• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
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    • 专利摘要:
    implantable medical device disconnect system with split tube. The present invention relates to a disconnect system for implanting an implantable medical device at a target site of a body vessel having a generally hollow distal tube. the distal tube includes a proximal end, a distal end, and a compressible portion of the tube itself, between the proximal and distal ends, which is axially movable from a compressed condition to an elongated condition. a generally hollow proximal tube has a proximal end and a distal end. a coupling system engages and positions the implantable medical device engaged at the distal end of the distal tube. the engaging system moves the compressible portion to the compressed condition when it engages the implantable medical device, and positions the implantable medical device and releases the compressible portion to the elongated condition.
    公开号:BR102019008433A2
    申请号:R102019008433-2
    申请日:2019-04-25
    公开日:2019-10-29
    发明作者:Lorenzo Juan
    申请人:Depuy Synthes Products Inc；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for DISCONNECTION SYSTEM OF IMPLANTABLE MEDICAL DEVICE WITH DIVIDED TUBE.
    FIELD OF THE INVENTION [0001] This invention relates generally to medical intervention device systems that are navigable through vessels in the body of a human individual. More particularly, this invention relates to disconnection systems for positioning an implantable medical device at a target location on a vessel in the body and methods of using them.
    BACKGROUND [0002] The use of catheter implantation systems to position and implant therapeutic devices, such as dilation balloons, stents and embolization springs, in the vasculature of the human body, has become a standard procedure for treating endovascular diseases. Such devices have been found to be particularly useful in the treatment of areas where traditional surgical procedures are impossible or represent a great risk for the patient, for example, in the treatment of aneurysms in cranial blood vessels. Due to the delicate tissue that surrounds cranial blood vessels, especially, for example, brain tissue, it is very difficult and often risky to perform surgical procedures to treat cranial blood vessel defects. Advances in catheter positioning systems have provided alternative treatment in such cases. Some of the advantages of catheter implantation systems are that they provide methods for treating blood vessels through an approach with which it has been found to reduce the risk of trauma to surrounding tissue, and also allow treatment of blood vessels that in the past would have been considered inoperable.
    Petition 870190039230, of 25/04/2019, p. 13/54
    2/13 [0003] Typically, these procedures involve inserting the distal end of a release catheter into a patient's vasculature and guiding it through the vasculature to a predetermined release site. A vascular occlusion device, such as an embolization spring, is attached to the end of an implantation member that pushes the spring through the catheter and out of the distal end of the catheter at the implantation site. Some of the problems associated with these procedures relate to ensuring complete release and positioning of the spring. For example, US Patent No. 5,250,071, of Palermo, which is incorporated herein by way of reference, describes a disconnection system by means of which the system and spring clips are held together by a control wire. . The control wire is moved proximally to disengage the locks from each other. However, the system does not include any positive means for separating the disengaged locks from each other, so merely the retraction of the control wire does not ensure the release and positioning of the spring. Several other disconnection systems currently in use suffer from similar problems.
    [0004] In addition, US Patent No. 8,062,325 features a single tubular support for supplying and positioning the vascular occlusion device, but has only a single compressible section. Therefore, there remains a need for a faster release removal system or method that can ensure the release and placement of an implantable medical device. Additional advantages can be obtained with a disconnection system or method that incorporates a simple and inexpensive locking and positioning system.
    SUMMARY [0005] A disconnection system deploys an implantable medical device in a target location of a vessel in the body that has a generally hollow distal tube. The distal tube has a proximal end,
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    3/13 a distal end, and a compressible portion of the distal tube itself axially movable from a compressed condition to an elongated condition, between the proximal and distal ends. It also includes a generically hollow proximal tube that has a proximal end and a distal end, the distal and proximal tubes being joined together, and an engaging system for engaging and positioning the implantable medical device engaged at the distal end of the distal tube. The engagement system moves the compressible portion to the compressed condition when engaging the implantable medical device, and positions the implantable medical device and releases the compressible portion to the elongated condition.
    [0006] In another example, the coupling system can be removably attached to the proximal end of the distal tube by engaging the implantable medical device to maintain the condition compressed. In addition, the coupling system can be removably attached to the proximal end of the proximal tube when engaging the implantable medical device.
    [0007] An example of the coupling system has a locking member and a loop wire. When the loop wire interacts with the locking member to engage the implantable medical device, a force on the loop wire moves the compressible portion to a compressed condition, and the loop wire is welded to the proximal end of the distal tube to secure the hitch system is removable. A force on the locking member releases the loop wire, disengages the implantable medical device and allows the compressible portion to return to the stretched condition.
    [0008] Other examples have the compressible portion of the distal tube as a spiral cut portion of the distal tube. The compressible portion can be adapted to position the implantable medical device engaged by the engagement system when the compressible portion is
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    4/13 moves to the stretched condition. In addition, the compressible portion of the distal tube is adapted to move automatically / resiliently to the elongated condition when the engagement system is disengaged from the implantable medical device. The proximal tube can also include a flexible portion of the proximal tube itself, between the proximal and distal ends, which is flexible, and the distal tube can comprise a flexible portion of the distal tube itself, between the proximal end and the compressible portion, which is flexible.
    [0009] A method for disconnecting an implantable medical device using the examples above can include the steps of forming a compressible portion in the distal tube between the proximal and distal ends, engaging the implantable medical device with a latching system, applying force to the coupling system to compress the compressible portion, fix the coupling system to the distal tube to maintain a compressed state, and connect the distal tube to the proximal tube. As above, the engagement system can be removably attached to the proximal end of the distal tube.
    [0010] The example of the disconnection method may also include the step of removably attaching the coupling system to the proximal end of the proximal tube when engaging the implantable medical device. The engagement step may include the step of using the loop wire with the locking member to engage the implantable medical device; and the application step further comprises the step of applying force to the loop wire to move the compressible portion to the compressed condition. Other exemplary steps include applying force to the locking member, disengaging the implantable medical device, and allowing the compressible portion to return to the stretched condition.
    [0011] Examples of the formation step may include the step of spiraling a portion of the distal tube and, further, the step of positioning the implantable medical device engaged by moving the portion
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    5/13 compressible for the elongated condition. In addition, the compressible portion of the distal tube can be adapted to move automatically / resiliently to the stretched condition when the engagement system is disengaged from the implantable medical device.
    [0012] In addition, the joining step also has the step of welding the tube proximal to the distal tube in the weld strip.
    BRIEF DESCRIPTION OF THE DRAWINGS [0013] The above and additional aspects of this invention are discussed in more detail with reference to the following description together with the accompanying drawings, in which similar numbers indicate similar structural elements and features in various figures. The drawings are not necessarily to scale, with emphasis being given instead to illustrating the principles of the invention. The figures represent one or more implementations of the devices of the invention only by way of example, not by way of limitation.
    [0014] Figure 1A is an exploded view of an example of the disconnection system of the present invention with the medical device partially disengaged;
    [0015] Figure 1B is an enlarged view of Figure 1A;
    [0016] Figure 2 is an exploded view of an example of the disconnection system of the present invention with the medical device engaged;
    [0017] Figure 3A is a side perspective view of an example of a loop wire according to an example;
    [0018] Figure 3B is a plan view of an example of a loop wire according to another example;
    [0019] Figure 4 is a view in detail in an anterior perspective of an opening of the loop wire in an upward condition in an alternative example;
    [0020] Figure 5A is an exploded view of an example of the disconnection system of the present invention with the medical device
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    6/13 engaged and the loop wire attached;
    [0021] Figure 5B is an enlarged view of the loop wire attached to the distal tube;
    [0022] Figure 6 is a plan view of a gap between the proximal and distal tubes;
    [0023] Figure 7 is a plan view of the proximal and distal tubes welded together;
    [0024] Figure 8 illustrates the proximal weld in the small tube;
    [0025] Figure 9 illustrates an example of the method for forming the disconnect system of the present invention;
    [0026] Figures 10A to 10D illustrate the medical device being disconnected with a partial cross section;
    [0027] Figure 11 is a side view of an example of the distal tube in the compressed and expanded state; and [0028] Figure 12 is a front perspective view of an example of the medical device being disconnected.
    DETAILED DESCRIPTION [0029] The Figures illustrate a generally hollow or tubular structure according to the present invention. When used in the present invention, the terms tubular and tube should be interpreted broadly and are not limited to a structure that is a straight cylinder or with a strictly circumferential cross section or with a uniform cross section along its length. For example, the tubular structure or system is, in general, illustrated as a substantially straight cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
    [0030] An example of a disconnect system 10 of the present invention, as illustrated in Figures 1A, 1B and 2, may have a set of proximal elongated deployment tube 100 and a
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    7/13 distal implantation 300. An implantable medical device 12 is engaged at one end of the distal implantation tube 300. The implantable medical device 12 can be a spring for embolization, but it will be understood that virtually any implantable medical device 12 can be implanted and positioned by the disconnection 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 for interfacing with an engaging system 140, 400.
    [0031] The proximal implantation tube 100 may have a proximal end portion 102, a distal end portion 104 and a flexible portion 106 between them. The proximal implantation tube 100 forms an axial lumen 108 within it. The proximal end 102 engages with a smaller diameter tube 110 (see Figures 5A and 6 to 8) along the axial lumen 108. The distal implant tube 300 may have a proximal end portion 302, a distal end portion 304 and between the two, a compressible portion 306. In one example, the compressible portion 306 may be closer to the distal end portion 304, and between the proximal end portion 302 and the compressible portion 306 there may be a flexible portion 305. The distal implantation tube 300 forms an axial lumen 308 therein.
    [0032] Implant tubes 100, 300 can be produced from a biocompatible material, such as stainless steel. Tubes 100, 300 can typically have a diameter between about 0.010 inch and about 0.018 inch, a preferred tube having a diameter of approximately 0.0145 inch. These tube size examples are suitable for implanting and positioning embolization springs at target sites, typically aneurysms, within the neurovasculature. Tubes of different sizes 100, 300 composed of other materials can be useful for different applications and are
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    8/13 within the scope of the present invention.
    [0033] The flexible portions 106, 305 allow the implantation tubes 100, 300 to bend and flex. This helps to track system 10 through the catheter and the tortuous path through the human vasculature. The flexible portions 106, 306 can be formed with interference spiral cuts. These cuts allow spans to allow bending, but in one example, they do not act as a spiral cutting spring. That way, they can bend and flex, but not compress.
    [0034] The compressible portion 306 is axially adjustable between an elongated condition and a compressed condition. Preferably, the compressible portion 306 is formed from a spiral cut portion of the tube 300, formed by a laser cutting operation. However, any other arrangement that allows axial adjustment (for example, a coiled wire or spiral ribbon) is also suitable for use with disconnection systems in accordance with the present invention. Most preferably, the compressible portion 306 is in the elongated condition at rest and automatically or resiliently returns to the elongated condition from a compressed condition, except if retained in any way. The function of the compressible portion 306 is described in more detail in this document.
    [0035] Figures 3A, 3B and 4 illustrate examples of loop wire 400.
    The loop wire 400 can be relatively small, having the thickness of a hair in some modalities, so it may be preferable that it is fully protected by the distal end 304 of the distal implant tube 300 to prevent damage caused by accidental contact . The yarn loop 400 may be an elongated yarn that is looped, as in Figure 3A. The loop yarn 400a can also be a single elongated yarn with an opening 405, as shown in Figure 3B. Opening 405 can be formed by folding loosely
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    9/13 the loop wire 400a in half. In an alternative example, the loop wire 400b comprises a flat ribbon that defines an opening 405a in a distal portion, and the opening 405b may be in an upward condition suitable for engaging one end of the implantable medical device 12. An example of loop wire 400, 400a, 400b can be elastically deformable for the upward-facing condition such that it returns to the substantially flat condition when not otherwise retained. The loop wire 400, 400a, 400b can be formed from any of a number of materials, including nitinol and stainless steel.
    [0036] To load the disconnect system 10, the locking member 140 is inserted axially into the lumens 108, 208, 308 of both tubes 100 and 300. A distal end 404 of the loop wire 400 is inserted into the distal implantation tube 300 through an anchor portion 310 located at the proximal end 302 of the distal tube 300 and passed through the lumen 308 to the distal end 304. The distal end of the loop wire 404 can then be looped to form the opening 405. A opening 405 is passed through the locking portion 18 and the locking member 140 is passed through the opening 405 to engage the medical device 12. See Figures 1A and 11A.
    [0037] Loop wire 400 is pulled at a proximal end of loop wire 402 and the continuous force F compresses the compressible portion 306. The amount of compression can be controlled by the amount of force F applied to the proximal end 402 of the wire loop 400 after the medical device 12 is mounted on the distal end 304 of the distal tube 300. Figures 2 and 11A illustrate the mounted medical device 12 and the distal tube 300 in a compressed state. Once the distal tube 300 is compressed to the appropriate amount, the loop wire 400 is welded by anchor 408 at the weld spot of wire 406 (between the proximal ends 402 and distal 404) to the proximal end 302 (ie, back
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    10/13 of the compressible portion 306) at or near the anchor portion 310 of the distal implantation tube 300. See Figures 5A and 5B. The distal compression level of the distal implantation tube 300 is adjusted by varying the amount of force F on the loop wire 400 before securing loop wire 400 in place with anchor weld 408.
    [0038] Figures 6 and 7 illustrate the union of the proximal implantation tube 100 and the distal implantation tube 300. Figure 6 illustrates the distal end 104 of the proximal tube 100 being pulled towards the proximal end 302 of the distal tube 300 and , in some examples, coming into contact with the proximal end 302 of the distal tube 300. The proximal and distal tubes 100 and 300, in this example, do not come into contact, but leave the weld strip 206 as a gap. The two tubes 100 and 300 are then circumferentially welded 210 together in the weld strip 206 to form a unitary device 10.
    [0039] Before welding the two tubes 100 and 300, the locking member 140 (as discussed above) is pulled through the lumen of the proximal tube 108 to the small tube 110. In a proximal opening 112 in the small tube 110, opposite the proximal end 102 of proximal tube 100, locking member 140 is welded 142 to small tube 110. This is illustrated in Figure 8.
    [0040] Figure 9 illustrates an example of a method of mounting the disconnect system 10. The method includes forming the compressible portion 306 in the distal tube 300 (step 1000) and forming the flexible portion 106 in the proximal tube 100 (step 1002) . Step 1002 may also include forming the flexible portion 305 on the distal tube 300. The compressible portion 306 can be formed by spiral cutting the distal tube 300 or by any other means to form a tube that can be compressed and then returned to its uncompressed state quickly. The flexible portion 106 of the proximal tube 100 can be cut by interference or by any other means to increase the flexibility of the proximal tube 100.
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    11/13
    When at least the distal tube 300 is ready, the medical device 12 can be engaged with an engagement system 140, 400 (step 1004) and a force F can be applied to the engagement system 140, 400 to compress the compressible portion 306 ( step 1006). Here it is observed that although an example is presented above with the use of the locking member 140 and the loop wire 400 as a latching system, the skilled person can perform different methods for securing the medical device 12 while still applying removal force. on the compressible portions 306 to be released when the engagement system 140, 400 is disengaged from the medical device 12. A section 406 of the engagement system 140, 400 is then engaged with the distal tube 300 to maintain the compressed state of the compressible portion 306 (step 1008). A portion of the engagement system 140, 400 is passed through the proximal tube 100 (step 1010). The distal tubes 300 and proximal 100 are joined to each other (step 1012). Here, in this example, ends 104 and 302 of tubes 100 and 300 are welded together 210. The end of the coupling system 140, 400 can then be joined to a proximal end 102 of proximal tube 100 (step 1014) to complete device 10.
    [0041] In relation to Figures 10A to 10D, the disconnection of the medical device 12 is illustrated in more detail. Figure 10A illustrates the engagement system 140, 400 locked in the locking portion 18 of the medical device 12. The opening 405 of the loop wire 400 can be placed through the locking portion 18. When the locking member 140 is placed through the opening 405, medical device 12 is now attached. Force F was previously applied to place the distal tube 300 in the compressed state. Figure 10B illustrates the locking member 140 being pulled proximally to initiate the release sequence of the medical device 12. Figure 10C illustrates the instant when the locking member 140 exits opening 405 and is pulled out of loop wire 400 . A
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    12/13 distal end 404 of loop wire 400 falls / returns to its preformed shape (as discussed above) and exits locking portion 18. As can be seen, there is now nothing that holds medical device 12 to the disconnecting system 10. Figure 10D illustrates the end of the release sequence. Here, the compressible portion 306 has expanded / returned to its original shape and has been released forward. An elastic force E is imparted by the distal end 304 of the distal tube 300 to the medical device 12 to push it in the opposite direction to ensure clean separation and implantation of the medical device 12.
    [0042] Figure 11 shows the distal tube 300 illustrated without the medical device 12, but with the compressible portion 306 shortened in axial length for the compressed condition. In particular, a distance d is illustrated, by which the distal tube 300 is axially shrunk when moving the compressible portion 306 from the elongated condition to the compressed condition. This compression can occur along the geometric axis A. Figure 12 illustrates another view of the medical device 12 at the point of disconnection. Locking member 140 was pulled proximally to separate from loop wire 400, allowing medical device 12 to separate as distal compressed portion 306 expands and further separates medical device 12 from implantation system 10. A arrow E denotes the elastic force that pushes the medical device 12 in the opposite direction from the distal end 304 to ensure clean separation and implantation at the target site within the patient. The elastic force E acts on the geometric axis A of the lumen 308 and pushes the medical device 12 along the same geometric axis A (see Figures 8 and 11).
    [0043] The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described in the present invention, the invention contemplates many variations and modifications of the delivery and implantation system of the invention for a vascular occlusion device, including several
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    13/13 configurations, various stiffness properties and methods for deploying them. In addition, there are many possible variations in the materials and configurations of the application mechanism. Modifications relating to this invention are evident to those skilled in the art, and are intended to be within the scope of the following claims.
    权利要求:
    Claims (20)
    [1]
    1. Disconnection system for implanting an implantable medical device in a target location of a vessel in the body, characterized by the fact that it comprises:
    a generally hollow distal tube comprising:
    a proximal end;
    a distal end; and a compressible portion of the distal tube itself, between the proximal and distal ends that is axially movable from a compressed condition to an elongated condition;
    a generally hollow proximal tube that has a proximal and a distal end;
    a weld disposed between the proximal end of the distal tube and the distal end of the proximal tube, joining the proximal and distal tubes;
    an engagement system that engages and positions the implantable medical device engaged at the distal end of the distal tube;
    wherein the engaging system moves the compressible portion to the compressed condition when engaging the implantable medical device, and where the engaging system positions the implantable medical device and releases the compressible portion to the elongated condition.
    [2]
    2. Disconnection system according to claim 1, characterized by the fact that the coupling system is removably attached to the proximal end of the distal tube when the implantable medical device is engaged to maintain the compressed condition.
    [3]
    3. Disconnection system according to claim 2, characterized by the fact that the coupling system is removably attached to the proximal end of the proximal tube when the implantable medical device is engaged.
    [4]
    4. Disconnection system, according to claim 2, characterized by the fact that the coupling system profile comprises:
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    2/5 a locking member; and a wire loop, in which when the loop wire interacts with the locking member to engage the implantable medical device, a force on the loop wire moves the compressible portion to the compressed condition, and where the loop wire is welded to the proximal end of the distal tube to removably secure the coupling system.
    [5]
    5. Disconnection system, according to claim 4, characterized by the fact that a force in the locking member releases the loop wire, disengages the implantable medical device and allows the compressible portion to return to the elongated condition.
    [6]
    6. Disconnection system according to claim 1, characterized in that the compressible portion of the distal tube is a spiral cut portion of the distal tube.
    [7]
    7. Disconnection system according to claim 1, characterized by the fact that the compressible portion is adapted to position the implantable medical device engaged by the coupling system when the compressible portion moves to the elongated condition.
    [8]
    8. Disconnection system according to claim 1, characterized in that the compressible portion of the distal tube is adapted to move automatically / resiliently to the elongated condition when the engagement system is disengaged from the implantable medical device.
    [9]
    9. Disconnection system, according to claim 1, characterized by the fact that it also comprises:
    a gap between the proximal tube and the distal tube comprising a weld strip for welding the proximal tube to the distal tube.
    [10]
    10. Disconnection system, according to claim 1, characterized by the fact that the proximal end of the distal tube
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    3/5 and the distal end of the proximal tube are in contact with each other when welded.
    [11]
    11. Disconnection system, according to claim 1, characterized by the fact that the proximal tube comprises a flexible portion of the proximal tube itself, between the proximal and distal ends which is flexible; and wherein the distal tube comprises a flexible portion of the distal tube itself, between the proximal end and the compressible portion, which is flexible.
    [12]
    12. Method for disconnecting an implantable medical device that comprises a hollow distal tube that has a proximal end and a distal end, and a hollow proximal tube that has a proximal end and a distal end, characterized by the fact that it comprises the steps of:
    forming a compressible portion in the distal tube between the proximal and distal ends;
    engaging the implantable medical device with a latching system;
    applying force to the coupling system to compress the compressible portion;
    fix the coupling system to the distal tube to maintain a compressed state;
    joining the distal tube to the proximal tube;
    [13]
    13. Disconnection method, according to claim
    12, characterized by the fact that the coupling system is removably fixed to the proximal end of the distal tube.
    [14]
    14. Disconnection method, according to claim
    13, characterized by the fact that it also comprises the step of removably fixing the coupling system to the proximal end of the
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    4/5 proximal tube when the implantable medical device is engaged.
    [15]
    15. Disconnection method according to claim 13, characterized in that the coupling system comprises a locking member and a loop wire, in which the hooking step further comprises the step of using the loop wire with the locking member for engaging the implantable medical device; and wherein the application step further comprises the step of applying force to the wire loop to move the compressible portion to the compressed condition.
    [16]
    16. Disconnection method, according to claim 15, characterized by the fact that it also comprises the steps of:
    applying force to the locking member;
    disengage the implantable medical device; and enabling the compressible portion to return to the elongated condition.
    [17]
    17. Disconnection method according to claim 12, characterized in that the forming step comprises the spiral cutting step of a portion of the distal tube.
    [18]
    18. Disconnection method according to claim 12, characterized by the fact that it further comprises the step of positioning the implantable medical device engaged by moving the compressible portion to the elongated condition.
    [19]
    19. Disconnection method according to claim 12, characterized in that the compressible portion of the distal tube is adapted to automatically / resiliently pass to the elongated condition when the coupling system is disengaged from the implantable medical device.
    [20]
    20. Disconnection method, according to claim 12, characterized by the fact that the joining step also comprises the
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    5/5 steps of:
    forming a gap between the proximal tube and the distal tube comprising a weld strip; and weld the tube proximal to the distal tube in the weld strip.
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    法律状态:
    2019-10-29| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US15/964,857|US10806461B2|2018-04-27|2018-04-27|Implantable medical device detachment system with split tube|
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