Compression cuff

By compressing the vein through the ring structure of the compression cuff, the complexities of adhesive delivery and vein closure in the treatment of venous reflux diseases are solved, resulting in simplified operation and improved time efficiency.

CN112426199BActive Publication Date: 2026-01-27COVIDIEN LP
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Patent Information

Application Number
CN202010867070.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-08-26
Filing Date
2020-08-26
Publication Date
2026-01-27
Estimated Expiration
2040-08-26

AI Technical Summary

Technical Problem

In the treatment of venous reflux diseases, the delivery of medical adhesives and the closure of veins using existing technologies are complex processes that require clinicians to manually compress the veins while waiting for the adhesive to cure, which increases the operation time and complexity.

Method used

A compression cuff is used, with compression members on both sides of the cuff forming a ring structure that wraps around and compresses the vein, providing an initial blockage and promoting adhesion between the vein wall and the adhesive, reducing the need for manual compression.

Benefits of technology

It simplifies the delivery process of medical adhesives, reduces surgical time, improves treatment efficiency, lowers costs, and allows the adhesive to continue moving to the next target location during the curing process.

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Abstract

The devices, assemblies, systems, and techniques described herein can facilitate sealing a hollow anatomical structure (e.g., a vein) with an adhesive delivered within the hollow anatomical structure. For example, a medical assembly can include a plurality of medial compression members extending from a central body in a first direction, each of the plurality of medial compression members including a first attachment element, and a plurality of lateral compression members extending from the central body in a second direction different from the first direction, each of the plurality of lateral compression members including a second attachment element. Each first attachment mechanism can be configured to attach to a respective second attachment element to form a respective loop configuration and the respective pair of medial and lateral compression members to compress a portion of a patient's limb.
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Description

Technical Field

[0001] This disclosure relates to medical components and medical technologies for compressing hollow anatomical structures within a patient's limb. Background Technology

[0002] Healthy leg veins contain valves that allow blood to flow unidirectionally from the lower limbs towards the heart. These valves open as blood flows towards the heart and close to prevent venous reflux or backflow. When veins weaken and enlarge, their valves cannot close properly, which can lead to poor venous return and drainage of venous blood from the legs, a condition known as venous insufficiency. Venous reflux can occur in superficial veins. The largest superficial vein is the great saphenous vein (GSV), which extends from the top of the foot to the groin, where it originates from a deep vein.

[0003] Many factors can contribute to venous reflux, such as genetics, lack of physical activity, obesity, pregnancy, or jobs that require prolonged standing. Venous reflux can be classified as asymptomatic or symptomatic depending on its severity. Symptomatic venous reflux disease represents a more advanced stage of the condition and can have a profound impact on a person's quality of life. Patients with symptomatic venous reflux disease may seek treatment due to a combination of symptoms and signs, which may include: leg pain and swelling; painful varicose veins; skin changes such as discoloration or inflammation; and, in more severe cases, open skin ulcers. Some non-invasive methods used to treat great saphenous vein reflux include radiofrequency (RF) ablation, laser ablation, and sclerotherapy (including foam sclerotherapy), each aiming to close the GSV. In more recent methods, a medical adhesive is injected into the GSV and external pressure is applied to close the vein by joining the sides together. Summary of the Invention

[0004] In some aspects, this disclosure describes exemplary medical components, devices, systems, and techniques for compressing a portion of a patient's limb to compress hollow anatomical structures within the limb and facilitate their closure. For example, a clinician may insert a catheter within a hollow anatomical structure to inject several clumps of viscous material at different target locations, and a compression cuff described herein applies compression to the patient's limb before, during, or after the injection of the viscous material. The compression cuff includes a plurality of compression members on each side of the cuff such that one compression member from each side of the cuff can wrap around the limb and attach to each other to form a ring structure that compresses the limb and thereby compresses the hollow anatomical structure, such as a vein, at that location. Other compression members positioned on each side of the cuff and along the length of the cuff can similarly wrap around the limb at corresponding locations and attach to each other to compress the limb, for example, on the surface of each target location receiving the clumps of viscous material. In this way, the compression provided by the rings of the cuff can facilitate the engagement of the walls of the hollow anatomical structure during the shaping and / or curing of the viscous material to close the hollow anatomical structure. This allows physicians to quickly move to the next treatment segment without having to manually compress and keep the hollow anatomical structure closed while waiting for the adhesive to cure. In one example, the hollow anatomical structure could be the great saphenous vein, and the limb could be the patient's leg.

[0005] In some examples, when the compression members are in a ring configuration, each compression member positioned along one side of the cuff includes a rib on the skin-facing surface of the compression member. Each rib can protrude from the surface of the compression member to contact and compress the limb. Thus, the ribs can concentrate and direct pressure to the hollow anatomical structure beneath the skin and facilitate the adhesion of the walls of the hollow anatomical structure to the injected viscous material.

[0006] In one example, a medical component configured to compress a portion of a patient's limb includes: a central body; a plurality of medial compression members extending from the central body along a first direction, each of the plurality of medial compression members including a first attachment element; a rib disposed on at least one of the plurality of medial compression members; and a plurality of lateral compression members extending from the central body along a second direction other than the first direction, each of the plurality of lateral compression members including a second attachment element, wherein each first attachment element is configured to attach to a corresponding second attachment element to form a corresponding ring configuration and the corresponding pair of medial and lateral compression members are used to compress a portion of the patient's limb, wherein the rib is disposed on the at least one medial compression member such that the rib is oriented radially inward in the ring configuration, and wherein the rib configuration is configured to apply pressure to the patient's skin to compress veins within the limb.

[0007] In another example, a medical system includes a compression sleeve configured to compress a portion of a patient's limb. The compression sleeve includes: a central body; a plurality of medial compression members extending from the central body along a first direction, each of the medial compression members including a first attachment element; and a plurality of lateral compression members extending from the central body along a second direction different from the first direction, each of the lateral compression members including a second attachment element. Each first attachment element is configured to attach to a corresponding second attachment element to form a corresponding ring configuration, and the corresponding pairs of medial and lateral compression members are used to compress a portion of the patient's limb. The medical system also includes a catheter configured to deliver an adhesive material to a hollow anatomical structure within the limb. The catheter includes a plurality of external markers, each of the plurality of external markers being spaced apart from adjacent external markers by a marker spacing corresponding to the spacing between adjacent medial compression members among the plurality of medial compression members.

[0008] In another example, a method for processing a hollow anatomical structure within a patient's body includes: delivering a first clump of viscous material from a catheter inserted into the hollow anatomical structure to a first target location within the hollow anatomical structure; wrapping a first set of compression members around a limb to form a first ring structure, the first ring structure surrounding and compressing a first portion of the limb corresponding to the first target location; wherein the first set of compression members includes one of a plurality of medial compression members extending from a central body along a first direction and one of a plurality of lateral compression members extending from the central body along a second direction different from the first direction; each of the plurality of medial compression members includes a first attachment element and a rib disposed on the respective medial compression member; wherein wrapping the first set of compression members includes positioning each rib of the respective medial compression member on the hollow anatomical structure to compress a portion of the hollow anatomical structure; and each of the plurality of lateral compression members includes a second attachment element; each first attachment element is configured to attach to the corresponding second attachment element to form a corresponding ring structure using the respective pairs of medial and lateral compression members. The method further includes retracting the catheter from the first target position to the second target position, delivering a second clump of viscous material from the catheter inserted into the hollow anatomical structure to the second target position within the hollow anatomical structure, and wrapping a second set of compression members of the compression sleeve around the limb to form a second ring structure, the second ring structure surrounding and compressing a second portion of the limb corresponding to the second target position.

[0009] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the examples according to this disclosure will be apparent from the description, drawings, and claims. Attached Figure Description

[0010] Figure 1A This is a bottom view of an exemplary compression sheath.

[0011] Figure 1B yes Figure 1A A top view of an exemplary compression sheath.

[0012] Figure 1C yes Figure 1A A side view of an exemplary compression sheath.

[0013] Figure 2A , 2B 2C, 2D, and 2E are used to deliver venous obstruction substances to patients and utilize... Figure 1A-1C A schematic diagram of an exemplary process of compressing the leg with an exemplary compression sleeve.

[0014] Figure 3 Is it by Figure 1A-1C A cross-sectional view of a limb compressed by an exemplary compression sleeve.

[0015] Figure 4 This is a bottom view of an exemplary compression sleeve with gaps between the various compression components.

[0016] Figure 5 This is a bottom view of an exemplary compression sleeve with a gap between pairs of compression members.

[0017] Figure 6 This is a side view of an exemplary catheter with external markings, the marking spacing of which corresponds to the spacing of the compression members of the compression sleeve.

[0018] Figure 7 This is a flowchart of an exemplary technique for injecting an adhesive material into a hollow anatomical structure and wrapping a compression sleeve around a limb to bond the walls of the hollow anatomical structure with the adhesive material. Detailed Implementation

[0019] This disclosure describes medical components, devices, systems, and techniques for compressing a portion of a patient's limb to close hollow anatomical structures (e.g., veins or arteries) within the limb. Venous reflux or venous insufficiency refers to a condition in which the valves of a vein no longer close properly, and blood is able to flow back within a vein (e.g., the great saphenous vein or perforating vein). Treatment for venous reflux may include closing or removing one or more veins that have experienced venous reflux. An exemplary treatment involves delivering a medical adhesive material to a vein such that the medical adhesive material adheres to the wall of a portion of the vein. Once the medical adhesive material hardens, the adhered and closed vein wall prevents blood from flowing through the vein. After the vein is closed, blood can flow back to other veins without affecting systemic blood flow.

[0020] An exemplary method for delivering medical adhesive into a vein may include using a syringe gun (or other device), a syringe, and a catheter. The medical adhesive may be stored in a container (e.g., a vial). A clinician may load some or all of the medical adhesive contained in the vial into a syringe. The clinician may then attach a catheter to the syringe, infuse the catheter with the medical adhesive, insert the distal end of the catheter into a target vein, and attach the syringe to the syringe gun. When the distal end of the catheter is at the target location within the vein, the clinician may activate the syringe gun to depress the plunger of the syringe and deliver a clump of medical adhesive from the distal end of the catheter. The clinician may retract the catheter proximally (i.e., toward the insertion point in the skin) one or more times to a short distance and deliver additional corresponding clumps of medical adhesive to other locations within the vein to achieve complete closure of the vein.

[0021] These multiple adhesive boluses, delivered to their respective target locations within the vein, must be compressed for a period of time to allow the vein wall to engage as each bolus sets or hardens, thus permanently closing that portion of the vein. Therefore, in some existing techniques, before a clinician can inject another bolus, they must manually compress the skin above the just-delivered bolus to cause the vein to at least partially collapse against the delivered adhesive within the vein. The clinician can use their fingers or the surface of an ultrasound probe to provide this pressure. The duration for which the clinician must maintain pressure on each bolus can vary depending on the composition of the delivered adhesive. The duration can be greater than thirty seconds, greater than sixty seconds, or greater than several minutes to ensure the adhesive has hardened and the vein has closed. For procedures requiring the delivery of several boluses (e.g., four, five, six, or more), the clinician may have to dedicate a significant portion of the procedure solely to maintaining pressure on the skin to facilitate vein closure, increasing the amount of time required to complete the procedure. Furthermore, in some examples, the clinician may need to manually use their fingers or ultrasound to collapse the vein to create a blockage before injecting the bolus to contain it at the target location within the vein.

[0022] The systems, devices, components, and techniques described herein can reduce the complexity of medical adhesive delivery and decrease the time required for clinicians to close hollow anatomical structures, such as patient veins. This reduction in complexity and surgical time can improve patient outcomes, lower surgical costs, and increase the efficiency of clinicians in treating patients. For example, when a clinician injects adhesive into different locations within a vein, a compression cuff with multiple sets of paired compression members can provide compression at corresponding locations along the vein, instead of requiring the clinician to manually apply pressure to the vein (e.g., the great saphenous vein in a patient's leg). Clinicians can connect the paired compression members to form a ring structure around a limb (e.g., a leg) that compresses the limb and thus the hollow anatomical structure to provide an initial occlusion (to which adhesive can be injected) and / or provide pressure to engage the vein wall with the delivered adhesive. For example, the initial occlusion formed by the first set of compression members can prevent the migration of a first clump of adhesive within the hollow anatomical structure.

[0023] In this way, the components and devices described herein (e.g., the pressure cuff) can be freely and continuously moved by the clinician during surgery to the next target location of the vein without waiting for the adhesive to set or cure (e.g., polymerize) during the application of manual compression. Furthermore, a set of compression members from the compression cuff are attached to each other to compress a portion of the limb and cause the vein to collapse to form a blockage, thus freeing the clinician's hand to assist in injecting the next bolus of adhesive. Sequential compression along the leg using the next pair of paired compression members can, for example, allow blood to drain from the vein, or induce blood to drain from the vein, thus facilitating better closure of the vein with the injected adhesive. Because the clinician can repeatedly attach pairs of compression members to form corresponding compression loops with the compression cuff, the clinician can also continue to use an ultrasound probe to image areas of the limb that were not treated while the previously injected adhesive was setting or curing.

[0024] In one example, the compression cuff includes a longitudinal axis extending along the length of the compression cuff and is typically aligned proximally to distally along the patient's limb. The compression cuff includes multiple compression members located on each side of the compression cuff, such that one compression member from each side of the cuff can wrap around the patient's limb and attach to each other to form a loop structure compressing the limb at that location. Other compression members positioned on each side of the cuff and along the length of the cuff (i.e., the longitudinal axis) can similarly wrap around the limb and attach to each other at corresponding locations to compress the limb (either by forming a blockage by collapsing the vein or by engaging the vein wall with a delivered adhesive bundle). Each pair of paired compression members (e.g., when oriented on the patient's limb, one compression member extends medially to the cuff while the corresponding compression member extends laterally to the cuff) can be attached to form a separate "band" capable of encircling the limb. In this way, the compression provided by the loop of the cuff can facilitate the shaping and / or curing of an adhesive material to close the hollow anatomical structure. In one example, the hollow anatomical structure may be the great saphenous vein, and the limb may be the patient's leg. In some examples, the inner compression member is described as including one or more structures (e.g., ribs) that are different from the outer compression member on the other side of the cuff. However, in other examples, the outer compression member may include a corresponding rib instead of the inner compression member.

[0025] In some examples, when the compression members are in a ring structure, each compression member positioned along one side of the compression sleeve includes a rib or other structure on the skin-facing surface of the compression member. The rib structure is a rigid or semi-rigid structure configured to resist compressive deformation, for example, when the compression member is wrapped around a patient's limb. Each rib can protrude from the surface of the compression member to contact and compress the skin of the limb. Thus, each rib concentrates and directs pressure from the compression member to a hollow anatomical structure beneath the skin, enabling the walls of the hollow anatomical structure to engage with an injected adhesive material, or enabling the formation of a barrier to which an adhesive can be injected. Ribs can also achieve the transfer of pressure to a specific location on the limb above the target location of the hollow anatomical structure without needing to contract the entire circumference of the limb, or at least reduce the contractile force otherwise required to engage the hollow anatomical structure. Thus, ribs can help provide sufficient pressure to the skin while reducing pressure in other areas of the limb. In other words, without ribs, the entire circumference of the leg can be contracted to achieve venous closure, thus reducing blood flow to the entire leg behind the contraction. In some examples, each rib may be movable along the length of each compression member. For example, the position of the rib can be adjusted along the compression member, either close to or far from the longitudinal axis of the compression cuff. This adjustment of the rib allows the surgeon to directly and optimally position the rib on hollow anatomical structures such as the great saphenous vein, without having to, for example, twist the compression cuff.

[0026] The pressure cuff described herein can also be used with other devices that facilitate the delivery of adhesive to a target location within the patient's body. For example, the catheter for delivering adhesive may include external markers having a marker spacing (e.g., the distance between adjacent markers) corresponding to the spacing of the compression members (specifically, ribs) along the length of the pressure cuff. As the clinician retracts the catheter proximally to a new target location within the hollow anatomy, the clinician can retract the catheter proximally until the proximal end of the guide inserted into the catheter is exposed to the next external marker. Because this exposed marker corresponds to the location of the next compression member on the cuff, the external markers allow the clinician to determine the location of another set of compression members corresponding to another set of compression members on the cuff, to which the delivered adhesive clump should be delivered, compressing the walls of the hollow anatomy with the delivered adhesive clump. Therefore, external markers on the catheter can reduce or eliminate the need for clinicians to perform continuous measurements or use ultrasound imaging between consecutive adhesive deliveries.

[0027] Although the devices and systems described herein are primarily illustrated by reference to delivering medical adhesives to a patient's veins and compressing the veins to treat venous return, these systems can be used to treat other conditions or to deliver medical fluids to other locations within a patient's body. For example, the systems described herein can be configured to deliver wound-closing adhesives to injured hollow anatomical structures (e.g., blood vessels in the arm) or other tissues, and to compress tissues at these locations using compression sleeves. While the structure of the human body is described herein, the medical components, devices, and techniques described herein can also be used to treat other animal species.

[0028] Figure 1A This is a bottom view of an exemplary compression sleeve 40, showing the surface of the compression sleeve 40 configured to face the limb. Figure 1AAs illustrated in the example, the compression sleeve 40 includes a plurality of inner compression members 42 extending from a central body 46 along a first direction. Each inner compression member 42 includes respective rib structures 50A, 50B, 50C, 50D, 50E, 50F, and 50G (collectively referred to as "rib structures 50"), which are supported on a surface 48 radially inward in the annular structure of the sleeve 40. The compression sleeve 40 also includes a plurality of outer compression members 44 extending from the central body 46 along a second direction different from the first direction. Although the first and second directions are shown as opposite to each other (e.g., 180° apart), in other examples, the first direction may be inclined relative to the second direction. Each outer compression member 44 includes respective attachment elements 52A, 52B, 52C, 52D, 52E, 52F and 52G (collectively referred to as "attachment elements 52"), which are carried on the surface of their respective outer compression members 44, the surfaces being radially inward in the ring structure.

[0029] Compression members 42 and 44 are configured to be flexible in the circumferential direction (i.e., the Z-direction or the outward extension direction of the plane of the compression sleeve 40), such that each compression member 42 and 44 can bend outward from the plane of the compression sleeve 40 to form a corresponding loop. In some examples, compression members 42 and 44 may be relatively non-stretchable. In other examples, compression members 42 and 44 may be stretchable or elastic to provide compression to the limb. Compression members 42 and 44 may be made of textiles, non-textiles, or at least one of one or more polymers. Similarly, in some examples, the central body 46 may be made of textiles, non-textiles, or at least one of one or more polymers. However, the central body 46 may be configured to be less flexible than the material used for compression members 42 and 44, or may be made of a material less flexible than the material used for compression members 42 and 44.

[0030] Typically, the compression sleeve 40 may include two or more inner compression members 42 and outer compression members 44. In some examples, the compression sleeve 40 includes at least five inner compression members 42 and at least five outer compression members 44. Figure 1AAs shown in the example, the compression cuff 40 includes seven medial compression members 42 and seven lateral compression members 44. In some examples, the compression cuff 40 may include a number of compression members 42 and 44, the number of which varies depending on the specific hollow anatomy to be treated and / or the type of adhesive used during the procedure. For example, the great saphenous vein may require six to eight swathes of adhesive over a relatively long length of venous treatment. Therefore, the compression cuff 40 may include, for example, eight sets of compression members 42 and 44. Typically, the compression cuff 40 includes the same number of medial compression members 42 and lateral compression members 44. However, in other examples, different numbers of compression members 42 and 44 may be used (e.g., to accommodate bends in the anatomy, avoid sensitive tissues, treat curved hollow anatomy, or for any other reason).

[0031] The compression sleeve 40 and compression members 42 and 44 can have any suitable width, which is parallel to the longitudinal direction and the direction in which the compression sleeve 40 extends along its length L. In some examples, each compression member 42 and 44 can have a width from about 0.5 cm to about 5.0 cm. In other examples, each compression member 42 and 44 can have a width from about 1.0 cm to about 3.0 cm. Measured from the central body 46 along the same direction as the width B, the length of each compression member 42 and 44 can be from about 5.0 cm to about 50 cm. In one example, the central body 46 is described as terminating along a line intersecting the ends of the slits between adjacent compression members 42 and 44. In other examples, the length of each compression member 42 and 44 can be from about 10 cm to about 30 cm. The width B of the central body 46 can be between about 10 cm and about 40 cm. The total width A, including the lengths of the compression members 42 and 44 and the central body 46, can be between about 30 cm and about 140 cm. However, the width B, the width A, and the lengths of the compression members 42 and 44 can be greater than or less than the exemplary ranges described above.

[0032] Although in some examples all compression members 42 and 44 preferably have the same length and width, in other examples, the length and / or width of compression members 42 and 44 may differ within the same compression sleeve 40. For example, the medial compression member 42 may be longer than the lateral compression member 44. In some examples, one medial compression member 42 may have a different length and / or width than another medial compression member 42, and / or one lateral compression member 44 may have a different length and / or width than another lateral compression member 44. For example, the lengths of compression members 42A and 44A may be greater than the lengths of compression members 42G and 44G, to accommodate a leg circumference that is typically larger in the middle of the leg compared to the leg circumference closer to the patient's knee. In this way, the compression sleeve 40 must be constructed to have dimensions that allow for configuration for different types of limbs or other anatomical regions, different patient body types, or different types of surgery. However, it is preferred that the compression sleeve 40 be symmetrical along the longitudinal axis 47. The symmetrical construction of the compression sleeve 40 allows it to be used in any orientation for any limb (i.e., clinicians do not need to orient the compression sleeve to have any specific end on the limb), thus saving surgical time. Furthermore, the symmetrical construction of the compression sleeve 40 allows clinicians to orient the medial compression member 42 towards the medial side of the limb, regardless of whether the surgery is performed on the right or left limb. Additionally, clinicians can orient the medial compression member 42 towards the lateral side of the limb, provided that this orientation allows for more comfortable wrapping of both the medial and lateral compression members 42 and 44.

[0033] The compression cuff 40 can have any suitable length. For example, the length L of the compression cuff 40 can be selected from about 10 cm to about 60 cm. The length L can be selected based on the desired number of compression members 42 and 44 or other factors, such as the type of limb to which the compression cuff 40 is intended, the patient's body size, etc. In some examples, the compression cuff 40 can have a length L that is chosen to be large enough to compress all sites treated with adhesive. In some examples of treating the vein 20, the total treatment site can have a length from about 2 cm to about 50 cm, or in other examples a length from about 5 cm to about 40 cm. Therefore, the length L of the compression cuff 40 can be selected from about 10 cm to about 60 cm.

[0034] like Figure 1A As shown, in some examples, adjacent inner compression members 42 and adjacent outer compression members 44 can be in a flat construction (such as...). Figure 1A(As shown) or in a ring structure surrounding the limb, they may contact or nearly contact each other. For example, adjacent medial compression members 42 may be separated from each other by a distance of less than about 0.5 cm, and adjacent lateral compression members 44 may be separated from each other by a distance of less than about 0.5 cm. In some examples, some or all portions of adjacent medial compression members 42 and lateral compression members 44 may even partially overlap to provide compression at a desired location along the limb. Similar to Figure 4 In some examples, compression members 42 and 44 can be separated by a greater distance (X).

[0035] In some examples, the inner compression member 42, the outer compression member 44, and the central body 46 can form a single integral structure. For example, the inner compression member 42, the outer compression member 44, and the central body 46 can be cut from or formed from a single piece of material. In other examples, the central body 46 can be formed from multiple central portions connected in series. Each central portion can be attached to or formed with one of the corresponding inner compression member 42 and outer compression member 44. In this way, each central portion and its corresponding compression members 42 and 44 can form a “band” that can be removably connected to other “bands” to form a complete compression sleeve similar to the compression sleeve 40. In some examples, each central portion can be attached to another central portion by a hook-and-loop closure, snap, zipper, buckle, or any other type of attachment mechanism. In other examples, each central portion can include two or more inner compression members 42 and two or more outer compression members 44. The compression sleeve formed by several attached "bands" allows clinicians to customize the length L of the compression sleeve 40 and / or the treatment length of the hollow anatomical structure for a specific patient. Furthermore, attaching several "bands" allows clinicians to save time during the procedure because instead of manipulating several separate bands, a single device is placed under the patient before the procedure begins.

[0036] Each rib structure 50 can be attached to the surface of a corresponding inner compression member 42 (or, in other examples, an outer compression member 44). When in a ring configuration, the surface supporting the rib structure 50 will be a radially inward-facing surface 48, so that each rib structure 50 can directly contact the limb (e.g., contact the skin) and apply pressure to compress the veins within the limb. Figure 1AThe rib structure 50 shown has an elliptical cross-sectional shape similar to that of an ultrasound transducer, but other cross-sectional shapes (e.g., rectangular, square, or non-linear shapes) can also be used for the rib structure 50. The rib structure 50 can be formed with a longer dimension parallel to the length of the inner compression member 42 to provide pressure to the hollow anatomical structure, even if the rib structure 50 is not entirely located at the center of the hollow anatomical structure. In some examples, the rib structure 50 can have a contact shape similar to that of an ultrasound transducer that can be placed against the patient's skin during imaging of the hollow anatomical structure to be treated. In this way, the rib structure 50 can have a flat surface that contacts the patient's skin. In other examples, the rib structure 50 can have a curved or semi-circular surface that contacts the patient's skin, which can correspond to the curve of the ring structure.

[0037] In some examples, each rib structure 50 may have a length from about 1.0 cm to about 10 cm, and more preferably from 2 cm to 5 cm. The width of each rib structure 50 may be less than the width of the corresponding inner compression member 42, for example, from about 0.3 cm to about 2 cm. However, the connecting mechanism (e.g., the slot through which the inner compression member 42 passes) may be slightly wider than the width of the inner compression member. In some examples, each rib structure 50 may have a height selected from about 0.5 cm to about 3 cm (e.g., the distance protruding from the corresponding compression member 42), but other heights may be used in other examples. Each rib structure may have a cross-sectional shape of quadrilateral, square, rectangular, trapezoidal, triangular, or any other shape. In some examples, the cross-sectional shape may have rounded corners to reduce potential skin irritation. In some examples, the rib structures 50 may have different dimensions and / or cross-sectional shapes on different compression members 42 in order to target different areas of tissue that need to be compressed or to provide different types of pressure to hollow anatomical structures.

[0038] Rib structure 50 can be made of any rigid or semi-rigid material, such as polymers, composites, rubber, or at least one of metals or metal alloys. In other examples, rib structure 50 can be an adhesive gel or a stretchable polymer encased in a flexible membrane. In some examples, rib structure 50 can be permanently attached to a corresponding medial compression member 42 using adhesives, sutures, clips, or any other type of permanent fastener. In other examples, rib structure 50 can be movably attached to medial compression member 42 to allow clinicians to adjust the position of rib structure 50 on medial compression member 42. In this way, clinicians can move each rib structure in the rib structure 50 laterally to apply pressure to the limb directly above the location of the hollow anatomical structure to be treated. In some examples, rib structure 50 can be attached using hook-and-loop fasteners. In other examples, the rib structure can be slidably attached to medial compression member 42 via a slot within rib structure 50 through which the medial compression member slides. In yet another example, the rib structure 50 can be inserted into an elongated pouch formed within a corresponding inner compression member 42, wherein the elongated pouch is longer than the rib structure, allowing the rib structure to be positioned at different locations within the pouch. Although the rib structure 50 can be formed separately from and subsequently attached to the compression member 42, in other examples, the rib structure 50 can be formed as part of the compression member 42.

[0039] Figure 1B yes Figure 1A A top view of an exemplary compression sheath 40 is shown, and the compression sheath 40 is shown in relation to... Figure 1A The opposite side shown. (As shown) Figure 1B As shown in the example, each medial compression member 42 includes respective attachment elements 54A, 54B, 54C, 54D, 54E, 54F, and 54G (collectively referred to as "attachment elements 54"), which, when the cuff 40 is in the ring configuration, are supported on the surface 49 of the medial compression member 42 opposite to the patient's limb. The attachment elements 54 are configured to... Figure 1A The attachment element 52 of the outer compression member 44 shown engages with it. In some examples, the attachment element 54 may be larger (e.g., longer) than the attachment element 52, so that it can be attached to the attachment element 52 at different locations and facilitates the formation of ring structures with different circumferences with the respective compression members 42 and 44.

[0040] Figure 1C yes Figure 1A A side view of an exemplary compression sheath 40. (See also:) Figure 1C As shown in the example, the longitudinal end of the compression sleeve 40 is shown to include compression members 42G and 44G, a central body 46, attachment elements 52G and 54G, and a rib structure 50G. Figure 1CThe flat configuration of the compression sleeve 40 is shown. The clinician winds both the inner compression member 42G and the outer compression member 44G upwards into a loop configuration such that the end of the outer compression member 44G is wound around the end of the inner compression member 42, and the attachment element 52G engages with the attachment element 54G. The attachment elements 52G and 54G can be configured, for example, using a hook-and-loop closure system, a buckle, or any other type of attachment element to support multiple locations for attachment along the length of the inner compression member 42.

[0041] Attachment elements 52 and 54 together form an attachment mechanism that secures the inner compression member 42 to the corresponding outer compression member 44. In one example, each attachment element 54 includes multiple rings, and each attachment element 52 includes multiple hooks configured to be secured to the multiple rings. This type of attachment mechanism may be referred to as a hook-and-loop closure system. In other examples, attachment elements 52 and 54 may include one or more snaps, protrusions, buttons, clips, buckles, or any other type of removable attachment element. In any case, when connected, attachment elements 52 and 54 may be configured to maintain the pressure required to close the hollow anatomical structure to be treated.

[0042] Figure 2A , 2B 2C, 2D, and 2E are hollow anatomical structures used to deliver venous obstruction substances to the patient's leg and utilize... Figure 1A-1C This is a schematic diagram illustrating an exemplary process of compressing the leg portion using the exemplary compression sleeve 40 shown. Figure 2A As shown, medical component 10 includes a compression cuff 40 and a flexible catheter 12. The compression cuff 40 is placed under the patient's leg, and the flexible catheter 12 has a proximal end 14A and a distal end 14B. The flexible catheter 12 is inserted into the patient's vein 20. In some examples, vein 20 may be the great saphenous vein, but in other examples, vein 20 may be any superficial vein, deep vein, or perforating vein. Vein 20 may include a lower portion 24 and an upper portion 22. A dispensing gun, syringe, or other pressurizing device (not shown) may hold a volume of medical adhesive material (e.g., Figure 2B-2E The medical adhesive 26 shown is delivered through the proximal end 14A of the flexible catheter 12 to the distal end 14B and discharged from the distal end 14B of the flexible catheter 12. The flexible catheter 12 is configured to be disposed within a hollow anatomical structure (e.g., vein 20) of the patient. The flexible catheter 12 may be an elongated structure (e.g., a tubular body) defining at least one lumen having a cross-sectional dimension of the lumen (e.g., diameter in the case of a cylinder), a proximal opening of the lumen near the proximal end 14A of the flexible catheter 12, and a distal opening of the lumen near or at the distal end 14B of the flexible catheter 12.

[0043] Clinicians can use imaging tools such as ultrasound transducer 16 to image vein 20 and / or assist in guiding flexible catheter 12 to one or more target locations where medical adhesive will be received. Ultrasound transducer 16 can be multifunctional. For example, ultrasound transducer 16 may include one or more ultrasound sensors for generating images that help clinicians guide catheter 12 (or another device, such as a guide tube or guidewire) through a patient's vascular system, can serve as a compression element of vein 20 after a wad of medical adhesive has been delivered into vein 20, and / or identify areas within vein 20 that may require further obstruction or closure. However, as described herein, compression cuff 40 is configured to provide compression to a target location within vein 20 as an alternative to or supplement to manual compression applied by a clinician via ultrasound transducer 16 or via another tool or the clinician's hand. In some examples, ultrasound transducer 16 may be positioned to contact the outer surface of the patient's skin before placement of flexible catheter 12 or any other device (e.g., a guide tube or guidewire through blood vessel 20). For example, clinicians can use the ultrasound transducer 16 to map and mark target vessels, enabling more precise placement of the compression cuff 40 and more specific, precise placement of the rib structure 50. The ultrasound transducer 16 can help generate images to aid in guiding one or more catheters or guiding devices to the target site where a venous occlusive material (e.g., medical adhesive) will be introduced. In some examples, the ultrasound transducer 16 may include Doppler flow detection capabilities and help identify areas within the vein 20 that may require further closure or obstruction, thereby allowing for the further application of the venous occlusive material.

[0044] In some examples, the flexible catheter 12 may include one or more features that facilitate visualization of one or more portions of the flexible catheter 12 in the case of ultrasound visualization by the ultrasound transducer 16. For example, the flexible catheter 12 may include one or more echogenic portions in its distal portion. Echogenic portions may include one or more cavities defined within the wall of the flexible catheter 12. These cavities may be circumferentially, axially, and / or radially disposed within the wall of the flexible catheter 12. The cavities may include gases (e.g., air or nitrogen), solid materials (e.g., metallic alloys), or other materials that can be distinguished from other anatomical structures or fluids within the patient's body. In some examples, the cavities may be formed of the material used to construct the wall of the flexible catheter 12, or the cavities may be defined by a material that traps air within a porous membrane (e.g., expanded polytetrafluoroethylene (EPTFE)).

[0045] like Figure 2BAs shown, the inner compression member 42A and outer compression member 42B from the compression cuff 40 are a paired pair or set of compression members and have been wrapped around the patient's leg to form a loop structure that provides compression force to the leg and a portion of the vein 20. Specifically, the inner compression member 42A and outer compression member 42B form an initial obstruction in the vein 20 (e.g., forcing the walls of the vein 20 into contact so that blood or other fluids cannot flow through the obstructed portion of the vein 20). As described herein, the compression cuff 40 includes inner compression members 42A, 42B, 42C, 42D, 42E, 42F, and 42G (collectively, "compression member 42") extending in a first direction and outer compression members 44A, 44B, 44C, 44D, 44E, 44F, and 44G (collectively, "compression member 44") extending in a second direction different from the first direction. The inner compression members 42A-42G will be wound generally toward the inside of the patient, while the outer compression members 44A-42G will be wound generally toward the outside of the patient.

[0046] After the compression members 42A and 44A are wrapped around the leg, the clinician can inject the drug adhesive puff 26 from the distal end 14B of the flexible catheter 12 and press it against the obstruction. In other examples, the ultrasound transducer 16 can be pressed against the leg to form an initial obstruction in the vein 20, against which the drug adhesive puff 26 can be delivered. Figure 2C As shown, the medical adhesive pouch 26 has been fully delivered into the vein 20, and the clinician has withdrawn the flexible catheter 12 proximally from the site where the medical adhesive pouch 26 was delivered.

[0047] like Figure 2D As illustrated in the example, once the flexible catheter 12 is removed from the area containing the adhesive pad 26, the clinician can apply pressure to that portion of the vein 20 using the next pair of compression members (e.g., medial compression member 42B and lateral compression member 44B). Each of the medial compression member 42 and lateral compression member 44 is independently movable, allowing the set of compression members 42 and 44 to be independently coupled together as needed during the medical procedure. For example, as... Figure 2D As shown, the inner compression member 42B and the outer compression member 44B are paired and have been wrapped around the patient's leg to form a ring structure that provides compression force on the leg and the portion of the vein 20 including the adhesive agglomerate 26. The compression cuff 40 is configured such that the clinician can adjust the attachment position between the compression members 42B and 44B to customize the circumference of the ring formed by the compression members 42B and 44B and thus the amount of compression applied to the leg. This compression facilitates the occlusion and collapse of the vein 20 to allow for closure of the vessel wall.

[0048] After delivering the adhesive pouch 26 and connecting the compression members 42B and 44B to compress the venous portion including the adhesive pouch 26, the clinician can leave the compression cuff 40 in place and retract the flexible catheter 12 proximally to move the distal end 14B to a new position within the vein 20, and repeat the process. Figure 2B-2D The process is illustrated to deliver another medical adhesive bolus to this new location within the vein 20. In some examples, the different target locations for delivering the medical adhesive may be spaced from adjacent target locations by about 0.5 cm to about 7 cm along the length of the vein 20. More preferably, the spacing between the different target locations (and therefore the different adhesive boluses 26) is between 1 cm and 3 cm. In some examples, the total treatment length of the vein 20 may have a length between about 2 cm and about 50 cm, or in some examples it may have a length between about 5 cm and about 40 cm.

[0049] In one example, conduit 12 may include multiple external markers (e.g., Figure 6 The external markers 112A-112E shown are spaced apart from adjacent markers by a certain marker spacing (measured in units of distance), which corresponds to the spacing between adjacent compression members 42 and / or adjacent compression members 44. When the clinician retracts the catheter 12 proximally from the guide sheath, exposure of the next external marker on the catheter 12 indicates that the distal end 14B is at the next target location within the vein 20. Therefore, the external markers provide visual assistance that the clinician can use to deliver the adhesive bolus 26 at the target location within the vein 20. By aligning the spacing between the external markers 112A-112E with the spacing between compression members 42 and 44, the time required for repositioning the catheter 12, delivering the adhesive bolus 26, and applying pressure to the adhesive bolus 26 can be reduced, thereby reducing the overall procedure time.

[0050] exist Figure 2E In this configuration, all compression members 42 are coupled to their respective mating compression members 44 to provide compression at all target locations where the complete adhesive bundle 26 has been delivered to the vein 20. In other examples, when the treatment length of the vein 20 is shorter than the length of the compression sleeve 40, the clinician may not need to use all compression members 42 and 44. The compression sleeve 40 can remain in place as long as it is necessary to shape or cure (e.g., polymerize) all adhesive bundles (e.g., all viscous materials). Figure 2EThe closed configuration is shown. For example, compression members 42 and 44 can remain connected to provide compression for a duration not exceeding approximately 5 minutes, 4 minutes, 3 minutes, 2 minutes, 1 minute, 30 seconds, 15 seconds, or less after the injection of the last bolus of adhesive. In some examples, the clinician can disengage all compression members 42 and 44 simultaneously. In other examples, the clinician can disengage compression members 42 and 44 from their connection in reverse order to maintain the desired compression duration at each location. For example, compression members 42A and 44A can be disengaged before disengaging compression members 42B and 44B.

[0051] As described herein, the compression sleeve 40 can be an exemplary medical component configured to compress a portion of a patient's limb. Figure 1A-3 The exemplary compression sleeve 40 shown includes a central body 46 having a longitudinal axis 47, an inner surface 48, and an outer surface 49. In use, the inner surface 48 will face the patient's skin, and the outer surface 49 will face away from the patient's skin. The compression sleeve 40 includes a plurality of inner compression members 42 (e.g., ...) extending from the central body 46 along a first direction. Figure 1A (As shown), each inner compression member 42 includes a respective attachment element 54. The compression sleeve 40 also includes a plurality of outer compression members 44 extending from the central body 46 in a second direction different from the first direction, wherein each outer compression member 44 includes a respective attachment element 52. The attachment elements 54 of the inner compression members 42 are configured to attach to or connect to the corresponding attachment elements 52 of the outer compression members 44. Figure 2E and Figure 3 As shown, when connected, an inner compression member 42 and an outer compression member 44 form a pair to create a corresponding ring structure to compress a part of the patient's limb.

[0052] Attachment elements 52, 54 may include corresponding mating elements, such as hooks and rings forming a hook-and-loop attachment mechanism, buttons and slots, snaps, protrusions, temporary adhesives, notches and pawls, or any other type of material or structure configured to form a removable connection. Preferably, attachment elements 52, 54 are hook-and-loop attachments to provide greater flexibility in adjusting the size of the ring and the resulting compressive force. In addition to attachment elements, in some examples, each compression member 42 includes a rib structure (e.g., Figure 3 The rib structure 50A shown is configured to apply more concentrated pressure to the patient's skin compared to the compression member 42 without a rib structure, in order to more effectively compress the target vein 20 within the limb. For example, each rib structure may be attached to the surface of the corresponding compression member 42, wherein, when in a ring configuration, this surface is the inner surface 48.

[0053] like Figure 2EAs shown, multiple clumps of medical adhesive have been delivered to vein 20 to bond vein 20 with the adhesive and form an obstruction portion of vein 20. The obstruction portion may include medical adhesive that has been delivered from catheter 12 into vein 20 and adhered to the wall of vein 20. In some examples, the obstruction portion may include a continuous length of medical adhesive facilitated by multiple delivered clumps. In other examples, the obstruction portion 30 may include multiple separate regions of vein 20 that have been bonded with medical adhesive by means of a compression cuff 40. After delivery of the medical adhesive, the clinician can remove the flexible catheter 12 from vein 20 and the patient.

[0054] In some examples, the viscosity of the medical adhesive described herein can be between about 40 centipoise (cP) and 3000 centipoise, preferably between 1000 centipoise and 2500 centipoise. Each clump of medical adhesive delivered to a single location within the container can be in the range of about 0.01 cubic centimeters (cc) to 3 cubic centimeters. In other examples, each adhesive clump can be in the range of about 0.05 milliliters (mL) to 0.5 milliliters, about 0.1 milliliters to 0.2 milliliters, or about 0.01 milliliters to 1.0 milliliters of medical adhesive. Each adhesive clump can be spaced about 2 centimeters to 6 centimeters or about 0.5 centimeters to 5 centimeters apart.

[0055] Exemplary medical adhesives may include cyanoacrylates (e.g., 2-octyl cyanoacrylate). In some examples, the cyanoacrylate may be aliphatic 2-cyanoacrylates, such as alkyl, cycloalkyl, alkenyl, or alkoxyalkyl 2-cyanoacrylates. In some embodiments, the alkyl group may have 1 to 16 carbon atoms and may be a C1-C8 alkyl ester or a C1-C4 alkyl ester. Some feasible esters include methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, pentyl, hexyl, cyclohexyl, heptyl, octyl, 2-methoxyethyl, and 2-ethoxyethyl esters of cyanoacrylate. Other medical adhesives that may be used include bioadhesives, such as bovine serum albumin-glutaraldehyde compositions (e.g., Cryolife's BIOGLUE in Atlanta, Georgia), PVA, Biogard, collagen, fibrinogen, fibronectin, fibronectin, laminin, thrombin, gelatin, mixtures thereof, or other biocompatible adhesives. Preferred medical adhesives are n-butyl cyanoacrylate, such as VenaSeal sold by Medtronic. TM Adhesive.

[0056] In some examples, the adhesive may also include therapeutic agents, such as anti-inflammatory agents, anti-infective agents, anesthetics, pro-inflammatory agents, cell proliferators, or combinations thereof. In some examples, the medical adhesive (e.g., cyanoacrylate adhesive) may have selected properties. In some examples, the medical adhesive may have a setting time between approximately 5 and 60 seconds. However, a longer setting time is feasible without prolonging the surgical time because the pressure cuff 40 allows the clinician to continue the procedure without waiting for the adhesive to polymerize or set.

[0057] As described herein, the compression cuff 40 can be used during surgical procedures to treat a patient's hollow anatomy. For example, the technique may include injecting a first clump of adhesive material (e.g., adhesive material clump 26) from a catheter 12 inserted into the patient's hollow anatomy to a first target location, and then mechanically connecting one medial compression member 42 (e.g., medial compression member 42A) of the compression cuff 40 to another lateral compression member 44 (e.g., lateral compression member 44A) to form a first ring structure around and compress a first portion of the limb corresponding to the first target location. The technique may then include retracting the catheter 12 a distance from the first target location to a second target location, injecting a second clump of adhesive material from the catheter 12 inserted into the patient's hollow anatomy to the second target location, and then mechanically connecting another medial compression member 42 (e.g., medial compression member 42B) and another lateral compression member 44 (e.g., lateral compression member 44B) to form a second ring structure around a second portion of the limb corresponding to the second target location and to compress the second portion of the limb. This technique can be repeated until the clinician has treated all desired target locations of the vein 20.

[0058] In some examples, compression members 42 and 44 can be used to form an obstruction in the vein 20 prior to the injection of the adhesive bundle 26. For example, one of the medial compression members 42 can be attached to one of the lateral compression members 44 to form a loop structure and create an obstruction in the vein 20. The clinician can then inject the adhesive bundle 26 proximal to and adjacent to the obstruction and wind the next set of compression members 42 and 44 into a loop structure to compress the delivered adhesive bundle. In some examples, the respective sets of compression members 42 and 44 can be used to form an obstruction distal to each adhesive bundle injected into the vein 20. In this exemplary use of the compression cuff 40, a first medial compression member 42A is attached to an lateral compression member 44A to form an obstruction, and then a first bundle of adhesive is injected onto the formed obstruction. Then, a medial compression member 42B is attached to an lateral compression member 44B to compress the vein and engage it with the first bundle of adhesive. Next, the medial compression member 42C is attached to the lateral compression member 44C to form another obstruction, and then a second wad of adhesive is injected onto the formed obstruction. Then, the medial compression member 42D is attached to the lateral compression member 44D to compress the vein and engage it with the second wad of adhesive. Next, the medial compression member 42E is attached to the lateral compression member 44E to form another obstruction, and then a third wad of adhesive is injected onto the formed obstruction. Then, the medial compression member 42F is attached to the lateral compression member 44F to compress the vein and engage it with the third wad of adhesive. In some embodiments, the medial compression member 42G is attached to the lateral compression member 44G to form another obstruction, and a fourth wad of adhesive is injected onto this obstruction, or the vein is engaged with another wad of adhesive. In some examples, the procedure may not require members 42G and 44G, or additional lateral and medial compression members may be provided to facilitate additional treatment along the limb. In examples where the medial compression member includes a corresponding rib, wrapping the compression member around the leg involves positioning the corresponding rib on the target vein to allow the rib to apply compressive force to the target vein. In some examples, the patient requires fewer compression members than all the mating sets of the compression member. In some examples, the clinician may first mark the location of the target vein (e.g., GSV) on the patient's skin with a surgical pen to help place the compression member and, in some examples, to help locate the corresponding rib.

[0059] Figure 3 This is a cross-sectional view of the limb 28 compressed by the compression members 42 and 44 of the exemplary compression sleeve 40. Figure 3 As shown in the example, the outer compression member 44A is connected to the inner compression member 42A via attachment elements 52A and 54A, respectively. Compression members 42A and 44A extend from the central body 46 around the limb 28 in opposite directions. Figure 3 In the example shown, the outer compression member 44A overlaps with the inner compression member 42A so that the attachment element 52A can contact the attachment element 54A, and the pair of compression members 42A and 44A form a ring structure. The outer compression member 44A can overlap with the inner compression member 42A to the extent required to attach the attachment elements 52A and 54A. More overlap can result in a smaller circumference of the ring structure. This ring structure can be formed with a suitable circumference to apply the desired pressure to a portion of the limb 28.

[0060] exist Figure 3 In the example shown, rib structure 50A is positioned on the radially inward-facing surface of the inner compression member 42A (when the inner compression member 42A and the outer compression member 44A are joined to define a ring configuration) to concentrate the compressive pressure applied to the limb 28 by rib structure 50A. This pressure applied by rib structure 50A can cause a portion of the vein 20 beneath rib structure 50A to collapse more specifically, potentially reducing the total pressure required to be applied to the limb 28. This collapse of the portion of vein 20 provides a blocking portion (to which adhesive can be delivered), or provides compression to allow the wall of vein 20 to engage with an adhesive clump delivered to a target location within vein 20. In some examples, rib structure 50A may be configured to move laterally on the radially inward-facing surface 48 (e.g., moving away from or toward the central body 46 along the length of the respective compression member) to facilitate direct placement of rib structure 50A onto vein 20. For example, hollow anatomical structures (such as the great saphenous vein) may twist medially or laterally as they extend through the leg, rather than forming a straight line. Therefore, clinicians may wish to move the rib structure relative to the corresponding medial compression member 42 to properly position the rib structure directly over the actual location of the vein. The rib structure 50 can be attached to the medial compression member 42 in any manner that allows the rib structure 50 to move along the length of the medial compression member 42. For example, the rib structure 50 can be attached to the medial compression member 42 via a hook-and-loop fastener. In another example, the rib structure 50 may include a circumferentially arranged slot through which the medial compression member 42 passes, allowing the rib structure 50 to slide along the length of the medial compression member (e.g., laterally or medially) to reach the location of the target vein.

[0061] Figure 4 This is a bottom view of an exemplary compression sleeve 60, with a distance of X between each compression member on each side of the compression sleeve 60. The compression sleeve 60 is similar to... Figure 1A-1C The compression sleeve 40. However, with Figure 1A Compared to the example of compression sleeve 40 shown, compression sleeve 60 can include a larger gap between adjacent compression members. For example... Figure 4As shown, the compression sleeve 60 includes inner compression members 62A, 62B, 62C, and 62D (collectively referred to as "inner compression members 62"), outer compression members 64A, 64B, 64C, and 64D (collectively referred to as "outer compression members 64"), a central body 66, rib structures 70A, 70B, 70C, and 70D (collectively referred to as "rib structures 70"), and attachment elements 72A, 72B, 72C, and 72D (collectively referred to as "attachment elements 72"). Compression members 62 and 64 may be similar to compression members 42 and 44 of the compression sleeve 40, respectively. The central body 66 is similar to the central body 46 of the compression sleeve 40, the rib structure 70 is similar to the rib structure 50 of the compression sleeve 40, and the attachment elements 72 are similar to the attachment elements 52 of the compression sleeve 40.

[0062] The compression sleeve 60 includes compression members 62 and 64 spaced apart from each other by a distance X. Distance X can be selected to correspond to the distance between target locations where a clinician will inject adhesive into the hollow anatomical structure to be treated. In other words, when the delivered adhesive clumps are spaced apart within the hollow anatomical structure, the compression sleeve 60 does not need to provide compression at those locations between the target locations where the adhesive clumps will be included. In some examples, adjacent inner compression members 62 are spaced apart from each other by a distance of approximately 0.5 cm to approximately 6.5 cm, and adjacent outer compression members 64 are spaced apart from each other by a distance of approximately 0.5 cm to approximately 6.5 cm. In other examples, the inner compression members 62 are spaced apart from each other by a distance of approximately 3 cm to approximately 5 cm, and the outer compression members 64 are spaced apart from each other by a distance of approximately 3 cm to approximately 5 cm.

[0063] In some examples, the distance X for compressing the cuff 60 is the same. In other examples, the distance X between different compression members can be different. For example, the distance X between the inner compression members 62A and 62B can be smaller than the distance between the outer compression members 62C and 62D. In this way, the distance X between compression members 62 and 64 can vary along the longitudinal direction of the compression cuff 60. In other examples, two or more compression members 62 and / or 64 can at least partially overlap. In this way, the distance between adjacent compression members 62 and 64 can be selected based on the specific hollow anatomy to be treated or the specific process used to deliver adhesive to the patient.

[0064] Figure 5 This is a bottom view of an exemplary compression sleeve 80 having a distance Y between adjacent groups (e.g., adjacent pairs) of compression members. The compression sleeve 80 is similar to... Figure 1A-1C The compression sleeve 40. However, the compression sleeve 80 may include gaps between multiple sets of adjacent compression members. For example... Figure 5As shown, the compression sleeve 80 includes inner compression members 82A, 82B, 82C, 82D, 82E, 82F, 82G, and 82H (collectively referred to as "inner compression members 82"), outer compression members 84A, 84B, 84C, 84D, 84E, 84F, 84G, and 84H (collectively referred to as "outer compression members 84"), a central body 86, rib structures 90A, 90B, 90C, 90D, 90E, 90F, 90G, and 90H (collectively referred to as "rib structures 90"), and attachment elements 92A, 92B, 92C, 92D, 92E, 92F, 92G, and 92H (collectively referred to as "attachment elements 92"). Compression members 82 and 84 are similar to compression members 42 and 44 of the compression sleeve 40, respectively. The central body 86 is similar to the central body 46 of the compression sleeve 40, the rib structure 90 is similar to the rib structure 50 of the compression sleeve 40, and the attachment element 92 is similar to the attachment element 52 of the compression sleeve 40.

[0065] The compression sleeve 80 includes pairs of compression members 82 and 84 spaced apart from each other by a distance Y. In other words, a gap of distance Y is provided between every other compression member 82 and 84, while gaps between other compression members are relatively small or nonexistent. For example, a gap of distance Y exists between a pair of inner compression members 82A and 82B and a pair of outer compression members 82C and 82D. The first set of compression members 82 and 84 in the pair is configured to compress and block the hollow anatomy, while the second set of compression members 82 and 84 in the pair is configured to compress and join the walls of the hollow anatomy with an injected adhesive. For example, compression members 82A and 84A are attached to form a ring structure and to form a blockage in the vein. Then, after a clump of adhesive is injected into the vein and adjacent to the blockage, the clinician forms a ring structure with compression members 82B and 84B. The next blockage can then be achieved with compression members 82C and 84C at a distance Y from the injected adhesive clump. The process can continue along the remaining length of the compression bladder 80.

[0066] The distance Y can be selected to correspond to the distance between target locations where the clinician will inject adhesive into the hollow anatomical structure to be treated, and where the next blockage will be formed by the compression sleeve 80. In other words, when the delivered adhesive clumps are spaced apart within the hollow anatomical structure, the compression sleeve 80 does not need to provide compression at those locations between the target locations that will include the adhesive clumps. In some examples, the paired inner compression members 82 are separated from each other by a distance of about 0.5 cm to about 5.5 cm, and the paired outer compression members 84 are separated from each other by a distance of about 0.5 cm to about 5.5 cm. In other examples, the paired inner compression members 82 are separated from each other by a distance of about 2 cm to about 4 cm, and the paired outer compression members 84 are separated from each other by a distance of about 2 cm to about 4 cm.

[0067] The distance Y between different pairs of compression members can be different. For example, the distance Y between inner compression members 82B and 82C can be smaller than the distance between inner compression members 82F and 82G. In this way, the distance Y between compression members 82 and 84 can vary along the longitudinal direction of the compression sleeve 80. In other examples, two or more pairs of compression members 82 and / or 84 can at least partially overlap. In this way, the distance between adjacent compression members 82 and 84 can be selected based on the specific hollow anatomy to be treated or the specific process used to deliver adhesive to the patient.

[0068] Figure 6 This is a side view of an exemplary catheter 100 with external markings, the spacing of which corresponds to the spacing of the compression members of the compression sheath. (Example) Figure 6 As shown in the example, conduit 100 is configured to deliver viscous material to a hollow anatomical structure, which is similar to... Figures 2A-2E The catheter 12. The catheter 100 includes an elongated member 102 defining a lumen (not shown), a proximal end 104, and a distal end 106. Ports 108 and 110 allow devices or materials such as adhesive materials and / or guidewires to be inserted into the lumen of the elongated member 102, and adhesive materials to be delivered to the distal end 106. The elongated member 102 may be transparent, partially transparent, or opaque. An external marking 112 may be located on the outside of the elongated member 102 or otherwise visible, and may be formed by ink, paint, or other coatings, and may be formed by etching, pawls, or any other type of visible and / or structural features. In some examples, structural features (e.g., pawls) may provide tactile indication to the clinician during catheter 100 retraction, indicating that the external marking 112 has exited the guide sheath and that the distal end 106 is at the next target location for adhesive.

[0069] The catheter 100 defines a lumen through which viscous material can be delivered to hollow anatomical structures within the limb, such as veins. The catheter 100 includes a plurality of external markers 112A, 112B, 112C, 112D, 112E, 112F, and 112G (collectively referred to as “external markers 112”). Adjacent external markers 112 have a marker spacing Z corresponding to the spacing between adjacent compression members of a compression cuff (e.g., compression cuff 40). During medical procedures, the catheter 100 may be positioned within a guide sheath (not shown). As the catheter 100 is retracted relative to the guide sheath, the next visible external marker 112 emerging from the proximal end of the guide sheath indicates that the distal end 106 of the catheter 100 is located at the next target position within the hollow anatomical structure.

[0070] In one example, the spacing Z between adjacent markers 112 may correspond to the distance between the midlines of the inner compression members 42A and 42B of the compression cuff 40. In this way, the spacing Z can indicate the distance between successive clumps to be injected into the hollow anatomy. Therefore, the markers 112 allow the rib structure 50 to be accurately positioned to apply pressure to the hollow anatomy at the target location for delivering the adhesive clump, without requiring the clinician to measure how far the catheter 100 should be retracted each time for the next target location. In some examples, the marker spacing Z of the multiple outer markers 112 ranges from approximately 1.0 cm to approximately 7.0 cm. The marker spacing Z and the number of outer markers 112 can be selected to correspond to the type of compression cuff used, such as any of the compression cuffs 40, 60, or 80 described herein. In other embodiments, for example when the inner compression member 42A is used to form a blockage (the adhesive bundle is placed against the blockage) and the inner compression member 42B is used to join the hollow anatomical structure with the adhesive, the clinician can retract the catheter to the two markers 112 so that the distal end 106 of the catheter 100 is in the proper target position.

[0071] Figure 7 This is a flowchart of an exemplary technique for injecting an adhesive material into a hollow anatomical structure and wrapping the compression members 42 and 44 of the compression sleeve 40 around the limb to bond the wall of the hollow anatomical structure to the adhesive material. For illustrative purposes, see the attached diagram. Figure 1A-2E The various aspects of the compression bladder 40 are described Figure 7 The technology. However, this description should not be construed as restrictive. Figure 7 The technology can be used with other devices or systems (such as compression bladders 60 or 80 in other examples).

[0072] like Figure 7 As the examples show, clinicians can use ultrasound transducers (e.g., Figure 2AAn ultrasound transducer 16) is used to identify the great saphenous vein (GSV) within the patient's leg, and the path of the GSV is then marked on the patient's skin (120). For example, a clinician can use marking to create a visual marker of the GSV path under the skin. Next, the clinician can place a compression cuff 40 under the patient's leg and then wrap a set of compression members 42 and 44 (e.g., compression members 42A and 44A) around the leg and attach attachment elements 52 and 54 (e.g., attachment elements 52A and 54A) to form a ring structure (122) leading to an obstruction of the GSV. In one example, the target location of this obstruction can be selected as proximal to the junction between the GSV and the femoral vein. Rib structures 50A help to apply pressure to the skin from the compression members 42A and 44B and cause closure and obstruction of the GSV. The first obstruction formed by the compression sleeve 40 in the GSV can reduce or prevent the amount of adhesive in the first adhesive cluster from migrating downstream (i.e., toward the heart) in the GSV.

[0073] Next, the clinician can place the distal end 14B of catheter 12 at a target location adjacent to the obstruction and then inject a wad of adhesive material into the target location (124). In some embodiments, the wad of adhesive material can be injected into and contact the obstruction. Once the adhesive has been injected into the obstruction, the clinician can wrap the next set of compression members 42 and 44 (e.g., compression members 42B and 44B) around the patient's leg and attach attachment elements 52 and 54 (e.g., attachment elements 52B and 54B) to form a ring structure that causes the wall of the compressed GSV to abut against the wad of adhesive injected into the GSV, thereby achieving a tight closure of the vein (126). If there is another target location to be treated with the adhesive ( Figure 7 If the "YES" option is selected, the clinician can retract catheter 12 to the next target location (130), then form another blockage (122) by wrapping the next set of compression members 42 and 44 around the patient's leg, inject another wad of adhesive into the formed blockage (124), and wrap the next set of compression members 42 and 44 around the patient's leg to achieve a tight closure of the vein (126). In some examples, a catheter such as catheter 100 can be used, allowing the clinician to use external markings to determine the distance to retract catheter 100.

[0074] If there is no other target location to be treated with adhesive ( Figure 7(In the "NO" branch), the clinician can completely remove catheter 12 (132) from the patient. Then, after sufficient time for the delivered adhesive bundle to set and / or cure (e.g., polymerize), the clinician can remove compression sleeve 40 (134) from the patient's leg by separating the inner compression member 42 from the corresponding outer compression member 44. In some examples, if the amount of time for adhesive setting is less than the amount of time required to complete the procedure, the clinician can remove some groups of compression members 42 and 44 from the leg before the procedure is completed.

[0075] Various examples have been described. These and other examples all fall within the scope of the appended claims.

Claims

1. A medical component configured to compress a portion of a patient's limb, the medical component comprising: Central body; A plurality of inner compression members extending from the central body along a first direction, each of the plurality of inner compression members including a first attachment element; Multiple rib structures, wherein each of the multiple rib structures is disposed on a corresponding inner compression member of the multiple inner compression members; as well as A plurality of lateral compression members extending from the central body along a second direction different from the first direction, each of the plurality of lateral compression members including a second attachment element, wherein each first attachment element is configured to attach to a corresponding second attachment element to form a corresponding ring configuration and corresponding pairs of medial and lateral compression members for compressing a portion of the patient's limb, wherein each rib structure is disposed on a corresponding medial compression member such that each rib structure is oriented radially inward in the ring configuration, and wherein each rib structure is configured to apply pressure to the patient's skin to compress veins within the limb.

2. The medical assembly of claim 1, wherein the plurality of inner compression members and the plurality of outer compression members are flexible in the lateral direction to form corresponding ring structures.

3. The medical assembly of claim 1, wherein the plurality of inner compression members comprises at least five inner compression members, and the plurality of outer compression members comprises at least five outer compression members.

4. The medical assembly of claim 1, wherein the plurality of inner compression members are separated from each other by a distance of less than about 0.5 cm, and wherein the plurality of outer compression members are separated from each other by a distance of less than about 0.5 cm.

5. The medical assembly of claim 1, wherein the plurality of inner compression members are separated from each other by a distance of about 0.5 cm to about 6.5 cm, and wherein the plurality of outer compression members are separated from each other by a distance of about 0.5 cm to about 6.5 cm.

6. The medical assembly of claim 1, wherein the plurality of inner compression members are arranged as a plurality of pairs of inner compression members, each pair of inner compression members being separated from adjacent pairs of inner compression members by a distance of about 0.5 cm to about 6.5 cm, and wherein the plurality of outer compression members are arranged as a plurality of pairs of outer compression members, each pair of outer compression members being separated from adjacent pairs of outer compression members by a distance of about 0.5 cm to about 6.5 cm.

7. The medical component of claim 1, wherein the plurality of inner compression members, the plurality of outer compression members, and the central body form an integral structure.

8. The medical component of claim 1, wherein each first attachment element includes a plurality of rings, and each second attachment element includes a plurality of hooks configured to be secured to the plurality of rings.

9. The medical component of claim 1, wherein each of the plurality of rib structures is attached to the surface of a corresponding inner compression member, the surface being the radially inward-facing surface of the ring structure.

10. The medical component of claim 9, wherein each of the plurality of rib structures comprises a cross-section having a quadrilateral shape.

11. The medical component of claim 9, wherein at least one of the plurality of rib structures is movable to different positions on the surface of the respective inner compression member.

12. A medical system, the medical system comprising: A compression sleeve, the compression sleeve being configured to compress a portion of a patient's limb, the compression sleeve comprising: Central body; A plurality of inner compression members extending from the central body along a first direction, each of the plurality of inner compression members including a first attachment element; Multiple rib structures, wherein each of the multiple rib structures is disposed on a corresponding inner compression member of the multiple inner compression members; and A plurality of lateral compression members extending from the central body along a second direction different from the first direction, each of the plurality of lateral compression members including a second attachment element, wherein each first attachment element is configured to attach to a corresponding second attachment element to form a corresponding ring configuration, and corresponding pairs of medial and lateral compression members are used to compress a portion of the patient's limb; and A catheter configured as a hollow anatomical structure for delivering an adhesive material into a limb, the catheter including a plurality of external markers, each of the plurality of external markers being spaced apart from adjacent external markers by a marker spacing corresponding to the spacing between adjacent medial compression members among the plurality of medial compression members.

13. The medical system of claim 12, wherein the marking spacing is from about 1.0 cm to about 7.0 cm.

14. The medical system of claim 12, wherein the plurality of inner compression members, the plurality of outer compression members, and the central body form an integral structure.

15. The medical system of claim 12, wherein each of the plurality of rib structures is attached to the surface of a corresponding inner compression member, the surface being a radially inward-facing surface in the ring structure, and the rib structure is configured to apply pressure to the patient's skin to compress the hollow anatomical structure within the limb.

Citation Information

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