Discharge device with porous plug

Abstract

This disclosure relates to a drainage device designed to allow the drainage of bodily fluids while reducing the risk of the drainage opening becoming clogged with tissue surrounding the device. In one example, the drainage device comprises a drainage tube and a porous plug attached to the distal end of the drainage tube. The porous plug defines a plurality of pores, including a porous outer opening along the exposed outer surface of the plug and interconnecting channels that fluidize between the porous outer opening along the inner uncoated surface of the plug, so that when a suction force is applied to the drainage tube, bodily fluids can flow through the porous outer opening, porous interconnecting channels, and porous inner opening toward the lumen of the drainage tube.

Description

[Technical Field]

[0001] This disclosure relates to a drainage device configured to drain bodily fluids from a patient's tissue, such as an organ or limb. [Background technology]

[0002] Lymphedema, also known as "lymphedema" or "lymphatic obstruction," is a condition in which a person experiences fluid accumulation in their limbs. This is caused by a disorder of the lymphatic system, resulting in swelling of the arms and / or legs, as well as other parts of the body. The lymphatic system is responsible for collecting and filtering interstitial fluid in the body. Primary lymphedema can occur when lymphatic vessels are damaged or missing, and can develop at birth, during adolescence (early onset), or in adulthood (late onset). Secondary lymphedema is caused by damage to lymphatic vessels or removal of lymph nodes due to cancer treatment, including surgery and / or radiation therapy. This type of lymphedema can also be seen in the lower extremities or groin after surgery for ovarian, uterine, or colon cancer that requires the removal of lymph nodes.

[0003] While a cure is not possible, treatment can potentially improve the prognosis. These treatments generally include compression therapy, good skin care, exercise, and manual lymphatic drainage (MLD), which together are known as combined congestion relief therapies.

[0004] In some cases, active drainage of lymphatic fluid is necessary. However, existing catheters inserted into the muscle and adipose tissue of swollen limbs are often blocked by surrounding tissue. Therefore, there is a need for improved devices that can drain fluid from edematous tissue while reducing the risk of blockage. [Overview of the Initiative]

[0005] In cases such as lymphedema, one of the major obstacles to draining fluid from an organ, tissue, or cavity is that when negative pressure is applied to drain the fluid, the drainage catheter, specifically the catheter opening, becomes clogged with tissue (e.g., adipose tissue or muscle tissue), blood, or other insoluble components. This disclosure relates to a drainage device for draining excess fluid from an organ in the body while mitigating the risk of the drainage opening becoming clogged with surrounding tissue.

[0006] In one of its basic configurations, a sterile drainage device for draining bodily fluids comprises a drainage tube and a porous plug. This basic configuration may preferably have one or more of the features described elsewhere in this specification, in particular the features of the examples described below. However, it should be understood that the basic configuration may also preferably have one or more of the features shown in the figures and / or described in conjunction with the figures, in addition to or instead of the features of the examples described below.

[0007] In some examples, the discharge tube includes a distal portion of the tube and defines a tube lumen that extends along the central longitudinal axis.

[0008] In some examples, the porous plug comprises a plug proximal portion attached to the distal end of the tube, an exposed outer surface of the plug, an uncoated inner surface of the plug, and a plurality of pores.

[0009] In some examples, the exposed outer surface of the plug faces away from the central longitudinal axis.

[0010] In some cases, the uncoated inner surface of the plug is exposed to the tube lumen and is in fluid communication with the tube lumen.

[0011] In some examples, the pores include a plurality of outer pore openings on the exposed outer surface of the plug, a plurality of inner pore openings on the uncoated inner surface of the plug, and a plurality of pore interconnection channels extending through the porous plug.

[0012] In some examples, the pore interconnection channel extends between the outer and inner pore openings so that the outer pore openings are in fluid communication with the tube lumen through the pore interconnection channel and the inner pore openings.

[0013] In some cases, the maximum bendability and maximum compressibility values ​​are tested by bendability and compressibility tests performed on porous rectangular parallelepiped specimens.

[0014] In some cases, the sample is made from the same material as the porous plug.

[0015] In some examples, the sample contains multiple pores that have the same dimensions and spatial arrangement as the pores of the porous plug.

[0016] In some examples, the sample has dimensions of 50 × 10 × 6 mm in length × width × height.

[0017] In some examples, the sample includes a lumen that extends from a first end of the sample and terminates proximal to a second end of the sample.

[0018] In some cases, the lumen of the sample has a length of 45 mm.

[0019] In some cases, the lumen of the sample has a diameter of 1.5 mm.

[0020] In some cases, the specimen cannot be bent more than 10° when a bending force of at least 10N is applied to the second end of the specimen while the first end of the specimen is fixed in place during the bending test.

[0021] In some cases, the specimen does not compress by more than 10% when a compressive force of at least 10 N is applied to its cross-section during the compressibility test.

[0022] In some examples, the porous plug has a closed end at its distal end so that fluid communication between the tube lumen and the environment surrounding the porous plug is achieved only through a number of pores.

[0023] In some examples, the porous plug may comprise a first surface extending between two lateral sides of the porous plug and a second surface extending between the two lateral sides, wherein the first surface may optionally be concave with respect to the central longitudinal axis, and the second surface may optionally be convex with respect to the central longitudinal axis.

[0024] In some examples, the sterile discharge device may include an access port attached to the proximal end of the discharge tube.

[0025] In some examples, the access port may comprise a housing that defines a chamber in fluid communication with a tube lumen, and a self-sealing partition attached to the housing that encloses the chamber.

[0026] In some implementations, the sterile discharge device may comprise an embedded pump attached to the proximal end of the discharge tube and an outlet tube attached to the embedded pump, the outlet tube optionally extending from the embedded pump to the outlet opening of the outlet tube.

[0027] The various innovations of this disclosure may be used in combination or separately. This summary is provided in a simplified form to introduce a selection of concepts that will be further described in the following detailed description. This summary is not intended to identify any important or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The aforementioned and other objects, features, and advantages of the present invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief explanation of the drawing]

[0028] Some examples of the present invention are described herein with reference to the accompanying figures. The description, along with the figures, will make it clear to those skilled in the art how some examples may be carried out. These figures are for illustrative purposes only, and no attempt has been made to show structural details of the examples in more detail than is necessary for a basic understanding of the present invention. For clarity, some of the objects shown in the figures are not to scale.

[0029] In the diagram, [Figure 1] This shows an exemplary drainage device partially implanted in the patient's body. [Figure 2A] An exemplary side perspective view of the distal portion of an exhaust device is shown. [Figure 2B] Figure 2A shows a cross-sectional view of the discharge device. [Figure 2C] Figure 2B shows an enlarged cross-sectional view of a portion of the porous plug of the discharge device. [Figure 3] A cross-sectional view of an exemplary discharge device is shown, which has its discharge tube inserted into a complete porous plug. [Figure 4] A cross-sectional view of an exemplary discharge device is shown, which has a discharge tube inserted into a cup-shaped hollow porous plug. [Figure 5A] An approximate perspective view of a hip flask-shaped porous plug is shown. [Figure 5B] Figure 5A shows a perspective view of an exemplary discharge device with a porous plug. [Figure 5C] Figure 5B shows a cross-sectional view of the discharge device. [Figure 5D] This shows a cross-sectional view of an exemplary exhaust device with various plug lumen shapes. [Figure 5E] This shows a cross-sectional view of an exemplary exhaust device with various plug lumen shapes. [Figure 5F] This shows a cross-sectional view of an exemplary exhaust device with various plug lumen shapes. [Figure 6A]An exemplary drainage device fully implanted in the patient's body is shown, which includes an implanted access port attached to a drainage tube. [Figure 6B] Figure 6A shows an enlarged cross-sectional view of the proximal portion of the discharge device. [Figure 6C] An exemplary efflux device with an external access port is shown. [Figure 7] An exemplary drainage device fully implanted in the patient's body is shown, comprising a drainage tube and an internal pump attached to the outlet tube. [Figure 8A] An example of a threaded, barbed connector is shown. [Figure 8B] An example of a threaded, barbed connector is shown. [Figure 9] A perspective view of an exemplary hip flask-shaped porous plug having a female thread at the proximal end of the plug is shown. [Figure 10] A cross-sectional view of the discharge device is shown, with the porous plug shown in Figure 9 attached to the discharge tube via a threaded barbed connector. [Figure 11A] An exemplary rectangular porous specimen is shown, which can be used to test the bendability of porous plugs. [Figure 11B] A schematic side view of a rectangular porous sample subjected to a bending force FB applied to its free end is shown. [Figure 11C] A schematic side view of such a rectangular prism is shown. [Modes for carrying out the invention]

[0030] For the purposes of this explanation, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various disclosed examples, both individually and in various combinations and partial combinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require the existence of any one or more particular advantages or the resolution of any problem. The technology from any example may be combined with the technology described in any one or more of the other examples. Given the many possible examples in which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are merely preferred examples and should not be construed as limiting the scope of the disclosed technology.

[0031] Some of the operations of the disclosed examples are described in a specific order for the sake of presentation; however, it should be understood that this method of description is inclusive of reordering unless a specific order is required by the specific language described below. For example, operations described sequentially may, in some cases, be performed in a different order or simultaneously. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. In addition, the description may use terms such as “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily recognizable to those skilled in the art.

[0032] All features described herein are independent of each other and can be used in combination with any other features described herein, except where structurally impossible.

[0033] Where used in this application and claims, the singular forms "a," "an," and "the" include the plural form unless otherwise explicitly indicated in the context. Furthermore, the terms "have" or "include" mean "equip." Furthermore, as used herein, the terms "engaged," "connected," "joined," and "attached" are interchangeable and generally mean to be joined or linked physically and / or mechanically, and do not exclude the presence of intermediate elements between joined or associated items unless there is a specific opposite word. Where used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0034] As used herein, the term "about" is intended to include a variation of + / -10%, + / -5%, + / -1%, or + / -0.1% from a specified value when referring to a measurable value such as quantity or duration of time.

[0035] When referring to numerical values, the term "at least" means "greater than or equal to."

[0036] Directions and other relative references may be used to facilitate the explanation of the drawings and principles herein, but are not intended to limit them. For example, certain terms such as “inner,” “outer,” “upper,” “lower,” “inside,” “outside,” “top,” “bottom,” “interior,” “exterior,” “left,” and “right” may be used. Such terms are used, where applicable, to provide some clarity in the explanation when dealing with relative relationships, particularly with respect to illustrated examples. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the “upper” part can become the “lower” part simply by turning the object inside out. Nevertheless, it is still the same part, and the object remains the same.

[0037] The terms "plurality" or "plural," when used with elements, mean two or more elements. Directions and other relative references (e.g., inside and outside, top and bottom, up and down, left and right, and proximal and distal) may be used to facilitate the consideration of the drawings and principles herein, but are not intended to limit them.

[0038] It should be understood that the disclosed examples may be adapted to drain fluid from an organ or limb of a patient's body (as well as any internal cavity or space within the patient's body) into an external bag or other container. Alternatively, the disclosed examples may be adapted to drain bodily fluid from one location on the body, such as a limb, to another location, such as the abdomen.

[0039] Throughout the drawings, different superscripts of the same reference number are used to represent different examples of the same element. Examples of disclosed devices and systems may include any combination of different examples of the same element. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element represented by the superscript. To avoid excessive confusion due to too many reference numbers and lead lines in a particular drawing, some components are introduced through one or more drawings and are not explicitly identified in all subsequent drawings containing that component.

[0040] Figure 1 shows an exemplary drainage device 100 configured to be at least partially implanted in a patient's body organ, such as a swollen limb (or any other tissue, organ, or cavity) 10, and to drain excess fluid from there. The drainage device comprises a drainage tube 102 extending from a distal end 112 (shown in Figure 2A) to a proximal end 116, and a porous plug 120 attached to the distal end 112 of the drainage tube 102.

[0041] As used herein, the term “organ” refers to an organ within a patient’s body from which bodily fluids may be transferred to an external location, for example, via a catheter and / or tubular lumen. In some examples, the organ may be a leg or a hand. Non-limiting examples of bodily fluids include lymph, blood, and interstitial fluid.

[0042] As used herein, the terms “catheter” and “tube” refer to a thin, flexible tube or cannula that can be extruded from a medical-grade material, and include an outer wall that is flexible in at least part of its length, but not over the entire length, and a lumen extending from one end of the catheter or tube to the other, such as between its proximal and distal ends.

[0043] As used herein, the terms “proximal” and “distal” refer to the directions closer to and further away from the operator implanting or inserting the drainage device 100, respectively. Thus, for example, one end of the drainage device 100, including the porous plug 120, is the distal end, and the other end is the proximal end.

[0044] Figures 2A and 2B show a side view and a cross-sectional view of the distal portion of an exemplary discharge device 100, respectively. Figure 2C shows an enlarged cross-sectional view of a portion of the porous plug 120 in Figure 2B. The discharge tube 102 is aligned along the central longitudinal axis C a A tube lumen 110 is defined along the tube, and the tube lumen 110 terminates at the distal opening 114 of the tube. The porous plug 120 has a total plug length L between the proximal end 150 and the distal end 152 of the plug. P It extends along the plug. The porous plug 120 includes a distal plug portion 122 extending proximal from the distal plug end 152, a proximal plug portion 126 extending distal from the proximal plug end 150, and an intermediate plug portion 124 extending between the proximal plug portion 126 and the distal plug portion 122. In some examples, the intermediate plug portion 124 is cylindrical in shape and the plug outer diameter D of the porous plug 120 PO The discharge tube 102 has an outer diameter D TO The tube lumen 110 is defined as having a tube lumen diameter D TL This defines the distance. In some examples, the distal portion of the tube 112 may be attached to the proximal portion of the plug 126.

[0045] The porous plug 120 has an exposed outer surface 128 defined as the surface of the porous plug 120 that faces the environment surrounding the porous plug 120 and is exposed. In some examples, the exposed outer surface 128 includes an outer surface defined by at least the distal portion 122 and the intermediate portion 124 of the plug. The porous plug 120 also has an inner uncoated surface 148 defined as the surface of the porous plug 120 that is exposed and oriented toward the tube lumen 110, either directly or through the cavity of the porous plug.

[0046] The porous plug 120 further comprises a plurality of pore outer openings 132 on the exposed outer surface 128 and a plurality of pore inner openings 134 on the plug's inner uncoated surface 148, and a plurality of pore interconnection channels 130 extending between them. The pore interconnection channels 130 are a network of interconnection passages extending through the porous plug 120 so that the plurality of pore outer openings 132 are in fluid communication with the plurality of pore inner openings 134 via the pore interconnection channels 130. The pore inner openings 134 defined on the plug's inner uncoated surface 148 are exposed to the tube lumen 110 and therefore in fluid communication with the tube lumen 110, so the pore outer openings 132 on the exposed outer surface 128 are also in fluid communication with the tube lumen 110.

[0047] The porous plug 120 may optionally have a closed end at its distal portion 122, meaning that the distal portion 122 of the plug does not contain an opening larger than the outer pore opening 132. The porous plug 120 may have any non-traumatic shape, such as cylindrical, cuboid, pyramidal, conical, spherical, curved, or cup-shaped. In some examples, the distal end 122 is formed as a non-traumatic distal end 122, for example, by being curved without having sharp edges. Considering the non-traumatic shape in such embodiments, the shape of the porous plug 120, at least along the exposed outer surface 128 of the plug, may be relatively smooth (i.e., without defining any sharp edges or corners facing circumferentially or distally, while still including the outer pore opening 132 defined thereon).

[0048] The term "porous plug" refers to a closed-end plug comprising a plurality of pores implemented in the form of a plurality of pore interconnect channels 130 that form a cavernous structure between the outer pore openings 132 and the inner pore openings 134. The term "pore opening" as used herein in reference to either the outer pore opening 132 or the inner pore opening 134 refers to an opening on the surface of the plug, such as a hole, tear, cavity, aperture, break, gap, or perforation on the surface of the plug, which may include openings on either the plug exposed outer surface 128 or the non-coated inner surface 148 of the plug. The term "pore" as used herein refers to the composite structure of the outer pore opening 132, the inner pore opening 134, and the pore interconnect channels 130 extending therebetween. The pore openings 132, 134 are interconnected through the network of internal channels 130 to form fluid communication between the plug exposed outer surface 128 and the non-coated inner surface 148 of the plug. Typically, the pore interconnect channels 130 are twisted and not linear and are pre-defined by the characteristics of the material from which the plug is fabricated.

[0049] As shown in FIG. 2C, the porous plug 120 defines a pore diameter D, which is the size of the space between the solid surfaces defined around the pores of the porous plug 120. P Considering that the pore space consists of an irregular network of pores, the pore diameter can vary in different regions of the pore, for example, becoming narrower at the pore throat (D P is shown in such a region of the pore throat in FIG. 2C) and relatively larger in the wider body portion of the pore interconnect channels 130. The pore diameter D P is defined at any portion of the pore including the pore interconnect channels 130, the outer pore opening 132, and the inner pore opening 134. The term "pore diameter" as used herein refers to the dimension of the pore, for example, the dimension of the outer pore opening, the dimension of the inner pore opening, or the (center longitudinal axis C aIt refers to the dimensions of the cross-section (along a plane parallel to the pore). In some examples, the pore diameter can refer to the longest dimension of the pore, for example, the diameter of a pore with a circular cross-section, or the length of the longest cross-sectional chord that can be constructed over a pore with a non-circular cross-section. In some examples, the pore diameter can refer to the shortest dimension of the pore.

[0050] Average pore diameter D Pm The hole diameter D P It can be defined as the average or averaged value of the average pore diameter D. In some examples, the average pore diameter D is defined as the average pore diameter D. Pm The average pore size is approximately 1 to 60 micrometers (μm). In some cases, the average pore size is approximately 1 to 50 μm. In some cases, the average pore size is approximately 1 to 20 μm. In some cases, the average pore size D Pm The average pore size D of the interconnection channel 130 is approximately 2 to 15 μm, approximately 3 to 12 μm, approximately 4 to 10 μm, approximately 5 to 8 μm, approximately 5 to 7 μm, approximately 4 to 8 μm, or approximately 6 μm. In some examples, the average pore size D of the interconnection channel 130 is approximately 2 to 15 μm, approximately 3 to 12 μm, approximately 4 to 10 μm, approximately 5 to 8 μm, approximately 5 to 7 μm, approximately 4 to 8 μm, or approximately 6 μm. Pm This is equal to the average pore diameter of pore openings 132 and / or 134.

[0051] Maximum pore diameter D PMX The hole diameter D P It can be defined as the maximum value of the maximum pore diameter D. PMX This can be defined as the maximum size along any portion of the pore, including any of the outer pore opening 132, the inner pore opening 134, and the pore interconnection channel 130. The outer maximum pore diameter can similarly be defined as the maximum size of the outer pore opening 132, for example, without referring to the pore interconnection channel. In some examples, the outer maximum pore diameter is 60 μm or less. In some examples, the outer maximum pore diameter is 50 μm or less. In some examples, the outer maximum pore diameter is less than 60 μm. In some examples, the outer maximum pore diameter is between 1 and 60 μm.

[0052] The pore size (including either the average pore size and / or maximum pore size) and porosity of the porous plug 120 can be measured by standardized techniques such as mercury porosimetry, capillary flow porosimetry, and nitrogen adsorption. It should be understood that if the plug 120 includes a plug proximal opening 138 at its proximal end 150, the plug proximal opening 138 is not considered a pore in that respect. In some examples, the maximum pore size D PMX The pore size is approximately 1 to 60 μm, or approximately 20 to 50 μm. In some examples, the maximum pore size D PMX It is 100 μm or less. In some cases, the maximum pore size D PMX The particle size is less than 100 μm, and can be greater than 1 μm if desired.

[0053] As used herein, the terms “porous” and “porosity” are generally used to describe a structure having a connected network of pores or voids (which may be openings, interstitial spaces, or other channels) throughout its entire volume. The term “porosity” is a measure of voids in a material, as a percentage of 0 to 50% (or 0 to 0.5) of the total volume.

[0054] The average pore size can be measured by any known method. For example, pore size and porosity can be measured by standardized techniques such as mercury porosimetry, capillary flow porometry, and nitrogen adsorption.

[0055] In some examples, the porous plug 120 is substantially inflexible and substantially incompressible, which can facilitate its easier insertion into the patient's body. Throughout this specification and the claims, it should be understood that references to a “non-flexible” porous plug can refer to absolute rigidity that would not allow the porous plug 120 to bend at all, or to moderate bendability of, for example, up to 5°, 10°, or 15° (or less) with respect to the central longitudinal axis Ca. The bendability of a porous plug can be tested by any method known in the art. Since the shape of the porous plug can change and affect its bendability, the standardized bendability test procedures proposed herein may, if desired, rely on bendability tests performed on a rectangular parallelepiped specimen of the porous material on which the porous plug is formed. Figure 11A shows an exemplary rectangular parallelepiped porous specimen 200 that can be used to test for bendability.

[0056] The rectangular parallelepiped sample 200 is made from the material forming the porous plug 120 and is porous with the same pore size and density as the corresponding porous plug 120. Therefore, the rectangular parallelepiped sample 200 contains multiple pores as a porous plug. Alternatively, it can be said that the rectangular parallelepiped sample 200 has the same porosity as the porous plug. The length × width × height of the rectangular parallelepiped porous sample may be approximately 50 × 10 × 6 mm, as desired. In some examples, the rectangular parallelepiped porous sample 200 further includes a lumen 220 having a diameter of approximately 1.5 mm, extending along a length of approximately 45 mm from the first end 202 of the rectangular parallelepiped porous sample 200 and terminating at a distal end 222 located axially distanced from the second end 204 of the sample 200.

[0057] Figure 11B shows the bending force F applied to the free end of the sample 200, such as the upper surface 206, during the bending test procedure. B A schematic side view of the rectangular porous sample 200 that has undergone the process is shown. The bendability of the rectangular porous sample is as shown in Figure 11B, when a bending force F is applied to the second end 204 in a direction perpendicular to the upper surface 206 with the first end 202 fixed in a predetermined position. BThis is evaluated by measuring the deflection angle α of the second end 204 with respect to the horizontal pre-bent orientation when a bending force F is applied. In some examples, a threshold deflection angle α is defined to evaluate whether the rectangular porous sample 200 meets the bendability criterion, which is the bending force F applied to the second (or free) end 204 of the sample. B When the force is 10N or greater, the deflection angle α is 10 degrees or less.

[0058] In some examples, a bending force F of approximately 12N is applied. B When the bending force F is applied to the second end of the sample, the deflection angle α is 10 degrees or less. In some examples, the bending force F is approximately 15 N. B When the bending force F is applied to the second end of the sample, the deflection angle α is 10 degrees or less. In some examples, the bending force F is approximately 20 N. B When the bending force F is applied to the second end of the sample, the deflection angle α is 10 degrees or less. In some examples, the bending force F is approximately 10 N to 100 N. B When the bending force F is applied to the second end of the sample, the deflection angle α is 10 degrees or less. In some examples, the bending force F is approximately 10 N to 80 N. B When the bending force F is applied to the second end of the sample, the deflection angle α is 10 degrees or less. In some examples, the bending force F is approximately 10N to 60N or 10N to 40N, or 20N to 60N or 20N to 40N. B When applied to the second end of the sample, the deflection angle α is 10 degrees or less.

[0059] Throughout this specification and the claims, references to a “non-compressible” porous plug should be understood to mean a moderate compressibility such that the porous plug 120 is not compressible at all, or can be reduced in size by, for example, up to 5% or 10% of its free state. The terms “squeezable” and “compressible” are used interchangeably herein. The compressibility of a porous plug can be tested by any method known in the art. Since the shape of the porous plug can change and affect its compressibility, the standardized compressibility test procedure proposed herein may, if desired, rely on a bendability test performed on a rectangular parallelepiped sample of the porous material on which the porous plug is formed, which may be similar to the rectangular parallelepiped porous sample 200 described above with respect to Figure 11A.

[0060] Figure 11C shows the compressive force F that can be applied to the sample from any direction in the cross-section of the sample. C The cross-sectional view of the rectangular porous sample 200 along line 11C-11C in Figure 11A is shown. The compressibility of the rectangular porous sample is given by the compressive force F C The compressibility threshold is evaluated by measuring the change in the cross-sectional distance between opposing sides to which the compressive force F is applied and dividing it by the original distance between the same sides. In some examples, the compressibility threshold, measured as the percentage change in the cross-sectional distance between opposing sides or faces of the tested specimen, is the compressive force F applied to the cross-section of the specimen. C When the compressive force is 10N or greater, it is defined to evaluate whether a rectangular porous sample meets the compressibility criterion so that the sample is not compressed by more than 10%. In some examples, a sample is defined as having a cross-section that is subjected to a compressive force of approximately 12N F C When subjected to F, it is not compressed by more than 10%. In some cases, the sample has a cross-section of approximately 15N F C When subjected to compressive force, it does not compress by more than 10%. In some cases, the sample's cross-section is subjected to a compressive force of approximately 20 N F. C When subjected to a compressive force F, the sample is not compressed by more than 10%. In some cases, the sample's cross-section is compressed by approximately 20 N F. CIt will not be compressed by more than 10% when it is received.

[0061] In some cases, the sample's cross-section is subjected to a compressive force F of approximately 10N to 100N. C When subjected to a compressive force F, the sample is not compressed by more than 10%. In some cases, the cross-section of the sample is compressed by a compressive force F of approximately 10N to approximately 80N. C When subjected to a compressive force F, the sample is not compressed by more than 10%. In some cases, the cross-section of the sample is compressed by a compressive force F of approximately 10N to 60N, 10N to 40N, or 20N to 60N, or 20N to 40N. C It will not be compressed by more than 10% when it is received.

[0062] To meet the compressibility criteria, a first compressive force F C Force 1 can be applied in a direction configured to compress the upper surface 206 and the lower surface 208 toward each other, while measuring the percentage change in the distance between the upper surface 206 and the lower surface 208. Second force F C 2 can be applied in a direction configured to compress side 210 and side 212 toward each other, while measuring the percentage change in the distance between side 210 and side 212. Optionally, a compressive force F C The sample is positioned in a test apparatus configured to apply 1, and then the compressive force F is applied. C It can be rotated 90 degrees so that 2 can be added in the same way. F C 1 and F C The size of 2 may be the same if desired. A cross-section of the sample 200 at the location of the lumen 220 is shown in Figure 11C, but it is necessary to test the compressibility of both the section of the sample 200 with the lumen and the section of the sample 200 without the lumen, so that a compressive force can be applied (in both directions) to the section with the lumen 220 as shown in Figure 11C, and then a similar compressive force can be applied (again in both directions) to the cross-section between the distal end 222 of the lumen and the second end 202 of the sample 200.

[0063] The term "plug outer dimension" refers to the distance between two opposing points along the exposed outer surface 128 of the plug. For a cup-shaped or otherwise substantially cylindrical porous plug 120, such as in the exemplary mounting configurations shown in Figures 2A to 4, the plug outer dimension is the plug outer diameter D. PO The maximum plug outer dimensions are, for example, the maximum plug outer diameter D when the porous plug 120 is formed to have a non-uniform diameter. PO This refers to the plug height H, which is defined in more detail below with respect to Figures 5A to 5C, in the case of the flask-shaped porous plug 120. P Or plug width W P It could be either of the following. In such an example, the maximum plug outer dimension may be defined at the plug proximal end 150 in the example shown in Figures 5A to 5C, where the plug height H P Or plug width W P It can refer to the maximum value.

[0064] Throughout this specification and the claims, the plug outer diameter D PO Any reference to external dimensions of any type of plug, including, refers to the external dimensions (e.g., outer diameter) of the porous plug 120 in a free state when not subjected to any external compressive forces, such as when it is surrounded by the outside atmosphere before implantation into the patient's body.

[0065] In some examples, the total length of the plug L P It can be designed according to the structural features and other dimensions of the discharge device 100. Length L P The considerations regarding this are the width of the plug or the outer diameter of the plug D PO This can include the width of the hollow portion of the plug, and ultimately, the pressure required to aspirate bodily fluids through the porous plug. In some examples, the total length of the plug L P The length is approximately 0.1 to 10 centimeters (cm). In some examples, the total length of the plug is L. P It is approximately 1 to 10 cm. In some examples, the length L PThese are approximately 3-7cm, 3-6cm, 4-6cm, 5-6cm, 1-4cm, 2-4cm, 3cm, or 5cm.

[0066] In some examples, the total length of the plug L P The plug outer diameter is D PO Larger than. In some cases, the total plug length L P The plug outer diameter is D PO The plug's outer dimensions are at least twice as long as the plug's overall length L. P The plug outer diameter is D PO The external dimensions of the plug are at least three times the length of the plug. In some examples, the total length of the plug is L. P The plug outer diameter is D PO The plug outer dimensions are at least five times the outer dimensions of the plug. If the porous plug 120 has non-uniform outer dimensions such as a non-uniform outer diameter, the plug outer diameter D is defined throughout this specification and the claims. PO Numerical values ​​or size relationships referring to the outer dimensions of the plug, such as the maximum plug outer diameter D PO It should be understood that this refers to the maximum outer dimensions of the plug, which in some examples may be at the proximal end 150 of the plug (as in the exemplary embodiments shown in Figures 3 to 5C), and in some examples may be in the middle portion of the plug (as in the exemplary mounting configuration shown in Figure 2B).

[0067] In some examples, the tube lumen diameter D TL The range is approximately 0.01 to 3 cm. In some examples, the diameter D TL The diameter is approximately 0.05 to 1 cm. In some examples, the diameter D TL The diameter is approximately 0.07 to 0.5 cm. In some examples, the diameter D TL The diameter is approximately 0.07 to 0.5 cm. In some examples, the diameter D TL The diameter is approximately 1 to 3 millimeters (mm). In some examples, the diameter D TL The diameter is approximately 1.5 to 2.5 mm. In some examples, the diameter D TL It is approximately 1.5 to 2 mm or approximately 2 mm in size.

[0068] In some examples, the outer diameter of the tube D TO It is adapted for use in the human body. In some cases, the outer diameter of the tube is D TO The diameter is approximately 0.01 to 3 cm. In some examples, the diameter D TO The diameter is approximately 0.05 to 1 cm. In some examples, the diameter D TO The diameter is approximately 0.07 to 0.5 cm. In some examples, the diameter D TO The diameter is approximately 0.07 to 0.5 cm. In some examples, the diameter D TL The diameter is approximately 1.5 to 4 mm. In some cases, the diameter D TO The diameter is approximately 2 to 4 mm. TO It is approximately 2.5 to 3.5 mm or 3 mm in size.

[0069] Any exemplary discharge device 100 disclosed herein is intended for use in mammals or the human body. Therefore, any example of a discharge device 100 disclosed herein is an implantable device. As used herein, the term “implantable” means that at least a portion of the device can be or is to be implanted in a living organism, such as the human body, but is not limited to this. Subsequently, all components and elements of any exemplary discharge device 100, configured to contact or be implanted in a mammal or the human body (and the body of any other organism of interest), including, for example, any porous plug 120 and / or a discharge tube 102 attached thereto, are biocompatible and sterilizable, including being made from biocompatible materials. The terms “sterilized discharge device” and “discharge device” as used herein and throughout the claims are interchangeable. The term “sterilized” is known in the art and can generally refer to the property of any object that does not contain, at least largely, any form of organism and / or other biological agents such as prions, viruses, fungi, bacteria, or spore forms. Therefore, the sterilized object may be treated by at least one sterilization process that reduces, removes, or inactivates the form of the biological and / or other biological agents. The discharge device 100 may comply with any standards required by government regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency. Examples of such standards are EN 556-1 and EN 556-2.

[0070] In some examples, the porous plug 120 is made from biocompatible ceramics. In some examples, the porous plug 120 is made from biocompatible glass. In some examples, the porous plug 120 is made from biocompatible polymers. In some examples, the porous plug 120 is made from biocompatible metals such as metal foams. Combinations of such materials that can form the porous plug 120 are also considered. In some examples, the porous plug 120 is molded as a porous cup.

[0071] Various exemplary implementations of the discharge device 100 and / or its components can be referenced in superscript throughout this specification to facilitate the description of features referring to such exemplary embodiments. However, it should be understood that any reference to structural or functional features of any device or component without superscript refers to the fact that these features are generally shared by all particular exemplary implementations, which may also be indicated by superscript. In contrast, features highlighted with respect to exemplary implementations of any device or component, including the discharge device 100 and / or its porous plug 120, are referenced in superscript and may be shared as desired by some, but not all, other exemplary implementations. For example, the discharge device 100 shown in Figure 1 a This is an exemplary implementation of the drainage device 100, and therefore the drainage device 100 can be partially or completely implanted in the patient's body, while the drainage device 100 a Except that the discharge tube 102 comprises an embedded tube portion 104 and an external tube portion 106, the external tube portion 106 may be configured to connect to an external device configured to apply suction to drain bodily fluids through a porous plug 120 and the discharge tube 102, the features of the discharge device 100 described throughout this disclosure are all described with respect to the discharge device 100.

[0072] As described above, the drainage device aims to enable the drainage of bodily fluids from human organs, such as swollen limbs, without causing blockages. To facilitate drainage, the bodily fluids may be aspirated by a pump in some examples. In some implementations, the drainage device 100 a It can be connected to an external pump 20. For example, the external pump 20 may be a pump located in a hospital or other medical facility, and as a result, the discharge device 100 implanted in the body aPatients having an implanted tubing portion 104 may periodically connect an extracorporeal tubing portion 106 to an external pump 20 to initiate the removal of excess fluid. In some examples, the extracorporeal tubing portion 106 may include a connector 108 for connecting to a corresponding external pump connection port 22. In some examples, the extracorporeal tubing portion 106 may include a removable cover (not shown) configured to seal the proximal end of the drainage tube 102 when not connected to the pump, and which can be removed before attaching the drainage tube 102 to the pump. The suction force applied by a pump such as the external pump 20 may be adapted according to the site where the drainage device is implanted, the size of the plug, its porosity, etc.

[0073] As used herein, the term “suction” means the flow of liquid toward a region of partial vacuum or lower pressure. A pressure gradient between this region and the ambient pressure propels material toward the lower pressure region. As used herein, the terms “suction means” and “suction source” encompass any device capable of drawing liquid through conduits, lumens, pipes, passages, etc. Such devices may include, but are not limited to, vacuum pumps, suction pumps, syringes, vacuum blowers, and suction systems / plenums commonly found in operating rooms.

[0074] As used herein, the term “fluid communication” relating to two or more components means that such components are interconnected by lumens, pipes, conduits, passages, etc., which enable and / or facilitate the passage of fluid from one component to another.

[0075] When an external suction means such as an external pump or syringe is connected, it may be replaced by a flushing means for flushing the porous plug and / or the organ in which the plug is embedded by reversing the direction of the liquid flowing from the flushing source towards the porous plug, or may include a reverse function that can be used for flushing. It should be noted that the flushing liquid used in such cases can include any suitable liquid (such as physiological saline) or gas.

[0076] Figures 2A - 2B illustrate an exemplary discharge device 100 which is an exemplary implementation of the discharge device 100 b and thus, the discharge device 100 b includes a cup - shaped porous plug 120 having a plug lumen 136 that extends through at least a plug proximal portion 126 b and a plug intermediate portion 124 b and includes all of the features described for the discharge device 100 throughout the present disclosure, except for this. The plug lumen 136 can extend distally from the plug proximal end 150 along a plug lumen length L b that is shorter than the overall plug length L P (i.e., L PL >L P >L PL ). The plug lumen 136 can be of a cylindrical shape defining a plug lumen diameter D PL , but other shapes that are not necessarily cylindrical are also contemplated for either the porous plug 120 (for example, the exposed outer surface 128 around the plug intermediate portion 124 can be non - cylindrical) and / or the plug lumen 136.

[0077] The plug lumen 136 is in fluid communication with the tube lumen 110 and may be continuous with the tube lumen 110. The uncoated inner surface 148 of the plug is exposed to and in fluid communication with the tube lumen 110, either directly or via the plug lumen 136. In some examples, at least a portion of the uncoated inner surface 148 of the plug is exposed to and in fluid communication with the plug lumen 136. At least some of the inner openings 132 of the pores face the plug lumen 136 and are in fluid communication with the plug lumen 136. Therefore, when an attractive force is applied to the proximal portion 116 of the tube, the porous plug 120 b The surrounding bodily fluids flow through the outer pore opening 132, the pore interconnection channel 130, and the inner pore opening 134 to the plug lumen 136, and are then drawn from the plug lumen 136 to the tube lumen 110.

[0078] In some examples, the plug lumen length L PL The length is approximately 0.1 to 10 cm. In some examples, the plug lumen length L PL The length is approximately 1 to 10 cm. PL It is approximately 2 to 10 cm. In some examples, the length L PL The length is approximately 3-7 cm, 3-6 cm, 4-6 cm, 5-6 cm, or 5 cm. In some examples, the length L P It is approximately 5-6 cm in length L PL The length is approximately 4.5 to 5.8 cm. In some examples, porous plug 120 a The plug's middle section 124 b Along and, if desired, the distal part 122 of the plug b Along the plug, the middle section 124 b and the distal part 122 of the plug b It has a uniform thickness defined as the thickness between the exposed outer surface 128 of the plug and the plug lumen 136 (or the uncoated inner surface 148 of the plug) at each position. In some examples, the plug lumen length L PL The plug length L PIt is more than 80% of the plug lumen length L. PL The plug length L P It is over 70%.

[0079] In some examples, the plug lumen diameter D PL The plug outer diameter is D PO It is more than 30% of the plug lumen diameter D. PL The plug outer diameter is D PO It is more than 50% of the plug lumen diameter D. PL The tube lumen diameter D TO It is more than 30% of the plug lumen diameter D. PL The tube lumen diameter D TO It is more than 50% of that.

[0080] In some examples, the plug lumen length L PL The plug lumen diameter is D PL Larger than. In some examples, the plug lumen length L PL The plug lumen diameter is D PL It is at least twice the length of the plug lumen L. In some examples, the plug lumen length L PL The plug lumen diameter is D PL It is at least three times the plug lumen length L. PL The plug lumen diameter is D PL It is at least five times that amount.

[0081] Cup-shaped porous plug 120 b The plug is further shown to have a rounded non-traumatic distal portion 122, which may optionally be hemispherical, as in the illustrated example, or may have other curved shapes, tapering from the plug middle portion 124 towards the curved distal end 152 of the plug.

[0082] The distal portion of the tube 112 can be attached to the porous plug 120 in various ways, including being attached directly or via one or more intermediate components. In some examples, the distal portion of the tube 112 can overlap the proximal portion of the plug 126 to a certain length. In some examples, the distal portion of the tube 112 can be attached to the outer surface of the porous plug 120. In some examples, the distal portion of the tube 112 can be positioned around the proximal portion of the plug 126. In some examples, the distal portion of the tube 112 can be attached to the inner surface of the porous plug 120. In some examples, the distal portion of the tube 112 can be positioned inside the proximal portion of the plug 126, for example, by extending through the proximal opening of the porous plug 120. Figure 2B shows the distal portion of the tube 112 attached to the proximal portion of the plug 126 b An exemplary mounting configuration is shown, arranged around the porous plug 120. b proximal part 126 b The outer stepped portion 140 of the plug around the proximal portion 126 can be defined, and the distal portion 112 of the tube can be fitted and attached thereon.

[0083] In some examples, the radial depth of the plug outer step 140 is substantially equal to the thickness of the discharge tube 102, and as a result, when the distal portion of the tube 112 is positioned inside the plug outer step 140, the outer surface of the discharge tube 102 is colplanar with the plug exposed outer surface 128, as shown in Figure 2B. This would otherwise prevent the discharge device 100 from entering the patient's body during implantation. b This has the advantage of avoiding distally oriented stepped protrusions that may interfere with the insertion of the tube. Attachment of the distal portion 112 of the tube to the porous plug 120 by any exemplary configuration disclosed herein can be achieved by any method known in the art, such as bonding, joining, welding, press-fitting, friction fitting, or threading.

[0084] In some implementations, a portion of the porous plug 120 may be covered by the distal portion 112 of the tube, which then seals the outer pore opening 132 in the covered area. Thus, the exposed outer surface 128 of the plug refers to the outer surface of the porous plug 120 that remains uncovered, and as a result, the outer pore opening 132 defined thereon remains exposed and unsealed. b This is shown in Figure 2B, and its plug proximal portion 126 b The distal end of the tube 112 is covered by the porous plug 120 b The plug proximal portion 126 may have been exposed before the installation of the discharge tube 102. b The porous outer opening 132 of the porous plug 120 is sealed. b Plug exposed outer surface 128 b The distal part of the plug 122 b and plug intermediate part 124 b It is defined only in accordance with the following.

[0085] In some implementations, for example, the discharge device 100 in Figure 2B b As shown in relation to, the tube lumen diameter D TL The plug lumen diameter is D PL It is larger than this. This then relates to the porous plug 120 at the plug proximal end 150. b It forms a surface facing the proximal side of the central longitudinal axis C. As used herein, the term “proximal oriented surface” means the central longitudinal axis C a This refers to a surface perpendicular to the direction, as shown in Figure 2B of the discharge device 100. b In this case, a stepped structure is formed facing the tube lumen 110. In the illustrated example, porous plug 120 b This proximal-oriented surface may also include an inner pore opening 134, thereby including an inner uncoated surface 148 of the plug, along with the inner surface surrounding the plug lumen 136. b It forms part of something.

[0086] Figure 3 shows the porous plug 120 c Exemplary discharge tube 100 including cThis shows the emission device 100. c This is an exemplary implementation of the emission device 100, and therefore the emission device 100 c However, the middle part of that plug 124 c and its distal plug portion 122 c A cup-shaped porous plug 120 that does not include a plug lumen 136 extending through either of the two. c Except for having the porous plug 120, it includes all the features described for the discharge device 100 throughout this disclosure. c This includes the plug's intermediate portion 124, other than the pores (i.e., other than the outer pore opening 132, the inner pore opening 134, and the pore interconnection channel 130). c and its distal plug portion 122 c It may also be called a complete plug, lacking any cavities or lumens formed inside or along its surface. In some examples, as shown in Figure 3, the porous plug 120 c This extends from the plug's proximal end 150 to the plug's proximal portion 126 c It extends along the plug, but the plug's middle section 124 c The plug lumen 136 may still be included, terminating either therein or nearby.

[0087] In some examples, the porous plug 120 may have a plug proximal opening 138 defined at the plug proximal end 150. The lumen 136 of the porous plug 120 may extend distally from the plug proximal opening 138. In some examples, the plug proximal opening 138 may have a plug opening diameter D PH (For example, as shown in Figure 5A) has a plug lumen diameter D PL It may be equal to or slightly larger than this. The distal portion of the tube 112 can be inserted into the plug lumen 136 through the plug proximal opening 138. In some examples, the plug outer diameter D PO The outer diameter of the tube is D TO It is larger than that.

[0088] Porous plug 120 c The plug's middle section 124 c and plug proximal portion 126c Uniform plug outer diameter D along PO It is shown to have the outer diameter of the tube D TO It is larger than this. This then relates to the porous plug 120 at the plug proximal end 150. c This forms a surface facing the proximal side of the porous plug 120 b Unlike the proximal-oriented surface shown in Figure 2B, it does not face the tube lumen, but rather is positioned around the discharge tube 102 and exposed to the environment surrounding the distal portion 112 of the tube. In the illustrated example, porous plug 120 c This proximal-oriented surface may also include a pore outer opening 132, thereby the plug proximal portion 126 c , plug middle section 124 c , and the distal part 122 of the plug c Along with the surrounding outer surface, the plug exposed outer surface 128 c It forms part of something.

[0089] In some implementations, the distal portion of the tube 112 is connected to the discharge device 100 in Figure 3. c As shown in relation to, it can extend along the entire length of the plug lumen 136. This can then cover the inner surface surrounding the plug lumen 136 in the circumferential direction, thereby the porous plug 120 c The plug proximal portion 126 may not have been covered before the installation of the discharge tube 102. c The porous plug 120 seals any inner opening 134 of the porous plug. c Uncoated inner surface of the plug 148 c The porous plug 120 is at the level of the distal opening 114 of the tube. c It is defined only by the surface oriented proximal to (this is also the plug middle portion 124 in the illustrated example). c This is the proximal boundary, which includes an unsealed inner pore opening 134 facing the tube lumen 110.

[0090] Porous plug 120 cAdvantages associated with complete plugs include simpler manufacturing procedures and improved structural integrity of porous plugs, which may be important when the porous plug 120 is inserted into muscular tissue, such as the muscle tissue of a swollen limb (e.g., a patient's leg or arm). However, the flow path along the pore interconnection channel 130 from the outer pore opening 132 to the inner pore opening 134 can be significantly longer compared to, for example, the type of hollow porous plug shown in Figure 2B, which, in turn, increases resistance to flow and may require a pump or any other suction device to apply greater suction force to drain fluid through the porous plug.

[0091] Figure 3 shows the porous plug 120, which is a complete plug, and the discharge tube 102, which is connected by being inserted into the porous plug 120. It should be understood that these are independent features that can be separated from each other. For example, the discharge tube 102 is connected to the discharge device 100 with respect to Figure 2B. b The complete porous plug 120 can be connected in any other manner, including arranging the distal portion 112 of the tube around the proximal portion 126 of the plug, in a manner similar to that described.

[0092] Figure 4 shows the porous plug 120 d Exemplary discharge device 100 including d This shows the emission device 100. d This is an exemplary implementation of the emission device 100, and therefore the emission device 100 d However, the plug proximal part 126 d and plug intermediate part 124 d A hollow cup-shaped porous plug 120 containing a plug lumen 136 extending through both sides. d Except for comprising a discharge tube 102 inserted into the discharge device 100, it includes all the features described throughout this disclosure for the discharge device 100.

[0093] Porous plug 120 d Exposed outer surface 128 d is a porous plug 120c The above may be largely the same as the above. Porous plug 120 d The plug's middle section 124 d and plug proximal portion 126 d Uniform plug outer diameter D along PO It is shown to have, which is the outer diameter of the tube D TO Larger than and therefore, the porous plug 120 at the proximal end 150 of the plug exposed to the environment surrounding the distal end 112 of the tube d It forms a surface facing the proximal side. In the illustrated example, porous plug 120 d This proximal-oriented surface may also include a pore outer opening 132, thereby the plug proximal portion 126 d , plug middle section 124 d , and the distal part 122 of the plug d Along with the surrounding outer surface, the plug exposed outer surface 128 d It forms part of something.

[0094] In some examples, the porous plug 120 is configured to fit and accommodate the distal portion 112 of the tube, an exemplary plug 120 d proximal part 126 d An inner plug step 142 can be defined inside the plug proximal portion 126, such as the inner plug step 142 inside the plug, and as a result the distal portion of the tube 112 can be inserted into and mounted therein. In some examples, the radial depth of the plug inner step 142 is substantially equal to the thickness of the discharge tube 102, and as a result when the distal portion of the tube 112 is positioned inside the plug inner step 142, the inner surface of the discharge tube 102 (around the tube lumen 110) is coplanar with the inner uncoated surface 148 of the plug (around the plug lumen 136), as shown in Figure 4. In the illustrated example, the plug opening diameter D PO The plug lumen diameter is D PL It may also be equal to twice the thickness of the distal portion 112 of the tube.

[0095] In some implementations, the distal portion of the tube 112 is connected to the discharge device 100 in Figure 4.d As shown in relation to, the plug proximal portion 126 d It can extend along a certain length of the plug lumen 136, such as along the length of the plug lumen 136 extending through the plug. This then extends along the proximal portion 126 d The inner surface surrounding the plug lumen 136 in the circumferential direction can be covered along this, thereby the porous plug 120 d The plug proximal portion 126 may not have been covered before the installation of the discharge tube 102. d The porous plug 120 seals any inner opening 134 of the porous plug. d Uncoated inner surface of the plug 148 d The plug's middle section 124 d Along and, if desired, the distal part 122 of the plug d A porous plug 120 surrounds the plug lumen 136 along the same line. d It is defined solely by its inner surface and therefore includes an unsealed inner pore opening 134 facing the plug lumen 136.

[0096] Figure 5A shows an exemplary porous plug 120. e Figures 5B and 5C show a perspective view of the porous plug 120 of Figure 5A, respectively. e Emission device 100 equipped with e The side perspective view and cross-sectional view of the porous plug 120 are shown. e This is an exemplary implementation of the porous plug 120, and therefore the porous plug 120 e However, at least the plug middle section 124 d Along and, if desired, also the proximal part 126 of the plug e Except for having a kidney-shaped cross-section along the curve and being generally hip-flask shaped, it includes all the features described for the porous plug 120 throughout this disclosure, which are best visualized, for example, at the proximal end 150 of the plug in Figures 5A and 5B.

[0097] Central longitudinal axis C a Exposed outer surface 128 of the surrounding plug dThe portion defines the first surface 144 and the second surface 146, each of which is curved with respect to the central longitudinal axis Ca. In some examples, the first surface 144 is curved with respect to the central longitudinal axis C a The second surface 146, opposite the first surface 144, has a concave contour, and the second surface 146 is convex with respect to the central longitudinal axis Ca.

[0098] In some examples, the radius of curvature of the first surface 144 is different from the radius of curvature of the second surface 146. In the illustrated example, the first surface 144 is shown to have a radius of curvature that is generally larger than that of the second surface 146, and as a result, both surfaces 144, 146 converge toward each other at their lateral sides 154. As shown in the figure, the porous plug 120 where both surfaces 144, 146 converge e The lateral side portion 154 is a porous plug 120 when embedded. e The edges may be rounded to avoid sharp edges that could damage surrounding tissue. Although the illustrated examples show different radii of curvature, it should be understood that in some examples the radii of curvature of both the first and second surfaces may be similar and extend substantially parallel to each other, and the porous plug may optionally further define curved (e.g., hemispherical) lateral sides connecting both the first and second surfaces (examples not shown).

[0099] Porous plug 120 e The plug height H is defined as the distance between the first surface 144 and the second surface 146 at a lateral position along the central longitudinal axis Ca. P It has. The term “lateral position” as used herein refers to a position that can vary between the lateral sides 154. Central longitudinal axis C a The lateral position is the midpoint between both lateral sides 154, which is also the position along which the cross-sectional view in Figure 5C is taken. If the radii of curvature of both surfaces 144, 146 are different, as in the illustrated example, the distance between the two surfaces is the plug height H P The central longitudinal axis C defines the central axis. aIt is largest at the lateral position and the size decreases towards the lateral side 154. In some examples, the maximum plug height H P These are approximately 2-15mm, 3-10mm, 3-7mm, or 5mm in length.

[0100] Porous plug 120 e The plug width W is defined as the distance between both lateral sides 154. P It has. Plug width W P The plug height H P It is perpendicular to the. In some examples, the maximum plug width W P The width is approximately 5 to 30 mm. P These are approximately 5-20mm, 5-15mm, 7-12mm, or 10mm in length.

[0101] In some examples, the porous plug 120 may taper distally, at least along its middle section 124. In some examples, the porous plug 120 may taper from the proximal end 150 to the distal end. For cylindrical or cup-shaped porous plugs, the plug outer diameter D PO The diameter can vary from a relatively large diameter at the proximal end of the plug to a narrower diameter towards the distal end (example not shown). Flask-shaped porous plug 120 e In this case, plug height H P The plug width W may decrease towards the distal end of the plug. P Similarly, the size may decrease distally. Tapered plug 120 e As illustrated, in some examples, the flask-shaped porous plug does not necessarily have to be tapered, and the plug height H is uniform along either the middle and / or proximal part of the plug. P Please understand that it may have (examples are not shown).

[0102] In the illustrated example, porous plug 120 e The plug proximal part 126 e and plug intermediate part 124 eThe plug is shown to have a plug proximal opening 138 that leads to a plug lumen 136 extending through the porous plug 120. As shown in the illustrated example, the plug lumen 136 is a porous plug 120 e Its outer surface 128 e Even if it is shaped to taper towards the end, at least the plug middle section 124 e Uniform plug lumen diameter D PL It can have. In some examples, the plug lumen 136 has an outer surface 128 e They may be of different sizes and shapes, including following a shape that can conform to the shape, and / or may be sized to narrow distally.

[0103] In some examples, porous plug 120 e Plug total length L P These are 10-100mm, approximately 20-80mm, approximately 30-70mm, approximately 40-60mm, approximately 45-55mm, or approximately 50mm.

[0104] In some examples, the maximum plug width W P The maximum plug height is approximately 5 to 15 mm, or approximately 10 mm. P The length is approximately 3 to 10 mm, or approximately 5 mm, and the total length of the plug is L P The length is approximately 40-60 mm, or approximately 50 mm.

[0105] In some examples, the maximum plug width W P The maximum plug height H P It is larger than that. As shown in Figures 5A and 5B, the plug width W P and plug height H P The maximum value may be at the plug proximal end 150. In some examples, the maximum plug width W P The maximum plug height H P It is at least twice as much as. In some cases, the maximum plug width W P The maximum plug height H P It is at least three times that amount.

[0106] In some examples, the maximum plug height HP and / or maximum plug width W P At least one of them has a tube outer diameter D TO Larger than that. Porous plug 120 e At the plug's proximal end 150, the tube outer diameter D TO Larger than the maximum plug height H P and maximum plug width W P It is shown to have both, and therefore, the porous plug 120 at the proximal end 150 of the plug exposed to the environment surrounding the distal end 112 of the tube e It forms a surface facing the proximal side. In the illustrated example, porous plug 120 e This proximal-oriented surface may also include a pore outer opening 132, thereby the plug proximal portion 126 e , plug middle section 124 e , and the distal part 122 of the plug e Along with the surrounding outer surface, the plug exposed outer surface 128 e It forms part of something.

[0107] Porous plug 120 e The plug's middle section 124 e Although shown as a hollow porous plug including a plug lumen 136 extending through it, this is shown as an example and not an limitation, and it should be understood that non-cylindrical porous plugs, such as flask-shaped porous plugs, can be implemented as complete plugs that completely lack any cavities or lumens other than pores formed inside or along the middle and distal parts of the plug.

[0108] Cup-shaped porous plug 120 b and 120 d , or curved porous plug 120 eIt should be understood that any porous plug disclosed herein, including the substantially cylindrical plug lumen shown in Figures 2B, 4, and 5C, may include an internal plug lumen 136 having any shape, including a nonlinear cylindrical shape. Examples of any nonlinear cylindrical shapes of the plug lumen 136 are shown in Figures 5D, 5E, and 5F, respectively, for branched plug lumen 136 h , 136 i , and 136 j An exemplary hollow porous plug 100 having h , 100 i , and 100 j This shows the branch plug lumen, in the illustrated example, on surface 148. h , 148 i , and 148 j This allows for a favorable increase in the total surface area of ​​the uncoated inner surface of the plug.

[0109] Emission device 100 e is a porous plug 120 e The diagram shows a discharge tube 102 inserted into a porous plug 120. e Although it is shown that the plug includes an inner stepped portion 142 that accommodates the distal portion of the tube 112, this is shown as an example and not limiting, and it should be understood that the discharge tube 102 may be attached to a non-cylindrical porous plug, such as a flask-shaped porous plug, in any other preferred manner, including being at least partially positioned around at least a portion of the proximal portion of the plug (examples not shown). According to some examples, the connection between the discharge tube 102 and the porous plug 120 may be made using a suitable biocompatible adhesive.

[0110] Porous plug 120 c , 120 d , or 120 e While some exemplary porous plugs are shown to include a stepped shape at their proximal end 150, this is shown as an example and not limiting, and it should be understood that in some examples the outer edge of the proximal end 150 of the plug may be rounded or chamfered.

[0111] While some exemplary discharge devices disclosed herein are shown having a discharge tube 102 directly attached to a porous plug 120 by optionally inserting and passing the discharge tube 102 through a plug proximal opening 138, it should be understood that any other suitable mounting method is contemplated. In some examples, hollow connectors can be used to ensure a proper leak-proof connection of the discharge tube 102 to the porous plug 120. In some examples, a threaded barbed connector 180, illustrated in Figures 8A and 8B, can be used to secure the discharge tube 102 to the porous plug 120. As shown in Figures 8A and 8B, the threaded barbed connector 180 includes a distal extension 182 having a male thread 183 and a proximal extension 186 having one or more barbs 187. A flange 184 may optionally be positioned between the proximal extension 186 and the distal extension 182. Figure 8A shows the proximal extension 186 with a single tapered barb 187. m Exemplary threaded barbed connector 180 m Figure 8B shows a proximal extension 186 with three tapered barbs 187. n Exemplary threaded barbed connector 180 n This indicates that any other number of barbs 187 is intended.

[0112] Figure 9 shows an exemplary discharge device 100 as shown in Figure 10. l An example of a porous plug 120 l This shows: Porous plug 120 l This is an exemplary implementation of the porous plug 120, and therefore the porous plug 120 l However, it includes all the features described for the porous plug 120 throughout this disclosure, except for further defining a female thread 156 along the proximal portion of the plug lumen 136, which is configured to engage with the male thread 183 of the threaded barbed connector 180, as shown in Figure 10. (Example porous plug 120 described above) e Similar hip flask-shaped porous plug 120l However, these are shown as examples only and not limiting, and it should be understood that any other type of porous plug 120 disclosed herein may include a female thread 156.

[0113] As further shown in Figure 10, the barbed proximal extension 186 is configured to grip the distal portion 112 of the tube, while the flange 184 can abut against the proximal end 150 of the plug. In some examples, as shown in Figure 10, a sealing member 190, such as an O-ring, is further added between the distal lip of the discharge tube 102 and the flange. A similar sealing member 190 (e.g., an O-ring) can be positioned between the flange 184 and the proximal end 150 of the plug in some examples. The lumen 188 defined by the hollow threaded barbed connector 180 is in fluid communication with the tube lumen 110 and the plug lumen 136. Although a circular flange 184 is shown, it should be understood that any other shape is contemplated. For example, the flange 184 may be provided in the form of a nut to allow the threaded barbed connector 180 to be secured by a suitable rotary tool (not shown). In some examples, the flange 184 may have a non-traumatic shape. The flange 184 is designed to avoid the formation of stepped radial extensions that could hinder the distal advancement of the porous plug 120 through the tissue, with respect to the plug outer diameter D PO Or plug height H P The outer diameter D is as follows: F It is possible to define it.

[0114] In the examples shown in Figures 8A and 8B, a barb 187 is shown, but it should be understood that the proximal extension 186 can include any other type of fastening characteristics. For example, the proximal extension 186 can include a male thread configured to mesh with a female thread formed on the distal portion of the tube 112 (not shown). Furthermore, it should be understood that the threaded barbed connector 180 is shown only as an example, and any other suitable type of connector can be used to form a sealed, fixed bond between the porous plug 120 and the discharge tube 102.

[0115] Porous plug 120 c or 120 d Some exemplary porous plugs, such as those shown above, have a uniform plug outer diameter D along the proximal portion 126 of their plugs. PO An exemplary porous plug 120 is shown having e The plug proximal portion 126 tapers distally. e While it is shown to have such a configuration, this is shown as an example and not an limitation, and in some examples the plug proximal portion 126 has a narrower plug outer diameter D from the plug middle portion 124 to the plug proximal end 150. PO Or a smaller plug height H P It should be understood that the plug can taper proximally to a certain extent (example not shown). The proximal taper of the plug 126, which narrows in size towards the proximal end 150 of the plug, can facilitate easier proximal-oriented movement of the porous plug 120 when it is already inside the patient's body, such as during the retrieval of the discharge device 100 from the patient's body.

[0116] Emission device 100 c , 100 d , or 100 e Some example discharge devices include tube outer diameter D TO The diagram shows a discharge tube 102 that can be inserted into the porous plug 120 through a plug proximal opening 138 having a similar size, the porous plug 120 optionally having an inner step 142 for receiving the distal portion 112 of the tube, these are shown as examples and not limiting, and in some examples the discharge tube 102 has an outer diameter D TO Smaller plug opening diameter D PH It should be understood that the porous plug can be inserted into the plug's proximal opening 138, and may or may not have an inner step. The discharge tube 102 may be made of silicone or other suitable material that is flexible and somewhat compressible, allowing the distal portion of the tube 112 to be compressed and pressed into place through the narrower plug's proximal opening 138.

[0117] Figures 6A and 6B show an exemplary discharge device 100. f This shows the emission device 100. f This is an exemplary implementation of the emission device 100, and therefore the emission device 100 f However, it includes all the features described throughout this disclosure for the discharge device 100, except that it further comprises an access port 160 attached to the discharge tube 102, such as the proximal portion 116 of the tube. f Access port 160 f This could be an embedded discharge port, and as a result, discharge device 100 f It is configured to be completely implanted within the patient's body, without including any external parts extending outside the patient's body. Figure 6A shows an ejection device 100 completely implanted in a patient, such as in the leg 10. f This shows, however, the discharge device 100 f Other organs, tissues, or cavities into which the device can be implanted are also considered. Figure 6B shows the drainage device 100 located within the patient's limb (limp), including the access port 160 and the proximal end of the tube 116. f This shows an enlarged cross-sectional view of the proximal part.

[0118] In some implementations, as shown in Figures 6A and 6B, the embedded access port 160 f It is located beneath the patient's skin 12. The access port 160 generally comprises a housing 162 defining a chamber 164 therein, and a self-sealing partition 166 attached to the rim of the housing 162 and enclosing the chamber 164. The chamber 164 is in fluid communication with the tube lumen 110. In some examples, the proximal end of the tube 116 can be connected to the housing 162 of the embedded access port 160 via a connector such as a tube coupler 168.

[0119] During use, discharge device 100 f However, the embedded access port 160 fWhen implanted, a needle 30, which can be attached to a discharge bag via a needle hub 32, is used to puncture the patient's skin 12 and a self-sealing septum 166 facing the skin 12, thereby providing access to the chamber 164. In this way, the needle 30 may be used periodically to apply suction to the chamber 164, which then drains the bodily fluids surrounding the porous plug 120 through the pores of the porous plug 120 into the tube lumen 110, and from there into the chamber 164 and the needle 30. The self-sealing septum 166 may be a rubber or silicone membrane that seals itself when the needle is removed to prevent infection or contamination of the site.

[0120] Figure 6C shows an exemplary discharge device 100. k This shows the emission device 100. k is the discharge device 100 k Access port 160 k Except for being configured to remain outside the patient's body, the discharge device 100 is connected to the discharge tube 102 and includes an access port 160 which is generally structured in a manner similar to that described above with respect to Figures 6A and 6B. f The above example may be generally similar to the example described above. Specifically, the discharge tube 102 is discharge device 100 a In a manner similar to that described above, it may include an implantable tube section 104 and an external tube section 106, and an external access port 160 k It is attached to the proximal end of the extracorporeal tube portion 106.

[0121] The needle 30 penetrates the seal partition 166 and the discharge device 100 in the same manner as described above. k It can be used to obtain access to the chamber 164 and tube lumen 110, however, external access port 160 k Since the needle 30 remains exposed whenever suction through it is needed, the needle 30 does not need to penetrate the patient's skin in such cases.

[0122] Figure 7 shows an exemplary emission device 100. gThis shows the emission device 100. g This is an exemplary implementation of the emission device 100, and therefore the emission device 100 g However, it includes all the features described throughout this disclosure for discharge device 100, except that it further comprises a recessed pump 170 attached to the discharge tube 102 and a recessed outlet tube 176 terminating at the outlet opening 178. Discharge device 100 g It is configured to be completely implanted within the patient's body, without including any external components extending outside the patient's body.

[0123] In some examples, the implanted pump 170 may include a pump inlet port 172 to which a discharge tube 102 may be attached. For example, the proximal end of the tube 116 may be coupled to the pump inlet port 172. In some examples, the implanted pump 170 may include a pump outlet port 174 to which an implanted outlet tube 176 may be attached. The implanted pump 170 is configured to apply suction force (i.e., negative pressure) to the discharge tube 102 so that the bodily fluids surrounding the porous plug 120 flow through the pores of the porous plug 120 into the tube lumen 110 toward the implanted pump 170, and then transport from the pump 170 through the lumen of the implanted outlet tube 176 toward the outlet opening and out thereafter. The outlet opening 178 of the implanted outlet tube 176 may be located at a target location within the patient's body from which the discharged fluid can be expelled, such as the abdomen 14 in the illustrated example, or any other organ, tissue, or cavity. In some cases, the implantable outlet tube 176 can be connected to a blood vessel, and the bodily fluids surrounding the porous plug 120 can be drained into the circulatory system, digestive system, urinary tract, lymphatic system, or any other suitable target system.

[0124] An exemplary emission device 100 is described with respect to Figure 1. a The discharge device 100 described in relation to Figures 6A to 6B f or the discharge device 100 described with respect to Figure 7 gAny of the porous plugs 120 can be implemented according to any example disclosed herein for porous plugs 120 including cup-shaped plugs or hip flask-shaped plugs, and it should be understood that either of them may be a hollow plug or a solid plug. An exemplary discharge device 100 is described with respect to Figure 1. a The discharge device 100 described in relation to Figures 6A to 6B f or the discharge device 100 described with respect to Figure 7 g It should be understood that the attachment of the discharge tube 102 to any of the porous plugs 120 can be implemented in any manner disclosed herein, including arranging the distal portion 112 of the tube around the outer surface of the proximal portion 126 of the plug, or inserting it through the proximal opening 138 of the plug.

[0125] Some examples of disclosed implementation forms Some examples of the above implementation forms are listed below. Note that one feature of a single example, or two or more features of an example taken in combination with one or more features of one or more of the following examples, are also examples that fall within the scope of the disclosure of this application.

[0126] Example 1: A sterile drainage device for draining bodily fluids, A discharge tube including a distal portion of the tube, comprising a discharge tube defining a tube lumen extending along the central longitudinal axis, A porous plug, The plug attached to the distal end of the tube, The exposed outer surface of the plug is facing away from the central longitudinal axis, The uncoated inner surface of the plug, which is exposed to the tube lumen and in fluid communication with the tube lumen, Multiple pores, Multiple pores on the exposed outer surface of the plug, Multiple pore-internal openings on the uncoated inner surface of the plug, A porous plug comprising a plurality of pores, each including a plurality of pore interconnection channels, the pores extending through the porous plug between the outer pore openings and the inner pore openings such that the outer pore openings are in fluid communication with the tube lumen via the pore interconnection channels and the inner pore openings, A porous rectangular parallelepiped sample of a porous plug cannot be bent more than 10° when a bending force of 10N or more is applied to its second end while its first end is fixed in place. The sample is made from the same material as the porous plug, has multiple holes similar to the porous plug, has a length × width × height of 50 × 10 × 6 mm, and has a lumen extending 45 mm from the first end, with the lumen having a diameter of 1.5 mm. When a compressive force of 10N or more is applied to the cross-section of a porous rectangular parallelepiped sample, it does not compress by more than 10%. A sterile discharge device in which a porous plug has a closed end at its distal end so that fluid communication between the tube lumen and the environment surrounding the porous plug is achieved only through multiple pores.

[0127] Example 2. Any example of this specification, in particular the sterile discharge device of Example 1, wherein the bending force applied to the second end of the sample is equal to at least 12 N.

[0128] Example 3. Any example of this specification, in particular the sterile discharge device of Example 1, wherein the bending force applied to the second end of the sample is equal to at least 15 N.

[0129] Example 4. Any example of this specification, in particular the sterile discharge device of Example 1, wherein the bending force applied to the second end of the sample is equal to at least 20 N.

[0130] Example 5. Any example of a sterile discharge device according to this specification, in particular any one of Examples 1-4, in which the compressive force applied to the cross-section of the sample is equal to at least 12 N.

[0131] Example 6. Any example of a sterile discharge device according to this specification, in particular any one of Examples 1 to 4, wherein the compressive force applied to the cross-section of the sample is equal to at least 12 N.

[0132] Example 7. Any example of a sterile discharge device according to this specification, in particular any one of Examples 1-4, wherein the compressive force applied to the cross-section of the sample is equal to at least 12N.

[0133] Example 8. Any example herein, particularly the sterile discharge device of Example 1, in which the porous plug is made from a biocompatible material selected from ceramics, glass, metals, polymers, and combinations thereof.

[0134] Example 9. Any example of a sterile discharge device according to this specification, in particular any one of Examples 1 to 8, wherein the porous plug further comprises a plug lumen surrounded by an uncoated inner surface of the plug, the plug lumen being continuous with and in fluid communication with a tube lumen.

[0135] Example 10. Any example of the sterile discharge device described herein, in particular any one of Examples 1 to 9, that defines an average pore size of 1 to 60 μm.

[0136] Example 11. Any example of this specification, in particular the sterile discharge device of Example 10, having an average pore size of 1 to 20 μm.

[0137] Example 12. Any example of this specification, in particular the sterile discharge device of Example 10, having an average pore size of 3 to 12 μm.

[0138] Example 13. Any example of this specification, in particular the sterile discharge device of Example 10, having an average pore size of 4–8 μm.

[0139] Example 14. Any example of the sterile discharge device described herein, in particular any one of Examples 1 to 13, where the plug length is 1 to 100 mm.

[0140] Example 15. A sterile discharge device of any example herein, in particular Example 14, wherein the total length of the plug is at least twice the outer dimensions of the plug.

[0141] Example 16. A sterile discharge device of any example herein, in particular Example 14, wherein the total length of the plug is at least three times the outer dimensions of the plug.

[0142] Example 17. A sterile discharge device of any example herein, in particular any one of Examples 1 to 16, wherein the distal portion of the plug has a non-traumatic shape lacking sharp edges.

[0143] Example 18. A sterile discharge device of any example herein, in particular any one of Examples 1 to 11, in which the distal portion of the tube is positioned around the proximal portion of the plug.

[0144] Example 19. A sterile discharge device of any example herein, in particular Example 18, wherein the proximal portion of the plug is provided with an outer step portion of the plug such that the outer surface of the discharge tube is coplanar with the exposed outer surface of the plug.

[0145] Example 20. Any example of a sterile discharge device according to this specification, in particular any one of Examples 1 to 17, wherein the distal portion of the tube extends into the proximal portion of the plug through a proximal opening defined at the proximal end of the porous plug.

[0146] Example 21. Any example of the sterile discharge device according to this specification, in particular Example 20, wherein the proximal portion of the plug further comprises an inner step portion of the plug such that the inner surface of the discharge tube is coplanar with the uncoated inner surface of the plug.

[0147] Example 22. A sterile discharge device of any example herein, in particular any one of Examples 1 to 17, wherein the distal end of the tube is connected to the proximal end of the plug by a hollow connector.

[0148] Example 23. A sterile discharge device of any example herein, in particular Example 22, comprising a hollow connector having a distal extension having a male thread that engages with a female thread of a plug lumen, and a proximal extension having one or more tapered barbs.

[0149] Example 24. A sterile discharge device of any example herein, in particular Example 22 or Example 23, further comprising a sealing member positioned between the distal end of the tube and the proximal end of the plug.

[0150] Example 25. A sterilization discharge device according to any example herein, particularly any one of Examples 1 to 24, wherein the porous plug has a circular cross-sectional shape and the outer dimension of the plug is the outer diameter of the plug.

[0151] Example 26. A sterilization discharge device according to any example herein, particularly the sterilization discharge device of Example 16, wherein the porous plug is cup-shaped.

[0152] Example 27. A sterilization discharge device according to any example herein, particularly the sterilization discharge device of Example 25 or Example 26, wherein the porous plug tapers in the distal direction to a narrower outer diameter of the plug.

[0153] Example 28. The porous plug includes a first surface extending between two lateral sides of the porous plug and a second surface extending between the two lateral sides, the first surface is concave with respect to the central longitudinal axis, the second surface is convex with respect to the central longitudinal axis, and the porous plug defines a plug width between the lateral sides and a plug height between the first surface and the second surface. The sterilization discharge device according to any one of claims 1 to 24.

[0154] Example 29. A sterilization discharge device according to any example herein, particularly the sterilization discharge device of Example 28, wherein the first surface and the second surface converge towards each other at the lateral sides.

[0155] Example 30. A sterilization discharge device according to any example herein, particularly the sterilization discharge device of Example 28 or Example 29, wherein the first surface and the second surface have different radii of curvature.

[0156] Example 31. A sterilization discharge device according to any example herein, particularly any one of Examples 28 to 30, wherein the maximum value of the plug width is 5 to 30 mm.

[0157] Example 32. A sterilization discharge device according to any example herein, particularly the sterilization discharge device of Example 28 or Example 31, wherein the plug width decreases in size in the distal direction.

[0158] Example 33. Any example of this specification, in particular any one of Examples 28-32, of a sterile discharge device, where the maximum plug height is 2-15 mm.

[0159] Example 34. A sterile discharge device in any example herein, particularly any one of Examples 28-33, in which the plug height decreases in size distally.

[0160] Example 35. Any example herein, in particular any one of Examples 28-30, of a sterile discharge device, wherein the maximum plug width is at least twice the maximum plug height.

[0161] Example 36. Any example herein, in particular any one of Examples 28-30, of a sterile discharge device, in which the maximum value of the plug width is at least three times the maximum value of the plug height.

[0162] Example 37. A sterile discharge device according to any example herein, in particular Example 1 or Example 36, comprising an implantable tube portion including a distal tube portion and an extracorporeal tube portion configured to extend outside the patient's body when the implantable tube portion is implanted in the patient's body.

[0163] Example 38. A sterile discharge device of any example herein, in particular Example 37, wherein the external tubular portion comprises a connector configured to connect to an external pump.

[0164] Example 39. A sterile discharge device of any example herein, in particular Example 1 or Example 36, further comprising an access port attached to the proximal end of the discharge tube, the access port comprising a housing defining a chamber in fluid communication with the tube lumen, and a self-sealing partition attached to the housing and enclosing the chamber.

[0165] Example 40. A sterile discharge device of any example herein, in particular Example 39, wherein the self-sealing partition comprises rubber or silicone.

[0166] Example 41. A sterile discharge device of any example herein, particularly Example 1 or Example 36, further comprising an embedded pump attached to the proximal end of a discharge tube and an embedded outlet tube attached to the embedded pump, wherein the embedded outlet tube extends from the embedded pump to the outlet opening of the embedded outlet tube.

[0167] Example 42. A sterile discharge device according to any example herein, in particular Example 41, wherein the embedded pump comprises a pump inlet port to which a discharge tube is attached, and a pump outlet port to which an embedded outlet tube is attached.

[0168] Example 43. A sterile discharge device of any example herein, in particular any one of Examples 1 to 42, wherein the body fluid is selected from lymph, interstitial fluid, and combinations thereof.

[0169] For clarity, certain features of this disclosure described in relation to separate examples may also be provided in combination in a single example. Conversely, various features of this disclosure described in relation to a single example for brevity may be provided separately, in any preferred partial combination, or in any other described example of this disclosure. Features described in the context of an example should not be considered essential features of that example unless expressly designated so.

[0170] Considering the many possible examples to which the principles of this disclosure may apply, it should be recognized that the illustrated examples are merely preferred examples and should not be construed as limiting the scope. Rather, the scope is defined by the following claims. Accordingly, we claim all that is contained within the scope and spirit of these claims.

Claims

1. A sterile drainage device for draining bodily fluids, A discharge tube including a distal portion of the tube, comprising a discharge tube defining a tube lumen extending along the central longitudinal axis, A porous plug, The plug proximal portion attached to the distal portion of the tube, The exposed outer surface of the plug facing away from the aforementioned central longitudinal axis, An uncoated inner surface of the plug that is exposed to the tube lumen and is in fluid communication with the tube lumen, Multiple pores, Multiple outer pore openings on the exposed outer surface of the plug, Multiple pore-inner openings in the uncoated inner surface of the plug, A porous plug comprising a plurality of pores, each including a plurality of pore interconnection channels, each extending through the porous plug between the outer pore opening and the inner pore opening such that the outer pore opening is in fluid communication with the tube lumen via the pore interconnection channels and the inner pore opening, The porous rectangular parallelepiped sample of the porous plug cannot be bent more than 10° when a bending force of 10 N or more is applied to its second end while its first end is fixed in a predetermined position, the sample is made from the material of the porous plug, has multiple holes similar to the porous plug, has a length × width × height of 50 × 10 × 6 mm, has a lumen extending 45 mm from the first end, and the lumen has a diameter of 1.5 mm. The porous rectangular sample, when subjected to a compressive force of 10 N or more on its cross-section, is not compressed by more than 10%. A sterile discharge device wherein the porous plug has a closed end at its distal portion such that fluid communication between the tube lumen and the environment surrounding the porous plug is achieved only through the plurality of pores.

2. The sterilization discharge device according to claim 1, wherein the bending force applied to the second end of the sample is equal to at least 12 N.

3. The sterilization discharge device according to claim 1, wherein the bending force applied to the second end of the sample is equal to at least 15 N.

4. The sterilization discharge device according to claim 1, wherein the bending force applied to the second end of the sample is equal to at least 20 N.

5. The sterilization discharge device according to any one of claims 1 to 4, wherein the compressive force applied to the cross-section of the sample is equal to at least 12 N.

6. The sterilization discharge device according to any one of claims 1 to 4, wherein the compressive force applied to the cross-section of the sample is equal to at least 12 N.

7. The sterilization discharge device according to any one of claims 1 to 4, wherein the compressive force applied to the cross-section of the sample is equal to at least 12 N.

8. The sterile discharge device according to claim 1, wherein the porous plug is made from a biocompatible material selected from ceramics, glass, metals, polymers, and combinations thereof.

9. The sterilization discharge device according to any one of claims 1 to 8, wherein the porous plug further comprises a plug lumen surrounded by the uncoated inner surface of the plug, the plug lumen being continuous with and in fluid communication with the tube lumen.

10. The sterilization discharge device according to any one of claims 1 to 9, wherein the pores define an average pore diameter of 1 to 60 μm.

11. The sterilization discharge device according to claim 10, wherein the average pore diameter is 1 to 20 μm.

12. The sterilization discharge device according to claim 10, wherein the average pore size is 3 to 12 μm.

13. The sterilization discharge device according to claim 10, wherein the average pore diameter is 4 to 8 μm.

14. A sterilization discharge device according to any one of claims 1 to 13, wherein the total length of the plug is 1 to 100 mm.

15. The sterilization discharge device according to claim 14, wherein the total length of the plug is at least twice the outer dimensions of the plug.

16. The sterilization discharge device according to claim 14, wherein the total length of the plug is at least three times the outer dimensions of the plug.

17. The sterile discharge device according to any one of claims 1 to 16, wherein the distal portion of the plug has a non-traumatic shape that lacks sharp edges.

18. The sterile discharge device according to any one of claims 1 to 17, wherein the distal portion of the tube is arranged around the proximal portion of the plug.

19. The sterilization discharge device according to claim 18, wherein the proximal portion of the plug is provided with an outer step portion of the plug such that the outer surface of the discharge tube is coplanar with the exposed outer surface of the plug.

20. The sterile discharge device according to any one of claims 1 to 17, wherein the distal portion of the tube extends into the proximal portion of the plug through a proximal opening defined at the proximal end of the porous plug.

21. The sterilization discharge device according to claim 20, wherein the proximal portion of the plug further comprises an inner step portion of the plug such that the inner surface of the discharge tube is coplanar with the uncoated inner surface of the plug.

22. The sterile discharge device according to any one of claims 1 to 17, wherein the distal portion of the tube is connected to the proximal portion of the plug by a hollow connector.

23. The sterilization discharge device according to claim 22, wherein the hollow connector comprises a distal extension having a male thread that engages with the female thread of the plug lumen, and a proximal extension having one or more tapered barbs.

24. The sterile discharge device according to claim 22 or 23, further comprising a sealing member disposed between the distal portion of the tube and the proximal portion of the plug.

25. The sterilization discharge device according to any one of claims 1 to 24, wherein the porous plug has a circular cross-sectional shape, and the outer dimension of the plug is the outer diameter of the plug.

26. The sterilization discharge device according to claim 25, wherein the porous plug is cup-shaped.

27. The sterile discharge device according to claim 25 or 26, wherein the porous plug tapers distally to a narrower plug outer diameter.

28. The sterilization discharge device according to any one of claims 1 to 24, wherein the porous plug comprises a first surface extending between two lateral sides of the porous plug and a second surface extending between the two lateral sides, the first surface being concave with respect to the central longitudinal axis and the second surface being convex with respect to the central longitudinal axis, and the porous plug defines the plug width between the lateral sides and the plug height between the first surface and the second surface.

29. The sterilization discharge device according to claim 28, wherein the first surface and the second surface converge toward each other at the lateral side portion.

30. The sterilization discharge device according to claim 28 or 29, wherein the first surface and the second surface have different radii of curvature.

31. The sterilization discharge device according to any one of claims 28 to 30, wherein the maximum value of the plug width is 5 to 30 mm.

32. The sterile discharge device according to claim 28 or 31, wherein the plug width decreases in size in the distal direction.

33. The sterilization discharge device according to any one of claims 28 to 32, wherein the maximum value of the plug height is 2 to 15 mm.

34. The sterile discharge device according to any one of claims 28 to 33, wherein the plug height decreases in size in the distal direction.

35. The sterilization discharge device according to any one of claims 28 to 30, wherein the maximum value of the plug width is at least twice the maximum value of the plug height.

36. The sterilization discharge device according to any one of claims 28 to 30, wherein the maximum value of the plug width is at least three times the maximum value of the plug height.

37. The sterile discharge device according to claim 1 or 36, wherein the discharge tube comprises an implantable tube portion including the distal portion of the tube, and an extracorporeal tube portion configured to extend outside the patient's body when the implantable tube portion is implanted inside the patient's body.

38. The sterile discharge device according to claim 37, wherein the external tube portion comprises a connector configured to connect to an external pump.

39. The sterile discharge device according to claim 1 or 36, further comprising an access port attached to the proximal end of the discharge tube, wherein the access port comprises a housing defining a chamber that is in fluid communication with the tube lumen, and a self-sealing partition attached to the housing that encloses the chamber.

40. The sterilization discharge device according to claim 39, wherein the self-sealing partition comprises rubber or silicone.

41. The sterile discharge device according to claim 1 or 36, further comprising an embedded pump attached to the proximal end of the discharge tube and an embedded outlet tube attached to the embedded pump, wherein the embedded outlet tube extends from the embedded pump to the outlet opening of the embedded outlet tube.

42. The sterilization discharge device according to claim 41, wherein the embedded pump comprises a pump inlet port to which the discharge tube is attached and a pump outlet port to which the embedded outlet tube is attached.

43. The sterile discharge device according to any one of claims 1 to 42, wherein the bodily fluid is selected from lymph, interstitial fluid, and combinations thereof.

Images