
[16] Fig. 4b depicts the crimper 100 being toggled from its expanded configuration to its crimped configuration, according to an embodiment of the present disclosure.
[17] Fig. 4c depicts the crimper 100 in its crimped configuration, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[18] 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.
[19] 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.
[20] 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.
[21] 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.
[22] The present disclosure relates to a crimper. The crimper may be used to crimp (or radially collapse) stent-like implants (or implants), including but not limited to, sinus implants, airway implants, bronchial implants, etc. In an exemplary embodiment, the implant is a self-expandable sinus stent.
[23] The crimper of the present disclosure helps to crimp an implant prior to the implantation of the implant with minimal human touch. The crimper helps to eliminate the need to manually hand-crimp the implant thereby maintaining implant properties and quality. For example, the implant retains its expandability after being crimped with the crimper. Further, any drug-based coating, if provided on the implant, is preserved.
[24] The crimper includes two plates, both including uniquely designed apertures. The implant to be crimped, is placed in the apertures and subjected to a crimping force by the plates. The plates of the crimper thus, crimp the implant.
[25] Now referring to the figures, Fig. 1 depicts an exemplary embodiment of a crimper 100. The crimper 100 is defined by at least two opposite ends. The two ends include a first end 100a and a second end 100b. Further, the crimper 100 can attain one of a crimped configuration or a non-crimped configuration. In the crimped configuration, the crimper 100 exerts a crimping force on the implant 10 that radially collapses the implant 10. In the non-crimped configuration, the implant 10 is partially or completely expanded as the crimping force exerted by the crimper 100 is insufficient to radially collapse the implant 10 completely. The implant 10 has a radially expanded state and a radially collapsed (or crimped) state. The implant 10, in its radially expanded state, has a diameter that is more than a diameter of the implant 10 in its radially collapsed state.
[26] The crimper 100 includes at least two plates, namely a first plate 110 and a second plate 130. The first end 100a and the second end 100b of the crimper 100 correspond to the first end 100a and second end 100b of the first plate 110 and the second plate 130. The first plate 110 and the second plate 130 are operationally coupled to each other to facilitate crimping (or radially collapsing) of an implant 10. The second plate 130 is configured to move relative to the first plate 110 upon coupling with the first plate 110. In an embodiment, the implant 10 is made of a self-expandable material. Details of the first plate 110 and the second plate 130 are elaborated below with the help of Figs. 2-2e and 3 respectively.
[27] Fig. 2 depicts the first plate 110. The first plate 110 may be made of one or more materials including, but not limited to, High-density polyethylene (HDPE), Polytetrafluoroethylene (PTFE), Polyethylene (PE), Stainless steel (SS), Aluminum, Polyethylene terephthalate glycol (PETG), Poly-Tartaric acid-co-Glycerol (PTCG), etc. In an exemplary embodiment, the first plate 110 is made of HDPE. The first plate 110 may have a thickness ranging from 0.3 mm to 2 mm. The first plate 110 may either be solid or hollow. In an exemplary embodiment, the first plate 110 is solid having and 0.8 mm thick. The first plate 110 may be of a pre-defined shape including, but not limited to, circular, oval, rectangular, parallelogram, rhombus, trapezoid, arrow, square, etc. shape. In an exemplary embodiment, as shown in Fig. 2, the first plate 110 is rectangular. In an alternate embodiment, as shown in Fig. 2a, the first plate 110 is cuboidal.
[28] The first plate 110 is provided with at least one slot and a first aperture 115. In an exemplary embodiment, as shown in Fig. 2, the first plate 110 is provided with two slots, namely, a second slot 113, and a first slot 111. The second slot 113 and the first slot 111 help act as channels or conduits for passage of the second plate 130.
[29] In an alternate embodiment, as shown in Fig. 2b, the first plate 110 is provided with two second slots 113 and two first slots 111. Providing two second slots 113 and first slots 111 helps to resize the first aperture 115 to crimp a diverse variant of implants 10.
[30] In yet another embodiment, as shown in Fig. 2c, the first plate 110 is provided with one second slot 113, one first slot 111 and two lateral slots 117. The two lateral slots 117 provide guided relative motion between the first plate 110 and the second plate 130 while preventing any dislocation of the first plate 110 and the second plate 130.
[31] Referring back to Fig. 2, the second slot 113 is disposed close to the first end 100a. In an exemplary embodiment, the second slot 113 enables the second plate 130 to pass from an upper surface of the first plate 110 to a bottom surface of the first plate 110. The second slot 113 helps to maintain alignment of the first plate 110 and the second plate 130 when they are moved relative to each other.
[32] The first slot 111 is disposed close to the second end 100b. The first slot 111 enables the second plate 130 to pass from the bottom surface of the first plate 110 to the upper surface of the first plate 110. The first slot 111 helps to maintain alignment of the first plate 110 and the second plate 130 when they are moved relative to each other.
[33] The second slot 113 and the first slot 111 enable the second plate 130 to be inter-weaved with the first plate 110, thereby providing support and maintaining alignment between the first plate 110 and the second plate 130.
[34] The first aperture 115 is disposed between the second slot 113 (i.e., close to the first end 100a) and the first slot 111. The first aperture 115 may be of a pre-defined shape including, but not limited to, circular, triangular, hexagonal, octagonal, pentagonal, cloudy, oval, rhombus, nonagonal, decagonal, etc. shape. In an exemplary embodiment, as shown in Fig. 2, the first aperture 115 is substantially oval in shape.
[35] In another embodiment, as shown in Fig. 2a, the first aperture 115 is rhombus shaped. In yet another embodiment, as shown in Fig. 2b, the first aperture 115 is circular shaped. Similarly, Figs 2c to 2e depict cloud shaped, hexagonal shaped, and keyhole shaped first aperture 115.
[36] The first aperture 115 is configured to at least partially receive the implant 10 (as shown in Fig. 1). In an embodiment, the diameter of at least a first portion 115a of the first aperture 115 corresponds to at least the radially expanded diameter of the implant 10 while the diameter of a second portion 115b of the first aperture 115 corresponds to at least the radially crimped diameter of the implant 10, i.e., the first portion 115a is wider compared to the second portion 115b. This configuration ensures that while the expanded implant 10 is properly placed in the first portion 115a of the first aperture 115, the expanded implant 10 can be crimped to the required diameter due to the reduced diameter of the second portion 115b. In the depicted embodiment of Fig. 2, the second portion 115b is disposed towards the first end 100a. In an alternate embodiment, pertaining to the first aperture 115 having symmetrical shapes like circle, rhombus, square, etc. the first aperture 115 includes uniform dimensions.
[37] Fig. 3 depicts the second plate 130. The second plate 130 can be made of one or more materials including, but not limited to, HDPE, PTFE, PE, SS, Aluminum, PETG, PTCG, etc. In an exemplary embodiment, the second plate 130 is made of HDPE. The second plate 130 may have a thickness ranging from 0.2 mm to 2.0 mm. In an exemplary embodiment, the thickness of the second plate 130 is 0.8. The second plate 130 may be of a pre-defined shape including, but not limited to, circular, oval rectangular, triangular, hexagonal, octagonal, pentagonal, cloudy, oval, rhombus, nonagonal, decagonal, etc. shape. In an exemplary embodiment, as shown in Fig. 2a, the second plate 130 is a solid rectangle. In an embodiment, the width of the second plate 130 is less than the width of the second slot 113 and the first slot 111 of the first plate 110.
[38] The second plate 130 is provided with a second aperture 131. In the depicted embodiment of Fig. 1, the second aperture 131 is configured to be at least partially aligned with the first aperture 115 and at least partially receive the implant 10.
[39] In an embodiment, the diameter of at least a first portion 131a of the second aperture 131 corresponds to at least the radially expanded diameter of the implant 10 while the diameter of a second portion 131b of the second aperture 131 corresponds to at least the radially crimped diameter of the implant 10, i.e., the first portion 131a is wider compared to the second portion 131b. This configuration ensures that while the expanded implant 10 is properly placed in the first portion 131a of the second aperture 131, the expanded implant 10 can be crimped to the required diameter due to the reduced diameter of the second portion 131b.
[40] In the depicted embodiment of Fig. 3, the second portion 131b is disposed towards the second end 100b. In an alternate embodiment pertaining to the second aperture 131 having symmetrical shapes like circle, rhombus, square, etc., the second aperture 131 includes uniform dimensions.
[41] In an embodiment, the second aperture 131 is an inverted mirror image of the first aperture 115. If the second portion 115b of the first aperture 115 is disposed towards the first end 100a, the second portion 131b of the second aperture 131 is disposed towards the second end 100b. Else, if the second portion 115b of the first aperture 115 is disposed towards the second end 100b, the second portion 131b of the second aperture 131 is disposed towards the first end 100a.
[42] In an embodiment, the second portion 115b of the first aperture 115 along with the second portion 131b of the second aperture 131 closely conform to the radially crimped diameter of the implant 10 thereby preventing the implant 10 to slip/dislocate within the crimper 100 after the implant 10 is radially collapsed with the help of the crimper 100.
[43] In the non-crimped configuration (as shown in Fig. 4a) of the crimper 100, the first plate 110 and the second plate 130 are arranged such that the first portion 115a of the first aperture 115 at least partially aligns with the first portion 131a of the second aperture 131, i.e., the first portion 115a of the first aperture 115 overlaps with the first portion 131a of the second aperture 131. The co-aligned first portion 115a of the first aperture 115 and the first portion 131a of the second aperture 131 is configured to at least partially receive the implant 10 in its radially expanded state.
[44] In the crimped configuration (as shown in Fig. 4c) of the crimper 100, the first plate 110 and the second plate 130 are arranged such that the second portion 115b of the first aperture 115 is in close proximity to the second portion 131b of the second aperture 131. The second portion 115b of the first aperture 115 and the second portion 131b of the second aperture 131 is configured to completely receive the implant 10 in its radially crimped state.
[45] The second plate 130 may be provided with at least one tab 133 disposed either at the first end 100a or the second end 100b. In an exemplary embodiment, as shown in Fig. 3, the tab 133 is disposed at the second end 100b. The tab 133 of the second plate 130 is used grasp the second plate 130 to either push or pull the second plate 130 with respect to the first plate 110.
[46] Fig. 3a depicts one or more projections 137 being optionally provided on the second plate 130 corresponding to the lateral slots 117 of the first plate 110. The projections 137 are configured to slide along the length of the lateral slots 117 (as shown in Fig. 2c) of the first plate 110. The projections 137 may either be coupled to the surface of the second plate 130 or be cut from the second plate 130 and bent projecting away from the second plate 130. In an exemplary embodiment, as shown in Fig. 3a, two projections 137 are cut and bent away from the surface of the second plate 130 projecting towards the lateral slots 117 of the first plate 110. The projections 137 along with the lateral slots 117 provide guided relative motion between the first plate 110 and the second plate 130 while preventing any dislocation of the first plate 110 and the second plate 130.
[47] Fig. 4 depicts an exemplary method 200 of crimping (or radially collapsing) the implant 10 using the crimper 100.
[48] The method 200 commences at step 201, by at least partially weaving the second plate 130 with the first plate 110. In an exemplary embodiment, the first end 100a of the second plate 130 is inserted into the first slot 111 of the first plate 110. The first end 100a of the second plate 130 (or at least a portion thereof) is therefore positioned beneath the first plate 110, i.e., the second plate 130 is at least partially positioned beneath the first plate 110.
[49] At step 203, the first end 100a of the second plate 130 is advanced beneath the first plate 110 (by pushing the tab 133) until the first aperture 115 of the first plate 110 is at least partially aligned with the second aperture 131 of the second plate 130 (as shown in Fig. 4a). In an exemplary embodiment, the first portion 115a of the first aperture 115 is aligned with the first portion 131a of the second aperture 131.
[50] At step 205, the implant 10 (in its radially expanded state) is inserted within the co-aligned first aperture 115 and the second aperture 131 of the crimper 100. In an exemplary embodiment, the implant 10 is inserted within the co-aligned first portion 115a of the first aperture 115 and the first portion 131a of the second aperture 131.
[51] At step 207, the first end 100a of the second plate 130 is gradually brought in towards the first end 100a of the of the first plate 110. In an embodiment, the first end 100a of the second plate 130 is gradually pushed towards the first end 100a of the first plate 110 by pushing the tab 133. In an alternate embodiment, the first end 100a of the first plate 110 is gradually pulled towards first end 100a of the second plate 130.
[52] The relative movement of the first plate 110 and the second plate 130, exerts a crimping force on the implant 10 disposed within the first aperture 115 and second aperture 131 thereby at least partially crimping (or radially collapsing) the implant 10 (as shown in Fig. 4b).
[53] At step 209, as shown in Fig. 4c, the first end 100a of the second plate 130 is positioned close to the first end 100a of the first plate 110 such that the first end 100a of the second plate 130 passes through the second slot 113 and emerges above the first plate 110. At this stage, the second portion 115b of the first aperture 115 and the second portion 131b of the second aperture 131 is in close proximity to each other thereby crimping the implant 10 to its radially crimped state.
[54] At step 211, the implant 10 (in its radially crimped state) is recovered from the crimper 100 and loaded within a delivery system (not shown) for implantation.
[55] Although the first plate 110 of the present disclosure is described as a two-dimensional structure with a substantially circular first aperture 115 and two slots 111, 113, other shapes and form of the first plate 110, the first aperture 115 and the slots 111 are within the scope of the teachings of the present disclosure.
[56] 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. A crimper (100) to radially collapse an implant (10), the crimper (100) comprising:
a. a first end (100a) and a second end (100b);
b. a first plate (110) having a first slot (111) disposed close to the second end (100b) and a first aperture (115) disposed between the first slot (111) and the first end (100a); and
c. at least one second plate (130) having a second aperture (131) being an inverted mirror image of the first aperture (115) of the first plate (110), the second plate (130) is configured to move relative to the first plate (110) upon coupling with the first plate (110);
wherein, the second aperture (131) is configured at least partially align with the first aperture (115) to at least partially receive an implant (10);
wherein, in a non-crimped configuration, the first plate (110) and the second plate (130) are arranged such that the first aperture (115) and the second aperture (131) are configured to receive the implant (10) in its radially expanded state; and
wherein, in a crimped configuration, the first plate (110) and the second plate (130) are arranged such that the implant (10) is disposed completely within the first aperture (115) and the second aperture (131) in its radially crimped state.
2. The crimper (100) as claimed in claim 1, wherein a width of the second plate (130) is less than a width of the first slot (111) of the first plate (110).
3. The crimper (100) as claimed in claim 1, wherein at least a portion of the second plate (130) is disposed beneath the first plate (110).
4. The crimper (100) as claimed in claim 1, wherein at least one of the first aperture (115) and the second aperture (131) is provided with a first portion (115a, 131a) and a second portion (115b, 131b), the first portion (115a, 131a) is wider compared to the second portion (115b, 131b).
5. The crimper (100) as claimed in claim 1, wherein the first plate (110) is provided with lateral slot(s) (117) and the second plate (130) is provided with projection(s) (137) corresponding to the lateral slots (117) of the first plate (110).
6. The crimper (100) as claimed in claim 4, wherein, in the non-crimped configuration, the first portion (115a) of the first aperture (115) and the first portion (131a) of the second aperture (131) are co-aligned with each other.
7. The crimped (100) as claimed in claim 4, wherein, in the crimped configuration, the second portion (115b) of the first aperture (115) and the second portion (131b) of the second aperture (131) are in close proximity to each other.
8. The crimper (100) as claimed in claim 1, wherein the first aperture (115) includes a pre-defined shape being at least one of circular, triangular, hexagonal, octagonal, pentagonal, cloudy, oval, rhombus, nonagonal, decagonal shape or combinations thereof.
9. The crimper (100) as claimed in claim 1, wherein the second plate (130) is provided with at least one tab (133) at one of the first end (100a) or the second end (100b).
10. The crimper (100) as claimed in claim 1, wherein the first plate (110) is provided with a second slot (113) disposed close to the first end (100a) of a crimper (100).
11. A method (200) to crimp an implant (10) using the crimper (100) as claimed in claim 1, the method (200) comprising:
a. positioning at least a portion of a second plate (130) beneath a first plate (110);
b. advancing the second plate (130) beneath the first plate (110) to at least partially align the second aperture (131) of the second plate (130) with the first aperture (115) of the first plate (110);
c. inserting an implant (10) within the at least partially aligned first aperture (115) and the second aperture (131);
d. gradually bringing the first end (100a) of the second plate (130) towards the first end (100a) of the first plate (110), thereby at least partially crimping the implant (10).
12. The method (200) as claimed in claim 11, wherein the step of positioning at least a portion of the second plate (130) beneath the first plate (110) includes inserting the first end (100a) of the second plate (130) into the first slot (111) of the first plate (110).
13. The method (200) as claimed in claim 11, wherein the step of advancing the second plate (130) beneath the first plate (110) includes aligning a first portion (115a) of the first aperture (115) with a first portion (131a) of the second aperture (131).
14. The method (200) as claimed in claim 13, wherein the step of inserting the implant (10) includes inserting the implant (10) within the co-aligned first portion (115a) of the first aperture (115) and the first portion (131a) of the second aperture (131).
15. The method (200) as claimed in claim 11, wherein the step of gradually pushing the first end (100a) of the second plate (130) towards the first end (100a) of the first plate (110) includes aligning a second portion (115b) of the first aperture (115) in close proximity to a second portion (131b) of the second aperture (131).