DESC:Field of Invention:
The present invention relates, generally, to a catheter for delivering an implant through a minimally invasive percutaneous procedure and more specifically, related to a delivery cable for an occluder.

Background:
A catheter is effectively used in minimally invasive percutaneous treatment procedures for treating various diseases including endovascular or cardiovascular diseases. Delivery cables are specific types of catheters that facilitate precise trackability and controlled manoeuvrability, precise positioning and accurate deployment of a medical device, specifically an implant, in a human body. These properties are required in delivery cables as they don’t track over a guidewire. Hence, they’re also used for procedures where a longer shaft is not required. However, these cables are designed to impart different functional properties such as flexibility, torque-ability and pushability that help in navigating the delivery cable through complex vasculature and anatomical structures. These delivery cables are used in variety of endovascular procedures, specifically in coronary, cerebral, and peripheral vasculature, and more specifically for delivering occluder for Left atrial appendage (LAA), Atrial septal defect (ASD), Ventricular septal defect (VSD), Patent foramen ovale (PFA), Patent ductus arteriosus (PDA) and vascular plugs. The medical devices are either connected or carried over to these delivery cables. Once the device reaches the target location, the device is detached or uncoupled from the delivery cable. Some examples of these medical devices, but not limited to, stents, balloons, occluders, plugs, embolic coils, filter etc.
Delivery cables are also used for deployment of occluder in cardiac region. However, insufficient torque-ability in a delivery cable leads to inefficient trackability that leads to improper deployment of the medical device. Also, cables with higher axial stiffness may help in better pushability but stiffer cables are difficult to manoeuvre in curvatures and results in storage of potential energy in the cable. Later on, during unplugging the medical device, this stored potential energy converts into kinetic energy resulting in unbalanced tensile forces in cable. This may be injurious to patient, or the operator may find it difficult to control the cable. This may also cause injury to the vasculature or organs as the delivery cable doesn’t track through guidewire. This may lead to additional medical procedures and bring uneasiness and pain to the patient.

Hence, there is need for a delivery cable to address above mentioned shortcomings and it is an objective of the present invention to provide a delivery cable with better torque-ability and flexibility.
Brief Description of Drawing
The Detail description is described with reference to the accompanying figures.
FIG. 1 illustrates a side view of a delivery cable without coil, according to an embodiment of the present invention;
FIG 2. Illustrates a side view of a delivery cable with coil, according to an embodiment of the present invention;
FIG 3. Illustrates a magnified side view of a second part of a delivery cable, according to an embodiment of the present invention; and
FIG. 4 and FIG. 4A. Illustrate a cross-sectional view of a first twisted wire set and a second twisted wire set, respectively, according to an embodiment of the present invention.
Detail Description of the Invention
Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or the like parts. Wherever possible, corresponding, or similar reference numbers will be used throughout the drawings to refer to the same or corresponding parts.
Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated.
The invention is described below in detail with reference to accompanying drawings to make the purposes, technical solutions and advantages of invention understood more clearly with help of the specific embodiment of the invention.
The invention explained in the present disclosure provides a medical device, specifically a delivery cable, that can be percutaneously inserted in a human body. Mainly the delivery cable is used to deploy an occluder at deployment site.
The invention, as per the present disclosure, explains a medical device, specifically a delivery cable that is used in minimally invasive endovascular percutaneous procedures. The delivery cable comprises a first part, a second part and a handle. The handle is situated most proximally to the operator while the second part is situated most distally with reference to the operator. The first part is situated in between the second part and the handle. The handle comprises a knob. The first part comprises a first twisted wire set and a first connector. The second part comprises a second twisted wire set, a second connector and a connecting end. One end of the first twisted wire set is connected to the distal end of the handle and functionally connected to the knob. Another end of the first twisted wire set is connected to the first connector. The first connector is attached to a proximal end of the second twisted wire set. The distal end of the second twisted wire set is connected to the second connector. The second connector is connected to the connecting end. The connecting end may comprise coupling means to attach the medical device to the connecting end. One of the coupling means, but not limited to, have threads on outer periphery of the connecting end.
By rotating the knob situated on the handle, the rotational movement is transferred through the first twisted wire set to the second twisted wire set to the connecting end. The connecting end has threads present on its outer periphery. The rotational movement is used to couple the connecting end to a medical device having a set of opposite threads.
Further, the first twisted wire set is formed using a plurality of wires that are twisted together to form the main core of the first part. The second twisted wire set is formed using a plurality of wires that are twisted together to form the main core of the second part. The number of wires in the first twisted wire set and/or the second twisted wire set are either equal or unequal. In addition, the overall diameter of the wires in the first twisted wire set and/or the wires in the second twisted wire set is either equal or unequal. Further, the material of the wires in the first twisted wire set and/orthe second twisted wire set is also same or different. Furthermore, within the first twisted wire set or the second twisted wire set, the wires may be of different materials, diameters, lengths and texture of peripheral surface. Also, within the first twisted wire set or the second twisted wire set, the arrangement of the wires may be symmetric or asymmetric. A combination of above configurations provides a delivery cable with a specific set of properties. Hence, according to the required application, a specific configuration of the wires is selected. Also, the length of the first part and the second part can be varied to achieve specific set of properties of performance collectively as well as in different parts of the delivery cable.
Further, a coil extends from the handle till the connecting end and covers the first part and the second part. The coil is a helical structure that provides singularity to the delivery cable. It ensures to utilize the delivery cable as a single unit and at the same time utilizing the functionalities of the first twisted wire set and the second twisted wire set. The coil also provides the delivery cable a uniform profile.
A lower number of wires in the core of either the first twisted wire set or the second twisted wire set, while having same overall core profile, gives strength to its core that helps in pushability and transfer of torque from one end to another. However, the core has less flexibility. On the other hand, a higher number of wires in the core of either the first twisted wire set or the second twisted wire set, while having same overall core profile, gives better flexibility, hence, better manoeuvring through complex vasculature. In a delivery cable, strength, and flexibility, both are required. However, unrequired stresses and strains also need to be in control. For example, while tracking through the tortuous vasculature, tortional stresses develop in the delivery cable, near the distal end, and get stored in form of potential energy. At the time of deployment, the stored potential energy converts into kinetic energy as soon as the delivery cable decouples from the medical device. This sudden release of the kinetic energy may harm the patient, and the operator may not control the device. Hence, it is important to design a delivery cable in a manner to mitigate such risks. The control design variables provided in the present invention are helpful in bringing the favourable properties or behaviour together while reducing the unfavourable properties or behaviour.
The number of wires in the core of either the first twisted wire set or the second twisted wire set, are usually in range of, but not limited to, 3 to 19.
According to an embodiment of the present invention, the coil in the delivery cable has at least one radiopaque marker on its peripheral surface, at suitable points along its length.
According to an embodiment of the present invention, the material of the wires, is selected from, but not limited to, metal, non-metal, alloy, polymer, shape memory alloy, shape memory polymer, bioresorbable material or combinations thereof. Specifically, the material of the wires is selected from, but not limited to, Stainless steel, Cobalt alloys, pure Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, Co-Cr, CuZnAl, CuAlNi, polytetrafluoroethylene, polylactide, ethylene-vinyl acetate, Polyurethane, Polypropylene, Polystyrene, Polyethylene, ePTFE, PET, Polyester silk or combinations thereof.
According to an embodiment of the invention, the coil, first twisted wire set, second twisted wire set or the wires, are coated, completely or partially, with a coating composition. The coating composition may be selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, pharmaceutical, chemical, non-polymeric or combinations thereof. In addition, the coating composition may contain at least an active agent, an additive to enhance either physical, chemical, or biological performance, a biodegradable polymer, a hydrophilic compound, or combinations thereof.
According to an embodiment of the present invention, the polymer used in the coating is selected from, but not limited to biodegradable polymers, non-biodegradable polymers, polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, and copolymers and combinations thereof.
According to an embodiment of the present invention, the term “active agent” refers to any biologically active compound or a pharmaceutical compound or a drug compound that can be used in a composition that is suitable for administration in mammals including humans. According to one embodiment of the present disclosure, the active agent is anti-cancer drug, antiproliferation drug, anti-restenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, anti-inflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, or a combination thereof. Examples of the drug include, but are not limited to, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin, and combination thereof. In another embodiment, there can be more than one active agent in the coating to deliver at the target lesion.
According to another embodiment of the present invention, the coating composition can be coated on the coil, first twisted wire set, second twisted wire set or the wires, through spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method, and 3-D printing.
Given below is an embodiment of the present invention described using accompanying drawings.
Fig 1. Illustrates a side view of a delivery cable (100) that comprises a first part (102), a second part (104) and a handle (106). The handle comprises a knob (107). The first part (102) comprises a first twisted wire set (110) and a first connector (108). The second part (104) comprises a second twisted wire set (110’), a second connector (112) and a connecting end (114). The handle (106), the first twisted wire set (110), the first connector (108), the second twisted wire set (110’), the second connector (112) and the connecting end (114) are connected in series where the handle (106) is proximal and the connecting end (114) is distal most to the operator. The knob (107) is functionally connected to the connecting end (114) and the torque generated by the knob (107) transfers to the connecting end (114) through the first part (102) and the second part (104).
Fig 2. Illustrates a side view of a delivery cable (100) wherein the first part (102) and the second part (104) are covered using a coil (109). The coil (109) is of helical form and provides a singularity to the delivery cable (100) while utilizing the properties and functionalities of the first part (102) and the second part (104).
Fig 3. Illustrates a magnified side view of a second part (104) of a delivery cable (100. The second part is made of a second twisted wire set (110’), a second connector (112) and a connecting end (114). The second twisted wire set is made of a plurality of wires twisted together to form a core. In a similar manner, the first twisted wire set is also made of a plurality of wires twisted together to form a core. The number of wires in these cores may be in range of 3 to 19. It should be noted that the number of wires in cores does not limit the scope of the present invention.
Fig 4. And Fig. 4A Illustrate cross-sectional views of the first part (102) and the second part (104), respectively, showing the first twisted wire set and the second twisted wire set while both the sets are covered with a coil (109). According to this embodiment, the first twisted wire set is made of three wires that are twisted together to form a core of a particular profile. Similarly, the second twisted wire set is made of seven wires that are twisted together to form a core of same profile. In this configuration, the first twisted wire set exhibits structural strength but less flexibility whereas the second twisted wire set shows improved flexibility.
In the above description, for the purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the present disclosure may be practiced without these details. One skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into a number of systems. Further, structures and devices shown in the figures are illustrative of exemplary embodiment of the present disclosure and are meant to avoid obscuring the present disclosure.

100 Delivery Cable
102 First part
104 Second part
106 Handle
107 Knob
108 First Connector
109 Coil
110 First Twisted Wire Set
110’ Second Twisted Wire Set
112 Second Connector
114 Connecting end

,CLAIMS:
1. A delivery cable (100) for a medical device, the delivery cable (100) comprising:
a first part (102) having a first twisted wire set (110);
a second part (104) having a second twisted wire set (110’);
a handle (106) having a knob (107); and
a coil (109) covering the first part (102) and the second part (104),
wherein at least one wire in either the first twisted wire set (110) or the second twisted wire set (110’) is different from the other wires in at least one aspect selected from diameter of the wires, number of the wires, material of the wires, length of the wires, and arrangement of the wires.

2. The delivery cable (100) as claimed in claim 1, wherein one end of the first twisted wire set (110) is connected to the knob (107) on the handle (106) and the other end is connected to a first connector (108) and the first connector (108) is connected to the proximal end of the second twisted wire set (110’).

3. The delivery cable (100) as claimed in claim 1, wherein the distal end of the second twisted wire set (110’) is connected to a second connector (112) and the second connector (112) is connected to a connecting end (114) having coupling means to connect to a medical device.

4. The delivery cable (100) as claimed in claim 1, wherein the wires present in the first twisted wire set (110) or the second twisted wire set (110’) have at least one difference selected from diameter of the wires, material of the wires, length of the wires and texture of the peripheral surface of the wires.

5. The delivery cable (100) as claimed in any one of claims 1, 2, or 4, wherein the number of wires in the first twisted wire set (110) are in the range of 3 to 19.

6. The delivery cable (100) as claimed in any one of claims 1, 3, or 4, wherein the number of wires in the second twisted wire set (110’) are in the range of 3 to 19.

7. The delivery cable (100) as claimed in any one of claims 1 to 6, wherein the material of the wire is selected from metal, non-metal, alloy, shape memory alloy, shape memory polymer, polymer, biodegradable material, bioresorbable material or a combination thereof.

8. The delivery cable (100) as claimed in any one of claims 1 to 7, wherein the material of the wire is selected from Stainless steel, Cobalt alloys, Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, CuZnAl, CuAlNi, polytetrafluoroethylene, polylactide, ethylene-vinyl acetate, Polyurethane, Polypropylene, Polystyrene, Polyethylene, ePTFE, PET, Polyester silk or a combination thereof.

9. The delivery cable (100) as claimed in any one of claims 1 to 8, wherein at least a part of the delivery cable (100), selected from the coil, the first twisted wire set (110), the second twisted wire set (110’) and the wires, is coated, completely or partially, with a coating composition.

10. The delivery cable (100) as claimed in claim 9, wherein the coating composition is selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, biodegradable, pharmaceutical, chemical, non-polymeric coatings or combinations thereof.

11. The delivery cable (100) as claimed in claim 9, wherein the coating composition comprises at least one active agent.

12. The delivery cable (100) as claimed in claim 9, wherein the coating composition comprises at least one additive to enhance either physical, chemical, therapeutical or biological performance of the coating.

13. The delivery cable (100) as claimed in claim 9, wherein the polymer used in the coating composition is selected from biodegradable polymers, nonbiodegradable polymers, polymers of L-lactide, Glycolide, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers or a combination thereof.

14. The delivery cable (100) as claimed in claim 11, wherein the active agent is selected from anti-cancer drug, antiproliferation drug, antirestenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, antiinflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin or a combination thereof.

15. The delivery cable (100) as claimed in claim 9, wherein the delivery device (100) is coated by a method selected from spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method, 3-D printing or combinations thereof.

16. The delivery cable (100) as claimed in claim 1, wherein the coil (109) comprises at least one radiopaque marker on its peripheral surface.