Interval Crossing System
Through the use of bending puncture pipes and capture catheter intervals through the circulation of the ring tie operation, the problem of RVOT positioning and catheter stability is solved, and the accurate and security methods of directly piercing from the coronary sinus to RVOT are realized.
Patent Information
- Application Number
- CN202080086500.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-13
- Filing Date
- 2020-12-14
- Publication Date
- 2025-01-28
- Estimated Expiration
- 2040-12-14
AI Technical Summary
In cerclage surgery for treating heart valve insufficiency, it is difficult to accurately locate the right ventricular outflow tract (RVOT) and the catheter needs to be stable during the heart contraction, especially for patients without septal veins, which directly puncture from the coronary sinus to RVOT There are challenges in the approach.
The ring -tie interval between the ring tie of the puncture catheter and the capture of the catheter is used. The puncture catheter has bendable design and coil parts to support the puncture position. The capture catheter capture and stabilize the catheter through a trap and deflection design.
Achieved accurately positioning and stabilizing the catheter without using the interval venue to ensure the accuracy and safety of puncture and suitable for various cardiac anatomy.
Smart Images
Figure CN115023189B_ABST
Abstract
Description
[0001] Related Applications
[0002] This application claims U.S. Provisional Patent Application 62 / 948,197 (filed on December 13, 2019) and U.S. Patent Application 63 / 125,346 (filed on December 14, 2020), the contents of which are incorporated herein in their entirety. Technical Field
[0003] The present invention relates generally to methods of treating heart valve regurgitation and, more particularly, to septal transseptal systems and methods of using target capture catheters and septal transseptal catheters therein. Background Art
[0004] In cerclage for the treatment of valvular insufficiency, the right ventricular outflow tract (RVOT) needs to be accurately located. However, it is impossible to accurately locate the RVOT in fluoroscopic view during the procedure. Secondly, even if the RVOT is accurately found, it is necessary to stabilize the catheter at the RVOT and maintain its position without movement throughout the process of cardiac contraction. Finally, since some patients do not have a septal vein, it is necessary to accurately puncture directly from the coronary sinus through the IVS. In addition, since it is sometimes difficult to access the septal vein with a guide wire, a method and system are needed to puncture directly from the coronary sinus through the IVS to access the RVOT without using the septal vein as a pathway. Summary of the invention
[0005] According to one aspect of the present invention, the puncture catheter includes a first lumen for inserting a guide wire therein. A coil component is disposed at a distal portion of the puncture catheter. A distal end of the pull wire is connected to a distal portion of the coil component. A proximal end of the pull wire extends to a distal portion of the puncture catheter. The pull wire is configured to bend the distal portion of the puncture catheter inwardly to have an angled configuration.
[0006] According to one aspect of the present invention, a capture catheter includes a first lumen for inserting a first guide wire therein and a second lumen for inserting a second guide wire therein. The distal end of the second guide wire has a snare, wherein a portion of the distal end has a deflectable end.
[0007] According to one aspect of the present invention, a cerclage septum crossing system includes a puncture catheter and a capture catheter. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Figure 1 A puncture device is shown.
[0009] Figure 2 The distal portion of the puncture device is shown.
[0010] Figure 3 The distal portion of the puncture device is shown.
[0011] Figure 4 A side view of the lancing device is shown.
[0012] Figure 5 A side view of the piercing device is shown.
[0013] Figure 6 A side view of the lancing device is shown.
[0014] Figure 7 A bendable component of a puncture device is shown.
[0015] Figure 8 A bendable component of a puncture device is shown.
[0016] Fig. 9 The puncture device in the coronary vein is shown.
[0017] Fig.10 The puncture device in the coronary vein is shown.
[0018] Fig.11 The puncture device in the coronary vein is shown.
[0019] Fig.12 The puncture device is shown puncturing the target site.
[0020] Fig.13 The puncture device under imaging analysis is shown.
[0021] Fig.14 The lancing device is shown in operation.
[0022] Fig.15 The lancing device is shown in operation.
[0023] Fig.16 The lancing device is shown in operation.
[0024] Fig.17 A cross-sectional view of a puncture device is shown.
[0025] Fig.18 A cross-sectional view of a puncture device is shown.
[0026] Fig.19 A cross-sectional view of the puncture device and lumen is shown.
[0027] Fig. 20 A capture device is shown.
[0028] Fig.21 A hub for capturing devices is shown.
[0029] Fig. 22 A top view and a side view of the capture device are shown.
[0030] Fig.23A cross-sectional view of a capture device is shown.
[0031] Fig.24 The capture device is shown positioned at the target site.
[0032] Fig.25 The target site of the RVOT interval is shown.
[0033] Fig.26 The capture device is shown positioned at the RVOT compartment.
[0034] Fig. 27 The capture device is shown capturing the puncture line.
[0035] Fig.28 The puncture line passing through the snare of the capture catheter is shown.
[0036] Fig.29 Actual images of the stabilization wire and target snare are shown.
[0037] Fig.30 The overall structure of the spacer traversal system is shown. DETAILED DESCRIPTION
[0038] Flexible puncture device
[0039] A bendable puncture device 10 in an embodiment of the present invention will be described with reference to the accompanying drawings. The bendable puncture device 10 of the present embodiment is a tubular medical instrument used when inserted into a patient's body.
[0040] Figure 1-19 A puncture device for a septal crossing system is shown. The bendable puncture device 10 includes a flexible tubular multi-lumen tube (main tube) 20 and a deflection member 50. The flexible tubular multi-lumen tube 20 includes a distal end 20a, a proximal end 20b, and a bendable member 22. The bendable member 22 is disposed at the distal end 20a of the main tube 20 and can be bent. The deflection member 50 is fixed to the proximal end 20b of the main tube 20 and is used to operate (deflect) the bendable member 22.
[0041] Supervisor 20
[0042] The main tube 20 is a flexible multi-lumen tube that can be inserted into the coronary sinus. The main tube 20 has a distal end 20a and a proximal end 20b. The main tube 20 includes a first lumen 26. The first lumen 26 has a distal end 26a and a proximal end 26b, and the distal end 26a and the proximal end 26b are both open to the distal end 20a and the proximal end 20b of the main tube 20. The proximal end 20b of the main tube 20 is fixed to the deflection member 50 (operating member). The first lumen 26 is configured for inserting a guide wire 42 or a puncture wire 44 therein.
[0043] The first side hole 22 and the second side hole 24
[0044] The main tube 20 further includes a first side hole 22 and a second side hole 24. The first side hole 22 and the second side hole 24 are both formed at a distal portion of the main tube 20. The main tube 20 further includes a second inner cavity 28. The second inner cavity 28 has a distal end 28a and a proximal end 28b. The distal end 28a of the second inner cavity 28 is open to the second side hole 24. The first side hole 22 and the second side hole 24 are configured for inserting a deflection wire (operating wire) therein.
[0045] Second inner cavity 28
[0046] The main tube 20 further includes a second lumen 28. The second lumen 28 has a distal end 28a and a proximal end 28b. The distal end 28a of the second lumen 28 opens to the second side hole 24. The proximal end 28b of the second lumen extends to the deflection member 50. The second lumen 28 is configured for the deflection wire 40 to be inserted therein.
[0047] Deflection line 40
[0048] The main tube 20 uses a deflection wire 40 to bend the distal end 20a of the main tube 20. The deflection wire 40 has a distal end 40a and a proximal end 40b. The distal end 40a is connected to the distal end 20a of the main tube 20. The proximal end 40b is connected to the deflection member 50. The portion of the deflection wire 40 defined between the first side hole 22 and the second side hole 24 is exposed, as shown in FIG. Figure 2 and 3 shown.
[0049] Coil component 30
[0050] The main tube 20 further includes a coil component 30 for supporting the puncture site. The coil component 30 has a distal end 30a and a proximal end 30b. The distal end 30a is disposed near the first side hole 22 of the main tube 20, and the proximal end 30b is disposed near the second side hole 24 of the main tube 20. The coil component 30 is configured to surround the first lumen 26 in a spiral shape to enhance the first lumen 26. The coil component 30 and the first lumen 26 have a common axis, and when the main tube 20 is bent, the coil component 30 is coaxially bent to support the puncture site.
[0051] Marking tape 32
[0052] The main tube 20 also includes at least one marker band 32 for imaging analysis. Figure 2 As shown, the distal end 20a of the main tube 20 is provided with a marker band 32 made of a material that appears on an X-ray transmission image. The plurality of marker bands 32 allow the operator to confirm the curvature (the amount of curvature) of the main tube 20 by referring to the X-ray transmission image before puncturing.
[0053] Bendable member 34
[0054] The bendable component 34 is disposed in the main tube 20 and is configured to be bendable. The bendable component 34 has a distal end 34a and a proximal end 34b. In one example of this embodiment, the bendable component 34 is preferably arranged between the first side hole 22 and the second side hole 24 of the main tube 20. It should be understood that this arrangement can be varied according to the patient's anatomical structure. Figure 3 As shown, the deflection wire 40 is preferably exposed over an area defined between the first side aperture 22 and the second side aperture 24 .
[0055] Line set for operation
[0056] The main tube 20 is operated using a set of wires. The first lumen 26 is configured for inserting a guide wire 42 therein. When the main tube 20 is positioned at the target location, the guide wire 42 can be exchanged with the puncture wire 44. The second lumen 28 is configured for inserting the puncture wire 44 therein. The distal end 40a of the deflection wire 40 is connected to the distal end 20a of the main tube 20 and exits through the first hole 22. The deflection wire 40 then returns through the second hole 24 and extends through the second lumen 26. The proximal end 40b of the deflection wire is connected to the deflection member 50. Before puncture, the operator pulls the puncture wire 44 through the deflection member 50 to find the best puncture angle of the bendable member 34.
[0057] Deflection member 50
[0058] The bendable puncture device 10 further includes a deflection member 50 for deflecting the bendable member 34. Figure 4 As shown, the deflection member 50 includes a distal end 50a and a proximal end 50b. The deflection member 50 includes a knob 52, a slider 54, and a hub 56 for performing a deflection operation. The deflection member 50 also includes an inner cavity 58 for inserting the guide wire 42 or the puncture wire 44 through the hub 56. The inner cavity 58 is open relative to the first inner cavity 26 for communication.
[0059] Knob 52 and Slider 52
[0060] The knob 52 operates the slide 54. Figure 4 and 5 As shown, the slider 54 is moved forward and backward (back and forth) by rotating the knob 52. The proximal end 40b is connected to the slider 54 so that the slider can pull or push the operating wire 40. For example, the operator can adjust the puncture angle of the bendable member 34 by rotating the knob 42.
[0061] Hub 56
[0062] The hub 56 is used to insert the guide wire 42 or the puncture wire 44 therein during the procedure. The hub 56 is open to the lumen 58 of the deflection member, and the lumen 58 of the deflection member is also open to the first lumen 26 of the main tube 20. It should be understood that various types of hubs can be used depending on the specific procedure.
[0063] Capture device 100
[0064] The figure shows a capture device 100 for use in a spacer crossing system. The capture device 100 includes a flexible tubular multi-lumen tube (main tube) 120. The capture device 100 also includes a deflection member 150 for bending the main tube 120.
[0065] Supervisor 120
[0066] The main tube 120 is a flexible multi-lumen tube for capture. The main tube 120 has a distal end 120a and a proximal end 120b. The proximal end 120b of the main tube 120 is fixed to the deflection member 150. The first lumen 124 is configured for insertion of a guide wire 140 (or stabilization wire) therethrough.
[0067] Side hole 122
[0068] The main tube 120 includes a side hole 122. The side hole 122 is formed on the main tube 120. The side hole 122 is configured to allow the stabilization wire 146 to be inserted therethrough.
[0069] First lumen 124 for snare wire 140
[0070] The main tube 120 further includes a first lumen 124. The first lumen 124 has a distal end 124a and a proximal end 124b, which are open relative to each of the distal end 120a and the proximal end 122a of the main tube 120. The first lumen 124 is configured to allow the snare wire 140 to be inserted therethrough.
[0071] Second lumen 126 for additional guide wire 142
[0072] The main tube 120 further includes a second lumen 126. The second lumen 126 has a distal end 126a and a proximal end 126b, which are respectively open to each of the distal end 120a and the proximal end 122a of the main tube 120. The second lumen 126 is configured for a guide wire 142 to be inserted therethrough.
[0073] Third lumen 128 for deflection wire 144
[0074] The main tube 120 further includes a third lumen 126. The third lumen 128 has a distal end 128a and a proximal end 128b. The third lumen 126 is configured to allow an operating wire 144 to be inserted therethrough.
[0075] Fourth lumen 130 for stabilizing wire 146
[0076] The main tube 120 further includes a fourth lumen 130. The fourth lumen 130 has a distal end 130a and a proximal end 130b. The fourth lumen 126 is configured for insertion of a stabilizing wire 146 therethrough. The distal end 130a of the fourth lumen 130 is open relative to the side hole 122 of the main tube 120.
[0077] Deflection anchor 132
[0078] The main tube 120 further includes a deflection anchor 132 for bending the main tube 120. The deflection anchor 132 is disposed in a portion of the distal end of the main tube 120. Fig.23 As shown, the deflection anchor 132 is in the shape of an X that longitudinally partially surrounds the first lumen 124 and the second lumen 126. The deflection anchor 132 includes an anchor connector 132a for connecting to the distal end 144a of the operating wire 144.
[0079] Marking tape 134
[0080] The main tube 120 also includes at least one marker band 134 for imaging analysis. As shown in the figure, the distal end 120a of the main tube 120 is provided with a marker band 134, and the marker band 134 is made of a material that can be presented on an X-ray transmission image. Multiple marker bands 134 allow the operator to confirm the curvature of the main tube 120 before puncturing with reference to the X-ray transmission image.
[0081] Bendable member 136
[0082] The main tube 120 further includes a bendable member 136 defined in a portion of the distal end of the main tube 120. In one example of this embodiment, the bendable member 136 is made of a braided structure. The bendable member 136 can be bent by operating the handle member 150 of the puncture device 100.
[0083] Snare line 140
[0084] The main tube 120 captures the target line using a snare line 140. The snare line 140 has a distal end 140a and a proximal end 140b. Figure 17-19 As shown, the distal end 140a is connected to a snare 140c. The proximal end 140b extends through the first lumen 124 to the handle member 150.
[0085] Guide Line 142
[0086] The main tube 120 also uses a guide wire 142. The guide wire 142 has a distal end 142a and a proximal end 142b. The guide wire 142 extends from the distal end 120a of the main tube 120 to the proximal end 120b through the second lumen 126.
[0087] Deflection line 144
[0088] The main tube 120 also uses a deflection wire 142 to bend the main tube 120. The deflection wire 144 has a distal end 144a and a proximal end 144b. The distal end 144a is connected to the deflection anchor 132 to bend the main tube 120. The proximal end 144b is connected to the handle component 150 for deflection.
[0089] Stable line 146
[0090] The main tube 120 also uses a stabilizing wire 146 to position the main tube 120 at the target location. The stabilizing wire 146 has a distal end 146a and a proximal end 146b. The stabilizing wire 146 passes through the side hole 122 and extends through the fourth lumen 130 to the handle component.
[0091] Deflection member 150
[0092] The capture device 100 includes a deflection member 150 for deflecting the bendable member 136. The deflection member 150 has a Fig.17 The deflection member 150 includes a knob 152, a slider 154, and a hub 156 to perform a deflection operation. The first lumen 124, the second lumen 126, and the fourth lumen 130 pass through the deflection member 150 and are connected to the hub 156, respectively.
[0093] Knob 152 and slider 154
[0094] Knob 152 operates slide 154. Fig.19 As shown, the slider 154 moves back and forth by rotating the knob 152. The proximal end 140b of the deflection wire 144 is connected to the slider 154 so that the slider can pull or push the deflection wire 144. For example, the operator can adjust the capture angle of the bendable member 136 by rotating the knob 142.
[0095] Hub 156
[0096] The hub 156 of the deflection member 150 has a plurality of ports. Each port of the hub is used to insert a snare wire 140, a guide wire 142, a stabilization wire 146 during the procedure.
Claims
1. A flexible catheter, comprising: a flexible tubular main tube, comprising a distal end and a proximal end, a first lumen extending between the distal end and the proximal end and for inserting a guide wire, The main tube includes a first side hole formed at a distal end, the main tube has a second inner cavity open to the side hole, the main tube includes a deflection wire, the deflection wire has a distal end and a proximal end, the distal end of the deflection wire is connected to the distal end of the main tube, the deflection wire is configured to pass through an outer surface of the main tube and enter the first side hole, and the proximal end of the deflection wire is configured to be pulled or pushed to bend the distal end of the main tube, Wherein, in the bendable catheter, the distal end of the flexible tubular main tube is provided with a coil component, the coil component is formed in a spiral shape and extends along the first inner cavity and surrounds the first inner cavity to reinforce the first inner cavity. 2 . The bendable catheter of claim 1 , further comprising a deflection member disposed in the proximal end of the main tube. 3 . The bendable catheter according to claim 1 , further comprising a second side hole formed at a distal end of the main tube. 4 . The flexible catheter according to claim 1 , further comprising at least one marker band disposed at a distal end of the main tube.
5. A flexible catheter comprising: A flexible tubular main tube having a distal end and a proximal end, a first lumen extending between the distal end and the proximal end for inserting a guide wire, the main tube including a first side hole formed at the distal end, the main tube having a second lumen leading to the side hole, the main tube having a deflection wire, the deflection wire having a distal end and a proximal end, the main tube having an anchor disposed in the distal end of the main tube, the distal end of the deflection wire being connected to the anchor, the proximal end of the deflection wire being configured to be pulled or pushed to bend the distal end of the main tube, Wherein, in the bendable catheter, the distal end of the flexible tubular main tube is provided with a coil component, the coil component is formed in a spiral shape and extends along the first inner cavity and surrounds the first inner cavity to reinforce the first inner cavity. 6 . The flexible catheter according to claim 5 , further comprising a marker band disposed at a distal end of the main tube.
7. A spacer crossing system, comprising: A puncture catheter, the puncture catheter comprising a flexible tubular main tube having a distal end and a proximal end, a first lumen extending between the distal end and the proximal end for inserting a guide wire, the main tube having a first side hole formed at the distal end, the main tube having a second lumen open to the side hole, the main tube having a deflection wire, the deflection wire having a distal end and a proximal end, the distal end of the deflection wire being connected to the distal end of the main tube, the deflection wire being configured to pass through an outer surface of the main tube and enter the first side hole, and the proximal end of the deflection wire being configured to pull or push the distal end of the curved main tube; as well as A capture catheter, the capture catheter comprising a flexible tubular main tube having a distal end and a proximal end, a first lumen extending between the distal end and the proximal end for inserting a guide wire, the main tube having a first side hole formed at the distal end, the main tube having a second lumen open to the side hole, the main tube having a deflection wire, the deflection wire having a distal end and a proximal end, the main tube having an anchor disposed at the distal end of the main tube, the distal end of the deflection wire being connected to the anchor, the proximal end of the deflection wire being configured to be pulled or pushed to bend the distal end of the main tube, The distal end of the flexible tubular main pipe is provided with a coil component, which is formed in a spiral shape and extends along the first inner cavity and surrounds the first inner cavity to reinforce the first inner cavity.
8. A puncture device for a septal traversing system, characterized in that: include: A flexible tubular multi-lumen tube, the flexible tubular multi-lumen tube comprising a distal end, a proximal end, a first lumen, and a second lumen, The first inner cavity is used for inserting a guide wire or a puncture wire. The second lumen is for inserting a deflection wire therein, and a distal end of the deflection wire is connected to the vicinity of the distal end of the flexible tubular multi-lumen tube, and the deflection wire is configured to be operable to cause the distal end of the flexible tubular multi-lumen tube to bend, The distal end of the flexible tubular multi-lumen tube is provided with a coil component, which is formed in a spiral shape and extends along the first lumen and surrounds the first lumen to reinforce the first lumen.
9. The puncture device according to claim 8, characterized in that: The flexible tubular multi-lumen tube is provided with a second side hole configured to allow the deflection wire to exit the second lumen, thereby allowing the deflection wire to pass through the outer surface of the flexible tubular multi-lumen tube, and the distal end of the deflection wire is fixed near the distal end of the flexible tubular multi-lumen tube.
10. The puncture device according to claim 9, characterized in that: The flexible tubular multi-lumen tube is provided with a first side hole, which is arranged near the distal end of the flexible tubular multi-lumen tube. The deflection wire passes through the outer surface of the flexible tubular multi-lumen tube and then enters the first side hole for fixation.
11. The puncture device according to claim 10, characterized in that: The flexible tubular multi-lumen tube is provided with a bendable member located near a distal end of the flexible tubular multi-lumen tube, the bendable member being bendable by manipulation of the deflection wire.
12. The puncture device according to claim 11, characterized in that: The bendable member is disposed between the second side hole and the distal end of the flexible tubular multi-lumen tube, or the bendable member is disposed between the second side hole and the first side hole.
13. The puncture device according to claim 8, characterized in that: The coil member is configured to be bent coaxially with the flexible tubular multi-lumen tube to support a puncture site.
14. The puncture device according to claim 8, characterized in that: Also included is at least one marker band disposed near the distal end of the flexible tubular multi-lumen tube so as to confirm the curvature of the flexible tubular multi-lumen tube based on the marker band.
15. The puncture device according to claim 8, characterized in that: Also included is a deflection member including a slider connected to the proximal end of the deflection wire and controllable to move so as to push or pull the deflection wire.
16. The puncture device according to claim 15, characterized in that: The deflection member further includes a knob that can be rotated to cause the slide to move.
17. The puncture device according to claim 15 or 16, characterized in that: The deflection member further includes a hub, into which the guide wire or puncture wire is inserted, and the guide wire or puncture wire enters the first lumen via the lumen of the deflection member.
18. The puncture device according to any one of claims 8 to 10, characterized in that: The flexible tubular multi-lumen tube is configured to be insertable into the coronary sinus.
Citation Information
Patent Citations
Steerable stylet and manipulative handle assembly
US5439006A
Rapid exchange catheter
US8758325B2