Claims:WE CLAIM
1. A delivery system for a medical device, the delivery system comprising:
a capture member for loading a medical device;
an outer sheath including a proximal end, a distal end and a lumen, the outer sheath including a first switch at its proximal end;
an outer shaft including a proximal end, a distal end and a lumen, the outer shaft is slidably placed inside the lumen of the outer sheath, the distal end of the outer shaft is coupled to the capture member, the outer shaft including a second switch at its proximal end;
an inner shaft including a proximal end, a distal end and a lumen, the inner shaft is slidably placed inside the lumen of the outer shaft, the inner shaft including a bumper, a pusher towards its proximal end, the inner shaft including a third switch at its proximal end; and
an inner lumen including a lumen, the inner lumen is slidably placed inside the lumen of the inner shaft;
wherein the outer sheath, the outer shaft, the inner shaft and the inner lumen are coaxially placed;
wherein the outer sheath, the outer shaft, the inner shaft and the inner lumen are slidably coupled with respect to each other; and
wherein the first switch, the second switch and the third switch trigger movement of the outer sheath, the outer shaft, and the inner shaft respectively.
2. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the delivery system includes a handle assembly.
3. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the outer sheath includes an inner layer, a braided layer and an outer layer.
4. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the capture member includes a hopper.
5. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the capture member is permanently coupled to the distal end of the outer shaft.
6. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the inner shaft includes at least three markers.
7. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the distal end of the inner shaft is coupled to an atraumatic tip.
8. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the inner lumen includes a guide wire inside the lumen.
9. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the bumper of the inner shaft holds the medical device between the outer sheath and the inner shaft.
10. The delivery system for the biodegradable medical device as claimed in claim 1 wherein the pusher of the inner shaft detaches the medical device from the capture member.
11. A method of loading a medical device in a delivery system, the method comprising:
a. sliding a third switch towards a proximal end of a handle in order to trigger movement of an inner shaft;
b. locking a second switch and the third switch with the help of a slider lock in order to maintain a distance between the second and the third switch;
c. sliding the second switch towards the proximal end of the handle in order to encapsulate a capture member into an outer sheath;
d. placing a funnel over the outer sheath;
e. radially compressing a medical device with the funnel;
f. sliding the second switch and the third switch towards the proximal end of the handle in order to release the capture member from the outer sheath;
g. placing the medical device inside the capture member;
h. sliding the second switch and the third switch towards the proximal end of the handle in order to fully capture the medical device in the outer sheath; and
i. sliding the second switch towards the proximal end of the handle in order to detach the medical device from the capture member.
12. The method of loading a medical device in a delivery system wherein the sliding the third switch includes manual sliding.
13. The method of loading a medical device in a delivery system wherein the sliding the second switch includes manual sliding.
14. The method of loading a medical device in a delivery system wherein the capture member is compressible.
15. The method of loading a medical device in a delivery system wherein the compressing the medical device comprises 40-90% of compression of the medical device. , 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 LOADING AND DEPLOYMENT OF A MEDICAL DEVICE

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

3. The following specification particularly describes the invention and the manner in which it is to be performed:
FIELD OF INVENTION
[1] The present invention relates to a delivery system for loading and delivery of a medical device, more specifically relates to a system for loading and delivery of the medical device made of a biodegradable material.
BACKGROUND
[2] An intraluminary prosthesis, for example, a medical device which is used for treatment of diseases in various body vessels to open and/or reinforce collapsed or partially occluded sections of a lumen.
[3] Medical devices may be formed of metallic, polymeric or biodegradable materials. In order to treat the diseased vessel, the medical device may be inserted and/or deployed using a delivery system in the blocked passageway of blood vessels (or treatment site). Generally, the metallic medical devices are preloaded on the delivery system in a crimped state and may be deployed at the treatment site as and when required.
[4] However, the biodegradable medical devices when preloaded on the delivery system in a crimped state for a considerably longer period of time under constant pressure may undergo plastic or permanent deformation. Therefore, the aforementioned delivery system is not efficient for the biodegradable medical devices. In order to avoid deformation of the biodegradable medical device, as per a known conventional method, the medical device is loaded in a sheath during assembly of the delivery system in order to make it ready for deployment. In another conventional delivery method, the biodegradable medical device is provided in an expanded state with the delivery system and may be loaded inside the delivery system just before deployment in the body.
[5] However, the loading of the biodegradable medical device using the conventional delivery method may require numerous steps and use of various components which might make the process of loading the medical device complex and cumbersome. Further, the conventional delivery systems for biodegradable medical devices pose increased risk of malfunction and reduced deployment accuracy of the medical devices. Therefore, there remains a need in the art for an improved delivery system.
SUMMARY
The present invention discloses a delivery system for loading and/or deployment of a medical device. The delivery system includes a capture member for loading a medical device, an outer sheath including a proximal end, a distal end and a lumen. Further, the outer sheath includes a first switch at its proximal end. An outer shaft including a proximal end, a distal end and a lumen, the outer shaft is slidably placed inside the lumen of the outer sheath, the distal end of the outer shaft is coupled to the capture member. Further, the outer shaft includes a second switch at its proximal end. An inner shaft including a proximal end, a distal end and a lumen, the inner shaft is slidably placed inside the lumen of the outer shaft, the inner shaft including a bumper, a pusher towards its proximal end. Further, the inner shaft including a third switch at its proximal end. An inner lumen including a lumen, the inner lumen is slidably placed inside the lumen of the inner shaft. The outer sheath, the outer shaft, the inner shaft and the inner lumen are coaxially placed and are slidably coupled with respect to each other. The first switch, the second switch and the third switch trigger movement of the outer sheath, the outer shaft, and the inner shaft respectively.

BRIEF DESCRIPTION OF DRAWINGS
The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended 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.
[6] FIG. 1 illustrates a delivery system in accordance with an embodiment of the present invention.
[7] FIG. 2 illustrates a cross-sectional view of a tubular assembly of the delivery system in accordance with an embodiment of the present invention.
[8] FIG. 3 illustrates a cross-sectional view of an outer sheath of the delivery system in accordance with an embodiment of the present invention.
[9] FIG. 4 illustrates a front view of a capture member of the delivery system in accordance with an embodiment of the present invention.
[10] FIG. 5 illustrates a front view of an inner shaft in accordance of the delivery system in accordance with an embodiment of the present invention.
[11] FIG. 6 illustrates a front view of a handle of the delivery system in accordance with an embodiment of the present invention.
[12] FIG. 7 illustrates a cross-sectional view of attachment of a tubular assembly and switches in accordance with an embodiment of the present invention.
[13] FIG.8 illustrates a flow chart for a process involved in loading of a medical device into the delivery system in accordance with an embodiment of the present invention.
[14] FIG.9 illustrates a front view of a funnel in accordance with an embodiment of the present invention.
[15] FIG.10 illustrates a front view of a medical device placed on a capture member of the delivery system in accordance with an embodiment of the present invention.
[16] FIG.11 illustrates a cross-sectional view of a medical device loaded into the delivery system in accordance with an embodiment of the present invention.
[17] FIG.12 illustrates a cross-sectional view of a medical device detached from a capture member in accordance with an embodiment of the present invention.
[18] FIG. 13 illustrates a flow chart for a process involved in deployment of a medical device in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF DRAWINGS
[19] 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, 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.
[20] Wherever possible, same reference numbers will be used throughout the drawings to refer to same or like parts. Moreover, references to various elements described herein are made collectively or individually when there may be more than one element of the same type. However, such references are merely exemplary in nature. It may be noted that any reference to elements in the singular may also be construed to relate to the plural and vice-versa without limiting the scope of the disclosure to the exact number or type of such elements unless set forth explicitly in the appended claims.
[21] 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 merely 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. In the present description and claims, the term proximal end refers to an end of an element that is closer to a user while the distal end refers to an end of the element which is farther from the user.
[22] The present invention discloses a delivery system for loading and/or deployment of a medical device. The delivery system may be used for the medical device made of biodegradable material. In various embodiments, the delivery system is used for loading and/or deployment of occlusion device, vena cava filter, non-vascular stents such as biliary, tracheal, esophageal stent. In an embodiment, the medical device is a self-expandable stent. The self-expandable stent of the present invention is made of a biodegradable polymer. The biodegradable polymer may include without limitation poly L- lactic Acid (PLLA), polyglycolic Acid (PGA), poly-l-lactide co-glycolide (PLGA), poly glycolic co-caprolactone (PGCL), poly L-lactide co-?-caprolactone (PLCL), polydioxanone (PDO) etc. In an embodiment, the medical device is made of poly-l-lactide co-glycolide (PLGA).
[23] In an embodiment, the delivery system includes four tubes co-axially placed with respect to each other. The tubes may include an inner lumen, an inner shaft, an outer shaft and an outer sheath. The inner lumen is the inner most tube while the outer sheath is the outer most tube of the delivery system. Further, the inner shaft may be present over the inner lumen and the outer shaft is disposed over the inner shaft.
[24] Each of the said tubes may be operatively coupled with a switch (three switches in total) to enable sliding of the respective tubes. Further, each of the co-axially placed tubes slide over the adjacently placed tube to facilitate loading and/or deployment of the medical device in an arterial lumen of the body. Further, the delivery system is provided with a capture member for holding and/or compressing the medical device for a predefined period of time.
[25] The delivery system of the present invention is a single unit which provides quick and hassle-free loading and/or deployment of the medical device. Further, the delivery system facilitates smooth and/or accurate deployment of the medical device without affecting structural integrity, coating integrity and/or elasticity of the medical device.
[26] Now referring specifically to drawings, FIG. 1 illustrates a front view of the delivery system 100. In an embodiment, the delivery system 100 includes a tubular assembly 200 and a handle 300.
[27] The tubular assembly 200 includes a distal end 201 and a proximal end 203. As represented in FIG. 1, the handle 300 is disposed towards the proximal end 203 of the tubular assembly 200.
[28] The tubular assembly 200 may include a plurality of tubes which are co-axially placed and slide with respect to each other. In an embodiment, the tubular assembly 200 includes four tubes of predefined length. In an exemplary embodiment as depicted in FIG. 2, the tubular assembly 200 includes an outer sheath 10, an outer shaft 20, an inner shaft 30 and an inner lumen 40.
[29] In an embodiment, the outer sheath 10 (as depicted in FIG. 3) is an outer most tube of the tubular assembly 200 of the delivery system 100. The length of the outer sheath 10 is predefined. In an embodiment, the length of the outer sheath 10 may be in a range of 800mm to 1500mm. In another embodiment, an outer diameter of the outer sheath 10 may be in a range of 5Fr to 10Fr, preferably in a range of 6Fr to 9Fr. The outer sheath 10 may act as a holder for the medical device at the time of implantation. In an exemplary embodiment of the present invention, the medical device is loaded and retained inside the outer sheath 10 until the medical device is deployed at the treatment site.
[30] The outer sheath 10 includes a proximal end 11, a distal end 13, and a lumen 15. The lumen 15 extends from the proximal end 11 and the distal end 13 to provide a passage for components like the outer shaft 20. Further, the outer sheath 10 includes an inner layer 12, a braided layer 14 and an outer layer 16. The inner layer 12 may be made of one or more of polymeric material having lubricious property such as without limitation Polytetrafluoroethylene (PTFE), High-density Polyethylene (HDPE), Low-density Polyethylene (LDPE), low friction polymers compounds, etc. In an embodiment, the inner layer is made of PTFE. The inner layer 12 may provide lubricity for smooth deployment of the medical device and/or prevent coating integrity of the medical device. In an embodiment, the wall thickness of the inner layer is in a range of 10µm to 50µm, more preferably in a range of 20µm to 40µm.
[31] The braided layer 14 may be made of shape memory material, for example, without limitation a nitinol wire, a stainless steel wire such as SS 304, SS 316, SS 316L, etc. In an embodiment, the braided layer 14 is made of SS304L. The braided layer 14 may provide flexibility and/or strength to the outer sheath 10. Further, the outer layer/ jacket 16 may be made of polymeric material without limitation nylon, polyether block amide, polyurethane, etc. In an embodiment, the outer layer is made of polyether block amide. The outer layer 16 may fix the braided layer 14 over the inner layer 12 and/or prevent damage to target arteries.
[32] In an embodiment, the outer shaft 20 of the delivery system 100 is provided coaxially inside the outer sheath 10 as depicted in FIG. 2. The outer shaft 20 may slide coaxially inside the outer sheath 10 or vice versa. The length of the outer shaft 20 may be less and/or equal to the outer sheath 10. The length of the outer shaft 20 may be in a range of 850mm to 1600mm. The diameter of the outer shaft 20 may be in a range of 0.5mm to 3mm, preferably in a range of 1mm to 2mm with a wall thickness in a range of 0.2mm to 0.5mm. The outer shaft 20 may facilitate loading of the medical device in the delivery system 100.
[33] The outer shaft 20 may be made of polymeric material. The polymeric material may include without limitation polytetrafluoroethylene (PTFE), polyether block amide, high density polyethylene (HDPE), etc. In an embodiment, the outer shaft 20 is made of polyether block amide with diameter ranges from 0.5mm to 3mm, more preferably from 1mm to 2mm with a wall thickness in a range of 150µm to 250µm.
[34] In an exemplary embodiment, the outer shaft 20 includes a distal end 22, a proximal end 24 and a lumen extending from the distal end 22 and the proximal end 24 to provide a passage for components like the inner shaft 30 as depicted in FIG.2. In order to achieve loading of the medical device, a capture member 50 may be disposed on the distal end 22 of the outer shaft 20 as depicted in FIG. 2. In an embodiment, the capture member 50 is useful for engaging the medical device and compressingly loading the medical device in the delivery system 100.
[35] In an embodiment, the capture member 50 is permanently attached on the distal end 22 of the outer shaft 20. The capture member 50 may be secured on the outer shaft 20 by any means known in the art such as without limitation adhesive bonding, UV bonding, laser bonding, etc. In an embodiment, the capture member 50 is secured by means of UV bonding.
[36] The permanent bonding between the capture member 50 and the outer shaft 20 imparts enough strength and/or eliminates the risk of loosening of the capture member during loading and/or detachment from the capture member 50. The strength of the bond between the outer shaft 20 and the capture member 50 may be tested by tensile strength test. In an embodiment, the bond strength ranges from 10N to 110N, more preferably ranges from 20N to 80N which provides enhanced support for expansion and/or compression of the medical device during the process of loading and/or deployment of the medical device.
[37] As depicted in FIG.4, the capture member 50 may include a basket type structure. In an embodiment, the capture member 50 includes a plurality of intersecting struts 56. The capture member 50 may be made by laser cutting of shape memory material. The shape memory material may include one or more of without limitation nitinol, Co-Cr alloy etc. In an embodiment, the capture member 50 is made of nitinol. Nitinol may impart shape memory property, strength, biocompatibility and/or self-expanding properties to the capture member 50.
[38] In an exemplary embodiment, the capture member 50 includes a distal end 54 and a proximal end 52. As represented, the proximal end 52 diverges outwardly in a proximal direction till the distal end 54 leading to a hopper shape of the capture member 50. The hopper shape of the capture member 50 may impart smooth and effective loading of the medical device into the delivery system 100 without affecting structural integrity and coating of the medical device. Further, the aforesaid shape of the capture member 50 may facilitate uniform crimping of the medical device as well as prevent trapping/locking at open ends of the medical device.
[39] The inclination of the distal end 54 with respect to the proximal end 52 of the capture member 50 may affect the profile of the medical device after radial compression before loading in the delivery system 100. In an embodiment, the angle of inclination between the distal end 54 and the proximal end 52 of the capture member 50 is in a range of 140°to 170°, preferably ranges from 155° to 165°.
[40] The strength of the capture member 50 may depend upon thickness of the struts 56. In an embodiment, the thickness of the strut 56 ranges from 100µm to 200µm. The proximal end 52 may have a diameter equal to and/or larger than the diameter of the outer shaft 20. In an embodiment, the proximal end 52 is narrow with a diameter ranging from 1.5mm to 2.5mm, preferable ranging from 2mm to 2.3mm. In another embodiment, the distal end 54 is a flair end with a diameter ranging from 7mm to 12mm, preferably ranging from 8mm to 10mm. In an embodiment, the distal end 54 is used for securing the medical device in the capture member 50.
[41] In an embodiment, the inner shaft 30 is provided coaxially inside the outer shaft 20 of the delivery system 100. The outer shaft 20 may coaxially slide over the inner shaft 30 or vice versa. The inner shaft 30 may have length greater than the outer shaft 20 and the outer sheath 10. The length of the inner shaft 30 may be in a range of 900mm to 1800mm. The diameter of the inner shaft 30 may be in a range of 0.5mm to 2 mm, preferably in a range of 1mm to 1.5mm. The inner shaft 30 may act as a passage for the medical device to be loaded inside and/or deployed from the delivery system 100.
[42] The inner shaft 30 may be made of a polymeric material. The polymeric material may include without limitation poly-ether ether ketone (PEEK), polyurethane (PU), etc. In an embodiment, the inner shaft is made of poly-ether ether ketone (PEEK). The diameter of the inner shaft 30 may range from 0.5mm to 2 mm, more preferably 1 mm to 1.5 mm.
[43] In an exemplary embodiment, the inner shaft 30 (as depicted in Fig.2) includes a distal end 31, a proximal end 33 and a lumen extending from the distal end 31 and the proximal end 33 to provide a passage for components like the inner lumen 40. Further, an atraumatic tip 35 may be attached at the distal end 31 of the inner shaft 30. The atraumatic tip 35 may be a soft polymer material attached at the distal end 31 of the inner shaft 30. The atraumatic tip 35 may act as a guiding member for the delivery system 100 for accurately locating the damaged tissue without affecting nearby tissues. The atraumatic tip 35 may be made of without limitation silicon, polyether block amide, polyamide, polyester, polyethylene. In an embodiment, the atraumatic is made of polyether block amide.
[44] In an exemplary embodiment, the inner shaft 30 is provided with a bumper 32 and a pusher 34. The bumper 32 and the pusher 34 may be provided towards the proximal end 33 on the inner shaft 30 at a predefined distance from each other as depicted in FIG. 5. In an embodiment, the bumper 32 and the pusher 34 are present at a distance of 20mm to 25mm from each other. The bumper 32 may be used to hold the medical device between the outer sheath 10 and the inner shaft 30 in compressed state until deployment. The pusher 34 may help in detachment of the medical device from the capture member 50 and/or facilitate deployment of the medical device.
[45] The bumper 32 and the pusher 34 may be attached on the inner shaft 30 by adhesive bonding techniques known in the art. In an embodiment, the bumper 32 and pusher 34 are attached by means of UV bonding. The bumper 32 and the pusher 34 may be made of polymeric material. The polymeric material may include without limitation polyether block amide, Polyurethane, etc. In an embodiment, the bumper 32 and the pusher 34 are made of polyether block amide. The length and the diameter of the bumper 32 and pusher 34 may be in a range of 1mm to 6mm, preferably between 2mm to 5mm and more preferably between 3mm to 4mm and diameter may be in range of 1mm to 2.5 mm, preferably between 1.2mm to 2mm and more preferably between 1.4mm to 1.8mm respectively.
[46] In another exemplary embodiment, the inner shaft 30 is provided with a plurality of makers as depicted in FIG.5. The markers may be attached by means of swaging followed by crimping. The aforesaid process may be processed by applying pressure on the marker to reduce its diameter followed by crimping of the markers over the inner shaft 30. The process of crimping may result in compression of the markers leading to fixation over the inner shaft 30. The markers may be made of one or more of but not limited to gold, platinum, platinum-iridium, silver, tantalum, niobium, zirconium, hafnium, etc. In an embodiment, the markers are made of platinum-iridium. The markers may be attached at a predefined distance from each other towards the distal end 31 and the proximal end 33 of the inner shaft 30. In an embodiment, the inner shaft 30 has three markers 36, 37 and 38 as depicted in FIG. 5. The markers 36, 37 and 38 may be attached at a distance between 5 mm to 90 mm from proximal end 33 of inner shaft 30.
[47] The positioning of the markers 36, 37 and 38 may depend upon the length of the medical device. In an embodiment wherein the length of the medical device is 40 mm, the marker 36 is attached at a distance of 5mm to 8mm from the soft tip 35 of the inner shaft 30. In another embodiment wherein the length of the medical device is 40mm, the marker 37 is attached at a distance of 20mm to 50mm from the marker 36. In yet another embodiment wherein the length of the medical device is 40mm, the marker 38 is attached at a distance of 80mm to 90mm from distal end 31 of inner shaft 30.
[48] In an embodiment, the inner lumen 40 of the delivery system 100 is an inner most tube of the tubular assembly 200. The inner lumen 40 may be a hypo tube. The inner lumen 40 has a distal end 42, a proximal end 44 and a lumen extending between the distal end 42 and the proximal end 44 to provide a passage for the components like a guide wire. The length of the inner lumen 40 is predefined. In an embodiment, the length of the inner lumen is in range of 900mm to 1950mm. The inner lumen 40 possess enough strength as well as flexibility in order to slidably support other tubes of the tubular assembly 200 and/or to accurately access a treatment site in the body.
[49] In an embodiment, the delivery system 100 includes the handle 300 as depicted in FIG. 6. The handle 300 comprises a slider lock 302, a stopper 304 and a plurality of switches. In an embodiment, the handle 300 including three switches 305a, 305b and 305c. Each of the three switches 305a, 305b and 305c may be slidably attached to the respective tubes of the tubular assembly 200 of the delivery system 100. For example, the switch 305a may be attached to the outer sheath 10. The switch 305b may be attached to the outer shaft 20. The switch 305c may be attached to inner shaft 30.
[50] The switches 305a, 305b and 305c may be moved manually. The movement of the switches 305a, 305b and 305c along with respective tubes of the tubular assembly 200 facilitates smooth and/or accurate loading and/or deployment of the medical device in uniform manner. The switches 305a, 305b and 305c may be attached to the tubular assembly 200 by means of without limitation adhesive bonding, UV bonding, laser bonding. In an embodiment, the switches 305a, 305b and 305c are attached by means of UV bonding technique. In another embodiment, the switches 305a, 305b and 305c are secured to each of the tubes of the tubular assembly 100 with the help of a gear assembly (not shown). Each of the switches 305a, 305b and 305c may be rolled with the aid of the gear assembly in order to move the tubes of the tubular assembly 200 of the delivery system 100.
[51] In an embodiment of the present invention, FIG.8 depicts a flow chart describing a process involved in loading of the medical device 70 with the help of delivery system 100. The process of loading may involve a series of multiple steps to be followed in a prescribed manner. In an exemplary embodiment, the process of loading of the medical device 70 commences at step 801. At the said step, the switch 305c is moved towards the proximal end 303 of the handle 300. In an embodiment, the switch 305c is moved manually. Movement of the switch 305c triggers movement of the inner shaft 30. The switch 305c is moved until the pusher 34 on the inner shaft 30 comes in contact with the narrow end 52 of the capture member 50. Once the pusher 34 reaches the narrow end 52 of the capture member 50, the switches 305b and 305c are locked at the step 803 with the help of a slide lock 301. The switches may be locked manually or automatically. The switches 305b and 305c may be locked to avoid unintentional damage to the medical device 70 during loading and/or deployment.
[52] Further at the step 805, the switch 305b is moved towards the proximal end 303 of the handle 300. In an embodiment, the switch is 305b is moved manually. Said movement of the switch 305b results in capturing of the capture member 50 into the outer sheath 10 of the delivery system 100. Subsequently, at the step 807, a funnel 60 (as shown in Fig.09) may be placed over the proximal end 11 of the outer sheath 10. Placement of the funnel 60 may lead to radial compression of the medical device 70 about 40-90% from its original diameter and/or assist in smooth loading of the medical device 70 in the outer sheath 10.
[53] Placement of the funnel 60 is followed by manual movement of the switch 305b and 305c towards the distal end 301 of the handle 300 in order to retract back the capture member 50 out of the outer sheath 10 at the step 809.
[54] At the step 811, the medical device 70 is placed in the capture member 50 as depicted in FIG. 10. Further, positioning of the medical device 70 in the capture member 50 is followed by manually moving the switches 305b and 305c towards the proximal end 303 of the handle 300 at the step 813. Said movement of the switches 305b and 305c is proceeded until the medical device 70 is fully captured in the outer sheath 10 as shown in figure 11.
[55] Further at the step 815, the switches 305b and 305c are unlocked with the help of the slider lock 301 by pulling the switch 305b towards distal end 301 of the handle 300. The said movement of the switch 305b leads to detachment of the medical device 70 from the capture member 50 with the aid of the bumper 32 and the pusher 34 as shown in FIG. 12. The bumper 32 may be used to hold the medical device 70 between the outer sheath 10 and the inner shaft 30 in compressed state until deployment. The pusher 34 may help in detachment of the medical device from the capture member 50 to further process deployment of the medical device 70.
[56] Lastly, following loading of the medical device 70 at the previous step, the funnel 60 is removed from the outer sheath 10 and the medical device 70 remains in a compressed state between the markers on the inner shaft 30.
[57] After loading the medical device 70 at the previous step, the medical device 70 is deployed at the treatment site. The process of deployment of the medical device 70 commences at the step 1201 as represented in FIG.12. At the said step, the delivery system 100 is inserted into an arterial lumen with the help of an introducer sheath (not shown). The diameter of the introducer sheath may be in a range of 6Fr to 12Fr. In an embodiment, the introducer sheath has a diameter in a range of 8Fr to 11Fr. Further, at the step 1202, the medical device 70 is deployed by moving the switch 305a towards the proximal end 303 of the handle 100 till it reaches the stopper 304. Said movement of the switch 305a may induce movement in the outer sheath 10. In an embodiment, the outer sheath 10 retracts in a backward direction leading to implantation of the medical device at a desired site. Post deployment, at the step 1203, the switch 305a is moved back towards the distal end 301 of the handle 300. Lastly, at the step 1204, the delivery system 100 is removed with the help of the introducer sheath.
[58] In another embodiment, the medical device deployed using the delivery system 100 is re-sheathed or repositioned. The marker on the inner shaft 30 may indicate position of the medical device in the body of a patient. In an embodiment, the second radiopaque marker mounted on inner shaft 30 of the delivery system 100 indicates the position of the medical device up to which re-sheathing of scaffold is possible. In an exemplary embodiment, the re-sheathing process is performed by sliding the switch 305a towards the proximal end 303 of the handle 300. Said movement of the switch 305a facilitate retraction of the medical device deployed in body lumen. In an embodiment, the medical device is re-sheathed during initial deployment when 10-30% of medical device has been released from the outer sheath 10.
[59] 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.