Medical devices and systems for manipulating foreign bodies and methods for their use
A tool with a sleeve element and operative part transitions between configurations to efficiently capture and relocate medical devices, addressing inefficiencies and damage in existing methods, enhancing procedural efficiency and reducing the need for replacements.
Patent Information
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- GYRUS ACMI INC
- Filing Date
- 2013-03-13
- Publication Date
- 2026-06-11
Smart Images

Figure 00000000_0000_ABST
Abstract
Description
RELATED REGISTRATIONS
[0001] The present application claims priority from the preliminary US application No. 61 / 617,572, entitled MEDICAL DEVICES AND SYSTEMS FOR MANIPULATING FOREIGN BODIES AND METHODS OF USING THE SAME, filed on March 29, 2012, which is hereby incorporated in its entirety into the present application. Any priority claims listed in the application data sheet, as well as any amendments to those claims, are hereby incorporated into the present application pursuant to 37 CFR § 1.57 (CFR = Code of Federal Regulations). BACKGROUND SUBJECT AREA
[0002] Embodiments of the disclosed devices generally relate to the field of medical devices, in particular methods, systems and devices for removing and / or moving medical devices. Description of the state of the art
[0003] The implantation of medical devices (e.g., medical valves) has proven effective in the treatment of chronic obstructive pulmonary disease (COPD). These devices include, in particular, the devices disclosed in US patents US 6 293 951 B1, US 6 592 594 B2, US 6 722 360 B2, US 6 929 637 B2, US 7 533 671 B2, US 7 691 151 B2, US 7 875 048 B2 and US patent publications US 2003 / 0 154 988 A1, US 2003 / 0 181 922 A1, US 2003 / 0 195 385 A1 and US 2003 / 0 212 412 A1, which are hereby incorporated as part of the present application.
[0004] In some procedures, it is desirable to remove and / or relocate a foreign body within a patient's body. For example, it may be desirable to remove or relocate a medical device after its use within a patient's body. In some cases, the implanted device is surrounded by hyperplasia. In some procedures, it is desirable for a removal and / or relocation tool to be configured to apply pressure to the medical device to be removed or relocated without causing significant damage. In some procedures, relocating a medical device, rather than removing it, can save time and money for both the patient and the physician, as this may reduce or eliminate the need for a replacement device. SUMMARY
[0005] According to some embodiments, a tool useful for removing and / or displacing a foreign body (e.g., a medical device) within a patient's body may include a sleeve element. The sleeve element may comprise a proximal end, a distal end, and a central axis. The sleeve element may have a tubular body defining an inner lumen and, in some embodiments, may be movable in both the proximal and distal directions.
[0006] In some embodiments, the tool may have an operating part comprising a proximal end, a distal end, and a central axis. The central axis of the operating part may generally be coaxial with the central axis of the sleeve element. In some embodiments, the operating part may have a stabilizer comprising a proximal end and a distal end. In some embodiments, the operating part may have multiple engagement elements, each comprising a proximal end and a distal end. The multiple engagement elements may be connected to the stabilizer and extend distally from the distal end of the stabilizer. The engagement elements may be configured to transition from an open to a closed configuration in response to a force acting upon them.The distal ends of the engagement elements can be configured such that they move away from the central axis of the surgical part during the transition from the closed to the open configuration. In some embodiments, the surgical part can have one or more handle elements arranged on the stabilizers. The handle elements can extend from the engagement elements toward the central axis of the surgical part when the engagement elements are in the closed configuration.
[0007] In some embodiments, the tool may have a clamping element comprising a proximal end, a distal end, and a central axis generally coaxial with the central axis of the sleeve element. The clamping element may be movable in both the proximal and distal directions. In some embodiments, the clamping element is configured to transition between an extended and a contracted configuration. The clamping element may be configured to expand from its central axis such that the distal end of the clamping element is further from the central axis than the proximal end is when the clamping element is in the extended configuration.
[0008] In some embodiments, the sleeve element and the operative part are configured to be contained within a working channel of an endoscope or other insertion device. In some embodiments, the clamping element is configured to be contained within a working channel of an endoscope or other insertion device. In some embodiments, at least a portion of the operative part is contained within the inner lumen of the sleeve element. In some embodiments, the sleeve element is configured to be movable relative to the operative part in both proximal and distal directions. In some embodiments, the sleeve element is configured to be movable relative to the operative part in both proximal and distal directions. In some embodiments, the operative part is configured to be movable relative to the clamping element in both proximal and distal directions.
[0009] In some embodiments of the tool, the engagement elements are biased towards the open configuration. In some embodiments, the clamping element is biased towards the extended configuration. In some embodiments, the engagement elements are configured such that they transition from the open to the closed configuration when the distal end of the sleeve element is moved laterally or distally from the proximal end of the engagement elements to the distal end of the engagement elements.
[0010] In some embodiments, the operative part includes indentations at the proximal ends of the engagement elements, configured to reduce the force required to transition the engagement elements between open and closed configurations. In some embodiments, the pressure element comprises a hollow conical, frustoconical, grooved, or trumpet-shaped piece. In some embodiments, the pressure element comprises a plurality of overlapping plates. In some embodiments, the pressure element has an opening extending through it, configured to allow visualization through the pressure element. In some embodiments, the sleeve element comprises a plurality of secondary conduits, each secondary conduit having a proximal and a distal end.In some variants, the clamping element comprises a plurality of compression wires, with at least a portion of each compression wire being contained within the plurality of secondary lines. Each of the compression wires has a proximal and a distal end and can be configured to transition between an extended and a contracted configuration. In some embodiments, the compression wires may be flattened.
[0011] A method for removing a foreign body (e.g., a medical device) from an insertion site in the body may include the use of an endoscope or other insertion device to position the tool close to and proximal to the foreign body (e.g., an implanted medical device). The method may also include the intervention elements transitioning into the open configuration and the pressure element transitioning into the extended configuration. In some embodiments, the method may include positioning the operative parts such that part of the foreign body is located within the openly configured intervention elements.
[0012] The procedure may further include the insertion elements transitioning into the closed configuration, so that the gripping elements grasp the foreign body. The procedure may also include the medical device being pulled proximally and the clamping element transitioning into the retracted configuration. The procedure may also include at least part of the foreign body being captured in the sleeve element, clamping element, or working channel of the endoscope or other insertion device, and the tool being moved to a second location inside or outside the body.
[0013] In some embodiments, the method may further include the pressure element transitioning into the open configuration, whereby the foreign body is pressed distally to such an extent that the medical device is released from the pressure element, sleeve element, and working channel, and the engagement elements transition into the open configuration, pushing the tool away from the foreign body. According to some embodiments, the foreign body is an inserted medical device.
[0014] In some embodiments, a tool for displacing or removing a foreign body within a patient's body comprises a grasping element having a proximal end, a distal end, and a central axis. The grasping element may include a body part having a proximal end and a distal end. This body part may be located at the proximal end of the grasping element, and the proximal end of the body part may be configured for detachable connection to an endoscope. The grasping element may have multiple clamping elements, each comprising a proximal end and a distal end. The proximal end of each clamping element may be rotatably connected to the distal end of the part. The clamping elements may be configured to switch between an open and a closed configuration when a force is applied to them.The distal end of each clamping element can be configured to move away from the central axis of the capture element as the clamping element transitions from the closed to the open configuration. In some embodiments, the capture element includes an operating part configured to transition between a closed and an open configuration. The operating part can be configured to capture a portion of the foreign body as the operating part transitions from the open to the closed configuration, while a portion of the foreign body remains within the operating part. The operating part can further be configured to be contained within a working channel of the endoscope. According to some embodiments, the foreign body can be an implanted medical device.
[0015] A tool for removing and / or displacing a foreign body in a patient's body may comprise: a sleeve element comprising a proximal end, a distal end, and a central axis; wherein the sleeve element comprises a tubular body defining an inner lumen and is movable in the proximal and distal directions; a surgical part comprising a proximal end, a distal end, and a central axis generally coaxial with the central axis of the sleeve element, comprising: a stabilizer comprising a proximal end and a distal end; a plurality of intervention elements, each comprising a proximal end and a distal end;wherein the majority of engagement elements are connected to the stabilizer and extend distally from the distal end of the stabilizer, wherein the engagement elements are configured to transition between an open and a closed configuration in response to a force acting upon them, wherein the distal ends of the engagement elements are configured to move away from the central axis of the surgical part when transitioning from the closed to the open configuration; and one or more grip elements arranged on the stabilizers, extending from the engagement elements to the central axis of the surgical part when the engagement elements are in the closed configuration.
[0016] In some embodiments, the tool may further comprise a pressure element comprising a proximal end, a distal end, and a central axis generally coaxial to the central axis of the sleeve element, wherein the pressure element is movable in the proximal and distal directions; wherein the pressure element is configured to transition between an extended and a contracted configuration, and wherein the pressure element is further configured to expand from the central axis of the pressure element such that the distal end of the pressure element is further from the central axis of the pressure element than the proximal end of the pressure element when the pressure element is in the extended configuration.
[0017] In some variants, the engagement elements are detachable from the stabilizer. According to some embodiments, the stabilizer includes a groove. In some variants, the tool may also include a band, with the majority of engagement elements connected to the band. The band may be configured for releasable engagement in the groove. In some embodiments, the sleeve element and the operative part are configured to be contained within a working channel of an endoscope or other insertion device. The pressure element may be configured to be contained within a working channel of an endoscope or other insertion device. In some embodiments, at least a portion of the operative part is contained within the inner lumen of the sleeve element. According to some embodiments, the sleeve element is configured to be movable relative to the operative part in both proximal and distal directions.In some embodiments, the sleeve element is configured to be movable relative to the operative part in both proximal and distal directions. The operative part can be configured to be movable relative to the pressure element in both proximal and distal directions. In some embodiments, the engagement elements are biased toward the open configuration. The pressure element can also be biased toward the open configuration. According to some variants, the engagement elements are configured to transition from the open to the closed configuration when the distal end of the sleeve element is moved laterally or distally from the proximal end of the engagement elements to the distal end of the engagement elements.The operative part may include indentations at the proximal ends of the engagement elements, configured to reduce the force required to transition the engagement elements between open and closed configurations. In some embodiments, the pressure element comprises a solid, conical piece. In some embodiments, the pressure element comprises a plurality of overlapping helical plates. The pressure element may have an opening extending through it, configured to allow visualization through the pressure element. In some embodiments, the sleeve element comprises a plurality of secondary conduits, each secondary conduit having a proximal and a distal end.According to some embodiments, the tool comprises a clamping element which includes a plurality of compression wires, wherein at least a portion of each of the compression wires is contained within the plurality of secondary lines, wherein each of the compression wires has a proximal and a distal end, and the compression wires are configured to transition between an extended configuration and a contracted configuration. The compression wires may be flattened. In some embodiments, a gap is formed between the plurality of engagement elements over at least a portion of the axial length of the engagement elements when the engagement elements are in the closed configuration.The foreign body can comprise an extended part and a central axis, such that the extended part can move through the gap formed between the engagement elements and the gripping elements can grasp the sides of the extended part if the central axis of the foreign body is not aligned with the central axis of the surgical part. According to some embodiments, the foreign body is an implanted medical device.
[0018] A procedure for removing a foreign body from a site in a patient's body using the tool described above may include: positioning the tool close to and proximal to a foreign body using an endoscope or other insertion device; transferring the intervention elements into the open configuration; positioning the surgical part such that part of the foreign body is located within the open-configured intervention elements; transferring the intervention elements into the closed configuration so that the gripping elements grasp the foreign body; pulling the foreign body proximally; capturing at least part of the foreign body in the sleeve element or working channel of the endoscope or other insertion device; and moving the tool to a second site inside or outside the body.In some embodiments, the method comprises: pushing the foreign body distally until it is released from the sleeve element and working channel; transferring the intervention elements to the open configuration; and pushing the tool away from the foreign body. According to some variants, the method comprises capturing the entire foreign body within the sleeve element or a working channel of the endoscope or other insertion device, so that the patient's tissue is substantially protected from contact with the foreign body during its displacement or removal. According to some embodiments, the foreign body is an inserted medical device.
[0019] A tool for displacing or removing a foreign body within a patient's body may comprise: a capture element having a proximal end, a distal end, and a central axis, comprising: a body part having a distal and a proximal end, wherein the body part is located at the proximal end of the capture element and the proximal end is configured for detachable connection to an endoscope; one or more compression elements, each having a proximal end and a distal end, wherein the proximal end of each compression element is connected to the distal end of the body part; and a surgical part configured to transition between an open and a closed configuration, wherein the surgical part is further configured to capture a portion of the foreign body when the surgical part transitions from the open to the closed configuration.while part of the foreign body is located in the operative part, wherein the operative part is further configured to be contained within a working channel of the endoscope. The one or more clamping elements may be configured to transition between an open and a closed configuration when force is applied to them, the distal end of each clamping element being configured to move away from the central axis of the grasping element when the clamping element transitions from the closed to the open configuration. According to some embodiments, the foreign body may be an implanted medical device.
[0020] A method for removing a foreign body from a location in a patient's body may include: providing a tool comprising: a retrieval element having a proximal end, a distal end, and a central axis; a body part having a distal and a proximal end, wherein the body part is positioned at the proximal end of the retrieval element and the proximal end is configured for detachable connection to an endoscope; one or more compression elements, each having a proximal end and a distal end, wherein the proximal end of each compression element is connected to the distal end of the body part;and an operative part configured to transition between an open and a closed configuration, wherein the operative part is further configured to capture part of the foreign body when the operative part transitions from the open to the closed configuration while part of the foreign body is located within the operative part, wherein the operative part is further configured to be contained within a working channel of the endoscope; positioning the tool close to and proximal to a foreign body using an endoscope or other insertion device; transitioning the clamping elements into the open configuration; positioning the operative part such that part of the foreign body is located within the open-configured operative part; transitioning the operative part into the closed configuration so that the operative part grasps the foreign body; pulling the foreign body in a proximal direction;Capturing at least part of the foreign body in the clamping elements; transferring the clamping elements into the closed configuration; and moving the tool to a second location inside or outside the body. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The accompanying drawings illustrate various embodiments; these are in no way to be interpreted as limiting the scope of protection of the embodiments. Furthermore, various features of one or more of the disclosed embodiments can be combined to form further embodiments; these further embodiments are also part of this application. Fig. 1 is a perspective view of a medical valve; Fig. 2A is a view of a tool useful for moving or removing a medical device, shown in the open configuration. Fig. 2B is a view of the tool of Fig. 2A in closed configuration. Fig. 2C is a view of another tool with a removable part in a detached and open configuration. Fig. 2D is a view of the tool of the Fig. 2C in connected and closed configuration. Fig. 3A is a view of another tool in an open configuration. Fig. 3B is a view of the tool of Fig. 3A in closed configuration. Fig. 3C is a view of the tool of Fig. 3A in closed configuration, which engages a device located away from the axis. Fig. 4A is a perspective view of the tool of the Fig. 3A in open configuration. Fig. 4B is a perspective view of the tool of the Fig. 3A in closed configuration. Fig. Figure 5 shows a view of a tool engaging with a valve loading tool. Fig. Figure 6 is a view of a tool with a flared distal end. Fig. Figure 7 is a view of a tool with a helical, flared distal end. Fig. Figure 8A is a view of the distal end of a multi-lumen tool with multiple guide wires. Fig. 8B is a perspective view of the multi-lumen tool of the Fig. 8A. Fig. 8C is a view of the multi-lumen tool of the Fig. 8A in an airway or other body lumen. Fig. 8D is a view of one embodiment of the tool. Fig. 8A with distal anchors on the guide wires. Fig. 8E is a distal end view of an embodiment of the tool. Fig. 8A with flat guide wires. Fig. Figure 9 shows a view of a tool inserted into an airway or other body lumen via a working channel in an endoscope. Fig. 10A is a view of a tool configured to be removed from the distal end of an endoscope. Fig. 10B is a view of the tool of Fig. 10A, which is connected to the distal end of an endoscope. Fig. 10C is a view of the tool of Fig. 10A in extended configuration. Fig. 10D is a view of the tool of Fig. 10A, which partially interferes with a medical device. Fig. 10E is a view of the tool of Fig. 10A, in which a medical device is being charged. DETAILED DESCRIPTION
[0022] Devices and methods for moving medical devices into and / or removing medical devices from a patient are now described with reference to the accompanying drawings of one or more embodiments. The terms used herein are in no way to be interpreted restrictively. Rather, the terms are used only in conjunction with a detailed description of the embodiments of the devices and methods. Although, for example, the removal and / or movement of medical valves within the body is mentioned, the present invention is not necessarily limited to medical valves. For example, embodiments according to the invention can be used for the removal and / or movement of implantable medical devices or medical devices that are accessible via pathways, vessels, cavities, lumens, and the like (e.g., stents, inserts, interfaces, etc.).Furthermore, some embodiments may include several new features, none of which is solely responsible for the desirable properties or is considered essential to the invention. Although some embodiments described herein relate to the removal and / or displacement of a medical device inserted in an airway, the present invention is not limited thereto. For example, devices and methods disclosed herein may be used for the removal of medical devices from other vessels, cavities, and lumens in humans and animals. Moreover, according to some embodiments, the removal and / or displacement device may comprise a plurality of components that are configurable for connection to or separation from one another.
[0023] Furthermore, in this context, "proximal" always refers to the smallest distance to the user of the device, and "distal" to the greatest distance from the user.
[0024] Fig. Figure 1 shows an embodiment of a removable medical device 10. In some embodiments, the removable medical device 10 may include a valve part 20. In some embodiments, the valve part 20 may connect to a junction 12. The valve part 20 may have one or more struts 24 extending from the junction 12. In some embodiments, the valve part 20 includes a diaphragm part 22. The diaphragm part 22 may be configured to extend over the one or more struts 24. In some embodiments, the diaphragm part 22 may extend over the outside (e.g., the side furthest from a central axis of the medical device 10) of the one or more struts 24. In some embodiments, the diaphragm part 22 may extend over the inside of the one or more struts 24.In some embodiments, the ends of the struts 24 opposite the node 12 may have curved sections 26. In some embodiments, the curved sections 26 face the central axis of the medical device 10. In other embodiments, the curved sections 26 face away from the central axis of the medical device 10.
[0025] In some embodiments, the removable medical device 10 may include a central rod 14. The rod 14 may be positioned along the central axis of the medical device 10. The rod 14 may be configured to connect to the node 12. In some embodiments, the rod 14 extends from the node 12 in the same direction as the valve part 20. In some embodiments, the rod 14 extends from the node 12 in a direction opposite to that of the valve part 20. In some embodiments, the rod 14 may have a cap 16 at its end opposite the node 12. In some embodiments, the rod 14 and / or the cap 16 may extend beyond the end of the valve part 20 opposite the node 12. In some embodiments, the cap 16 has a larger diameter or cross-section than the puller rod 14.
[0026] As in the Fig. As shown in Figure 1, the removable medical device 10 can have an anchor part 30. The anchor part 30 can connect to the node 12. In some embodiments, the anchor part 30 connects to the part of the node 12 opposite the valve part 20. In some embodiments, the anchor part 30 connects to the same part of the node as the valve part 20. The anchor part 30 can have one or more anchors 31. The one or more anchors 31 can connect to the node 12. In some embodiments, the one or more anchors 31 connect to the part of the node 12 opposite the valve part 20. In some embodiments, the anchors 31 connect to the same part of the node as the valve part 20. In some embodiments, the anchors 31 comprise an anchor arm 32.In some embodiments, the anchors 31 include a piercing element 34 at their end opposite the node 12. The piercing element 34 can be configured to pierce the tissue of the region where the medical device 10 is inserted. In some embodiments, the anchors 31 include a cushion 36 at their end opposite the node 12, in addition to the piercing element 24. In some embodiments, the cushion 36 can limit the depth to which the piercing elements 34 can penetrate the tissue.
[0027] In some embodiments, the valve part 20 can be configured to transition between an extended and a contracted configuration. For example, the struts 24 can be configured such that, when pressure is applied to the struts 24 and / or the diaphragm part 22, they press inwards towards the rod 14. In some embodiments, the struts 24 are pre-tensioned towards the extended configuration. In some embodiments, the struts 24 are shaped to conform to the extended configuration. In some embodiments, the struts 24 can be made of nitinol or another suitable material.
[0028] In some embodiments, the anchor part 30 can be configured to transition between an extended and a contracted configuration. For example, the anchors 31 can be configured to bend inwards and away from the rod 12 when pressure is applied to them. In some embodiments, the anchors 24 are pre-tensioned in the direction of the extended configuration. In some embodiments, the shape of the anchors 31 is adapted to the extended configuration. In some embodiments, the anchors 31 can be made of nitinol or another suitable material.
[0029] The Fig. 2A and Fig. Figure 2B shows an embodiment of an operative part 60 of a tool that can be used to remove and / or move a medical device 10. In some embodiments, the operative part 60 can be configured to switch between a (in the Fig. 2A shown) opened and one (in the Fig. (2B shown) transitions to a closed configuration. In some embodiments, the removal device 60 may have a proximal part 62. In some embodiments, the proximal part 62 may be hollow. In some embodiments, at least a portion of the proximal part 62 is solid. In some embodiments, the proximal part 62 may be made of a rigid, semi-rigid, or flexible material. In some embodiments, the proximal part 62 may be made of the same material as the remaining operative part 60 of the tool for removing and / or moving a medical device 10. In some embodiments, the proximal part 62 and the operative part 60 may be integrated or configured monolithically.
[0030] In some embodiments, the operative part 60 may have one or more engagement elements 66. In some embodiments, the one or more engagement elements 66 are connected to the distal end of the proximal part 62. The one or more engagement elements 66 may be configured to move towards each other. In some embodiments, the operative part 60 may be caused to transition into the closed configuration by the one or more engagement elements 66 moving towards each other. In some embodiments, the operative part 60 may be caused to transition into the open configuration by the one or more engagement elements 66 moving away from each other. In some embodiments, the engagement elements 66 are biased in the direction of the open configuration. In some embodiments, the operative part 60 may have one or more indentations 63.In some embodiments, the indentations 63 can reduce the force required for the transition of the engagement elements 66 between open and closed configurations.
[0031] The one or more engagement elements 66 may have an extended part 65 adjoining the distal end of the proximal part 62. In some embodiments, the extended part 65 extends outward from the proximal part 62 relative to a central axis of the operative part 60 when the operative part 60 is in the closed configuration. In some embodiments, the extended part 65 extends outward from a connection point between the engagement elements 66 and the proximal part 62 when the operative part 60 is in the open or closed configuration. In some embodiments, the connection point between the engagement elements 66 and the proximal part 62 defines a proximal grip back 64 (e.g., when the proximal part 62 includes a solid part). In some embodiments, the engagement elements 66 have a grip part 67.In some embodiments, the handle part 67 can be connected to the distal end of the extended part 65. In some embodiments, the handle part 67 can extend from the extended part 65 relative to the central axis of the surgical part 60.
[0032] In some embodiments, the operative part 60 has distal tips 68 at the ends of the engagement elements 66. In some embodiments, the distal tips 68 of the engagement elements can be connected to the distal ends of the handle elements 67. In some embodiments, the distal tips 68 extend outwards from the handle elements 67 relative to the central radius of the operative part 60. In some embodiments, the distal tips 68 define atraumatic structures such that any body structure can be reasonably protected upon contact between the distal tips 68 and the body structure. The distal tips 68 and / or other parts of the engagement elements 66 can be used to enlarge the body structure (e.g., body lumen such as an airway) in which the engagement elements 66 transition into the open configuration.For example, the intervention elements 66 (or a part thereof) can widen the body lumen into which a device 10 is implanted. In some embodiments, the widening of the body lumen into which a device 10 is implanted can assist in the detachment of the device 10 (or a part thereof) from the walls of the body lumen (e.g., helping to free the device 10 from surrounding hyperplastic parts of the body lumen).
[0033] The Fig. 2C and Fig. Figure 2D shows an embodiment of an operative part 60' of a tool that can be used to remove and / or move a medical device 10. Some reference numerals of the components of the Fig. 2C and Fig. The 2D components are, except for the addition of a dash ('), the same (or similar) as those already described in operative part 60. It is understood that the components are functionally identical or similar to those already described. The operative part 60' of the Fig. 2C and Fig. 2D shows different variations of the operative part 60 of the Fig. 2A and Fig. 2B.
[0034] In some embodiments, the engagement elements 66' are detachable from the proximal part 62'. In some embodiments, the proximal part 62' has a groove 83. The proximal ends of the engagement elements 66' can be configured for connection to a band 81. The band 81 can be made of Nitinol or another suitable material. In some embodiments, the band 81 can be configured for releasable engagement in the groove 83. In some embodiments, the engagement elements 66' can be made of Nitinol or another suitable material. In some embodiments, the engagement element 66' and the band 81 form a single component. In some embodiments, the engagement elements 66' are biased in the direction of the open configuration.
[0035] The Fig. Figures 3A-4B show an embodiment of an operative part 160 of a tool that can be used to remove and / or move a medical device 10. In some embodiments, the operative part 160 can be configured to switch between a (in the Fig. 3A shown) opened and one (in the Fig. (3B shown) transitions to a closed configuration. In some embodiments, the operative part 160 may have a proximal part 162. In some embodiments, the proximal part 162 is hollow. In some embodiments, at least a portion of the proximal part 162 is solid. In some embodiments, the proximal part 162 may be made of a rigid, semi-rigid, or flexible material. In some embodiments, the proximal part 162 may be made of the same material as the rest of the operative part 160 of the tool for removing and / or moving a medical device 10. In some embodiments, the operative part 160 consists of a tubular piece (e.g., nitinol or another suitable material). In some embodiments, the proximal part 162 and the operative part 160 may be configured monolithically or as an integrated unit.
[0036] In some embodiments, the operative part 160 has one or more engagement elements 166. The engagement elements 166 can extend distally from the proximal part 162. In some embodiments, the engagement elements 166 have extended parts 165. The extended parts 165 can extend outward away from a central axis of the operative part 160 when the operative part 160 is in a closed or open configuration. In some embodiments, the extended part 165 can extend distally substantially parallel to the walls of the proximal part 162 when the operative part is in the closed configuration. In some embodiments, the extended part 165 can extend inward away from the operative part 160 in the direction of its central axis when the operative part 160 is in the closed configuration.
[0037] In some embodiments, the engagement elements 166 can have one or more handle parts 167. In some embodiments, the handle parts 167 extend inward from the engagement elements 166 toward the central axis of the surgical part 160. In some embodiments, the handle parts 167 extend inward and proximally. In some embodiments, the handle parts 167 extend inward and distally. In some embodiments, the handle parts 167 are formed by two or more incisions in the engagement elements 166 and bending the cut portion of the engagement elements 166 inward toward the central axis of the surgical part 160.In some embodiments, the handle parts 167 are formed by at least two substantially parallel incisions in the engagement elements 166 and bending the cut portion of the engagement elements 166 inward toward the central axis of the operative part 160. In some embodiments, the handle parts 167 are formed by two incisions in the engagement elements 166, each incision extending toward a distal end 168 of the engagement elements 166 such that the cut portion can be folded downward toward the central axis of the operative part 160 to form the handle parts 167. In some embodiments, the radial length of each of the handle parts 167 is less than half the length of the inner diameter of the engagement elements 166. In some embodiments, the radial length (e.g.,The length (extending substantially perpendicular to the central axis of the operative part 160) of each of the handle parts 167 is less than half the distance between the inner walls of the engagement elements 166. In some embodiments, the total radial length of one or more handle parts 167 is less than the distance between the inner walls of the engagement elements 166.
[0038] In some embodiments, the connection between the engagement elements 166 and the proximal part 162 can form a rear part 164. In some embodiments, the distal ends 168 of the engagement elements 166 can contact each other when the operative part 160 is in the closed configuration. In some embodiments, the distal ends 168 of the engagement elements 166 can be semicircular or curved (e.g., when viewed along the central axis of the operative part 160). In some embodiments, the distal ends 168 of the engagement elements 166 can be flat (e.g., when viewed along the central axis of the operative part 160). In some embodiments, the space formed between the rear part 164 and the engagement elements 166 can be essentially teardrop-shaped when the operative part 160 is in the closed configuration, as shown in the Fig. 3B shown.
[0039] In some embodiments, the operative part 160 may have one or more indentations 163. In some embodiments, the indentations 163 may be located near the proximal ends of the engagement elements 166. In some embodiments, the thickness of the indentations 163 in a direction substantially perpendicular to the central axis of the operative part 160 may be less than the thickness of the operative part 160 distal and / or proximal to the indentations 163 in a direction substantially perpendicular to the central axis of the operative part 160. The indentations 163 may reduce the force required for the operative part 160 to transition between its open and closed configurations.
[0040] In some embodiments, a method for removing and / or displacing a medical device 10 from an airway or other body lumen may include the step of grasping the medical device 10 by means of the operative part 160 of a tool for removing and / or displacing a medical device 10. For example, the operative part of the tool for removing and / or displacing a medical device 10 – as in the Fig. Figures 3A-4B show a sleeve. In some embodiments, the sleeve 40 may be a catheter, the working channel of an endoscope, or any other suitable lumen, conduit, or tube. In some embodiments, the sleeve 40 includes a sleeve lumen 42. In some embodiments, the sleeve 40 includes sleeve walls 44. In some embodiments, the total radial length of the one or more handle parts 167, the diameter of the rod 14 of the medical device 10, and the wall thicknesses at the distal end of the two or more engagement elements 166 may be less than the inner diameter of the sleeve 40.
[0041] In some embodiments, the sleeve 40 can be moved relative to the operative part 160 in a distal and / or proximal direction. As described above, the engagement elements 166 of the operative part 160 can be biased in the direction of the open configuration. In some embodiments, the engagement elements 166 can be configured such that they transition into the closed configuration when the sleeve 40 moves over the distal ends 168 of the engagement elements 166, as is the case, for example, with the Fig. 3B and Fig. 4B. In some embodiments, the engagement elements 166 can be configured such that they transition to the open configuration when the distal end of the sleeve 40 is displaced from beyond the distal ends 168 of the engagement elements 166 proximal to the engagement elements 166. As already mentioned above with reference to the Fig. As explained in Figures 2A and 2B, the engagement elements 166 can be configured to widen the body lumen in which the engagement elements transition into the open configuration. In some embodiments, the widening of the body lumen by the engagement elements 166 (or a part thereof) can facilitate the detachment of a target device 10 (e.g., a device to be removed) from adjacent parts of the body lumen (e.g., hyperplastic parts of the body lumen).
[0042] In some embodiments, the tool for removing and / or repositioning medical devices may include a stabilizer arranged proximal to the proximal part 162 of the surgical part 160. The stabilizer may enable the surgical part 160 to be secured within the patient's body while the sleeve 40 is moved proximal and / or distally relative to the surgical part 160. In some embodiments, the stabilizer may be a wire extending proximal from the proximal end of the proximal part 162. In some embodiments, the stabilizer may be a tube extending proximal from the proximal end of the proximal part 162. In some embodiments, the proximal part 162 may be formed integrally with the stabilizer.In some embodiments, the stabilizer can enable the user of the operative part 160 to move the operative part 160 relative to the sleeve 40 in a distal and / or proximal direction.
[0043] With reference to the Fig. 3A and Fig. 4A The operative part 160 can be arranged near the cap 16 at the end of the central rod 14 of a medical device 10. In some embodiments, the sleeve 40 can be pulled out of the operative part 160 in the proximal direction. The engagement elements 166 can then move into the open configuration. The operative part 160 can then be moved towards the central rod 14 of the medical device 10 until the central rod 14 and / or the cap in the engagement elements 166 are positioned such that the cap 16 is arranged proximal to the handle parts 167, as is the case, for example, with the Fig. 3A and Fig. 4A. The sleeve 40 can then be moved distally relative to the operative part 160, so that the intervention elements 166 transition into the closed configuration, as is the case, for example, with the Fig. 3B and Fig. Show 4B.
[0044] In some embodiments, the handle parts 167 can secure the cap 16 in the operative part 160 when the engagement elements 166 transition into the closed configuration, while the cap 16 is positioned proximal to the handle parts 167. The medical device 10 can then be pulled proximally using the operative part 160. In some embodiments, the operative part 160 can be configured to push the medical device 10 distally when the cap 16 is secured in the operative part 160.
[0045] In some embodiments, the “teardrop-shaped” space formed by the rear part 164 and engagement elements 166 can make it easier for the user of the surgical part 160 to grasp a cap 16 at the end of a central rod 14 in situations where the central axes of the medical device 10 and the surgical part 160 are not aligned with each other, as the Fig. Figure 3C shows that in such a situation, the operative part 160 can be used, according to some embodiments, to pull the medical device 10 proximally and / or push it distally.
[0046] Although a procedure for grasping a medical device 10 within the framework of the Fig. As described in the embodiment of the operative part 160 shown in Figures 3A-4B, the same general method can be used by means of the one described in the Fig. 2A and Fig. Perform the embodiment of the operative part 60 shown in 2B.
[0047] The Fig. Figure 5 shows a method for drawing a medical device 10 through the interior of a compression device 90 into the interior of the sleeve 40 by means of the operative part 60 of a medical device removal and / or displacement tool. In some embodiments, the compression device 90 may have a tapered section 92. The tapered section 92 may be made of a flexible or semi-flexible material configured to expand and / or bend upon contact with the medical device 10 and / or the walls of the body lumen in which the medical device 10 is implanted. In some embodiments, the tapered section 92 is made of a rigid or semi-rigid material. The operative part 60 can grasp the cap 16 at the end of the central rod 14 and draw the device 10 toward the sleeve 40.In some embodiments, the tapered portion 92 can assist the transition of the struts 24 and / or anchors 31 of the device 10 from the expanded to the contracted configuration as the device 10 is pulled toward the sleeve 40. Examples of tapered devices are provided in U.S. Patents 8,043,301 and 8,136,230, which are incorporated in their entirety into this application.
[0048] In some embodiments, a tool for removing and / or moving medical devices 10 may include a pressure element 46. In some embodiments, the pressure element 46 is conical or frustoconical, as shown in the Fig. 6 and Fig. Figure 7 shows. In some embodiments, the pressure element 46 is grooved (e.g., the radius of the pressure element 46 increases progressively more slowly towards its distal end) or trumpet-shaped (e.g., the radius of the pressure element 46 increases progressively more rapidly towards its distal end). In some embodiments, the pressure element 46 may comprise grooved, trumpet-shaped, conical, frustoconical sections, or a combination thereof. In some embodiments, the pressure element 46 is connected to the distal end of the sleeve 40. The sleeve 40 can be supplied to a location of the medical device 10 via a working channel 82 of an insertion device 80 (e.g., the working channel of a catheter, bronchoscope, endoscope, or other insertion device). In some embodiments, the pressure element 46 is connected to a rod or wire 48.In some embodiments, the pressure element 46 is attached to the wire 48 by welding, gluing, soldering, magnets, or another suitable method for securing the wire 48 to the pressure element 46. In some embodiments, the pressure element 46 can be displaced distally and / or proximally relative to the sleeve 40. In some embodiments, the pressure element 46 can be displaced distally and / or proximally relative to the operative part 60. In some embodiments, the pressure element 46 is fixed to the sleeve 40. In some embodiments, the pressure element 46 is formed integrally with the sleeve 40.
[0049] The pressure element 46 can be made of a rigid, semi-rigid, or flexible material. In some embodiments, the pressure element 46 is made of the same material as the sleeve 40 and / or the operative part 60. In some embodiments, the pressure element 46 is made of nitinol or another shape-memory material. The pressure element 46 can consist of a series of overlapping helical plates, as shown in the Fig. Figure 7 shows that in some embodiments, the pressure element 46 can consist of a single piece. In some embodiments, a window can be cut into the pressure element 46 to allow visualization through the pressure element 46.
[0050] In some embodiments, the pressure element 46 can be configured to transition between a contracted and an extended configuration. In some embodiments, the pressure element 46 is configured such that when the insert device 80 is withdrawn from the pressure element 46, it transitions from the contracted to the extended configuration (e.g., as in the Fig. 6). In some embodiments, the pressure element 46 can be biased in the direction of the extended configuration, as shown in the Fig. 6 and Fig. Figure 7 shows. For example, the pressure element 46 can be pre-tensioned in the direction of the extended configuration such that, as the distal end 84 of the insertion device 80 is withdrawn from the pressure element 46, the pressure element 46 expands within the airway 4 or other body lumen. In some embodiments, the pressure element 46 can be configured to transition into the retracted configuration when the pressure element 46 is located within the sleeve 40 or another lumen or conduit (e.g., the working channel of an endoscope). In some embodiments, the pressure element 46 can be configured to retract at least partially into the sleeve 40. In some embodiments, the pressure element 46 can be configured to exert an expansion force on the tissue 6 of an airway 4 or other body lumen, thus expanding it, when the pressure element 46 is in the extended configuration.
[0051] In some embodiments, the tool for removing and / or repositioning medical devices may have a plurality of compression wires 146, as shown by the Fig. 8A and Fig. Figure 8B shows the compression wires 146, which can be arranged in one or more secondary leads 143 within a sleeve 140. In some embodiments, the number of compression wires 146 and / or corresponding secondary leads 143 used can correspond to the number of struts 24 on the medical device 10 to be removed / moved. In some embodiments, the number of wires 146 and / or corresponding secondary leads 143 used can be less than the number of struts 24. In some embodiments, the number of wires 146 and / or secondary leads 143 can be greater than the number of struts 24. In some embodiments, the compression wires 146 can be configured such that they extend from the secondary leads 143 into an extended configuration.In some embodiments, the compression wires 146 can be configured such that they transition from an extended to a closed configuration upon returning to the secondary lines. In some embodiments, the compression wires 146 can be made of nitinol or another suitable material. In some embodiments, the compression wires 146 can have a stabilizer. In some embodiments, the stabilizer can be circular or semicircular and be located between each of the individual compression wires 146 (e.g., one or more rings of material connecting one or more of the individual compression wires 146). In some embodiments, the stabilizer can restrict the movement of the compression wires 146 toward or away from each other in a tangential direction (e.g., tangential to the central axis of the sleeve 140).In some designs, the stabilizer can form a loop that controls the diameter to which the wires can expand.
[0052] In some embodiments, the wires 146 may have anchor parts. In some configurations, the anchor parts may be formed at the distal ends of the wires 146, as shown in the Fig. Figure 8D shows that in some embodiments, the anchor points of the wires 146 may have a piercing element 147. In some embodiments, the piercing elements 147 may be configured to penetrate the tissue 6 of an airway 4 or other body lumen when the wires 146 are in the extended configuration. In some embodiments, the anchor points of the wires 146 may have pads 149. The pads 149 may be configured to limit the depth to which the piercing elements 147 can penetrate the tissue.
[0053] The wires can have any desired cross-section. The cross-section can be substantially uniform along the length of the wire or vary. In some embodiments, a tool for removing and / or moving medical devices 10 can comprise a plurality of flat compression wires 246. The flat compression wires 246 can be arranged in a plurality of secondary leads 243 within a sleeve 240. The flat wires 246 can be configured such that, upon expansion of the flat wires 246 from the secondary leads 243, they transition into an expanded configuration. In some embodiments, the flat wires 246 can be configured such that, upon retraction of the flat wires 246 into the secondary leads 243, they transition from the expanded to the contracted configuration.
[0054] A method for pressing a medical device 10 into a device for removing and / or displacing a medical device 10 may include the step of gripping the cap 16 at the end of a rod 14 of the medical device 10, as described above. In some embodiments, the method may include the pressing element 46 transitioning into the extended configuration, as shown in the Fig. Figure 6 shows that the operative part 60 can be used to pull or stabilize the medical device 10 toward the pressure element 46 as the pressure element 46 moves toward the medical device 10. In some embodiments, the operative part 60 can be used to hold the medical device 10 in place while the pressure element 46 is pushed toward it. As the medical device 10 is received into the pressure element 46, the expanded shape of the pressure element 46 can cause the medical device 10 to transition into a contracted configuration. For example, the struts 24 of the medical device 10 can contact the pressure element 46 and be forced toward the central rod 14 of the medical device 10. This compression of the struts 24 can cause the valve part 20 of the medical device to transition into the contracted configuration.In some embodiments, the anchors 31 of the medical device 10 can be configured such that the piercing elements 34 of the anchors 31 detach from the tissue 6 as a result of the bending of the anchors 31 when the medical device 10 is pulled proximally.
[0055] In some embodiments, the operative part 60 can continue to pull the medical device 10 toward the sleeve 40, so that the anchors 31 are brought into contact with the pressure element 46. In some embodiments, the operative part 60 can continue to stabilize the medical device 10 while the pressure element 46 continues to be pushed toward the medical device 10. In some embodiments, the pressure element 46 is configured such that it presses the anchors 31 into a retracted position as the anchors 31 move toward the sleeve 40 through the pressure element 46. In some embodiments, the medical device 10 can be completely transferred into the sleeve 40 before being removed and / or moved. In some embodiments, at least or only a portion of the medical device 10 can be pushed into the sleeve 40.In some embodiments, the medical device 10 is not transferred into the sleeve 40 during its removal and / or displacement. In some embodiments, the anchors 31 can be captured and / or covered by the tool so that, while the captured device 10 is being moved within the body, the tool can reduce the likelihood that the anchors 31 or other parts of the medical device 10 could damage tissue in the patient's body (e.g., vocal cords, airways, trachea, or other body parts).
[0056] In some embodiments, the tool for removing and / or repositioning medical devices 10 within the body can be moved after the medical device has been moved from a first position. In some embodiments, the medical device 10 can be moved to a second location within the body with the tool. In these embodiments, the surgical part 60, the pressure element 46, and / or the sleeve 40 can be moved to a second location within the body. In some embodiments, the sleeve 40 and / or pressure element 46 can have visual and / or radiopaque markings. The markings can be visualized using a camera in the insertion device, fluoroscopy, and / or another known display method. The markings can provide visual and / or fluoroscopic confirmation of the location of the tool and / or the compressed medical device 10 within the tool.In some embodiments, a user of the tool can use the markings as a guide to position the tool at the second location. The markings may include one or more colored bands, pigmented bands, metallic bands, translucent sections, and / or any suitable means or structures to enable visualization of the tool's and / or medical device's location. In some embodiments, the markings are attached to the distal end of the sleeve 40 and / or the pressure element 46. In some embodiments, the markings identify the location of a specific part (e.g., the node, the proximal end of the struts, the distal end of the anchors, etc.) of the medical device 10 within the sleeve.
[0057] Once positioned at the second site, the sleeve 40 and / or the pressure element 46 of the device can be withdrawn from the surgical part 60 (e.g., displaced proximally relative to the surgical part 60). In some embodiments, the medical device 10 is configured such that it transitions into an extended configuration at the second site while the sleeve 40 and / or pressure elements 46 are withdrawn from the surgical part 60 and / or the medical device 10. In some embodiments, withdrawing the sleeve 40 from the surgical part allows the intervention elements 66 to transition into the open configuration and the handle parts 67 to detach from the medical device 10. In this way, a medical device 10 can be inserted at a second site in the body.
[0058] Although the procedure for compressing and removing / moving a medical device 10 with reference to the in the Fig. The method described in the embodiment of the device shown in section 6 is also applicable to the embodiments described in the Fig. The embodiments shown in Figures 7-8E can be implemented. For example, the valve part 20 of the medical device can be compressed by the compression wires 146 while the surgical part 60 pulls the medical device toward the sleeve 146. In some embodiments, the compression wires 146 can engage in the diaphragm parts 22 between the struts 24. In some embodiments, the compression wires 146 can penetrate accumulated (e.g., hyperplastic) tissue surrounding the valve part 20 and assist in removing the valve part 20 of the medical device 10 from the walls of an airway 4 or other body lumen.In some embodiments, the anchor parts at the ends of the compression wires 146 can assist in securing the compression wires 146 while the valve part 20 is compressed and can reduce the deflection of the compression wires 146 while the medical device 10 is pulled toward the sleeve 140. In some embodiments, the anchor parts at the ends of the compression wires 146 can be configured to release from the tissue 6 of the airway 4 when the compression wires 146 are pushed distally. In some embodiments, the anchor parts at the ends of the compression wires 146 can be configured to release from the tissue 6 of the airway 4 when the compression wires 146 are pushed proximally.In some embodiments, the use of flat compression wires 246 can reduce the probability that the wires 246 will rotate relative to the central axis of the operative part 60, 160 and / or the central axes of the respective secondary leads 243 when the medical device 10 is pulled toward the sleeve 240. In some embodiments, contact between the distal end of the sleeve 40, 140, 240 and the anchors 31 of the medical device 10 can cause the anchors 31 to enter a contracted configuration.
[0059] Fig. Figure 9 shows an embodiment of the tool for removing and / or repositioning medical devices, configured for use in an endoscope 50 or other insertion device. In some embodiments, the tool can be positioned in a working channel 54 of the endoscope 50. In some embodiments, the endoscope 50 or the other insertion device can be used to navigate the tool through the patient's body to the location of a medical device 10 of interest. The endoscope 50 can be guided from outside the patient's body into an airway 4 or other body lumen. In some embodiments, a lock can be used to hold parts (e.g., the operative part 60, sleeve 40, and / or pressure element 46) of the tool immobile relative to the patient's body, the endoscope 50, and / or the other parts of the tool.In some embodiments, the lock 70 can be fully or partially released to allow controlled movements of the tool parts relative to one another (e.g., displacing the sleeve distally and / or proximally relative to the surgical part 60). The endoscope 50 may have a handle 52. In some embodiments, the handle 52 has one or more control or other input means (e.g., light control, joint control, vacuum control).
[0060] Fig. Figures 10A-10E show an embodiment of a tool for moving and / or removing a medical device. The tool may include a grasping element 340. The grasping element 340 may comprise a body part 342 having a proximal end. The proximal end 345 of the grasping element 340 may be configured to be detachably connected to the distal end of an endoscope 50 or other insertion device by means of adhesive bonding, press fit, threading, magnets, or another joining method. The grasping element 340 may have one or more contact elements 346. The contact elements 346 may have joints 343 at which the contact elements 346 connect to the body 342 of the grasping element 340. In some embodiments, the grasping element 340 may have a single contact element 346. In some embodiments, the pressure element 346 can be conical, grooved, trumpet-shaped, or a combination thereof.In some embodiments, the pressure element 346 can consist of a single piece. In some embodiments, the pressure element 346 can consist of overlapping material plates. In some embodiments, the pressure element 346 can consist of a plurality of wires. In some embodiments, the pressure element 346 can consist of a plurality of wire meshes.
[0061] In some embodiments, the pressure elements 346 can be configured such that they are separated by a (in the Fig. 10C shown) extended and one (in the Fig. In the contracted configuration shown in Figure 10B, the clamping elements 346 move about the joints 343. In some embodiments, the clamping elements 346 can be fixed in the extended configuration. In some embodiments, the clamping elements 346 can be biased in the direction of the contracted configuration. In some embodiments, the clamping elements 346 can be biased in the direction of the extended configuration. In some embodiments, the clamping elements 346 can be made of nitinol or another suitable material. In some embodiments, the clamping elements 346 can be transferred into the extended configuration by rotating a central ring 347 of the catching element 240. The central ring 347 can be configured to rotate about an axis of rotation that is normal to, or otherwise at an angle to, the central axis of the catching element 340.In some embodiments, the rotation of the central ring 347 can exert a force on the interior of the pressure elements 346, causing the pressure elements to transition into the extended configuration. For example, the central ring 347 can be elliptical, such that a major diameter of the central ring 347 causes the ring 347 to contact the pressure elements 346 when the central ring 347 is rotated in the direction of a coaxial alignment (relative to the central axis of the catch element 340) with the catch element 340.
[0062] In some embodiments, each of the pressure elements 346 can have one or more inner lumina that are connected to one or more inner lumina in the body 342. The one or more inner lumina can contain a plurality of actuating wires. The actuating wires can have a curved shape such that, as the wires extend from the body 342 into the lumina of the pressure elements 346, they exert a radially outward force on the pressure elements 346. In some embodiments, such a radially outward force can cause the pressure elements 346 to transition from the contracted to the expanded configuration. In some embodiments, the one or more inner lumina can contain a plurality of push rods. In some embodiments, the push rods are straight.The push rods can be configured such that they extend from and retract from the inner lumina of the body 342 into and out of the inner lumina of the pressure elements 346. In some embodiments, if the pressure elements 346 are biased towards the extended configuration, the insertion of the push rods into the inner lumina of the pressure elements 346 can cause the pressure elements 346 to transition from the extended to the retracted configuration.
[0063] In some embodiments, the capture element 340 may include an operative part 160. In some embodiments, the operative part 160 of the capture element 340 is functionally and structurally similar to, or even the same component as, the operative part 160 described above. In some embodiments, the operative part 160 of the capture element 340 is functionally and structurally similar to, or even the same component as, the operative part 60 described above. In some embodiments, the operative part 160 may be contained within a working channel of the endoscope 50. In some embodiments, the operative part 160 may be contained within the capture element 340.
[0064] A method for using the in the Fig. The tool shown in Figures 10A-10E for removing and / or displacing a foreign body (e.g., medical device 10) may include connecting the proximal end 345 of the grasping element 340 to the distal end of the endoscope 50, as shown in the Fig. 10A shown. In some embodiments, the method may include guiding the capture element 340 to the location of a medical valve 10, as shown in the Fig. Figure 10B shows this. In some embodiments, the method may include extending the pressure elements 346 to the extended configuration by rotating the central ring 347 or applying other forces to the pressure elements 346. In some embodiments, the extension of the pressure elements 346 may also extend the tissue near the catching element 340. This tissue extension near the catching element 340 may aid in detaching the medical valve 10 from the surrounding tissue (e.g., detaching hyperplastic tissue from the medical valve 10). In some embodiments, the pressure elements 346 may be fixed in the extended configuration.
[0065] In some embodiments, the method may further include grasping the cap 16 of the medical device 10 – as described above – using the operative part 160 of the grasping element 340. The operative part 160 can then be used to pull the medical device 10 proximally towards the endoscope 50, as shown in the Fig. Figure 10D shows that in some embodiments, the operative part 160 can hold the medical device 10 in place while the grasping element 340 is moved toward the medical device 10. As the medical device 10 approaches the endoscope 50, struts 24 and / or membrane part 22 of the medical device 10 can contact the pressure elements 346. As the medical device 10 is pulled toward the endoscope 50, this contact can cause the valve part 20 to move into its retracted configuration. In some embodiments, the medical device 10 can be pulled proximally so that the anchors 31 contact the pressure elements 346. This contact can facilitate the transition of the anchors 31 from the extended to the retracted configuration. In some embodiments, the medical device 10 can be pulled completely into the grasping element 340.In some embodiments, the pressure elements 346 can then transition into the contracted configuration, as in the . Fig. Figure 10E shows that in some embodiments, the clamping elements 346 can be fixed in the extended configuration. In some embodiments, the endoscope 50 can be used to remove the grasping element 340 and the medical device 50 from the patient.
[0066] In some embodiments, the endoscope 50 can be used to navigate the grasping element 340 and the medical device 10 to a different location within the patient's body. In some embodiments, the clamping elements 346 can then transition to the extended configuration. The surgical part 160 can then be used to extract the medical device 10 from the grasping element 340 and advance it distally. In some embodiments, the clamping elements 346 can be shifted proximally relative to the surgical part 160. The medical device 10 can then transition to the extended configuration and engage the tissue surrounding the medical device 10. The surgical part 160 can then transition to the open configuration to release the medical device 10 from the medical device removal and / or advancement tool. In some embodiments, the endoscope 50 can be used to navigate the grasping element 340 out of the patient's body.
[0067] Although the tool for removing and / or moving medical devices has been disclosed in connection with various embodiments and examples, it is clear to those skilled in the art that the present invention extends beyond the specifically disclosed embodiments and encompasses further alternative embodiments and / or applications of the tool, as well as obvious modifications and equivalents thereof. Although various variations of the tool have been shown and described in detail, those skilled in the art will also recognize further modifications that fall within the scope of protection of the invention. It is assumed that various combinations or sub-combinations of the specific features and aspects of the embodiments are possible, which still fall within the scope of protection of the invention.It should be noted that various features and aspects of the disclosed embodiments can be combined or substituted to produce variations or embodiments of the tool. The scope of protection of the present invention is therefore not intended to be limited by the specific disclosed embodiments.
Claims
[1] Tool for removing and / or displacing a foreign body in a patient's body, comprising: a sleeve element (40) comprising a proximal end, a distal end and a central axis, wherein the sleeve element (40) comprises a tubular body defining an inner lumen (42) and is movable in the proximal and distal direction; an operative part (160) comprising a proximal end, a distal end and a central axis generally coaxial to the central axis of the sleeve element (40): a stabilizer which has a proximal end and a distal end; a plurality of intervention elements (166), each comprising a proximal end and a distal end; wherein the majority of engagement elements (166) are connected to the stabilizer and extend distally from the distal end of the stabilizer, wherein the engagement elements (166) are configured such that they transition between an open and a closed configuration in response to a force acting on the engagement elements (166), wherein the distal ends of the engagement elements (166) are configured such that they move away from the central axis of the operative part (160) when transitioning from the closed to the open configuration; and one or more grip elements (167) arranged on the stabilizers, extending from the engagement elements (166) to the central axis of the operative part (160) when the engagement elements (166) are in a closed configuration, wherein the sleeve element (40) comprises a plurality of secondary conduits (243), each of the secondary conduits (243) having a proximal and a distal end, and wherein the tool further comprises a pressure element (46) which includes a plurality of compression wires (146), wherein at least a part of each of the compression wires (146) is contained in the plurality of secondary lines (243), wherein each of the compression wires (146) has a proximal end and a distal end, wherein the compression wires (146) are configured such that they transition between an extended and a contracted configuration. [2] Tool according to claim 1, further comprising a pressure element (46) comprising a proximal end, a distal end and a central axis generally extending coaxially to the central axis of the sleeve element (40), wherein the pressure element (46) is movable in the proximal and distal direction, wherein the pressure element (46) is configured such that it transitions between an extended and a contracted configuration, wherein the pressure element (46) is further configured such that it expands from the central axis of the pressure element (46) such that the distal end of the pressure element (46) is further spaced from the central axis of the pressure element (46) than the proximal end of the pressure element (46) when the pressure element (46) is in the extended configuration. [3] Tool according to claim 1, wherein the engagement elements (166) are removable from the stabilizer. [4] Tool according to claim 3, wherein the stabilizer comprises a groove (83). [5] Tool according to claim 4, wherein the tool further comprises a band (81) wherein the plurality of engagement elements (166) are each connected to the band (81). [6] Tool according to claim 5, wherein the band (81) is configured to engage releasably in the groove (83). [7] Tool according to claim 1, wherein the sleeve element (40) and the operative part (160) are configured such that they are contained in a working channel of an endoscope (50) or other insertion device. [8] Tool according to claim 2, wherein the pressure element (46) is configured such that it is contained in a working channel of an endoscope (50) or other insertion device. [9] Tool according to claim 1, wherein at least a part of the operative part (160) is contained in the inner lumen (42) of the sleeve element (40). [10] Tool according to claim 1, wherein the sleeve element (40) is further configured such that it is movable in the proximal and distal direction relative to the operative part (160). [11] Tool according to claim 2, wherein the sleeve element (40) is further configured such that it is movable in the proximal and distal direction relative to the pressure element (46). [12] Tool according to claim 2, wherein the operative part (160) is further configured such that it is movable in the proximal and distal direction relative to the pressure element (46). [13] Tool according to claim 1, wherein the engagement elements (166) are pre-tensioned in the direction of the open configuration. [14] Tool according to claim 2, wherein the pressure element (46) is pre-tensioned in the direction of the open configuration. [15] Tool according to claim 1, wherein the engagement elements (166) are configured such that they transition from the open to the closed configuration when the distal end of the sleeve element (40) is moved laterally or distally from the proximal end of the engagement elements (166) to the distal ends of the engagement elements (166). [16] Tool according to claim 1, wherein the operative part (160) further comprises indentations (163) at the proximal ends of the engagement elements (166) which are configured to reduce the force required to transition the engagement elements (166) between open and closed configuration. [17] Tool according to claim 2, wherein the pressure element (46) comprises a solid conical piece of material. [18] Tool according to claim 2, wherein the pressure element (46) comprises a plurality of overlapping helical plates. [19] Tool according to claim 2, wherein the pressure element (46) has an opening extending through the pressure element (46) which is configured such that visualization through the pressure element (46) is possible. [20] Tool according to claim 1, wherein the compression wires (146) are flattened. [21] Tool according to claim 1, wherein a gap is formed over at least a part of the axial length of the engagement elements (166) between the plurality of engagement elements (166) when the engagement elements (166) are in the closed configuration. [22] Tool according to claim 21, wherein the foreign body comprises an extended part and a central axis, such that the extended part can move through the gap formed between the engagement elements (166) and the gripping elements (167) can grip the sides of the extended part when the central axis of the foreign body is not aligned with the central axis of the operative part (160). [23] Tool according to one of claims 1-22, wherein the foreign body is an inserted medical device.