Delivery system with telescopic inner lumen

Abstract

A delivery device (10) for delivering an associated self-expanding intravascular treatment device (2) into a blood vessel, comprising: an inner sheath (12); an outer sheath (14) provided at one end thereof with a sheath opening (16), the inner sheath being coaxially disposed inside the outer sheath and being movable through the outer sheath; a handle (24), wherein the proximal end of the outer sheath is disposed inside the handle; a fixed support tube (26) disposed inside the handle and fixed to the handle, the fixed support tube being disposed coaxially inside the inner sheath, and the inner sheath being movable relative to the fixed support tube; and a transmission mechanism (28) configured for controlling a forward movement of the inner sheath through the outer sheath and a backward movement of the outer sheath in a direction opposite the forward movement of the inner sheath.

Description

Technical Field

[0001] The following content generally relates to catheter technology, vascular treatment, lesion treatment technology and related technologies. Background Art

[0002] Expandable metallic support structures (eg, stents) delivered via intravascular devices are commonly used to treat intravascular disease, arterial and venous disease, and larger areas of the anatomy (eg, the esophagus).

[0003] Delivery systems for deploying metallic structures typically include a catheter component that utilizes relative axial motion to deploy the stent. In one design, an outer sheath that constrains the expandable structure is axially retracted (moved toward the user) while the inner support catheter remains stationary or moves forward in the opposite direction of the outer sheath. In the latter case of "dual motion deployment," the forward movement of the inner support catheter compensates for the typical shortening of the stent length (as it expands as it is deployed from the outer sheath). This compensation allows the stent to be placed more accurately in the vessel. For some current delivery system handle mechanisms, the inner support lumen component includes a Luer connector and extends proximally from the handle. During dual motion deployment, the inner lumen / Luer connector moves inward toward the handle and may become kinked or entangled with nearby objects.

[0004] The following discloses some improvements to overcome these and other problems. Summary of the invention

[0005] In some embodiments disclosed herein, a delivery device for delivering an associated self-expandable intravascular treatment device into a blood vessel comprises: an inner sheath; an outer sheath, the outer sheath being provided with a sheath opening at one end thereof, the inner sheath being coaxially disposed inside the outer sheath and being capable of moving through the outer sheath; a handle, wherein the proximal end of the outer sheath is disposed inside the handle; a fixed support tube, which is disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath, the inner sheath being capable of moving relative to the fixed support tube; and a transmission mechanism configured to control forward movement of the inner sheath through the outer sheath and backward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath.

[0006] In some embodiments disclosed herein, a delivery device for delivering an associated self-expandable intravascular treatment device into a blood vessel comprises: an inner sheath; an outer sheath, the outer sheath having a sheath opening at one end thereof, the inner sheath being coaxially disposed inside the outer sheath and being movable through the outer sheath; a handle, wherein the proximal end of the outer sheath is disposed inside the handle; a fixed support tube disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath, the inner sheath being movable relative to the fixed support tube; and a transmission mechanism configured to control the forward movement of the inner sheath through the outer sheath and the backward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath. The fixed support tube has a central lumen with a diameter of d1; and the inner sheath has a central lumen with a diameter of d1.

[0007] In some embodiments disclosed herein, a delivery device for delivering an associated self-expandable intravascular treatment device into a blood vessel comprises: an inner sheath; an outer sheath, the outer sheath being provided with a sheath opening at one end thereof, the inner sheath being coaxially disposed inside the outer sheath and being movable through the outer sheath; a handle, wherein the proximal end of the outer sheath is disposed inside the handle; a fixed support tube, which is disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath and the inner sheath being movable relative to the fixed support tube; a transmission mechanism configured to control forward movement of the inner sheath through the outer sheath and backward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath; a Luer connector fixed to an end of the fixed support tube extending to the outside of the handle; a first shuttle configured to prevent the inner sheath from moving out of the outer sheath; and a second shuttle configured to prevent the Luer connector from moving out of the outer sheath.

[0008] One advantage resides in providing a catheter delivery device having a telescoping inner lumen that does not extend variably in length from a catheter handle.

[0009] Another advantage resides in providing a catheter delivery device having an outer sheath and an inner sheath that move in opposite directions without a corresponding change in the overall length of the handle.

[0010] Another advantage resides in providing a catheter delivery device having an inner sheath that does not kink during movement.

[0011] A given embodiment may provide none, one, two, more, or all of the advantages described above, and / or may provide other advantages that will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present disclosure may take the form of various components and arrangements of components, and various steps and arrangements of steps. The drawings are only for the purpose of illustrating the preferred embodiments and are not to be construed as limiting the present disclosure.

[0013] Figure 1 and Figure 2 Schematically illustrated are cross-sectional views of a vascular treatment device according to the present disclosure showing different positions of a movable inner sheath.

[0014] Figure 3 and Figure 4 Schematically shows Figure 1 The removable inner sheath of the device ( Figure 3 ) and fixed support tube ( Figure 4 ) of an independent cross-section.

[0015] Figure 5 Schematically shows the use of Figure 1 A method of performing a vascular treatment method using a device. DETAILED DESCRIPTION

[0016] The dual motion handle assembly is used to deliver stents or other devices that experience foreshortening during endovascular procedures. For example, if the device is a self-expanding nitinol stent (or braided stent, or woven stent), then as it expands in the radial direction during deployment, it will contract in the longitudinal direction. This longitudinal contraction (i.e., "foreshortening") can cause misalignment of the stent. The dual motion handle assembly solves this problem by simultaneously pulling back the outer sheath while extending the inner sheath ("dual motion"), so that the stent position is maintained during deployment despite the foreshortening.

[0017] However, as the inner sheath is pulled back, the end with the Luer connector for connecting the tube to the inner sheath extends further and further from the rear end of the handle and may interfere with the operation of the handle.

[0018] To address this problem, a dual tube support device is disclosed below. Inner support #1 moves normally during a dual motion deployment operation. A second inner support #2 is coaxially located within the inner support and is fixed to the handle. The Luer connector is connected to inner support #2 and thus has a fixed position with the fixed inner support #2. The purpose of inner support #2 is to provide a sealed fluid flow path from the inner lumen to the Luer connector, regardless of the position of the movable inner support #1.

[0019] On the other hand, in order to ensure that the fluid path from the inner sheath to the Luer connector has a (mostly) constant inner diameter (ID), the inner support #1 appropriately has a smaller ID on the proximal side of the inner sheath, which widens to accommodate the larger ID of the inner support #2. The smaller ID near the inner sheath is the same as the ID of the inner support #2. When the inner support #1 moves away from the inner support #2 as the inner sheath is extended, this provides a constant ID for the fluid path, except at the gap between the ID step and the end of the inner support #2. This larger ID area cannot be avoided, but the ID step of the inner support #1 and the end of the inner support #2 can be chamfered to provide an inclined transition. This design facilitates the insertion of a guidewire or other instrument through the inner sheath without hanging up along the path between the Luer connector and the inner sheath.

[0020] Although designed for use with a dual motion catheter, the disclosed design may be used with any device having an inner sheath that moves relative to an outer sheath.

[0021] Reference Figure 1 , schematically shows an illustrative vascular treatment (i.e., thrombectomy or plaque removal) device 1. Figure 1 As shown, the apparatus 1 includes a delivery device 10 for delivering a self-expanding vascular treatment device (e.g., a self-expanding stent, a self-expanding filter, etc.) into a blood vessel. The delivery device 10 includes an inner sheath 12 surrounded by an outer sheath 14. The inner sheath 12 is coaxially disposed inside the outer sheath 14 and is movable through the outer sheath 14. The inner sheath 12 is movable within the outer sheath 14 in a longitudinally forward (i.e., advancement) translation direction and a longitudinally backward (i.e., withdrawal) translation direction. At one end of the outer sheath 14 is a sheath opening 16, through which the distal end of the inner sheath 12 can be moved into and out of the outer sheath 14.

[0022] like Figure 1 As shown, the delivery device 10 further includes a handle 24, and the proximal end of the outer sheath 14 is disposed inside the handle 24. A fixed support tube 26 is disposed inside the handle 24 and fixed to the handle 24. The fixed support tube 26 is coaxially disposed inside the inner sheath 12, and the inner sheath 12 can move relative to the fixed support tube 26.

[0023] Figure 1 Also shown is a transmission mechanism 28 configured to control the forward movement of the inner sheath 12 through the outer sheath 14 and the rearward movement of the outer sheath 14 in a direction opposite to the forward movement of the inner sheath 12. The movement of both the catheter 12 and the containment sheath 14 is relative to the handle 24 (i.e., into, out of, or through the handle 24). The transmission mechanism 28 may be disposed on or within a portion of the handle 24.

[0024] The Luer connector 30 is fixed to the end of the fixed support tube 26 extending to the outside of the handle 24. The fixed support tube 26 is coaxially disposed inside the inner sheath 12 and forms a sealed fluid flow path from the inner sheath to the Luer connector 30.

[0025] Figure 1 The delivery device 10 is also shown with a portion of the handle 24 (i.e., the cover) removed, and the internal components of the delivery device 10 are shown. The transmission mechanism 28 is configured to adjust the ratio of the speed of the forward movement of the inner sheath 12 to the speed of the rearward movement of the outer sheath 14. To this end, the transmission mechanism 28 may include a thumb wheel 32 disposed on a portion of the handle 24 (on the outside). The thumb wheel 32 is operatively connected or engaged with one or more components disposed within a portion of the handle 24 (on the inside), for example, via a control line, so as to drive the movement of the inner sheath 12 and the outer sheath 14. As shown in FIG. Figure 1 As shown, the transmission mechanism 28 includes a first shuttle 34, which is connected to the inner sheath 12 and the outer sheath 14 and is configured to drive the outer sheath 14 to move backward relative to the handle 24 when the user manually moves the thumb wheel 32 through the first control line 36. The first shuttle 34 is connected to the outer sheath 14 and is configured to pull the outer sheath 14 backward relative to the handle 24 when the user moves the thumb wheel 32 through the first control line 36. The second shuttle 38 is connected to the inner sheath 12 and is configured to drive the inner sheath 12 to move forward relative to the handle 24 when the user manually moves the thumb wheel 32 through the second control line 40. The fixed support tube 26 is fixed to the handle 24 to prevent it from moving.

[0026] like Figure 1 As shown, the fixed support tube 26 has a central lumen 18 with a diameter d1, and the inner sheath 12 has a central lumen 20 with a diameter d1 (i.e., the same diameter as the central lumen 18). In one example, the diameter d1 of the central lumen 20 of the inner sheath 12 is sized to receive a self-expanding vascular treatment device (not shown) at its distal end, which is inserted into the patient's body during an endovascular treatment procedure. In another example, the outer diameter (not shown) of the inner sheath 12 is sized to fit the vascular treatment device (wherein the distal portion of the inner sheath 12 is stepped), thereby allowing the vascular treatment device to be positioned between the inner sheath 12 and the outer sheath 14. When the outer sheath 14 is retracted, the stepped portion serves as a stop for pushing the vascular treatment device. A portion of the inner sheath 12 proximal to the fixed support tube 26 has an enlarged diameter d2 of its central lumen, wherein d2 is greater than d1 (illustrated with reference numeral 42; see also Figure 3The fixed support tube 26 has an outer diameter d2, which is equal to the diameter d2 of the portion of the central lumen 20 of the inner sheath 12 close to the fixed support tube 26. The transition portion of the central lumen 20 of the inner sheath 12 from the diameter d1 to the diameter d2 (at Figure 3 The end of the fixed support tube 26 , which is coaxially arranged inside the inner jacket 12 , has an inclined chamfer (indicated by reference numeral 46 ).

[0027] Continue to refer to Figure 1 , Figure 2 An example movement of the inner sheath 12 and outer sheath 14 relative to each other is shown. As described above, the outer sheath 14 moves rearwardly while the inner sheath 12 moves forwardly. To achieve this movement, the inner sheath 12 must extend a length "L1" outside the handle 24 to compensate for the forward movement. In the absence of a fixed support tube 26, the Luer connector would typically be connected directly to the movable inner sheath, and the Luer connector would then move inwardly or outwardly from the end of the handle, where the movement is equal to the extended length of the movable inner sheath. Such a variably extendable Luer connector may get caught on other items, pinched, or kinked during use.

[0028] However, by comparison Figure 1 and Figure 2 It can be seen that in Figure 1 and Figure 2 In the design of the movable inner sheath 12, during deployment of the stent or other therapeutic device, the movement of the movable inner sheath 12 does not extend outside the handle 24. This is because the luer connector 30 is fixed to the fixed support tube 26, and the fixed support tube 26 is fixed to the handle 24. The fixed support tube 26 forms a fluid seal with the movable inner sheath 12. Therefore, the movement of the proximal end of the inner sheath 12 is completely contained within the handle 24. The aspirated blood or other fluid flowing through the central lumen of the movable inner sheath 12 flows through the fixed support tube 26 to the luer connector 30, so that the luer connector 30 remains in a fixed position during the movement of the movable inner sheath 12 during deployment, and also maintains fluid communication with the central lumen of the movable inner sheath 12.

[0029] like Figure 2 As shown, the fixed support tube 26 is fixed to the handle 24 and is slidably inserted into the inner sheath 12. When the thumb wheel 32 is activated, the second shuttle 38 moves forward, thereby moving the inner sheath 12, while the fixed support tube 26 remains stationary. This allows for dual motion delivery without the fixed support tube 26 moving and extending from the handle 24. In some examples, the first shuttle 34 can move proximally toward the fixed support tube 26.

[0030] Figure 3An isolated cross-sectional view of the inner sheath 12 is shown, wherein the diameters d1 and d2 are marked along with the inclined chamfer 44. The inner sheath 12 is the main inner support lumen of the delivery device 10, which extends from the handle (eg, Figure 1 and Figure 2 The inner sheath 12 is a removable inner sheath 12 having a diameter d2. The inner sheath 12 is provided with a plurality of proximal and distal ends thereof, and the inner sheath 12 is provided with a plurality of proximal and distal ends thereof, and the proximal ends thereof are provided with a plurality of proximal and distal ends thereof, and the proximal ends thereof are provided with a plurality of proximal and distal ends thereof, and the plurality of proximal and distal ...

[0031] The inner sheath 12 can be made into a single component having a step (i.e., the inclined chamfered portion 44) by drilling or machining. Alternatively, the inner sheath 12 can be made of a plurality of single lumen tube components that are joined together to form the inclined chamfered portion 44. At the location of the inclined chamfered portion 44, the step surface can be chamfered to facilitate the insertion of an auxiliary device (guide wire) during surgery.

[0032] Figure 4An isolated cross-sectional view of the fixed support tube 26 is shown, with the inclined chamfered end 46 marked. The fixed support tube 26 comprises a single lumen tube, which is long enough to slide into the inner sheath 12 over a distance L1 (L2 ≥ L1), and has the following diameter requirements: the inner diameter d1 is equal to the inner diameter d1 of the inner support 12, and the outer diameter d3 is equal to the inner diameter (d2) of the stepped portion of the inner support 1. In a variant embodiment, in order to provide a slightly compressed fit to improve the fluid seal between the fixed support tube 26 with an outer diameter d3 and the widened inner lumen of the widened portion of the movable inner sheath 12 with a diameter d2, it is envisaged that the outer diameter d3 of the fixed support tube 26 is slightly larger than the lumen diameter d2 of the widened lumen of the movable inner sheath 12. In this design variant, the fixed support tube 26 is slightly compressed within the widened lumen of the movable sheath 12. However, the advantage of this compression in improving the fluid seal is that it can balance the friction forces introduced thereby, which may interfere with the movement of the inner sheath 12 during deployment of the treatment device. The optimal balance depends on factors such as the coefficient of friction between the materials of the two tubes 12 and 26 and the compressibility of these materials. The material of the inner sheath 12 and the fixed support tube 26 should be lubricious (low coefficient of friction) to allow close tolerance fit but still allow the parts to slide easily against each other (e.g., PEEK, high durometer PEBAX with lubricating fillers, PTFE). If a tight seal is required to prevent leakage, an O-ring seal can also be inserted between the components, in which case the outer diameter d3 can be slightly smaller than the lumen diameter d2, with the O-ring bridging the gap.

[0033] Figure 5An example of a flow chart showing a vascular treatment method 100 using the treatment apparatus 1 is shown. To begin the method 100, at operation 102, the delivery device 10 is inserted into a target tissue (e.g., an artery or vein or the esophagus of a patient). When the device 10 is at the delivery site, at operation 104, the inner sheath 12 is moved forward in the target tissue. At operation 106, which is performed simultaneously with operation 104, the outer sheath 14 is moved backward in the target tissue. At operation 108, which is performed simultaneously with operations 104, 106, an operator may observe the deployment of the self-expanding vascular treatment device through fluorescent image guidance or another suitable imaging mode. The fluorescent image guidance 108 preferably images the self-expanding vascular treatment device 2 with sufficient resolution to enable the operator to see the degree of bunching (or lack of bunching) of the self-expanding vascular treatment device 2 during delivery. At operation 110, the operator adjusts the ratio of the speed of the forward movement of the catheter at operation 104 to the speed of the rearward movement of the containment sheath at operation 106 in order to achieve a desired amount of bundling, wherein more bundling is provided in areas where the operator believes the self-expandable vascular treatment device 2 should have greater stiffness, and less (or no) bundling is provided in areas where the operator believes the self-expandable vascular treatment device 2 should have less stiffness. Operations 104, 106, 108, 110 are performed simultaneously until the self-expandable vascular treatment device 2 is fully deployed at operation 112, after which the delivery device 10 is retracted (e.g., withdrawn from the artery into which it is inserted) at operation 114.

[0034] The present disclosure has been described with reference to preferred embodiments. Various modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be interpreted as including all such modifications and alterations as long as they fall within the scope of the appended claims or their equivalents.

Claims

1. A delivery device (10) for delivering an associated self-expanding intravascular treatment device (2) into a blood vessel, the delivery device comprising: Inner sheath (12); An outer sheath (14) having a sheath opening (16) at one end thereof, wherein the inner sheath is coaxially arranged inside the outer sheath and is movable through the outer sheath; a handle (24), wherein the proximal end of the outer sheath is disposed within the interior of the handle; a fixed support tube (26) disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath, and the inner sheath being movable relative to the fixed support tube; and A transmission mechanism (28) is configured to control forward movement of the inner sheath through the outer sheath and rearward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath.

2. The conveying device (10) according to claim 1, wherein: The conveying device also includes: A Luer connector (30) is fixed to the end of the fixed support tube (26) extending to the outside of the handle (24).

3. The conveying device (10) according to claim 2, wherein: The fixed support tube (26) is coaxially disposed inside the inner sheath (14) and forms a sealed fluid flow path from the inner sheath to the Luer connector (30).

4. The conveying device (10) according to any one of claims 1 to 3, wherein: The transmission mechanism (28) is arranged on a part of the handle (24) or in a part of the handle (24).

5. The conveying device (10) according to any one of claims 1 to 4, wherein: The fixed support tube (26) has a central lumen (18) with a diameter of d1; and The inner sheath (12) has a central lumen (20) with a diameter d1.

6. The conveying device (10) according to claim 5, wherein: A portion of the inner sheath (12) close to the fixed support tube (26) has an increased diameter d2 of its central lumen, wherein d2 is greater than d1.

7. The conveying device (10) according to claim 6, wherein: The fixed support tube (26) has an outer diameter d2 which is equal to the diameter d2 of the portion of the central lumen (20) of the inner sheath (12) proximal to the fixed support tube.

8. The conveying device (10) according to claim 7, wherein: The transition portion of the central lumen (20) of the inner sheath (12) from the diameter d1 to the diameter d2 includes an inclined chamfer.

9. The conveying device (10) according to claim 8, wherein: The end of the fixed support tube (26) coaxially arranged inside the inner jacket (12) has an inclined chamfer.

10. The conveying device (10) according to any one of claims 4 to 9, wherein: The inner sheath (12) and the outer sheath (14) are sized to receive a self-expandable vascular treatment device (2) therebetween.

11. The conveying device (10) according to any one of claims 1 to 10, wherein: The conveying device also includes: a first shuttle (34) configured to prevent the inner sheath (12) from being removed from the outer sheath (14); and A second shuttle (38) is configured to prevent the Luer connector (30) from being removed from the outer sheath.

12. A delivery device (10) for delivering an associated self-expanding intravascular treatment device (2) into a blood vessel, the delivery device comprising: Inner sheath (12); an outer sheath (14) having a sheath opening (16) at one end thereof, wherein the inner sheath is coaxially arranged inside the outer sheath and is movable through the outer sheath; a handle (24), wherein the proximal end of the outer sheath is disposed within the interior of the handle; a fixed support tube (26) disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath, the inner sheath being movable relative to the fixed support tube; and a transmission mechanism (28) configured to control forward movement of the inner sheath through the outer sheath and rearward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath; in: The fixed support tube (26) has a central lumen (18) with a diameter d1; and The inner sheath (12) has a central lumen (20) with a diameter d1.

13. The conveying device (10) according to claim 12, wherein: The conveying device also includes: A Luer connector (30) is fixed to the end of the fixed support tube (26) extending to the outside of the handle (24).

14. The conveying device (10) according to claim 13, wherein: The fixed support tube (26) is coaxially disposed inside the inner sheath (14) and forms a sealed fluid flow path from the inner sheath to the Luer connector (30).

15. The conveying device (10) according to any one of claims 12 to 14, wherein: The transmission mechanism (28) is arranged on a part of the handle (24) or in a part of the handle (24).

16. The conveying device (10) according to any one of claims 12 to 15, wherein: A portion of the inner sheath (12) close to the fixed support tube (26) has an increased diameter d2 of its central lumen, wherein d2 is greater than d1.

17. The conveying device (10) according to claim 16, wherein: The fixed support tube (26) has an outer diameter d2 which is equal to the diameter d2 of the portion of the central lumen (20) of the inner sheath (12) proximal to the fixed support tube.

18. The conveying device (10) according to claim 17, wherein: The transition portion of the central lumen (20) of the inner sheath (12) from the diameter d1 to the diameter d2 includes an inclined chamfer.

19. The conveying device (10) according to claim 18, wherein: The end of the fixed support tube (26) coaxially arranged inside the inner jacket (12) has an inclined chamfer.

20. A delivery device (10) for delivering an associated self-expanding intravascular treatment device (2) into a blood vessel, the delivery device comprising: Inner sheath (12); An outer sheath (14) having a sheath opening (16) at one end thereof, wherein the inner sheath is coaxially arranged inside the outer sheath and is movable through the outer sheath; a handle (24), wherein the proximal end of the outer sheath is disposed within the interior of the handle; a fixed support tube (26) disposed inside the handle and fixed to the handle, the fixed support tube being coaxially disposed inside the inner sheath, and the inner sheath being movable relative to the fixed support tube; a transmission mechanism (28) configured to control forward movement of the inner sheath through the outer sheath and rearward movement of the outer sheath in a direction opposite to the forward movement of the inner sheath; a Luer connector (30) fixed to the end of the fixed support tube (26) extending to the outside of the handle (24); a first shuttle (34) configured to prevent the inner sheath from being removed from the outer sheath; as well as A second shuttle (38) is configured to prevent the Luer connector from being removed from the outer sheath.

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