Implantable medical device isolation system with split tubes and cylindrical joints

Abstract

To provide a quick release detachment system or method capable of releasing and unfolding an implantable medical device reliably.SOLUTION: A method of constructing a detachment system for delivering an implantable medical device to a target location of a body vessel is presented. The method includes: forming a compressible portion on a distal tube; engaging an implantable medical device with an engagement system; extending the engagement system through the distal tube such that the implantable medical device is distal of a distal end of the distal tube; applying a force to the engagement system to compress the compressible portion to a compressed state; fixing the engagement system to the distal tube to maintain the compressed state of the compressible portion; and joining a proximal end of the distal tube to a distal end of a proximal tube. The engagement system can include a loop wire that is fixed to the distal tube and engages the medical device.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] (Cross-Reference to Related Applications) This application is a continuation-in-part of U.S. Patent Application No. 17 / 064,907, filed on October 7, 2020, which is a divisional application of U.S. Patent Application No. 15 / 850,993, filed on December 21, 2017, issued as U.S. Patent No. 10,806,462 on October 20, 2020, the contents of which are incorporated herein by reference in their entirety as if fully set forth herein.

[0002] (Field of the Invention) The present invention generally relates to interventional medical device systems navigable through blood vessels in the body of a human subject. More specifically, the present invention relates to a detachment system for deploying an implantable medical device to a target location in a blood vessel of the body, and to methods of using the same. [Background Art]

[0003] The use of catheter delivery systems to position and deploy therapeutic devices such as inflatable balloons, stents, and embolic coils within the vascular structure of the human body has become a standard procedure for treating intravascular diseases. Such devices have been found to be particularly effective where conventional surgical procedures are not possible, or when treating regions that pose significant risk to the patient, for example, when treating aneurysms in cerebral blood vessels. Due to the delicate tissue surrounding cerebral blood vessels, particularly for example brain tissue, performing surgical procedures to treat defects in cerebral blood vessels is very difficult and often dangerous. Advances in catheter deployment systems have provided alternative treatments in such cases. Advantages of catheter delivery systems include providing a method for treating blood vessels with an approach that has been found to reduce the risk of trauma to surrounding tissue, and further enabling the treatment of blood vessels previously considered inoperable.

[0004] Generally, these procedures involve inserting the distal end of a delivery catheter into the patient's vascular structure and guiding it through the vascular structure to a designated delivery site. A vascular occlusion device, such as an embolization coil, is attached to the end of the delivery member, which pushes the coil through the catheter, forcing it out from the distal end of the catheter to the delivery site. Some of the problems associated with these procedures concern ensuring the complete release and deployment of the coil. For example, U.S. Patent No. 5,250,071 by Palermo, incorporated herein by reference, describes a separation system in which interlocking clasps of the system and coil are held together by a control wire. The control wire is moved proximal to disengage the clasps from each other. However, this system does not include a reliable means for separating the disengaged clasps from each other, and therefore, simply pulling back the control wire does not guarantee the release and deployment of the coil. Many other separation systems currently in use suffer from similar problems.

[0005] In addition, U.S. Patent No. 8,062,325, incorporated herein by reference, discloses a single tubular carrier for delivering and deploying a vascular occlusion device, which has only a single compressible portion. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, there remains a need for faster release and separation systems or methods that can ensure the release and deployment of implantable medical devices. Further advantages may be realized by separation systems or methods that incorporate simple and inexpensive locking and deployment systems. [Means for solving the problem]

[0007] The separation system delivers an implantable medical device to a target location in the body's blood vessels via a substantially hollow distal tube. This distal tube has a proximal end, a distal end, and a compressible portion of the distal tube itself located between the proximal and distal ends, which is axially movable from a compressed state to an extended state. The system also includes a substantially hollow proximal tube having a proximal and distal end, a joint disposed between the proximal and distal ends of the distal tube connecting the proximal and distal tubes, and an engagement system that engages with and deploys an implantable medical device engaged with the distal end of the distal tube. When engaged with the implantable medical device, the engagement system moves the compressible portion to a compressed state, deploys the implantable medical device, and releases the compressible portion to an extended state.

[0008] In another embodiment, the engagement system can be detachably attached to the proximal end of the distal tube to maintain a compressed state when engaged with an implantable medical device. Furthermore, the engagement system can be detachably attached to the proximal end of the proximal tube when engaged with an implantable medical device.

[0009] An example of an engagement system includes a locking member and a loop wire. When the loop wire interacts with the locking member to engage with an implantable medical device, the force on the loop wire moves the compressible portion into a compressed state, and the loop wire is welded to the proximal end of the distal tube to removably secure the engagement system. The force on the locking member releases the loop wire, disengaging the implantable medical device and allowing the compressible portion to return to an extended state.

[0010] Other embodiments have a compressible portion of the distal tube as a helical cut portion of the distal tube. This compressible portion can be adapted to deploy an implantable medical device engaged by an engagement system when the compressible portion moves to an extended state. Furthermore, the compressible portion of the distal tube is adapted to move automatically / elastically to an extended state when the engagement system is disengaged from the implantable medical device. The proximal tube may also include a flexible portion of the proximal tube itself between the proximal and distal ends, and the distal tube may have a flexible portion of the distal tube itself between the proximal end and the compressible portion.

[0011] A further embodiment includes a proximal tube that partially overlaps the joint and a distal tube that partially overlaps the joint, wherein the gap formed on the joint between the proximal and distal tubes includes a weld band that welds the joint to the proximal and distal tubes. In one embodiment, the joint is radiopaque.

[0012] A method for separating an implantable medical device using the above-described embodiment may include the steps of: forming a compressible portion on the distal tube between the proximal and distal ends; engaging the implantable medical device with an engagement system; applying force to the engagement system to compress the compressible portion; fixing the engagement system to the distal tube to maintain the compressed state; and joining the distal tube and the proximal tube together using a joint. As described above, the engagement system may be removably fixed to the proximal end of the distal tube.

[0013] An example of a separation method may further include the step of removably securing the engagement system to the proximal end of the proximal tube when engaged with an implantable medical device. This engagement step may include engaging the implantable medical device using a loop wire together with a locking member, and this force application step may further include applying force to the loop wire to move the compressible portion into a compressed state. Other exemplary steps include applying force to the locking member, disengaging the implantable medical device, and returning the compressible portion to an extended state.

[0014] An example of this forming process may include a step of helically cutting a portion of the distal tube, and further a step of deploying the engaged implantable medical device by moving the compressible portion into an extended state. In addition, the compressible portion of the distal tube may be adapted to automatically / elastically move into an extended state when the engagement system is disengaged from the implantable medical device.

[0015] Furthermore, this joining process further includes the steps of partially overlapping the proximal tube with the joint, partially overlapping the distal tube with the joint, forming a gap on the joint including a weld band between the proximal tube and the distal tube, and welding the joint to the proximal tube and the distal tube with this weld band. [Brief explanation of the drawing]

[0016] The above and further aspects of the present invention are further discussed below with reference to the accompanying drawings, where similar figures in various drawings indicate similar structural elements and features. The drawings are not necessarily to scale and are primarily intended to illustrate the principles of the present invention. The figures depict one or more implementations of the apparatus of the present invention, not as limitations, but merely as examples. [Figure 1A] This is an exploded view of an example of the separation system of the present invention, showing a medical device in a partially disengaged state. [Figure 1B] This is an enlarged view of Figure 1A. [Figure 2] Fig. 1 is an exploded view of an example separation system of the present invention with a medical device engaged thereto. [Figure 3A] Fig. 2 is a side perspective view of an example loop wire according to one embodiment. [Figure 3B] Fig. 3 is a plan view of an example loop wire according to another embodiment. [Figure 4] Fig. 4 is a detailed front perspective view of an opening of a loop wire in an upward-facing state according to another embodiment. [Figure 5A] Fig. 5 is an exploded view of an example separation system of the present invention with a medical device and a loop wire fixed thereto. [Figure 5B] Fig. 6 is an enlarged view of a loop wire fixed to a distal tube. [Figure 6] Fig. 7 is a plan view of a proximal tube and a distal tube overlapping a joint. [Figure 7] Fig. 8 is a plan view of a proximal tube and a distal tube welded to a joint. [Figure 8] Fig. 9 illustrates a proximal weld on a small tube. [Figure 9] Fig. 10 illustrates a fluoroscopic view of an example separation system. [Figure 10] Fig. 11 illustrates an exemplary method of forming the separation system of the present invention. [Figure 11A] Fig. 12 illustrates a medical device being separated using a partial cross-section. [Figure 11B] Fig. 13 illustrates a medical device being separated using a partial cross-section. [Figure 11C] Fig. 14 illustrates a medical device being separated using a partial cross-section. [Figure 11D] Fig. 15 illustrates a medical device being separated using a partial cross-section. [Figure 12] Fig. 16 is a side view of an example distal tube in a compressed state and an expanded state. [Figure 13] Fig. 17 is a front side perspective view of an example medical device being separated. [Figure 14] Fig. 18 is a plan view of a first flexible portion and a second flexible portion of a distal tube. [Figure 15] This is an enlarged view of Figure 14. [Figure 16] This is a side view of an exemplary distal tube within a tortuous pathway of a vascular structure. [Figure 17] Figures A through D illustrate exemplary positions of the distal tube during engagement and disengagement. [Modes for carrying out the invention]

[0017] The figures illustrate a substantially hollow or tubular structure according to the present invention. As used herein, the terms “tubular” and “tube” are to be interpreted broadly and are not limited to structures having a right cylindrical cross-section, a strictly circular cross-section, or a uniform cross-section along its entire length. For example, a tubular structure or tubular system is generally illustrated as a substantially right cylindrical structure. However, a tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.

[0018] As illustrated in Figures 1A, 1B, and 2, an example of the separation system 10 of the present invention may have a proximal elongated delivery hypotube assembly 100, an intermediate joint 200, and a distal delivery tube 300. An implantable medical device 12 is engaged with one end of the distal delivery tube 300. The implantable medical device 12 may be an embolization coil, however substantially, it will be understood that any implantable medical device 12 can be delivered and deployed by the separation system 10 according to the present invention. The medical device 12 is engaged with the system using a locking member 140 and a loop wire 400. The medical device 12 has a locking portion 18 that connects to the engagement systems 140, 400.

[0019] The proximal delivery tube 100 may have a proximal end portion 102, a distal end portion 104, and a flexible portion 106 between them. The proximal delivery tube 100 forms an axial lumen 108 within it. The proximal end 102 engages with a smaller diameter tube 110 along the axial lumen 108 (see Figures 5A, 6-8). The distal delivery tube 300 may have a proximal end portion 302, a distal end portion 304, and a compressible portion 306 between these two. In one embodiment, the compressible portion 306 may be closer to the distal end portion 304, and the area between the proximal end portion 302 and the compressible portion 306 may be a flexible portion 305. The distal delivery tube 300 forms an axial lumen 308 within it.

[0020] The delivery tubes 100 and 300 can be made from biocompatible materials such as stainless steel. The tubes 100 and 300 can typically have a diameter of about 0.010 inches to about 0.018 inches, with preferred tubes having a diameter of about 0.0145 inches. Examples of these tube dimensions are suitable for delivering and deploying embolic coils to target locations within the neurovascular system, typically aneurysms. For other applications, tubes 100 and 300 of different dimensions made from other materials may be useful, and these are also within the scope of the present invention.

[0021] The flexible portions 106 and 305 allow the delivery tubes 100 and 300 to bend and flex. This helps track the system 10 through the catheter and along the meandering pathway through the human vascular structure. The flexible portions 106 and 305 can be formed by interference helical cuts. These cuts provide gaps that allow for bending, but in one embodiment, these cuts do not act as helical cut springs; that is, they can bend and flex, but they cannot be compressed.

[0022] The compressible portion 306 is axially adjustable between an extended and a compressed state. Preferably, the compressible portion 306 is formed from a helical cut portion of the tube 300 formed by a laser cutting operation. However, any other arrangement that allows for axial adjustment (e.g., a wound wire or a helical ribbon) is also suitable for use with the separation system according to the present invention. Most preferably, the compressible portion 306 is in an extended state when at rest and, unless otherwise constrained, automatically or elastically returns from the compressed state to the extended state. The function of the compressible portion 306 is described in detail herein.

[0023] An example of the joint 200 has a proximal portion 202, a distal portion 204, a welded band 206 between them, and an axial lumen 208 within them. The joint 200 bridges both delivery tubes 100 and 300 and can further provide radiopaque markings to assist in the alignment of the separation system 10 within the delivery catheter during clinical use. An example of the intermediate joint 200 may be a marker band or a coil segment.

[0024] Figures 3A, 3B, and 4 illustrate examples of loop wires 400. In some embodiments, the loop wire 400 may be relatively small, about the thickness of a hair, and therefore may be preferably completely shielded by the distal end 304 of the distal delivery tube 300 to prevent damage from accidental contact. The loop wire 400 may be an elongated wire in the shape of a loop, as shown in Figure 3A. The loop wire 400a may further be a single elongated wire with an opening 405, as illustrated in Figure 3B. The opening 405 can be formed by loosely bending the loop wire 400a in half. In an alternative embodiment, the loop wire 400b includes a flat ribbon shape with an opening 405a defined at the distal portion, which may be in an upward position suitable for engagement with the end of the implantable medical device 12. Examples of loop wires 400, 400a, and 400b may be elastically deformable into an upward position, thereby returning to a substantially flat state when no other constraints are present. Loop wires 400, 400a, and 400b can be formed from any number of materials, including nitinol and stainless steel.

[0025] To mount the separation system 10, the locking member 140 is inserted axially into the lumens 108, 208, and 308 of both tubes 100, 300 and the joint 200. The distal end 404 of the loop wire 400 is inserted into the distal delivery tube 300 through the anchor portion 310 at the proximal end 302 of the distal tube 300, and through the lumen 308 to the distal end 304. The distal end of the loop wire 404 can then form a loop to create an opening 405. The opening 405 passes through the locking portion 18, and the locking member 140 passes through the opening 405 to engage the medical device 12. See Figures 1A and 11A.

[0026] The loop wire 400 is tensioned and pulled at the proximal end of the loop wire 402, compressing the compressible portion 306 with a continuous force F. The degree of compression can be controlled by the amount of force F applied to the proximal end 402 of the loop wire 400 after the medical device 12 is attached to the distal end 304 of the distal tube 300. Figures 2 and 11A illustrate the attached medical device 12 and the distal tube 300 in a compressed state. Once the distal tube 300 is compressed to the appropriate degree, the loop wire 400 is anchor-welded 408 to the anchor portion 310 of the distal delivery tube 300 or the nearby proximal end 302 (i.e., behind the compressible portion 306) at the wire welding point 406 (between the proximal end 402 and the distal end 404). See Figures 5A and 5B. The compression level of the distal delivery tube 300 is adjusted by changing the amount of force F applied to the loop wire 400 before fixing the loop wire 400 in place at the anchor weld 408.

[0027] Figures 6 and 7 illustrate a joint using a connector 200 between a proximal delivery tube 100 and a distal delivery tube 300. Figure 6 illustrates how the distal end 104 of the proximal tube 100 is pulled toward the proximal end 202 of the connector 200 and overlaps with it. Similarly, the proximal end 302 of the distal tube 300 is pulled toward the distal end 204 of the connector 200 and overlaps with it. In this embodiment, the proximal tube and distal tubes 100 and 300 are not in contact, but a weld strip 206 is left as a gap on the connector 200. The two tubes 100 and 300 are then joined circumferentially at a welded joint 210 with the weld strip 206 to form an integrated device 10. The intermediate joint 200 bridges both delivery tubes 100 and 300 and also provides radiopaque markings for aligning the system 10 with the delivery catheter (not illustrated) during clinical use.

[0028] Before the two tubes and fittings 100, 200, and 300 are overlapped and welded together, the locking member 140 (as discussed above) is stretched through the fitting lumen 208 and the proximal tube lumen 108 and the smaller tube 110. At the proximal opening 112 of the smaller tube 110 (opposite the proximal end 102 of the proximal tube 100), the locking member 140 is welded 142 to the smaller tube 110. This is illustrated in Figure 8.

[0029] Figure 9 illustrates a fluorescence pathogram of the separation system 10. If the fitting 200 and the medical device 12 are typically made of or have radiopaque markings, it becomes possible to see the proximal tube 100a and distal tube 300a with a different contrast than the fitting 200a or the medical device 12a. This provides visual feedback indicating that the device 12a has been released (discussed in further detail below).

[0030] Figure 10 illustrates an example of a method for assembling the separation system 10. This method includes forming a compressible portion 306 in the distal tube 300 (step 1000) and forming a flexible portion 106 in the proximal tube 100 (step 1002). Step 1002 may further include forming a flexible portion 305 in the distal tube 300. The compressible portion 306 can be formed by helically cutting the distal tube 300 or by any other means, thereby forming a tube that can be compressed and then quickly return to an uncompressible state. The flexible portion 106 of the proximal tube 100 may be an interference cut or by any other means that increases the flexibility of the proximal tube 100. Once at least the distal tube 300 is ready, the medical device 12 can be engaged with the engagement systems 140, 400 (step 1004), and a force F can be applied to the engagement systems 140, 400 to compress the compressible portion 306 (step 1006). Herein, although the above embodiment is shown using the locking member 140 and loop wire 400 as the engagement system, it should be noted that different methods may be recognized for securing the medical device 12 while applying a releaseable force to the compressible portion 306 (released when the engagement systems 140, 400 are disengaged from the medical device 12). Next, the portion 406 of the engagement systems 140, 400 engages with the distal tube 300 and maintains the compressed state of the compressible portion 306 (step 1008). A portion of the engagement systems 140, 400 is passed through the joint 200 and the proximal tube 100 (step 1010). The distal tube 300 and the proximal tube 100 are joined together using a joint 200 (step 1012). In this embodiment, the ends 104 and 302 of tubes 100 and 300 overlap the joint 200, and all three are welded together 210. Next, the ends 144 of the engagement systems 140 and 400 are joined to the proximal end 102 of the proximal tube 100 (step 1014), and the apparatus 10 can be completed.

[0031] Referring to Figures 11A to 11D, the separation of the medical device 12 is illustrated in more detail. Figure 11A illustrates the engagement systems 140, 400 locked to the locking portion 18 of the medical device 12. The opening 405 of the loop wire 400 can be positioned through the locking portion 18. Once the locking member 140 is positioned through the opening 405, the medical device 12 is secured. A force F has been applied in advance to compress the distal tube 300. Figure 11B illustrates the locking member 140 being pulled proximal to initiate the release sequence of the medical device 12. Figure 11C illustrates the point in time when the locking member 140 is pulled out of the opening 405 and without the loop wire 400. The distal end 404 of the loop wire 400 detaches or returns to its pre-formed shape (as discussed above) and exits the locking portion 18. As can be seen from the figure, there is now nothing holding the medical device 12 to the separation system 10. Figure 11D illustrates the end of the release sequence. Here, the compressible portion 306 expands / returns to its original shape and "snaps" forward. The distal end 304 of the distal tube 300 applies an elastic force E to the medical device 12, "pushing" it out and ensuring the complete separation and delivery of the medical device 12.

[0032] Figure 12 shows a distal tube 300 without the medical device 12, illustrating a compressed state in which the compressible portion 306 is shortened in the axial direction. Specifically, a distance "D" is illustrated in which the distal tube 300 is shortened in the axial direction when the compressible portion 306 is moved from an extended state to a compressed state. This compression can occur along axis A.

[0033] Figure 13 illustrates another diagram of the medical device 12 at the separation point. The locking member 140 is pulled proximal, thereby separating it from the loop wire 400, so that the medical device 12 can be separated as the distal compression portion 306 expands, further pulling the medical device 12 away from the delivery system 10. The arrow "E" indicates an elastic force that "pushes" the medical device 12 away from the distal end 304, thereby ensuring clean separation and delivery to the target site in the patient's body. The elastic force E acts on axis A of the lumen 308, "pushing" the medical device 12 along axis A (see Figures 8 and 12).

[0034] An example of the separation system 10 of the present invention may include a proximal elongated delivery hypotube assembly 100, an intermediate joint 200, and a distal delivery tube 300 having a first flexible portion 305 and a second flexible portion 330. As shown in Figure 14, an implantable medical device 12 is engaged at one end of the distal delivery tube 300. The implantable medical device 12 may be an embolization coil, however substantially, it will be understood that any implantable medical device 12 can be delivered and deployed by the separation system 10 according to the present invention. The medical device 12 is engaged with the system using a locking member 140 and a loop wire 400. The medical device 12 has a locking portion 18 that connects to the engagement systems 140, 400.

[0035] Figure 15 shows an enlarged view of Figure 14. To enable controlled isolation of the implantable medical device 12, the distal delivery tube 300 may have a proximal end portion 302, a distal end portion 304, and a second flexible or incompressible portion 330 located between the two. In one example, the second flexible or incompressible portion 330 may be closer to the distal end portion 304 and located between it and the proximal end portion 302. The second flexible or incompressible portion 330 may be adjacent to the first flexible portion 305.

[0036] As illustrated in Figure 16, the flexible portions 106, 305, and 330 allow the delivery tubes 100 and 300 to bend and flex laterally. This helps to track the system 10 through the catheter via a meandering path through the human vascular structure. The flexible portions 106, 305, and 330 can be formed by interference helical cuts. These cuts provide gaps that allow for bending, but in one embodiment, these cuts do not act as helical cut springs; that is, they can bend and flex, but not compress. The second flexible portion or incompressible portion 330 may have different interference helical cuts than the first flexible portion 305. Preferably, the second flexible portion 330 may be formed by a laser cutting operation, and is formed from modulated cut angles and spacing in the interference helical cuts compared to the first flexible portion 305 of the tube 300. The interference helical cuts of the first and second flexible portions 305 and 330 may include cut portions of approximately 240 degrees and uncut portions of approximately 20 degrees.

[0037] Referring again to Figure 15, the first flexible portion 305 may have a first pitch P1, and the second flexible portion 330 may have a second pitch P2 that is different from the first pitch P1. The first pitch P1 of the first flexible portion 305 may range from about 0.12 mm to about 0.18 mm, and preferably about 0.15 mm. The second pitch P2 of the second flexible portion 330 may range from about 0.08 mm to about 0.12 mm, and preferably about 0.1 mm.

[0038] As shown in Figures 17A to 17D, the second flexible or incompressible portion 330 limits the amount of compression of the distal tube 300 necessary to securely hold the implantable medical device 12 while still being controllable and able to be deployed. Figure 17A shows that the distal tube 300 has a first length L1 before the implantable medical device 12 is engaged. Figure 17B illustrates that after the engagement system has engaged the implantable medical device 12, the distal tube 300 may have a second length L2 that is smaller than the first length L1, in which case the first flexible portion 305 is compressed to a different degree than the second flexible portion 330, for example, the first flexible portion 305 is compressed to a smaller degree than the second flexible portion 330. When the implantable medical device 12 is engaged before deployment, the distal tube 300 can experience a force F of approximately 13 grams (gf) to approximately 26 grams (gf). This force F can compress the distal tube to approximately 0.15 mm to approximately 0.45 mm. Figure 17C shows a third length L3, which is the maximum length of the distal tube 300 when the implantable device 12 is deployed. The maximum extended length of the distal tube 300 when the implantable device 12 is deployed can range from approximately 0.4 mm to approximately 0.8 mm from the compressed position of the second length L2. Furthermore, the first flexible portion 305 extends to a different extent than the second flexible portion 330; for example, the first flexible portion 305 can extend to a smaller extent than the second flexible portion 330 when the implantable medical device 12 is deployed from the distal tube 300. After deployment of the implantable medical device 12, the distal tube 300 can relax to a fourth length L4, which is the same as or approximately the same as the first length L1, before engaging with the implantable medical device 12. The interference spiral cut feature can restrict distal movement when deploying the implantable medical device 12.

[0039] Where used herein, the terms “about” or “approximately” for any number or range of numbers indicate a suitable dimensional tolerance that enables a part or set of components to function in accordance with its intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the listed values; for example, “about 90%” may refer to a range of values ​​between 71% and 99%.

[0040] The descriptions contained herein are examples of embodiments of the present invention and do not limit the scope of the invention in any way. As described herein, the present invention envisions numerous variations and modifications of the delivery and release system of the present invention for vascular occlusion devices, including numerous configurations, numerous rigidity characteristics, and methods of delivery thereof. There are also many possible variations in the materials and configuration of the release mechanism. These modifications will be obvious to those skilled in the art to whom the present invention relates and are intended to fall within the scope of the following claims.

[0041] [Implementation Method] (1) A separation system, A substantially hollow distal tube comprising a defined longitudinal axis, a distal end, a first flexible portion, and a second flexible portion having an interference spiral cut throughout the entire tube and positioned between the first flexible portion and the distal end, The system comprises an engagement system configured to engage an implantable medical device with the distal end of the distal tube, and to deploy the implantable medical device from the distal end of the distal tube, When the engagement system engages with the implantable medical device, it compresses the second flexible portion along the longitudinal axis to a greater extent than the first flexible portion. A separation system in which the second flexible portion is configured to extend along the longitudinal axis to a greater extent than the first flexible portion when the engagement system deploys the implantable medical device. (2) The first flexible portion is provided with interference spiral cuts having a first pitch, The second flexible portion comprises an interference spiral cut having a second pitch, The separation system according to Embodiment 1, wherein the first pitch is different from the second pitch. (3) The first pitch is in the range of approximately 0.12 mm to approximately 0.18 mm, The separation system according to Embodiment 2, wherein the second pitch is in the range of approximately 0.08 mm to approximately 0.12 mm. (4) The separation system according to Embodiment 1, wherein the interference spiral cuts of the first flexible portion and the second flexible portion comprise a cut portion of about 240 degrees and an uncut portion of about 20 degrees. (5) The distal tube has a first length before the engagement system is engaged with the implantable medical device. The distal tube has a second length when the engagement system is engaged with the implantable medical device. The separation system according to Embodiment 1, wherein the difference between the first length and the second length is approximately 0.1 mm to approximately 0.25 mm.

[0042] (6) The distal tube has a second length when the engagement system is engaged with the implantable medical device. The distal tube has a third length, which is the maximum length of the distal tube, when the implantable medical device is deployed by the engagement system. The separation system according to Embodiment 1, wherein the difference between the third length and the second length is approximately 0.4 mm to approximately 0.8 mm. (7) The distal tube has a final length which is the net length of the distal tube when the first flexible portion and the second flexible portion of the distal tube are released from compression. The separation system according to Embodiment 5, wherein the difference between the first length and the final length is approximately 0 mm to approximately 0.5 mm. (8) The separation system according to Embodiment 1, wherein the distal tube is under compression of a force of about 0.127 N to about 0.255 N (about 13 gf to about 26 gf) when the engagement system is engaged with the implantable medical device. (9) The separation system according to Embodiment 8, wherein the force compresses the distal tube by about 0.15 mm to about 0.45 mm. (10) The engagement system Locking member and It also features a loop wire, The separation system according to Embodiment 7, wherein when the loop wire interacts with the locking member and engages with the implantable medical device, the force on the loop wire causes the first flexible portion and the second flexible portion to move along the longitudinal axis from the first length to the second length of the distal tube when the loop wire engages with the implantable medical device.

[0043] (11) Separation system, A nearly hollow distal tube, The distal end and A first flexible portion of the distal tube, having an interference spiral cut having a first pitch, A substantially hollow distal tube comprising a second flexible portion of the distal tube having an interference spiral cut having a second pitch, An engagement system configured to engage with an implantable medical device at the distal end of the distal tube, wherein the engagement system is Locking member and A loop wire and an engagement system comprising, When the loop wire interacts with the locking member and engages with the implantable medical device, the force on the loop wire causes the first flexible portion and the second flexible portion to move along the longitudinal axis from the first length to the second length of the distal tube as the loop wire engages with the implantable medical device. A separation system wherein the loop wire, when engaged with the implantable medical device, moves the second flexible portion along the longitudinal axis to a greater extent than the first flexible portion. (12) The separation system according to Embodiment 11, wherein the difference between the first length and the second length of the distal tube is about 0.1 mm to about 0.25 mm. (13) The engagement system is further configured to deploy the implantable medical device from the distal end of the distal tube, The separation system according to embodiment 11, wherein the second flexible portion is configured to extend to a greater extent along the longitudinal axis than the first flexible portion when the engagement system deploys the implantable medical device. (14) When the implantable medical device is deployed from the distal tube, the elastic force on the distal tube causes the first flexible portion and the second flexible portion to move along the longitudinal axis from the second length to the third length of the distal tube as the implantable medical device is deployed by the loop wire, The separation system according to Embodiment 13, wherein the difference between the third length and the second length is approximately 0.4 mm to approximately 0.8 mm. (15) The separation system according to embodiment 11, wherein the first pitch is different from the second pitch.

[0044] (16) The first pitch is in the range of approximately 0.12 mm to approximately 0.18 mm, The separation system according to Embodiment 15, wherein the second pitch is in the range of approximately 0.08 mm to approximately 0.12 mm. (17) A substantially hollow proximal tube having a proximal end and a distal end, The separation system according to embodiment 11, further comprising: a joint disposed inside the proximal end of the distal tube and inside the distal end of the proximal tube, which connects the proximal tube and the distal tube. (18) A method, A first flexible portion and a second flexible portion are formed on the distal tube between the proximal end and the distal end of the distal tube, wherein the first flexible portion and the second flexible portion are formed to have interference spiral cuts. Engaging an implantable medical device with an engagement system, The engagement system is extended through the distal tube such that the implantable medical device is located distal to the distal end of the distal tube, The engagement system is fixed to the distal tube, A method comprising joining the proximal end of the distal tube to the distal end of the proximal tube. (19) Forming the interference spiral cut on the first flexible portion having the first pitch, The further includes forming the interference spiral cut on the second flexible portion having a second pitch, The method according to embodiment 18, wherein the first pitch is different from the second pitch. (20) The method according to embodiment 19, wherein the second flexible portion is configured to extend to a greater extent along the longitudinal axis than the first flexible portion when the engagement system deploys the implantable medical device.

Claims

1. It is a separation system, A substantially hollow distal tube comprising a defined longitudinal axis, a distal end, a first flexible portion, a spiral cut throughout the entire length, and a second flexible portion positioned between the first flexible portion and the distal end, The system comprises an engagement system configured to engage an implantable medical device with the distal end of the distal tube, and to deploy the implantable medical device from the distal end of the distal tube, When the engagement system engages with the implantable medical device, it compresses the second flexible portion along the longitudinal axis to a greater extent than the first flexible portion. The second flexible portion is configured to extend along the longitudinal axis to a greater extent than the first flexible portion when the engagement system deploys the implantable medical device. The first flexible portion is provided with a spiral cut having a first pitch, The second flexible portion is provided with a spiral cut having a second pitch, The first pitch is greater than the second pitch. The first pitch is in the range of 0.12 mm to 0.18 mm. The second pitch is in the range of 0.08 mm to 0.12 mm. The distal tube has a first length before the engagement system is engaged with the implantable medical device. The distal tube has a second length when the engagement system is engaged with the implantable medical device. The first length is greater than the second length. The difference between the first length and the second length is 0.1 mm to 0.25 mm, and the distal tube has a third length, which is the maximum length of the distal tube, when the implantable medical device is deployed by the engagement system. The third length is greater than the second length. The difference between the third length and the second length is 0.4 mm to 0.8 mm. The distal tube has a final length which is the net length of the distal tube when the first flexible portion and the second flexible portion of the distal tube are released from compression. The difference between the first length and the final length is 0 mm to 0.5 mm. The distal tube is under compression of a force of 0.127 N to 0.255 N (13 gf to 26 gf) when the engagement system is engaged with the implantable medical device. A separation system in which the force compresses the distal tube by 0.15 mm to 0.45 mm.

2. The separation system according to claim 1, wherein the spiral cuts of the first flexible portion and the second flexible portion comprise a 240-degree cut portion and a 20-degree uncut portion.

3. The engagement system, Locking member and It also features a loop wire, The separation system according to claim 1, wherein when the loop wire interacts with the locking member and engages with the implantable medical device, the force on the loop wire causes the first flexible portion and the second flexible portion to move along the longitudinal axis from the first length to the second length of the distal tube when the loop wire engages with the implantable medical device.

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