PERICARDIAL ACCESS DEVICE

• US 20170119435A1
• Filed: 10/31/2016
• Published: 05/04/2017
• Est. Priority Date: 11/04/2015
• Status: Active Grant

• Current Assignee: Rainbow Medical Ltd.
• Original Assignee: Rainbow Medical Ltd.
• Inventors: GROSS, Yossi, KARDOSH, Michael, KISHON, Amir, SADAN, Ido, YALOM, Jonathan, SOHN, Zev, GINO, Omri, YANOVITZ, Leonid, RIMER-COHEN, Ofir
• Granted Patent: US 10,327,812 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/045 Control thereof
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

A method is provided for accessing a pericardial space of a subject. The method includes advancing a guide member toward a heart, having (a) a transparent blunt distal end, and (b) a side-facing suction port. During advancing of the guide member, an imaging device disposed in the guide member generates an image of part of the heart. Subsequently to contacting the pericardium with the suction port, the imaging device is retracted proximally in the guide member. Subsequently, a portion of the pericardium is drawn into the guide member through the suction port. Following the drawing of the portion into the guide member, an image of the pericardium disposed within the suction port, is generated. Subsequently, a puncturing element is advanced in the guide member to puncture the portion of the pericardium that is in the guide member. Other applications are also described.

Claims

1. A method comprising:

distally advancing a longitudinal guide member toward a heart of a subject, the guide member (a) shaped to define a blunt distal end having an outer surface at least part of which is transparent, and (b) shaped to define an at least partially side-facing suction port at a distal portion of the longitudinal guide member;

during the advancing, using an imaging device disposed at least partially in the guide member to generate an image of at least part of the heart;

contacting an outer surface of a pericardium of the heart with the suction port;

subsequently, retracting the imaging device proximally in the guide member;

subsequently, drawing a portion of the pericardium into the guide member by applying suction to the pericardium through the suction port,

at at least one time following the drawing of the portion of the pericardium into the guide member, generating an image of the pericardium disposed within the suction port;

subsequently, advancing a puncturing element into the guide member; and

puncturing the portion of the pericardium that is in the guide member using the puncturing element.

2. The method according to claim 1, wherein the method further comprises:

subsequently to drawing the portion of the pericardium into the guide member and prior to advancing the puncturing element,

removing the imaging device from the guide member, while continuing to maintain the portion of the pericardium in the guide member.

3. The method according to claim 1, wherein using the imaging device disposed at least partially in the guide member during the advancing of the longitudinal guide member comprises using the imaging device while the imaging device is disposed distally to at least part of the suction port.

4. The method according to claim 3, wherein using the imaging device while the imaging device is disposed distally to at least part of the suction port comprises using the imaging device while the imaging device at least partially blocks the suction port.

5. The method according to claim 1, wherein the method further comprises, subsequently to advancing the longitudinal guide member, rotating the longitudinal guide member such that the suction port faces the pericardium.

6. The method according to claim 1, further comprising using the imaging device to generate an image of the suction port prior to the drawing of the portion of the pericardium into the guide member.

7. The method according to claim 1, further comprising using the imaging device to generate an image of the suction port during the drawing of the portion of the pericardium into the guide member.

8. The method according to claim 1, wherein the puncturing element includes a needle, and wherein using the puncturing element comprises using the needle to puncture the portion of the pericardium.

9. The method according to claim 8, further comprising passing a guidewire through a lumen of the needle, following the puncturing of the portion of the pericardium using the needle.

10. The method according to claim 9, wherein the method further comprises, prior to passing the guidewire through the lumen of the needle, rotating the needle by greater than 90 degrees such that an opening at a distal end of the needle lumen faces the myocardium tissue of the subject.

11. Apparatus comprising:

a longitudinal guide member (a) comprising a blunt distal end having an outer surface at least part of which is transparent, (b) configured to be advanced distally toward a heart of a subject, and (c) shaped to define an at least partially side-facing suction port at a distal portion of the longitudinal guide member, the apparatus being configured to contact a pericardium of the heart to facilitate drawing a portion of the pericardium through the suction port and into the longitudinal guide member;

an imaging device disposed distally in the longitudinal guide member and configured to be retracted proximally in the longitudinal guide member subsequently to the suction port contacting the pericardium; and

a puncturing element disposed proximally in the longitudinal guide member and configured to be advanced distally in the longitudinal guide member to puncture the portion of the pericardium while the portion of the pericardium is in the longitudinal guide member.

12. The apparatus according to claim 11, wherein the imaging device is disposed distally to at least part of the suction port.

13. The apparatus according to claim 11, wherein a distal portion of the longitudinal guide member is shaped to define an undivided lumen.

14. The apparatus according to claim 11, wherein the puncturing element comprises a needle.

15. The apparatus according to claim 14, further comprising a guidewire configured to be passed through a lumen of the needle, following the puncturing of the portion of the pericardium using the needle.

16. Apparatus comprising:

a longitudinal guide member (a) comprising a blunt distal end having an outer surface at least part of which is transparent, (b) configured to be advanced distally toward a heart of a subject, and (c) shaped to define a suction port at a distal portion of the longitudinal guide member, the apparatus being configured to facilitate drawing a portion of a pericardium of the heart through the suction port and into the longitudinal guide member;

an imaging device disposed in the longitudinal guide member;

at least one light baffle (a) positioned to face the distal end of the longitudinal guide member and (b) being aligned generally perpendicular with a center of the imaging device; and

a puncturing element configured to puncture the portion of the pericardium while the portion of the pericardium is in the longitudinal guide member.