Artificial lymph vessel for secondary lymphedema

Abstract

The present invention relates to an "artificial" lymph vessel that allows lymph restoration in order to reach the lymph nodes, in cases where reconstruction is not possible. The invention comprises a tubular body having at least one inlet end with a first diameter and at least one outlet end with a second diameter, with a one-way valve arranged near the at least one outlet end. The one-way valve comprises a sudden reduction in the first diameter in order to create a third diameter, followed by an area in which the third diameter decreases uniformly until it reaches a discharge area with a fourth diameter.

Description

ARTIFICIAL LYMPHATIC VESSEL FOR SECONDARY LYMPHEDEMA Object of the invention

[0001] The general objective of this application is to obtain a lymphatic vessel as an internal medical device that could represent an option for treating and restoring lymphatic circulation in patients affected by breast cancer treatments in severe and severe stages due to damage to the lymphatic vessels beyond reconstruction. Background

[0002] Breast cancer treatment requires a multidisciplinary approach, with surgery playing a key role. The breast is treated with conservative or complete surgery; lymph node dissection is required to assess the extent of the disease. It can be selective or radical. This allows for determining the treatment the patient should receive, as it must be completely personalized.

[0003] Through studies conducted by the American Cancer Society, it has been observed that lymphedema occurs during cancer surgery. The doctor may remove lymph nodes near the tumor to determine if the cancer has spread. When this occurs, the lymphatic vessels that carry fluid from that area to the rest of the body are also removed, as they pass through the nodes and are connected around them. Removing lymph nodes and vessels makes it difficult for lymphatic fluid to flow from the arms, legs, and other parts of the body to the chest, where it flows back into the bloodstream. If the remaining lymphatic vessels cannot collect enough fluid from the area, it accumulates and causes swelling, or lymphedema.

[0004] Another treatment that could cause lymphedema is radiation therapy, which can affect the transport of lymphatic fluid by causing damage and scar tissue in lymph nodes and vessels. Occasionally, the tumor itself can block part of the lymphatic system and cause lymphedema, as can infections that restrict the flow of lymphatic fluid. There is no foolproof way to prevent all cases of lymphedema, but there are ways to reduce the risk of developing the condition. For example, when lymph nodes need to be removed, some modern surgical techniques can be useful. This is due to the procedure the doctor performs by selecting only the infected nodes. This means that, while previous methods involved dissecting all the nodes without knowing which one is diseased, with this type of method, the removal is safer and less invasive for the patient.

[0005] Based on the functioning of the lymphatic system, which is made up of lymphatic vessels and organs, interstitial fluid is reabsorbed and transported in vessels of increasing caliber to the precollector and collector vessels. Lymph nodes filter lymph and prevent pathogens from entering the bloodstream. To this end, there are two compartments within the lymphatic system:

[0006] 1.- The superficial one in charge of draining the dermis

[0007] 2.- The deep drains the lymph produced in the muscles, bones, joints and nerves.

[0008] The present invention is intended solely to resolve secondary lymphedema; therefore, it focuses on curing, not just treating, the symptoms. However, to begin, it is necessary to present the concepts of lymph, lymph nodes, and lymphatic vessels as a preamble.

[0009] The lymph:

[0010] It is a clear, slightly whitish or yellowish fluid when it is loaded with fat. It is composed of 90% water and 10% protein, fat, dead cells, bacteria, and malignant cells if any type of cancer is present.

[0011] Lymph comes from interstitial fluid (fluid found in the spaces surrounding cells and created by substances leaking from blood capillaries, the smallest type of blood vessel). Lymph helps bring oxygen and nutrients to cells and remove waste from them. As new interstitial fluid forms, it replaces the old fluid, which drains into the lymph vessels. When it enters the lymph vessels, interstitial fluid is called lymph.

[0012] The function of lymph is to return proteins and excess interstitial fluid to the bloodstream. It can collect bacteria and deposit them in the lymph nodes, which then destroy them.

[0013] Lymph has a viscosity comparable to that of blood plasma, the difference between them being that lymph contains white blood cells; its purpose is to supply cells with water and nutrients, collecting waste products from those cells along the way. Lymph enters the lymphatic vessels from the interstitial spaces.

[0014] The difference between the cardiovascular system and the lymphatic system is that it is not closed and does not have a central pump; transport is slow and sporadic with low pressure; lymphatic movement is due to the natural contraction of the stomach and intestines, the valves, and compression during contraction of adjacent skeletal muscle and arterial propulsion.

[0015] Lymphatic fluid is very similar in viscosity to blood. Its pressure, velocity, and circulation depend largely on the movements of the body's joints, muscles, and even human breathing.

[0016] The lymph nodes:

[0017] They are small, flattened organs, similar in shape to a small kidney (reniform), arranged in chains along the path of the lymphatic vessels. Their size varies greatly, depending primarily on their level of activity.

[0018] These nodes vary in size, measuring between 1 mm for the smallest and between 1-2 cm for the largest. They are found in the armpit, groin, along the large vessels of the neck, and in large numbers in the thorax and abdomen.

[0019] The lymph nodes filter the lymph that passes through them. Lymph flows slowly through the sinuses, and the reticular filaments that crisscross them act as a mechanical filter, stopping or slowing the passage of infectious microorganisms and other cells. Lymph usually passes through at least two lymph nodes on its way from the tissues to the blood.

[0020] Lymph nodes are located interspersed along the lymphatic vessels. They have a functional structure that allows for the cross-linking of antigen-presenting cells, antagonistic substances from the lymph, and lymphocytes. The lymph node plays a key role in the initial immune response.

[0021] Radioisotope lymphangiography measured the lymph node capacity in terms of lymph volume to be an average of 0.4 ml.

[0022] Lymphatic vessel:

[0023] They are responsible for carrying the lymph formed in the tissues to the venous system, where it empties, specifically at the base of the neck, in the angle formed by the internal jugular and subclavian veins. The lymphatic vascular system adapts to the amount of lymph produced. If this amount increases, the frequency and amplitude of the lymphatic duct pulsations also increase, so the lymphatic vascular system acts as a safety valve or compensatory mechanism when Starling's balance is altered. To better understand this invention, let's learn about the existing treatments commonly called "conventional treatments." These treatments describe the different types of treatments currently performed on patients with lymphedema by specialists in the field, along with their advantages and disadvantages.

[0024] Mechanical treatments:

[0025] • Elevation of the affected limb. Although elevation can be helpful, reducing lymphedema through the principle of gravity, it is often impractical and uncomfortable.

[0026] • Elastic compression. Elastic compression between 20 and 60 mm Hg is an effective measure for managing lymphedema and can be used as primary therapy. The patient must wear an elastic sleeve from the wrist to the armpit. It must be replaced every 4 to 6 months or when it begins to lose elasticity. It has some drawbacks, including the discomfort associated with compression, its relative difficulty in applying, and its high cost. The professional who prescribes this type of accessory must instruct patients on its proper application. In this regard, this task is often confined to a medical supply store employee who lacks specific training.

[0027] • Exercises. Moderate active exercises of the arm and forearm muscles can be used to activate the "muscle pump," in the hope of increasing venous and lymphatic flow. Exercises are best performed with minimal limb movement, allowing the patient to perform them moderately whenever desired. Excessive repetition of exercises can cause an exaggerated increase in arterial blood flow to the limb, which can increase edema formation.

[0028] • Manual lymphatic drainage. This is a massage technique that stimulates the lymphatic vessels to contract more frequently, anatomically following the body's lymphatic pathways. Lymphatic drainage massages begin centrally in the neck and trunk to empty the main lymphatic pathways, thereby facilitating the drainage of accumulated lymph in the affected upper limb.

[0029] • Bandages. Immediately after manual lymphatic drainage, multi-layered, low-pressure bandages can be used. The bandaged patient is then guided through exercises that involve an active range of motion with the muscles and joints functioning within the enclosed space of the bandage.

[0030] • Pneumatic compression pumps. These have been proposed as an alternative to lymphatic massage. There are a variety of device models, but there are basically two types: those that use a single chamber and more modern ones that have multiple chambers. The single-chamber system provides intermittent, non-segmented compression along the entire treated arm; however, it can also cause retrograde lymph flow, which can lead to increased lymphedema in the distal end of the arm. Those with multiple chambers can provide sequential compression from distal to proximal, theoretically propelling fluid forward of its compression. It is difficult to compare the effectiveness of both methods because there is no consensus regarding the optimal pump pressure, duration, and frequency of sessions.

[0031] • Comprehensive decongestive physiotherapy. This therapeutic procedure addresses lymphedema affecting an entire quadrant of the body, although its effects are most significant in the arm and hand. It includes skin care, manual lymphatic drainage, low-pressure multi-layered compression bandages (followed by a tight-fitting compression garment once the edema has subsided), and therapeutic exercises with the garments or bandages. It must be performed by specialized and specially trained therapists.

[0032] • Physiotherapy treatments with bandages for secondary lymphedema due to breast cancer have resulted in patients reducing the volume of the affected limb, provided it is the case of mild lymphedema.

[0033] Drug treatments:

[0034] • Antibiotics. From a pharmacological perspective, the most important approach is early treatment of erysipelas or lymphangitis with sodium penicillin G. Administration of delayed-release penicillin for long periods is also useful to prevent infectious outbreaks, which are significantly associated with the progressive worsening of lymphedema.

[0035] • Diuretics. They are not effective in reducing protein-rich edema, such as lymphedema. Although they can temporarily mobilize water, the increased oncotic pressure exerted by the high concentration of protein in the interstitial spaces causes rapid recurrence of lymphedema and may even accelerate the fibrosis process.

[0036] • Benzopyrones. Some benzopyrones and plant derivatives improve chronic lymphedema by activating proteolysis, removing excess protein from tissue spaces, leading to a decrease in oncotic pressure and edema fluid.

[0037] • Skin lubricants. It is especially important to keep the skin of the affected limb well lubricated with protective emulsions.

[0038] Surgical treatment:

[0039] Surgery has only been considered in cases where all conservative measures have failed. Numerous procedures have been proposed, but their results have been poor. In general, there are two types of surgical methods: physiological and reductive.

[0040] • Physiological procedures: these aim to restore lymphatic flow to the limb by anastomosing the dilated lymphatic ducts with veins using microsurgical techniques.

[0041] • Reduction techniques simply resect excess edematous tissue to reduce the limb to a more functional size. These procedures involve the removal of skin and subcutaneous tissue followed by skin grafting. More recently, in Sweden, good short-term results have been reported with liposuction, although the long-term efficacy of the procedure is not yet known.

[0042] In the case of surgical treatment, the main goals in lymphedema management are to limit patient morbidity and improve functionality and quality of life. Surgical treatment is an alternative when conservative measures are no longer sufficient. There are procedures that aim to prevent the development of lymphedema, and techniques that include physiological (reconstructive) and receptive procedures used when lymphedema is already established. Success depends on careful patient selection and individualized treatment.

[0043] Innovative Treatments:

[0044] The International Lymphedema Framework (ILF), a platform comprised of industry professionals, patients, and companies, created to research and disseminate up-to-date information on lymphedema and its associated conditions.

[0045] • Margaret McNeely (associate professor in the Department of Physical Therapy at the University of Alberta in Edmonton, Canada) spoke about progressive resistance exercise (resistance exercise + compression garment + decongestive exercise sequence), highlighting the strong evidence supporting the benefits of exercise for cancer survivors, which improves their quality of life. Presentations on lymphedema in cancer patients focused on breast cancer. The possibility of cooling the skin to 10 degrees Celsius before manual lymphatic drainage was discussed. Preliminary observations showed a decrease in fibrotic tissue and a softer consistency of the edema.

[0046] • On the other hand, a very interesting study by Cestari provided data on the use of ultrasound for diagnosis and for choosing the most appropriate treatment strategy in patients with upper limb lymphedema. They studied the morphology and vascularization of the lymph nodes in the area, the structural characteristics of the edematous tissues, etc., obtaining a wealth of relevant and useful information for treatment.

[0047] • JP Belgrade explained the possibility of early detection of secondary lymphedema in cancer treatments using infrared fluorescence images obtained in both limbs, before and after lymph node excision.

[0048] In summary, research related to lymphedema as a consequence of cancer is geared toward early detection and immediate symptom reduction in an effort to provide the patient with the highest quality of life.

[0049] Document US 2021 / 01137523 A1, dated May 13, 2021, which refers to devices and methods for performing a lymphovenous bypass procedure. A first ring is attached to tissue connected to at least one lymphatic channel of a patient and a second ring is attached to a vein of the patient. One end of the lymphatic channel extending through the first ring is inserted into an open end of the vein and the rings are connected to each other to establish the flow of fluid from the lymphatic channel to the vein; that is, it talks about the connection that is made between a lymphatic vessel and a vein, this procedure is carried out by means of 2 tips that are connected, in the invention being defended, the connection is made from the vessel to the lymph, being able to interconnect pieces to grow said connection, necessary for the lymph to continue functioning.

[0050] Document US 2017 / 0172765 A1, dated June 22, 2017, which mentions that the invention provides a three-dimensional bioprinter for manufacturing cellular constructs such as tissues and organs using electromagnetic radiation (EMR) at 405 nm or higher. The bioprinter includes a material deposition device comprising a cartridge for receiving and containing a biomaterial-containing composition that cures upon exposure to EMR.

[0051] The bioprinter also includes an EMR module that emits EMR at a wavelength of approximately 405 nm or higher. A bioprinter cartridge is also provided containing cells and a curable material at a wavelength of approximately 405 nm or higher. The cells are present in a chamber and extruded through an orifice to form the cellular construct; this refers to protecting a bioprinter that can recreate organs and tissue. While it is true that the lymphatic vessel is included in this section, it is also true that neither the printer nor the software are protected, but rather a form that is created to reconnect the damaged lymphatic vessel with the lymph. This form is not similar to the body's original form. It also has the ability to be assembled again and again up to an "n" number of times depending on the length required to replace the damaged duct.

[0052] US 2014 / 0012407 A1, dated January 9, 2014, which mentions that with a bioprinter comprising: one or more printer heads, wherein a printer head comprises means for receiving and holding at least one cartridge, and wherein said cartridge comprises contents selected from one or more of: bioink and support material; means for calibrating the position of at least one cartridge; and means for dispensing the contents of the at least one cartridge. Further described herein are methods for manufacturing a tissue construct, comprising: a computing module that receives input of a visual representation of a desired tissue construct; a computing module that generates a series of commands, wherein the commands are based on the visual representation and are readable by a bioprinter; a computing module that provides the series of commands to a bioprinter;and the bioprinter deposits bioink and support material according to the commands to form a construction with a defined geometry; this in the same sense as the previous one, what was intended to be protected is an invention about the bioprinter and some organ and tissue printing processes, which are not patentable matter within the present invention, in this order of ideas, what they intend to protect is how to create various products, in the case of the present invention, what is intended to be protected is the final product, not the manufacturing process, which is mentioned only as a reference to understand the type of final product in terms of shape, functionality, assembly and characteristics thereof, necessary to be able to be introduced into the human body, without damage or side effects.;

[0053] Finally, document US 2007 / 0129788 A1 was published on June 7, 2007, with a number, which refers to a series of venous valves that can be positioned in the vein, in order to achieve a connection from point A to point B. This system could be similar in terms of the connection. However, it is different to use a conduit with multiple connections, as opposed to a series of valves, where the latter, by their nature, only regulate the flow of the conduit. In this sense, they support the vein, but do not restore the damaged conduit, that is, part of the lymphatic vessel itself.

[0054] In this order of ideas, the detailed description will highlight the novelty that the intended invention has with respect to these documents and other products known to date. Brief description of the invention

[0055] The present invention relates to an artificial lymphatic vessel for secondary lymphedema comprising a tubular body having at least one inlet end with a first diameter and at least one outlet end with a second diameter; at least one one-way valve disposed inside the tubular body near the at least one outlet end; wherein the at least one one-way valve comprises a sudden reduction in the first diameter to generate a third diameter, followed by a zone of uniform decrease in the third diameter until reaching a discharge zone with a fourth diameter; wherein the ratio between the first diameter and the fourth diameter is between approximately 2.94:1 and approximately 1.25:1. Detailed description of the figures

[0056] The illustrative modality can be described with reference to the accompanying figures, which refer to: Fig. 1

[0057]

[0058] Figure 1 is a side view of the artificial lymphatic vessel for secondary lymphedema of the present invention; Fig. 2

[0059]

[0060] Figure 2 is a longitudinal section of the artificial lymphatic vessel for secondary lymphedema of the present invention; Fig. 3

[0061]

[0062] Figure 3 is a detailed view of a one-way valve of the artificial lymphatic vessel for secondary lymphedema of the present invention; Fig. 4

[0063]

[0064] Figure 4 is a side view of an artificial lymphatic vessel system of the present invention; Fig. 5

[0065]

[0066] Figure 5 is a side view of an alternative embodiment of the artificial lymphatic vessel for secondary lymphedema of the present invention; Fig. 6

[0067]

[0068] Figure 6 is a side view of another alternative embodiment of the artificial lymphatic vessel for secondary lymphedema of the present invention; Fig. 7

[0069]

[0070] Figure 7 is a side view of an alternative embodiment of the artificial lymphatic vessel system of the present invention; Fig. 8

[0071]

[0072] Figure 8 is a side view of another alternative embodiment of the artificial lymphatic vessel system of the present invention. Detailed description of the invention

[0073] The following detailed description is exemplary only and is not intended to limit the embodiments described or the application and uses of the described embodiments. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” should not necessarily be construed as preferred or advantageous over other implementations. All implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure, and are not intended to limit the scope of the disclosure. Furthermore, there is no intention to be bound by any explicit or implicit theory presented in the foregoing technical field, background, brief summary, or the following detailed description.It should also be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following description, are merely exemplary embodiments of the inventive concepts defined in the appended claims.

[0074] The illustrations generally show non-limiting aspects of the systems and methods of the present disclosure. Although the various aspects of the present disclosures are devices, they should not be construed in any way as limiting the disclosure. Furthermore, modifications, concepts, and applications of aspects of the disclosure are to be interpreted by those skilled in the art as being encompassed by, but not limited to, the illustrations and descriptions herein. Various modifications, equivalents, variants, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variants, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0075] As used herein, the singular articles “a,” “an,” and “the” include plural referents unless expressly and unequivocally limited to one referent. The term “proximal” refers to a direction toward the center or a central region of a device. The term “distal” refers to an outward direction extending away from a central region of a device. However, it should be understood that the description may assume various alternatives, variations, and sequences of steps, except where expressly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following description are non-limiting representations of various aspects of the description.Therefore, the specific dimensions and other physical characteristics related to the aspects described herein are not intended to be and should not be considered as limiting.

[0076] Unless otherwise indicated, all ranges or ratios described herein are understood to encompass any and all subranges or subratios incorporated herein. For example, a stated range or ratio of “1 to 10” should be deemed to include any and all subranges between (and including) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 10 or less, such as, but not limited to, 1 to 6.1, 3.5 to 7.8, and 5.5 to 10. Unless otherwise indicated, all numbers expressing dimensions, amounts of ingredients, flow rates, pressures, etc. used in the description and claims, are to be construed as modified in all instances by the term “about.”For the purposes of this description, the term “approximately” defines a range of ± 10%, so if a value of “approximately 30%” is specified, the value is within a range of 27% to 33%.

[0077] The artificial lymphatic vessel (100) for secondary lymphedema of the present invention allows the restoration of lymph circulation to reach the lymph nodes, in cases without possible reconstruction.

[0078] The basic functions will be to connect parts and dispense substance, while the material must meet specifications and regulations that ensure the medical grade required for an implant, just as a real lymphatic vessel does.

[0079] The artificial lymphatic vessel (100) for secondary lymphedema of the present invention is configured as modules so that, depending on the distance from the affected lymphatic vessels, they can be replaced by the surgeon at the time of extraction. The material required for the lymphatic vessel to function must meet biocompatibility specifications and not be allergenic to the human body.

[0080] The artificial lymphatic vessel (100) for secondary lymphedema comprises a tubular body (110) having at least one inlet end (111) with a first diameter (D1) and at least one outlet end (112) with a second diameter (D2); wherein the second diameter (D2) is greater than the first diameter (D1) (D2>D1).

[0081] In a further configuration illustrated in Figure 5, the tubular body (110) has two inlet ends (111, 111') and one outlet end (112); in another further configuration, illustrated in Figure 6, the artificial lymphatic vessel (100) for secondary lymphedema has one inlet end (111) and two outlet ends (112, 112'); in another further configuration, illustrated in Figures 7 and 8, the artificial lymphatic vessel (100) for secondary lymphedema has “n” inlet ends (111) and “n” outlet ends (112), “n” being an integer greater than or equal to 1.

[0082] Inside the tubular body (110) there is located at least one one-way valve (120) near the at least one outlet end (112). Said at least one one-way valve (120) only allows the flow of fluid in one direction, indicated by arrow 3 in Figure 2, such that the allowed backflow varies from a range of 0% to approximately 36%.

[0083] The at least one unidirectional valve (120) comprises a sudden reduction (121) of the first diameter (D1) to generate a third diameter (D3), followed by a zone of uniform decrease (122) of the third diameter (D3) until reaching a discharge zone (123) with a fourth diameter (D4); said zone of uniform decrease (122) of the third diameter (D3) has a convergent truncated conical configuration.

[0084] After the at least one one-way valve (120), a sudden increase (124) in dimensions is located which determines a fifth diameter (D5), followed by an area of ​​uniform increase (125) in diameter until reaching said second diameter (D2), where the first diameter (D1) and the fifth diameter (D5) are equal (D1=D5); said area of ​​uniform increase (125) in diameter has a divergent truncated conical configuration. Said sudden reduction and increase (121, 124) create turbulence inside the tubular body (110), which is desirable for the correct functioning of the artificial lymphatic vessel (100) for secondary lymphedema.

[0085] The uniform decrease zone (122) of the third diameter (D3) is overlapped with the fifth diameter (D5), while the discharge zone (123) is located in front of the fifth diameter (D5).

[0086] Additionally, the sudden increase in dimensions (124) is carried out in the opposite direction to the flow of the fluid; said sudden increase in dimensions (124) has an inclination α of between approximately 61° and approximately 45° with respect to the horizontal, preferably it has an inclination α of approximately 53°; in an alternative embodiment, said sudden increase in dimensions (124) has an angle of approximately 90°.

[0087] The backflow range in the at least one one-way valve (120) is achieved by diameter ratios, wherein the ratio between the first diameter (D1), corresponding to said at least one inlet (111) and the fourth diameter (D4), corresponding to the discharge zone (123), is between approximately 2.94:1 to approximately 1.25:1; in laboratory tests, for an inlet (111) with a first diameter (D1) of up to 500 microns (μm), the discharge zone (123) has a fourth diameter (D4) that can range from 170 μm to 400 μm. Below the lower range indicated above, there is no fluid flow through the at least one one-way valve (120), while above the upper range indicated above, backflow of the fluid begins to occur through the at least one one-way valve (120).

[0088] The artificial lymphatic vessel (100) for secondary lymphedema has a circumferential channel (130) on its external surface in the area where the second diameter (D2) begins to indicate to the surgeon how far it is possible to introduce either a second artificial lymphatic vessel (100') or a natural lymphatic vessel (not illustrated).

[0089] An artificial lymphatic vessel system (200) may comprise at least one pair of artificial lymphatic vessels (100, 100') for secondary lymphedema, as described above, connected to one another, such that the at least one outlet (112) of a first artificial lymphatic vessel (100) for secondary lymphedema is coupled to the at least one inlet (111') of a second artificial lymphatic vessel (100') for secondary lymphedema and so on, to replace sections of natural lymphatic vessel. In an example where only two artificial lymphatic vessels (100, 100') for secondary lymphedema were used, the at least one inlet (111) of a first artificial lymphatic vessel (100) for secondary lymphedema is adapted for connection to a natural lymphatic vessel, and the at least one outlet (112') of the second artificial lymphatic vessel (100') for secondary lymphedema is adapted for connection to a natural lymphatic vessel.

[0090] In the configurations illustrated in Figures 4, 5 and 6, the artificial lymphatic vessel (100) for secondary lymphedema has a one-way valve (120), regardless of the number of inlet ends (111) and outlet ends (112); while in the configurations illustrated in Figures 7 and 8, the artificial lymphatic vessel (100) for secondary lymphedema has one-way valves (120) matching the same number of outlet ends (112, 112', 112''), regardless of the number of inlet ends (111, 111', 111'').

[0091] Alterations to the structure described herein may be anticipated by those skilled in the art. However, it should be understood that the present description relates to the preferred embodiments of the invention, is for illustrative purposes only, and should not be construed as a limitation of the invention. All obvious modifications within the spirit of the invention, such as changes in the shape, material, and dimensions of the elements comprising the invention, should be considered within the scope of the appended claims.

Claims

1. An artificial lymphatic vessel for secondary lymphedema comprising: a tubular body having at least one inlet end with a first diameter and at least one outlet end with a second diameter; at least one one-way valve disposed within the tubular body proximate the at least one outlet end; wherein the at least one one-way valve comprises a sudden reduction in the first diameter to generate a third diameter, followed by a zone of uniform decrease in the third diameter until reaching a discharge zone with a fourth diameter; wherein the ratio between the first diameter and the fourth diameter is between approximately 2.94:1 to approximately 1.25:

1. The artificial lymphatic vessel for secondary lymphedema, according to claim 1, wherein the second diameter is greater than the first diameter. The artificial lymphatic vessel for secondary lymphedema, according to claim 2, wherein after the one-way valve, a sudden increase in dimensions is located that determines a fifth diameter, followed by an area of ​​uniform increase in diameter until reaching said second diameter. The artificial lymphatic vessel for secondary lymphedema, according to claim 3, wherein the first diameter and the fifth diameter are equal. The artificial lymphatic vessel for secondary lymphedema, according to claims 1 and 3, wherein the sudden reduction and sudden increase in diameters have sharp edges. The artificial lymphatic vessel for secondary lymphedema, according to claim 1, wherein the area of ​​uniform decrease of the third diameter has a convergent truncated conical configuration. The artificial lymphatic vessel for secondary lymphedema, according to claim 3, wherein the area of ​​uniform increase in diameter has a divergent truncated conical configuration. The artificial lymphatic vessel for secondary lymphedema, according to claim 3, wherein said sudden increase in dimensions is performed in the opposite direction to the flow of the fluid. The artificial lymphatic vessel for secondary lymphedema, according to claim 8, wherein said sudden increase in dimensions has an inclination of between approximately 61° to approximately 45° with respect to the horizontal. The artificial lymphatic vessel for secondary lymphedema, according to claim 9, wherein said sudden increase in dimensions has an inclination of approximately 53°. The artificial lymphatic vessel for secondary lymphedema, according to claim 8, wherein the area of ​​uniform decrease of the third diameter overlaps the fifth diameter. The artificial lymphatic vessel for secondary lymphedema, according to claim 9, wherein the discharge zone is located in front of the fifth diameter. The artificial lymphatic vessel for secondary lymphedema, according to claim 1, wherein it has a circumferential channel on its external surface in the area where the second diameter begins. The artificial lymphatic vessel for secondary lymphedema, according to claim 1, wherein the number of outlet ends coincides with the number of one-way valves.

15. Artificial lymphatic vessel system comprising at least one pair of artificial lymphatic vessels for secondary lymphedema according to claims 1 to 14 connected to each other, wherein the at least one outlet of a first artificial lymphatic vessel for secondary lymphedema is coupled to the at least one inlet of a second artificial lymphatic vessel for secondary lymphedema. The artificial lymphatic vessel system according to claim 15, wherein the at least one inlet of the first artificial lymphatic vessel for secondary lymphedema is adapted for connection to a natural lymphatic vessel. The artificial lymphatic vessel system according to claim 15, wherein the at least one outlet of the second artificial lymphatic vessel for secondary lymphedema is adapted for connection to a natural lymphatic vessel.

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