CN113558812B - Enterostomy is with artifical anus controller - Google Patents

Abstract

The invention provides an artificial anus controller for enterostomy, which relates to the technical field of auxiliary medical appliances and comprises a flow guide pipe, a blocking piece and a driving component for driving the blocking piece to deform along the radial direction of the flow guide pipe; the blocking piece comprises a plurality of supporting pieces fixedly arranged on the inner side wall of the flow guide pipe, the supporting pieces are uniformly arranged along the radial direction of the flow guide pipe, the supporting pieces are made of two-way shape memory polymers and have initial shapes and temporary shapes, under the initial shapes, the supporting pieces are mutually attached to form a sealing state to block the flow passage, and under the temporary shapes, the supporting pieces are mutually separated to form an open state to open the flow passage. The invention adopts the support piece made of the two-way shape memory polymer to simulate the function of the sphincter of the human body, ensures the plugging efficiency and the plugging effect of the stoma, and can effectively control defecation and prevent the leakage of liquid dung.

Description

Enterostomy is with artifical anus controller

Technical Field

The invention relates to the technical field of auxiliary medical appliances, in particular to a controller of an artificial anus for enterostomy.

Background

The sphincter is a ring muscle distributed on the wall of some hollow viscera in human body, is commonly found in digestive tract and urinary system, and plays an important role in controlling the normal flow of the content in the hollow viscera. The reduction or loss of sphincter function due to various reasons can cause clinically serious adverse effects, such as reflux esophagitis caused by the reduction of the function of the lower esophageal cardia sphincter, bile reflux gastritis caused by the relaxation of the pyloric sphincter, urinary incontinence caused by the damage of the urethral sphincter, and fecal incontinence caused by the failure of the anal function of a human body caused by the damage of the anal sphincter. The above diseases, although not fatal, cause both physical and mental pains to patients and also bring a great burden to the families and the society of patients. Therefore, how to recover and rebuild the sphincter function of the hollow organ has become a serious clinical challenge.

Taking the case of the failure of the anal function of a human body due to the damage of the urethral sphincter, some patients after the rectum and a part of the colon are removed due to the lesion are sutured with the skin of the abdomen by surgery to form an artificial anus, which is called a stoma medically, but the artificial anus loses the normal physiological function of the anal sphincter and cannot actively control defecation. The patient needs to be provided with an ostomy bag for passively receiving excrement and urine and needs to be cleaned regularly, which not only brings pain to the patient himself, but also brings great burden to the family and social life of the patient. Therefore, the bionic anus is developed to control the incontinence of urine and feces, and a new way is opened for the treatment of the human anal dysfunction.

At present, artificial biomimetic anal devices can be broadly divided into two categories: one is to use the plugging device to plug the stoma of the artificial anus, the plugging device needs to be removed completely or partially like a stoma bag containing excrement when defecation occurs, the operation is troublesome and unhygienic, the other is to simulate the anal sphincter, the stoma or the artificial anus of the artificial anus is plugged by applying a force in a lateral direction to shrink, and the stoma or the artificial anus of the artificial anus needs to be opened by removing the applied external force when defecation occurs. Devices that simulate the anal sphincter are also classified into two categories based on the different ways of lateral force application: one is that the clamping device is directly acted on the outer wall of the elastic intestinal canal to close or open the intestinal canal, but the intestinal canal is easy to generate pathological changes due to ischemia; the other type is that the intestinal canal is butted with the capsule canal, and the air inflation or water filling controls the blockage or the opening of the capsule canal, so that the blocking effect is generally difficult to meet the requirement, once the liquid dung flows out from the artificial anus, great inconvenience is caused to the life of the patient, and serious psychological problems are also brought to the patient.

Disclosure of Invention

In view of the above problems in the prior art, it is an object of the present invention to provide an artificial anus controller for enterostomy.

In order to achieve the purpose, the invention is realized by the following technology:

an artificial anal controller for enterostomy comprising a flow conduit, a closure and a drive assembly for driving radial deformation of the closure along the flow conduit;

the plugging piece comprises a plurality of supporting pieces fixedly arranged on the inner side wall of the guide pipe, the supporting pieces are uniformly arranged along the radial direction of the guide pipe, the supporting pieces are made of two-way shape memory polymers and have initial shapes and temporary shapes, under the initial shapes, the supporting pieces are mutually attached to form a sealing state to plug the flow channel of the guide pipe, and under the temporary shapes, the supporting pieces are mutually separated to form an open state to open the flow channel of the guide pipe.

Further, in the initial shape, the maximum outer diameter of the support is equal to the inner diameter of the draft tube, and in the temporary shape, the maximum outer diameter of the support is less than the inner diameter of the draft tube.

Further, a plurality of the supporting pieces are distributed in a central symmetry mode at the same radial height.

Furthermore, the plurality of supporting pieces comprise a plurality of first supporting pieces and a plurality of second supporting pieces, the first supporting pieces and the second supporting pieces are arranged in a vertically staggered mode, and the first supporting pieces located on the upper layer are attached to the upper surfaces of the second supporting pieces located on the lower layer.

Furthermore, the plugging piece comprises a plurality of groups, and the plugging pieces are arranged in a vertically contacting manner along the axial direction of the flow guide pipe.

Further, the cross section of the supporting piece is arc-shaped.

Further, the driving mode of the driving component is electric driving or magnetic driving, when the driving mode is magnetic driving, the change frequency of the driving magnetic field is 10-30Hz, and when the driving mode is electric driving, the magnitude of the driving current is 2-6 mA.

Further, when the driving mode is magnetic driving, the driving assembly comprises a power supply, a single-pole double-position switch, a first spiral coil, a second spiral coil and magnetic induction particles, the first spiral coil and the second spiral coil are connected with the power supply in parallel through a lead, and the magnetic induction particles are uniformly dispersed in the support;

when the driving mode is electrically driven, the driving assembly comprises a power supply, a single-pole double-set switch, a first spiral coil, a second spiral coil and a heating coil, the first spiral coil and the second spiral coil are connected with the power supply in parallel through a wire, and the heating coil is sleeved on the outer side wall of the flow guide pipe.

Furthermore, an external thread is arranged at one end of the outer side wall of the flow guide pipe.

Furthermore, a biological film layer is arranged on the outer side wall of the flow guide pipe.

Further, the raw material of the two-way shape memory polymer comprises a shape memory polymer, wherein the shape memory polymer is one or more of shape memory polycaprolactone, shape memory polylactic acid, shape memory polyurethane and shape memory chitosan. Further, the raw material of the two-way shape memory polymer also comprises a fluorescent dye, and the fluorescent dye comprises fluorescein isothiocyanate, phycoerythrin, propidium iodide and Alexa

One or more of the dyes.

Furthermore, the raw material of the flow guide pipe comprises a biocompatible polymer, and the biocompatible polymer is one or more of polyvinyl alcohol, polyurethane, polycaprolactone, polyethylene and polypropylene which have biocompatibility and do not have a shape memory effect. Furthermore, the raw material of the draft tube also comprises a bactericide.

In addition, the present invention provides a method for preparing the artificial anus controller for enterostomy as described above, comprising the steps of:

s1, acquiring size information of a patient stoma by using medical imaging equipment, and designing a catheter model suitable for the patient by using three-dimensional modeling software;

s2, preparing raw materials of the draft tube;

s3, printing the raw materials of the flow guide pipe into the flow guide pipe by adopting a 3D printing technology according to the flow guide pipe model;

s4, preparing a two-way shape memory polymer material;

s5, depositing the two-way shape memory composite material on the inner side wall of the flow guide pipe by an in-situ growth method to obtain the flow guide pipe with a plugging piece;

and S6, attaching a biomembrane layer outside the diversion tube, then processing threads and assembling a driving assembly to obtain the artificial anus controller for enterostomy.

The invention has the beneficial effects that:

the invention adopts the support piece made of the two-way shape memory polymer to simulate the function of the sphincter of the human body, realizes the functions of blocking and opening the stoma by utilizing the shape transformation, is convenient to regulate and control, and a plurality of support pieces in the initial shape are mutually extruded and matched after plastic deformation and are tightly attached by abutting, thereby ensuring the blocking efficiency and the blocking effect of the stoma, and effectively controlling defecation and preventing the leakage of liquid dung. And through the shape memory effect, only tens of seconds are usually needed to realize the shape transformation, and the response speed to the defecation requirement is high.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the description below are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a perspective view of a draft tube according to an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of a draft tube according to an embodiment of the present invention;

fig. 3 is a schematic structural view illustrating a deformation process of a support according to an embodiment of the present invention, wherein fig. a is a temporary shape of a duct, and fig. b is an original shape of the duct;

FIG. 4 is a schematic cross-sectional view of a draft tube according to another embodiment of the present invention;

fig. 5 is a schematic structural view illustrating a deformation process of a support according to another embodiment of the present invention, wherein fig. a is a temporary shape of a flow guide tube, and fig. b is an original shape of the flow guide tube;

FIG. 6 is a schematic structural diagram of a driving assembly according to an embodiment of the present invention;

FIG. 7 is a schematic view of the heating coil and the draft tube according to the embodiment of the present invention;

description of reference numerals: 1. a flow guide pipe; 2. a support member; 21. a first support member; 22. a second support member; 3. a drive assembly; 31. a power source; 32. a single-pole double-set switch; 33. a first spiral coil; 34. a second spiral coil; 35. a heating coil; 4. and (4) threading.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. It should be apparent that the described embodiments are only some of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without any inventive step, are within the scope of the present invention.

It should be noted that the technical terms used in the specification and the claims of the present invention should have the ordinary meanings that those having ordinary skill in the art to which the present invention belongs. The use of the terms "comprising" or "including" and the like in the description and in the claims is intended to mean that the elements or items listed before "comprising" or "including" cover the elements or items listed after "comprising" or "including" and their equivalents, and not to exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, nor are they restricted to direct or indirect connections. Furthermore, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

It is to be understood that the terms "upper", "lower", "inner", "outer", "radial", "axial", and the like as used in the description and claims of the present invention are used in an orientation or positional relationship indicated in the drawings only for the convenience of describing the present invention and for simplicity of description, and are not intended to indicate or imply that the referenced components or items must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the present invention.

An embodiment of the present invention provides an artificial anus controller for enterostomy, see fig. 1-5, comprising a flow guide tube 1, a blocking piece and a driving assembly 3 for driving the blocking piece to deform along the radial direction of the flow guide tube 1; the honeycomb duct 1 is a hollow cylindrical body with openings at two ends, a flow channel is formed in the inner cavity of the honeycomb duct for defecation, and the honeycomb duct 1 is suitable for being butted with a stoma and communicated with the stoma.

The block piece is used for closing or opening the flow passage of the flow guide pipe 1, the block piece comprises a plurality of support pieces 2 fixedly arranged on the inner side wall of the flow guide pipe 1, the support pieces 2 are uniformly arranged along the radial direction of the flow guide pipe 1, the support pieces 2 are made of two-way shape memory polymer, the support pieces 2 have an initial shape and a temporary shape, and the support pieces 2 can be driven to be converted between the initial shape and the temporary shape and generate volume change by applying stimulation through the driving component 3; in the initial shape, the plurality of support members 2 are attached to each other to form a sealed state to close the flow path, and in the temporary shape, the plurality of support members 2 are separated from each other to form an open state to open the flow path.

In the context of the present invention, the term "two-way shape memory polymer" is a smart material having a two-way memory effect, in which an article having an initial shape changes its initial shape and is fixed to form a temporary shape upon stimulation by an external condition (e.g., heat, electricity, light, chemical induction, etc.), and the initial shape is restored upon stimulation by the external condition.

In the context of the present invention, radial and axial refer to both radial and axial directions of the draft tube 1.

The sealing state refers to a state that the plurality of supporting pieces 2 are in contact with each other and are tightly attached to enable the flow guide pipe 1 to be closed, and further, the liquid dung is prevented from flowing out, the sealing state is provided with a sealing surface, the sealing surface has the same area as the pipe orifice of the flow guide pipe 1 and can completely cut off the flow guide pipe 1, and the opening state refers to a state that the plurality of supporting pieces 2 are separated from each other and leave gaps to enable the flow guide pipe 1 to be opened, and further, the liquid dung is released to flow out. Specifically, in the initial shape, the support members 2 are in an expanded state and have a large volume, and radially adjacent support members 2 are in contact with each other and are in close contact with each other, so that a gap between them is eliminated, and a sealed state having a sealing surface is formed, so that the flow channel is closed and the stoma is sealed. Under the stimulation of the driving assembly 3, the supporting pieces 2 generate radial deformation, in the process of converting to the temporary shape, the supporting pieces 2 shrink towards the inner side wall of the flow guide pipe 1, the volume is reduced, the supporting pieces are mutually separated, after the temporary shape is fixed, the supporting pieces 2 are in a shrinking state, the volume is small, large gaps exist among the supporting pieces 2, an opening state is formed, the flow channel is opened, and normal defecation is realized.

In this embodiment, the artificial anus controller is adapted to interface with the stoma while the support member 2 is in the initial shape, and thereafter to apply a stimulus to effect a transition between the initial state and the temporary state, simulating the expansion and contraction process of the human sphincter by the shape memory of the support member 2, to control the artificial anus to defecate. The using method comprises the following steps: when the patient needs defecation, the support member 2 is transformed from the initial shape to the temporary shape by the stimulation applied by the driving assembly 3, and the flow passage of the flow guide tube 1 presents a passage, so as to carry out defecation. After defecation of the patient is finished, stimulation is applied again, the support part 2 is made to expand and deform radially and is changed into an initial shape, the support in the initial shape simulates contraction of a human sphincter, at the moment, the flow channel is in a blocking state, and defecation is stopped. The support member 2 made of the two-way shape memory polymer has a two-way shape memory function, can be reversibly transformed for multiple times between an initial shape and a temporary shape after being shaped once, has the advantage of convenient regulation and control, and the support members 2 in the initial shape are mutually extruded and matched after being plastically deformed and are tightly attached to each other by abutting, so that the plugging efficiency and the plugging effect are ensured, and the defecation and the leakage of liquid dung can be effectively controlled. Moreover, through the shape memory effect, the shape transformation can be realized only by tens of seconds, and the response speed to the defecation requirement is high. In addition, the artificial anus controller does not need to act on the intestinal canal for closing or opening the stoma, thereby avoiding the intestinal canal from generating pathological changes due to ischemia, and having higher safety and stronger practicability.

Optionally, the plugging member includes a plurality of sets, and the plurality of sets of plugging members are arranged up and down along the axial direction of the flow guide pipe 1. Through setting up multiunit shutoff piece, have higher fault-tolerant rate, when certain shutoff piece broke down, another group can produce the closed effect equally, has prolonged life.

It is noted that there may be gaps between the blocks in the axial direction (see fig. 2) or there may be no gaps, i.e. the upper surface of the lower block is in contact with the lower surface of the upper block (see fig. 4). Preferably, the plugging pieces are arranged adjacent to each other in a contact manner, so that no gap exists between the plugging pieces of the upper layer and the lower layer, and the plugging pieces of the lower layer can provide support and bearing for the plugging pieces of the upper layer.

In a group of plugging members, a plurality of the supporting members 2 are fixedly arranged on the inner side wall of the flow guide pipe 1 at the same or different radial heights, as long as the plurality of the supporting members 2 are matched with each other to form a sealing surface with a plugging function. In the initial shape, the maximum outer diameter of the support 2 is equal to the inner diameter of the duct 1, and in the temporary shape, the maximum outer diameter of the support 2 is smaller than the inner diameter of the duct 1.

In some embodiments, a plurality of said supports 2 are distributed with central symmetry at the same radial height (shown in fig. 2-3); fig. 3 is a top view of the flow duct 1, illustrating the deformation process of the support 2. It will be appreciated that the plurality of supports 2 may be 2, 3, 4, even more, preferably 4. Referring to fig. 3, 4 supporting members 2 are symmetrically distributed in the axial direction of the flow guide pipe 1 to form a plugging member. When the supporting parts 2 are in an expansion state (original shape), the 4 supporting parts 2 are oppositely extruded and folded, a flow passage for defecation is closed, and the gravity pressure of excrement is resisted, so that the liquid dung is prevented from leaking.

In other embodiments, the plurality of supporting members 2 include a plurality of first supporting members 21 and a plurality of second supporting members 22 (shown in fig. 4 to 5), the first supporting members 21 and the second supporting members 22 are arranged in a staggered manner, in this embodiment, an included angle between the first supporting members 21 and the second supporting members 22 in the radial direction is 90 degrees, and the first supporting members 21 on the upper layer are attached to the upper surface of the second supporting members 22 on the lower layer. Specifically, the plurality of first supporting members 21 have the same radial height, the plurality of second supporting members 22 have the same radial height, but the first supporting members 21 and the second supporting members 22 have different radial heights, and the first supporting members 21 and the second supporting members 22 are arranged in an up-down crossing manner, in the original shape, the first supporting members 21 on the upper layer are closely attached to the upper surfaces of the second supporting members 22 on the lower layer, the second supporting members 22 on the lower layer just fill in gaps between the plurality of first supporting members 21 on the upper layer, and in the temporary shape, the projected areas of the first supporting members 21 on the upper layer and the second supporting members 22 on the lower layer in the axial direction are partially overlapped. Fig. 5 is a top view of the flow duct 1, illustrating the deformation process of the support 2. It will be appreciated that the number of first supports 21 and the number of second supports 22 may be 2, 3, 4, or even more, preferably 2, when there are 2 first supports 21 and 2 second supports 22 each, then 4 supports 2 cooperate in the axial direction to form a closure. When the supporting member 2 is in an expanded state (original shape), the upper and lower supporting members 2 cooperate with each other to produce a blocking effect, closing the flow passage for defecation. In this arrangement, the first and second supporting members 21 and 22 support each other, thereby improving the overall pressure-bearing capacity and preventing the leakage of the liquid dung in a sealed state more effectively. In addition, when the plugging pieces are arranged in close proximity, namely, the upper plugging piece and the lower plugging piece are contacted with each other, the arrangement method is more flexible compared with the prior method, and if the first supporting piece 21 in the upper plugging piece breaks down, the first supporting piece 21 in the lower plugging piece can be matched with the second supporting piece 22 in the upper plugging piece to form another plugging structure, so that the fault tolerance rate is greatly improved, and the closing effect is ensured.

In order to better achieve the blocking effect of the support 2, the cross section of the support 2 is preferably curved.

Since the artificial anus controller needs to be used on the human body, the most common contact type thermal driving is inconvenient to use, and the driving mode of the driving assembly 3 is preferably electric driving or magnetic driving. The two-way shape memory polymer is placed in an alternating magnetic field, then the alternating magnetic field is induced through magnetic induction ions or a conductive heating coil 35, the temperature of the polymer can be induced to rise, when the temperature is higher than the glass transition temperature of the polymer, the polymer is converted from a glass state to a rubber state, the modulus is reduced, the shape memory polymer in the rubber state is endowed with a temporary shape through an external force, the external force is kept, the temperature is rapidly reduced to be lower than the glass transition temperature, the polymer is maintained in the temporary shape, and then the polymer can be restored to the original shape when the temperature is higher than the glass transition temperature through applying stimulation again.

When magnetic drive is selected, the change frequency of the drive magnetic field is 10-30 Hz; when electric drive is selected, the magnitude of the drive current is 2-6mA, and within the range, the shape conversion of the support part 2 can be better realized. And in the range of the current safe to human body, the electric current can not cause harm to patients.

When the driving manner is magnetic driving, referring to fig. 6, the driving assembly 3 includes a power source 31, a single-pole double-position switch 32, a first spiral coil 33, a second spiral coil 34, and magnetic induction particles, the first spiral coil 33 and the second spiral coil 34 are connected in parallel with the power source 31 through a conducting wire, and the magnetic induction particles are uniformly dispersed in the support 2. The single-pole double-position switch 32 is used for controlling the opening or closing of the circuit, and the first spiral coil 33 and the second spiral coil 34 can generate an alternating magnetic field when the circuit is closed. Namely: when the single-pole double-position switch 32 is shifted to be connected to the A gear, the first spiral coil 33 is connected to the circuit to generate a first alternating magnetic field, magnetic induction particles in the alternating magnetic field generate heat due to hysteresis loss and heat is conducted to the support member 2, so that the temperature of the two-way shape memory polymer reaches the glass transition temperature, and the support member 2 is further changed from an initial shape to a temporary shape; when the toggle single-pole double-position switch 32 is connected to the B-position, the second solenoid 34 is switched into the circuit, generating a second alternating magnetic field for transforming the support 2 from the temporary shape to the initial shape.

In particular, magnetic inductive particles such as Fe can be produced by ₃ O ₄ Mixing the nanoparticles with the raw materials for preparing the flow guide tube 1 such as shape memory polymer to obtain a mixture with good shape fixing and shape recovery properties, and then forming the mixture to obtain the magnetic inductionThe support 2 for the particles. The preparation method is prior art in the field and will not be elaborated here.

When the driving mode is electric driving, referring to fig. 6 to 7, the driving assembly 3 includes a power supply 31, a single-pole double-position switch 32, a first spiral coil 33, a second spiral coil 34, and a heating coil 35, the first spiral coil 33 and the second spiral coil 34 are connected in parallel with the power supply 31 through a wire, and the heating coil 35 is sleeved on the outer side wall of the flow guide tube 1, and specifically can be adhered to the outer side wall of the flow guide tube 1 through silicone rubber to prevent falling off. The heating coil 35 is used to heat the support member 2. Specifically, the alternating magnetic field generated by the external first spiral coil 33 causes the heating coil 35 outside the flow guide tube 1 to generate an eddy current, the eddy current induces the heating coil 35 to generate heat, a large amount of heat is generated, the heat is transferred to the support member 2 through the flow guide tube 1, the support member 2 is further transformed from the initial shape to the temporary shape under thermal stimulation, and after the second spiral coil 34 is turned on, the support member 2 is stimulated again to transform from the temporary shape to the initial shape.

The heating coil 35 is a copper coil, the diameter of the copper wire is 0.1-0.3mm, the diameter of the spiral coil is 5-10mm, and the optimal value can be selected according to the two-way shape memory polymer material.

By adopting the driving mode, the control part (the power supply 31, the single-pole double-position switch 32, the first spiral coil 33 and the second spiral coil 34) of the driving component 3 can be arranged outside the body, and an alternating magnetic field is generated to induce the induction part (magnetic induction ions or the heating coil 35) to generate magnetic signals or electric signals, so that stimulation and response are performed in a wireless mode, on one hand, the carrying of a patient is more convenient, and on the other hand, the danger that the driving component 3 is incompatible with the human body and generates rejection reaction when being positioned in the body is avoided.

Optionally, one end of the outer side wall of the draft tube 1 is provided with a thread 4. When in use, the drainage tube 1 is detachably connected with the intestinal canal through the thread 4 and then implanted into the stoma of a patient. It will be noted that the support member 2 is in an expanded state when inserted into the patient.

Optionally, a biomembrane layer is arranged on the outer side wall of the flow guide tube 1, and the biomembrane layer is made of a material with characteristics of biocompatibility, heat resistance, aging resistance and the like, such as a silicone rubber film. The biomembrane can be attached to the honeycomb duct by a dip coating method or a vacuum bag pressing method, the service life of the honeycomb duct 1 can be prolonged by the biomembrane layer, and the lubricity of the outer side wall of the honeycomb duct 1 and the stoma can be improved.

Optionally, the raw material of the two-way shape memory polymer comprises a shape memory polymer, the shape memory polymer is one or more of shape memory polycaprolactone, shape memory polylactic acid, shape memory polyurethane and shape memory chitosan, and the raw material is non-toxic and harmless and has good biocompatibility when used for preparing the two-way shape memory polymer.

Optionally, the raw material of the two-way shape memory polymer further comprises a fluorescent dye, and the fluorescent dye comprises fluorescein isothiocyanate, phycoerythrin, propidium iodide and Alexa

One or more of the dyes. Through adding the fluorochrome, under the illumination of specific wavelength, induce it to show specific fluorescence, rethread optical imaging equipment observes the fluorescence labeling effect, can trail degradation and the damage condition of detecting support piece 2, guarantees the result of use, can also monitor artifical anus's security and practicality.

Optionally, the raw material of the flow guide tube 1 includes a biocompatible polymer, and the biocompatible polymer is one or more of polyvinyl alcohol, polyurethane, polycaprolactone, polyethylene and polypropylene which have biocompatibility and do not have a shape memory effect.

Optionally, the raw material of the draft tube 1 also includes a bactericide, such as an iodine-containing filler. The iodine-containing filler can be potassium iodide, sodium iodide or iodine simple substance. The iodine-containing filler exists in the honeycomb duct 1 in a molecular form or an ionic form, has the functions of sterilization and inflammation diminishing, and has the following mechanism: iodine molecules or iodide ions have the super-strong oxidation effect, can damage the cell membrane structure and protein molecules of pathogens, realize sterilization and reduce the risks of pathological changes and inflammation when a patient uses the iodine molecules or iodide ions.

It is understood that the flow conduit 1 acts as a fixed support 2, which does not deform under various excitatory stimuli, and needs to meet certain stiffness requirements, typically with a radial load strength higher than 4 kPa. Furthermore, it will be appreciated by those skilled in the art that the dimensions of the draft tube 1, such as its length and inner diameter, are designed according to the actual needs to better meet the needs of different individuals. When the honeycomb duct is used by infants, the inner diameter of the honeycomb duct 1 is within the range of 1-3cm, and when the honeycomb duct is used by adults, the inner diameter is within the range of 2-5 cm.

Another embodiment of the present invention provides a method for preparing an artificial anus controller for enterostomy as described above, comprising the steps of:

s1, acquiring the size information of the stoma of the patient by using medical imaging equipment, and designing a honeycomb duct 1 model suitable for the patient by using three-dimensional modeling software;

s2, preparing the raw material of the draft tube 1;

in view of the need to introduce an antibacterial function into the draft tube 1, an iodine-containing filler is introduced into the biocompatible polymer, and preferably, the iodine-containing filler is blended with the biocompatible polymer to obtain a blend having a good co-continuous structure as a raw material for preparing the draft tube 1.

S3, printing the raw material of the flow guide pipe 1 into the flow guide pipe 1 by adopting a 3D printing technology according to the flow guide pipe 1 model;

s4, preparing a two-way shape memory polymer material;

when the magnetic driving is adopted, magnetic induction particles need to be filled into the shape memory polymer, and in addition, in consideration of the need of monitoring the use condition and the wear condition of the support 2, fluorescent dye needs to be added into the shape memory polymer, and preferably, the magnetic induction particles, the fluorescent dye and the shape memory polymer are blended to obtain a blend with good shape fixing and shape recovery properties, so as to be used as a two-way shape memory polymer material.

S5, depositing the two-way shape memory composite material on the inner side wall of the draft tube 1 by an in-situ growth method to obtain the draft tube 1 with a plugging piece;

and S6, attaching a biofilm layer outside the guide pipe 1, then processing the screw thread 4 and assembling the driving assembly 3 to obtain the artificial anus controller for enterostomy.

It should be noted that, although the steps S1, S2 and S4 are limited in sequence in the embodiment of the present invention, the sequence is limited only for description, and the three steps are not in substantial order.

Although the present disclosure has been described above, the scope of the present disclosure is not limited thereto. Various changes and modifications may be effected therein by one of ordinary skill in the pertinent art without departing from the spirit and scope of the present disclosure, and these changes and modifications are intended to be within the scope of the present disclosure.

Claims (8)

1. An artificial anal controller for enterostomy, comprising a flow duct (1), a closure and a drive assembly (3) for driving the closure to deform radially along the flow duct (1);

the plugging piece comprises a plurality of supporting pieces (2) fixedly arranged on the inner side wall of the guide pipe (1), the supporting pieces (2) are uniformly arranged along the radial direction of the guide pipe (1), the supporting pieces (2) are made of two-way shape memory polymers, the supporting pieces (2) have initial shapes and temporary shapes, the supporting pieces (2) are mutually attached to form a sealing state to plug the flow channel of the guide pipe (1) in the initial shapes, and the supporting pieces (2) are mutually separated to form an opening state to open the flow channel of the guide pipe (1) in the temporary shapes.

2. The artificial anal control for enterostomy according to claim 1, wherein a plurality of support members (2) are arranged centrally symmetrically with the same radial height.

3. The anal control device according to claim 1, wherein the plurality of support members (2) comprises a plurality of first support members (21) and a plurality of second support members (22), wherein the first support members (21) and the second support members (22) are arranged in a staggered manner, and wherein the first support members (21) at an upper level are engaged with the upper surface of the second support members (22) at a lower level.

4. An artificial anal controller for enterostomy according to any one of claims 1 to 3, wherein the block piece comprises a plurality of sets of block pieces arranged in contact up and down in the axial direction of the flow guide tube (1).

5. An enterostomy artificial anus controller according to any one of claims 1-3, characterized in that the drive means of the drive assembly (3) is electrically or magnetically driven;

when the driving mode is magnetic driving, the change frequency of the driving magnetic field is 10-30 Hz;

when the driving mode is electric driving, the magnitude of the driving current is 2-6 mA.

6. The enterostomy artificial anus controller according to claim 5, characterized in that when the driving means is magnetic driving, the driving assembly (3) comprises a power source (31), a single-pole double-position switch (32), a first spiral coil (33), a second spiral coil (34) and magnetically inductive particles, the first spiral coil (33) and the second spiral coil (34) are connected in parallel with the power source (31) by a wire, and the magnetically inductive particles are uniformly dispersed within the support (2);

when the driving mode is electrically driven, the driving assembly (3) comprises a power supply (31), a single-pole double-position switch (32), a first spiral coil (33), a second spiral coil (34) and a heating coil (35), the first spiral coil (33) and the second spiral coil (34) are connected with the power supply (31) in parallel through a conducting wire, and the heating coil (35) is sleeved on the outer side wall of the flow guide pipe (1).

7. An enterostomy artificial anus controller according to any one of claims 1-3, characterized in that the flow guide tube (1) is provided with a thread (4) at one end of its outer side wall.

8. The artificial anal controller for enterostomy according to any one of claims 1 to 3, wherein the outer side wall of the drainage tube (1) is provided with a biofilm layer.

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