TW202135735A - Apparatus and method for deploying medical device for gastrointestinal diseases - Google Patents

Abstract

Provided herein as a transoral minimally invasive method and a system thereof for the treatment of gastrointestinal diseases and/or obesity, which at least partially encircles a part of the gastrointestinal tract, such as esophagus of the patient by advancing a pre-shape dissector endoluminally, laterally, anteriorly or posteriorly to the subfascial area from outer wall outer wall of the esophagus and introducing the pre-shape dissector sub-fascially in the subfascial area, whereby at least one part of the encircled esophagus will be provided with an additional mechanical augmentation.

Description

Apparatus and method for configuring medical equipment for gastrointestinal diseases

This specification relates to surgical devices, systems, and procedures for the treatment of gastrointestinal diseases and/or obesity. More specifically, this description relates to surgical devices, systems, and procedures for controlling, navigating, and configuring medical equipment to a target location.

Gastrointestinal diseases refer to diseases involving the gastrointestinal tract, namely the esophagus, stomach, small intestine, large intestine, and rectum, as well as the auxiliary organs of digestion, liver, gallbladder, and pancreas, including gastroesophageal reflux, abdominal pain, constipation, and irritable bowel syndrome , Hemorrhoids, anal fissure, perianal abscess, anal fistula, perianal infection, colorectal diverticulosis, colitis, colorectal polyps, and cancer and other symptoms.

Gastroesophageal reflux disease (GERD) is the most common gastrointestinal disease of the esophagus. It is a chronic and progressive disease. The most typical manifestations are heartburn and reflux, while atypical manifestations are chest pain, dysphagia, chronic cough, hysteria, or sore throat. The main methods to diagnose and determine the characteristics of the disease are upper gastrointestinal endoscopy (esophagoduodenoscopy, EGD), high-resolution esophageal pressure gauge, and symptom-related ambulatory esophageal pH impedance monitoring. Epidemiological data has shown that obesity is an important risk factor for the development of gastroesophageal reflux disease. There is also more and more data showing that obesity is associated with long-term reflux-related complications, such as erosive esophagitis, Barrett’s esophagus, and esophageal adenocarcinoma.

The treatment of gastroesophageal reflux disease (GERD) includes various diet and lifestyle adjustments (for example, avoiding acidic foods, carbonated drinks, alcohol, and cigarettes), and pharmaceutical compositions (for example, antisecretory drugs, most commonly hydrogen ion Pump blockers (proton pump inhibitors, PPIs)) and surgery. There are many surgical methods for the treatment of gastroesophageal reflux disease (GERD) known in the prior art. One of the methods for surgical treatment of gastroesophageal reflux disease (GERD) is laparoscopic fundoplication, which is a minimally invasive operation that restores the function of the lower esophageal sphincter (the valve between the esophagus and the stomach) by wrapping the stomach Around the esophagus, a new "functional valve" is formed between the esophagus and the stomach, and prevents gastric acid and bile (non-acidic liquid) from returning from the stomach to the esophagus.

Another treatment for gastroesophageal reflux disease (GERD) is gastric bypass, which is a bariatric surgery that involves creating a pouch from the stomach and connecting the newly created pouch directly to the small intestine, resulting in reduced nutrient absorption and relief by the patient Symptoms of gastroesophageal reflux disease (GERD). Another method is the application of magnetic bead sphincter enhancement, which is designed to enhance the lower esophageal sphincter (LES ), the magneto-mechanical means consists of magnetic beads, which are connected by titanium chains, which allow the magnetic beads to be opened when swallowing or hiccups. Magnetic attraction exerts force to strengthen the lower esophageal sphincter (LES)). Another method is electrical stimulation (EndoStim LES stimulation system; EndoStim BV, The Hague, Netherlands) with laparoscopically implanted electrodes in the lower esophageal sphincter (LES), which automatically transfers tiny electrical pulses from the implanted The pulse generator is delivered to the weakened lower esophageal sphincter (LES) muscle. The pulse stimulates the muscle to function as a healthy lower esophageal sphincter (LES), which opens during swallowing, hiccups, and other normal behaviors, but remains closed at other times.

In addition, several techniques have been developed to provide an oral minimally invasive treatment of gastroesophageal reflux disease (GERD). These operations are usually performed endoscopically under general anesthesia. The Esophyx® device (Endogastric Solutions, Redmond, Washington) claims to restore the dynamics of the endoscopic angle with internal wrapping or fundoplication greater than 270°. The device utilizes a tissue grasping mechanism through a standard endoscope and a proprietary suture system. Compared to the Esophyx® device, the MUSE™ system (Medigus, Israel) is an ultrasonic surgical stapler that is embedded in a customized endoscope to perform a similar oral fundoplication.

The surgery outlined above is limited by various factors. For example, patients undergoing laparoscopic fundoplication require hospitalization and a recovery period of 7 to 10 days. Similarly, various gastric bypass operations in which a part of the gastrointestinal tract is surgically removed result in insufficient nutrition or malnutrition in patients. Furthermore, this type of operation is usually highly invasive and irreversible. In addition, the use of magnetic bead sphincter enhancement is only discussed in small esophageal hernias that are undergoing primary femoral repair at the same time. In addition, the Linx™ system using multiple titanium beads with magnetic cores is used to treat gastroesophageal reflux disease (GERD). However, the Linx™ system is not compatible with magnetic resonance imaging (MRI).

It can be seen that there is a need for safe, reliable, cost-effective, and minimally invasive devices, systems, and methods for gastrointestinal diseases and/or obesity.

The present invention provides systems, devices, and methods for effective and minimally invasive treatment of gastrointestinal diseases (eg, gastroesophageal reflux disease (GERD)) and/or obesity. In a specific embodiment, the present invention provides a minimally invasive method to configure a medical device for treating a patient. The device is adjustable in at least one dimension (e.g., deformable, bendable, or expandable) to partially surround one or more target tissues or organs in order to provide additional mechanical reinforcement on the enclosed portion.

According to the present invention, there is provided a method of arranging a medical device to a target position of a patient, comprising: a) placing an endoscopic device in the cavity of the patient at a first position in the esophagus of the patient; b) corresponding to The image captured by the endoscopic device introduces a flexible and elongated sheath into a second position in a subfascial area outside the esophagus, wherein the sheath has a hollow interior and further includes: a steerable The guiding member is movably disposed inside the sheath, and includes a guided portion and a formable part, the formable part is adjacent to the distal end of the guided part, wherein the formable part is guided To deflect from its longitudinal axis and return to its longitudinal axis; and a pre-formed dissector, comprising a deformable elongated body, the pre-formed dissector is located on at least a portion of the formable portion and can be guided from the guide member Delivery; c) deflecting the formable portion of the guiding member from the second position along the subfascial region, whereby the deformable elongated body of the preformed dissector forms a line thereon The shapeable portion advances a curved portion of the path to at least partially surround the esophagus; and d) when the guide member is retracted, the curved portion of the dissector is at least partially retained around the esophagus, and thereby Mechanical reinforcement is applied to the esophagus through the curved portion.

In a specific embodiment, the flexible and elongated sheath of b) above can be introduced into the second position. In another embodiment, the flexible and elongated sheath tube may further include a connector that connects the sheath tube to the endoscopic device, and the connector includes a connector that allows the endoscopic device to extend therethrough And a second opening that allows the sheath to extend through it. Therefore, the sheath and the endoscopic device can be configured at the same time.

In some embodiments, the flexible and elongated sheath of b) above can be introduced into the second position through different positions of the patient's body. For example, in a specific embodiment, the sheath can be inserted transversely through a part of a phrenoesophageal ligament (POL) to approach the second position. In another embodiment, the sheath can be inserted forward through a part of the phrenic esophageal ligament (POL) to approach the second position. In another embodiment, the sheath can be inserted backwards through a part of the phrenic esophageal ligament (POL) to approach the second position.

In some embodiments, the method may further include the steps of: providing a first magnet at a distal end of the endoscopic device and providing a second magnet at a distal end of the flexible elongated sheath. magnet. In other embodiments, when a magnetic field is applied, the distal end of the sheath can be guided to the second position in response to the movement of the endoscopic device.

In some embodiments, the first location in the esophagus may be at the esophagus-gastric junction, the esophagus-diaphragm junction, or the stomach-diaphragm junction.

In some embodiments, the above b) may further include: forming an opening between the first position and the second position so that the flexible and elongated sheath can be advanced and retracted therethrough; and At least one inflatable balloon is provided at the distal end of the flexible and elongated sheath, and the subfascial region is dissected and supported when the balloon is inflated. In another embodiment, a needle or a cannula can be used to form the opening.

In some embodiments, the formable portion of b) above may include a shape memory material, such as a shape memory alloy, including but not limited to an alloy containing nickel and titanium.

In some embodiments, the pre-shaped dissector can be a coil or spring-like member.

These and other features, aspects and advantages of the present invention will be better understood with reference to the following drawings, descriptions, and the scope of the patent application.

Figure 1A herein is a cross-sectional view of a part of human gastrointestinal (GI) tract 10 (hereinafter referred to as gastrointestinal tract 10) disclosed in, for example, US Patent No. 8,868,215 B2 and US Patent No. 8,874,216 B2, all of which are incorporated by reference in the above-mentioned US patents. The content is incorporated herein, except for any definitions, subject disclaimers or denials, and except to the extent that the incorporated materials are inconsistent with the express disclosure of this article, in this case, the language in the present disclosure shall prevail. Fig. 1B is a transverse section of the gastrointestinal tract 10 of Fig. 1A. Fig. 1C is an enlarged view of a part of the gastrointestinal tract 10 of Fig. 1B. The gastrointestinal tract 10 includes the esophagus 12, the stomach 14, the diaphragm 16, and the cardia 18. The histological changes between the esophagus tissue 20 of the esophagus 12 and the stomach tissue 22 of the stomach 14 occur at the esophagus-gastric junction 24, which is also called the "z-line." The esophagus 12 passes through the opening of the diaphragm 16 called the esophageal space 26. Approximately above the esophageal space 26, the esophagus 12 is fixed to the diaphragm 16 through the upper edge of the phrenoesophageal ligament (POL) 28 (hereinafter referred to as POL 28). The POL 28 is composed of two closely aligned layers, including one layer derived from the intrathoracic fascia 30 and another layer derived from the transverse fascia 32. The lower edge of the POL 28 is attached to the stomach 14 approximately below the esophageal space 26. A subfascial area 34 (that is, a gastroesophageal (GE) space) is formed between the inner wall 280 of the POL 28 and the outer wall 122 of the esophagus 12 and the cardia 18. The subfascial region 34 is filled with fatty tissue and is penetrated by blood vessels.

This document describes and shows a method that uses a delivery system to deploy a medical device cavity into the esophagus 12 at its intended placement location around the esophagus, and then pass through the inner wall 120 of the esophagus 12 and pass outwards therethrough The outer wall 122 (see, for example, FIG. 4), and enters the subfascial region 34, and a medical device (for example, see FIG. 9) is introduced under the fascia in the subfascial region 34 to surround or substantially surround the At least a portion of the esophagus 12 in order to apply mechanical reinforcement (ie, additional mechanical pressure from the medical device) to the enclosed or substantially enclosed portion of the esophagus 12.

2 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment of the present invention, which describes a "binocular" shaped endoscope 50 and a guide relative to the patient's esophagus 12 The organ cavity is introduced to the target location near the junction of the esophagus and stomach. As shown in FIG. 1, the endoscope device may be a conventional endoscope 50 or an ultrasonic endoscope placed at the esophagus-stomach junction 24 relative to the inside of the patient's esophagus 12. The endoscope 50 can be of any type known in the art, including, for example, a device configured as follows: a flexible insertion tube 52 (partially shown) having a proximal end (not shown) and a distal end 54 The sexual insertion tube 52 is configured to extend in the longitudinal direction and can be inserted into an integrated cavity, which is the esophagus 12 here, to generate detailed images of the inner membrane and walls 120 and 122 of the esophagus 12. In order to accurately navigate a medical device to the target location, the flexible insertion tube 52 includes a first magnet 56 provided at its distal end 54. The first magnet 56 is configured to attract and guide a corresponding The second magnet 68 is mounted at a distal end 66 of a catheter shaft 62 extending outward from an introducer 42 (see, for example, FIG. 3). The first magnet 56 here is designed as an annular member to surround a part of the outer wall 55 of the distal end 54 of the endoscope 50. The endoscope 50 further includes a handle (not shown) provided at the proximal end of the flexible insertion tube 52. The handle includes a deflection control knob (not shown). The operator can move the deflection control knob to selectively and controllably bend the distal end 54 of the flexible insertion tube 52, so that the operator of the endoscope 50 can The distal end 54 of the flexible insertion tube 52 is navigated to a target position in the esophagus 12 according to the detailed image provided by the endoscope 50. In one embodiment, the distal end 54 of the flexible insertion tube 52 includes a camera, one or more additional working channels for slidingly providing tool access and control, and an illumination device, such as an LED or a light beam (not shown) , And flushing and suction ports (not shown), or inflatable devices, such as one or more inflatable components, such as balloons.

As shown in FIG. 2, an introducer 42 is connected to the endoscope 50 via a coupling 44. The coupler 44 is made of stainless steel or other biocompatible materials, and is used to position the distal end 54 of the flexible insertion tube 52 and the introducer 42 relative to each other. The coupling 44 includes an outer wall 55 surrounding the flexible insertion tube 52 and a connecting portion 440 of the introducer 42, and a plurality of, in the described embodiment, there are two, extending substantially side by side therethrough The openings 442, 444. The flexible insertion tube 52 extends through and tightly fits into the first opening 442 of the coupling 44, and the introducer 42 extends through and tightly fits into the second opening 444, thereby forming the flexible insertion The tube 52 and the guide 42 have a side-by-side "double-cylinder" structure. Therefore, the introducer 42 is fixed to move intracavitary together with the endoscope 50 to a target position close to the esophagus-gastric junction 24. Here, the introducer 42 is a tubular structure, which includes a hollow interior 43 to accommodate a catheter 60 movably disposed therein, and an opening 430 at the distal end 420 thereof. In some embodiments, the introducer 42 can be an endoscope trocar or a tube.

FIG. 3 includes a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment of the present invention, which depicts a catheter advanced outward from the distal end of the introducer 42. The catheter 60 here includes a flexible and elongated catheter shaft 62 (FIG. 4 ), a proximal end (not shown), and a distal end 66. The catheter shaft 62 has a hole 620 such that a wire 70 (see, for example, FIG. 7) can extend or retract through the hole 620, and can extend outward from an opening (not shown) at the distal end 66 thereof. A second magnet 68 is disposed at the distal end 66 of the catheter 60 and is configured to be attracted and guided by the first magnet 56. The second magnet 68 is designed as an annular member here to surround a part of the outer wall 61 of the distal end 66 of the catheter 60. Adjacent to the second magnet 68 is an inflatable balloon area 63 surrounding a portion of the outer wall 61 of the catheter 60 at its distal end 66. The balloon region 63 is configured to open or dissect the subfascial region 34 (see, for example, FIG. 7) when inflated, and can be inflated by any prior art known in the art. For example, the balloon technology is disclosed in US Patent No. US 8,868,215 B2, the entire contents of which are incorporated herein by reference, except for any definitions, subject disclaimers or disclaimers, and except that the incorporated materials are inconsistent with the express disclosure of this article In this case, the language in this disclosure shall prevail.

4 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts that when the balloon region 63 is inflated, the distal end 66 of the catheter 60 is in the subfascial region 34. The catheter shaft 62 passes through the interior 43 of the guide 42 at a position (not shown) extending outward from the patient’s mouth, and is pushed along the interior 43 of the guide 42 toward and through the inner wall 120 of the esophagus 12 And outer wall 122. In order to deliver the distal end 66 of the catheter 60 to the subfascial region 34, an incision is formed between the inner wall 120 and the outer wall 122 of the esophagus 12 at the esophagus-gastric junction 24. For example, a puncture device (not shown) advances from one of the working channels (not shown) of the endoscope 50 toward the inner wall at the esophagus-gastric junction 24, enters and passes through the inner wall to form a connected channel 124 or by passing through the structure of the esophagus 12 from the inner and outer walls of the esophagus 12, the connecting channel 124 is formed to extend between the interior of the esophagus 12 and the subfascial region 34 of the POL 28. The piercing device includes a flexible elongated member with a piercing part at its distal end. In one embodiment, the puncture device is a flexible needle, a cannula, or an ablation catheter. Once the puncture portion reaches the target position of the esophagus-stomach junction 24, the puncture portion is pushed into the inner wall 120 of the esophagus 12, thereby perforating the local inner wall 120 and the outer wall 122 of the esophagus 12, which is due to mechanical force. An anchor (not shown) is applied to it through the piercing part (for example, a needle tip or a set of tube tip). Alternatively, the inner wall 120 and the outer wall 122 of the esophagus 12 can be perforated by heat or cold energy applied by a puncture part (for example, the tip of the ablation catheter). Thus, a connecting channel 124 is created, which connects the internal volume of the esophagus 12 with the subfascial region 34 of the POL 28. When the distal end of the catheter 60 is introduced into the subfascial area 34, the inflatable balloon area 63 is inflated to help open or dissect the subfascial area 34, thereby benefiting the distal end 66 of the catheter 60 Advance within this subfascial region 34.

5 is a schematic diagram of placing the distal end 66 of the catheter 60 in the subfascial region as shown in FIG. 1C according to a specific embodiment, which depicts a first magnet 56 at the distal end of the endoscope 50 It is manipulated to attract and guide a corresponding second magnet 68 at the distal end 66 of the catheter 60 to advance the distal end of the catheter 60 in the subfascial region 34. 6 is a schematic diagram of the distal end of the catheter 60 being advanced in the subfascial region 34 as shown in FIG. 1C according to a specific embodiment, which describes that the distal end 66 of the catheter 60 is guided under the fascia The area 34 moves to surround the outer wall of the esophagus. As also shown in Figures 5 and 6, the operator can selectively and controllably use the handle (not shown) of the endoscope 50 to rotate the endoscope 50 around its longitudinal axis L so as to rotate around the The first magnet 56 of the distal end 54 of the endoscope 50 can be rotated accordingly, which attracts the second magnet 68, thereby pulling the distal end 66 of the catheter 60 toward the outer wall 122 of the esophagus 12 near the subfascial region 34 And move along it. Once configured, the configured distal end 66 of the catheter 60 forms a guide 65 through which a guide wire 70 (see, for example, FIG. 7) is guided to be positioned around or substantially at the outer wall 122 of the esophagus 12 Its surroundings.

7 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts a guide wire being introduced into the distal end 66 of the catheter 60 and outward from the distal end 66 of the catheter 60 extend. 8 is a schematic diagram of a step of a method of configuring a medical device according to a specific embodiment, which depicts a shapeable portion 74 of a guide wire formed of a shape memory material, which is in the subfascial region 34 Regain its shape to surround the outer wall where it was eaten. The catheter shaft 62 has a hole 620 to accommodate a guide wire 70 and a pre-formed dissector 80 over a portion of the wire 70 (see, for example, FIG. 9). The wire 70 is movably disposed in the hole 620 of the catheter 60 and extends outward from the distal end 66 of the catheter 60. The wire 70 includes a flexible elongate shaft 72 and a formable portion 74 adjacent to and extending from the distal end 76 of the wire shaft 72. The guide wire shaft 72 can extend or retract through the hole 620, and extends outward from an opening (not shown) at the distal end 66 of the catheter 60. When configured to pass through the hole 620 of the catheter 60, the The distance is sufficient to extend to a location outside the patient's mouth (not shown), plus at least the length of the formable portion 74. The formable portion 74 is composed of a shape memory material (for example, a shape memory alloy including nickel and titanium), which can maintain a substantially linear configuration in a constrained state, and restore its shape in an unconstrained state. The wire shaft 72 does not need to be made of a shape memory material, but can be any suitable biocompatible material of the wire 70. The operator can operate any wire controller known in the art (for example, a handheld controller) to selectively and controllably manipulate the movement or deflection of the formable portion 74. In an unconstrained state, the formable portion 74 with the guide wire shaft 72 is introduced into the hole 620 from the proximal end 64 of the catheter 60, advances in the hole 620, and enters the guide portion of the catheter 60 65. The formable portion 74 is then restricted to the shape of the guide portion 60 so that it is deflected along the wire shaft 72 from its longitudinal axis L1 to form a bent portion 78, which then extends substantially along the circumference of a circle to be located at the The outer wall 122 of the esophagus 12 surrounds or substantially surrounds the outer wall 122 of the esophagus 12. The operator of the guide wire 70 can also use the camera of the endoscope 50 and a monitor (not shown) adjacent to the working area outside the patient to view the connected channel 124 and the position of the guide portion 65 of the catheter 60 , So that the wire 70 extends inward from the guide portion 65. When the formable portion 74 is configured to surround the esophagus 12, the balloon area 63 of the catheter 60 is flattened, and the catheter 60 is retracted inwardly from the opening 430 in the introducer 42, for example, from the Pull out the patient's external position. As a result, when the catheter 60 is retracted, the formable portion 74 of the guide wire 70 remains around the esophagus 12.

9 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts a pre-shaped dissector located above a shaped part of the guide wire surrounding the outer wall of the esophagus along the advancing path of the shaped part . FIG. 10 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which describes that when the guide wire 74 has been retracted, a pre-formed dissector remains around the outer wall of the esophagus. The pre-formed dissector 80 is configured to open or dissect the subfascial region 34 when advanced in the subfascial region 34, and when configured to provide additional mechanical compression to squeeze the surrounding portion of the esophagus 12 . The pre-formed dissector 80 is here designed as a coil or a spring-like member, in which a biocompatible shape memory material is wound as a coil and wound longitudinally along the central axis, and the resulting coil is in its unconstrained state It is configured as a C-shaped member 82 as shown in FIGS. 9 and 10. In an unconstrained state, the outer diameter or span of the entire circumference of the C-shaped member 82 is smaller than the minimum width of the inner 43 of the guide 42, and the size of its inner diameter is set to be slightly larger than the guide shaft 72 and The maximum diameter of the portion 74 that can be formed. Therefore, the C-shaped member 82 cannot be retracted along the curved portion 78 of the formable portion 74 so that the C-shaped member 82 is disposed around the esophagus 12 while the formable portion 74 is disposed around the esophagus 12. Thereafter, the guide wire 70 is retracted from the subfascial region 34, and the C-shaped member 82 remains in place, as shown in FIG. 10. To prepare for configuration, the C-shaped member 82 is pushed through a push tube (not shown) extending from a location outside the patient's mouth and extending through the inner portion 43 of the introducer 42. The distal end of the push tube abuts on the first end 820 of the C-shaped member 82 to push the C-shaped member 82 and push it out from the catheter 70 along the guide wire shaft 72 and enter the connecting In the channel 124, and therefore outward along the formable portion 74. Once the C-shaped member 82 has been deployed in the subfascial region 34 and around the esophagus 12, as shown in FIG. 9, the guide wire 70 is pulled out of the opening of the introducer 42 by pulling out from a position outside the patient 430 retracts inward. Since the C-shaped member 82 can expand to increase the gap 84 between the first end 820 and the second end 822 thereof, when a material such as food or liquid passes through the esophagus 12, the outer wall of the esophagus 12 will push outward To increase the length of the gap 84, but once the material passes the position of the C-shaped member 82, it will spring back to its free shape to prevent the material from leaching in the opposite direction (stomach-to-oral direction). Therefore, the additional mechanical reinforcement provided by the C-shaped member 82 is applied to the muscle layer around the outer wall 122 of the esophagus 12 (for example, the lower esophageal sphincter (LES)), thereby reducing or preventing gastric reflux and effectively treating gastroesophageal reflux disease (GERD).

11A and 11B are schematic diagrams of one step of a method for configuring a medical device according to another specific embodiment, which depicts a delivery system being inserted laterally adjacent to or through a patient’s diaphragm and entering a subfascial area through POL 34 to deliver the medical device. Figure 11A is a cross section of the gastrointestinal tract as shown in Figure 1B. Figure 11B herein is a cross-sectional view of a part of the gastrointestinal tract as shown in Figure 1A. The delivery system 90 here includes an introducer, a catheter, a guide wire, and a pre-shaped dissector as described above. Using any suitable surgical tool known in the art, such as a laparoscopic tool, an incision 94 is formed on the outer side 92 of the patient's abdomen to allow the introducer (for example, a cannula needle) to be inserted laterally into the transverse The diaphragm 16 or passes through the diaphragm 16 to enter and pass toward the POL 28. Once the introducer is configured, when a balloon region 91 is inflated according to the configuration method described above, a catheter is advanced outward from the distal end of the introducer, and its distal end is introduced into the rib from the POL 28下膜区34。 Under the film area 34. Thereafter, similar to the previous paragraph, a guide wire and a pre-shaped dissector are deployed from the POL 28 into the subfascial region 34, as shown in FIG. 9, leaving the C-shape The component surrounds the esophagus 12.

FIG. 12 is a schematic diagram of one step of a method of configuring a medical device according to another specific embodiment, which depicts a delivery system 90 being inserted forward into a subfascial area to deliver the medical device. FIG. 13 is a schematic diagram of one step of a method of configuring a medical device according to another specific embodiment, which depicts a delivery system 90 being inserted back into a subfascial region 34 to deliver the medical device. Alternatively, as shown in FIG. 12, any suitable surgical tool known in the art can be used to insert the delivery system 90 into the front side 96 of the patient's abdomen, and then advance toward the front of the cardia 18/esophagus 12 through the The diaphragm 16 and the POL 28 enter a subfascial area 34 to deliver the medical device using the method described above. Moreover, in FIG. 13, any suitable surgical tool known in the art (for example, a spinal needle) can be used to insert the delivery system 90 into the back side 98 of the patient's abdomen, thereby advancing it close to the spine 36 In the diaphragm 16 and through the POL 28 into a subfascial area 34, the medical device can be delivered using the method described above.

It should be noted that various modifications or changes can be made to the above exemplary embodiments of the present invention without departing from the technical features of the present invention defined by the scope of the attached patent application.

10: Human Gastrointestinal (GI) Tract 12: Esophagus 14: stomach 16: diaphragm 18: Cardia 22: Stomach tissue 24: Junction of esophagus and stomach 26: Esophagus gap 28: phrenic esophageal ligament (POL) 30: Intrathoracic fascia 34: subfascial area 36: Spine 42: Introducer 43: internal 44: Connector 50: Endoscope 52: Flexible insertion tube 54: remote 55: Outer Wall 56: The first magnet 60: Catheter 61: Outer Wall 62: Catheter shaft 63: Balloon area 64: Near end 65: boot part 66: remote 68: second magnet 70: Wire 72: Wire shaft 74: Formable part 76: remote 78: bend 80: Dissector 82: C-shaped member 84: Clearance 90: delivery system 91: Balloon area 92: Outside 94: incision 96: front 98: rear side 120: inner wall 122: Outer Wall 124: Channel 420: remote 430: open 440: connecting part 442: first opening 444: second opening 620: bore 820: first end 822: second end L1: Longitudinal axis

Figure 1A is a cross-sectional view of a portion of a human gastro-intestinal (GI) tract. Figure 1B is a cross-section of the gastrointestinal tract of Figure 1A. Fig. 1C is an enlarged view of Fig. 1B.

2 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment of the present invention, which depicts the "binocular" shaped endoscope and introducer in the cavity relative to the patient's esophagus Introduce to a target location close to the junction of the esophagus and stomach.

Fig. 3 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment of the present invention, which depicts a catheter advanced outward from a distal end of the introducer.

4 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts that when a balloon area is inflated, the distal end of the catheter is introduced into the subfascial area.

Fig. 5 is a schematic diagram of placing a distal end of the catheter in the subfascial region shown in Fig. 1C according to a specific embodiment, which describes that the first magnet at the distal end of the endoscope is manipulated to The distal end of the catheter attracts and guides a corresponding second magnet, and then advances the distal end of the catheter in the subfascial region.

Fig. 6 is a schematic diagram of advancing the distal end of the catheter into the subfascial area shown in Fig. 1C according to a specific embodiment, which describes that the distal end of the catheter is guided to move in the subfascial area The outer wall surrounding the esophagus.

7 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts a guide wire being guided within the distal end of the catheter and extending outward from the distal end of the catheter .

FIG. 8 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts the shapeable portion of the guide wire recovering its shape in the subfascial region to surround the outer wall of the esophagus.

9 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts a formable part of the guide wire surrounding the outer wall of the esophagus, along a path of advancement of the formable part Pre-shaped dissector.

10 is a schematic diagram of one step of a method of configuring a medical device according to a specific embodiment, which depicts a pre-shaped dissector retained around the outer wall of the esophagus when the guide wire is retracted.

11A and 11B are schematic diagrams of one step of a method of configuring a medical device according to another specific embodiment, which depicts a delivery system that is inserted laterally into an adjacent patient or through the diaphragm of the patient, and passes through the POL Insert a subfascial area to deliver the medical device. Fig. 11A is a transverse section of the gastrointestinal tract shown in Fig. 1B. Fig. 11B is a cross-sectional view of a part of the gastrointestinal tract shown in Fig. 1A.

Fig. 12 is a schematic diagram of one step of a method of configuring a medical device according to another specific embodiment, which describes forwardly inserting a delivery system into a subfascial area to deliver the medical device.

FIG. 13 is a schematic diagram of one step of a method of configuring a medical device according to another specific embodiment, which describes inserting a delivery system backwards into a subfascial area to deliver the medical device.

without

10: Human Gastrointestinal (GI) Tract

12: Esophagus

14: stomach

16: diaphragm

24: Junction of esophagus and stomach

34: subfascial area

42: Introducer

43: internal

44: Connector

50: Endoscope

52: Flexible insertion tube

54: remote

55: Outer Wall

56: The first magnet

120: inner wall

122: Outer Wall

420: remote

430: open

440: connecting part

442: first opening

444: second opening

Claims (13)

A method for arranging a medical device to a target location of a patient, including: a) Place an endoscopic device in a cavity of the patient's esophagus at a first position; b) Corresponding to the image captured by the endoscopic device, a flexible and elongated sheath is introduced to a second position in a subfascial area outside the esophagus, wherein the sheath has a hollow interior and further includes : A steerable guide member, which is movably disposed inside the sheath, and includes a guided portion and a shapeable portion, the shapeable portion is adjacent to the distal end of the guided portion, wherein the shapeable portion The part is guided to deflect from its longitudinal axis and return to its longitudinal axis; and A pre-formed dissector comprising a deformable elongate body, the pre-formed dissector is located on at least a part of the formable portion and can be delivered from the guide member; c) deflecting the shapeable portion of the guiding member from the second position along the subfascial region, whereby the deformable elongated body of the pre-shaped dissector forms a shape along the shapeable portion thereon A curved portion of the propelling path of the shaped portion to at least partially surround the esophagus; and d) When the guiding member is retracted, the curved part of the dissector is at least partially retained around the esophagus, thereby applying mechanical reinforcement to the esophagus through the curved part. The method according to claim 1, wherein the flexible and elongated sheath of step b) is introduced into the second position. The method according to claim 2, wherein the flexible and elongated sheath of step b) further includes a connector for connecting the sheath to the endoscopic device, and the connector includes a connector that allows the endoscope A first opening through which the device extends, and a second opening allowing the sheath to extend therethrough. According to the method described in claim 1, the flexible and elongated sheath of step b) is introduced into the second position by inserting the sheath transversely through a part of a phrenoesophageal ligament (POL) to the second position. The second position. The method according to claim 1, by inserting the sheath forward through a part of a phrenoesophageal ligament (POL) to reach the second position, and introduce the flexible and elongated sheath of step b) The second location. According to the method of claim 1, the flexible and elongated sheath of step b) is introduced into the second position by inserting the sheath backward through a part of a phrenoesophageal ligament (POL) to reach the second position. The second position. The method according to claim 1, further comprising: a step of providing a first magnet at a distal end of the endoscopic device and providing a second magnet at a distal end of the flexible elongated sheath . The method of claim 7, wherein when a magnetic field is applied, the distal end of the sheath is guided to the second position in response to the movement of the endoscopic device. The method according to claim 1, wherein the first position in step a) is at the esophagus-gastric junction, the esophagus-diaphragm junction, or the stomach-diaphragm junction. According to the method described in claim 1, the step b) further includes: An opening is formed between the first position and the second position to allow the flexible and elongated sheath to advance and retract therethrough; and At least an inflatable balloon is provided at the distal end of the flexible and elongated sheath, and the subfascial region is dissected and supported when the balloon is inflated. The method according to claim 10, wherein the opening is formed using a needle or a set of tubes. The method according to claim 1, wherein the formable part of step b) comprises a shape memory material. The method of claim 1, wherein the pre-shaped dissector is configured as a coil or spring-like member.

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