"an equipment for magnetic recanalization of benign biliary strictures"

Abstract

The present invention relates to an equipment for magnetic recanalization of benign biliary strictures. The equipment (100) includes a wire-guided magnet pusher tube (102a), atleast one magnet (110), and a magnet retrieval tube (102b). The equipment (100) works in conjunction with a visualization system to guide placement of the magnet (110) at the target site for recanalization of the biliary stricture. The magnet (110), may be deployed at opposing ends of a biliary stricture to create a controlled recanalization channel via magnetic attraction. The deployment process can be performed using endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic biliary drainage (PTBD), or a combination of both. Magnets may be retrieved following recanalization using biopsy forceps or allowed to pass naturally through the digestive tract, avoiding permanent implantation.

Description

[0001] “AN EQUIPMENT FOR MAGNETIC RECANALIZATION OF BENIGN BILIARY STRICTURES”

[0002] FIELD OF INVENTION

[0003] The present invitation relates to the field of medical devices. More particularly, the invention relates to an equipment used for magnetic recanalization of benign biliary stricture that aims to provide a solution for treating benign biliary strictures that are less than 2 cm (<2cm) in size.

[0004] BACKGROUND OF INVENTION

[0005] Terminologies as referred to in the present invention:

[0006] Benign biliary stricture: It is the narrowing of the bile duct due to disease, scarring or blockage, that can block bile from flowing from the liver to the intestines.

[0007] Refractory biliary stricture: It is a benign biliary stricture that does not respond well to standard treatment methods, is difficult to manage and may persist despite interventions like endoscopic stenting or dilation.

[0008] Anastomosis: A surgical procedure that connects two tubular structures, such as blood vessels or loops of intestine, to each other.

[0009] Post surgical anastomotic stricture: Narrowing of the passageway at the site where two tissues were surgically joined (anastomosis) after surgery, usually caused by scar tissue formation, which can lead to partial or complete obstruction of the affected organ or pathway depending on the location of the anastomosis.

[0010] USG abdomen: It refers to the ultrasound Sonography of abdomen.

[0011] MRCP: It stands for Magnetic Resonance Cholangio-pancreatography. It's a type of MRI scan that produces detailed images of the biliary and pancreatic systems, including the gallbladder, pancreas, bile ducts, and liver.

[0012] ERCP: It stands for endoscopic retrograde cholangiopancreatography. It's a procedure that uses an endoscope and X-ray to examine the bile andpancreatic ducts, and to diagnose and treat problems in the liver, gallbladder, pancreas, and bile ducts.

[0013] PTBD: Percutaneous transhepatic biliary drainage (PTBD) is a minimally invasive procedure that treats or diagnoses bile duct obstruction.

[0014] CBD: It stands for common bile duct.

[0015] Biliary stricture, a narrowing of the bile ducts, is a common complication following liver transplantation, biliary tract surgery, or inflammatory bowel disease. It can lead to significant health problems, including jaundice, abdominal pain, and impaired liver function. While endoscopic and percutaneous interventions are commonly used to treat these strictures, they often have limitations, such as difficulty in accessing complex strictures, risk of complications, and suboptimal long-term outcome.

[0016] While non-surgical treatments like endoscopic and interventional therapies are preferred over surgery, they have limitations as these non-surgical approaches may not always provide long-term solutions, especially in cases of severe or recurrent strictures. Many conventional techniques require devices that feature a guidewire, to treat the strictures. However, in cases of severe bile duct obstruction and stricture, such conventional techniques may be ineffective due to the inability to insert a guidewire. As a result, patients often require external PTBD (Percutaneous transhepatic biliary drainage), which can negatively impact quality of life and pose a heightened risk of infection. In such cases, re-transplantation may be necessary, but this is a major surgical procedure with significant risks and complications. Therefore, there is a pressing need for innovative techniques which are minimally invasive, to address the challenges of biliary stricture treatment.

[0017] Magnetic recanalization is a promising technique that utilizes the power of magnets to treat various medical conditions, including biliary strictures. While magnetic recanalization shows promise for treating biliary strictures, there are limitations associated with current equipment and techniques: • Precision Challenges: Existing magnets used in recanalization are bulkier in size as there is no standard size of the magnets used for the procedure.Thus, accurately positioning those magnetic components within a narrow stricture can be technically challenging and could lead to more tissue damage.

[0018] • Over-Compression of tissues: Excessive magnetic force caused from larger magnets can cause tissue necrosis and damage to the surrounding healthy tissue.

[0019] • Lack of standard equipment: There is no standard equipment for deploying and retrieval of magnets in conventional magnetic recanalization device, hence making the procedure difficult.

[0020] Therefore, accordingly, there is a need for equipment which are minimally invasive, to address the challenges of treating smaller biliary strictures.

[0021] PRIOR ART AND ITS DISADVANTAGES

[0022] A Chinese patent application number CN201811069411A relates to a biliary recanalization device, in particular to a magnetic anastomosis biliary recanal device. Said device disclosed in the cited prior art comprises a mother magnet and a release device. The mother magnet consists of a sub-magnet and a parent magnet, which are magnetically attracted to each other. The submagnet, cylindrical with a smooth surface and a development line, is positioned at the distal end of the biliary tract. The parent magnet, also cylindrical with a smooth surface, is connected to a pick-and-place device via a connecting member, which can be a connecting knot or a connecting ring. The release device, either a snare-type or clamp-type connecting device, facilitates the removal of the parent magnet. The device's design, including the development line on the sub-magnet and the efficient pick-and-place mechanism, simplifies the procedure and improves its overall effectiveness.

[0023] However, the size and configuration of said equipment, including the magnetic rings and connecting mechanisms, may be too large for smaller strictures. This could hinder its insertion and manoeuvrability within narrow bile ducts. Furthermore, the device may fail to provide precise control of the magnetic force between the sub-magnet and parent magnet, which may lead tounintended tissue damage or perforation. Moreover, removing the components of the device, especially the sub-magnet, from a narrow stricture may be technically demanding due to its size and may lead to more severe complications and may compromise effective treatment.

[0024] Another Chinese patent application number CN201210083313A relates a dredging device for a narrow biliary tract by means of magnetic compression. The said dredging device for narrow biliary tract comprises a guide wire with a first conduit and two magnetic rings sequentially sleeved on it. The magnetic rings, made of neodymium iron boron, are anisotropic and attract each other. The first conduit, connected to the first magnet ring, has a drainage hole. The device is introduced into the narrowed biliary tract via PTC or duodenoscope. The magnetic rings, guided by the wire, move to opposite ends of the stricture and attract each other, squeezing and necrotizing the scar tissue. This process facilitates the formation of a smooth biliary tract anastomosis, effectively treating the narrow biliary tract. The use of neodymium iron boron, a biocompatible and affordable material with high magnetic energy, ensures the device's safety, efficacy, and cost-effectiveness. The guide wire ensures accurate positioning and orientation of the magnetic rings, enabling precise three-dimensional attraction and effective tissue removal.

[0025] However, because the two magnetic rings utilized in the dredging device have a diameter of 3 to 6 mm with a central hole of 1.5 to 2 mm, the cited invention is limited in its applicability in the treatment of benign biliary strictures of less than 2cm as the stated construction of the device hinders its insertion into severely narrow biliary tracts with strictures of 2cm. Furthermore, the device may fail in providing accurate placement and precise positioning of the magnetic rings, which raises concerns about misalignment and compromised treatment efficacy.

[0026] DISADVANTAGES OF THE PRIOR ART

[0027] All of the prior arts suffer from all or at least one of the following disadvantages:• Most of the prior arts provide a recanalization equipment that is bulky in construction, thus failing to consider a treatment device for severely constricted biliary tract.

[0028] • Most of the prior arts pose mortality and morbidity risks of reoperation and are invasive and surgical.

[0029] • Most of the prior arts require extra catheters and devices during the surgical procedures of treating strictures, thereby placing a major burden on the patient by lowering the quality of life and conferring a high risk of infection.

[0030] • Most of the prior arts lead to incomplete removal of the devices, leading to complications like residual inflammation or recurrent stricture.

[0031] • Most of the prior arts often have limitations such as difficulty in accessing complex strictures, risk of complications, and suboptimal long-term outcome.

[0032] OBJECTS OF THE INVENTION

[0033] The main object of the present invention is to provide an equipment for magnetic recanalization of benign biliary stricture.

[0034] Another object of the invention is to provide an equipment for magnetic recanalization of benign biliary strictures of less than 2cm (<2cm).

[0035] Yet another object of the invention is to provide an equipment for magnetic recanalization of benign biliary strictures that provides easy insertion and retrieval mechanism for the magnet.

[0036] Yet another object of the present invention is to provide an equipment for magnetic recanalization of benign biliary strictures that is minimally invasive and eliminates the risk of re-operation.

[0037] Yet another object of the present invention is to provide an equipment for magnetic recanalization of benign biliary strictures that does not require long treatment procedures to be performed.Yet another object of the present invention is to assess the recanalization time for magnetic recanalization of benign biliary strictures.

[0038] Yet another object of the present invention is to assess the complications related to magnetic recanalization of benign biliary stricture procedure.

[0039] Yet another object of the present invention is to assess the recurrence of strictures on long term follow up post magnetic recanalization of benign biliary stricture.

[0040] BRIEF DESCRIPTION OF DRAWINGS

[0041] Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein:

[0042] Fig. 1A : Shows a cross-sectional view of an equipment for magnetic recanalization of benign biliary strictures comprising a wire-guided pusher tube according to the present invention.

[0043] Fig. IB : Shows a cross-section view of an equipment for magnetic recanalization of benign biliary strictures comprising a section of guide wire pusher tube extending out of the pusher tube according to the present invention.

[0044] Fig. 1C : Shows a cross-sectional view of an equipment for magnetic recanalization of benign biliary strictures comprising a wire-guided pusher tube with a magnet according to the present invention.

[0045] Fig. ID : Shows a cross-sectional view of an equipment for magnetic recanalization of benign biliary strictures comprising a wire-guided pusher tube with a magnet according to the present invention.

[0046] Fig. IE : Shows a cross-sectional view of an equipment for magnetic recanalization of benign biliary strictures comprising a magnet retrieval tube according to the present invention.Fig. IF : Shows an exploded side view of a magnet of an equipment for magnetic recanalization of benign biliary strictures according to the present invention.

[0047] Fig. 2 : Shows a flow diagram of a method performing magnetic recanalization of common bile duct stricture utilizing an equipment for magnetic recanalization of benign biliary strictures.

[0048] Fig. 3: Shows a block diagram of a visualization system encompassing the magnetic recanalization system by utilizing an equipment for magnetic recanalization of benign biliary strictures.

[0049] List of Reference Numerals

[0050] (100) Magnetic Recanalization equipment

[0051] (102a) Wire-guided pusher tube

[0052] (102b) Magnet retrieval tube

[0053] (104a) Section of guide-wire extending out from the through hole of magnet (104b) Section of guide-wire extending out pushing mechanism

[0054] (110) Magnet

[0055] (110a, 110c) Flat sides of the magnet

[0056] (110b) First half of cylindrical surface of the magnet

[0057] (1 lOd) Second half of cylindrical surface of the magnet

[0058] (112) Pusher sheath

[0059] (120) Pushing mechanism

[0060] (150) Axis

[0061] (300) Visualization system

[0062] (302) Display

[0063] (310) Imaging system

[0064] (312) External imaging device(314) Imaging processor

[0065] (320) Biliary system

[0066] (322) Internal imaging device

[0067] SUMMARY OF THE INVENTION

[0068] The present invention pertains to an equipment for magnetic recanalization of benign biliary strictures. Said equipment includes at least one magnet configured for insertion into the bile duct. The equipment further includes a wire-guided magnet pusher tube for controlled delivery of the at least one magnet. Finally, the equipment includes a magnet retrieval tube for magnet removal after magnetic recanalization.

[0069] When utilizing said equipment for magnetic recanalization of benign biliary strictures, advance a magnet pusher tube toward a stricture to deploy at least one magnet, wherein the magnet pusher tube is assisted by a guide wire; deploy of at least one magnet to at least one of: an upper end of the stricture, or a lower end of the stricture; and retrieve of at least one magnet using a magnet retrieval tube.

[0070] Said equipment for magnetic recanalization works in conjunction with a visualisation system to provide visualization of the biliary duct in order to assist in controlled delivery magnet at the site of stricture, using the guidewire.

[0071] DETAILED DESCRIPTION OF THE INVENTION

[0072] The following description is presented to enable any person skilled in the art to make and use the invention and is provided in the context of a particular application and its requirements. Various modifications to the disclosed embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Thus, the present invention is not intended to be limited to theembodiments shown but is to be accorded the widest scope consistent with the principles and features disclosed herein.

[0073] It is to be understood that the term “comprising” or “comprises” used in the specification and claims refers to the element of the invention which comprises X, Y, and Z, which means that the invention might have other elements in addition to X, Y, and Z. For example, their invention could include A, B, and / or C as long as it also has X, Y, and Z.

[0074] According to the embodiments of the present invention, an equipment for magnetic recanalization of benign biliary strictures is disclosed.

[0075] The present invention provides an improved equipment and system for treating benign biliary strictures of less than 2cm (<2cm) in size. According to the embodiments, said equipment (100) is primarily indicated for biliary strictures that have not responded to conventional treatments like ERCP (endoscopic retrograde cholangiopancreatography) or PTBD (Percutaneous trans hepatic biliary drainage) and is specifically suitable for refractory Biliary Strictures, Post-Liver Transplant Strictures and Post-Surgical Anastomotic Strictures.

[0076] Referring to the embodiments shown in Figures 1A to IF, an equipment for magnetic recanalization of benign biliary strictures (100), according to the present invention, comprises:

[0077] o at least one magnet (110),

[0078] o a wire-guided pusher tube (102a), configured for the controlled delivery and deployment of said magnet to the target stricture site during the recanalization procedure, and

[0079] o a magnet retrieval tube (102b), devoid of a guide-wire, configured for the extraction of said magnet, following the recanalization procedure.

[0080] According to the embodiments illustrated in Figures 1C to IE, said magnet (110) is a solid cylinder comprising of neodymium, and has a diameter ranging from 0.1 inches to 0.2 inches, with a preferred diameter of 0.125 inches, anda length ranging from 0.25 inches to 0.75 inches, with a preferred length of 0.500 inches. The magnet is adapted for insertion into the bile duct, and its subsequent retrieval from the bile duct during the biliary stricture treatment procedure.

[0081] In an alternate embodiment, said magnet (100) may be configured as a wire-guided magnet (110). Said wire-guided magnet has a diameter of 3 mm and a length within the range of 5mm to 10mm, inclusive. Furthermore, as per the embodiments shown in Figures 1C and ID, said wire-guided magnet comprises a central aperture of 0.5mm, hereinafter referred to as through hole, to accommodate a guide-wire (104) to pass through as it is guided to the Common Bile Duct (CBD).

[0082] Further referring to other embodiments in Figure IF, said cylindrical magnet (110), is aligned along an axis (150). Said magnet (110) comprises two flat end surfaces (110a and 110c) and a cylindrical surface. Said cylindrical side surface is divided by the plane containing the axis (150) into a a first half cylindrical surface (110b) and a second half cylindrical surface (l lOd). Said first half cylindrical surface (110b) and second half cylindrical surface (1 lOd).

[0083] Said magnet (110) may be magnetized along its first flat side (110a) to define one pole of the magnet (for example, north), and along the second flat side (110c) to define the opposing pole of the magnet (for example, south). In other embodiment, the magnet (110) may be side magnetized, wherein the first half cylindrical surface (110b) defines a first pole of the magnet (for example, north) and the second half cylindrical surface (1 lOd) defines the opposing pole (for example, south). Further, as shown in Figure IF, the magnet (110) and its through-hole are aligned along the axis (150), allowing the guide wire (104) to pass through and extend out of said magnet (110).

[0084] Further, as per yet another embodiment, said magnet (110) is a biocompatible magnet. Said biocompatible magnet is configured for use in a variety of medical applications, which may include, without limitation, drug delivery systems, medical imaging devices, and implantable medical devices. When introduced into a biological environment, the biocompatible magnet isadapted to operate without eliciting detrimental physiological responses or systemic toxicity. In an embodiment, said magnet (110) comprises a core formed from a non-toxic and non-reactive material, said core being encapsulated by a biocompatible coating. Said non-toxic and non-reactive material include, but are not limited to, titanium or cobalt-chromium alloy. The biocompatible coating applied to magnet (110) may be gold. The biocompatible coating prevents release of toxic or reactive substances into the body reducing the risk of adverse reaction or tissue damage.

[0085] The presence of this biocompatible coating serves to inhibit the leaching of potentially toxic or reactive substances into the biological body, thereby reducing the likelihood of adverse reactions or tissue damage.

[0086] Now, referring to the embodiments in Figure 1A - ID, said wire-guided pusher tube (102a) has a diameter of lOFr (French) and is comprised of Teflon. Said pusher tube (102a) incorporates a guide wire (104) which is configured to facilitate the entry of the magnet (110) into the common bile duct (CBD) and its subsequent positioning at a target stricture site where recanalization is required. The target location may correspond to either an upper end (proximal end) of the affected stricture or a lower end (distal end) of the affected stricture. Said guide-wire (104) has a diameter in the range of 0.018 inches to 0.035 inches and is comprised of nitinol. The wire-guided pusher tube (102a) is particularly suited for magnet deployment during endoscopic procedures and percutaneous magnet deployment.

[0087] Referring again to Figures 1A - IE, a pushing mechanism (120) is used to actuate the guide wire (104), thereby advancing the magnet (110). Said pushing mechanism (120) may be attached to the pusher tube (102a) or may be external to the tube (102a).

[0088] In an embodiment, said guide wire (104) may extend beyond the pushing mechanism (120). As shown in Figures 1A - ID, a section (104b) of the guide wire (104) may extend out of the pushing mechanism (120) and into the pusher tube (102a). Further, as depicted in Figure 1C, said pushing mechanism (120) may incorporate a pusher sheath (112) to push the magnet(110) out of said pusher tube (102a). Additionally, a section (104a) of guide wire 104 extends out from the through-hole of magnet (110).

[0089] Now, referring to the embodiments shown in Figure IE, the magnet retrieval tube (102b) has a diameter of 9 Fr and is used to retrieve the magnet (110) back from the CBD after the recanalization procedure.

[0090] According to the embodiments shown in Figure 3, said equipment (100) for magnetic recanalization of benign biliary stricture works in conjunction with a visualization system (300) to guide pusher tube (102a) and the retrieval tube (102b) through the biliary stricture. Said visualization system (300) comprises of:

[0091] o an imaging system (310) consisting of:

[0092] — an external imaging device (312) configured to capture visuals in the biliary system from outside the body,

[0093] — an internal imaging device (322) configured to capture visuals in the biliary tract from within the body;

[0094] o an imaging processor (314);

[0095] o a display (302); and

[0096] o a biliary system (320) being visualized.

[0097] Said external imaging device (312) may include, but is not limited to, a fluoroscope, wherein a catheter may be inserted into the bile duct to inject contrast dye and images may be captured with the aid of an external fluoroscope. The visuals from the external imaging device (312) may be captured under the guidance of X-ray and in real-time.

[0098] Said internal imaging (322) device may be inserted in one or more sections of biliary system. Said internal imaging device (322) may include, but is not limited to, a tiny scope that can pass through the working channel of a duodenoscope directly into the bile duct for visualization, such as a cholangiogram.

[0099] Said external imaging device (312) and internal imaging device (322) work alongside each other.The imaging processor processes (314) the images captured by said internal and external imaging devices and display them on said display (302) to provide visualisation of anatomy of the biliary system (320).

[0100] In yet another embodiment of the present invention as illustrated in Figure 2, a technique for operation (200) for utilizing said equipment (100) for magnetic recanalization of benign biliary strictures is shown, wherein the steps followed are as stated below:

[0101] — 204: a lOFr wire-guided pusher tube (102a) is advanced toward a stricture within the bile duct, wherein a guide-wire is utilized to assist and deploy at least one magnet (110) to said affected stricture within the bile duct through the wire-guided pusher tube (102a);

[0102] — 206: at least one magnet (110) is deployed using a wire-guided pusher tube (102a) to position a first magnet (110) at the upper end of the stricture and a second magnet at the lower end of the stricture, simultaneously, wherein:

[0103] the first magnet (110) is delivered to the upper end of the stricture following a percutaneous transhepatic biliary drainage (PTBD) procedure, and

[0104] the second magnet (110) is delivered to the lower end of the stricture following an endoscopic retrograde cholangiopancreatography (ERCP) guided delivery process, which includes cannulation of the common bile duct (CBD) and endoscopic sphincterotomy; and

[0105] the first magnet, positioned at the upper end of the stricture, and the second magnet, positioned at the lower end of the stricture, are simultaneously pushed towards each other;

[0106] — 208: at least one magnet is retrieved using a 9Fr magnet retrieval tube, wherein:

[0107] some biopsy forceps with metal tips are inserted into the common bile duct (CBD), through a pusher tube (102a), and said magnet is pulled out of the stricture, or / anda catheter is utilized to push the magnet out of the CBD and into the small intestine.

[0108] WORKING OF THE INVENTION

[0109] Referring again to the embodiments shown in Figure 2, a method of performing magnetic recanalization of benign biliary stricture (200) is provided using said equipment (100). Said method (200) comprises the following steps:

[0110] a. performing a percutaneous transhepatic biliary drainage (PTBD) procedure by inserting a 7Fr (French) sheath into one section of the hepatic duct followed by visualizing the anatomy of the bile duct with the help of the visualization system (300), thereby assessing the severity of the stricture and establishing a path for subsequent interventions;

[0111] b. dilating (202), a bile duct upto lOFr by performing stricture dilation to expand an affected stricture within said bile duct upto 10mm CRE (controlled radial expansion), wherein said stricture dilation comprises performing balloon dilation;

[0112] c. advancing (204), a lOFr wire-guided magnet pusher tube (102a) toward said stricture within the bile duct, wherein said advancing comprises utilizing a guidewire (104) to assist and deploy at least one magnet to said affected stricture within the bile duct through the wire-guided pusher tube;

[0113] d. deploying (206), at least one magnet using a wire-guided pusher tube to simultaneously position a first magnet at the upper end of the stricture and a second magnet at the lower end of the stricture, wherein,

[0114] the first magnet is delivered to the upper end of the stricture following a percutaneous transhepatic biliary drainage (PTBD) procedure, and

[0115] the second magnet is delivered to the lower end of the stricture following an endoscopic retrograde cholangiopancreatography (ERCP)guided delivery process, which includes cannulation of the common bile duct (CBD) and endoscopic sphincterotomy, and

[0116] the first magnet, positioned at the upper end of the stricture, and the second magnet, positioned at the lower end of the stricture, are simultaneously pushed towards each other;

[0117] e. retrieving (208), the at least one magnet using a 9Fr magnet retrieval tube by:

[0118] either inserting some biopsy forceps with metal tips into the common bile duct (CBD), through a pusher tube, and pulling said magnet out of the stricture, or / and

[0119] utilizing a catheter composed of Teflon, to push the magnet out of the CBD and into the small intestine;

[0120] f. conducting post-operative monitoring either immediately following magnet placement or after the resolution of the stricture, and wherein said post-operative monitoring comprises examining abdominal X-rays for the first 72 hours, monitoring bile duct drainage, observing stool colour, or / and performing cholangioscopy to perform recanalization.

[0121] ADVANTAGES OF THE INVENTION

[0122] An equipment for magnetic recanalization of benign biliary stricture as illustrated in the above provides the following advantages:

[0123] • treats benign biliary strictures of less than 2cm size (<2cm).

[0124] • provides easy insertion and retrieval mechanism for the magnet.

[0125] • is minimally invasive

[0126] • eliminates the risk of re-operation

[0127] • does not require long operative procedures to be performed.

Claims

CLAIM,1. An equipment (100) for magnetic recanalization of benign biliary strictures, comprising:at least one magnet (110) configured for insertion into the bile duct and subsequent retrieval from the bile duct;a wire-guided magnet pusher tube (102a) configured for controlled delivery and deployment of the at least one magnet to the target site; a magnet retrieval tube (102b) configured for removal of magnet from the biliary system (320) after magnetic recanalization; wherein, said magnet (110) may be a solid cylinder or may be configured as a wire-guided magnet comprising a through hole to allow guide wire (104) to pass through;said wire-guided magnet pusher tube incorporates a guide wire (104) configured to facilitate the entry of the magnet (110) into the common bile duct (CBD) to a target stricture site where recanalization is required; said magnet retrieval tube (102b) is devoid of guide-wire (104) and is configured for removal of magnet from the biliary system (320) after magnetic recanalization.

2. The equipment (100) as claimed in claim 1, wherein said magnet (110) is a solid cylinder comprising of neodymium and has a diameter ranging from 0.1 inches to 0.2 inches, preferably 0.125 inches, and a length ranging from 0.25 inches to 0.75 inches, preferably 0.500 inches.

3. The equipment (100) as claimed in claims 1 & 2, wherein said magnet (110) is a wire-guided magnet having a diameter of 3 mm and a length within the range of 5mm to 10mm, inclusive, and comprise a through- hole, to allow a guide-wire (104) to pass through it.

4. The equipment (100) as claimed in claims 1 & 2, wherein said magnet (110) is a biocompatible magnet having a coating of gold.

5. The equipment (100) as claimed in claim 1, wherein said pusher tube (102a) has a diameter of 10 French and is comprised of Teflon.

6. The equipment (100) as claimed in claim 1, wherein said pusher tube (102a) may comprise a pushing mechanism (120) to actuate the guide wire (104) to push said magnet (110) out of the pusher tube (102a).

7. The equipment (100) as claimed in claim 1, wherein said guidewire, has a diameter of within a range of 0.018 inches and 0.035 inches and is made of nitinol.

8. The equipment (100) as claimed in claim 1, wherein the magnet retrieval tube has a diameter of 9 Fr.

9. The equipment (100) as claimed in claim 1, wherein said equipment (100) works in conjunction with a visualization system (300) to guide pusher tube through the biliary stricture and wherein said visualization system (300) uses an imaging system (310) to provide visualization of the biliary duct.

10. The equipment (100) as claimed in claim 9, wherein said visualization system comprises:an imaging system (310) consisting of an external imaging device (312) working alongside and an internal imaging device (322) to capture visuals in the biliary system from outside the body and of the inside of biliary tract from within the body, respectively.

11. The equipment (100) as claimed in claim 1, wherein said equipment (100) is utilized in the following way:advancement (204), of magnet pusher tube (102a) toward a stricture to deploy at least one magnet, wherein the magnet pusher tube (102a) is assisted by a guide wire (104);deployment (206), of the at least one magnet (110) to at least one of:an upper end of the stricture; ora lower end of the stricture;wherein the deployment of at least one magnet includes simultaneously delivering a first magnet to the upper end of the stricture and a second magnet to the lower end of the stricture retrieval (208), of at least one magnet (110) using a magnet retrieval tube (104b), wherein retrieval of at least one magnet includes at least one of the following methods:utilization of the pusher tube to insert biopsy forceps with metal tip into the CBD and pull at least one magnet out of the stricture; orutilization of a catheter to push at least one magnet out of the CBD and into the small intestine.

12. A method for performing magnetic recanalization of benign biliary stricture by utilizing said equipment (100), comprises:performing a percutaneous transhepatic biliary drainage (PTBD) procedure by inserting a 7Fr (French) sheath into one section of the hepatic duct followed by visualizing the anatomy of the bile duct with the help of the visualization system (300),dilating (202), a bile duct up to 10 French by performing stricture dilation to expand an affected stricture within the bile duct to up to 10 mm CRE, wherein said performing stricture dilation further comprises performing balloon dilation;advancing (204), a magnet pusher tube toward a stricture to deploy at least one magnet, wherein the magnet pusher tube is assisted by a guide wire;deploying (206), the at least one magnet to at least one of:an upper end of the stricture; ora lower end of the stricture after performing cannulation of the common bile duct (CBD) and performing endoscopic sphincterotomy;retrieving (208), the at least one magnet using a magnet retrieval tube, followed by conducting post-operative monitoring.

13. The method as claimed in claim 12, wherein said deploying at least one magnet further comprises simultaneously delivering a first magnet to the upper end of the stricture and a second magnet to the lower end of the stricture.

14. The method as claimed in claim 12, wherein said conducting post- operative monitoring further comprises at least one of:examining abdominal X-rays for the first 72 hours;monitoring bile duct drainage;observing colour of the stool; orperforming cholangioscopy to confirm recanalization.

Images