Claims:WE CLAIM:
1. A delivery device (10) comprising:
a. a handle assembly (100) for controlling the deployment of a device (1), the handle assembly (100) including:
a roller (103);
a sheath driver (111) being rotatably coupled to the roller (103), the sheath driver 111 having a hollow tube-like structure including an outer surface, the outer surface of the sheath driver (111) including a pair of slots (111c), each slot (111c) having a first portion (c1) and a second portion (c2); and
a lever (113) housed within the sheath driver (111), the lever (113) being capable of sliding within the slot (111c) to engage with one of the first portion (c1) or the second portion (c2),
b. a catheter assembly (200) coupled to the handle assembly (100), the catheter assembly (200) including:
an inner shaft (203) having a groove (203b) to accommodate the device (1); and
an outer sheath (201) mounted over the inner shaft (203), the outer sheath (201) being coupled to the lever (113);
wherein, on clockwise rotation of the roller (103), the lever (113) engages with the second portion (c2) of the slot (111c) to allow longitudinal motion of the sheath driver (111) to allow retraction of the outer sheath (201) and exposure of the device (1),
wherein, on anti-clockwise rotation of the roller (103), the lever (113) engages with the first portion (c1) of the slot (111c) to enable forward movement of the outer sheath (201) thereby enclosing the inner shaft (203) completely.
2. The delivery device (10) as claimed in claim 1, wherein the slot (111c) is an L-shaped slot.
3. The delivery device (10) as claimed in claim 1, wherein the roller (103) and the sheath driver (111) are coupled together via corresponding threads.
4. The delivery device (10) as claimed in claim 1, wherein the inner shaft (203) encloses an inner tube (205).
5. The delivery device (10) as claimed in claim 1, wherein the inner shaft (203) and the inner tube (205) are coupled to a tube (107) of the handle assembly (100).
6. A screw jack loader (300) for crimping a device (1) over a delivery device, the screw jack loader (300) comprising:
• a plurality of travel shafts (301) , each of the plurality of travel shafts (301) including a threaded portion (301a);
• a plurality of plates being mounted along a length of the respective plurality of travel shafts (301) , the plurality of plates including a first plate (304) and a second plate (305) disposed below the first plate (304), each of the first plate (304) and the second plate (305) including an aperture (a1’/b2’) for holding a device (1); and
• a roller (302) being operatively coupled with the first plate (304),
wherein the roller (302) is capable of being rotated to allow the longitudinal movement of the first plate (304) away from the second plate (305) over the plurality of travel shafts (301) thereby crimping the device (1).
7. The screw jack loader (300) as claimed in claim 6 wherein the travel shafts (301) include a non-treaded portion (301b) with at least one projection (301c).
8. The screw jack loader (300) as claimed in claim 6 wherein the plurality of plates include a third plate (306) which acts as a firm platform for the assembly and operation of the screw jack loader (300).
9. The screw jack loader (300) as claimed in claim 6 wherein the first plate (304) and the second plate (305) include a curved top surface (304a1) and curved bottom surface (305a2) respectively.
10. The screw jack loader (300) as claimed in claim 6 wherein the third plate (306) includes a plurality of sockets (306a) to secure the travel shafts (301).
11. A method of loading a device using the screw jack loader (300) of claim 6, the method including:
securing a device (1) to a first plate (304) and a second plate (305), the securing the device (1) including securing a flat end of the device (1) to the second plate (305) and securing a curved end of the device (1) to the first plate (304);
moving the first plate (304) away from the second plate (305) via a roller (302) in order to crimp the device (1); and
loading the crimped device (1) within a delivery device (10) via a pusher rod
(505).
12. A slidable funnel loader (500) for crimping a device (1) over a delivery device, the slidable funnel loader (500) comprising:
• a plurality of tubes including:
a third tube (503), the third tube (503) being configured to hold a device (1) having a crimped flat end;
a second tube (502) being slidable over the third tube (503) and the device (1), wherein the second tube (502) is equipped to crimp a curved end of the device (1); and
a first tube (501) being equipped to couple with the third tube (503) for assisting in loading the device (1) within a delivery device,
• a plurality of rods, including a first rod (504) and a pusher rod (505), the first rod (504) being capable of fixing and pushing the device (1) within the third tube (503), the pusher rod (505) being equipped to push the device (1) within the delivery device (10) from the first tube (501).
13. The slidable funnel (500) as claimed in claim 12, wherein a length of the second tube (502) is smaller than the first tube (501).
14. The slidable funnel (500) as claimed in claim 12, wherein the third tube (503) has a tapered inner diameter along its entire length.
15. The slidable funnel (500) as claimed in claim 12, wherein the first rod (504) is tapered between a first end (504a) and a third end (504c).
16. A method of loading a device (1) using the slidable funnel loader (500) of claim 12, the method including:
providing a device (1) having a flat end and a curved end, the flat end of the device (1) being crimped manually;
securing the device (1) at a first end (503a) of the third tube (503), securing the device (1) includes fixing the flat end of the device within the third tube (503) using a first rod (504);
crimping the curved end of the device (1) via a second tube (502) and pushing the device (1) within the third tube (503) with the help of the first rod (504), the second tube (502) being equipped to slide over the curved end of the device (1),
loading the crimped device (1) within a delivery device, loading the crimped device includes attaching a first tube (501) with the second end (503b) of the third tube (503) and replacing the first rod (504) with a pusher rod (505), wherein the pusher rod (505) pushes the device (1) within the delivery device (10) via the first tube(501). , 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:
DELIVERY SYSTEM FOR MEDICAL DEVICE AND METHOD OF LOADING THEREOF

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

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 delivery system. More specifically, the present invention relates to a delivery system for inter-atrial shunts.
BACKGROUND
[002] Heart failure affects millions of people all around the globe. Heart failure includes failure of either the left side of the heart, the right side of the heart, or both. Heart failure leads to elevated pressure in left atrium or in pulmonary veins thereby impeding proper flow of oxygenated blood through the blood supply.
[003] In order to treat heart failures, devices such as shunts have been devised. The shunts mostly include complex structures having a curved end. The shunts are placed across the septum of upper atrium chambers to relieve pressure in atrium thereby minimizing the chance of heart failures.
[004] Conventionally, to deliver such shunt devices, a delivery system with a sliding mechanism is used. A physician controls the sliding mechanism of the delivery system by a switch. Such an arrangement may be associated with unintentional pre-deployment of the device and/or unnecessary push/pull of the switch thereby causing damage to the septal wall of the heart. Moreover, there is a chance of unnecessary jerk force caused by the curved end of the device during deployment with a conventional delivery system which may cause improper implantation at the treatment site and can cause damage to surrounding area of septal wall.
[005] Further, due to the complex geometry of the device, it is very challenging to uniformly load the device into a catheter and uniformly deploy device without affecting structural integrity of the device. The conventional loaders that are used to crimp and load the device are limited to a minimum catheter size of 14F which pose difficulties in navigating the body’s vasculature for deployment of the device.
[006] Therefore, there arises a requirement of a delivery system which overcomes the aforementioned challenges associated with the conventional delivery system.
SUMMARY
[007] The present invention relates to a delivery device for a device and associated method of loading is disclosed. The delivery device includes a handle assembly and a catheter assembly. The handle assembly includes a roller, a sheath driver and a lever. The sheath driver includes slots having a first portion and a second portion. The lever slides within the slot to engage with the first portion or the second portion. The catheter assembly includes an inner shaft having a groove to accommodate the device. An outer sheath is mounted over the inner shaft. On clockwise rotation of the roller, retraction of the outer sheath and exposure of the device take place. On anti-clockwise rotation of the roller, forward movement of the outer sheath takes place to enclose the inner shaft completely. The device is loaded within the delivery device (10) using a screw jack loader or a slidable funnel loader.
[008] The screw jack loader includes a plurality of travel shafts. Each of the plurality of travel shafts include a threaded portion. A plurality of plates are mounted along a length of the respective plurality of travel shafts. The plurality of plates include a first plate and a second plate disposed below the first plate. Each of the first plate and the second plate include an aperture for holding the device. A roller is operatively coupled with the first plate. The roller is capable of being rotated to allow the longitudinal movement of the first plate away from the second plate over the plurality of travel shafts thereby crimping the device.
[009] The slidable funnel loader includes a plurality of tubes having a third tube, a second tube and a first tube. The third tube is configured to hold a device having a crimped flat end. The second tube is slidable over the third tube and the device. The second tube is equipped to crimp a curved end of the device 1. The first tube couples with the third tube for assisting in loading the device within a delivery device. The loader further includes a plurality of rods having a first rod and a pusher rod. The first rod is capable of fixing and pushing the device 1 within the third tube. The pusher rod is equipped to push the device within the delivery device from the first tube.
[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 a delivery device 10 in accordance with an embodiment of the present invention.
[0013] Fig. 2 depicts a handle assembly 100 of the delivery device 10 with a rolling and sliding mechanism in accordance with an embodiment of the present invention.
[0014] Fig. 2a depicts an exploded view of the handle assembly 100 in accordance with an embodiment of the present invention.
[0015] Fig. 2b depicts a tube 107 along with a luer hub 109 of the handle assembly 100 in accordance with an embodiment of the present invention.
[0016] Fig. 2c depicts a sheath driver 111 of the handle assembly 100 in accordance with an embodiment of the present invention.
[0017] Fig. 2d depicts a lever 113 of the handle assembly 100 in accordance with an embodiment of the present invention.
[0018] Fig. 2e depicts the lever 113 disposed within the sheath driver 111 of the handle assembly 100 in accordance with an embodiment of the present invention.
[0019] Fig. 3 and 3a depicts a catheter assembly 200 in accordance with an embodiment of the present invention.
[0020] Fig. 3b depicts an attachment between an outer sheath 201 of the catheter assembly 200 and the lever 113 in accordance with an embodiment of the present invention.
[0021] Fig. 3c depicts the outer sheath 201 of the catheter assembly 200 and the lever 113 disposed within the sheath driver 111 in accordance with an embodiment of the present invention.
[0022] Fig. 4 depicts a method 20 to deploy the device 1 using the delivery device 10 in accordance with an embodiment of the present invention.
[0023] Fig. 4a depicts the deployment of the device 1 using the delivery device 10 in accordance with an embodiment of the present invention.
[0024] Fig. 5 depicts a screw jack loader 300 in accordance with an embodiment of the present invention.
[0025] Fig. 6 and 6a-d depict a method 400 to load the device 1 using the screw jack loader 300 in accordance with an embodiment of the present invention.
[0026] Fig. 7 depicts a slidable funnel loader 500 in accordance with an embodiment of the present invention.
[0027] Fig. 8 and Fig. 8a-e depicts a method 600 to load the device 1 using the slidable funnel loader 500 in accordance with an embodiment of the present invention.
[0028] Fig. 9 depicts a method 700 to assemble the delivery device 10 in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] In accordance with the present disclosure, a delivery system is disclosed. The delivery system of the present invention is used to deploy an implantable device (or device) at a treatment site. The implantable device may be an inter-atrial shunt which is to be deployed across the septum between two heart chambers.
[0034] The delivery system of the present invention employs a combination of a roller as well as a sliding mechanism to deploy the device. The roller mechanism ensures uniform and smooth deployment of the device at the treatment site. Post deployment of the implantable device, the sliding mechanism ensures quick and smooth retraction of the delivery system.
[0035] Further, the present invention includes an inner shaft with a groove, which maintains the structural integrity of the device in a crimped state. The groove accommodates the device to be deployed and acts as a pusher which helps in effortless and uniform deployment of the device at the treatment site.
[0036] The implantable device is mounted over the delivery system of the present invention via a pre-defined apparatus. The apparatus helps to crimp as well as load the implantable device onto a low profile catheter (10F-14F). The apparatus also helps in achieving uniform crimping profile of the device without any strut overlapping.
[0037] Further, owing to the use of the low profile catheter, a small opening for insertion of the delivery system is required which thereby reduces trauma to a patient. Further, low profile catheters have higher flexibility to reach the treatment site through uneven or complex blood vessels and provide effortless performance to a physician while deploying the device.
[0038] Therefore, the delivery system of the present invention enables uniform, smooth and controlled deployment of the device without any jerking effect at a treatment site.
[0039] As an exemplary embodiment shown in FIG. 1, the delivery device 10 of the present invention includes a handle assembly 100 and a catheter assembly 200. The handle assembly 100 is utilized for controlling the deployment of a device 1. The device 1 to be deployed may be mounted over the catheter assembly 200 in a crimped condition.
[0040] An exemplary embodiment of the handle assembly 100 is shown in FIG. 2. The handle assembly 100 includes a rolling as well as sliding mechanism (explained below).
[0041] The handle assembly 100 may be in the form of an elongated body of a conventional shape. In an embodiment, the handle assembly 100 is a hollow cylindrical body. The handle assembly 100 may be made of a cap 101, a roller 103 and a back cover 105. The handle assembly 100 may be used for holding the delivery device 10. The handle assembly 100 may extend from a proximal end 100a to a distal end 100b.
[0042] The cap 101 may be disposed at the distal end 100b of the handle assembly 100. The cap 101 may be made of a material including but not limited to acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyamide (nylon), glass filled polyamide, epoxy resins etc. In an embodiment, the cap 101 is made of ABS. The cap 101 may have a length ranging from 50mm to 70mm. In an embodiment, the cap 101 is 55mm in length. The cap 101 may include a passageway for the catheter assembly 200.
[0043] The cap 101 may have a first end 101a and a second end 101b. In an exemplary embodiment depicted in FIG. 2, the cap 101 is conical in shape with the first end 101a having lesser diameter than the second end 101b. It should be noted that other shapes of the cap 101 are also within the scope of the present invention.
[0044] The cap 101 of the handle assembly 100 may have an elongated slot 101c. The elongated slot 101c of the cap 101 may have a length ranging from 20mm to 50mm. In an embodiment, the length of the elongated slot 101c of the cap 101 is 35mm. The elongated slot 101c of the cap 101 may enable a longitudinal movement of a lever 113 (described below) along the length of the slot 101c.
[0045] The roller 103 may be disposed between the second end 101b of the cap 101 and the back cover 105. The roller 103 may be connected with the cap 101 and the back cover 105 via an attachment means. As an exemplary embodiment, the second end 101b of the cap 101 includes a protruded circumferential groove 101b1 and the roller 103 may include a complementary recessed circumferential groove as attachment means. The said grooves may be connected with each other using threads or snap fit mechanism. The roller 103 may be attached to the back cover 105 in a similar manner.
[0046] The roller 103 may be connected in such a manner that free rotational movement of the roller 103 in clockwise as well as anti-clockwise direction may be achieved.
[0047] The roller 103 may be made of a material including but not limited to acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyamide (nylon), glass filled polyamide, epoxy resins etc. In an embodiment, the roller 103 is made of ABS. The roller 103 may include a conventional shape and pre-defined dimensions. In an embodiment as shown in FIGs. 2 & 2a, the roller 103 is a ring like structure. The roller 103 may have a length ranging from 15mm to 30mm. In an embodiment, the length of the roller 103 is 25mm. The roller 103 may have a diameter ranging from 20mm to 50mm. In an embodiment, the diameter of the roller 103 is 35mm.
[0048] The roller 103 may be manufactured as a single unit or multiple units that are assembled together. In an embodiment shown in FIG. 2a, the roller 103 is made by assembling two units via a conventional means such as snap-fitting, threading, etc.
[0049] The roller 103 may include an outer surface having a plurality of projections (or depression) 103a. The projections 103a may be disposed circumferentially spaced at a pre-defined distance from each other. Such projections 103a provide better grip while rotating the roller 103. Alternately, the outer surface of the roller 103 may be smooth.
[0050] The back cover 105 may be disposed at the proximal end 100a of the handle assembly 100. The back cover 105 may be made of a material including but not limited to acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyamide (nylon), glass filled polyamide, epoxy resins etc. In an embodiment, the back cover 105 is made of ABS. The back cover 105 may have a length ranging from 90mm to 120mm. In an embodiment, the length of the back cover 105 is 105mm.
[0051] The back cover 105 may include an undulating outer surface. The undulating outer surface provides ergonomic advantage to the physician while handling the handle assembly 100.
[0052] Like the roller 103, the back cover 105 may be manufactured as a single unit or multiple units that are assembled together to form the back cover 105. As an exemplary embodiment, the back cover 105 may have two units i.e. a top half 105a and a bottom half 105b. At least one of the top half 105a and/or the bottom half 105b may have a plurality of projections (or depression). In an embodiment, the bottom half 105b includes multiple projections 105b1. The projections 105b1 provide ergonomic advantage while handling the handle assembly 100.
[0053] As mentioned above, the back cover 105 may be connected with the roller 103 via a recessed circumferential groove 105c.
[0054] The above disclosed components of the handle assembly 100 may house a tube 107, a luer hub 109 and a sheath driver 111 as shown in FIG. 2a.
[0055] The tube 107 may extend within the hollow cavity formed by the handle assembly 100 from the distal end 100b to the proximal end 100a. The tube 107 may be made of a material including but not limited to stainless steel, nitinol, cobalt chromium (CoCr). In an embodiment, the tube 107 is made of stainless steel. The tube 107 may have a length ranging from 120mm to 170mm. In an embodiment, the length of the tube 107 is 155mm.
[0056] The tube 107 may have an outer diameter ranging from 1.5mm to 2.5mm. The tube 107 may have an inner diameter ranging from 1mm to 1.5mm. In an embodiment, the outer diameter and the inner diameter of the tube 107 is 2mm and 1.3mm respectively. The tube 107 includes a proximal end 107a and a distal end 107b. The proximal end 107a of the tube 107 is attached to the luer hub 109 (as shown in FIG. 2b). The distal end 107b is attached to the catheter assembly 200 (described below in detail).
[0057] The tube 107 helps to keep an inner shaft and an inner tube of the catheter assembly 200 in a static condition with respect to an outer sheath of the catheter assembly 200. The tube 107 also provides support to the outer sheath during its longitudinal movement for deployment of the device 1 at a treatment site.
[0058] The luer hub 109 may be disposed within a proximal cavity 105d of the back cover 105. The proximal cavity 105d of the back cover 105 may provide a snug fit to the luer hub 109. The luer hub 109 may have a length ranging from 20mm to 50mm. In an embodiment, the length of the luer hub 109 is 30mm. The luer hub 109 enables insertion of a guide wire and helps to flush contrast media.
[0059] The luer hub 109 may have a proximal end 109a and a distal end 109b. The proximal end 109a of the luer hub 109 may protrude outward from the proximal end 100a of the handle assembly 100. The proximal end 109a of the luer hub 109 enables the delivery system 10 to travel over a guide wire to reach the treatment site as well as enable a physician to inject contrast media for fluoroscopy purposes. The distal end 109b of the luer hub 109 may be connected with the proximal end 107a of the tube 107 with the help of any conventional procedure, say, adhesive bonding procedure.
[0060] The sheath driver 111 may be placed over the tube 107. The sheath driver 111 may be made of a material including but not limited to acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyamide (nylon), glass filled polyamide, epoxy resins etc. In an embodiment, the sheath driver 111 is made of ABS. The sheath driver 111 may have a hollow tube-like structure. The sheath driver 111 may have a length ranging from 40mm to 80mm. The sheath driver 111 may have a diameter ranging from 5mm to 15mm. In an embodiment, the length and diameter of the sheath driver 111 is 60mm and 8mm respectively.
[0061] The sheath driver 111 may include an outer surface. The outer surface of the sheath driver 111 may include a pair of oppositely disposed flat portions 111a and a pair of curved portions 111b. The flat portions 111a and the curved portions 111b may be alternately disposed as clearly shown in FIG. 2c. The flat portions 111a of the sheath driver 111 helps to restrict rotary motion of the sheath driver 111 and allows the longitudinal motion of the sheath driver 111 only due to the rotation of the roller 103.
[0062] The pair of flat portions 111a of the sheath driver 111 may slide over a pair of inner slabs 105e disposed within the back cover 105. The pair of inner slab 105e provides support for smooth longitudinal motion of the sheath driver 111 within the handle assembly 100.
[0063] The curved portions 111b of the sheath driver 111 may be threaded. The curved portions 111b have a uniform pitch ranging from 1.0mm to 3.0mm. In an embodiment, the pitch of the threads of the sheath driver 111 is 1.8mm. The threads of the sheath driver 111 may complement an inner thread of the roller 103 disposed at an inner surface of the roller 103. The aforesaid feature allows operative coupling between the roller 103 and the sheath driver 111 which further leads towards controlled, smooth and effective deployment of the device 1 at the treatment site.
[0064] The sheath driver 111 is rotatably coupled to the roller 103. The sheath driver 111 may have a longitudinal motion translated by the rotation of the roller 103. In an embodiment, the roller 103 is rotated clockwise to move the sheath driver 111 longitudinally backward resulting in deployment of the device 1.
[0065] The outer surface of the sheath driver 111 of the handle assembly 100 may have a pair of slots 111c at a distal end. In an embodiment, the slots 111c may be L-shaped. The slot 111c may include a first portion c1 and a second portion c2. The first portion c1 may be disposed along a longitudinal axis of the handle assembly 100 and the second portion c2 may be disposed perpendicular to the longitudinal axis. The pair of slot 111c may be provided on the pair of oppositely disposed flat portions 111a such that each flat portion 111a includes a mirror image of the slot 111c with respect to the other flat portion 111a as shown in FIG. 2c.The dimensions of the slot 111c may be dependent upon the dimension of the lever 113. The first portion c1 of the slot 111c may have a length ranging from 10mm to 20mm. The second portion c2 of the slot 111c may have a length ranging from 2mm to 8mm. In an embodiment, the length of the first portion c1 and the second portion c2 of the slot 111c is 15mm and 5mm respectively.
[0066] FIG. 2d illustrates an exemplary lever 113 of the present invention. The lever 113 may be housed within the sheath driver 111. The lever 113 may further include a first unit 113a, a second unit 113b and a third unit 113c. The first unit 113a may have a ring like structure and disposed between the second unit 113b and the third unit 113c. The first unit 113a may be coupled to the catheter assembly 200.
[0067] The second unit 113b and the third unit 113c may slide across the pair of slots 111c of the sheath driver 111 as shown in FIG. 2e. The third unit 113c of the lever 113 may protrude out of the elongated slot 101c of the cap 101 to enable a physician slide the lever 113.
[0068] As shown in Fig. 2e, the lever 113 may be disposed across the slots 111c such that the lever 113 may have a free state and a locked state. The free state of the lever 113 may correspond to a state when the lever 113 is capable of free movement across a length of the first portion of the slot 111c. In locked state of the lever 113, the lever 113 is operatively engaged within the second portion c2 of the slot 111c and is incapable of any movement with respect to the sheath driver 111. The lock state of the lever 113 restricts longitudinal movement of the lever 113 while deploying the device 1 at the treatment site. Post deployment of the device 1, the lever 113 may be disengaged from its locked state to its free state and pushed in a longitudinally forward direction along the length of the first portion of the slot 111c resulting in forward movement of the outer sheath of the catheter assembly 200 to enclose the inner shaft of the catheter assembly 200.
[0069] In the presence of the lever 113, the rotation of the roller 103 of the handle assembly 100 may be limited to only one direction to enable controlled deployment of the device 1. In an embodiment, the roller 103 is rotated clockwise to move the sheath driver 111 longitudinally backward resulting in deployment of the device 1.
[0070] Fig. 3 and 3a illustrates the catheter assembly 200 of the delivery device 10. The catheter assembly 200 may extend from the distal end 100b of the handle assembly 100. The catheter system 200 may include an outer sheath 201, an inner shaft 203, and an inner tube 205.
[0071] The outer sheath 201 may be the outermost component of the catheter assembly 200. The outer sheath 201 may be made of a material including but not limited to PEBAX, nylon, PTFE, nitinol, stainless steel, etc. The outer sheath 201 may have a size ranging from 10F to 14F. The size of the outer sheath 201 may depend upon the size of the device 1 and the anatomy of the heart. The outer sheath 201 may have a length ranging from 800mm to 1500mm. In an embodiment, the length of the outer sheath 201 is 1200mm. The outer sheath 201 may have a flexibility to pass through complex lumens and reach the treatment site.
[0072] The outer sheath 201 may have a distal end 201a and a proximal end 201b. The distal end 201a of the outer sheath 201 may include one or more radiopaque markers. The radiopaque marker may be made of a material including but not limited to barium sulfate, bismuth, tungsten, etc. In an embodiment, the radiopaque marker is made of bismuth. The radiopaque marker helps the physician to track and position the device 1 at the treatment site under fluoroscopy.
[0073] The proximal end 201b of the outer sheath 201 may firmly be attached/coupled to the first unit 113a of the lever 113 (as shown in FIG. 3b). Post attaching the outer sheath 201 with the lever 113, the outer sheath 201 and the lever 113 may be disposed within the sheath driver 111 such that the lever 113 may have a longitudinal motion along the slot 111c of the sheath driver 111 (as shown in FIG. 3c). Such attachment of the outer sheath 201 with the sheath driver 111 helps in the forward movement of the outer sheath 201 to enclose the inner shaft 203 and the inner tube 205 with the help of the lever 113.
[0074] The outer sheath 201 may have a longitudinal motion corresponding to the movement of the sheath driver 111 caused by the rotation of the roller 103 when the lever 113 may be in the locked state. The outer sheath 201 may have a longitudinal motion corresponding to the sliding of the lever 113 alone (i.e., disregarding any longitudinal movement of the sheath driver 111) along the length of the first portion c1 of the slot 111c of the sheath driver 111 when the lever 113 may be in the free state. The attachment of the outer sheath 201 to the lever 113 may enable quick forward movement of the outer sheath 201 to enclose the inner shaft 203 and inner tube 205 by sliding the lever 113 along the length of the first portion c1 of the slot 111c of the sheath driver 111 post deployment of the device 1.
[0075] The inner shaft 203 may reside within the outer sheath 201 i.e the outer sheath 201 is mounted over the inner shaft 203. The inner shaft 203 may be made of a material including but not limited to PEBAX, PTFE, and PEEK. In an embodiment, the inner shaft 203 is made of PEBAX for better lubricity and strength. The inner shaft 203 may have a length ranging from 1000mm to 1700mm. The inner shaft 203 may have a diameter ranging from 1.5mm to 3mm. In an embodiment, the length and diameter of the inner shaft 203 are 1500mm and 2.7mm respectively.
[0076] The inner shaft 203 may include a distal end 203a and a proximal end (not shown). The proximal end (not shown) of the inner shaft 203 may be connected to the outer diameter of the tube 107 by any conventional technique. The inner shaft 203 may be stationary.
[0077] The inner shaft 203 may include a groove 203b at its distal end 203a. The groove 203b may have a length ranging from 10mm to 50mm. The groove 203b may have a diameter ranging from 1.5mm to 3.0mm. In an embodiment, the length and the diameter of the groove 203b are 28mm and 2mm respectively. The groove 203b accommodates the device 1 in a crimped state between the inner shaft 203 and the outer sheath 201.
[0078] The groove 203b may also act as a pusher to deploy the device 1 in uniform, smooth and controlled manner by reducing jerking effect of the device 1 during deployment (shown in Fig. 4a). The groove 203b further helps to maintain structural integrity and avoids over-lapping of struts of the device 1.
[0079] The inner tube 205 may reside within the inner shaft 203. The inner tube 205 may be made of a material including but not limited to PEEK, PEBAX, and PTFE. In an embodiment, the inner tube 205 is made of PEEK for sufficient lubricity and strength. The inner tube 205 may have a length ranging from 1100mm to 1800mm. The inner tube 205 may have an outer diameter ranging from 1.0mm to 2.0mm, preferably from 1.2mm to 1.8mm. In an embodiment, the length and the outer diameter of the inner tube 205 is 1600mm and 1.6mm respectively.
[0080] The inner tube 205 may have a distal end 205a and a proximal end 205b. The proximal end 205b of the inner tube 205 may be connected to the inner diameter of the tube 107 by any conventional technique known in the art like adhesive bonding technique.
[0081] The inner tube 205 may have a soft tip 206 disposed at the distal end 205a. The soft tip 206 may prevent trauma to the vasculature while navigating the device 1 to the treatment site. The inner lumen 230 helps the delivery system 10 to travel over a guide wire to reach the treatment site and also provide a passageway for contrast media to be injected by a physician for fluoroscopy purposes.
[0082] The device 1 may be disposed in a crimped state over the inner shaft 203 of the delivery device 10. The device 1 may be crimped and loaded via a pre-defined apparatus (described below in detail). The pre-defined apparatus may be a screw jack loader 300, or a slidable funnel loader 500 (described below in detail). The apparatus enables uniform and smooth loading of the device 1 without affecting the assembly of the delivery device 10.
[0083] The device 1 may have a length ranging from 6mm to 12mm. The device 1 may have an inner diameter ranging from 6mm to 9mm. The device 1 may have an outer diameter ranging from 15mm to 21mm. In an embodiment, the length, the inner diameter and the outer diameter of the device 1 is 10mm, 8mm, and 20mm respectively. The device 1 in the crimped state may have a diameter ranging from 2.0mm to 3.5mm. In an embodiment, the diameter of the device 1 in the crimped state is 2.8mm. The device 1 may include a flat end and a curved end. The flat end of the device 1 may be disposed distal to curved end of the device 1 in a crimped state on the inner shaft 203.
[0084] Fig. 4 depicts a method 20 to deploy the device 1 using the delivery device 10 at the treatment site. At step 20a, an atrial septal wall may be punctured using a trans-septal needle kit. The trans-septal needle kit may have a size ranging from 6F to 8.5F. In an embodiment, the trans-septal needle kit is 8F in size. Post-puncturing the atrial septal wall, the delivery device 10 may be inserted over a guide wire to deploy the device at the treatment site.
[0085] At step 20c, a guide wire may be passed through the trans-septal needle.
[0086] At step 20e, the trans-septal needle may be retracted from the treatment site.
[0087] At step 20g, the delivery device 10 may be navigated with the loaded device 1 over the guide wire to the treatment site. The device 1 may be loaded over the delivery device 10 using the apparatus.
[0088] At step 20i, the roller 103 may be rotated in a clockwise direction to move the outer sheath 201 longitudinally back resulting in smooth and controlled deployment of the device 1 at the treatment site.
[0089] At step 20k, the outer sheath 201 is moved forward to completely enclose the inner shaft 202 and inner tube 203. In an embodiment, the lever 113 is moved from the locked state to a free state and pushed forward along the length of the first portion c1 of the slot 111c of the sheath driver 111 resulting in quick and smooth movement of the outer sheath 201. In another embodiment, the roller 103 is rotated in an anti-clockwise direction to move the outer sheath 201 longitudinally forward resulting in retraction of the inner shaft 202 and inner tube 203.
[0090] At step 20m, the delivery device 10 and the guide wire may be retracted from the treatment site.
[0091] FIG. 5 illustrates the screw jack loader 300 which helps in loading the device 1 within the catheter assembly 200. The screw jack loader 300 may be formed by assembling a plurality of components such as a plurality of travel shafts 301, a plurality of rollers 302, a plurality of secure pins 303, and a plurality of plates. In the depicted embodiment, the plurality of plates include a first plate 304, a second plate 305 and a third plate 306. The first, second and third plates 304, 305, 306 are mounted along a length of the travel shafts 301.
[0092] The present invention may include at least two travel shafts 301. The travel shafts 301 may provide a travel path for linear movement of the first plate 304. The travel shafts 301 may include a conventional shape. In an embodiment as shown in FIG. 5, the travel shafts 301 have a tube-like structure.
[0093] As an exemplary embodiment, the travel shafts 301 may include a threaded region 301a and a non-threaded region 301b. The threaded region 301a of the travel shaft 301 may have a length ranging from 30mm to 60mm. In an embodiment, the length of the threaded region 301a of the travel shaft 301 is 45mm. The threaded region 301a may enable a controlled movement of the first plate 304 over the travel shafts 301.
[0094] The non-threaded region 301b of the travel shaft 301 may be smooth. Alternately, the non-threaded region 301b may be non-uniform and includes a plurality of projections 301c. The projections 301c may be axially disposed as shown in FIG. 5. The projections 301c may help to secure and prevent rotational movement of the travel shafts 301 while loading the device 1.
[0095] The roller 302 may enable controlled linear movement of the first plate 304 over the travel shafts 301. The roller 302 may have any shape such that it complements the tube-like structure of the travel shafts 301. In an embodiment, the roller 302 has a ring-like shape. An inner surface of the roller 302 may have a plurality of threads. The threads of the roller 302 may be complimentary to the threaded region 301a of the travel shaft 301.
[0096] The first plate 304 helps to hold the device 1 at the time of crimping. The first plate 304 may include a top surface 304a1 and a bottom surface 304a2. In an exemplary embodiment depicted in FIG. 5, the top surface 304a1 includes a curved portion a1 while the bottom surface 304a2 is flat. The curved portion a1 may be dipped inwardly to receive the curved end of the device 1.
[0097] The first plate 304 may include a central slit having an aperture a1’ to hold the device 1. The aperture a1’ may extend from the top surface 304a1 to the bottom surface 304a2.
[0098] The first plate 304 may include at least two passages 304b. The passages 304b may longitudinally extend from the top surface 304a1 to the bottom surface 304a2 of the first plate 304. The passages 304b may allow the entry of the travel shafts 301. The passages 304b of the first plate 304 may have a diameter corresponding to the travel shaft 301.
[0099] The first plate 304 may have a cavity 304c disposed between the top and the bottom surfaces 304a1, 304a2. The cavity 304c may be laterally disposed to house the roller 302. The cavity 304c of the first plate 304 may have a depth corresponding to the width of the roller 302 such that the roller 302 may protrude out of the cavity 304c. In an embodiment, the cavity 304c may be so disposed that the cavity 304c perpendicularly intersects with the passage 304b.
[00100] The second plate 305 may be disposed below the first plate 304 and mounted over the third plate 306. The second plate 305 may be secured to the third plate 306 via a securing means. In an embodiment, the securing means includes secure pins 303 as shown in FIG. 5.
[00101] The second plate 305 enables fixing of the flat end of the device 1 at the time of crimping. The second plate 305 may include a top surface 305a1 and a bottom surface 305a2. As shown in FIG. 5, the top surface 305a1 may be flat while the bottom surface 305a2 may include a curved portion b2. The curved portion b2 may hold the flat end of the device 1.
[00102] The second plate 305 may include a central slit having an aperture b2’ to hold the device 1. The aperture b2’ may extend from the top surface 305a1 to the bottom surface 305a2.
[00103] The third plate 306 may provide a firm platform for the assembly and operation of the screw jack loader 300. The third plate 306 may have a plurality of sockets 306a. The sockets 306a may have a diameter and a length to secure the non-threaded region 301b of the travel shafts 301. In an embodiment, the third plate 306 has two sockets 306a. The sockets 306a may be shaped to accommodate the projection 301c of the travel shaft 301. Such an arrangement helps to limit any rotational motion of the travel shaft 301.
[00104] The third plate 306 may be an integral unit or include a plurality of units. In an embodiment as depicted in FIG. 5, the third plate 306 is made up of two symmetrical units.
[00105] The above disclosed first plate 304, second plate 305 and the third plate 306 may have any three dimensional shape known in the art. In an embodiment, the first plate 304, second plate 305 and the third plate 306 are cuboidal shape.
[00106] FIG. 6 and 6a-d illustrates the method 400 to crimp/load the device 1 using the screw jack loader 300. At step 401, the flat end of the device 1 is secured to the second plate 305 and the curved end of the device 1 to the first plate 304 (Fig. 6a) through their respective central aperture a1’, b2’.
[00107] At step 403, the first plate 304 is moved away from the second plate 305 by rotating the roller 302 in order to crimp the curved end of the device 1 (Fig. 6b and 6c). The movement of the first plate 304 is mediated by rotating the roller 302. In an embodiment, the roller 302 is rotated in a clockwise direction to allow movement of the first plate 304 away from the second plate 305. Alternately, movement of the roller 302 in anti-clockwise direction allows movement of the first plate 304 away from the second plate 305.
[00108] At step 405, the first plate 304 is further moved away from the second plate 305 till an end of the threaded region 301a of the travel shaft 301. Once the first plate 304 reaches the end of the threaded region 301a, the device 1 is fully crimped. The movement of the first plate 304 allows crimping of the flat as well as curved end of the device 1 as shown in Fig. 6d of the present invention.
[00109] At step 407, the crimped device 1 obtained at the previous step is loaded within the outer sheath 201. The flat end of the device 1 is pushed with a pusher rod for loading the device 1. The loading of the device 1 via the present invention does not affect the structural integrity of the crimped device 1.
[00110] Fig. 7 illustrates the slidable funnel loader 500. The slidable funnel loader 500 may include a plurality of distinct components. Alternately, the slidable funnel loader 500 may have an integrated structure. In an embodiment, the slidable funnel loader 500 includes a plurality of tubes and rods. As depicted in FIG. 7, the slidable funnel loader 500 includes a first tube 501, a second tube 502, a third tube 503, a first rod 504 and a pusher rod 505. The said components of the loader 500 may operate independent of each other to finally crimp as well as load the device 1.
[00111] The first tube 501 allows gradual lowering of the crimp profile of the device 1 after which it may be loaded within the catheter assembly 200. The first tube 501 may have provisions to connect the distal end 201a of the outer sheath 201 at the time of loading the device 1 over the delivery device 10.
[00112] The first tube 501 may have a length ranging from 35mm to 45mm. The first tube 501 may have an inner diameter ranging from 2mm to 4mm. In an embodiment the length and inner diameter of the first tube 501 is 40mm and 3mm respectively. The first tube 501 may have provisions for attachment of catheter assembly 200 of the delivery system 10. In an embodiment, the provision for attaching the first tube 501 with the catheter assembly 200 includes an inner diameter at one of an end of the first tube 501 which corresponds to the outer diameter of the outer sheath 201. The provision for attaching the first tube 501 with the catheter assembly 200 helps facilitate smooth pushing of the device 1 from within the first tube 501 to the outer sheath 201.
[00113] The second tube 502 may help to crimp the curved end of the device 1. The second tube 502 may have a length smaller than the first tube 501. The length of the second tube 502 may range from 20mm to 30mm. The second tube 502 may have an inner diameter larger than the first tube 501. The inner diameter of the second tube 502 may range from 6mm to 8mm. In an embodiment the length and inner diameter of the second tube 502 is 25mm and 7mm respectively.
[00114] The third tube 503 may help to crimp and hold the flat end of the device 1. The third tube 503 may have a length ranging from 35mm to 45mm. In an embodiment the length of the third tube 503 is 40mm. The third tube 503 may have a tapered inner diameter along its entire length. The third tube 503 may have a first end 503a and a second end 503b. The third tube 503 may have an inner diameter at the first end 503a ranging from 3.5mm to 4mm. The third tube 503 may have an inner diameter at the second end 503b ranging from 2.8mm to 3mm. In an embodiment, the inner diameter at the first end 503a and at the second end 503b of the third tube 503 is 3.8mm and 2.9mm respectively.
[00115] The second end 503b of the third tube 503 may connect with the first tube 501 with the help of any conventional means. In an embodiment, the second end 503b of the third tube 503 is connected with the first tube 501 through corresponding interlocking projections on the third tube 503 and the first tube 501.
[00116] The first rod 504 may help to hold and fix the position of the device 1 at the time of loading/crimping. The first rod 504 may also help to push the device 1 within the third tube 503. The first rod 504 may have a length ranging from 50mm to 70mm. In an embodiment the length of the first rod 504 is 65mm. The first rod 504 may be tapered and includes a first end 504a, a second end 504b and a third end 504c. The first rod 504 may have a diameter at the first end 504a ranging from 3mm to 4mm. The first rod 504 may have a diameter at the second end 504b ranging from 2mm to 3mm. The third end 504c may be disposed between the first end 504a and the second end 504b of the first rod 504. The third end 504c of the first rod 504 may have a diameter same as the second end 504b of the first rod 504.In an embodiment, the diameter at the first end 504a and at the second end 504b of the first rod 504 is 2.4mm and 3mm respectively.
[00117] The pusher rod 505 may help push the device 1 from the slidable funnel loader 500 to the catheter assembly 200. The pusher rod 505 may have a length ranging from 50mm to 70mm. The pusher rod 505 may have a diameter ranging from 2mm to 4mm. In an embodiment, the length and diameter of the pusher rod 505 is 65mm and 2.9mm respectively.
[00118] Fig. 8 and 8a-e illustrates a method 600 to load the device 1 using the slidable funnel loader 500 as described above. At step 601, the flat end of the device 1 may be crimped via application of uniform radial pressure and inserted into the third tube 503 (shown in Fig. 8a). In an embodiment, the flat end of the device 1 is manually crimped and thereafter the device 1 is inserted within the third tube 503. The flat end of the device 1 is fixed at the first end 503a of the third tube 503. At this stage, the device 1 may be locked at its crimping position to prevent migration of the device 1 during further process of crimping and loading. The device 1 may be locked within the third tube 503 with the help of the first rod 504. The first rod 504 is inserted via a central cavity of the device 1 into the third tube 503.
[00119] At step 603, the curved end of the device 1 is crimped. The crimping of the curved end of the device 1 is mediated via the second tube 502. The second tube 502 is slid over the third tube 503 and the curved end of the device 1 as shown in Figs. 8b-8c. The second tube 502 gradually lowers the crimp profile of the device 1.The first rod 504 further lowers the crimp profile of the device 1 within the third tube 503.
[00120] At step 605, once the flat end as well as the curved end of the device 1 are fully crimped, the second end 503b of the third tube 503 and the first tube 501 are coupled to each other (as shown in FIG. 8d). Such a coupling mediates the loading of the crimped device 1 over the delivery device. Further, at this moment, the first rod 504 is replaced with the pusher rod 505. Post attachment, the device 1 may be pushed (shown in Fig. 8d and 8e) within the outer sheath 201 using the pusher rod 505. The first tube 501 and the outer sheath 201 may be aligned concentrically for smooth and easy loading of the device 1.
[00121] At step 607, when the crimped device 1 is completely mounted within the outer sheath 201, the components of the slidable funnel loader are detached from the outer sheath 201.
[00122] In an embodiment, the delivery device 10 is assembled before deploying the device 1 at the treatment site. In an alternate embodiment, the delivery device 10 is provided pre-assembled along with the loaded device 1.
[00123] Fig. 9 illustrates the method 700 to assemble the delivery device 10. At step 701 may include loading the device 1 into the outer sheath 201 with the help of any one of the above described loaders.
[00124] At step 703, the inner shaft 203 may be inserted inside the outer sheath 201 without affecting the crimped state of the loaded device 1. The loaded device 1 may rest on the groove 203b of the inner shaft 203. Thereafter, the inner tube 205 may be inserted within the inner shaft 203.
[00125] At step 705, the outer sheath 201 may be attached with the lever 113 and further with the sheath driver 111, the inner tube 205 with the inner diameter of the Tube 107 and the inner shaft 203 with the outer diameter of the tube 107.
[00126] At step 707, the sheath driver 111 may be assembled with the roller 103 by matching their respective threads and the inner slab 105e of the back cover 105. Thereafter, the luer hub 109 may be attached with the tube 107. Further, the luer hub 109 may be placed within the proximal cavity 105d of the back cover 105. Post assembly of the delivery device 10, the delivery device 10 may be ready to deploy the device 1 at the treatment site.
[00127] The present invention may be supported by the following example:
[00128] Example 1: The device 1 was loaded into the outer sheath by using a conventional funnel loader. The funnel loader included uniform diameter only. Due to the complex shape of the device 1, its flat distal end was crimped manually and inserted into the funnel and the device 1 was pushed towards the catheter. During loading of the device 1 into funnel, it was observed that the struts of the device 1 overlapped over each other thereby affecting the structural integrity of the device during deployment. Further, the loading of the device 1 inside 10F catheter was found to be improper.
[00129] Example 2: The slidable funnel loader of the present invention was used to load the device 1 within the outer sheath. The slidable funnel loader included a tapered inner cavity which resulted in gradual decrease of the diameter of the device 1 and helped to provide uniform lower crimping profile without affecting the structural integrity of the device 1. The slidable funnel loader was found to be very handy and easy to operate while loading the device 1 into a 10F outer sheath. The loaded device was then deployed at an in-vitro simulated heart model with smooth and uniform deployment without affecting structural integrity of the device.
[00130] Example 3: A screw jack loader of the present invention was used to crimp and load the device into outer sheath. The screw jack loader helped to provide uniform lower crimping profile of the device 1 without affecting the structural integrity of the device 1. The screw jack loader was found to be very handy and easy to operate while loading the device 1 into a 10F outer sheath.
[00131] Example 4 (Prior art): A delivery system having a sliding mechanism included an outer sheath, inner shaft and inner lumen. The device was directly loaded over the inner lumen of the delivery system. Due to the device being loaded over the inner lumen, the crimping profile of the device was high resulting in requirement of a higher french outer sheath of around 14F. However, the device was force loaded in a lower french catheter which resulted in non-uniform loading of the device meaning strut overlapping which lead to uneven deployment of device. Moreover, deployment of the device with sliding mechanism was performed by push/pull switch. Such an arrangement lead to unintentional pre-deployment of the device thereby generating sudden jerk induced at curved end of the device during deployment process resulting in improper implantation at an in-vitro simulated heart model.
[00132] Example 5: The delivery system of the present invention including the rolling and sliding mechanism was used. The inner shaft with a groove, maintained the structural integrity of the device in a lower crimping profile without any strut overlapping as well as enabled loading of the device into a low french catheter. The groove accommodated the device to be deployed and acted as a pusher which helped in effortless and uniform deployment of the device at the treatment site. The implantable device was mounted over the delivery system of the present invention via a pre-defined apparatus. Due to the use of low french catheter, a small opening for insertion of the delivery system was required. Further, the low profile catheter had higher flexibility to reach at the device deployment site through uneven or complex paths and provided effortless performance to an operator while deploying the device. Further, the roller mechanism of the delivery system ensured uniform, controlled and smooth deployment of the device inside an in-vitro simulated heart model. The sliding mechanism ensured quick and smooth retraction of the delivery system post deployment of device which helps to minimize the overall procedural time.
[00133] 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.