Enhanced dilator and methods of using the same

Patent metadata

Field	Value
Publication number	US-12564706-B2
Application number	US-202318185515-A
Country	US
Kind code	B2
Filing date	Mar 17, 2023
Priority date	Mar 17, 2022
Publication date	Mar 3, 2026
Grant date	Mar 3, 2026

Abstract

An enhanced dilator includes a dilator shaft defining a lumen for receiving a functional device (e.g., a puncturing device) therethrough. The dilator shaft includes a proximal portion for manipulation by a user and a distal portion to placement in or near the heart. A dilator hub is coupled to the proximal portion of the dilator shaft and includes a rotational coupling structure for coupling to a corresponding hub of a therapy sheath.

First claim

We claim:

1 . A dilator for facilitating access to a patient's heart and for coupling with a sheath including a sheath hub, the dilator comprising:
a dilator shaft defining a lumen adapted to receive and support a puncturing device, the dilator shaft including a proximal portion for manipulation by a user and a distal portion for placement in or near the heart for manipulation by a user; and a hub coupled to the proximal portion of the dilator shaft, the hub including a cylindrical body having a hexagonal distal end and an angled proximal end, the hub including a rotational coupling structure for coupling to the sheath hub so as to inhibit relative rotation between the dilator and the sheath, wherein the rotational coupling structure comprises a resilient coupling system comprising the hexagonal distal end including flat portions and rounded edges for contacting an inner surface of the sheath hub.

2 . The dilator of claim 1 wherein the sheath is a therapy sheath.

3 . The dilator of claim 1 wherein the puncturing device is an RF puncturing device.

4 . The dilator of claim 1 wherein the rotational coupling structure includes a protrusion adapted to mate with a recess in the sheath hub.

5 . The dilator of claim 1 wherein the dilator hub includes an angled disengagement surface adapted to contact a mating surface on the sheath hub, the mating surface being configured to generate an axial disengagement force upon the disengagement surface.

6 . The dilator of claim 5 , wherein the angled disengagement surface includes a first surface that is not parallel to a second surface associated with the mating surface.

7 . The dilator of claim 1 , wherein the shaft includes a reinforcing member.

8 . The dilator of claim 1 , wherein the distal portion includes one or more radiopaque markers.

9 . The dilator of claim 1 , wherein the rotational coupling structure includes a first surface configured to contact a first surface of a recess located on the sheath hub.

10 . The dilator of claim 9 , wherein the rotational coupling structure includes a second surface configured to contact a second surface of the recess located on the sheath hub.

11 . An enhanced dilator for coupling with a therapy sheath having a sheath hub, the enhanced dilator comprising:
a dilator shaft defining a lumen for receiving a puncturing device therethrough, the dilator shaft being structured to provide support for the puncturing device when the puncturing device is used to create a puncture in a tissue, the dilator shaft having a proximal portion and a distal portion; and a dilator hub connected to the proximal portion of the dilator shaft, the dilator hub including a cylindrical body having a hexagonal distal end and an angled proximal end, the hub including a resilient coupling system for coupling to the sheath hub, wherein the resilient coupling system comprises the hexagonal distal end including flat portions and rounded edges for contacting an inner surface of the sheath hub.

12 . The enhanced dilator of claim 11 , wherein the hexagonal distal end is made of a resilient material, wherein gaps formed between the flat portions and the inner surface of the sheath hub provides space into which the resilient material may deflect.

13 . The enhanced dilator of claim 11 , wherein the dilator shaft includes a reinforcing member for supporting a flexible puncture device.

14 . The enhanced dilator of claim 11 , wherein the distal portion includes a radiopaque marker.

15 . The enhanced dilator of claim 11 , wherein the resilient coupling system includes a cylindrical body having an angled proximal end.

16 . The enhanced dilator of claim 11 , wherein the resilient coupling system includes a plurality of circumferentially disposed protrusions.

17 . A system for facilitating access to a patient's heart, the system comprising:
a dilator including a shaft defining a lumen adapted for receiving and supporting a puncturing device, the shaft including a proximal portion for manipulation by a user and a distal portion for placement in or near the heart for manipulation by a user; a dilator hub coupled to the proximal portion of the dilator shaft, the dilator hub including a cylindrical body having a hexagonal distal end and an angled proximal end, the hub including a rotational coupling structure, wherein the rotational coupling structure comprises a resilient coupling system comprising the hexagonal distal end including flat portions and rounded edges; a sheath including a sheath body defining a lumen adapted for receiving the dilator; and a sheath hub coupled to a proximal portion of the sheath body, the sheath hub including a recess for coupling with the rotational coupling structure to inhibit relative rotation between the dilator and the sheath.

18 . The system of claim 17 , wherein the hexagonal distal end is made of a resilient material, wherein gaps formed between the flat portions and the inner surface of the sheath hub provides space into which the resilient material may deflect.

19 . The system of claim 17 , wherein the recess includes a generally rectangular shape surrounding the lumen adapted for receiving the dilator.

20 . The system of claim 17 , wherein the rotational coupling structure includes a first surface configured to contact a first inner portion of the recess and a second surface configured to contact a second inner portion of the recess.

Assignees

• Boston Scientific Medical Device Limited

Inventors

• Arnett Jeffery
• Rees David

Classifications

• A61B17/3478

  Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067) · CPC title

• A61M25/0097

  characterised by the hub (connectors A61M39/10) · CPC title

• A61M29/00 Primary

  Dilators with or without means for introducing media, e.g. remedies · CPC title

• A61M29/02 Primary

  Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} · CPC title