EP-4739232-A1 - HUB LOCK FOR A TISSUE PERFORATION DEVICE

Abstract

A perforation system for accessing a location in or near a patient's heart is disclosed. The system includes a puncture device having a proximal portion and a distal portion including a distal tip. The system further includes an elongated introducer defining a lumen adapted to receive and allow longitudinal translation of the puncture device therein, the elongated introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a locking hub. The locking hub includes a slot and an engaging surface configured so that the proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the puncture device with respect to the elongated introducer.

Inventors

• MILLER, BROCK
• Fok, Kai-Lon
• GRAVETT, MATTHEW

Assignees

• Boston Scientific Medical Device Limited

Dates

Publication Date

20260513

Application Date

20240704

Claims (20)

1. 1 . A perforation system for accessing a location in or near a patient’s heart, the system comprising: a puncture device having a puncture device proximal portion and a puncture device distal portion including a distal tip; and an elongated introducer defining a lumen adapted to receive and allow longitudinal translation of the puncture device therein, the elongated introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a locking hub; wherein the locking hub includes a slot and an engaging surface configured so that the puncture device proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the puncture device proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the puncture device with respect to the elongated introducer.
2. 2. The perforation system of claim 1 , wherein the slot is a J-shaped opening.
3. 3. The perforation system of any of claims 1-2, wherein the slot further includes an entry slot.
4. 4. The perforation system of any of claims 1-3, wherein the slot further includes a locking slot.
5. 5. The perforation system of any of claims 1-4, wherein the puncture device proximal portion can be positioned in the entry slot and bent towards the locking slot.
6. 6. The perforation system of any of claims 1-5, wherein the puncture device proximal portion bends at about 45 degrees to 90 degrees with respect to the locking hub.
7. 7. The perforation system of any of claims 1-5, wherein the puncture device is an RF puncture wire having an electrically active distal tip and the proximal portion of the RF puncture wire is inserted into the slot via the entry slot and is manipulated by a user into the locking slot for the RF puncture wire to be locked therein.
8. 8. The perforation system of claim 1 , wherein the elongated introducer may include multiple slots on the locking hub.
9. 9. The perforation system of claim 1 , wherein the puncture device is a Nitinol radiofrequency guidewire, and wherein the puncture device includes at least one or more line markers along the puncture device elongated body.
10. 10. The perforation system of claim 1 , wherein the elongated introducer further includes a dilator.
11. 11 . The perforation system of claim 1 , wherein the engaging surface promotes friction with the puncture device.
12. 12. The perforation system of claim 1 , wherein the engaging surface is an interior surface of the slot that engages the proximal portion of the puncture device.
13. 13. The perforation system of claim 1 , wherein the engaging surface is the interior surface of the locking slot that secures with the puncture device.
14. 14. The perforation system of claim 1 , wherein the engaging surface is made of a high coefficient of friction material to enhance the frictional force between the engaging surface and the puncture device.
15. 15. The perforation system of claim 1 , wherein the engaging surface includes a surface finish that promotes friction with the puncture device.
16. 16. A radiofrequency perforation system for accessing a location in or near a patient’s heart, the system comprising: a radiofrequency puncture wire having a wire proximal portion and a wire distal portion including an electrically active distal tip; and an elongated introducer defining a lumen adapted to receive and allow longitudinal translation of the radiofrequency puncture wire therein, the elongated introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a locking hub; wherein the locking hub includes a slot and an engaging surface configured so that the wire proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the wire proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the radiofrequency puncture wire with respect to the elongated introducer.
17. 17. The radiofrequency perforation system of claim 16, wherein the slot is a J-shaped opening.
18. 18. The radiofrequency perforation system of claim 17, wherein the slot further includes an entry slot.
19. 19. The radiofrequency perforation system of claim 18, wherein the slot further includes a locking slot.
20. 20. The radiofrequency perforation system of claim 19, wherein the wire proximal portion can be positioned in the entry slot and bent towards the locking slot.

Description

HUB LOCK FOR A TISSUE PERFORATION DEVICE CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority to U.S. Provisional Patent Application No. 63/512,409, filed July 7, 2023, the entire disclosure of which is incorporated herein by reference. TECHNICAL FIELD [0002] The present invention relates generally to methods and devices for accessing anatomical structures in the body of a patient. More specifically, the present invention is concerned with a hub lock for use in combination with a tissue perforation system. BACKGROUND [0003] Devices currently exist for creating a puncture, channel, or perforation within a tissue located in a body of a patient. A radiofrequency (RF) guidewire used for accessing a location in or near the patient’s heart, for example epicardial or transseptal access, involves the RF guidewire being inserted in an opening at the proximal end of an introducer and guided through the introducer until the guidewire emerges from the distal end of the introducer with a RF electrode on the tip of the RF guidewire protruding from the distal end of the introducer. In this case, the RF guidewire is free to move forward and backwards into the introducer. The precise positioning of the electrode tip of the RF guidewire is required for accurate and repeatable puncture of a target site. [0004] Some currently available devices include a collar that is placed behind the tip electrode of the RF guidewire which is used as a hard stop to position the electrode at the precise position relative to the rigid sheath. Thus, once a user is ready to advance the RF guidewire using the rigid sheath, the force of advancing the rigid sheath will be transmitted to the RF guidewire through the electrode collar so that the proper electrode positioning on the target site is maintained relative to the rigid sheath while a force is applied to advance the rigid sheath into a patient. Other current devices are positioned using a proximal marker. Such devices, however, do not have a mechanism to ensure the electrode tip remains in place at the tip of the introducer when there is a force acting on the tip electrode in the direction away from the introducer sheath. This force can include the electrode being pinched or caught on tissue while the introducer is being retracted or the user unintentionally pushing the RF guidewire forward. Additionally, the tip electrode may be pushed back inside the introducer and once inside the introducer and/or the dilator the tip is no longer in contact with tissue and results in failure to puncture or perforate a tissue. [0005] Against this background, there exists a continuing need in the industry to provide improved locking mechanism for radiofrequency perforation devices and methods. An object of the present invention is therefore to provide such a method and device. SUMMARY [0006] In Example 1 , a perforation system for accessing a location in or near a patient’s heart includes a puncture device having a puncture device proximal portion and a puncture device distal portion including a distal tip; and an elongated introducer defining a lumen adapted to receive and allow longitudinal translation of the puncture device therein, the elongated introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a locking hub; wherein the locking hub includes a slot and an engaging surface configured so that the puncture device proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the puncture device proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the puncture device with respect to the elongated introducer. [0007] Example 2 is the perforation system of Example 1 , wherein the slot is a J- shaped opening. [0008] Example 3 is the perforation system of any of Examples 1-2, wherein the slot further includes an entry slot. [0009] Example 4 is the perforation system of any of Examples 1-3, wherein the slot further includes a locking slot. [0010] Example 5 is the perforation system of any of Examples 1-4, wherein the puncture device proximal portion can be positioned in the entry slot and bent towards the locking slot. [0011] Example 6 is the perforation system of any of Examples 1-5, wherein the puncture device proximal portion bends at about 45 degrees to 90 degrees with respect to the locking hub. [0012] Example 7 is the perforation system of any of Examples 1-5, wherein the puncture device is an RF puncture wire having an electrically active distal tip and the proximal portion of the RF puncture wire is inserted into the slot via the entry slot and is manipulated by a user into the locking slot for the RF puncture wire to be locked therein. [0013] Example 8 is the perforation system of Example 1 , wherein the elongated introducer may include multiple slots o