Pleated fold system, pleated fold / spring system, and method of using the same.

Abstract

The precator system may have two nesting components, each having one or more windows into which, for example, tubular organ tissue can invaginate when positioned in an open configuration. The invaginated tissue can be secured within the windows when the precator system transitions to a closed configuration. Closing the windows may, for example, act to clamp and pierce the invaginated tubular organ tissue within the windows, thereby securing the invaginated tubular organ tissue within the windows. In some cases, an axially extending spring may be positioned between the two precator systems, and when this assembly is implanted in a tubular organ, the axial extension of the spring may exert an expansive force on the tubular organ, which may stimulate its growth.

Description

Technical Field

[0001] Related Applications This application is a patent application filed under the Patent Cooperation Treaty, and claims priority to U.S. Provisional Patent Application No. 63 / 332,230, entitled "PLICATION SYSTEMS,PLICATION / SPRING SYSTEMS,AND METHODS OF USE THEREOF", filed on April 18, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure herein generally relates to plication systems for use with tubular organs, and more particularly, to plication / spring systems and delivery devices, and methods of using the same to facilitate the growth of, and / or elongate, a tubular organ.

Background Art

[0003] Short bowel syndrome (SBS) is a syndrome caused by a shortened or dysfunctional small intestine, which impairs the body's ability to properly digest food and / or absorb sufficient nutrients from ingested food to sustain the body. Medical treatment for SBS includes the administration of parenteral nutrition to provide necessary nutrients and fluids. Surgical treatment options for SBS include intestinal transplantation, procedures to constrict and extend the intestine to increase the absorptive area, and procedures to slow the transit time for food and / or nutrients to move through the small intestine. More recently, the idea of ​​using mechanical force to stretch intestinal tissue has been explored using various tissue expander devices. However, many of these methods require repeated invasive interventions such as sequential screw advancement or saline injections. Techniques for distraction enterogenesis, in which axial force is applied by a spring implanted in the small intestine, have also been used to increase intestinal length. [Overview of the project] [Means for solving the problem]

[0004] The plicator systems disclosed herein, configured for implantation within tubular organs, may include nesting cylindrical inner and outer components that can be configured to fit together and move relative to each other from an open position to a closed position. The outer components may include a first lumen, a first notch, and a retention mechanism. In some embodiments, the outer components may include one or more teeth extending into the first notch. The teeth may be configured to engage with and retain the invaginated tubular organ tissue within the window, for example, by gripping and / or piercing the tissue.

[0005] The retaining mechanism may be one or more clipping mechanisms, for example, configured to engage with one or more projections of a plurality of projections when the precator system is translated from an open configuration to a closed configuration, which may optionally lock the inner component in place relative to the outer component. Additionally or alternatively, the retaining mechanism may be a ratcheting mechanism and / or include a cantilever snap configured to engage with one of a plurality of projections and maintain the position of the inner component relative to the outer component.

[0006] The internal component may include a second lumen, a second notch, and a plurality of projections extending from the outer surface of the internal component, each of which is positioned and configured to engage with a retaining mechanism. A portion of the internal component may be positioned within the external component such that the first lumen is aligned with the second lumen, thereby generating a central lumen for the precator system. The internal component may include one or more teeth extending into the second notch, one or more of which are configured to engage with and retain invaginated tubular organ tissue within the window, for example, through tissue gripping and / or puncture. The size of one or more teeth of the internal component and / or external component may depend on at least one of the size and thickness of the tubular organ.

[0007] The first and second notches may be positioned and configured to form a window having an open area into which a portion of the tubular organ tissue can invaginate when the precator system is implanted within the tubular organ and the precator system may be positioned in an open configuration.

[0008] The precator system may be configured to shift from an open configuration to a closed configuration when the internal components can be pushed toward the external components, thereby reducing the size of the open area of ​​the window and gripping and / or capturing the invaginated tubular organ tissue so that the precator system can be reliably implanted within the tubular organ.

[0009] In some embodiments, the precator system may include a occlusion component that can be attached to the end of an internal component not located within an external component and configured to occlude a second lumen. Additionally, or alternatively, the precator system may include a delivery extension that can be attached to the end of an internal component not located within an external component. The delivery extension may be configured to cooperate with the precator system delivery device.

[0010] The plicator and spring system disclosed herein may include a first plicator system, a second plicator system, and a spring positioned between and attached to the first and second plicator systems. The first and second plicator systems may have the same, similar, and / or different dimensions relative to one another. The spring may have a cylindrical body through which lumens are aligned with the lumens of the first and second plicator systems. The spring may be configured to stretch axially, thereby pushing the first plicator system away from the second plicator system.

[0011] In some cases, the precator-spring system may also include a occlusion component that is attached to the end of a first inner component not located within the first outer component and configured to occlude a second lumen. Additionally or alternatively, the precator-spring system may include a delivery extension, which is detachably attached to the end of a second inner component not located within the second outer component and configured to be attached to a delivery device for the precator-spring system. In these embodiments, the precator-spring system may include a delivery device configured to be coupled to the delivery extension. The delivery device may be configured to facilitate the invagination of tubular organ tissue into the first window of the first precator system and the second window of the second precator system, to facilitate the closure of the first and second windows, and thereby to fix the tubular organ tissue that has invaginated into the first and second windows.

[0012] A method for implanting a precator-spring system into a subject's tubular organ may include positioning the precator-spring system within the tubular organ, applying negative pressure (e.g., vacuum or suction) to the precator-spring system to draw the tubular organ tissue into the window of the precator-spring system, and activating the precator-spring system to fix the tubular organ tissue within the window, for example, by tissue clamping and / or puncture. This method may be performed by a healthcare provider, such as a surgeon or physician. When the precator-spring system includes an occlusion component configured to occlude the lumen of a first precator-spring system and / or a second precator-spring system, the method may further include removing the occlusion component after implanting the precator-spring system within the tubular organ. The delivery of the precator and spring system to a target site within a subject's tubular organ can be performed, for example, using a delivery device and / or inserter configured to be coupled to a delivery extension of the precator and spring system.

[0013] The accompanying drawings, incorporated into and constituting part thereof, illustrate exemplary embodiments and, together with the description, serve to illustrate the disclosed invention. [Brief explanation of the drawing]

[0014] [Figure 1A1] This is a front view of a precator system according to several embodiments of the present invention, and the rear view is a mirror image thereof. [Figure 1A2] This is a top view of a precator system in the same orientation as Figure 1A1, according to some embodiments of the present invention. [Figure 1A3] This is a bottom view of a precator system in the same orientation as Figure 1A1, according to some embodiments of the present invention. [Figure 1B1] This is a right side view of a precator system according to several embodiments of the present invention, and the left side view is a mirror image thereof. [Figure 1B2]This is a top view of a precator system in the same orientation as Figure 1B1, according to some embodiments of the present invention. [Figure 1B3] This is a bottom view of a precator system in the same orientation as Figure 1B1, according to some embodiments of the present invention. [Figure 1C1] This is a three-quarter side view of a precator system according to several embodiments of the present invention, and the one-quarter side view is a mirror image thereof. [Figure 1C2] This is a top view of a precator system in the same orientation as Figure 1C1, according to some embodiments of the present invention. [Figure 1C3] This is a bottom view of a precator system in the same orientation as Figure 1C1, according to some embodiments of the present invention. [Figure 2A] Figure 1A2 is a top view of a precator system shown in Figure 1A2, in which the dividing lines of a horizontal and a vertical section are superimposed, according to some embodiments of the present invention. [Figure 2B] This is a horizontal cross-sectional view of the precator system shown in Figure 2A, according to some embodiments of the present invention. [Figure 2C] This is a vertical cross-sectional view of the precator system shown in Figure 2A, according to some embodiments of the present invention. [Figure 3A] This is a schematic diagram of a spring that may be used with one or more of the precator systems disclosed herein, according to some embodiments of the present invention. [Figure 3B] This is a schematic diagram of a spring in a compressed state having three clips, according to some embodiments of the present invention. [Figure 3C] Figure 3B is a schematic diagram of the spring with the first segment extended, according to some embodiments of the present invention. [Figure 3D] Figure 3B is a schematic diagram of the spring with the first and second segments extended, according to some embodiments of the present invention. [Figure 3E] This is a schematic diagram of the spring in Figure 3B when fully extended, according to some embodiments of the present invention. [Figure 3F]Schematic diagram of a pre-catheter and spring system with first and second pre-catheter systems positioned on both sides of a spring, according to some embodiments of the present invention. The first and second pre-catheter systems are in an open configuration, and the spring is in a compressed configuration. [Figure 3G] Schematic diagram of a pre-catheter and spring system of FIG. 3F, according to some embodiments of the present invention. The first and second pre-catheter systems are in a closed configuration, and the spring is in a compressed configuration. [Figure 3H] Schematic diagram of a pre-catheter and spring system of FIG. 3G with the occlusion component removed, according to some embodiments of the present invention. [Figure 3I] Schematic diagram of a pre-catheter and spring system of FIG. 3H, according to some embodiments of the present invention. The spring is in an open or extended configuration. [Figure 4A] Photograph of a tubular organ tissue trapped within a window of a pre-catheter system, according to some embodiments of the present invention. [Figure 4B] Photograph of a tubular organ tissue trapped within a window of a pre-catheter and spring system including one pre-catheter and one spring, according to some embodiments of the present invention. [Figure 5] Schematic diagram of a pre-catheter and spring system coupled to a pre-catheter and spring system delivery device, according to some embodiments of the present invention. [Figure 6] Flowchart showing a process for treating a patient using a pre-catheter and spring system, according to some embodiments of the present invention. [Figure 7A] Schematic diagram of an exemplary pre-catheter and spring system configured to be inserted through an opening in the skin and / or through a stoma into a tubular organ while in a compressed state, according to some embodiments of the present invention. [Figure 7B] Schematic front view of a flange included in an exemplary pre-catheter and spring system of FIG. 7A, according to some embodiments of the present invention. [Figure 7C]This is a schematic diagram of an exemplary precator and spring system in the extended state, according to some embodiments of the present invention, as shown in Figure 7A. [Figure 7D] Figure 7A provides a side view of a precator, spring, and flange system implanted in a tubular organ of a subject and in a non-extended state, according to several embodiments of the present invention. [Figure 7E] Figure 7A provides a side view of a system of a precator, spring, and flange implanted in a tubular organ of a subject and in an extended state, according to several embodiments of the present invention. [Figure 7F] This is a schematic diagram of another exemplary precator and spring system configured for insertion into a tubular organ through a skin opening and / or via a stoma, according to some embodiments of the present invention. [Figure 7G] Figure 7F is a schematic diagram of an exemplary precator and spring system in an extended state, according to some embodiments of the present invention. [Figure 8] This flowchart shows a process for treating a patient using a system of precator and spring configured for insertion into a tubular organ through a skin opening and / or via a stoma, according to some embodiments of the present invention. [Figure 9] This is a block diagram of a kit according to several embodiments of the present invention. [Modes for carrying out the invention]

[0015] Throughout the drawings, unless otherwise stated, the same numerals and letters are used to indicate similar features, elements, components, or parts of the illustrated embodiments. Furthermore, the present invention will now be described in detail with reference to the drawings, but the description will be made in relation to exemplary embodiments. It is intended that changes and modifications may be made to the embodiments described without departing from the true scope and spirit of the invention as defined by the appended claims.

[0016] Exemplary embodiments are described with reference to the accompanying drawings. In the drawings, the leftmost digit of the reference numeral identifies the drawing in which the reference numeral first appears. Whenever it is convenient, the same reference numeral is used throughout the drawings to refer to the same or similar parts. Examples and features of the disclosed principles are described herein, but they can be modified, adapted, and otherwise implemented without departing from the spirit and scope of the disclosed embodiments. Throughout this specification, references to “one embodiment,” “this embodiment,” and similar phrases mean that a particular feature, structure, or characteristic described in relation to an embodiment is included in at least one of its one or more embodiments. Thus, appearances of these phrases in various places throughout this specification do not necessarily refer to the same embodiment. Furthermore, these particular features, structures, or characteristics can be combined in any preferred way in one or more embodiments. Unless otherwise defined herein, scientific and technical terms used in connection with this application have the meanings generally understood by those skilled in the art to which this disclosure belongs.

[0017] Embodiments of the present disclosure provide a precator system, a precator-spring system, a delivery device, a kit comprising the precator-spring system and the delivery device, and methods for using them in tubular or hollow organs and / or tissues (collectively referred to herein as “tubular organs”), such as the small intestine, urethra, and / or fallopian tubes, to stimulate the growth (e.g., elongation) of tubular organs by exerting an elongating force on them. The precator-spring systems disclosed herein can be implanted in a tubular organ, for example, via laparoscopy or by invasive surgical procedure, and can be fixed along the length of the tubular organ by forming one or more folds at each end of the precator-spring system to fix the precator-spring system to the tubular organ tissue, for example, by tissue pinching and / or puncture as described herein.

[0018] The number of precator and spring systems placed within a patient's tubular organ (e.g., 1 to 5) may depend on various factors, including the implanted tubular organ, the desired amount of tubular organ extension, and / or the type of precator and spring system used. When multiple precator and spring systems are used within a patient, they may be inserted into the patient's tubular organ simultaneously in series, for example, along the length of a portion of the organ, and / or sequentially over time. When multiple precator and spring systems are implanted simultaneously within a tubular organ, they may be distributed evenly and / or unevenly along the length of the organ.

[0019] The plication systems and precator-spring systems disclosed herein generally include a proximal end, a distal end, an extension configuration, and a compression configuration. While typically axially extendable, the plication systems and / or precator-spring systems may also extend radially, for example, to extend the diameter of a tubular organ. In some variants, the precator-spring systems disclosed herein may extend over a period that may range, for example, from one to eight weeks, applying a steady extensional force to the tubular organ into which it is implanted, thereby stimulating the growth of adjacent tubular organs.

[0020] In one embodiment, the precator-spring system disclosed herein may be placed by using a delivery device to incise a tubular organ and surrounding tissue via an invasive surgical procedure, inserting the precator-spring system into the incised tubular organ, applying vacuum to the precator-spring system, drawing the tissue into an opening or window positioned within the precator-spring system so that the tissue can be grasped by teeth positioned within the window, and finally closing the precator system of the precator-spring system to fix the tissue within the window, for example, by clamping and / or puncturing the tissue. The precator-spring system may then be released from the delivery device, the delivery device may be removed from the patient's body, and the surgical opening may be closed. In another embodiment, the device may be placed via a minimally invasive method, for example, via an endoscopic procedure. In another embodiment, if a portion of a tubular organ extends to or outside the patient's skin, thereby creating a stoma (for example, in a patient whose small intestine extends beyond the abdominal wall to facilitate feeding through a feeding tube), the precator and spring system disclosed herein may be placed inside the tubular organ through the stoma.

[0021] The precator and spring systems disclosed herein may be surgically removed, for example, when they are fully extended and / or when the tubular organ has been extended to the desired length. Alternatively, the precator and spring systems disclosed herein may detach through the natural tissue growth of the tubular organ and pass through the patient's digestive tract.

[0022] Referring next to the drawings, Figures 1A1 to 1C3 provide schematic diagrams of various views of the precator system 100, including inner components 130 and outer components 132 having various diameters that cooperate as nesting cylinders, which may in some cases allow for small compression widths / operating widths and closed vacuum volumes. Additionally, or alternatively, the precator system 100 may include, and / or interlocking hollow discs.

[0023] In particular, Figure 1A1 is a front view of the precator system 100, and the rear view is its mirror image; Figure 1A2 is a top view of the precator system 100 in the same orientation as Figure 1A1; Figure 1A3 is a bottom view of the precator system 100 in the same orientation as Figure 1A1; Figure 1B1 is a right side view of the precator system 100, and the left side view is its mirror image; Figure 1B2 is a top view of the precator system 100 in the same orientation as Figure 1B1; Figure 1B3 is a bottom view of the precator system 100 in the same orientation as Figure 1B1; Figure 1C1 is a three-quarter side view of the precator system 100, and the one-quarter side view is its mirror image; Figure 1C2 is a top view of the precator system 100 in the same orientation as Figure 1C1; and Figure 1C3 is a bottom view of the precator system 100 in the same orientation as Figure 1C1.

[0024] As can be seen in Figure 1A1, the inner component 130 includes a first notch 136 from which three projections or teeth 115, positioned along the upper edge (in the same orientation as in Figure 1A1), protrude into a space formed by the first notch 136. The outer portion of the inner component has an array of projections 120 (discussed in more detail below with respect to Figure 1B1) configured to cooperate with a locking and / or retaining mechanism 135 to hold the inner component 130 in a desired position relative to the outer component 132. In one embodiment, the array of projections 120 and / or the locking and / or retaining mechanism 135 may be embodied to include a ratcheting locking mechanism. Other variations for the array of projections 120 and / or the locking and / or retaining mechanism 135 may include threaded / screwed mechanisms, friction fit and / or press fit mechanisms, annular snaps, J-lock mechanisms, and / or latching mechanisms.

[0025] The outer component 132 has a second notch 138 from which four teeth 115 positioned along the lower edge (in the same orientation as in Figure 1A1) protrude into a space formed by the second notch 138. When the inner component 130 is seated within the outer component 132 as shown in Figure 1A1, the window 110 is positioned between them. The window 110 may be configured to receive invagination of a portion of tubular organ tissue, and the teeth 115 may be configured and arranged to hold the invaginated tissue within the window 110, for example, by gripping and / or piercing the tissue, as shown and described herein.

[0026] As can be seen in Figures 1A2, 1A3, 1B2, 1B3, 1C2, and 1C3, the precator system 100 may have a lumen 125 located near its center. The lumen 125 may be configured to allow the passage of substances (e.g., water, partially digested food, etc.) so that the function of the tubular organ is not impaired by the implantation of the precator system 100 or a device containing the precator system 100.

[0027] As shown in Figure 1B1, the precator system 100 includes a locking and / or retaining mechanism 135 configured to engage with one or more of the projections of the projection array 120 via a clipping mechanism, and to maintain the position of the inner component 130 with respect to the outer component 132. Figure 1C1 shows the relative positions of the window 110, teeth 115, projection array 120, and the locking and / or retaining mechanism 135 when they are circumferentially positioned around the inner component 130 and the outer component 132, respectively.

[0028] Figure 2A is a top view of the precator system shown in Figure 1A2 with the horizontal section dividing line AA and the vertical section dividing line BB superimposed; Figure 2B is a horizontal section of the precator system 100 taken along line AA (in the same orientation as in Figure 1A1) from top to bottom; and Figure 2C is a horizontal cross-sectional view of the precator system 100 taken along line BB (in the same orientation as in Figure 1A1) from top to bottom. As can be seen in Figure 2B, the inner component 130 and the outer component 132 engage with two locking and / or retaining mechanisms 135 positioned on both sides of the outer component 132 (i.e., 180 degrees to each other) at position 142, which in this embodiment are configured as two cantilever snaps 150 that engage with one of the projections of the projection array 120 as shown in the figure, to hold the outer component 132 in a fixed position relative to the inner component 130.

[0029] Figure 3A is a schematic diagram of a spring 320A that may be used with one or more of the precator systems disclosed herein. In many embodiments, the spring 320A may be an axially elongated hollow tubular body, aligned with the lumen 125, through which a lumen maintaining that lumen of the tubular organ in which the spring 320A is implanted allows internal contents (e.g., digested food and / or bodily fluids) to pass. The spring 320A may be constructed, for example, as a hollow tube, an expandable polymer, a coil, and / or a spring. Additionally, or alternatively, the spring 320A may comprise / include a stent-like structure of braid or woven fabric, which may be made from, for example, filaments or wires.

[0030] In some embodiments, the spring 320A may include a single release point that extends like a spring, or it may include multiple release points that, for example, use a bioabsorbable clip and / or retaining mechanism 350 to keep a spring like the spring 320B compressed, as shown in Figure 3B, and then release, resulting in multi-stage component extensions, as shown in Figures 3C-3E. In particular, Figure 3B is a schematic diagram of the spring 320B in a compressed state. The spring 320B is similar to the spring 320A, except that it includes a first clip 350A, a second clip 350B, and a third clip 350C positioned along the length of the spring 320B as shown in the figure. The first clip 350A, the second clip 350B, and the third clip 350C divide the spring 320B into a first segment 355, a second segment 360, and a third segment 370. The first clip 350A, the second clip 350B, and / or the third clip 350C may be made from a bioabsorbable and / or biodegradable compound and, after being implanted in the body, be absorbed and / or decomposed, thereby releasing a force that would otherwise prevent the axial extension of the spring 320B, allowing the spring 320B to extend. In some cases, the first clip 350A, the second clip 350B, and the third clip 350C may be configured to be absorbed and / or decomposed at different rates so that the axial extension of the spring 320B occurs gradually. In one example, the first clip 350A may be configured to decompose and / or be absorbed initially (e.g., 1 to 14 days after implantation), which may release the first segment 355 of the spring 320B as shown in Figure 3C; the second clip 350B may be configured to decompose and / or be absorbed after the absorption of the first clip 350A (e.g., 3 to 20 days after implantation), which may release the second segment 360 of the spring 320B as shown in Figure 3D; and the third clip 350C may be configured to decompose and / or be absorbed last (e.g., within 6 to 30 days after implantation), which may release the third segment 370 of the spring 320B as shown in Figure 3E.After the third clip 350C absorbs the force, the spring 320B can also release the third segment 370, and as a result, the spring 320B is fully extended as shown in Figure 3E.

[0031] Figure 3F is a schematic diagram of a precator-spring system 300, which includes a first precator system 110A and a second precator system 100B positioned on either side of spring 320A or spring 320B, with the first precator system 100A and the second precator system 100B in an open configuration and spring 320A or spring 320B in a compressed configuration. The precator-spring system 300 also includes a closing component 310 positioned at the end of the first precator system 100A. Figure 3F also shows a portion of the delivery extension, or an inserter 340 of the precator-spring system delivery device, which will be discussed in more detail below with respect to Figure 5. The first precator system 100A and the second precator system 100B are shown in Figure 3F as being the same size (e.g., length and diameter), but this is not necessarily required. In some embodiments, the first precator system 100A and the second precator system 100B may be of various sizes depending on, for example, the tubular organ to be inserted, and / or the anatomical shape of the patient and / or the desired elongation rate of spring 320A or spring 320B.

[0032] The first end of spring 320A or spring 320B may be integrated into or otherwise attached to the first precator system 100A, for example, as shown in Figure 3F, and the second end of spring 320A or spring 320B may be integrated into or otherwise attached to the second precator system 100B. Spring 320A or spring 320B may be attached to the first precator system 100A and / or the second precator system 100B within the outer diameter of spring 320A or spring 320B, for example, via one or more interlocking recesses, which may be configured to cooperate with corresponding extensions protruding from the inner components 130 of the first precator system 100A and / or the second precator system 100B.

[0033] The precator and spring system 300 and / or its components may be available in various sizes depending, for example, the patient's anatomical shape, tubular organ type, and / or tubular organ diameter. Exemplary dimensions for the outer diameter of the precator / spring system 300 and / or its components may range, for example, from 8 mm to 30 mm, and the exemplary length of the precator and spring system 300 in the compressed state may range, for example, from 8 mm to 40 mm, and in the extended state, from 15 to 100 mm. The spring force exerted by the precator and spring system 300 on the tubular organ into which it is implanted may range, for example, from 0.2 N to 1.5 N. In some cases, the spring force exerted on the tubular organ tissue may be proportional to the size of the precator and spring system 300 used. For example, when the precator-spring system 300 has a diameter of 10 mm when compressed, the maximum compressed spring force that can be exerted on the tubular organ tissue may be in the range of 0.25 to 0.45 N, and for the precator-spring system 300 with a diameter of 20 mm, it may be in the range of 0.6 to 0.95 N.

[0034] The precator and spring system 300 and / or its components may be made from any suitable material, 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 from any suitable material, but not limited to, metals (e.g., stainless steel), nickel-titanium alloys (nitinol), plastics, and / or biodegradable / bioabsorbable or non-biodegradable polymers.

[0035] Examples of biodegradable / bioabsorbable polymers include, but are not limited to, polyarylates (derived from L-tyrosine or free acid), poly(α-hydroxyesters), poly(-hydroxyesters), polyamides, poly(amino acids), polyalkanoates, polyalkylene alkylates, polyalkylene oxilates, polyalkylene succinates, polyanhydrides, polyanhydride esters, polyaspartic acid, polybutylene diglycolates, poly(caprolactone), poly(caprolactone) / poly(ethylene glycol) copolymers, and poly (Carbonate), L-tyrosine-derived polycarbonate, polycyanoacrylate, polydihydropyran, poly(dioxanone), poly-p-dioxanone, poly(ε-caprolactone), poly(ε-caprolactone-dimethyltrimethylene carbonate), poly(esteramide), poly(ester), aliphatic polyester, poly(ether ester), poly(ethylene glycol) / poly(orthoester) copolymer, poly(glutaric acid), poly(glycolic acid), poly(glycolide), poly(glycolide) / poly(ethylene glycol) copolymer Poly(glycolide-trimethylene carbonate), poly(hydroxyalkanoate), poly(hydroxybutyric acid), poly(hydroxybutyric acid-co-barrel acid), poly(iminocarbonate), polyketal, poly(lactic acid), poly(lactic acid-co-glycolic acid), poly(lactic acid-co-glycolic acid) / poly(ethylene glycol) copolymer, poly(lactide), poly(lactide-co-caprolactone), poly(DL-lactide-co-glycolide), poly(lactide-co-glycolide) / poly(ethylene glycol) copolymer, poly(lactide) Poly(Lactide) / Poly(ethylene glycol) copolymer, Poly(lactide) / Poly(glycolide) copolymer, Polyorthoester, Poly(oxyethylene) / Poly(oxypropylene) copolymer, Polypeptide, Polyphosphazene, Polyphosphoester, Polyphosphoester urethane, Poly(propylene fumarate-co-ethylene glycol), Poly(trimethylene carbonate), Polytyrosine carbonate, Polyurethane, PorLastin or silk elastin polymer, Spider silk, Tefaflex, Terpolymer (glycolide, lactide,It includes copolymers of dimethyltrimethylene carbonate (or dimethyltrimethylene carbonate), and combinations, mixtures, or copolymers thereof. In one variant, the biodegradable polymer is polycaprolactone (PCL).

[0036] Examples of non-biodegradable polymers, though not limited to these, include poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides such as cellulosic polymers and cellulose derivatives, acyl-substituted cellulose acetates and their derivatives, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorinated polyolefins, polyethylene oxide, and copolymers and blends thereof.

[0037] As shown in Figure 3F, the first precator system 100A and the second precator system 100B are arranged in a first open configuration with the window 110 open, as may be the case before the precator and spring system 300 is implanted in a tubular organ, and the springs 320A and / or 320B are in a compressed or closed configuration. The occlusion component 310 may be configured as a component that occludes the lumen 125 for the first precator system 100A, for example, so that negative air pressure (i.e., vacuum) can be applied to the precator and spring system 300. The occlusion component 310 may be, for example, an occlusion balloon, an elastomer umbrella (e.g., with or without ribbed nitinol), a braided occlusion device, and / or a vascular occlusion device.

[0038] After the precator-spring system 300 is delivered to a tubular organ (not shown), the tissue of the tubular organ may be drawn into the windows 110 of the first precator system 100A and the second precator system 100B by applying negative pneumatic pressure to the precator-spring system 300, and the tissue may engage with one or more teeth 115 of the first precator system 100A and / or the second precator system 100B. In some cases, a degree of negative pneumatic pressure sufficient to compensate for anatomical variability in the tissue may be applied to the precator-spring system 300 when drawing the tissue into the windows 110. When in the second closed configuration shown in Figure 3, the tissue may be grasped by the teeth 115 and held in the windows 110 by the teeth 115, for example, as shown in photographs 401 and 402 of Figures 4A and 4B, respectively, as described below.

[0039] After the tissue is positioned within the window 110, the first precator system 100A and the second precator system 100B can transition from a first open configuration shown in Figure 3F to a second closed configuration shown in Figure 3G, for example, via through-wires, breakaway fuses, and / or mechanical fuse functions. Additionally, or alternatively, the first precator system 100A and the second precator system 100B can transition from a first open configuration shown in Figure 3F to a second configuration shown in Figure 3G via the application of negative pneumatic pressure to the precator and spring system 300 (i.e., the first and / or second precator systems can be suction-closed via the application of vacuum). As an addition or alternative, the transition from the first open configuration to the second closed configuration of the first precator system 100A and the second precator system 100B can be triggered by the operation (e.g., gripping together) of a handle provided by the precator and spring system 300 delivery device, as shown in Figure 5 and discussed below.

[0040] After the tissue is secured, clamped, captured, and / or impaled within the closed window 110, the negative pressure may be reduced and / or stopped, and the occlusion component 310 may be removed from the precator and spring system 300, as shown in Figure 3H. The occlusion component 310 may be removed from the precator and spring system 300, for example, by partially or completely retracting the occlusion component into the delivery device and / or the first precator system 100A or the second precator system 100B, so as not to interfere with the disengagement of the first precator system 100A or the second precator system 100B from the delivery device. At this time, or simultaneously with the removal of the occlusion component 310, the delivery extension 340 may be retracted from within the precator system 100B.

[0041] Over time, springs 320A and / or 320B may extend within the tubular organ in which they are implanted, thereby exerting tensile and / or expansive forces on the tubular organ, promoting and / or facilitating the growth and / or elongation of the portion of the tubular organ engaged with the precator-spring system 300. Figure 3I is a schematic diagram of the precator-spring system 300 when the coils are in an extended or open configuration, as can be the case for 1 to 6 weeks after the precator-spring system 300 has been implanted in the tubular organ.

[0042] Figure 4A is a photograph 401 of a single precator system 100 positioned within a tubular organ 410, which in this case is the small intestine. Photograph 401 shows a portion of the invaginated tissue 420 of the tubular organ 410, which is retracted into a window, such as a window 110, and sealed through the transition of the precator system 100 from an open configuration to a closed configuration.

[0043] Figure 4B is a photograph of tubular organ tissue invaginated within a window of a precator and spring system, which includes one precator system 100 and one spring 320A and / or spring 320B positioned within the tubular organ 410, which in this case is the small intestine. Photograph 402 shows a portion of the invaginated tissue 420 of the tubular organ 410, which has been retracted into a window such as window 110 and sealed via a transition of the precator system 100 from an open configuration to a closed configuration, also showing springs 320A and / or spring 320B in an extended state within the tubular organ.

[0044] Figure 5 is a schematic diagram of a precator and spring system 300 coupled to a precator and spring system delivery device 500, which may include a delivery extension 340, a vacuum / vent port 512, an occlusion component control interface 514, an actuator 516, an accessory port 518, a first operating handle 520A, and a second operating handle 520B. The precator and spring system delivery device 500 may be configured to allow a clinician (e.g., a surgeon or physician) to place the precator and spring system 300 into a tubular organ through an opening. The opening in the tubular organ may be, for example, a surgical opening or a stoma (i.e., a portion of a tubular organ extending from the body, such as when a portion of a tubular organ extends outward from the patient's skin).

[0045] The vacuum / vent port 512 may be configured to be coupled to a vacuum pump or suction pump which can be configured to apply negative air pressure to the precator and spring system 300 and the precator and spring system delivery device 500 to draw tubular organ tissue into the window 110, for example, as shown in photographs 401 or 402 of Figures 4A and 4B, respectively. An actuator is then applied which transitions the first precator system 100A and / or the second precator system 100B from the open configuration shown in Figure 3F to the closed configuration shown in Figure 3G.

[0046] The accessory port 518 may be used to insert a secondary device (e.g., a camera, fiberscope, and / or excision device) to observe the delivery of the precator and spring system 300 to the target portion of the tubular organ and / or tissue to be treated.

[0047] The position of the occlusion component 310 may be controlled via an occlusion component control interface 514, which may be a handle for a wire or another device physically coupled to the occlusion component 310, and can be used to remove the occlusion component 310 from the first precator system 100A (for example, a clinician can pull a wire coupled to the occlusion component 310 via the occlusion component control interface 514 to pull the occlusion component 310 out of the precator and spring system 300). In some embodiments, the occlusion component 310 may be retracted into the delivery extension 340 after the precator and spring system 300 has been placed in the tubular organ. In these embodiments, a scope or other device inserted into an accessory port 518 may be used, for example, to visually and / or tactilely confirm that the occlusion component 310 has been successfully removed from the precator and spring system 300 and / or is no longer in the patient's tubular organ and / or surgical opening. In other embodiments, the occlusion component 310 may be drawn from the precator and spring system delivery device 500 via the component control interface 514.

[0048] The delivery extension 340 may be long enough to insert the precator and spring system 300 into a tubular organ. Depending on the circumstances, the delivery extension 340 may be relatively short (e.g., 7cm to 17cm) as may be required when inserting the precator and spring system 300 into an infant, or long (e.g., 17cm to 25cm) as may be required when inserting the precator and spring system 300 into an adult. The delivery extension 340 may be rigid and / or flexible and may be hollow, for example, so that negative pressure applied to the vacuum / vent port 512 can communicate with the precator and spring system 300 and / or the occlusion component 310 can be drawn into the delivery extension 340 by suction or other means. The delivery extension 340 may also be configured so that wires or other devices coupled to the occlusion component 310 and / or the occlusion component control interface 514 can be positioned within it and move through the delivery extension 340. Additionally, or alternatively, the delivery extension 340 may be configured so that a mechanism (through-wire, breakaway fuse, and / or mechanical fuse) configured to transition the first precator system 100A and the second precator system 100B from a first open configuration to a second closed configuration can be positioned within the delivery extension 340 and / or move through the delivery extension 310. Additionally, or alternatively, the delivery extension 340 may be configured so that a scope or other device passing through the accessory port 518 can be positioned within and move through the delivery extension 340.

[0049] The end of the delivery extension 340 may be configured to connect to the second precator system 100B via an extension that fits into a corresponding notch in the inner component 130, as shown in Figures 3F and 3G. The second precator system 100B and / or the precator and spring system 300 may be released from the delivery extension 340 via manual operation (e.g., gripping) of the actuator 516. In some embodiments, the operation (e.g., gripping together) of the first actuation handle 520A and the second actuation handle 520B may cause the first precator system 100A and the second precator system 100B to transition from a first open configuration to a second closed configuration.

[0050] Once placed within the tubular organ (for example, the first fold-forming system 100A and the second fold-forming system 110B) invaginate the tubular organ tissue into their respective windows, which are in a closed configuration (see, for example, Figure 3G), thereby holding the invaginated tissue within the closed windows, the precater and spring system 300 begins to transition within the tubular organ from a compressed state shown in Figure 3H to an extended state shown in Figure 3I, thereby facilitating the growth of tubular organ tissue, which can result in elongation of the tubular organ. The precator-spring system 300 may be removed and / or purged from a tubular organ, for example, by bioabsorption of one or more components of the precator-spring system 300, by natural shedding of tissue within a closed window 110 and / or by releasing tissue held by teeth 115, and / or by surgical removal of the precator-spring system 300 or a portion thereof.

[0051] Figure 6 is a flowchart illustrating an exemplary process 600 for treating a patient using the precator and spring system disclosed herein. Process 600 may be performed by a provider of medical care, such as a surgeon or physician, and / or a group of providers of medical care.

[0052] First, in step 605, the precator and spring system, such as the precator and spring system 300, may be positioned within a tubular organ. Step 605 may be performed, for example, by using a precator and spring system delivery device, such as a precator and spring system delivery device 500, to insert the precator and spring system into a surgical opening within the patient's tubular organ. Alternatively, step 605 may be performed via a minimally invasive procedure and / or endoscopic procedure. Alternatively, step 605 may be performed transanally and / or orally by using a device such as an endoscope to position the precator and spring system within a target location within the subject's tubular organ.

[0053] Next, in step 610, negative pressure (i.e., a vacuum) may be applied to the precator and spring system to fix the precator and spring system within the tubular organ, for example, by tissue clamping and / or puncture. In some cases, the execution of step 610 may work to draw the tubular organ tissue into a window, such as a window 110 of the precator system, such as the precator system 100, thereby causing the tubular organ tissue to invaginate into the window.

[0054] In step 615, the precator-spring system may be operated so that the precator system contained therein transitions from a first open configuration (see, for example, Figure 3F) to a second closed configuration (see, for example, Figure 3G), thereby sealing or holding tissue that has entered the open window of the precator system within the closed window. In some embodiments, step 615 may be performed via the use of an operating handle of a delivery device, such as the operating handles 520A and 520B of the precator-spring system delivery device 500, as described above with respect to Figure 5. Additionally, or alternatively, a negative pressure applied in step 610 may cause the precator-spring system to move in parallel from an open configuration (see, for example, Figure 3F) to a closed configuration (see, for example, Figure 3G), thereby fixing tubular organ tissue drawn into the window within the closed window.

[0055] When the precator-spring system includes an occlusion component such as an occlusion component 310 or some other device to facilitate the creation of a vacuum within the precator-spring system, the occlusion component may be removed from the precator-spring system after deployment in the tubular organ, thereby opening the lumen of the precator-spring system so that a substance (e.g., bodily fluids, digested food, water, etc.) can flow through the precator-spring system positioned within the tubular organ (step 620).

[0056] In step 625, the delivery device (if used) may then be detached from the precator and spring system, and the delivery device may be removed from the tubular organ and the patient. Optionally (for example, in situations where process 600 is being performed during an invasive surgical procedure), the surgical opening may then be closed (step 630), and process 600 may be completed. In some embodiments, steps 605–625 may be repeated to position multiple precator and spring systems simultaneously or sequentially within a tubular organ (when performed sequentially, it may also be necessary to repeat step 630).

[0057] In some embodiments, the precator-spring system may spontaneously disengage from the tubular organ over time, for example, through the shedding of tubular organ tissue that has intruded into the window of the precator-spring system, and after disengagement, may pass through the patient's digestive tract. When this does not occur, or when otherwise necessary, the precator-spring system may be removed from the patient, for example, by surgery (step 635). Often, spontaneous passage of the precator-spring system or surgical removal of the precator-spring system may occur 1 to 6 weeks after the execution of step 605, for example, when the target amount of enterogenesis of the tubular organ has occurred.

[0058] Figures 7A–7G are schematic diagrams of a precator, spring, and flange system for delivering a tubular organ through a patient's opening and / or stoma (e.g., a functional or defunctional limb of the small intestine extending through the abdomen). Figure 7A provides a side view of the precator, spring, and flange system 00, which includes a precator system 100, a spring 320, and a tube 710 with a flange 715. In some embodiments, the precator system 100, the spring 320, and the tube 710 with a flange 715 may be a single system (e.g., fused together), and in other embodiments, the precator, spring, and flange system 700 may include separate precator system 100, spring 320, and tube 710 with flange 715 components that are assembled before the implantation procedure. Figure 7D provides a side view of the precator, spring and flange system 700 when implanted in a non-extended state within a subject having epidermis 725 and a tubular organ 730A.

[0059] Figure 7B provides a front view of the flange 715 showing the lumen of the tube 710 and the opening 720 into which the precator-spring-flange system 700 is aligned with a tubular organ to be inserted, for example, through a stoma or opening in the abdominal wall, until the flange 715 abuts against the skin 725. The tube 710 and / or flange 715 may be configured to provide a fixed surface into which springs 320A and / or springs 320B may abut to exert an elongating force to stretch the tubular organ 730A into the stretched tubular organ 730B as shown in Figure 7E (side view of the precator-spring-flange system 700 when the tubular organ 730B is stretched and implanted in the subject) and described herein. In some embodiments, an adhesive may be applied to the skin-facing side of the flange 715 and / or to the skin adjacent to the opening into which the precator-spring-flange system 700 is inserted, in order to hold the precator-spring-flange system 700 in place. As an addition or alternative, an adhesive mechanism (e.g., tape or strap) may be applied to the outside of the flange 715 to hold the precator and spring system 700 in place. After insertion, the precator system 100 engages with / attaches to the tissue of the tubular organ as described herein, for example with reference to Figures 3F to 5. After seating within the tubular organ, the springs 320A and / or 320B may extend as shown in Figures 7C and 7E, stretching the tubular organ as shown in Figure 7E and described herein.

[0060] The precator, spring, and flange system 700 can be inserted, for example, into a stoma or opening in the abdominal wall until the flange 715 reaches the patient's skin. In some embodiments, the tube 710 may be manufactured to be flexible and relatively pliable so as not to hinder the patient's movement or cause discomfort. In some embodiments, a flexible but rigid inserter (e.g., a delivery extension 340) may be removably inserted through the central lumen of the precator, spring, and flange system 700 before it is placed in the tubular organ. The inserter may serve to provide sufficient rigidity to the precator, spring, and flange system 700 so as to maintain structural integrity (e.g., not to collapse or fold) when inserted into the tubular organ. In some embodiments, the inserter may also serve to remove the occlusion component 310 and / or actuate the precator system 100 from an open to a closed state, as described herein.

[0061] In embodiments in which the precator, spring, and flange system 700 comprises separate components, the precator system 100 may first be inserted into and attached to a tubular organ, as described herein. The springs 320A and / or 320B (in a compressed and / or extended state) may then be inserted into the tubular organ until they contact the precator system 100. When extended, the springs 320A and / or 320B may be compressed via the force exerted by the flanged tube 710 until the flange 715 contacts the patient's skin when inserted into the tubular organ.

[0062] Figures 7F and 7G provide side views of another exemplary precator-spring-flange system 701 configured to be inserted through an opening in the skin or body, similar to the precator-spring-flange system 700. The precator-spring system 701 includes a precator system 100, a spring 320, and an elongated tube 730 with a flange 715. The precator-spring system 701 can be deployed in situations where it is desirable to place the precator system 100 further into the body and / or extend a tubular organ (compared to the precator-spring system 700). As an addition or alternative, the precator-spring system 701 can be used sequentially after the precator-spring system 700 has been used and the tubular organ has been extended to further extend the tubular organ, for example, as shown in Figure 7E. In these embodiments, the elongated tube 730 may be inserted into a tubular organ, and the springs 320A and / or 320B may be compressed (or recompressed) so that the precator system 100 and springs 320A and / or 320B, already positioned within the tubular organ, can be reused, for example, sequentially (e.g., 2 to 6 times) to further extend or stretch the tubular organ. Alternatively, springs 320A and / or 320B may be removed from the tubular organ and replaced with different springs (e.g., springs similar to springs 320A and / or 320B, and / or springs having one or more different properties (e.g., size, spring force, etc.) from spring 320). The elongated tube 730 with flange 715 can then be inserted into the tubular organ such that it contacts the second spring (when the second spring is already compressed) and / or compresses and then contacts the second spring (when the second spring is uncompressed) when the precator, spring, and flange system is fully seated within the patient. - For example, it can be placed within the subject in the same manner as described above with respect to Figures 7D and 7E.

[0063] Figure 8 is a flowchart illustrating a process 800 for treating a patient using a precator, spring and flange system, such as a precator, spring and flange system 700 and / or a precator, spring and flange system 701, which can be inserted into a tubular organ (e.g., the small and large intestines) through an exposed opening and / or stoma. The process 800 may be performed, for example, by a medical care provider and / or a group of medical care providers.

[0064] First, in step 805, a precator-spring-flange system, such as the precator-spring-flange system 700 or 701, may be positioned within a tubular organ via insertion through an opening in the patient, such as a stoma. Step 805 may be performed, for example, by using a precator-spring-flange system delivery device, such as the precator-spring-flange system delivery device 500, to insert the precator-spring-flange system into a surgical opening within the patient's tubular organ. Alternatively, step 805 may be performed using an inserter device positioned within the lumen of the precator-spring-flange system, which provides structural rigidity to the precator-spring-flange system and / or allows for easier operation of the precator-spring-flange system within the tubular organ.

[0065] In some embodiments, for example, when the precator, spring, and flange system includes multiple components, the execution of step 805 may include, but not limited to, several substeps, including inserting a precator, such as the precator system 100, into the tubular organ through the stoma and attaching the precator to the tubular organ, as described herein (e.g., steps 610 and 615). Next, a spring, such as the spring 320 of the precator, spring, and flange system, may be inserted into the tubular organ so that the spring abuts against the precator. In some cases, the spring may be compressed before insertion into the tubular organ. In other embodiments, the spring may be uncompressed before insertion into the tubular organ. In these embodiments, the spring may be compressed to a desired length through the insertion of a stoma interface, such as the tube 710 and flange 715, into the tubular organ.

[0066] When the precator-spring-flange system includes an occlusion component such as occlusion component 310 or some other device to facilitate the creation of a vacuum within the precator-spring-flange system, the occlusion component may be removed from the precator-spring-flange system, thereby opening the lumen of the precator-spring-flange system so that a substance (e.g., bodily fluids, digested food, water, etc.) can flow through the precator-spring-flange system positioned within the tubular organ (step 810).

[0067] In step 815, the delivery device (if used) may then be detached from the precator-spring-flange system, and the delivery device may be removed from the tubular organ and the patient. In step 820, it may be determined whether the tubular organ has been sufficiently stretched by the expansion force exerted on it by the precator-spring-flange system. Step 820 may be performed, for example, 1 to 5 weeks after insertion of the precator-spring-flange system. If the tubular organ has not been sufficiently stretched, the attending physician or medical staff may check again later until the tubular organ has been sufficiently stretched (step 825).

[0068] When the tubular organ is sufficiently stretched, it may be determined whether to reuse the precator and / or spring that is already in proper position within the tubular organ to further stretch it. If not to reuse, the precator, spring and flange system may be removed from the tubular organ and / or the patient (step 835). If to reuse, the flange of the precator, spring and flange system may be disengaged from the spring, and in some cases, the spring may be disengaged from the precator (step 840). A stretched tube with a new spring and / or flange may be inserted into the tubular organ such that the spring contacts and compresses against the precator, and as a result, the spring and the precator, spring and flange system may exert further expansion force on the tubular organ. Steps 820-845 may be repeated multiple times to further stretch the tubular organ, provided that the precator is still in proper position and functioning as intended.

[0069] This disclosure further provides a kit comprising, for example, one or more precator-spring systems 300, which may be of various sizes in some cases, and a precator-spring system delivery device, such as a precator-spring system delivery device 500. When a patient can be treated with multiple precator-spring systems 300, for example, the kit may include several precator-spring systems 300 for sequential and / or simultaneous use to stretch the patient's tubular organ to a greater extent than is possible with simply a single precator-spring system 300. When multiple precator-spring systems 300 are placed in the patient's tubular organ at the same time, they may be placed, for example, every 50.8 to 101.6 mm (2 to 4 inches) along the length of the patient's tubular organ.

[0070] Figure 9 provides a diagram of one exemplary kit 900, including a housing 905, a first container 910, and a second container 920. It should be understood that the components of kit 900 may be. The housing 905 may be any suitable housing configured to hold the first and second containers 920, such as a plastic tray and / or bag. Often, the housing 905 may be sterile and / or configured to keep the contents of the first and second containers 920 sterile and dry. The first and / or second containers may be, for example, bags and / or plastic trays.

[0071] The first container 910 may include or house one or more precator-spring systems 300, components of the precator-spring system 300, one or more precator-spring-flange systems 700 and / or 701, and / or components of one or more precator-spring-flange systems 700 and / or 701. In some cases, the first container 910 may house one or more precator-spring systems 300, components of the precator-spring system 300, one or more precator-spring and flange systems 700 and / or 701, and / or components of one or more precator-spring and flange systems 700 and / or 701, which may be of different sizes and / or may be configured for use in different situations, including but not limited to implantation in adults, implantation in children, and / or components that can be assembled on demand according to clinical needs and / or the preference of the physician.

[0072] The second container 920 may include, for example, a delivery device and / or inserter, such as a delivery device 500 configured for use with a system of precator and spring and flange 700 and / or 701, and / or components required for the sequential implantation of one or more precator and spring systems as disclosed herein.

Claims

1. In a precator system configured for implantation within a tubular organ, the precator system is: External components including a first lumen, a first notch, and a retaining mechanism, The device comprises an inner component including a second lumen, a second notch, and a plurality of projections extending from the outer surface of the inner component, each of the plurality of extensions being arranged and configured to engage with the retaining mechanism, A portion of the inner component is positioned within the outer component such that the first lumen is aligned with the second lumen, thereby generating a central lumen for the precator system. The first and second notches are positioned and configured to form a window having an open area into which a portion of the tubular organ tissue can invaginate when the precator system is implanted in the tubular organ and the precator system is positioned in an open configuration. A precator system configured such that when the inner component is pushed toward the outer component, it moves in parallel from an open configuration to a closed configuration, thereby reducing the size of the open area of ​​the window and gripping the invaginated tubular organ tissue so that the precator system is reliably implanted within the tubular organ.

2. The precator system according to claim 1, wherein the outer component includes one or more teeth extending into the first notch, and the one or more teeth are configured to pierce tubular organ tissue intruded into the window.

3. The precator system according to claim 1 or 2, wherein the internal component includes one or more teeth extending into the second notch, and the one or more teeth are configured to pierce tubular organ tissue intruded into the window.

4. The precator system according to claim 3, wherein the size of one or more teeth of at least one of the internal and external components corresponds to at least one of the size and thickness of the tubular organ.

5. The precator system according to claim 1 or 2, wherein the holding mechanism is a clip mechanism configured to engage with each of the multiple protrusions when the precator system moves in parallel from the open configuration to the closed configuration.

6. The precator system according to claim 1 or 2, wherein the holding mechanism is a clip mechanism configured to engage with each of the plurality of protrusions when the precator system moves in parallel from the open configuration to the closed configuration, thereby locking the inner component in a fixed position relative to the outer component.

7. The precator system according to claim 1 or 2, wherein the holding mechanism is a ratchet mechanism.

8. The precator system according to claim 1 or 2, wherein the retaining mechanism comprises a cantilever snap configured to engage with one of the plurality of protrusions and maintain the position of the inner component relative to the outer component.

9. The precator system according to claim 1 or 2, further comprising a blocking component, the blocking component being attached to the end of the inner component not located within the outer component and configured to block the second lumen.

10. The precator system according to claim 1 or 2, further comprising a delivery extension, the delivery extension being attached to the end of the inner component not located within the outer component, and the delivery extension being configured to cooperate with a precator system delivery device.

11. The precator system according to claim 1 or 2, further comprising a spring, the spring being attached to the end of the outer component where the inner component is not located.

12. The precator system according to claim 1 or 2, wherein the internal component and the external component are cylindrical.

13. In a precator and spring system, A first precator system, wherein the first precator system is A first lumen, a first notch, and a first outer component including a retaining mechanism, and It comprises a first inner component including a second lumen, a second notch, and a plurality of projections extending from the outer surface of the inner component, each of the plurality of extensions being arranged and configured to engage with the retaining mechanism, A portion of the inner component is positioned within the outer component such that the first lumen is aligned with the second lumen, thereby generating a central lumen for the precator system. The first and second notches are positioned and configured to form a first window having an open area into which a portion of the tubular organ tissue can invaginate when the precator system is implanted in the tubular organ and the precator system is positioned in an open configuration. The first precator system is configured such that when the first inner component is pushed toward the outer component, it moves in parallel from the open configuration to the closed configuration, thereby reducing the size of the open area of ​​the first window and gripping the invaginated tubular organ tissue so that the precator system is reliably implanted within the tubular organ, A second precator system, wherein the second precator system is A third lumen, a third notch, and a second outer component including a retaining mechanism, and It comprises a second inner component including a fourth lumen, a fourth notch, and a plurality of projections extending from the outer surface of the second inner component, each of the plurality of extensions being arranged and configured to engage with the retaining mechanism, A portion of the second inner component is positioned within the second outer component such that the third lumen is aligned with the fourth lumen, thereby generating a central lumen for the second precator system. The first and second notches are positioned and configured to form a second window having an open area into which a portion of the tubular organ tissue can invaginate when the precator system is implanted in the tubular organ and the precator system is positioned in an open configuration. The second precator system is configured such that when the second inner component is pushed toward the outer component, it moves in parallel from the open configuration to the closed configuration, thereby reducing the size of the open area of ​​the second window and gripping the invaginated tubular organ tissue so that the precator system is reliably implanted within the tubular organ. A spring having a cylindrical body through which lumens aligned with the first, second, third, and fourth lumens pass, the spring being attached to the first outer component and the second outer component and positioned between them, A precator and spring system equipped with [a specific feature].

14. The precator and spring system according to claim 13, wherein the spring is configured to extend axially, thereby pushing the first precator system away from the second precator system.

15. The precator and spring system according to claim 13 or 14, wherein the spring is an axially extending spring.

16. The precator and spring system according to claim 13 or 14, wherein the size of the first precator system is different from the size of the second precator system.

17. The precator and spring system according to claim 13 or 14, further comprising a occlusion component, the occlusion component being attached to the end of the first inner component not located within the first outer component and configured to occlude the second lumen.

18. The precator and spring system according to claim 13 or 14, further comprising a delivery extension, the delivery extension being removably attached to an end of the second inner component not located within the second outer component and configured to be attached to a delivery device for the precator and spring system.

19. The precator and spring system according to claim 18, further comprising a delivery device coupled to the delivery extension, wherein the delivery device is configured to facilitate the intrusion of tubular organ tissue into the first window of the first precator system and the second window of the second precator system, to facilitate the closure of the first window and the second window, and thereby fix the tubular organ tissue that has intruded into the first window and the second window.

20. In a method for implanting a precipitator and spring system into a subject's tubular organ, Positioning the precator and spring system within the tubular organ, A negative pressure is applied to the precipitator and spring system, thereby drawing the tubular organ tissue into the window of the precipitator and spring system. A method comprising acting the precator and spring system to fix the tubular organ tissue within the window.

21. The precator and spring system includes a lumen and a blocking component configured to block the lumen, and the method is The method according to claim 20, further comprising removing the occluding component after implanting the precator and spring system into the tubular organ.

22. The method according to claim 20 or 21, wherein a precipitator and spring system delivery device is used to position the precipitator and spring system within the tubular organ.

23. The precator-spring system includes a delivery extension configured to cooperate with the precator-spring system delivery device, and the method is The method according to claim 22, further comprising removing the delivery extension after the operation of the precator and spring system.

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