Folding piece system, folding piece / spring system and using method thereof

Abstract

A fold system may have two telescoping members that, when aligned in an open configuration, form one or more windows in which tissue, such as a tubular organ, is trapped. The recessed tissue may be secured in the window when the fold system is transitioned to the closed configuration. For example, closing the window may clamp, pierce, and secure the recessed tubular organ tissue within the window, tubular organ tissue recessed into the window. In some cases, an axially expanding spring may be placed between two fold systems, the axial expansion of the spring may generate an expanding force on the tubular organ when the assembly is implanted into the tubular organ, thereby stimulating the growth of the tubular organ.

Description

Related Applications

[0001] This application is a patent application filed under the Patent Cooperation Treaty, claiming priority to U.S. Provisional Patent Application 63 / 332,230 and incorporating its entirety into this application, which was filed on April 18, 2022 and is entitled "PLICATION SYSTEMS, PLICATION / SPRING SYSTEMS, AND METHODS OF USE THEREOF". Technical Field

[0002] The present disclosure relates generally to fold systems for tubular organs and, more particularly, to fold / spring systems and delivery devices and methods of using fold / spring systems to promote growth and / or elongation of tubular organs. Background Art

[0003] Short bowel syndrome (SBS) is a syndrome caused by a shortened or dysfunctional small intestine, with people who have difficulty adequately digesting food and / or absorbing enough nutrients from the food they ingest to maintain bodily function. Medical treatments for SBS include parenteral nutrition to provide necessary nutrients and water. Surgical treatment options for SBS include intestinal transplantation, surgery to thin and lengthen the intestine to increase the absorption area, and surgery to slow the transit time of food and / or nutrients through the small intestine. Recently, research has been conducted on the use of mechanical forces to lengthen intestinal tissue using various tissue expander devices. However, many of these methods require repeated invasive interventions such as serial screw advancement or saline injections. In addition, stretch enterogenesis (the application of axial force via springs implanted in the small intestine) has also been used to increase intestinal length. Summary of the invention

[0004] The present invention discloses a folding member system for implanting a tubular organ, which may include a retractable cylindrical inner component and an outer component, which may cooperate and hinge between an open position and a closed position. The outer component may include a first lumen, a first groove and a fixing mechanism. In some embodiments, the outer component may include one or more teeth extending into the first groove. These teeth may be configured to engage with the tissue of the trapped tubular organ and fix it in the window portion by clamping and / or piercing the tissue.

[0005] The securing mechanism may be, for example, one or more clip mechanisms configured to engage with one or more of the plurality of protrusions when the folder system is, for example, converted from an open configuration to a closed configuration, thereby locking the inner component in place relative to the outer component in some cases. Additionally or alternatively, the securing mechanism may be a ratchet mechanism and / or include a cantilevered snap configured to engage with a protrusion of the plurality of protrusions and maintain the position of the inner component relative to the outer component.

[0006] The inner component may include a second lumen, a second groove, and a plurality of protrusions extending from an outer surface of the inner component, each of the plurality of protrusions being arranged and configured to engage with a securing mechanism, and a portion of the inner component may be disposed within the outer component such that the first lumen is aligned with the second lumen to form a central lumen for the folding member system. In some cases, the inner component may include one or more teeth extending into the second groove, the one or more teeth being configured to engage with trapped tubular organ tissue and secure it within the window portion by, for example, clamping and / or piercing the tissue. The size of the one or more teeth in the inner component and / or the outer component may correspond to at least one of the size and thickness of the tubular organ.

[0007] The first groove and the second groove may be arranged and configured to form a window having an open area into which a portion of the tubular organ tissue is trapped when the folder system is implanted in the tubular organ and arranged in the open configuration.

[0008] When the inner component is pushed toward the outer component, the folding member system can be configured to transition from an open configuration to a closed configuration, thereby reducing the size of the open area of ​​the window portion and clamping and / or trapping the trapped tubular organ tissue in the open area, thereby firmly implanting the folding member system in the tubular organ.

[0009] In some embodiments, the folding member system may include an occlusion assembly connected to an end of the inner assembly not disposed within the outer assembly and configured to occlude the second lumen. Additionally or alternatively, the folding member system may include a delivery extension device connected to an end of the inner assembly not disposed within the outer assembly. The delivery extension device may be configured for use with a delivery device of the folding member system.

[0010] The folding member and spring system disclosed herein may include a first folding member system, a second folding member system, and a spring disposed between and connected to the first and second folding member systems. The first and second folding member systems may be the same, similar, and / or different in size. The spring may have a tubular body having a lumen that is aligned with the lumens of the first and second folding member systems. The spring is configured to expand axially to push the first folding member system away from the second folding member system.

[0011] In some embodiments, the folding piece and spring system may include an occlusion assembly that can be connected to an end of the first internal component that is not disposed within the first external component and is configured to occlude the second lumen. Additionally or alternatively, the folding piece and spring system may include a delivery extension that is removably connected to an end of the internal component that is not disposed within the second external component and is configured to connect to a delivery device of the folding piece system. In these embodiments, the folding piece and spring system may include a delivery device that is configured to be connected to the delivery extension device. The delivery device may be configured to promote the entrapment of tubular organ tissue into the first window portion of the first folding piece system and the second window portion of the second folding piece system, and promote the closing of the first window portion and the second window portion, thereby fixing the tubular organ tissue entrapped in the first window portion and the second window portion therein.

[0012] A method for implanting a folding member and spring system into a tubular organ of a subject may include positioning the folding member and spring system within the tubular organ, applying negative pressure (e.g., vacuum or suction) to the folding member and spring system, thereby pulling the tubular organ tissue into the window portion of the folding member and spring system, and driving the folding member and spring system to fix the tubular organ tissue within the window portion by clamping and / or puncturing the tissue. For example, the method may be performed by a medical service provider such as a surgeon or a physician. If the folding member and spring system includes an occlusion component that is used to occlude the lumen of the first and / or second folding member and spring system, the method may further include removing the occlusion component after the folding member and spring system is implanted into the tubular organ. For example, a delivery device and / or an inserter may be used to deliver the folding member and spring system to a target site of the subject's tubular organ. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary embodiments and, together with the description, serve to explain the disclosed invention.

[0014] Figure 1A1 is a front side view of a folder system according to some embodiments of the present invention, and the back side view is its mirror image.

[0015] Figure 1A2 is drawn according to some embodiments of the present invention. Figure 1A1 Top view of the folding part system based on the reference.

[0016] Figure 1A3 is drawn according to some embodiments of the present invention. Figure 1A1 Bottom view of the folding system as a reference.

[0017] Figure 1B11 is a right side view of a folder system according to some embodiments of the present invention, and the left side view is its mirror image.

[0018] Figure 1B2 is drawn according to some embodiments of the present invention. Figure 1B1 Top view of the folding part system based on the reference.

[0019] Figure 1B3 is drawn according to some embodiments of the present invention. Figure 1B1 Bottom view of the folding piece system as a reference.

[0020] Fig.1C1 is a three-quarter side view of a folder system according to some embodiments of the present invention, and the one-quarter side view is its mirror image.

[0021] Fig.1C2 is drawn according to some embodiments of the present invention. Fig.1C1 Top view of the folding part system based on the reference.

[0022] Fig.1C3 is drawn according to some embodiments of the present invention. Fig.1C1 Bottom view of the folding piece system as a reference.

[0023] Figure 2A is drawn according to some embodiments of the present invention Figure 1A2 A top view of a folder system is shown with horizontal and vertical section dividing lines superimposed thereon.

[0024] Figure 2B According to some embodiments of the present invention Figure 2A Horizontal section through the folding piece system.

[0025] Figure 2C is drawn according to some embodiments of the present invention Figure 2A Vertical section through a folding piece system.

[0026] Figure 3A is a schematic diagram of a spring according to some embodiments of the present invention that may be used with one or more of the folder systems disclosed herein.

[0027] Figure 3B is a schematic diagram of a spring according to some embodiments of the present invention, wherein the spring is in a compressed state and has three clips.

[0028] Figure 3C According to some embodiments of the present invention Figure 3B Schematic diagram of a spring with the first segment unrolled.

[0029] Figure 3DAccording to some embodiments of the present invention Figure 3B Schematic diagram of a spring with the first and second segments expanded.

[0030] Figure 3E According to some embodiments of the present invention Figure 3B Schematic diagram of a spring with the spring fully extended.

[0031] Figure 3F A schematic diagram of a folder and spring system according to some embodiments of the present invention, wherein the first and second folder systems are located on both sides of the spring, wherein the first and second folder systems are in an open configuration and the spring is in a compressed configuration.

[0032] Figure 3G yes Figure 3F Schematic diagram of a folder and spring system, according to some embodiments of the present invention, wherein the first and second folder systems are in a closed configuration and the spring is in a compressed configuration.

[0033] Figure 3H According to some embodiments of the present invention Figure 3G Schematic diagram of the folding member and spring system with the occlusion assembly removed therefrom.

[0034] Fig. 3I is drawn according to some embodiments of the present invention Figure 3H Schematic diagram of a folding member and spring system with the spring in an open or extended configuration.

[0035] Figure 4A is a photograph taken according to some embodiments of the present invention showing tubular organ tissue being trapped in the window of the folding member system.

[0036] Figure 4B is a photograph taken according to some embodiments of the present invention of tubular organ tissue trapped in a window of a fold and spring system, wherein the fold and spring system includes a fold and a spring.

[0037] Figure 5 is a schematic diagram of connecting a folding member and a spring system with a conveying device for the folding member and the spring system according to some embodiments of the present invention.

[0038] Figure 6 is a flow chart illustrating a process for treating a patient using a fold and spring system according to some embodiments of the present invention.

[0039] Fig. 7A is a schematic diagram of an exemplary fold and spring system configured in accordance with some embodiments of the present invention for insertion of a tubular organ through a skin opening and / or a stoma in a compressed state.

[0040] Figure 7B is drawn according to some embodiments of the present invention Fig. 7A Schematic front view of the flange included in the exemplary folding member and spring system in.

[0041] Figure 7C is drawn according to some embodiments of the present invention Fig. 7A Schematic diagram of an exemplary folding member and spring system in the unfolded state.

[0042] Fig.7D According to some embodiments of the present invention, Fig. 7A A side view of the fold, spring, and flange system in an unstretched state while implanted in a tubular organ of a subject.

[0043] Fig. 7E According to some embodiments of the present invention, Fig. 7A A side view of the fold, spring, and flange system implanted in a tubular organ of a subject and in an extended position.

[0044] Figure 7F is a schematic diagram of another exemplary fold and spring system configured in accordance with some embodiments of the present invention for insertion of a tubular organ through a skin opening and / or a stoma in a compressed state.

[0045] Figure 7G is drawn according to some embodiments of the present invention Figure 7F Schematic diagram of an exemplary folding member and spring system in the unfolded state.

[0046] Figure 8 is a flow chart illustrating a process for treating a patient using a fold and spring system configured for insertion into a tubular organ through a skin opening and / or a stoma, according to some embodiments of the present invention.

[0047] Fig. 9 is a block diagram of a kit according to some embodiments of the present invention.

[0048] Throughout the drawings, unless otherwise indicated, the same reference numerals and characters are used to represent similar features, elements, components or parts of the illustrated embodiments. In addition, although the present invention will now be described in detail with reference to the accompanying drawings, the description is made in conjunction with the illustrative embodiments. Changes and modifications may be made to the described embodiments without departing from the true scope and spirit of the invention as defined by the appended claims. DETAILED DESCRIPTION

[0049] The exemplary embodiments will be described with reference to the accompanying drawings. In the accompanying drawings, the leftmost digit of a reference number indicates the drawing in which the reference number first appears. Where convenient, the same reference numbers are used throughout the drawings to refer to the same or similar parts. Although examples and features of the disclosed principles are described herein, modifications, adjustments and other implementations may be made without departing from the spirit and scope of the disclosed embodiments. "One embodiment" or "this embodiment" mentioned throughout this specification refers to a specific feature, structure or characteristic associated with the embodiment that is included in at least one of the one or more embodiments of the present invention. Therefore, these terms appearing throughout this specification do not necessarily refer to the same embodiment. In addition, in one or more embodiments, specific features, structures or characteristics may be combined in any suitable manner. Unless otherwise defined herein, scientific and technical terms related to this application shall have the meanings commonly understood by ordinary technicians in the technical field to which the present disclosure belongs.

[0050] Embodiments of the present disclosure provide a folding piece system, a folding piece and spring system, a delivery device, a kit including the folding piece and spring system and the delivery device, and methods of using the same for the purpose of stimulating growth (e.g., elongation) by applying an expansion force to a tubular or hollow organ and / or tissue (collectively referred to herein as a "tubular organ") (e.g., the small intestine, the urethra, and / or the fallopian tube). The folding piece and spring system disclosed herein can be implanted into a tubular organ, for example, by laparoscopy or open surgery, and fixed along the length of the tubular organ by forming one or more folds at each end of the folding piece and spring system, and then fixed to the tubular organ tissue by clamping and / or puncturing the tissue.

[0051] The number of folds and spring systems implanted in a patient's tubular organ (e.g., 1-5) may depend on a variety of factors, such as the tubular organ being implanted, the desired amount of tubular organ extension, and / or the type of folds and spring systems being used. When multiple folds and spring systems are used in a patient's body, they can be inserted into the patient's tubular organ simultaneously, for example, at a series of length portions along the tubular organ and / or inserted sequentially over time. When multiple folds and spring systems are implanted simultaneously in a tubular organ, they may be evenly and / or unevenly distributed along the length of the tubular organ.

[0052] The folding member systems, folding member and spring systems disclosed herein generally include a proximal end, a distal end, an expanded configuration and a compressed configuration. Although the folding member system and / or the folding member and spring system are generally axially retractable, they can also be radially retractable, for example, to expand the diameter of a tubular organ. In some variations, the folding member and spring system disclosed herein can be expanded over a period of time, such as 1-8 weeks, so as to apply a stable expansion force to the implanted tubular organ, thereby stimulating the growth of the nearby tubular organ.

[0053] In one embodiment, the fold and spring system disclosed in the present embodiment can be placed using a delivery device through an open surgical procedure by cutting a tubular organ and surrounding tissue, inserting the fold and spring system into the cut tubular organ, applying a vacuum to the fold and spring system to pull the tissue into the opening or window of the fold and spring system so that the tissue can be grasped by the teeth located in the window, and finally closing the fold of the fold and spring system to fix the tissue in the window by clamping and / or piercing the tissue. The fold and spring system can then be released from the delivery device, the delivery device can be removed from the patient, and the surgical opening can be closed. In another embodiment, the device can be placed through a minimally invasive method such as endoscopic surgery. In another embodiment, if a portion of the tubular organ extends beyond the patient's epidermis or beyond the epidermis, thereby forming a stoma (for example, the patient's small intestine extends beyond the abdominal wall to facilitate feeding through a feeding tube), the fold and spring system disclosed in the present embodiment can be placed in the tubular organ through the stoma.

[0054] After the folds and spring system is fully expanded and / or the tubular organ is expanded to a desired length, the folds and spring system disclosed herein can be surgically removed. Alternatively, the folds and spring system disclosed herein can be shed through the natural tissue growth of the tubular organ and discharged through the patient's digestive tract.

[0055] Now refer to the accompanying drawings, Figures 1A1 to 1C3 Schematic diagrams of various views of a folding member system 100 are provided, the folding member system 100 including an inner component 130 and an outer component 132, the inner component 130 and the outer component 132 having different diameters, cooperating like a telescoping cylinder, in some cases, to achieve a smaller compression / actuation width and enclosed vacuum volume. Additionally, or alternatively, the folding member system 100 can be and / or include interlocking hollow discs.

[0056] Specifically, Figure 1A1 is a front side view of the folder system 100, wherein the rear side view is a mirror image thereof; Figure 1A1 As a benchmark, Figure 1A2 is a top view of the folding member system 100; Figure 1A1 As a benchmark, Figure 1A3 is a bottom view of the folder system 100, Figure 1B1 is a right side view of the folder system 100, wherein the left side view is its mirror image; Figure 1B1 As a benchmark, Figure 1B2 is a top view of the folding member system 100; Figure 1B1 As a benchmark, Figure 1B3 is a bottom view of the folder system 100; Fig.1C1is a three-quarter side view of the folder system 100, wherein the one-quarter side view is a mirror image thereof; Fig.1C1 As a benchmark, Fig.1C2 is a top view of the folding member system 100; Fig.1C1 As a benchmark, Fig.1C3 is a bottom view of the folder system 100 .

[0057] like Figure 1A1 As shown, the inner component 130 includes a first groove 136, the upper edge of which (with Figure 1A1 The inner component has an array of protrusions 120 on the outside that cooperate with a locking and / or retaining mechanism 135 (hereinafter referred to as Figure 1B1 Detailed discussion) to maintain the inner component 130 in a desired position relative to the outer component 132. In one embodiment, the protrusion array 120 and / or the locking and / or retaining mechanism 135 may include a ratchet locking mechanism. Other variations of the protrusion array 120 and / or the locking and / or retaining mechanism 135 may include a threaded / screw mechanism, a friction and / or press-fit mechanism, a ring snap, a J-lock mechanism, and / or a latch mechanism.

[0058] The outer component 132 has a second groove 138 with four teeth 115 along the lower edge (with Figure 1A1 As a reference), it is arranged and extends into the gap formed by the second groove 138. Figure 1A1 As shown, when the inner component 130 is located within the outer component 132, the window 110 is located between the inner component 130 and the outer component 132. The window 110 can be configured to receive a portion of tubular organ tissue trapped therein, and the teeth 115 can be configured and arranged to fix the trapped tissue within the window 110 by, for example, clamping and / or piercing the tissue, for example, as shown and described herein.

[0059] from Figure 1A2 , Figure 1A3 , Figure 1B2 , Figure 1B3 , Fig.1C2 and Fig.1C3 As can be seen in FIG. 1 , the folding member system 100 can have a cavity 125 located approximately in the center thereof. The cavity 125 can be configured to allow material (e.g., water, partially digested food, etc.) to pass through so that, for example, the function of the tubular organ is not affected by implanting the folding member system 100 or a device including the folding member system 100.

[0060] like Figure 1B1As shown, folder system 100 includes a locking and / or retaining mechanism 135 configured to engage one or more protrusions of protrusion array 120 via a clamping mechanism and maintain a position of inner component 130 relative to outer component 132 . Fig.1C1 The relative positions of the window 110, teeth 115, protrusion array 120, and locking and / or retaining mechanism 135 are shown, which are arranged circumferentially around the inner component 130 and the outer component 132, respectively.

[0061] Figure 2A yes Figure 1A2 A top view of the folding element system shown, with the horizontal section dividing line AA and the vertical section dividing line BB superimposed thereon, Figure 2B The folder system 100 is along line AA from top to bottom (with Figure 1A1 as a reference), and Figure 2C The folder system 100 is along line BB from top to bottom (with Figure 1A1 As a vertical section diagram of Figure 2B As shown, the internal component 130 and the external component 132 are interlocked at position 142 by two locking and / or retaining mechanisms 135 located on both sides of the external component 132 (i.e., on both sides 180 degrees from each other). In the present embodiment, the two locking and / or retaining mechanisms 135 are configured as two cantilevered clips 150 to engage with the protrusions of the protrusion array 120, thereby fixing the external component 132 in place relative to the internal component 130.

[0062] Figure 3A is a schematic diagram of a spring 320A that can be used in conjunction with one or more folding member systems disclosed herein. In many embodiments, the spring 320A can be an axially expanded hollow tubular body, the lumen of which matches the lumen 125 and maintains the lumen of the implanted tubular organ so that body contents (such as digested food and / or body fluids) can pass through the lumen. The structure of the spring 320A can be a hollow tube, an expanded polymer, a coil and / or a spring, etc. Additionally, or alternatively, the spring 320A can include or contain a braided or woven stent-like structure, which can be made of, for example, filaments or wires.

[0063] In some embodiments, spring 320A may include a single release point that extends like a spring, or may include multiple release points, for example, using a bioabsorbable clip and / or a retaining mechanism 350 to hold spring 320B as Figure 3B The compressed state shown is then released to form Figure 3C-3E The multi-stage assembly shown is extended. In particular, Figure 3B320B is a schematic diagram of a spring 320B in a compressed state. The spring 320B is similar to the spring 320A, except that the spring 320B includes a first clip 350A, a second clip 350B and a third clip 350C, which are arranged along the length direction of the spring 320B as shown in the figure. The first, second and third clips 350A, 350B and 350C divide the spring 320B into a first section 355, a second section 360 and a third section 370. The first clip 350A, the second clip 350B and / or the third clip 350C can be made of a bioabsorbable and / or biodegradable compound, so that when they are absorbed and / or degraded after being implanted in the human body, the force that prevents the axial expansion of the spring 320B will be released, and the spring 320B can expand. In some cases, the first, second and third clips 350A, 350B and 350C can be configured to absorb and / or degrade at different rates, so that the axial expansion of the spring 320B is carried out in a progressive manner. In one example, the first clip 350A can be configured to degrade and / or be absorbed first (eg, 1-14 days after implantation), thereby releasing the first segment 355 of the spring 320B, such as Figure 3C As shown; the second clip 350B can be configured to degrade and / or be absorbed after the first clip 350A is absorbed (eg, 3-20 days after implantation), thereby releasing the second section 360 of the spring 320B, such as Figure 3D as shown; Figure 3E As shown, the third clip 350C can be configured to eventually degrade and / or be absorbed (e.g., within 6-30 days after implantation), thereby releasing the third segment 370 of the spring 320B. After the third clip 350C is absorbed, the spring 320B can also release the third segment 370, allowing the spring 320B to fully expand, such as Figure 3E shown.

[0064] Figure 3F is a schematic diagram of a folder and spring system 300, the folder and spring system 300 including a first folder system 110A and a second folder system 100B located on both sides of a spring 320A or 320B, wherein the first folder system 100A and the second folder system 100B are in an open configuration, and the spring 320A or 320B is in a compressed configuration. The folder and spring system 300 also includes a blocking component 310, which is located at one end of the first folder system 100A. Figure 3F Also shown is a portion of a delivery extension or inserter 340 of a folding member and spring system delivery device, which will be described below in conjunction with Figure 5 This is discussed in more detail. Figure 3FThe first and second folding member systems 100A and 100B are shown to have the same size (e.g., length and diameter), but may be different. In some embodiments, the sizes of the first and second folding member systems 100A and 100B may be different, depending on, for example, the tubular organ to be inserted and / or other factors, such as the patient's anatomy and / or the required expansion rate of the spring 320A or 320B.

[0065] like Figure 3F As shown, the first end of the spring 320A or 320B can be integrated into the first folder system 100A or otherwise connected to the first folder system 100A, and the second end of the spring 320A or 320B can be integrated into the second folder system 100B or otherwise connected to the second folder system 100B. The spring 320A or 320B can be connected to the first folder system 100A and / or the second folder system 100B through, for example, one or more interfaces having grooves in the outer diameter spring 320A or 320B, which can be configured to cooperate with corresponding extensions extending from the internal component 130 of the first folder system 100A and / or the second folder system 100B.

[0066] The fold and spring system 300 and / or its components can have a variety of sizes, depending on the patient's anatomy, the type of tubular organ, and / or the diameter of the tubular organ, etc. Example sizes of the outer diameter of the fold / spring system 300 and / or its components can be, for example, in the range of 8 mm to 30 mm, and example lengths of the fold and spring system 300 in a compressed state can be, for example, in the range of 8 mm to 40 mm, and example lengths in an expanded state can be in the range of 15 mm to 100 mm. The spring force applied to the tubular organ by the fold / spring system 300 implanted in the tubular organ may be, for example, in the range of 0.2N-1.5N, and in some cases, the spring force applied to the tubular organ tissue may be proportional to the size of the cannula and spring system 300 used. For example, when the diameter of the folding member and spring system 300 is 10 mm, when the folding member and spring system 300 is compressed, the maximum compression spring force applied to the tubular organ tissue may be in the range of 0.25-0.45N, while for the folding member and spring system 300 with a diameter of 20 mm, the maximum compression spring force may be in the range of 0.6-0.95N.

[0067] The fold and spring system 300 and / or its components may be made of any suitable material, including but not limited to metals (e.g., stainless steel), nickel titanium alloys (nitinol), plastics, and / or biodegradable / bioabsorbable or non-biodegradable polymers. The springs 320A and / or 320B may be made of any suitable material, including but not limited to metals (e.g., stainless steel), nickel titanium alloys (nitinol), plastics, and / or biodegradable / bioabsorbable or non-biodegradable polymers.

[0068] Exemplary biodegradable / bioabsorbable polymers include, but are not limited to, polyarylates (L-tyrosine derived acid or free acid), poly(α-hydroxy esters), poly(-hydroxy esters), polyamides, poly(amino acids), polyalkoxylates, polyalkylene alkanoates, polyalkyleneoxylates, polyalkylene succinates, polyanhydrides, polyanhydride esters, polyaspartic acid, polybutylene glycolate, polycaprolactone, polyacrylates, polyacrylates, polyacrylates, polyacrylates, polyacrylate polyalkoxylates, poly Alkoxylates, polyalkyl succinates, polyanhydrides, polyanhydride esters, polyaspartic acid, polybutylene glycol diglycolate, polycaprolactone, polycaprolactone / polyethylene glycol copolymer, polycarbonate, tyrosine-derived polycarbonate, polycyanoacrylate, polydihydropyran, poly(dioxolane ketone), poly(p-dioxolane ketone), poly(ε-caprolactone), poly(ε-caprolactone-dimethyltrimethylene carbonate), poly(ester amide), poly(ester), aliphatic polyester, polyether ester, polyethylene glycol / poly-orthoester copolymer, polypentylene glycol, Acid, polyglycolic acid, polyglycolic acid ester, polyglycolic acid ester / polyethylene glycol copolymer, polyhydroxytrimethyl carbonate, poly(hydroxyalkanoic acid), poly(hydroxybutyric acid), poly(hydroxybutyric acid-co-valeric acid), poly(imidocarbonate), polyketone, poly(lactic acid), poly(lactic acid-co-glycolic acid), poly(lactic acid-co-glycolic acid) / poly(ethylene glycol) copolymer, poly(lactone), poly(lactone-co-caprolactone), poly(DL-lactone-co-ethylene glycol), poly(lactone-co-ethylene glycol) / poly(ethylene glycol) copolymer , poly(lactone) / poly(ethylene glycol) copolymers, poly(lactone) / poly(ethylene glycol) copolymers, polypeptides, polyphosphene, polyphosphoesters, polyphosphoester polyurethanes, poly(propyl fumarate-co-ethylene glycol), poly(trimethyl carbonate), polytyrosine carbonate, polyurethane, PorLastin or silk-elastin polymers, spider silk, tephaflex, terpolymers (copolymers of glycidyl ethers, lactams or dimethyl trimethyl carbonates), and compositions, mixtures or copolymers thereof. In one variant, the biodegradable polymer is polycaprolactone (PCL).

[0069] Examples of non-biodegradable polymers include, but are not limited to, poly(ethylene-vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides (such as cellulosic polymers and cellulose derivatives), acyl-substituted cellulose acetate and its derivatives, copolymers of polyethylene glycol and polybutylene terephthalate, polystyrene, polyvinyl chloride, polyvinyl fluoride, polyvinylimidazole, chlorosulfonated polyolefins, polyethylene oxide, and copolymers and mixtures thereof.

[0070] like Figure 3F As shown, the first and second folding member systems 100A and 100B are in a first open configuration, wherein the window 110 is open and the spring 320A and / or the spring 320B are in a compressed or closed configuration, which configuration may be the case before implanting the folding member and spring system 300 into a tubular organ. The occluding assembly 310 may be configured as an assembly for occluding the lumen 125 of the first folding member system 100A so as to apply, for example, negative air pressure (i.e., vacuum) on the folding member and spring system 300. The occluding assembly 310 may be, for example, an occluding balloon, an elastic umbrella (e.g., with or without nitinol ribs), a braided occluding device, and / or a vascular occluding device.

[0071] After the folding member and spring system 300 is delivered to a tubular organ (not shown), negative air pressure applied to the folding member and spring system 300 can pull tissue of the tubular organ into the window portion 110 of the first and second folding member systems 100A and 100B, wherein the tissue can engage with one or more teeth 115 of the first and / or second folding member systems 100A and / or 100B. In some cases, a certain degree of negative air pressure can be applied to the folding member and spring system 300 when the tissue is pulled into the window portion 110, and the negative air pressure needs to take into account the anatomical variability of the tissue. When in the second closed configuration shown in Figure 3, the tissue can be grasped by the teeth 115 and retained in the window portion 110, as described below, for example, respectively. Figure 4A and Figure 4B As shown in photos 401 and 402.

[0072] Once tissue is placed within window 110, first and second folder systems 100A and 100B may be disconnected from the window 110 by, for example, a pull wire, a disconnect fuse, and / or a mechanical fuse feature. Figure 3F First, turn on the configuration transition to Figure 3G Additionally, or alternatively, the first and second folder systems 100A and 100B may be closed by applying negative air pressure to the folder and spring system 300 (i.e., the first and / or second folder systems may be closed by applying a vacuum). Figure 3F The first opening configuration shown in the transition to Figure 3GAdditionally, or alternatively, the transition of the first and second folder systems 100A and 100B from the first, open configuration to the second, closed configuration may be triggered by actuation (e.g., squeezing together) of a handle provided by the delivery device of the folder and spring system 300, such as Figure 5 This is shown and will be discussed below.

[0073] like Figure 3H As shown, once the tissue is secured, clamped, trapped and / or pierced through the closed window 110, the negative pressure is reduced and / or stopped, and the occluder assembly 310 is removed from the folder and spring system 300. The occluder assembly 310 can be removed from the folder and spring system 300 by, for example, partially or completely pulling the occluder assembly into the delivery device and / or the first or second folder system 100A and 100B in a manner that does not prevent the first folder system 100A or the second folder system 100B from being disengaged from the delivery device. At this time, or while removing the occluder assembly 310, the delivery extension device 340 can be withdrawn from the folder system 100B.

[0074] Over time, spring 320A and / or spring 320B may expand within the implanted tubular organ, thereby exerting a tensile and / or expansion force on the tubular organ, thereby promoting and / or facilitating the growth and / or elongation of the portion of the tubular organ engaged with fold and spring system 300. Fig. 3I is a schematic diagram of the fold and spring system 300 in an expanded or open configuration 1-6 weeks after implantation in a tubular organ.

[0075] Figure 4A 4 is a photograph of a single folder system 100 located in a tubular organ 410, here the small intestine. Photo 401 shows a portion of the tubular organ 410 that has been engulfed in tissue 420 and has been rolled into the window-like window portion 110 and sealed therein by the folder system 100 transitioning from an open configuration to a closed configuration.

[0076] Figure 4B is a photograph of tubular organ tissue being trapped in a window of a fold and spring system, the fold and spring system including the fold system 100 and springs 320A and / or 320B placed in a tubular organ 410, in this case the small intestine. Photo 402 shows a portion of the tubular organ 410 being trapped in tissue 420, which has been rolled into the window-like window 110 and sealed therein by the transition of the fold system 100 from an open configuration to a closed configuration, and the springs 320A and / or 320B are in an expanded state within the tubular organ.

[0077] Figure 5Schematic diagram of a fold and spring system 300 connected to a fold and spring system delivery device 500, which may include a delivery extension device 340, a vacuum / inflation port 512, an occlusion assembly control interface 514, an actuator 516, an attachment port 518, a first actuation handle 520A, and a second actuation handle 520B. The fold and spring system delivery device 500 can be configured to enable a clinician (e.g., a surgeon or doctor) to place the fold and spring system 300 into a tubular organ through an opening of the tubular organ. The opening on the tubular organ can be a surgical opening or a stoma (i.e., the portion of the tubular organ that extends from the body, such as the portion of the tubular organ that extends from the patient's epidermis).

[0078] The vacuum / inflation port 512 can be configured to connect to a vacuum pump or a suction pump, which can be configured to apply negative air pressure to the fold and spring system 300 and the fold and spring system delivery device 500 to draw the tubular organ tissue into, for example, Figure 4A and Figure 4B In the window portion 110 shown in the photo 401 or the photo 402 in FIG. At this time, the actuator is applied to move the first folder system 100A and / or the second folder system 100B from Figure 3F The open configuration shown translates to Figure 3G Closed configuration shown.

[0079] The accessory port 518 may be used to insert auxiliary equipment (eg, a camera, fiberscope, and / or ablation device) to visualize the delivery of the fold and spring system 300 to the target portion of the tubular organ and / or to treat the tissue.

[0080] The position of the occluder assembly 310 can be controlled via the occluder assembly control interface 514, which can be, for example, a handle or other device for a wire physically connected to the occluder assembly 310, which can be used to remove the occluder assembly 310 from the first folding member system 100A (e.g., a clinician can pull the wire connected to the occluder assembly 310 via the occluder assembly control interface 514 to remove the occluder assembly 310 from the folding member and spring system 300). In some embodiments, after the folding member and spring system 300 is placed in the tubular organ, the occluder assembly 310 can be pulled into the delivery extension device 340. In these embodiments, a microscope or other device inserted at, for example, the accessory port 518 can be used to visually and / or tactilely verify that the occluder assembly 310 has been successfully removed from the folding member and spring system 300 and / or is no longer located in the patient's tubular organ and / or surgical opening. In other embodiments, the occluder assembly 310 can be pulled out of the folding member and spring system delivery device 500 via the assembly control interface 514.

[0081] The length of the delivery extension 340 should be sufficient to insert the folds and spring system 300 into a tubular organ. In some cases, the delivery extension 340 can be relatively short (e.g., 7 cm-17 cm) or long (e.g., 17 cm-25 cm), and a shorter delivery extension may be required when inserting the folds and spring system 300 into an infant, or a longer delivery extension may be required when inserting the folds and spring system 300 into an adult. The delivery extension 340 can be rigid and / or flexible, and can be hollow so that, for example, negative pressure applied to the vacuum / inflation port 512 can be transmitted to the folds and spring system 300 and / or the occlusion assembly 310, thereby sucking or otherwise pulling it into the delivery extension 340. A wire or other device connected to the occlusion assembly 310 and / or the occlusion assembly control interface 514 can be configured in the delivery extension 340 and can be moved through the delivery extension 340. Additionally, or alternatively, the delivery extension 310 can be configured such that a mechanism (pull wire, disconnect fuse, and / or mechanical fuse) that transitions the first and second folder systems 100A and 100B from the first, open configuration to the second, closed configuration can be configured in the delivery extension 340 and / or can be moved through the delivery extension 310. Additionally, or alternatively, the delivery extension 310 can be configured such that a scope or other device that passes through the accessory port 518 can be configured in the delivery extension 340 and can be moved through the delivery extension 340.

[0082] like Figure 3F and Figure 3G As shown, one end of the delivery extension 340 can be connected to the second folder system 100B via an extension that cooperates with a corresponding groove in the inner component 130. The second folder system 100B and / or the folder and spring system 300 can be released from the delivery extension 340 by manually operating (e.g., squeezing) the actuator 516. In some embodiments, actuation (e.g., squeezing together) of the first and second actuation handles 520A and 520B can cause the first and second folder systems 100A and 100B to transition from a first, open configuration to a second, closed configuration.

[0083] Once placed in the tubular organ (e.g., the first and second folding member systems 100A and 110B), the tubular organ tissue will sink into the corresponding window and be in a closed state (e.g., see Figure 3G ), thereby retaining the trapped tissue within the closed window, the folding member and spring system 300 can begin to move from within the tubular organ Figure 3H The compression state shown transitions to Fig. 3IThe fold and spring system 300 may be removed and / or expelled from the tubular organ by: one or more components of the fold and spring system 300 are bioabsorbed; tissue within the tubular organ naturally falls off, releasing tissue fixed within the closed window 110 and / or teeth 115, allowing the fold and spring system 300 to pass through the patient's digestive system and be expelled from the patient's body; and / or the fold and spring system 300 or a portion thereof is surgically removed.

[0084] Figure 6 An exemplary procedure 600 for treating a patient using the fold and spring system disclosed herein is described. For example, the procedure 600 may be performed by a healthcare provider such as a surgeon or physician and / or a group of healthcare providers.

[0085] First, in step 605, a fold and spring system (such as fold and spring system 300) can be placed in a tubular organ. For example, step 605 can be performed by using a fold and spring system delivery device (such as fold and spring system delivery device 500) to insert the fold and spring system into a surgical opening of a patient's tubular organ. In addition, step 605 can also be performed through minimally invasive and / or endoscopic surgery. Alternatively, step 605 can also be performed through the anus or through the mouth, for example, using an endoscope-like device to position the fold and spring system at a target location within the subject's tubular organ.

[0086] Next, negative pressure (i.e., vacuum) may be applied to the fold and spring system to secure the fold and spring system within the tubular organ by, for example, clamping and / or puncturing tissue in step 610. In some cases, performing step 610 may draw the tubular organ tissue into a window (e.g., window 110) of a fold system (e.g., fold system 100), thereby trapping the tubular organ tissue within the window.

[0087] In step 615, the folder and spring system may be activated such that the folder system is moved from a first, open configuration (e.g., see Figure 3F ) to a second, closed configuration (see, for example, Figure 3G ), thereby sealing or retaining the tissue trapped in the open window of the folding member system within the closed window. In some embodiments, step 615 can be performed by using a drive handle of the delivery device, for example, as described above with respect to Figure 5 The actuating handles 520A and 520B of the folding member and spring system delivery device 500 are described. Additionally, or alternatively, negative pressure is applied in step 610 to move the folding member and spring system from an open configuration (e.g., Figure 3F ) into a closed configuration (such as Figure 3G), thereby fixing the tubular organ tissue sucked into the window within the closed window.

[0088] If the folds and spring system includes an occlusion assembly (such as occlusion assembly 310) or other device for forming a vacuum therein, after the folds and spring system is deployed within the tubular organ, the occlusion assembly can be removed from the folds and spring system, thereby opening the lumen of the folds and spring system to allow material (such as body fluids, digested food, water, etc.) to flow through the folds and spring system positioned within the tubular organ (step 620).

[0089] In step 625, the delivery device (if used) is then separated from the folding member and spring system and the delivery device is removed from the tubular organ and the patient. Optionally (e.g., where process 600 is performed during an open surgical procedure), the surgical opening is then closed (step 630) and process 600 may end. In some embodiments, steps 605-625 may be repeated to position multiple folding members and spring systems within the tubular organ simultaneously or sequentially (when performed sequentially, step 630 may also need to be repeated).

[0090] In some embodiments, over time, for example, tubular organ tissue trapped in the window of the fold and spring system will fall off, allowing the fold and spring system to naturally detach from the tubular organ and, once detached, pass through the patient's digestive tract. If this does not occur, or if otherwise necessary, the fold and spring system can be removed from the patient by surgery or the like (step 635). In many cases, within 1-6 weeks of performing step 605, when the intestinal production of the tubular organ reaches the target amount, the fold and spring system can be naturally passed through, or removed by surgery.

[0091] Figures 7A-7G is a schematic diagram of a fold, spring, and flange system for delivery to a tubular organ through an opening and / or a stoma (eg, a functional or dysfunctional limb of small intestine extending through the abdomen) of a patient. Fig. 7A A side view of a fold, spring and flange system 700 is provided that includes a fold system 100, a spring 320, and a tube 710 with a flange 715. In some embodiments, the fold system 100, spring 320, and tube 710 with flange 715 can be an integral system (e.g., fused together), while in other embodiments, the fold, spring and flange system 700 can include separate fold system 100, spring 320, and tube 710 with flange 715 components that are assembled together prior to an implantation procedure. Fig.7DA side view of a fold, spring and flange system 700 implanted in a subject having an epidermis 725 and a tubular organ 730A is provided, with the fold, spring and flange system 700 in an unstretched state.

[0092] Figure 7B A front view of flange 715 is provided, showing opening 720 aligned with the lumen of tube 710 and the tubular organ, into which fold, spring and flange system 700 is inserted through a stoma or opening in, for example, the abdominal wall, until flange 715 engages epidermis 725. Tube 710 and / or flange 715 can be configured to provide an anchoring surface to which spring 320A and / or spring 320B can apply an expansion force to elongate tubular organ 730A to a desired position. Fig. 7E The elongated tubular organ 730B ( Fig. 7E 70B is a side view of the fold, spring and flange system 700 when implanted in an elongated tubular organ 730B of a subject). In some embodiments, an adhesive may be applied to the side of the flange 715 facing the epidermis and / or to the epidermis near the opening into which the fold, spring and flange system 700 is inserted to secure the fold, spring and flange system 700 in place. Additionally or alternatively, an adhesive mechanism (e.g., tape or strap) may be used on the outside of the flange 715 to secure the fold and spring system 700. After insertion, the fold system 100 may be engaged / secured to the tissue of the tubular organ in a manner that may be described herein, for example, in conjunction with Figure 3F to Figure 5 Description of Figure 7C and Fig. 7E As shown, spring 320A and / or spring 320B can be expanded after being installed in the tubular organ, thereby stretching the tubular organ, for example, Fig. 7E shown and described herein.

[0093] The folding piece, spring and flange system 700 can be inserted into an opening at a stoma or abdominal wall, etc., until the flange 715 is connected to the patient's epidermis. In some embodiments, the tube 710 can be made flexible and relatively soft so as not to hinder the patient's movement or cause discomfort. In some embodiments, a flexible but hard inserter (e.g., a delivery extension device 340) can be removably inserted into the central cavity of the folding piece, spring and flange system 700 and then placed in the tubular organ. The role of the inserter is to provide sufficient rigidity for the folding piece, spring and flange system 700 so that it maintains structural integrity (e.g., does not collapse or fold) when inserted into the tubular organ. In some embodiments, the inserter can also be used to remove the occlusion assembly 310 and / or actuate the folding piece system 100 from an open state to a closed state as described herein.

[0094] In embodiments where the fold, spring, and flange system 700 are comprised of separate components, the fold system 100 may first be inserted into a tubular organ and secured to the tubular organ as described herein. The spring 320A and / or spring 320B (in a compressed and / or expanded state) may then be inserted into the tubular organ until it engages the fold system 100. When in the expanded state, the spring 320A and / or spring 320B may be compressed by the force applied to the tube 710 having the flange 715 when inserted into the tubular organ until the flange 715 engages the patient's skin.

[0095] Figure 7F and Figure 7G A side view of another exemplary fold, spring and flange system 701 is provided, which is configured similarly to fold, spring and flange system 700 and can be inserted through the skin or an opening in the body. Fold and spring system 701 includes fold system 100, spring 320, and an elongated tube 730 with flange 715. Fold and spring system 701 can be used (compared to fold and spring system 700) in situations where it is necessary to place fold system 100 further into the body and / or to further expand a tubular organ within the body. Additionally, or alternatively, fold and spring system 701 can also be used after using fold and spring system 700 to further extend a tubular organ, such as Fig. 7E As shown. In these embodiments, the long tube 730 can be inserted into the tubular organ and the spring 320A and / or spring 320B can be compressed (or recompressed), so that the folding member system 100 and spring 320A and / or spring 320B positioned in the tubular organ can be reused, for example, to further extend or elongate the tubular organ in a sequential (e.g., 2-6) manner. Alternatively, the spring 320A and / or spring 320B can be removed from the tubular organ and replaced with a different spring (e.g., a spring similar to the spring 320A and / or spring 320B and / or a spring having one or more characteristics different from the spring 320 (e.g., size, elasticity, etc.)). Then, the long tube 730 with the flange 715 can be inserted into the tubular organ to connect with the second spring (when the second spring has been compressed) and / or when the folding member, spring and flange system are fully installed in the patient's body, the second spring is compressed and then connected with the second spring (when the second spring is not compressed). The fold, spring and flange system may be similar to that described above (e.g., Fig.7D and Fig. 7E ) is implanted into a subject.

[0096] Figure 8is a flow chart illustrating a process 800 of treating a patient using a fold, spring and flange system (e.g., fold, spring and flange system 700 and / or fold, spring and flange system 701) that can be inserted through a tubular organ (e.g., the small intestine or large intestine) and / or an exposed opening of a stoma. Process 800 can be performed, for example, by a healthcare provider and / or a group of healthcare providers.

[0097] First, in step 805, a fold, spring, and flange system (such as fold, spring, and flange system 700 or 701) can be positioned within a tubular organ by inserting into an opening (such as a stoma) of a patient. For example, step 805 can be performed by using a fold, spring, and flange system delivery device (such as fold and spring system delivery device 500) to insert the fold, spring, and flange system into a surgical opening of a tubular organ of a patient. In addition, step 805 can also be performed using an insertion device that is located within the lumen of the fold, spring, and flange system to provide structural rigidity to the fold, spring, and flange system and / or make the fold, spring, and flange system easier to manipulate within the tubular organ.

[0098] In some embodiments, for example, when the folding piece, spring and flange system includes multiple components, the execution of step 805 may include multiple sub-steps, including but not limited to inserting the folding piece (such as folding piece system 100) into the tubular organ through the stoma, and attaching the folding piece to the tubular organ as described herein (such as steps 610 and 615). Next, the spring (such as spring 320) of the folding piece, spring and flange system can be inserted into the tubular organ so that the spring is connected to the folding piece. In some embodiments, the spring can be compressed before being inserted into the tubular organ. In other embodiments, the spring may not be compressed before being inserted into the tubular organ. In these embodiments, the spring can be compressed by inserting the stoma interface (such as tube 710 and flange 715) into the tubular organ until the spring is compressed to a desired length.

[0099] If the fold, spring and flange system includes an occlusion assembly (such as occlusion assembly 310) or other device for forming a vacuum therein, the occlusion assembly can be removed from the fold, spring and flange system, thereby opening the lumen of the fold, spring and flange system so that material (such as body fluids, digested food, water, etc.) can flow through the fold, spring and flange system located within the tubular organ (step 810).

[0100] In step 815, the delivery device (if used) is then separated from the fold, spring and flange system, and the delivery device is removed from the tubular organ and the patient. In step 820, it can be determined whether the tubular organ has been sufficiently elongated by the tensile force applied to the tubular organ by the fold, spring and flange system. For example, step 820 can be performed within 1-5 weeks after the insertion of the fold, spring and flange system. When the tubular organ is not sufficiently elongated, the attending physician or medical staff can check again later (step 825) until the tubular organ is sufficiently elongated.

[0101] When the tubular organ is sufficiently elongated, it can be determined whether to reuse the folding member and / or spring already in place in the tubular organ to further elongate the tubular organ. If not, the folding member, spring and flange system can be removed from the tubular organ and / or the patient (step 835). If necessary, the flange of the folding member, spring and flange system can be detached from the spring. In some cases, the spring can be detached from the folding member (step 840), and then a new spring and / or a long tube with a flange is inserted into the tubular organ, so that the spring is connected to the folding member, and the spring and folding member are compressed. Steps 820-845 can be repeated multiple times to further elongate the tubular organ as long as the folding member is still in place and performs the intended function.

[0102] The present disclosure further provides a kit, for example, including one or more folds and spring systems 300, which in some cases may be of various sizes, and a folds and spring system delivery device, such as a folds and spring system delivery device 500. In some cases, such as when multiple folds and spring systems 300 are used to treat a patient, the kit may include multiple folds and spring systems 300 for use in sequence and / or simultaneously to extend the patient's tubular organ to a greater extent than can be achieved using only a single folds and spring system 300. When multiple folds and spring systems 300 are placed simultaneously in a patient's tubular organ, for example, one fold and spring system 300 may be placed every 2-4 inches along the length of the patient's tubular organ.

[0103] Fig. 9 A schematic diagram of an example kit 900 is provided, which includes a housing 905, a first container 910, and a second container 920. It is understood that the components of the kit 900 can be the housing 905, and can also be any suitable housing for accommodating the first container and the second container 920, such as a plastic tray and / or a bag. In many cases, the housing 905 can be sterile and / or can be configured to keep the contents of the first container and the second container 920 sterile and dry. The first container and / or the second container can be a bag and / or a plastic tray, etc.

[0104] First container 910 may include or contain one or more folds and spring systems 300, components of folds and spring systems 300, one or more folds, springs and flange systems 701 and / or 701, and / or components of one or more folds, springs and flange systems 701 and / or 701. In some cases, first container 910 may contain one or more folds and spring systems 300, components of folds and spring systems 300, one or more folds, springs and flange systems 701 and / or 701, and / or components of one or more folds, springs and flange systems 701 and / or 701, the sizes and / or configurations of which may be used in different situations, including but not limited to implantation in adults, implantation in children, and / or components that can be assembled on demand based on clinical needs and / or physician preferences.

[0105] The second container 920 may include a delivery device and / or an inserter, such as delivery device 500, which is configured for use with components required for sequential implantation of, for example, a folding member, a spring and flange system 701 and / or 701 and / or one or more implanters and spring systems disclosed herein.

Claims

1. A foldable member system for implanting a tubular organ, the foldable member comprising: an external component, the external component comprising a first lumen, a first groove and a fixing mechanism; as well as an inner component comprising a second lumen, a second recess, and a plurality of protrusions extending from an outer surface of the inner component, each of the plurality of protrusions being arranged and configured to engage with the securing mechanism, wherein a portion of the inner component is disposed within the outer component such that the first lumen is aligned with the second lumen to form a central lumen for the folding member system, wherein the first groove and the second groove are arranged and configured to form a window having an open area, and when the folding member system is implanted in a tubular organ and arranged in an open configuration, a portion of the tubular organ tissue is sunk into the open area, When the inner component is pushed toward the outer component, the folding member system is configured to transform from an open configuration to a closed configuration, thereby reducing the size of the open area of ​​the window and clamping the trapped tubular organ tissue in the open area, thereby firmly implanting the folding member system in the tubular organ.

2. The folding member system of claim 1, wherein the outer component comprises one or more teeth extending into the first groove, the one or more teeth being configured to pierce tubular organ tissue trapped in the window portion.

3. The folding member system according to claim 1 or 2, wherein the inner component includes one or more teeth extending into the second groove, and the one or more teeth are configured to pierce the tubular organ tissue trapped in the window portion.

4. The folding member system of claim 3, wherein the size of the one or more teeth of at least one of the inner component and the outer component corresponds to at least one of the size and thickness of the tubular organ.

5. The folder system according to any one of claims 1 to 4, wherein the securing mechanism is a clip mechanism, and the clip mechanism is configured to engage with each of the plurality of protrusions when the folder system is converted from an open configuration to a closed configuration.

6. A folding piece system according to any one of claims 1 to 5, wherein the fixing mechanism is a clip mechanism, and when the folding piece system is converted from an open configuration to a closed configuration, the clip mechanism is configured to engage with each of a plurality of protrusions to thereby lock the internal component in place relative to the external component.

7. The folder system according to any one of claims 1 to 6, wherein the securing mechanism is a ratchet mechanism.

8. The folder system according to any one of claims 1 to 7, wherein the securing mechanism comprises a cantilevered snap, the cantilevered snap being configured to engage with a protrusion of the plurality of protrusions and maintain the position of the inner component relative to the outer component.

9. The folder system according to any one of claims 1 to 8, further comprising: An occlusion assembly is coupled to an end of the inner assembly that is not disposed within the outer assembly and is configured to occlude the second lumen.

10. The folder system according to any one of claims 1 to 9, further comprising: A conveying extension device is connected to an end of the inner component that is not disposed in the outer component, and the conveying extension device is configured to cooperate with the conveying device of the folder system.

11. The folder system according to any one of claims 1 to 10, further comprising: A spring is connected to an end of the outer component where the inner component is not disposed.

12. The folder system of any one of claims 1 to 11, wherein the inner component and the outer component are both cylindrical.

13. A folding member and spring system comprising: A first folding member system, comprising: a first external component, the first external component comprising a first lumen, a first groove, and a securing mechanism; and a first internal component comprising a second lumen, a second recess, and a plurality of protrusions extending from an outer surface of the internal component, each of the plurality of protrusions being arranged and configured to engage with a securing mechanism, wherein a portion of the inner component is disposed within the outer component such that the first lumen is aligned with the second lumen to form a central lumen for the folding member system, wherein the first groove and the second groove are arranged and configured to form a first window portion, the first window portion having an open area, and when the folding system is implanted in the tubular organ and arranged in an open configuration, a portion of the tubular organ tissue is sunk into the open area, wherein, when the first inner component is pushed toward the outer component, the folding member system is configured to transform from an open configuration to a closed configuration, thereby reducing the size of the open area of ​​the first window portion and clamping the trapped tubular organ tissue in the open area, thereby firmly implanting the folding member system in the tubular organ; The second folder system comprises: a second outer component, the second outer component comprising a third lumen, a third recess, and a securing mechanism; and a second internal component comprising a fourth lumen, a fourth recess, and a plurality of protrusions extending from an outer surface of the second internal component, each of the plurality of protrusions being arranged and configured to engage with the securing mechanism, wherein a portion of the second inner component is disposed within the second outer component such that the third lumen is aligned with the fourth lumen to form a central lumen for the second folding member system, wherein the first groove and the second groove are arranged and configured to form a second window portion, the second window portion having an open area, and when the folding system is implanted in the tubular organ and arranged in an open configuration, a portion of the tubular organ tissue is sunk into the open area, wherein, when the second inner component is pushed toward the outer component, the folding member system is configured to transform from an open configuration to a closed configuration, thereby reducing the size of the open area of ​​the second window portion and clamping the trapped tubular organ tissue in the open area, thereby firmly implanting the folding member system in the tubular organ; and A spring having a tubular body having a lumen communicating with the first lumen, the second lumen, the third lumen, and the fourth lumen, the spring being connected to the first external component and the second external component and disposed therebetween.

14. The folder and spring system of claim 13, wherein the spring is configured to expand axially to push the first folder system away from the second folder system.

15. A folder and spring system according to claim 13 or 14, wherein the spring is an axial expansion spring.

16. A folder and spring system according to any one of claims 13 to 15, wherein the dimensions of the first folder system are different to the dimensions of the second folder system.

17. The folding member and spring system according to any one of claims 13 to 16, further comprising: An occlusion assembly is connected to an end of the first inner assembly that is not disposed within the first outer assembly and is configured to occlude the second lumen.

18. The folding member and spring system according to any one of claims 13 to 17, further comprising: A delivery extension is removably connected to an end of the inner component that is not disposed within the second outer component and is configured to connect to a delivery device of the folder system.

19. The folder and spring system of claim 18, further comprising: A delivery device connected to the delivery extension device, wherein the delivery device is configured to promote the tubular organ tissue to sink into the first window portion of the first folding member system and the second window portion of the second folding member system, and to promote the closing of the first window portion and the second window portion, thereby fixing the tubular organ tissue sunk into the first window portion and the second window portion.

20. A method of implanting a fold and spring system into a tubular organ of a subject, the method comprising: positioning folds and spring systems within tubular organs; applying negative pressure to the fold and spring system, thereby drawing the tubular organ tissue into the window of the fold and spring system; as well as The folding member and spring system are activated to fix the tubular organ tissue in the window.

21. The method of claim 20, wherein the fold and spring system comprises a lumen and an occluding member, the occluding member being configured to occlude the lumen, the method further comprising: After implantation of the fold and spring system within the tubular organ, the occluding assembly is removed.

22. The method of claim 20 or 21, wherein the fold and spring system is positioned within the tubular organ using a fold and spring system delivery device.

23. The method of claim 22, wherein the folding member and spring system includes a conveyor extension device configured to cooperate with the conveyor device of the folding member and spring system, the method further comprising: After actuating the folding element and the spring system, remove the conveyor extension.

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