Drainage device, system and method

Abstract

Devices, systems, and methods for treating defects of an anatomical structure are disclosed. In one embodiment, a device may include a first portion configured to engage body tissue and a second portion extending distally from the first portion. The second portion may be elongate and configured to extend into and / or engage with defective tissue in the anatomical structure. The device may have an expanded or deployed configuration in which at least the second portion of the device has a first diameter. The device may be configured to be adjusted to a closed configuration, wherein the second portion of the device has a second diameter that is reduced relative to the first diameter. The second portion of the device may include one or more tissue engaging elements configured to engage the defect such that the second portion is adjusted to the reduced second diameter to close the defect.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 517,035, filed August 1, 2023, which is incorporated herein by reference. Technical Field

[0002] This disclosure relates in whole to, but not limited to, devices and systems for treating defects, as well as methods of treatment. More specifically, this disclosure relates to devices, systems, and methods for closing defects in a patient's anatomical structures, such as body lumens, body passages, body cavities, etc. Background Technology

[0003] A wide variety of in vivo and extracorporeal medical devices have been developed for medical applications, such as endoscopic surgery. Some of these devices and systems include guidewires, catheters, catheter systems, endoscopic instruments, and devices for treating trauma or defects. These devices and systems are manufactured using any of a variety of different methods and can be used according to any of these methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a continuing need for alternative medical devices and systems, as well as alternative methods for manufacturing and using medical devices and / or systems. Summary of the Invention

[0004] This disclosure provides designs, materials, manufacturing methods, and alternative uses for medical devices.

[0005] In a first instance, a device for implantation in or through anatomical defects in body tissue may include a first portion and a second portion; the first portion is configured to engage body tissue; the second portion extends distally from the first portion and is configured to engage tissue of an anatomical defect having a first opening, a second opening, and a passage extending between the first and second openings; and wherein the second portion is configured to reduce its diameter to close the anatomical defect when engaging tissue of the anatomical defect.

[0006] In addition to any of the examples above, or alternatively, the second part may be tubular.

[0007] In addition to any of the examples described above or alternatively, the device may include one or more barbs extending from the second portion, the one or more barbs being configured to engage tissue of an anatomical defect.

[0008] In addition to any of the examples described above or alternatively, one or more barbs may extend in a circumferential direction around the second part and be configured to engage tissue of the anatomical defect in response to rotation of the second part.

[0009] In addition to any of the examples described above or alternatively, the device may include a first set of one or more barbs and a second set of one or more barbs; the first set of one or more barbs extending from a first portion in a first circumferential direction and configured to engage body tissue; the second set of one or more barbs extending from a second portion in a second circumferential direction and configured to engage tissue with anatomical defects.

[0010] In addition to any of the examples described above or alternatively, a second set of one or more barbs may be configured to engage tissue of an anatomical defect in response to rotation of the second portion in the second circumferential direction; and when engaging tissue of an anatomical defect, the second portion may be configured to reduce its diameter to close the anatomical defect in response to rotation of the first portion in the second circumferential direction.

[0011] In addition to any of the examples described above or alternatively, the first group of one or more barbs may be configured to engage body tissue to prevent rotation of the first and second portions in the first circumferential direction.

[0012] In addition to any of the examples described above or alternatively, the device may include a first set of one or more barbs and a second set of one or more barbs; the first set of one or more barbs extending from a first portion and configured to engage body tissue; the second set of one or more barbs extending from a second portion and configured to engage tissue remote from the anatomical defect.

[0013] In addition to any of the examples described above or alternatively, the apparatus may include a tool for engaging the first portion, wherein the first portion may have an opening for receiving a distal end of the tool, and the tool is configured to rotate to reduce the diameter of the second portion when received within the opening.

[0014] In addition to any of the examples above or alternatively, the device may include a rope that is wound around the second portion and extends adjacent to the first portion, wherein the rope may cause the second portion to reduce in diameter in response to tension applied to the rope.

[0015] In addition to any of the examples above or alternatively, the device may include a clamp configured to be secured to the rope at a location adjacent to the first portion when tension is applied to the rope, in order to maintain tension on the rope.

[0016] In addition to any of the examples above or alternatively, the first part may include a wedge configured to receive the rope and maintain tension on the rope after tension is applied to it.

[0017] In addition to any of the examples above or alternatively, the first and second portions may be formed of one or more interwoven wires.

[0018] In another example, a system for implanting an implantable device into or through anatomical defects in body tissue may include an elongated tube, a deployment device, and an implantable medical device; the elongated tube is configured for insertion into body tissue adjacent to the anatomical defect; the deployment device is configured to be received within the elongated tube; the implantable medical device is configured to be received within the elongated tube and engage the deployment device, the implantable medical device comprising: a first portion and a second portion, the first portion being configured to engage body tissue, the second portion extending distally from the first portion, the second portion being configured to engage tissue of the anatomical defect having a first opening, a second opening, and a passage extending between the first and second openings; and wherein the deployment device is configured to be actuated to advance the second portion of the implantable medical device away from the elongated tube to the deployment configuration, the deployment configuration having a first diameter within the anatomical defect, and configured to reduce the diameter of the second portion of the implantable medical device within the anatomical defect to a second diameter.

[0019] In addition to any of the examples above or alternatively, the deployment device may be configured to engage and rotate a first portion of the implantable medical device to reduce the diameter of a second portion of the implantable device.

[0020] In addition to any of the examples above or alternatively, an implantable medical device may include a cord wrapped around a second portion; and a deployment device may be configured to engage the cord and apply tension to the cord to reduce the diameter of the second portion of the implantable medical device to a second diameter.

[0021] In another instance, a method of implanting an implantable medical device into or through an anatomical defect in body tissue may include: positioning an elongated portion of the implantable medical device within the anatomical defect; closing the anatomical defect in response to reducing the diameter of the implantable medical device within the anatomical defect from a first diameter to a second diameter; and securing the implantable medical device at or near the anatomical defect in a configuration having the second diameter.

[0022] In addition to any of the examples above or alternatively, closing an anatomical defect in response to reducing the diameter of the elongated portion may include engaging one or more barbs extending from the elongated portion of the implantable medical device with the anatomical defect or tissue in or near it.

[0023] In addition to any of the examples above or alternatively, closing an anatomical defect in response to reducing the diameter of the elongated portion may include applying tension to a rope wound around the elongated portion.

[0024] In addition to any of the examples above or alternatively, securing an implantable medical device to an anatomical defect or near it in a configuration having a second diameter may include engaging body tissue with barbs extending from the implantable medical device.

[0025] The above summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. These embodiments are illustrated more specifically by the following drawings and detailed description. Attached Figure Description

[0026] This disclosure can be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0027] Figure 1A and Figure 1B This is a schematic diagram illustrating the implantation of an exemplary device into a defect that penetrates body tissue;

[0028] Figure 2 This is a schematic diagram of an exemplary device for implantation in defects that penetrate body tissue;

[0029] Figure 3A and Figure 3B This is a schematic diagram of an exemplary device for implantation in a defect that penetrates body tissue, wherein a portion of the exemplary device transitions between a first diameter and a second diameter;

[0030] Figure 4 This is a schematic diagram of an exemplary system for implanting a device into a defect that penetrates body tissue;

[0031] Figure 5 This is a schematic diagram of an exemplary device for implantation in defects that penetrate body tissue;

[0032] Figure 6 This is a schematic diagram of an exemplary device for implantation in defects that penetrate body tissue;

[0033] Figure 7 A schematic diagram of an exemplary device for implantation in a defect that passes through body tissue.

[0034] Figures 8A to 8D This is a schematic diagram illustrating the implantation of an exemplary device into a defect that penetrates body tissue;

[0035] Figures 9A to 9C This is a schematic diagram illustrating the implantation of an exemplary device into a defect that penetrates body tissue.

[0036] Although this disclosure can be modified in various ways and alternatives, its details have been shown by way of example in the drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0037] The definitions given below shall apply unless otherwise defined in the claims or elsewhere in this specification.

[0038] All numerical values ​​herein are assumed to be modified by the term "approximately," whether explicitly indicated or not. The term "approximately" generally refers to a range of numbers that those skilled in the art consider equivalent to the values ​​expressed (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure.

[0039] The range of values ​​expressed by the endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its meaning as including “and / or” unless the context clearly indicates otherwise.

[0041] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such expressions do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that such features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless expressly indicated to the contrary.

[0042] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The drawings (which are not necessarily drawn to scale) illustrate exemplary embodiments and are not intended to limit the scope of this disclosure.

[0043] Defects in a patient's tissues can form openings or connections in or through one or more anatomical structures. Defects may be congenital and / or present due to trauma, clinical surgery, surgical procedures, or infection. The defects referred to herein may be anatomical defects, which are defects of anatomical structures, such as fistulas between congenital or surgically formed anatomical structures and / or between openings or passageways leading to or through the walls of such congenital or surgically formed anatomical structures. In some instances, an anatomical defect may have a first open end, a second open end, and a passageway between the first and second open ends, wherein the passageway may be elongated or non-elongated (e.g., wherein the anatomical defect may be an opening in or through the body tissue of an anatomical structure that causes leakage), but other suitable anatomical defects are contemplated. Some examples of anatomical defects may include, but are not limited to, fistulas (abnormal openings through or connecting to organs, blood vessels, and / or other body structures), gastrogastric fistulas, diverticulum sacs, perforations, and / or other defects in body tissues. Such defects can occur in or affect a variety of body parts, including but not limited to: body parts of the gastrointestinal tract (e.g., upper and lower gastrointestinal tract), stomach, intestines, feces, body parts of the reproductive tract, uterus, and / or other body parts.

[0044] In the absence of defects, a body part may have body tissue that defines a body cavity or passageway for that body part. Defective tissue may be the tissue that defines the body part that is defective.

[0045] When a defect forms within or through an opening, sac, or junction of one or more body parts, it is crucial to actively close the defect to prevent the migration of material or fluid into a body structure that is not designed to receive it, as the defect typically does not heal without intervention. If the defect is not closed, it can grow larger and may eventually lead to cancer and / or other diseases.

[0046] Defects that form openings or connections in or through one or more body parts can be closed using endoscopic surgery. In some instances, the device for implantation in or at the anatomical defect (e.g., an implantable medical device) may be or may include a stent device that can be delivered to the defect during endoscopic surgery.

[0047] Figure 1A and Figure 1BA schematic diagram of system 10 is shown, which includes an implantable device 12 (e.g., an implantable medical device), wherein system 10 is configurable to facilitate implantation of the implantable device 12 into or through a defect 14 (e.g., an anatomical defect) in body tissue 16 of body site 17. System 10 may include an elongated tube 18 (e.g., a catheter, sheath, etc.), a deployment device 20, the implantable device 12, and / or one or more other suitable components.

[0048] The elongated tube 18 may be a catheter, sheath, and / or other elongated tube suitable for delivering the implantable device 12 to a defect (e.g., defect 14 or other suitable defect) located at, within, or affecting body part 17. In some cases, the elongated tube 18 may be configured to receive the deployment device 20 and the implantable device 12 for delivery to defect 14.

[0049] The deployment device 20 may be any one or more elongated components configured to be at least partially received within the elongated tube 18 and to engage the device 12 for deployment of the device 12 from the elongated tube 18. The deployment device 20 may be and / or may include a shaft, tube, wire, and / or other elongated components.

[0050] The deployment device 20 may be configured to engage and / or grip the proximal or first portion 12a of the device 12. In some instances, the deployment device 20 may thread the device 12, may have a keyway engagement with the proximal portion of the device 12, may clamp the device 12, and / or may be otherwise configured to engage and / or grip the proximal or first portion 12a of the device 12.

[0051] The deployment device 20 may be configured to move relative to the elongated tube 18. In some instances, the deployment device 20 may be configured to translate longitudinally or axially relative to the elongated tube 18 to advance and / or deploy the device 12 away from the elongated tube. Alternatively, the deployment device 20 may be configured to rotate relative to the elongated tube 18 about a central axis to rotate the device 12, which may close the passage (e.g., lumen, opening, etc.) through the device 12 and thus close the defect 14.

[0052] like Figure 1A As shown, the device 12 can be delivered toward or through a defect 14 in or through body tissue 16. While other suitable defects are contemplated, the defect 14 may include a first open end or opening 14a, a second open end or opening 14b, and a passage 14c extending between the first opening 14a and the second opening 14b. The device 12 may include a first portion 12a and a second portion 12b, wherein the second portion 12b may be elongated and may be configured to extend distally from the first portion 12a in a manner that advances into the defect 14 in the direction of arrow A.

[0053] Device 12 may be configured to adjust between one or more dimensions (e.g., diameter), including but not limited to dimensions associated with a delivery configuration, dimensions associated with an expansion or deployment configuration (e.g., such as...). Figure 1A (as shown), and the dimensions associated with the closed configuration, for example, such as Figure 1B (As shown). In a delivery configuration, the first portion 12a and the second portion 12b of the device may be constrained or restricted when delivered to the defect 14 within the elongated tube 18. In a deployment configuration, at least the second portion 12b of the device 12 may be advanced away from the elongated tube 18 and may expand upon insertion into the defect 14 to engage the internal wall of the defect 14, while the first portion 12a of the device 12 may remain constrained or restricted within the elongated tube 18. Alternatively, in a deployment configuration, the first portion 12a and the second portion 12b of the device 12 may be advanced away from the elongated tube 18 and may expand, wherein the second portion 12b may be located within the defect 14 and the first portion may be located at or adjacent to the defect 14 to act as a barrier to fluid or material flowing into the defect 14, such as... Figure 1A As shown.

[0054] Once the device 12 is positioned within the defect 14, the second portion 12b of the device 12 can engage the tissue of the defect 14 and can reduce its diameter to close the defect 14. In some instances, the diameter of the second portion 12b of the device 12 can be reduced from a first diameter associated with the deployment configuration to a second diameter associated with the closure configuration. If the first portion 12a of the device 12 is not deployed or advanced away from the elongated tube 18 before the defect is closed with the second portion 12b of the device 12, then the first portion 12a can be advanced away from the elongated tube 18 and can expand after the defect 14 is closed to act as another barrier to fluid or material flowing into or through the defect 14.

[0055] Using any suitable technique, including but not limited to applying longitudinal tension to the device 12, applying tension to a rope wound (e.g., spirally wound) around the second portion 12b of the device 12, rotating the first portion 12a of the device to twist the second portion 12b, and / or by one or more other suitable techniques, the diameter of the second portion 12b of the device 12 can be reduced.

[0056] Device 12 can be configured in any suitable manner. In some instances, the body of device 12 may be formed from one or more interwoven wires (e.g., metal wires, polymer wires, yarns, strands, filaments, etc.), braided wires, cut tubes, and / or may be formed in one or more other suitable manners. Additionally, device 12 may be a scaffold, or a scaffold-like structure configured to collapse during implantation, but this is not mandatory.

[0057] The body of device 12 can be formed of any suitable material. For example, the interlaced wires, cut tubes and / or other components of the body of device 12 can be formed of metallic materials, polymeric materials, combinations of metallic and polymeric materials, nickel-titanium alloys (e.g., Nitinol™), shape memory materials, and / or other suitable materials.

[0058] One or more layers of biocompatible material (e.g., coating, sheet, or sheet-like material, etc.) may be applied to the external and / or internal surfaces of device 12. In some cases, the biocompatible material may be configured to promote the growth of tissue at or around the defect 14, but this is not necessary.

[0059] The device 12 may be thermoformable, and / or formed in one or more other suitable ways that can bias the material of the device 12 into a predetermined shape. When the shape of the device 12 in the delivery configuration is different from the shape of the device 12 in the deployment configuration, the forming device 12 may automatically adjust (e.g., bias) from the delivery configuration to the deployment configuration when deployed or advanced away from the elongated tube 18. In some cases, the device 12 may be constrained when in the delivery configuration; and may be fully or at least partially relaxed when in the deployment configuration.

[0060] Figure 2 A schematic perspective view of an exemplary device 12 in a deployment configuration is shown, wherein the device 12 may include a first portion 12a at a proximal end 22, a distal end 24, and a second portion 12b extending between the first portion 12a and the distal end 24. In some cases, the second portion 12b may at least partially define a closable lumen 26 extending through the device 12 from the proximal end 22 to the distal end 24.

[0061] The first portion 12a of the device 12 may be configured to engage body tissue 16 of the body part 17 (e.g., the first portion 12a of the device 12 may be located within a body cavity or passageway of the body part 17), with the defect 14 located at the body tissue 16. In some cases, the first portion 12a of the device 12 may be an expansion disc or flange, or may have a disc-shaped or flange-shaped form that can act as a barrier; when the device 12 is placed at or within the defect 14, the barrier prevents fluid or material within the body part 17 from passing through the defect 14. In some instances, the first portion 12a of the device 12 may extend radially beyond the circumference of the first opening 14a of the defect 14 and may engage the body tissue 16 radially outward from the defect 14. Although Figure 2Not shown, but the first portion 12a may include one or more tissue engagement elements configured to engage body tissue 16 and connect the device 12 to the body tissue 16. The tissue engagement elements of the first portion 12a of the device 12 may include, but are not limited to, hooks, barbs, sharp strands, fangs, and / or other suitable components configured to engage body tissue 16.

[0062] The first portion 12a of the device 12 may be configured such that, when the device 12 is implanted in or located in the defect 14, this configuration acts as a barrier and prevents fluid or material from entering the defect 14. To facilitate its function as a barrier, the first portion 12a may be or may include a densely interwoven wire structure, a dense strut, a coating, additional sheet or sheet-like material (applied to the wire or tube structure), and / or other suitable components (which may act as a barrier to the flow of fluid and / or other materials).

[0063] The second portion 12b of the device 12 may be elongated (e.g., relative to the first portion 12a) and may generally have a smaller diameter than the first portion 12a, such as, for example... Figure 2 As shown. The elongated second portion 12b of the device 12 may be configured to extend the entire length of the defect 14 or at least a portion thereof. In some instances, the second portion 12b may not be elongated relative to the first portion 12a, but instead have the same length or a shorter length than the first portion 12a of the device 12.

[0064] The second portion 12b of the device 12 may be tubular. When the second portion 12b is tubular, the inner diameter and / or outer diameter of the second portion 12b may be reduced so that the lumen 26 of the tubular second portion 12b of the device 12 may be selectively closed.

[0065] The second portion 12b of the device 12 may expand radially outward at its distal end 24, but this is not mandatory. When included, the expanded distal end 24 may be configured to seal and / or facilitate sealing of the second opening 14b by extending to or beyond the circumference of the second opening 14b.

[0066] The second portion 12b of the device 12 is configured for insertion into the defect 14 and may include an outer surface configured to abut the surface of the defect 14. In some cases, the second portion 12b may include one or more tissue engagement elements 28 configured to engage the surface of the defect 14 when the second portion 12b of the device 12 is located within the defect 14. The tissue engagement elements 28 of the first portion 12a of the device 12 may include, but are not limited to, hooks, barbs, sharp strands, fangs, and / or other suitable components configured to engage the tissue of the defect 14. In some instances, the tissue engagement elements 28 may extend from the second portion 12b of the device 12 such that the tissue engagement elements 28 engage the tissue of the defect 14 to prevent or mitigate withdrawal of the device 12 in the proximal direction. Additionally, in some cases, the tissue engagement elements 28 may be configured to engage the tissue of the defect 14 and reduce or close the diameter of the defect 14 as the diameter of the second portion 12b decreases, as will be discussed further below. The tissue engagement element 28 of or extending from the second portion 12b may extend from the distal end or region of the second portion 12b, from one or more longitudinal and / or circumferential portions of the second portion 12b, and / or from multiple or all locations along the second portion 12b of the device 12.

[0067] Figure 3A and Figure 3B An exemplary device 12 is shown for implantation in or through a defect 14 in body tissue 16. Figure 3A and Figure 3B The device 12 shown can be configured to reduce the diameter of the second part 12b in response to rotation of the first part 12a in the direction of arrow R2.

[0068] Figure 3A and Figure 3B The device 12 may be formed in other configurations similar to those discussed herein. In one instance, the device 12 may be formed from one or more interwoven wires, but this is not mandatory.

[0069] To facilitate the joining of tissue defect 14, the first portion 12a and / or the second portion 12b of the device 12 may include one or more tissue joining elements 28. For example... Figure 3A and Figure 3BAs shown, the tissue-engaging element 28 extending from the first portion 12a of the device 12 may extend in a first circumference or rotational direction R1, and the tissue-engaging feature of the second portion 12b of the device 12 may extend in a second circumference or rotational direction R2, which may be opposite or substantially opposite to the first rotational direction R1, but this is not mandatory. In some cases, one or more of the tissue-engaging elements 28 of the first portion 12a and / or the second portion 12b may extend at least partially in the proximal or distal longitudinal direction.

[0070] Figure 3A The device 12 is shown in a deployment configuration, wherein a first portion 12a and a second portion 12b are expanded. When expanded in the deployment configuration, the second portion 12b of the device 12 may have a diameter D1.

[0071] To reduce Figure 3A The diameter of the second portion 12b of the device 12 shown is such that the first portion 12a of the device 12 is rotatable to apply torsional motion to the device 12. When the second portion 12b of the device is located at or within the defect 14 and the first portion 12a rotates in the second rotation direction R2, as the diameter of the second portion 12b decreases to a diameter D2 in response to the rotation of the first portion 12a relative to the second portion 12b, the tissue engagement element 28 of the second portion 12b in the second rotation direction R2 or extending therefrom can engage the tissue of the defect 14 and pull the wall of the defect radially inward to close the defect 14.

[0072] As discussed above, relative to the tissue engagement element 28 of the second portion 12b, the tissue engagement element 28 of or extending therefrom of the first portion 12a of the device 12 may extend in a first rotation direction R1 opposite to the second rotation direction R2 (e.g., the tissue engagement element 28 of the first portion 12a may be tilted in the opposite direction). Therefore, when the first portion 12a of the device 12 rotates and a torsional force is applied to the device 12, the tissue engagement element 28 extending from the first portion 12a may rotate in the second rotation direction R2 without engaging tissue; and then when the rotation stops or the rotational force in the second rotation direction R2 is removed from the device 12, body tissue 16 may be engaged to prevent the device 12 (e.g., the first portion 12a and / or the second portion 12b) from unwinding or unwinding due to the energy stored in the device 12 due to winding or twisting (e.g., because the device 12 may be biased to a deployment configuration) and to maintain the second portion 12b in a closed configuration. When the tissue engagement element 28 is configured on the first portion 12a and the second portion 12b of the device 12, the diameter of the second portion 12b can be reduced using ratchet technology, wherein the first portion 12a can be repeatedly rotated and then released until the device 12 is adjusted from the deployment configuration to a fully closed configuration, which closes or blocks the defect 14.

[0073] Although Figure 3B A second portion 12b of a device 12 with a constant diameter is shown; however, it is contemplated that only a portion of the elongated second portion 12b may be configured to reduce its diameter in response to torsion or rotation of the first portion 12a of the device 12. For example, the second portion 12b of the device 12 may include one or more regions of a lower density structure (e.g., one or more axial regions having a desired pitch of the wire or strand, a desired thickness of the wire or strand, a desired wall thickness (e.g., via different coatings applied to the wire or strand, different thicknesses of coatings applied to the wire or strand, coated areas and uncoated areas, etc.)) for reducing its diameter in response to rotation of the first portion 12a.

[0074] Rotation of device 12 can be achieved in any suitable manner. For example, rotation of device 12 can be achieved using a tool, a portion of a delivery component (e.g., deployment device 20, etc.) or via other suitable components; the tool engages device 12 (e.g., engages the first portion 12a of device 12); the portion of the delivery component engages at least the first portion 12a of the device (e.g., device 12 can be held within the elongated tube 18 during rotation of device 12).

[0075] Figure 4 The schematic diagram illustrates an exemplary configuration of system 10, device 12, and tool 30; device 12 is for implantation in or through a defect 14 in body tissue 16 at or through body site 17; tool 30 is for engaging and rotating a first portion 12a of device 12. In some instances, tool 30 may be considered part of device 12, but this is not necessary. Figure 4 The device 12 shown can be configured to be adjusted so that the first part 12a rotates in the direction of arrow R2, and the diameter of the second part 12b of the device 12 is reduced accordingly.

[0076] Figure 4 The device 12 may be formed in other configurations similar to those discussed herein. In one instance, the device 12 may be formed from one or more interwoven wires, but this is not mandatory.

[0077] To facilitate the joining of tissue defect 14, the first portion 12a and / or the second portion 12b of the device 12 may include one or more tissue joining elements 28. For example... Figure 4As shown, the tissue-engaging element 28 extending from the first portion 12a of the device 12 may extend in a first rotational direction R1, and the tissue-engaging feature 28 of the second portion 12b of the device 12 may extend in a second rotational direction R2, which may be opposite or substantially opposite to the first rotational direction R1, but is not mandatory. In some cases, one or more of the tissue-engaging elements 28 of the first portion 12a and / or the second portion 12b may extend at least partially in the proximal and / or distal longitudinal directions.

[0078] The tool 30 may be elongated and may include a first keyway engagement portion 32 at the distal end of the tool 30. The first keyway engagement portion 32 of the tool may be configured to engage a second keyway engagement portion 34 at the first portion 12a of the engagement device 12. In some embodiments, the second keyway engagement portion 34 may be aligned with the central longitudinal axis of the device 12, but this is not necessary.

[0079] The first keyway mating portion 32 and the second keyway mating portion 34 can be configured in any suitable way to cause the device 12 to rotate in response to rotation of the tool 30 when the first keyway mating portion 32 and the second keyway mating portion 34 are engaged. For example, one of the first keyway mating portion 32 and the second keyway mating portion 34 can be a convex member, and the other of the first keyway mating portion 32 and the second keyway mating portion 34 can be a concave member (e.g., an opening). The first keyway mating portion 32 and the second keyway mating portion 34 can have mating shapes, including but not limited to rectangular, square, elliptical, star-shaped, and / or other suitable shapes that facilitate rotation of the device 12 in response to rotation of the tool 30. In some instances, the first keyway mating portion 32 can be a convex member, the second keyway mating portion 34 can be a concave member, and the first keyway mating portion 32 and the second keyway mating portion 34 can be rectangular, such as... Figure 4 As shown, but other suitable configurations are envisioned.

[0080] Figures 5 to 7 An exemplary configuration of the device 12 is shown schematically for implantation in or through a defect 14 in body tissue 16 of body part 17. Figures 5 to 7 The device 12 shown can be configured to reduce the second portion 12b of the device 12 in response to tension being applied to the rope 36 (e.g., suture, yarn, thread, etc.), the rope 36 being wound around the second portion 12b of the device 12 and extending adjacent to the first portion 12a.

[0081] Figures 5 to 7 The device 12 may be formed in other configurations similar to those discussed herein. In one instance, the device 12 may be formed from one or more interwoven wires, but this is not mandatory.

[0082] To facilitate the joining of tissue defect 14, the first portion 12a and / or the second portion 12b of the device 12 may include one or more tissue joining elements 28. For example... Figures 5 to 7 As shown, the second portion 12b of the device 12 may include tissue engagement elements 28 extending in a circumferential or rotational direction. In some cases, one or more of the tissue engagement elements 28 may extend at least partially in the proximal and / or distal longitudinal directions.

[0083] Rope 36 may be wound around the second portion 12b of device 12 (e.g., spirally wound around it and / or otherwise wound). In some instances, rope 36 may be enclosed within the second portion 12b, spread out around the second portion 12b, twisted through the second portion 12b, and / or otherwise wound around or along the wire or post of the second portion 12b such that when tension or proximal force is applied to rope 36, the second portion 12b of device 12 collapses or its diameter expands from the expansion diameter D1 of device 12 in an expanded configuration (e.g., as shown in the image). Figure 5 (as shown) reduced to a reduced diameter D2 in the closed configuration of device 12 (e.g., as shown) Figure 6 and Figure 7 (As shown).

[0084] In some cases, the distal end of the rope 36 may be coupled to or coupled relative to the second portion 12b of the device 12, and / or may include an anchor or stop 38 configured to prevent the rope 36 from being fully pulled through and away from the second portion 12b of the device 12. The stop 38 may be any suitable component configured to engage the rope 36 with the second portion 12b of the device 12, including but not limited to adhesives, knots, balls, and / or other suitable stop components configured to engage wires, supports, layered materials, and / or other components of the distal end 24 of the second portion 12b.

[0085] In response to a proximal force applied to the rope 36, the rope 36 can be radially tensioned, and the second portion 12b of the device 12 can be compressed into a closed configuration with a reduced diameter D2. For example, when a proximal force is applied to the rope 36, tension is applied to the rope 36, the stop 38 engages the surface or structure of the second portion 12b of the device 12, and a portion of the rope 36 wound around the second portion 12b squeezes or compresses the second portion 12b to adjust the device 12 into a closed configuration. When the second portion 12b is located within the defect 14, as the second portion 12b adjusts into a closed configuration in response to tension applied to the rope 36, the tissue engagement element 28 can engage the wall tissue of the defect 14 and pull the wall radially inward.

[0086] One or more components may be used to maintain tension on rope 36 and prevent device 12 from shifting from a closed configuration to an expanded configuration. Examples of suitable components for maintaining tension on rope 36 include, but are not limited to, clamps, wedges, and / or other suitable components configured to grip rope 36 and maintain tension relative to device 12 applied thereto.

[0087] Figure 6 The device 12 is shown, wherein tension is applied to the rope 36 in a proximal direction (e.g., as indicated by an arrow pointing in the proximal direction) to reduce the diameter of the second portion 12b to a diameter D2 associated with the closed configuration of the device 12. In some instances, the clamp 40 may be applied to the rope 36 at a location adjacent to where the rope 36 proximally exits the first portion 12a of the device 12, such that the clamp 40 is coupled to the rope 36 and the wire or post of the first portion 12a; and / or the clamp 40 may be coupled to the rope 36 at a location adjacent to the proximal surface of the first portion 12a to maintain the tension applied to the rope 36 and prevent the second portion 12b from expanding into an expanded configuration. Once the clamp 40 has been applied to the rope 36 at or near the first portion 12a of the device 12, the portion of the rope 36 adjacent to the clamp 40 may be separated from the portion of the rope at or away from the clamp 40, but this is not necessary.

[0088] When tension is applied to the rope 36 and secured relative to the device 12 (e.g., fixed with a structure that does not pass through the device 12 (e.g., wire, support, strand, etc.)) to maintain tension on the rope 36, the clamp 40 can be any suitable type of clamp, which can be placed or adjusted to a position adjacent to the first portion 12a. Examples of suitable types of clamps 40 include, but are not limited to, vascular clamps, ligation clamps, spring clamps, magnetic clamps, and / or other suitable types of clamps.

[0089] Figure 7 The device 12 is shown, wherein tension is applied to the rope 36 in a proximal direction (e.g., as indicated by an arrow pointing proximal) to reduce the diameter of the second portion 12b to a diameter D2 associated with the closed configuration of the device 12. In some instances, one or more wedges 42 may be formed at or attached to the first portion 12a of the device 12. One or more wedges 42 may be located on the proximal side or end of the first portion 12a such that the tension rope 36 can be inserted into the wedges 42 and secured therein by friction fit or other type of connection that maintains the tension applied to the rope 36 and prevents the second portion 12b from expanding into an expanded configuration. Figure 7As shown, the device 12 may include two wedges facing each other, but a single wedge 42 or more wedges may be used as needed. When multiple wedges 42 are used, the rope 36 may be screwed into and / or secured within the multiple wedges to redundantly secure the rope 36 relative to the first portion 12a of the device 12. Once one or more wedges 42 have received and secured the rope 36, portions of the rope 36 adjacent to the wedge 42 may be separated from portions of the rope 36 at or away from the wedge 42, but this is not mandatory.

[0090] The wedge 42 can be any suitable type of wedge configured to receive and secure the rope 36 therein. In some instances, the wedge 42 may include a V-shape, a generally V-shape, or other suitable shape, such that the rope 36 can slide or screw into the apex of the wedge 42. Once the rope 36 is at the apex of the wedge 42, the rope 36 cannot slide relative to the wedge 42 and / or the first portion 12a of the device 12, and tension on the rope 36 is maintained.

[0091] One or more wedges 42 may be formed in any suitable manner. In some instances, the wedges 42 may be formed from the wires or supports of the forming device 12, but this is not mandatory. Additionally or alternatively, one or more wedges 42 may be welded to or otherwise secured to the wires or supports of the forming device 12.

[0092] Figures 8A to 8D An exemplary technique for applying device 12 to a defect 14 in body tissue 16 of body part 17 is schematically shown, wherein the left side of each figure is a view within a cavity or passage of body part 17, and the right side of each figure is a view of the exterior of body part 17. Figures 8A to 8D As shown, the defect 14 extends through body tissue 16 and includes a first opening 14a, a second opening 14b, and a passage 14c that extends between the first opening 14a and the second opening 14b.

[0093] like Figure 8A As shown, the elongated tube 8 can be inserted into the defect 14 (e.g., into the passage 14c of the defect 14). The elongated tube 18 can be delivered to the defect 14 endoscopically and / or in one or more other suitable manners.

[0094] Figure 8BThe diagram schematically illustrates the positioning and deployment of a partial deployment or expansion configuration of device 12 within defect 14, wherein a second portion 12b is located within and extends within defect 14, while a first portion 12a of device 12 may be held within elongated tube 18. In some cases, elongated tube 18 may be withdrawn to deploy the second portion 12b of device 12, and / or deployment device 20 may be advanced relative to elongated tube 18 to push the second portion 12b away from the distal end of elongated tube 18.

[0095] Figure 8C The device 12 is schematically shown deployed at the defect 14. In some cases, once the second portion 12b is within the defect 14, the device 12 can be partially rotated or otherwise adjusted such that the tissue-engaging element 28 initially engages the tissue of the defect 14, as... Figure 8C As shown (e.g., represented by a portion of the tissue-joining element 28 shown in dashed lines). Partial rotation or other adjustments of the device 12 can be achieved by using the elongated tube 18, the deployment device 20, or the tool 30 ( Figures 8A to 8D (not shown in the image), apply tension to rope 36 ( Figures 8A to 8D (not shown in the image), and / or utilize one or more other suitable components configured to engage the device 12 and facilitate adjustment of the device 12 within the defect 14.

[0096] Although the device 12 has been rotated or otherwise adjusted such that the combination engagement element 28 of the second portion 12b of the device 12 engages the tissue of the defect 14, the tissue engagement element 28 of the first portion 12a (when included) may or may not (e.g., as...) Figure 8C (As shown) Engages body tissue 16. In some cases, the first portion 12a of the device 12 may be held within the elongated tube 18, while the device 12 is initially rotated or adjusted such that the tissue engagement element 28 of the second portion 12b engages the tissue of the defect 14.

[0097] After the tissue engagement element 28 of the second portion engages the tissue of the defect 14, the device 12 may be further rotated or adjusted (e.g., via the elongated tube 18, deployment device 20, tool 30, rope 36, and / or other suitable components) to reduce the diameter of the second portion 12b and close the defect 14. In one example, the deployment device 20 may be actuated to advance the device 12 (e.g., the first portion 12a and / or the second portion 12b) away from the elongated tube 18 to a deployment configuration (such as...). Figure 8CAs shown), the gripping device 12's first portion 12a is used to rotate the device 12 and reduce the diameter of the second portion 12b. In another example, the deployment device 20 can be actuated to advance the device 12 (e.g., the first portion 12a and / or the second portion 12b) away from the elongated tube 18 into a deployment configuration to grip the rope 36 and to apply tension to the rope 36 to reduce the diameter of the second portion 12b.

[0098] Figure 8D The device 12 is shown within the defect 14 and in a closed configuration, with the deployment device 20 and the elongated tube 18 removed from the first portion 12a. In the closed configuration, the device 12 has been rotated or otherwise adjusted in the direction of arrow R2 to reduce the diameter of the second portion 12b from the diameter associated with the expanded configuration to the diameter associated with the closed configuration. Figure 8D As shown on the right, the second opening 14b of the defect 14 has been closed. Figure 8D As shown on the left, the tissue engagement element 28 of the first portion 12a of the device 12 can engage body tissue 16 (e.g., as indicated by the tissue engagement element 28 shown in dashed lines) to prevent the device 12 from unwinding from the closed configuration and adjusting to the expanded configuration.

[0099] Figures 9A to 9C The illustration shows the schematic positioning and implantation of the device 12 at or through a defect 14 in the body tissue 16 of the body site 17 (e.g., a fistula extending through the tissue of the body site along the gastrointestinal tract and / or other defects). Figures 9A to 9C The device 12 shown can be configured to be adjusted to seal the defect 14 by closing the lumen 26 of the device 12 after it has been positioned within the defect 14.

[0100] Figures 9A to 9C The device 12 can be formed in other configurations similar to those discussed herein. In one example, the device 12 may be formed from one or more interwoven wires, but this is not mandatory. Additionally, Figures 9A to 9C The body of the device 12 shown may be configured to prevent fluid and / or other materials from passing through, such that when the device 12 within the defect 14 is adjusted to close the lumen 26 passing through the device, the body of the device 12 seals the defect 14.

[0101] The tissue engagement element 28 may extend from the proximal end 22 and / or the distal end 24 of the body of the device 12 to engage tissue adjacent to the first opening 14a and / or the second opening 14b of the defect 14. Alternatively, the tissue engagement element 28 may be located at other positions along the device 12 to engage tissue of the defect 14 and / or tissue adjacent to the defect as needed.

[0102] Figure 9ADevice 12 is shown, aligned with a defect 14 of body tissue 16 extending through body part 17. Device 12 may be advanced into defect 14 in the direction of arrow A until the distal end 24 of device 12 is adjacent to a second opening 14b of the defect. In some cases, device 12 may be configured to contact the wall of passage 14c of defect 14, such that fluid and / or other materials passing through defect 14 pass through lumen 26 of device 12 when device 12 is placed in defect 14. Although not shown, device 12 may be initially located within defect 14 while simultaneously located in an elongated tube or other suitable delivery mechanism.

[0103] Once the distal end 24 of the device 12 is positioned adjacent to the second opening 14b of the defect 14, the tissue engagement element 28 at the distal end 24 of the device 12 can engage the tissue adjacent to the second opening 14b of the defect 14, such as, for example Figure 9B As shown. In some instances, the user can manipulate or adjust (e.g., laterally, rotatably, etc.) the device 12 to cause the tissue engaging element 28 to engage tissue adjacent to the second opening 14b of the defect 14. In one instance, the user can extend the device 12 through the defect 14 such that the distal end 24 of the device 12 extends through the second opening 14b, and then return the traction device 12 to cause the tissue engaging element 28 to engage tissue adjacent to the second opening 14b. When positioned in this way, the proximal end 22 of the device 12 can extend proximally away from the first opening 14a of the defect 14, such as, for example Figure 9B As shown, but this is not mandatory.

[0104] Once the tissue engagement element 28 at the distal end 24 of device 12 engages with the tissue adjacent to the second opening 14b of defect 14 and / or the tissue of defect 14 to fix the distal end 24 relative to defect 14, the proximal end 22 of device 12 can be rotated. When the distal end 24 is fixed relative to defect 14, rotation of the proximal end 22 of device 12 can cause the central portion 44 of device 12 to twist and close the lumen 26, which reduces the diameter of device 12 at the central portion 44, such as Figure 9C As shown.

[0105] As the device 12 is twisted, its length can be shortened, such that the tissue engagement element 28 at the proximal end 22 of the device 12 is positioned adjacent to the first opening 14a of the defect 14 or at another suitable location along the defect 14. Once the tissue engagement element 28 at the proximal end 22 of the device 12 is adjacent to the first opening 14a of the defect 14, the tissue engagement element 28 can engage the body tissue 16 and / or the tissue of the defect 14 adjacent to the first opening 14a and / or other tissue of the defect 14 to maintain the device 12 in a twisted configuration that seals the defect 14.

[0106] When the rotational force that caused the device 12 to twist is removed, one or more of the tissue engagement elements 28 at the proximal end 22 of the device 12 may actively engage the body tissue 16 or the tissue of the defect 14, and / or one or more of the tissue engagement elements 28 may automatically engage other tissues of the body tissue 16 and / or the defect 14, such that the tissue engagement elements 28 prevent the device 12 from untwisting. As discussed above, the tissue engagement elements 28 located at the proximal end 22 of the device 12 may extend radially outward from the body of the device 12 in a circumferential direction opposite to the direction of the rotational force applied to the device 12 to twist the device 12 and seal the lumen 26 and the defect 14, but this is not necessary and other suitable configurations are contemplated.

[0107] It should be understood that this disclosure is illustrative in many respects only. Variations may be made in detail without departing from the scope of this disclosure, particularly with respect to the arrangement of shapes, dimensions, and steps. To the appropriate extent, this may include the use of any of the features of one example embodiment that is being used in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A device for implantation in or through anatomical defects in body tissue, the device comprising: A first part, the first part being configured to engage the body tissue; and The second portion extends distally from the first portion and is configured to engage tissue of the anatomical defect having a first opening, a second opening, and a pathway extending between the first and second openings. The second portion is configured to reduce its diameter to close the anatomical defect when it engages with the tissue of the anatomical defect.

2. The apparatus of claim 1, wherein the second portion is tubular.

3. The apparatus according to claim 1 or claim 2, further comprising: One or more barbs, the one or more barbs extending from the second portion and configured to engage the tissue of the anatomical defect.

4. The device of claim 3, wherein the one or more barbs extend in a circumferential direction around the second portion and are configured to engage the tissue of the anatomical defect in response to rotation of the second portion.

5. The apparatus according to any one of claims 1 to 4, further comprising: A first group of one or more barbs extends from the first portion in a first circumferential direction and is configured to engage the body tissue; and A second group of one or more barbs extends from the second portion in a second circumferential direction and is configured to engage the tissue of the anatomical defect.

6. The apparatus according to claim 5, wherein: The second set of one or more barbs is configured to engage the tissue of the anatomical defect in response to rotation of the second portion in the second circumferential direction, and When the tissue of the anatomical defect is engaged, the second portion is configured to reduce its diameter in response to rotation of the first portion in the second circumferential direction to close the anatomical defect.

7. The apparatus of claim 5 or claim 6, wherein the first set of one or more barbs is configured to engage the body tissue to prevent rotation of the first portion and the second portion in the first circumferential direction.

8. The apparatus according to any one of claims 1 to 7, further comprising: Tools, the tools being used to engage the first part, and The first portion has an opening for receiving the distal end of the tool, and the tool is configured to rotate when received within the opening to reduce the diameter of the second portion.

9. The apparatus according to any one of claims 1 to 8, further comprising: A rope, which is wrapped around the second part and extends adjacent to the first part, and The rope causes the second portion to reduce its diameter in response to the tension applied to the rope.

10. The apparatus according to claim 9, further comprising: Fixture, and The clamp is configured to be secured to the rope at a location adjacent to the first portion when tension is applied to the rope, in order to maintain the tension on the rope.

11. The apparatus of claim 9 or claim 10, wherein the first portion includes a wedge configured to receive the rope and maintain the tension on the rope after the tension is applied to it.

12. The apparatus according to any one of claims 1 to 11, wherein the first portion and the second portion are formed of one or more interwoven wires.

13. A system for implanting an implantable device into or through anatomical defects in body tissue, the system comprising: A slender tube configured for insertion into body tissue adjacent to the anatomical defect; A deployment device configured to be received within the elongated tube; and An implantable medical device configured to be received within the elongated tube and engaged with the deployment device, the implantable medical device comprising: A first part, the first part being configured to engage the body tissue; and The second portion extends distally from the first portion and is configured to engage tissue of the anatomical defect having a first opening, a second opening, and a pathway extending between the first and second openings. The deployment device is configured to be actuated to advance the second portion of the implantable medical device away from the elongated tube to a deployment configuration in which the second portion has a first diameter within the anatomical defect, and to reduce the diameter of the second portion of the implantable medical device within the anatomical defect to a second diameter.

14. The system of claim 13, wherein the deployment means is configured to engage and rotate the first portion of the implantable medical device to reduce the diameter of the second portion of the implantable device.

15. The apparatus according to claim 13 or claim 14, wherein: The implantable medical device includes a cord that is wound around the second portion; and The deployment device is configured to engage the rope and apply tension to the rope to reduce the diameter of the second portion of the implantable medical device to the second diameter.

Images