VESSEL LINING DEVICE AND RELATED METHODS
20230157855 · 2023-05-25
Assignee
Inventors
- Shawn Sabu Cherian (Plymouth Meeting, PA, US)
- Francois Jouin (Malvern, PA, US)
- Greg A. Walters (Exton, PA, US)
Cpc classification
A61F2/90
HUMAN NECESSITIES
A61M2025/0687
HUMAN NECESSITIES
A61F2/966
HUMAN NECESSITIES
International classification
Abstract
A deployment device for lining a vessel having a housing having a proximal end and a distal end opposite the proximal end, the housing defining a guidewire channel, a tube elongated along a longitudinal axis, the tube having a proximal end and a distal end spaced from the proximal end of the tube along the longitudinal axis, a sheath assembly having a hub removably coupled to the distal end of the housing, and a mesh removably coupled to the tube and positioned along the tube. The tube and the sheath assembly are configured to move along the guidewire and into the vessel through a puncture and release the mesh inside the vessel when at least one of the tube and the mesh is actuated. The device is used as a method of mitigating potential injury or harm to the integrity of the patient’s vessel lining.
Claims
1. A method of lining a vessel, the method comprising the steps of: inserting a guidewire into the vessel through a puncture in a vessel wall; sliding a deployment device along the guidewire until a distal end of the deployment device is inside the vessel; actuating at least one of a tube and a mesh positioned along the tube to cause a lock to release the mesh from the distal end of the deployment device such that the mesh expands inside the vessel; and while maintaining the mesh in the vessel, removing the tube from within the mesh.
2. The method of claim 1, wherein the sliding step further comprises placing the tube on a proximal end of the guidewire and advancing the tube in a distal direction along the guidewire and into the vessel.
3. The method of claim 2, wherein the sliding step further comprises advancing the tube along the guidewire into the vessel until a hub of the tube is in contact with a skin surface near the puncture.
4. The method of claim 3, wherein the actuating step occurs when the hub is in contact with the skin surface near the puncture.
5. The method of claim 4, further comprising removing the mesh, the hub, and the guidewire from the vessel after removing the tube.
6. The method of claim 1, wherein the actuating step further comprises engaging an actuator to actuate the tube when the distal end of the deployment device abuts the puncture.
7. The method of claim 1, wherein the actuating step further comprises engaging an actuator to actuate the tube when the mesh is completely inside the vessel.
8. The method of claim 1, wherein the actuating step further comprises moving the lock from a locked position, where the mesh is fixed to the tube, to an unlocked position, where the mesh is not fixed to the tube.
9. The method of claim 8, wherein the actuating step further comprises extending the tube from a first position where the lock is in the locked position to a second position where the lock is in the unlocked position.
10. The method of claim 9, wherein the actuating step further comprises moving the lock from the locked position where the lock is disposed on a protrusion positioned between a proximal surface and a distal stop surface that is spaced from the proximal surface along a longitudinal axis in a distal direction, to an unlocked position where the lock is not disposed on the protrusion, to release the mesh in the unlocked position.
11. A method of lining a vessel, the method comprising the steps of: inserting a guidewire into the vessel through a puncture in a vessel wall; sliding an elongated tube along the guidewire until a distal end of the tube is inside the vessel, the tube having a proximal end, a distal end spaced from the proximal end of the tube, a protrusion, and a distal groove between the protrusion and the distal end of the tube; actuating at least one of the tube and a mesh positioned along the protrusion of the tube to cause a lock to release the mesh from between the proximal end of the tube and the distal groove such that the mesh expands inside the vessel; and while maintaining the mesh in the vessel, removing the tube from within the mesh.
12. The method of claim 11, wherein the sliding step further comprises placing the tube on a proximal end of the guidewire and advancing the tube in a distal direction along the guidewire and into the vessel.
13. The method of claim 12, wherein the sliding step further comprises advancing the tube along the guidewire into the vessel until a hub of the tube is in contact with a skin surface near the puncture.
14. The method of claim 13, wherein the actuating step occurs when the hub is in contact with the skin surface near the puncture.
15. The method of claim 14, further comprising removing the mesh, the hub, and the guidewire from the vessel after removing the tube.
16. The method of claim 11, wherein the actuating step further comprises engaging an actuator to actuate the tube when the distal end of the deployment device abuts the puncture.
17. The method of claim 11, wherein the actuating step further comprises engaging an actuator to actuate the tube when the mesh is completely inside the vessel.
18. The method of claim 11, wherein the actuating step further comprises moving the lock from a locked position, where the mesh is fixed to the tube, to an unlocked position, where the mesh is not fixed to the tube.
19. The method of claim 18, wherein the actuating step further comprises extending the tube from a first position where the lock is in the locked position to a second position where the lock is in the unlocked position.
20. The method of claim 19, wherein the actuating step further comprises moving the lock from the locked position where the lock is disposed on the protrusion positioned between a proximal surface and a distal stop surface that is spaced from the proximal surface along a longitudinal axis in a distal direction, to an unlocked position where the lock is not disposed on the protrusion, to release the mesh in the unlocked position.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. The drawings show illustrative embodiments of the disclosure. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown.
[0010]
[0011]
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0026] As shown in
[0027] Referring to
[0028] The housing assembly 104 is configured to allow a user to manipulate the deployment device 100 with the user’s hands and insert the deployment device 100 into a patient’s vessel via a puncture site. The housing assembly 104 has a proximal end 132 and a distal end 136 opposite the proximal end 132. The interior of the housing assembly 104 is sized to permit a guidewire (not depicted) to pass therethrough to insert the deployment device 100 into the vessel. The housing assembly 104 is operably coupled to the tube 120 at the distal end 136. In addition, the housing assembly 104 is removably coupled to the sheath assembly 108 at the distal end 136.
[0029] The sheath assembly 108 includes the mesh 112 and a hub 114 removably coupled to the distal end 136 of the housing assembly 104. In the illustrated embodiment, the mesh 112 is positioned along the tube 120. The mesh 112 is configured to be compressed against the tube 120 when the deployment device 100 is inserted into the vessel, and expand inside the vessel when released or decoupled from the tube 120. The mesh thus lines the interior of the vessel when it is released. In its compressed state, the mesh 112 surrounds the tube 120 and is removably coupled to the hub 114 and to the tube 120. In the illustrated embodiment, the inner diameter of the mesh 112 when compressed against the tube 120 is 7 French (“FR”), or approximately 1 mm. In other embodiments, the inner diameter of the mesh 112 may vary. In the illustrated embodiment, the inner diameter of the mesh 112 when expanded is sized to conform or contact the vessel. In alternative embodiments, the inner diameter of the mesh 112 when expanded may vary. The mesh 112 must be comprised of a flexible material in order to be compressed around the tube 120 and also expand to line the interior of the vessel. However, the mesh 112 must also be strong enough to protect the interior vessel from the insertion and removal of various equipment. In the illustrated embodiment, the mesh 112 is made of nitinol. In alternative embodiments, the mesh 112 may be made of various materials, including stainless steel, other metallic alloys, nylon, polyurethane, or other polymers.
[0030] The actuator 116 is configured to extend the tube 120 in a distal direction from a first position to a second position that is distal to the first position along the central axis A when the actuator 116 is engaged, thereby releasing the mesh 112 from the tube 120 and into the vessel. The actuator 116 is coupled to the proximal end 132 of the housing assembly 104. The actuator 116 is also operably coupled to the tube 120. In the illustrated embodiment, the actuator is a release lever; however, in alternative embodiments, the type of actuator may vary. The release lever rotates about the y-axis, which causes a transfer of rotational motion of the lever to translational motion of the tube 120 in the distal direction about the perpendicular x-axis. The tube 120 extends in a distal direction along the central axis A. The movement of the tube 120 releases the compressed mesh 112.
[0031] The tube 120 is configured to be inserted inside the vessel via the puncture site and is further configured to transport the mesh 112 inside the vessel. The tube 120 is sized to permit a guidewire (not depicted) to pass therethrough. The tube 120 is elongated along the central axis A and has a proximal end 140 and a distal end 144. The tube 120 has a length that extends from the proximal end 140 to the distal end 144 along the central axis A. In the illustrated embodiment, the length of the tube can vary as clinically required. In alternative embodiments, the length of the tube 120 may vary. The proximal end 140 of the tube 120 is coupled to the distal end 136 of the housing assembly 104.
[0032] Referring to
[0033] The lock 148 is positioned on a portion of the tip 152. The tip 152 is sized and shaped to be inserted smoothly into the vessel and allow the lock 148 to transition from a locked position to an unlocked position. In the illustrated embodiment, a distal portion of the tip 152 is conical in shape. In another embodiment, the distal portion of the tip 152 may be round in shape. In alternative embodiments, the shape of the tip 152 may vary. In the present disclosure, the tip 152 includes a proximal surface 156, a protrusion 160 located in a distal direction along the central axis A from the proximal surface 156, and a distal stop surface 164 located in a distal direction along the central axis A from the proximal surface 156 and the protrusion 160. The protrusion 160 is therefore positioned between and spaced from the proximal surface 156 and the distal stop surface 164. The proximal surface 156 and protrusion 160 are separated by a proximal groove 168. Similarly, the distal stop surface 164 and the protrusion 160 are separated by a distal groove 268.
[0034] The lock is disposed between the proximal surface 156 and the distal stop surface 164. The distal stop surface 164 is sized to prevent the lock 148 from advancing over the tip 152. In the present disclosure, the diameter of the distal stop surface 164 is larger than the diameter of the lock 148 to stop the lock 148 from moving past the distal stop surface 164 in the distal direction. The proximal surface 156 tapers in a distal direction toward the proximal groove 168 and the protrusion 160 to aid in insertion of the tip into the patient’s vessel.
[0035] The lock 148 is positioned on the protrusion 160 and compresses the mesh 112 against the protrusion 160 in the locked position. The lock 148 is released from the protrusion 160 and moves in the proximal direction toward the proximal surface 156 in the unlocked position. The diameter of the tube 120 is sized to stop the lock 148 from advancing past the proximal surface 156 in the proximal direction, and the lock 148 is displaced into the proximal groove 168. Upon release of the lock 148 from the protrusion 160, the lock 148 releases the mesh 112 from the tube 120. The lock 148 transitions from the locked position to the unlocked position when the actuator 116 (not depicted) actuates the tube 120 to extend in a distal direction along the central axis A.
[0036]
[0037]
[0038] When a user rotates the screw 516 about the x-axis via the screw head 517, the threaded body 518 of the screw 516 provides translational movement of the tube 120 about the same axis. Rotation of the screw 516 therefore extends the tube 120 in the distal direction along the central axis A. Extension of the tube 120 transitions the lock 148 from the locked position on the protrusion 160 to the unlocked position off of the protrusion 160 and in the proximal groove 168, thereby releasing the compressed mesh 112. The mesh 112 then expands in the patient’s vessel to line the interior of the vessel.
[0039]
[0040] When a user depresses the button 616 about the x-axis, the spring transfers compressive energy from the depression of the button 616 into translational movement in the tube 120 about the same axis. Depression of the button 616 extends the tube 120 in the distal direction along the central axis A. Extension of the tube 120 transitions the lock 148 from the locked position on the protrusion 160 to the unlocked position off of the protrusion 160 and in the proximal groove 168, thereby releasing the compressed mesh 112. The mesh 112 then expands in the patient’s vessel to line the interior of the vessel.
[0041]
[0042] Prior to displacement of the pin 716, the spring is in a compressed state. When a user displaces the pin 716 about the z-axis, the spring is released about the x-axis, providing translational movement of the tube 120 in the distal direction about the x-axis. Displacement of the pin 716 extends the tube 120 in the distal direction along the central axis A. Extension of the tube 120 transitions the lock 148 from the locked position on the protrusion 160 to the unlocked position off of the protrusion 160 and in the proximal groove 168, thereby releasing the compressed mesh 112. The mesh 112 then expands in the patient’s vessel to line the interior of the vessel.
[0043]
[0044] When a user progresses the tab 816 along the track 817 about the x-axis, the tab 816 and track 817 provide translational movement of the tube 120 in the distal direction about the same axis. Extension of the tube 120 transitions the lock from the locked position on the protrusion 160 to the unlocked position off of the protrusion 160 and in the proximal groove 168, thus releasing the compressed mesh 112. The mesh 112 then expands in the patient’s vessel to line the interior of the vessel. When the tab 816 is progressed over the at least one ridge, the tab 816 locks in the current position, preventing the tab 816 from progressing in the proximal direction and preventing translational movement of the tube 120 in a proximal direction about the x-axis.
[0045]
[0046] When a user rotates the gear 916 about the y-axis, the track system provides translational movement of the tube 120 in the distal direction about the x-axis. The tube 120 extends in a distal direction along the central axis A, causing the lock 148 to transition from the locked position on the protrusion 160 to the unlocked position off of the protrusion 160 and in the proximal groove 168, thereby releasing the compressed mesh 112. The mesh 112 then expands in the patient’s vessel to line the interior of the vessel.
[0047]
[0048] Referring to
[0049] Referring to
[0050] Referring to
[0051]
[0052] The distal end 144 of the tube 120 includes the lock 1148. The lock 1148 is configured to hold the mesh 1112 in a compressed state against the tube 120 in a locked position prior to engagement of the actuator 116. The lock 1148 is disposed on a portion of the tip 152. The lock 1148 is positioned on the protrusion 160 and compresses the mesh 1112 against the protrusion 160 prior to engagement of the actuator 116. This configuration allows the deployment device 1100 to be compact in order to be inserted into the patient’s vessel. Once the deployment device 1100 is inserted into the patient’s vessel, the actuator 116 may be engaged.
[0053] In the illustrated embodiment, engagement of the actuator 116 about the x-axis causes translational motion of the mesh 1112 in the x-axis. For example, rotation of the actuator 116 causes the mesh 1112 to retract in a proximal direction along the central axis A. Retraction of the mesh 1112 releases the mesh 1112 from beneath the lock 1148. The mesh 1112 then expands in the vessel to line the interior of the vessel. In the illustrated embodiment, retraction of the mesh 1112 causes the lock 1148 to be transition from the locked position on the protrusion 160 to an unlocked position on the proximal groove 168. In alternative embodiments, the lock may stay in place on the protrusion 160 when the mesh 1112 retracts.
[0054]
[0055] The inner tube 1221 and the outer tube 1222 are configured to be inserted inside the vessel via the puncture site. The inner tube 1221 is sized to permit a guidewire (not depicted) to pass therethrough. The inner tube 1221 therefore has a diameter of approximately 6 FR, while the outer tube 1222 has a diameter of approximately 8 FR. The inner tube 1221 and outer tube 1222 are elongated along the central axis A and have a proximal end 1240 and a distal end 1244. The inner tube 1221 and the outer tube 1222 have a length that extends from the proximal end 1240 to the distal end 1244 along the central axis A. The proximal end 1240 is coupled to the distal end 136 of the housing assembly 104. The distal end 1244 tapers in a distal direction and includes a screw insert 1250.
[0056] The deployment device 1200 further includes a tip 1252. The tip 1252 is sized and shaped to be inserted smoothly into the vessel. In the illustrated embodiment, a distal portion of the tip 1252 is conical in shape. In another embodiment, the distal portion of the tip 1252 may be round in shape. In alternative embodiments, the shape of the tip 1252 may vary. In the present disclosure, the tip 1252 includes a screw head 1251 located in a proximal direction along the central axis A, a protrusion 1260 located in a distal direction along the central axis A from the screw head 1251, and a distal stop surface 1264 located in a distal direction along the central axis A from the screw head 1251 and the protrusion 1260. The protrusion 1260 is therefore positioned between and spaced from the screw head 1251 and the distal stop surface 1264. The screw head 1251 and protrusion 1260 are separated by a proximal groove 1268. Similarly, the distal stop surface 1264 and the protrusion 1260 are separated by a distal groove 1269.
[0057] The tip 1252 is configured to be attached to the inner tube 1221 and the outer tube 1222. Specifically, the screw head 1251 is configured to be inserted into the screw insert 1250. The tip 1252 includes a hollow channel that extends along the length of the tip 1252 to allow a guidewire to pass through both the tip 1252 and the inner tube 1221 when the tip 1252 and the inner tube 1221 and outer tube 1222 are attached.
[0058] The deployment device 1200 further includes a mesh 1212. The mesh 1212 is configured to be compressed against the outer tube 1222 when the deployment device 1200 is inserted into a patient’s vessel, and expand inside the vessel when released from the outer tube 1222. The mesh thus lines the interior of the vessel when it is released. In its compressed state, the mesh 1212 surrounds the outer tube 1222 and is removably coupled to the hub 114 and to the outer tube 1222. The mesh 1212 is operably coupled to the actuator 116.
[0059] The deployment device 1200 further includes a lock 1248. The lock 1248 is configured to hold the mesh 1212 in a compressed state against the outer tube 1222 in a locked position prior to engagement of the actuator 116. The lock 1248 is disposed on a portion of the tip 1252. The lock 1248 is positioned on the protrusion 1260 and compresses the mesh 1212 against the protrusion 1260 prior to engagement of the actuator 116. This configuration allows the deployment device 1200 to be compact in order to be inserted into the patient’s vessel. Once the deployment device 1200 is inserted into the patient’s vessel, the actuator 116 may be engaged.
[0060] In the illustrated embodiment, engagement of the actuator 116 about the y-axis causes translational motion of the mesh 1212 in the x-axis. For example, rotation of the actuator 116 causes the mesh 1212 to retract in a proximal direction along the central axis A. Retraction of the mesh 1212 releases the mesh 1212 from beneath the lock 1248. The mesh 1212 then expands in the vessel to line the interior of the vessel. In the illustrated embodiment, retraction of the mesh 1212 causes the lock 1248 to transition from the locked position on the protrusion 1260 to an unlocked position on the distal groove 1269. In alternative embodiments, the lock may stay in place on the protrusion 1260 when the mesh 1212 retracts.
[0061] Now referring to
[0062] The present disclosure is described herein using a limited number of embodiments, these specific embodiments are not intended to limit the scope of the disclosure as otherwise described and claimed herein. Modification and variations from the described embodiments exist. More specifically, the following examples are given as a specific illustration of embodiments of the claimed disclosure. It should be understood that the invention is not limited to the specific details set forth in the examples.