An implantable device for controlled compression of a hollow organ

Abstract

The utility model relates to implantable devices for acting on hollow organs to enhance their occlusion function. The technical problem lies in the use of assemblies without the ability to gently regulate the lumen of the hollow organ. The technical result consists of limiting the peak contact pressure of the cuff on the outer surface of the hollow organ wall during electrically controlled, adjustable compression of the hollow organ along its outer wall surface. The device comprises a coated cuff, electrical leads, and a DC power source. The cuff is designed as a detachable loop of a single, elongated cylindrical artificial muscle, with a tape insert secured around the perimeter of the inner surface. The cuff coating and insert are made of elastically deformable materials. 3 fig.

Description

[0001] Field of technology to which the utility model belongs

[0002] The utility model relates to medicine, namely to implantable devices for influencing hollow or tubular parts of organs in order to improve their locking function.

[0003] Technology Level

[0004] Many clinical applications require the provision or restoration of adjustable occlusion within the lumen of hollow (tubular) organs in patients whose natural occlusion structures are deficient, leading to impaired continence. Known implantable solutions utilize various cuffs placed around the hollow organ and a system that compresses these cuffs. These existing solutions utilize elements for pumping the working fluid. For example, the UroMems artificial sphincter is an implantable electronic device comprising a cuff implanted around the bulbar urethra and a control unit connected to it. The cuff is connected to a reservoir, a pump, and a power source with electronic components for wireless communication.During follow-up visits, the physician can read the data recorded by the control unit and set the device's operating parameters using the programmer, while the patient can control the cuff's opening for emptying and pressure reduction in the supine position using a remote control. Additionally, a safety feature is included that automatically deactivates the device if emptying is not achieved within a specified interval (see https: / / www.uromems.com / wp-content / uploads / 2025 / 08 / EAU_2024_Poster.pdf, accessed February 12, 2026).

[0005] However, even electronically controlled hollow organ closure systems with hydraulic architecture inevitably inherit the key limitations of pumping solutions. Firstly, for the surgeon, this means implanting multiple, spaced-apart components and creating additional pockets for the reservoir and control unit, routing connecting lines, and ensuring their stability. Each such component increases the scope of the procedure and the number of potential points of mechanical damage or infection. Secondly, for the patient, this often entails operational limitations: the risk of hydraulic system failure and the need for periodic leak inspections (see https: / / www.mdpi.com / 2077-0383 / 13 / 7 / 1913, accessed 12.02.2026). In addition, such solutions create prolonged circular pressure on the wall of the hollow organ, which can lead to tissue atrophy in the area of ​​cuff action (see https: / / pubmed.ncbi.nlm.nih.gov / 9933793 / , accessed 12.02.2026).

[0006] In this regard, it seems logical to move away from the implementation of hollow organ compression using devices in which the closing force is generated not by a fluid circuit, but by a distributed drive that mimics the action of muscle tissue. So-called "artificial muscles"—soft actuators that, under the influence of an electrical, chemical, thermal, or pneumatic signal, undergo deformation, manifested by their contraction, bending, or expansion—have been widely described in the engineering literature. These actuators can be used as actuators for controlled compression of a hollow organ for medical purposes.

[0007] Ionic polymer-metal composites are known, consisting of a thin ion-exchange polymer membrane with metal electrodes on both sides. When an electrical voltage is applied, the ions and associated water are redistributed within the membrane, resulting in asymmetric deformation, most often in the form of bending (see https: / / pubs.rsc.org / en / content / articlehtml / 2017 / ra / c6ra25771b, accessed 12.02.2026).

[0008] Conductive polymers are known in which deformation occurs due to electrochemical processes (see https: / / www.mdpi.com / 2073-4360 / 15 / 16 / 3455, accessed 12.02.2026).

[0009] Dielectric elastomers are known for which high electric fields and voltages are required for deformation to occur (see https: / / www.nature.com / articles / s44182-025-00030-7, accessed 12.02.2026).

[0010] An artificial muscle is typically an elongated cylindrical actuator made of an electroactive material, equipped with electrical leads and, if necessary, a protective polymer coating, which, when a control electrical signal is applied, reversibly changes its length or diameter, creating a mechanical force (see https: / / pmc.ncbi.nlm.nih.gov / articles / PMC9693343, accessed 12.02.2026).

[0011] Thus, known implantable locking systems using hydraulic architecture are characterized by structural complexity and the need to use fully implantable sealed power and control units.

[0012] Disclosure of the essence of the utility model

[0013] The technical problem that the utility model is aimed at solving is the creation of an implantable locking device, made without pumping units and providing electrically controlled and gentle regulation of the lumen of a hollow or tubular organ.

[0014] The technical result achieved by the utility model consists in limiting the peak contact pressure of the cuff on the outer surface of the wall of a hollow organ during electrically controlled adjustable compression of the hollow organ along the outer surface of its wall.

[0015] The technical result is achieved using an implantable device for controlled compression of a hollow organ, comprising a cuff with a coating, electrical leads and a direct current source connected to the electrical leads, characterized in that the cuff is made in the form of a detachable loop of one cylindrical elongated artificial muscle, along the perimeter of the inner surface of which a tape insert is fixed, wherein the cuff coating and the insert are made of elastically deformable materials; the electrical leads are designed with the possibility of percutaneous output through the patient's skin; the electrical leads are connected to a direct current source located outside the patient's body; the electrical leads are provided with contact ends protruding above the surface of the patient's skin, on which connecting elements made of corrosion-resistant metal with dielectric insulation are placed;the direct current source is designed with the ability to regulate the current strength and set the current supply mode by time.

[0016] The use of the proposed implantable device ensures a more physiological and controlled restoration of the occlusion function of hollow organs through controlled, electrically controlled compression. In a broader medical context, this solution opens the possibility of creating gentle implantable actuators with individualized operating mode settings tailored to the patient's anatomical characteristics and specific clinical needs.

[0017] Brief description of drawings

[0018] Fig. 1 shows a general view of an implantable device for controlled compression of a hollow organ.

[0019] Fig. 2 illustrates an example of placement of an implantable device on the lower part of the esophagus for its controlled compression.

[0020] Fig. 3 illustrates an example of using an implantable device on the lower part of the esophagus with controlled compression.

[0021] The following elements are indicated on the figures:

[0022] 1 - cuff;

[0023] 2 - coating;

[0024] 3 - electrical terminals;

[0025] 4 - DC power supply;

[0026] 5 - loop;

[0027] 6 - tape insert;

[0028] 7 - contact ends;

[0029] 8 - connecting elements.

[0030] Implementation of a utility model

[0031] An example of the implementation of the claimed technical solution is an implantable device comprising a cuff (1) with a coating (2), electrical terminals (3), and a direct current source (4). In the described example, the source (4) is located outside the patient's body and is connected to the terminals (3) (see Fig. 1).

[0032] The cuff (1) is made of a single cylindrical elongated artificial muscle. The cuff (1) is designed as a ring-shaped contour - an openable loop (5) formed by a so-called semi-grasping knot (in the specialized literature also known as a cow knot, lark knot, lark's head or rustling knot), which is formed by inserting the free ends of the contour into the formed bend with the ability to self-tighten when tensioned. Tension of the artificial muscle occurs when a control signal from the source (4) is applied to the electrical terminals (3), thereby changing the internal diameter of the loop (5), thereby simulating muscle contraction. An insert (6) made in the form of a tape elastic gasket is fixed to the inner surface of the loop (5) along its perimeter to increase the contact area with the outer surface of the hollow organ wall and redistribute the contact load when squeezing the hollow organ.The cuff (1) lining (2) and inner liner (6) are made of elastically deformable materials with residual elastic compliance during deformation. For example, biocompatible foam materials can provide dielectric insulation between the artificial muscle and the patient's body tissue.

[0033] The electrical leads (3) are designed for percutaneous output through the patient's skin and terminate in contact tips (7) protruding 5-10 mm above the patient's skin surface. Connecting elements (8) are located on these contact tips (7), made in the form of corrosion-resistant, tin-plated, removable metal clamps with dielectric insulation and ensuring the integrity of the electrical circuit from the source (4) to the cuff (1).

[0034] The source (4) is configured to regulate the current strength and set the current supply mode by time, wherein the mode includes at least the parameters of the on-time and off-time, as well as the duration of the current supply, which ensures the operation of the declared device at pre-set intervals.

[0035] The above implantable device is used as follows.

[0036] For example, to reduce the symptoms of gastroesophageal reflux disease after surgical implantation, the device is placed in the lower esophagus so that the loop (5) encircles the corresponding section of the esophagus along its outer surface. Due to the cuff (1) being designed as an openable annular contour, it is installed by opening, encircling the esophagus, and then closing the contour into a semi-gripping knot on the esophagus, ensuring adhesion of the loop (5) to the outer wall of the esophagus through the inner liner (6) (see Fig. 2). Thus, during operation, contact between the cuff (1) and the esophageal wall is achieved through the inner liner (6).

[0037] After implantation, the electrical leads (3) are passed through the soft tissue and percutaneously through the patient's skin. The contact ends (7) of the leads (3) are positioned 5-10 mm above the skin surface, to which connecting elements (8) are attached. These connecting elements (8) are designed for repeated connection and disconnection of a controlled DC source (4) located outside the patient's body.

[0038] Before the operation of the claimed device, the connecting elements (8) are connected to a controlled source (4), after which the source (4) supplies direct current to the electrical terminals (3) and, accordingly, to the cuff (1). Under the action of the supplied direct current, the cuff (1), made of a single artificial muscle, contracts, resulting in a decrease in the enveloping diameter of the loop (5) and a metered compression of the lower part of the esophagus. Due to the presence of an internal tape liner (6), the contact pressure is distributed over the coverage area, reducing local peak loads on the esophageal wall by redistributing the contact load over the contact area when compressing the hollow organ, thereby limiting the peak contact pressure. At the same time, the polymer coating (2) and the internal liner (6), being made of biocompatible materials, provide insulation of the artificial muscle material of the cuff (1) from the tissues of the patient's body.

[0039] The degree of impact of the liner (6) on the surface of the hollow organ is adjusted by changing the current intensity set by the source (4). As the current intensity increases, the cuff (1) contracts and, accordingly, the compression force increases and the diameter of the loop (5) decreases - the lumen of the hollow organ decreases (see Fig. 3). Due to the manufacturing of the covering (2) of the cuff (1) and the liner (6) from elastically deformable materials possessing residual elastic compliance, when the lumen of the hollow organ is completely blocked, additional limitation of the peak contact pressure is ensured, reducing the risk of atrophic changes in the tissues at the point of contact of the liner (6) with the hollow organ.

[0040] As the current strength decreases, the degree of contraction of the cuff (1) decreases, increasing the diameter of the loop (5)—the lumen of the hollow organ widens. The stimulation is terminated by de-energizing the cuff (1). In this case, the current source (4) normally stops supplying current, or, in an emergency, disconnects the connecting elements (8) from the contact ends (7). After the current is terminated, the cuff (1) returns to its original state without active contraction, which leads to the opening of the loop (5) and the reduction or removal of the compression of the esophagus it creates. The lumen of the hollow organ returns to its original state before stimulation.

[0041] If it is necessary to stop using the device as a whole, the elements (8) are disconnected, a repeat surgical intervention is performed, during which the loop (5) is transferred to an open state, the cuff (1) is removed from the esophagus and removed together with the elements of the device, including the electrical leads (3).

[0042] The claimed device can be used not only for the sphincter zone of the digestive tract, but also for other luminal sections of internal hollow organs that require controlled compression and maintenance of the locking function, including in the area of ​​the pylorus (pyloric sphincter), which regulates the passage of the contents of the stomach into the duodenum, as well as as part of the biliary tract (bile ducts), which ensures the transport of bile, including areas where the flow of bile is regulated by muscular valve structures.

[0043] The essence of the utility model as a technical solution related to the device is expressed in the combination of the following essential features, sufficient to obtain the stated technical result, namely, limiting the peak contact pressure of the cuff during electrically controlled adjustable compression of the hollow organ along the outer surface of its wall:

[0044] The cuff is made in the form of an openable semi-gripping unit made of one cylindrical elongated artificial muscle, the configuration of which allows the formed loop, when a control signal is supplied to the electrical terminals, to change the internal diameter and ensure compression of the hollow organ around the circumference with adjustable closure of its lumen;

[0045] A tape insert is fixed to the inner surface of the loop, designed with the ability to redistribute the contact load over the contact area when compressing the hollow organ, thereby limiting the peak contact pressure;

[0046] The cuff covering and liner are made of elastically deformable materials, providing additional limitation of peak contact pressure due to elastic compliance when compressing the hollow organ.

[0047] The use of an implantable device ensures a more physiological and controlled restoration of the occlusion function of hollow organs through controlled, electrically controlled compression. In a broader medical context, this solution opens the possibility of creating gentle implantable actuators with individualized operating mode settings tailored to the patient's anatomical characteristics and specific clinical needs.

Claims

1. An implantable device for controlled compression of a hollow organ, comprising a cuff with a coating, electrical terminals and a direct current source connected to the electrical terminals, characterized in that the cuff is made in the form of an openable loop of one cylindrical elongated artificial muscle, along the perimeter of the inner surface of which a tape insert is fixed, made with the possibility of redistributing the contact load over the contact area during compression of the hollow organ and limiting the peak contact pressure, wherein the cuff coating and the insert are made of elastically deformable materials.

2. An implantable device according to claim 1, characterized in that the electrical terminals are designed with the possibility of percutaneous output through the patient’s skin.

3. An implantable device according to paragraph 2, characterized in that the direct current source is located outside the patient’s body and is connected to the electrical terminals through their percutaneously brought out contact endings.

4. An implantable device according to paragraph 2 or 3, characterized in that the electrical terminals are provided with contact ends protruding above the surface of the patient’s skin, on which connecting elements made of corrosion-resistant metal with dielectric insulation are placed.

5. An implantable device according to paragraph 1, characterized in that the direct current source is designed with the ability to regulate the current strength and set the current supply mode over time.

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