Medical device release device, system, and method of use

Abstract

To provide a medical device releasing device and a method for using the same.SOLUTION: A delivery device 10 has a head element 11 provided at a proximal end of the device. A head is constituted to extend through a medical device and proximally protrude from the medical device. The head element has one or more hook elements 13 for being engaged with a control loop connected to the medical device. The one or more hook elements are fixed in an axial direction to the head element.SELECTED DRAWING: Figure 4A

Description

Technical Field

[0001] The present invention relates to a medical device release apparatus and a method of using the same.

Background Art

[0002] In this regard, medical devices such as intravascular stent devices generally use a control loop, an eyelet, and a release wire in combination and are attached to their delivery systems. As shown in FIGS. 1 to 3, this connection is achieved by passing the free end of the control loop 2 of the control thread through the eyelet 3 and fixing the other end to the tip of the delivery system. Then, the release wire 4 is passed through the open loop of the control thread formed when the control thread passes through the eyelet to prevent the control thread from being pulled back through the eyelet. By removing the release wire 4, the control loop 2 is pulled back through the eyelet, and the medical device 5 is released from the delivery system, enabling the device to be freed from the delivery system. In this configuration, problems may occur when the release wire is damaged and cannot be removed from the control loop. This may prevent the user from removing the delivery system from the patient unless additional remedial measures are taken or a complete conversion to laparotomy is performed. Also, problems may occur if the user forgets to remove the release wire before attempting to remove the delivery system. This may cause the device to move from the intended sealing area, break the seal, and potentially damage the blood vessel during the process.

[0003]

[0004]

[0005]

Summary of the Invention

[0006] The present invention provides an apparatus and method aimed at mitigating the problems of such known configurations. To provide. [Means for solving the problem]

[0007] According to the present invention, a medical device delivery device is provided, the device having a head at the proximal end of the device. Equipped with elements, the head extends through the medical device and proximally away from the medical device. The head element is configured to protrude and engage with a control loop connected to a medical device. It has one or more hook elements, and the one or more hook elements are axial to the head element. It is fixed in the direction of the line.

[0008] In this way, the medical device allows the delivery system to be pulled without any additional mechanical operation of the device. It can be released at the same time as being pulled out.

[0009] Preferably, one or more hook elements face forward, and one or more hook elements are free The ends extend in a direction toward the proximal end of the head element.

[0010] Conveniently, the head element has two hook elements.

[0011] Preferably, the hook elements are provided on both sides of the head element in the diametrical direction.

[0012] Conveniently, one or more hook elements extend proximal to the head element's longitudinal profile It protrudes radially outward from the il.

[0013] Preferably, one or more hook elements are provided at the distal end of the head element.

[0014] Conveniently, one or more hook elements each have the form of an inclined slot, open at the proximal end and closed at the distal end.

[0015] Preferably, each slot has a tapered profile.

[0016] Conveniently, the head element comprises a head body and a head plate, the head plate being connected to the distal end of the head body to define the one or more hook elements between the head body and the head plate.

[0017] <()000083>Preferably, the head body is chamfered at the distal end of the head body to define the one or more hook elements.

[0018] Conveniently, the device further comprises one or more attachment points for the ends of the control loop.

[0019] Preferably, the one or more attachment points are provided on the head element proximal to the one or more hook elements.

[0020] Conveniently, the one or more hook elements are movable between a deployed position and a non-deployed position.

[0021] Preferably, the one or more hook elements are pivotable between a deployed position and a non-deployed position.

[0022] Conveniently, the one or more hook elements are stowable in a plane substantially co-planar with the longitudinal profile of the device.

[0023] Preferably, rotation of the head element is caused by the one or more hook elements ​​​​It is profiled to facilitate the release of any control loops that are engaged.

[0024] Preferably, one or more hook elements include an angled portion having a radially extending portion. The radially extending portion is configured to engage with the control loop.

[0025] The device preferably connects one or more hook elements to one or more eyelets of a medical device. It further includes alignment means for aligning with the T.

[0026] According to a further aspect of the present invention, a medical device deployment system for deploying medical devices The system is provided, and the medical device deployment system has a head element at the proximal end of the device. Equipped with a medical device delivery device, the head extends through the medical device and also delivers medical devices The head element is configured to protrude proximally from the chair and is connected to a medical device. It has one or more hook elements for engaging with the loop, and one or more hook elements are head It is fixed to the element in the axial direction.

[0027] According to yet another aspect of the present invention, medical A method is provided for deploying a device, which involves passing the delivery device inside the medical device. The steps include causing it to protrude from the proximal end of the medical device and using one or more control loops. The steps include connecting the medical device and one or more hook elements of the delivery device, and deploying the device. Steps include advancing the device to the site, deploying the medical device at the site, and delivery device. The steps include a step to set it back, and one or more control loops from one or more hook elements. Once released, one or more hook elements are fixed axially to the head element.

[0028] Preferably, the one or more control loops are attached to the head element of the delivery device, It passes through one or more eyelets provided in the medical device, and then the one or more F Pass around the eyelet element, then pass through one or more eyelets again.

[0029] Conveniently, one or more control loops are attached to the medical device, and one or more feet Pass around the element.

[0030] Preferably, the medical device has a wavy proximal end profile and one or more controll The loop is attached to the proximal peak of the medical device.

[0031] Conveniently, moving one or more hook elements makes it easier to release one or more control loops. To make something worse.

[0032] Preferably, one or more hook elements are pivoted backward to release one or more control loops. To make it easier.

[0033] Conveniently, the head element rotates around its longitudinal axis to control one or more controls Makes it easier to break the loop. [Brief explanation of the drawing]

[0034] [Figure 1] Figure 1 shows a known configuration for delivering a medical device to a site. [Figure 2] Figure 2 shows a known configuration for delivering a medical device to a site. [Figure 3] Figure 3 shows known configurations for delivering medical devices to a site. [Figure 4] Figures 4a to 4d show a first embodiment of the present invention. [Figure 5]Figures 5a to 5e show a second embodiment of the present invention. [Figure 6] Figures 6a to 6c show a third embodiment of the present invention. [Figure 7] Figures 7a and 7b show a fourth embodiment of the present invention. [Modes for carrying out the invention]

[0035] Herein, embodiments of the present invention will be described as examples and with reference to the accompanying drawings.

[0036] Figures 1-3 illustrate conventional delivery systems for intravascular devices, as described above. Such systems may fail if the release wire is damaged or if the user removes the delivery system. Problems can arise if you forget to remove the release wire before attempting to remove the cable.

[0037] Therefore, the present invention provides a medical device delivery system that does not require a release wire. This is what they intend to do.

[0038] In this regard, as shown in Figures 4a to 4d, the delivery device 10 is located near the longitudinal axis 12 The end portion is provided with a tip or head element 11. The head element is directed toward the proximal end of the head element. It has a hook element 13 that is radially outward and protrudes forward. The hook element is arbitrary It can be formed in a precise manner, and in this embodiment, to form the slot 15, the head The distal end of the element is chamfered, and plate 14 is connected to it to form the element. As shown in the figure, The end portion 16 of the plate preferably follows the general outer longitudinal profile of the head element 11. It protrudes radially outward.

[0039] As shown in the figure, the head element passes through the inside of a medical device 17 such as an intravascular stent. The head element 11 is positioned to extend from the proximal end of the medical device 17 when in use. It protrudes. For clarity, the structure of the medical device is not shown in detail in the diagram, but the symbols The device may be an expandable stent having a wavy proximal end as shown in 17. In the embodiments shown in Figures 4a to 4d, the control loop 19 is located above the hook element, i.e., the head. At a mounting point 20 near the proximal end of the element, one end is attached to the head element.

[0040] Each control loop extends to the rear and passes through eyelets 21 connected to the medical device. Next, the loop returns to the head element, loops around the hook element 11, and then the eyelet It returns to the front and then rises towards the proximal end of the device.

[0041] Figures 4a-4d show the progression of the head element onto the medical device 17. In Figure 4a, the medical The therapeutic device moves to the correct position for a part that can be fixed in a predetermined position. It is. This is because the device is designed to seal against the inner surface of the blood vessel into which it is deployed. This can be done by extending the chair.

[0042] Once correctly secured in place, the delivery device retracts as shown in Figures 4b-4d, and the debit It passes posteriorly through the device towards the distal end of the chair.

[0043] When the eyelet is horizontal with the hook element 11, the control loop is pulled downwards within the hook element. The tension will be lost, and therefore it may begin to detach from the hook element as shown in Figures 4b and 4c. Next, in Figure 4d, the control loop no longer gets caught around the hook element, and delivery The device can pass through the eyelet when it retracts.

[0044] The design of the head element eliminates the need for a release wire in the mounting method, and the delivery system As soon as the Tem is removed from the patient, the device is released and does not require any further action from the user. do not.

[0045] As mentioned above, this increases the length of the control loop and adds 1 to both sides of the head element or tip. This can be achieved by incorporating the two hooks one by one onto the same line as the control loop. Yes, it is possible. To assemble the device into the delivery system, the control loop is routed through the eyelets. After supplying the material, attach the free end to the hook at the tip.

[0046] When the device's eyelet is lower than the tip, the control loop is attached to the hook. It remains as is. Therefore, during compression and unsheathing, the device It remains attached to the delivery system. However, the tip moves below the eyelet. When it moves (for example, when the delivery system is removed from the device), the control loop thumps It can be detached from the casing and pulled out from the eyelet, freeing the device from the delivery system. ru.

[0047] This configuration of the present invention does not require a separate mechanical step when withdrawing the device. This means that the device simply pulls out the head element, i.e., the tip of the delivery system. To be released.

[0048] In this regard, the hook element is fixed axially to the appropriate location on the tip of the delivery system. The relative position of the graft to the hook determines whether the device is fixed or released.

[0049] In this regard, the hook element / slot is preferably integrated into the delivery system. It is positioned above the device and angled toward the device, with a hook / slot. The "closed" part is closest to the device, and one end is open, allowing the control loop to detach freely. It should be done this way. The control loop is preferably delivered with one end (leaving the other end free). It attaches to the system, loops through the eyelet, and attaches to the hook. It is of a suitable length. The eyelet is preferably attached to the device.

[0050] A second embodiment of the present invention will be described with reference to Figures 5a to 5e.

[0051] In this embodiment, the control loop 30 is taken to the peak 31 of the first ring of the medical device. It is attached. When assembling the device into a delivery system, the control loop is attached to the tip. The mounting method is simply latched to the provided hook element 32. It functions in the same way as described above (the relative position of the tip to the control loop mounting point) (The location determines whether the device is attached to the delivery system.) In this embodiment, the control loop attached to the device will remain in place. .

[0052] The hook element allows the control loop to be freely pulled out from the eyelet, while the header A second component can be provided that can be removed from the dome element or tip. This is useful in any situation where the control loop gets caught on a hook element and the device is not released. stand.

[0053] Figures 6a to 6c show that the hook element 40 can be retracted to release the device. A third embodiment is shown.

[0054] As shown in the fourth embodiment in Figures 7a and 7b, the hook element 50 is connected to the head element 11 The rotation of the control loop will cause it to exit the hook, or the control loop will exit the hook. The material can be angled or shaped to make it easier to remove.

[0055] The control loop 52 may extend over the length of the delivery system, and the control loop 52 may be interrupted. By disconnecting and removing the device, it can be freed from the delivery system. This controls It functions as a failsafe in case the loop gets caught on a hook element.

[0056] Various embodiments of the present invention are medical devices for more accurate deployment and easier manufacturing. While retaining the advantage of connecting the top of the chair to the delivery system, they are related to known methods. This involves removing the release wire, top cap, etc., allowing the user to access the device from the delivery system. Eliminate any additional steps required to remove it.

Claims

1. A medical device delivery device, the device, The device is provided with a head element at its proximal end, The medical device delivery device comprises one or more hook elements that are radially outward and project forward toward the proximal end of the head element, The head element of the medical device delivery device is configured to extend through the medical device and protrude proximally from the medical device. The one or more hook elements on the head element engage with a control loop connected to the medical device, One end of the one or more hook elements is fixed to the distal end of the head element, and the other end of the one or more hook elements protrudes in the proximal direction. Each of the one or more hook elements is movable relative to the head element between an extended position and an unextended position. The medical device delivery device comprises at least one of the control loops attached to a part of the medical device, A device wherein, when the control loop is disengaged from the one or more hook elements, the one or more hook elements become coplanar with the longitudinal profile of the device.

2. The one or more hook elements are facing proximal, The apparatus according to claim 1, wherein the free ends of one or more hook elements extend toward the proximal end of the head element.

3. The apparatus according to claim 1, wherein the head element has two hook elements.

4. The apparatus according to claim 3, wherein the hook elements are provided on both sides of the head element in the diametrical direction.

5. The apparatus according to claim 1, wherein one or more hook elements extend proximal to the head element and protrude radially outward from the side.

6. The apparatus according to claim 1, wherein one or more hook elements are provided at the distal end of the head element.

7. The apparatus according to claim 1, wherein each of the one or more hook elements is in the shape of an inclined slot, opening at the proximal end and closing at the distal end.

8. The apparatus according to claim 7, wherein each slot has a tapered profile.

9. The head element comprises a head body and a head plate, The apparatus according to claim 1, wherein the head plate is connected to the distal end of the head body, and one or more hook elements are defined between the head body and the head plate.

10. The apparatus according to claim 9, wherein the head body is chamfered at the distal end of the head body.

11. The apparatus according to claim 1, wherein one or more hook elements are pivotable between the deployed position and the undeployed position.

12. The apparatus according to claim 1, wherein one or more hook elements are retractable relative to the head element.

13. The apparatus according to claim 1, wherein the one or more hook elements are profiled to facilitate the release of any control loops engaged by the one or more hook elements as the rotation of the head element around the longitudinal axis of the head element occurs.

14. The one or more hook elements include an angled portion having a radially extending portion, The apparatus according to claim 13, wherein the radially extending portion is configured to engage with a control loop.

15. The apparatus according to claim 13, wherein the head element is configured to move toward the medical device so that one or more hook elements align with one or more eyelets of the medical device.

16. The apparatus according to claim 1, wherein the at least one control loop is attached to the first ring of the medical device.

17. The apparatus according to claim 1, wherein the at least one control loop is permanently attached to the medical device.

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