专利摘要:
implantable medical device disconnect system with split tube and cylindrical coupling. 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 connects the proximal and distal tubes. a coupling system engages and positions the implantable medical device engaged at the distal end of the distal tube. the coupling 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.102018067399-8
公开号:BR102018076822A2
申请号:R102018076822-0
申请日:2018-12-21
公开日:2019-06-25
发明作者:Juan Lorenzo
申请人:DePuy Synthes Products, Inc.;
IPC主号:
专利说明:

Summary of the Invention Patent for "DEPLOYMENT SYSTEM OF IMPLANTABLE MEDICAL DEVICE WITH DIVIDED TUBE AND CYLINDRICAL COUPLING".
FIELD OF THE INVENTION
The present invention relates generally to medical intervention device systems which are navigable through vessels of the body of a human subject. More particularly, this invention relates to disconnection systems for positioning an implantable medical device at a target site of a vessel of the body and methods of use thereof.
BACKGROUND
The use of catheter implantation systems for positioning and implanting therapeutic devices, such as dilatation balloons, stents and embolization springs, into the vasculature of the human body has become a standard procedure for treating endovascular- . It has been found that such devices are particularly useful in the treatment of areas where traditional surgical procedures are impossible or pose a great risk to the patient, for example, in the treatment of aneurysms in cranial blood vessels. Due to the delicate tissue surrounding cranial blood vessels, especially for example brain tissue, it is very difficult and often risky to perform surgical procedures to treat defects of the cranial blood vessels. Advancements in catheter positioning systems have provided an alternative treatment in such cases. Some of the advantages of catheter implantation systems are that they provide methods for treating blood vessels by an approach which has been found to reduce the risk of trauma to the surrounding tissue and also to allow the treatment of blood vessels which in the past would have been considered inoperable.
Typically, these procedures involve insertion of the distal end of a delivery catheter into the vasculature of a patient and its orientation through the vasculature to a predetermined delivery site. A vascular occlusion device, such as an embolization spring, is attached to the end of a deployment member which 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, U.S. Patent Nos. 5,250,071, Palermo, which is hereby incorporated by reference, discloses a disconnection system through which the system and spring engaging closures are held together by a control wire . The control wire is moved proximally to disengage the latches from each other. However, the system does not include any positive means for separating the latches disengaged from each other, so merely 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.
In addition, U.S. Patent 8,062,325 teaches a single tubular support for providing 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 positioning 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
A disconnection system deploys an implantable medical device at a target site of a vessel of the body having a generally hollow distal tube. The distal tube has a proximal end, a distal end, and a compressible portion of the axially movable distal tube itself from a condition compressed into an elongate condition between the proximal and distal ends. Also includes a generally hollow proximal tube having a proximal end and a distal end, a coupling disposed between the proximal end of the distal tube and the distal end of the proximal tube, joining the proximal and distal tubes, and a engaging system that engages and positions the implantable medical device engaged in 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 elongate condition. In another example, the engaging system may be removably secured to the proximal end of the distal tube by engaging the implantable medical device to maintain the compressed condition. Further, the engaging system may be removably secured to the proximal end of the proximal tube when engaging the implantable medical device.
An example of the engaging system has a trailing 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 coupling system. A force on the locking member releases the loop wire, disengages the implantable medical device and allows the compressible portion to return to the elongate condition.
Other examples have the compressible portion of the distal tube as a spirally cut portion of the distal tube. The compressible portion may be adapted to position the implantable medical device engaged by the engaging system when the compressible portion moves into the elongate condition. In addition, the compressible portion of the distal tube is adapted to move automatically / resiliently to the elongate condition when the engaging 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, which is flexible, and the distal tube may comprise a flexible portion of the distal tube itself, between the proximal end and the compressible portion, which is flexible.
A further example has the proximal tube partially overlapping the coupling, the distal tube partially overlapping the coupling, and a gap formed in the coupling between the proximal tube and the distal tube includes a welding strip for welding the coupling to the proximal tube and to the distal tube. In one example, the coupling is radiolabelling.
A method of disconnecting an implantable medical device using the examples above may include the steps of forming a compressible portion in the distal tube between the proximal and distal ends, engaging the implantable medical device with an engagement system, applying a force to the engaging system to compress the compressible portion, securing the engaging system to the distal tube to maintain a compressed state, and attaching the distal tube and the proximal tube together with the use of the coupling. As above, the engaging system may be removably attached to the proximal end of the distal tube.
The example of the disconnection method may additionally have the step of removably securing the engaging system to the proximal end of the proximal tube upon engaging the implantable medical device. The engaging step may include the step of using the loop wire with the locking member to engage the implantable medical device; and the step of applying additionally comprises the step of applying force to the loop wire to move the compressible portion to the compressed condition. Other exemplary steps include applying a force on the locking member, disengaging the implantable medical device, and allowing the compressible portion to return to the elongated condition.
Examples of the forming step may include the step of spirally cutting a portion of the distal tube and, additionally, the step of positioning the implantable medical device engaged by moving the compressible portion into the elongate condition. In addition, the compressible portion of the distal tube may be adapted to move automatically / resiliently to the elongate condition when the engaging system is disengaged from the implantable medical device. Additionally, the step of joining additionally has the steps of partially overlapping the proximal tube over the coupling, partially overlapping the distal tube over the coupling, forming a gap over the coupling between the proximal tube and the distal tube which comprises a strip weld the coupling to the proximal tube and the distal tube in the weld strip.
BRIEF DESCRIPTION OF THE DRAWINGS
The above aspects and additional aspects of this invention are discussed in more detail with reference to the following description in conjunction with the accompanying drawings in which like numerals indicate structural elements and similar features in various figures. The drawings are not necessarily to scale, with emphasis being instead given to the illustration of the principles of the invention. The figures represent one or more implementations of the devices of the invention by way of example only, not by way of limitation.
Figure 1A is an exploded view of an example of the disconnection system of the present invention with the medical device partially disengaged;
Figure 1B is an enlarged view of Figure 1A;
Figure 2 is an exploded view of an example of the disconnection system of the present invention with the medical device engaged; Figure 3A is a side perspective view of an example of a loop wire according to an example;
Figure 3B is a plan view of an example of a loop wire according to another example;
Figure 4 is a front perspective detail view of an opening of the loop wire in an upwardly facing condition in an alternative example;
Figure 5A is an exploded view of an example of the disconnection system of the present invention with the medical device engaged and the looped wire attached;
Figure 5B is an enlarged view of the loop wire attached to the distal tube;
Figure 6 is a plan view of the proximal and distal tubes overlying the coupling;
Figure 7 is a plan view of the proximal and distal tubes welded to the coupling;
Figure 8 shows the proximal weld on the small tube;
Figure 9 shows the fluoroscopic view of an example of the disconnect system;
Figure 10 shows an example of the method of forming the disconnection system of the present invention.
Figures 11A to 11D illustrate the medical device being disconnected with a partial cross-section;
Figure 12 is a side view of an example of the distal tube in the compressed and expanded state; and Figure 13 is a front perspective view of an example of the medical device being disconnected.
DETAILED DESCRIPTION
The Figures show a generally hollow or tubular structure according to the present invention. When used in the present invention, the terms "tubular" and "tube" are to be broadly interpreted and are not limited to a structure which 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 generally 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.
An example of a disconnection system 10 of the present invention, as shown in Figures 1A, 1B and 2, may have a proximal elongated implantation hypotube assembly 100, an intermediate coupling 200 and a distal implantation tube 300. One implantable medical device 12 is engaged in one end of the distal implantation tube 300. The implantable medical device 12 may be a coil spring, but it will be understood that virtually any implantable medical device 12 can be implanted and positioned by the disconnection system 10 according to with the present invention. The medical device 12 is engaged to the system with the use of 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. [0033] The proximal implantation tube 100 may have a proximal end portion 102, a distal end portion 104 and a flexible portion 106 therebetween. The proximal implantation tube 100 forms an axial lumen 108 therein. The proximal end 102 engages a smaller diameter tube 110 (see Figures 5A and 6 to 8) along the axial lumen 108. The distal implantation 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.
The implantation tubes 100, 300 may be produced from a biocompatible material, such as stainless steel. Tubes 100, 300 may typically have a diameter of between about 0.0254 centimeters and about 0.0457 centimeters (about 0.010 inches to about 0.018 inches), a preferred tube having a diameter of approximately 0.03683 centimeters 0.0145 inch). Such 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 comprising other materials may be useful for different applications and are within the scope of the present invention.
The flexible portions 106, 305 allow the implant tubes 100, 300 to bend and flex. This helps to trace the system 10 through the catheter and the tortuous trajectory through human vasculature. The flexible portions 106, 306 may be formed with interference spiral cuts. These cuts allow spans to allow flexing, but in one example, they do not act as a spiral cut spring. This way, they can bend and flex, but not compress.
The compressible portion 306 is axially adjustable between an elongate condition and a compressed condition. Preferably, the compressible portion 306 is formed from a spirally cut portion of the tube 300, formed by a laser cutting operation. However, any other arrangement allowing axial adjustment (e.g., a rolled 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 resting condition and automatically or resiliently returns to the elongated condition from a compressed condition, except if otherwise retained. The function of the compressible portion 306 is described in more detail herein.
An example of the coupling 200 has a proximal section 202, a distal section 204, a weld strip 206 therebetween and an axial lumen 208 therein. The coupling 200 connects both the implantation tubes 100, 300, and may provide a radiopaque marking to assist in aligning the disconnection system 10 in a delivery catheter during clinical use. An example of the intermediate coupling 200 may be a marker strip or a spring segment.
Figures 3A, 3B and 4 illustrate examples of the loop yarn 400. The loop yarn 400 may be relatively small having the thickness of a hair in some embodiments, so that it may be preferable that it be fully protected by the distal end 304 of the distal deployment tube 300 to prevent accidental contact damage. The wire loop 400 may be an elongated wire that is looped, as in Figure 3A. The loop wire 400a may also be a single elongated wire having an aperture 405, as shown in Figure 3B. The aperture 405 may be formed by loosely folding the loop yarn 400a in half. In an alternative example, the loop wire 400b comprises a flat ribbon defining an aperture 405a in a distal portion, and the aperture 405a may be in an upwardly facing condition suitable for engaging an end of the implantable medical device 12. An example of the loop wire 400, 400a, 400b may be elastically deformable to the upwardly facing condition such that it returns to the substantially flat condition when not otherwise retained. The loop yarn 400, 400a, 400b may be formed from any one of a number of materials, including nitinol and stainless steel.
To load the disconnection system 10, the locking member 140 is inserted axially into the lumen 108, 208, 308 of both tubes 100 and 300 and of the coupling 200. A distal end 404 of the loop wire 400 is inserted in the distal deployment 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 yarn 404 may then be looped to form the aperture 405. The aperture 405 is passed through the locking portion 18 and the locking member 140 is passed through the aperture 405 to engage the medical device 12. Refer to Figures 1A and 11A.
The loop yarn 400 is drawn at a proximal end of the loop yarn 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 yarn 402. loop 400 after the medical device 12 is mounted to the distal end 304 of the distal tube 300. Figures 2 and 11A illustrate the assembled medical device 12 and the distal tube 300 in a compressed state. Once the distal tube 300 is compressed to the proper amount, the loop wire 400 is anchored 408 at the wire soldering point 406 (between the proximal ends 402 and distal 404) to the proximal end 302 (i.e., behind of the compressible portion 306) at or near the anchor portion 310 of the distal deployment tube 300. See Figures 5A and 5B. The distal compression level of the distal deployment tube 300 is adjusted by varying the amount of force F on the loop wire 400 prior to securing the loop wire 400 in place with the anchor solder 408.
Figures 6 and 7 illustrate the attachment of the proximal implantation tube 100 and the distal implantation tube 300 with the use of the coupling 200. Figure 6 shows the distal end 104 of the proximal tube 100 being drawn toward the proximal end 202 of the coupling 200 and overlaps it. Similarly, the proximal end 302 of the distal tube 300 is drawn toward and distally over the distal end 204 of the coupling 200. The proximal and distal tubes 100, 300 in this example do not come in contact but leave the solder strip 206 as a gap in the coupling 200. The two tubes 100 and 300 are then circumferentially welded 210 together in the weld strip 206 to form a unitary device 10. The intermediate coupling 200 connects both the implantation tubes 100, 300 as well as provides a radiopaque marking for alignment of the system 10 to a delivery catheter (not shown) while in clinical use.
Before overlapping and welding the two tubes and the coupling, 100, 200, 300, the locking member 140 (as discussed above) is pulled through the coupling lumen 208 and 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 the proximal tube 100, the catch member 140 is welded 142 to the small tube 110. This is illustrated in Figure 8.
[0043] Figure 9 shows the disconnection system 10 in a fluoroscopic view. Because coupling 200 and medical device 12 are typically made of or have radiopaque marking, it allows a view of proximal tubes 100a and distal 300a having a different contrast from coupling 200a or medical device 12A. This provides visual feedback to indicate when the device 12a has been released (to be discussed further below).
Figure 10 shows an example of a method of assembling the disconnection 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 may be formed by spirally cutting the distal tube 300 or by any other means to form a tube which can be compressed and then returned to its uncompressed state quickly. The flexible portion 106 of the proximal tube 100 may be clipped by interference or by any other means to increase the flexibility of the proximal tube 100. When at least the distal tube 300 is ready, the medical device 12 may be engaged with an engagement system 140 , 400 (step 1004) and a force F can be applied to the engaging system 140, 400 to compress the compressible portion 306 (step 1006). It is noted here that although an example is presented above with the use of the locking member 140 and the loop wire 400 as an engagement system, the person skilled in the art may carry out different methods for securing the medical device 12 while still applying withdrawal force on the compressible portions 306 to be released when the engaging system 140, 400 is disengaged from the medical device 12. A section 406 of the engaging 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 engaging system 140, 400 is threaded through coupling 200 and proximal tube 100 (step 1010). The distal 300 and proximal tubes 100 are joined with the use of a coupling 200 (step 1012). Here, in this example, the ends 104, 302 of the tubes 100, 300 overlap the coupling 200 and all three are welded together 210. The end 144 of the coupling system 140, 400 may then be attached to a proximal end 102 of the proximal tube 100 (step 1014) to complete the device 10.
Turning to Figures 11A to 11D, disconnection of medical device 12 is illustrated in more detail. Figure 11A shows the engaging system 140, 400 locked in the locking portion 18 of the medical device 12. The aperture 405 of the loop wire 400 may be placed through the locking portion 18. When the locking member 140 is placed through the locking member 140, opening 405, the medical device 12 is now secured. The force F has previously been applied to place the distal tube 300 in the compressed state. Figure 11B shows the locking member 140 being pulled proximally to initiate the release sequence for the medical device 12. Figure 11C shows the instant that the locking member 140 exits the aperture 405 and is pulled out of the wire of the loop 400. The distal end 404 of the loop wire 400 falls back into its preformed shape (as discussed above) and exits the locking portion 18. As can be seen, there is now nothing to hold the medical device 12 to the disconnect system 10. Figure 11D shows the end of the release sequence. Here, the compressible portion 306 expanded / returned to its original shape and was "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.
Figure 12 shows the distal tube 300 shown without the medical device 12, but with the compressible portion 306 shortened in axial length to the compressed condition. In particular, a distance "d" is illustrated, whereby the distal tube 300 is axially shrunk by moving the compressible portion 306 from the elongated condition to the compressed condition. Such compression may occur along the axis A. Figure 13 shows another view of the medical device 12 at the point of disconnection. The locking member 140 has been drawn proximally so as to separate from the loop wire 400, allowing the medical device 12 to separate as the distal compressed portion 306 expands and further separates the medical device 12 from the deployment system 10. A arrow "E" denotes the elastic force that "pushes" the medical device 12 in the opposite direction of the distal end 304 to ensure clean separation and implantation into the target site within the patient. The elastic force E acts on the axis A of the lumen 308 and "pushes" the medical device 12 along the same axis A (see Figures 8 and 12).
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 various configurations, various stiffness properties and methods for implanting them. In addition, there are many possible variations in the materials and configurations of the application mechanism. The modifications relating to this invention are apparent 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]
Disconnection system for implanting an implantable medical device at a target site of a vessel of the body, characterized in 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 which is axially movable from a compressed condition to an elongated condition; a generally hollow proximal tube having a proximal end and a distal end; a coupling disposed between the proximal end of the distal tube and the distal end of the proximal tube, joining the proximal and distal tubes; an engaging system that engages and positions the implantable medical device engaged in 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 wherein the engaging system positions the implantable medical device and releases the compressible portion to the elongate condition.
[2]
Disconnecting system according to claim 1, characterized in that the engaging system is removably secured to the proximal end of the distal tube by engaging the implantable medical device to maintain the compressed condition.
[3]
Disconnection system according to claim 2, characterized in that the engaging system is removably secured to the proximal end of the proximal tube by engaging the implantable medical device.
[4]
Disconnecting system according to claim 2, characterized in that the engaging system comprises: a locking member; and a yarn loop, wherein when the loop yarn interacts with the trailing member to engage the implantable medical device, a force on the loop yarn moves the compressible portion to the compressed condition, and wherein the loop yarn is welded to the proximal end of the distal tube for removably securing the engaging system.
[5]
A disconnection system according to claim 4, characterized in that a force on the locking member releases the loop wire, disengages the implantable medical device and allows the compressible portion to return to the elongate condition.
[6]
Disconnection system according to claim 1, characterized in that the compressible portion of the distal tube is a spirally cut portion of the distal tube.
[7]
Disconnection system according to claim 1, characterized in that the compressible portion is adapted to position the implantable medical device engaged by the engaging system when the compressible portion moves into the elongate condition.
[8]
Disconnection system according to claim 1, characterized in that the compressible portion of the distal tube is adapted to automatically / resiliently move to the elongate condition when the engaging system is disengaged from the implantable medical device.
[9]
A disconnection system according to claim 1, characterized in that: the proximal tube partially overlaps the coupling, the distal tube partially overlaps the coupling, a gap formed in the coupling between the proximal tube and the distal tube comprises a welding strip for welding the coupling to the proximal tube and the distal tube.
[10]
Disconnection system according to claim 1, characterized in that the coupling is radiopaque.
[11]
Disconnection system according to claim 1, characterized in that: the proximal tube comprises a flexible portion of the proximal tube itself, between the proximal and distal ends, which is flexible; and the distal tube comprises a flexible portion of the distal tube itself, between the proximal end and the compressible portion, which is flexible.
[12]
Method for disconnecting an implantable medical device comprising a hollow distal tube having a proximal end and a distal end, a hollow proximal tube having a proximal end and a distal end and a coupling, characterized in 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 an engagement system; applying a force to the engaging system to compress the compressible portion; securing the engaging system to the distal tube to maintain a compressed state; attaching the distal tube and the proximal tube together with the use of the coupling;
[13]
A disconnection method according to claim 12, characterized in that the engagement system is removably secured to the proximal end of the distal tube.
[14]
A disconnection method according to claim 13, characterized in that it further comprises the step of removably securing the engaging system to the proximal end of the proximal tube by engaging the implantable medical device.
[15]
The disconnection method according to claim 13, characterized in that the engaging system comprises a locking member, and a loop wire, wherein 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 step of applying further comprises the step of applying force to the wire loop to move the compressible portion to the compressed condition.
[16]
Disconnection method according to claim 15, characterized in that it further comprises the steps of: applying a force on the locking member; disengaging the implantable medical device; and allowing the compressible portion to return to the set condition.
[17]
Disconnection method according to claim 12, characterized in that the forming step comprises the step of spirally cutting a portion of the distal tube.
[18]
A disconnection method according to claim 12, characterized in that it further comprises the positioning step of the engaged implantable medical device by moving the compressible portion to the elongate condition.
[19]
A disconnection method according to claim 12, characterized in that the compressible portion of the distal tube is adapted to automatically / resiliently move to the elongate condition when the engaging system is disengaged from the implantable medical device.
[20]
A disconnection method according to claim 12, characterized in that the joining step further comprises the steps of: partially overlapping the proximal tube over the coupling; partially overlapping the distal tube over the coupling; forming a gap in the coupling between the proximal tube and the distal tube comprising a strip of solder; and weld the coupling to the proximal tube and the distal tube in the weld strip.
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公开号 | 公开日
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法律状态:
2019-06-25| 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
US15/850,993|US10806462B2|2017-12-21|2017-12-21|Implantable medical device detachment system with split tube and cylindrical coupling|
US15/850,993|2017-12-21|
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