Pericardial needle mechanism

• US 10,667,842 B2
• Filed: 11/24/2017
• Issued: 06/02/2020
• Est. Priority Date: 11/24/2017
• Status: Active Grant

• Current Assignee: Rainbow Medical Ltd.
• Original Assignee: Rainbow Medical Ltd.
• Inventors: Fostick, Gideon, Uchitel, Ilan, Venislavski, Evgeni, Lis, Michael
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Byrd, Brigid K
• Application Number:
  US15/821,973
• Publication Number:
  US 20190159808A1
• Time in Patent Office: 921 Days
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00902 transparent or translucent
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras

Abstract

Apparatus is provided including a surgical tool configured to be advanced distally within a body of a subject. The surgical tool is shaped to define a side-facing suction port at a distal portion of the surgical tool to facilitate drawing tissue through the suction port and into the surgical tool, and includes a slidable transparent shutter configured to be disposed over the suction port, and to be slidably removed from the suction port. A needle is configured to be slidably disposed within the surgical tool and configured to puncture the tissue while the tissue is in the surgical tool. Other applications are also described.

Claims

1. A method for puncturing a pericardium of a heart of a subject, the method comprising:

using apparatus comprising;

a surgical tool shaped to define a lumen and comprising a handle disposed at a proximal end of the surgical tool;

a driving assembly disposed within the handle and comprising proximal and distal portions, the proximal and distal portions being slidably coupled to each other; and

a needle slidably disposed within the lumen of the surgical tool and coupled to the proximal portion of the driving assembly such that (i) during distal advancement of the driving assembly with respect to the handle the needle is advanced distally within the lumen of the surgical tool, the needle being rotationally stationary with respect to a longitudinal axis of the surgical tool, and (ii) subsequently to the needle being advanced distally within the lumen of the surgical tool, distal advancement of the distal portion of the driving assembly with respect to the proximal portion of the driving assembly rotates the needle in a first rotational direction around the longitudinal axis of the surgical tool;

distally advancing the surgical tool toward the heart of a subject, the surgical tool (a) shaped to define a distal end having an outer surface at least part of which is transparent, and (b) shaped to define a suction port at a distal portion of the surgical tool;

drawing a portion of the pericardium into the surgical tool by applying suction to the pericardium through the suction port; and

activating a user control to distally advance the driving assembly of the surgical tool, the distal advancement of the driving assembly having a distal-mode first phase and a distal-mode second phase,

the distal-mode first phase distally advancing the needle into the suction port while the needle is rotationally stationary with respect to the longitudinal axis of the surgical tool, thereby puncturing the portion of the pericardium within the suction port, and

the distal-mode second phase rotating the needle in the first rotational direction while a puncturing tip of the needle is between the pericardium and myocardium of the heart.

2. The method according to claim 1, wherein activating the user control comprises executing the distal-mode first and second phases of the distal advancement of the driving assembly in a single smooth motion of the user control.

3. The method according to claim 1, wherein activating the user control comprises executing the distal-mode second phase of the distal advancement of the driving assembly to rotate the needle in the first rotational direction without further distally advancing the needle.

4. The method according to claim 1, wherein activating the user control comprises executing the distal-mode second phase of the distal advancement of the driving assembly to rotate the needle by 120-240 degrees.

5. The method according to claim 1, wherein activating the user control comprises sliding a slide-bar coupled to the driving assembly of the surgical tool.

6. The method according to claim 5, wherein activating the user control comprises executing the distal-mode first and second phases of the distal advancement of the driving assembly in a single smooth distally-directed motion of the slide-bar.

7. The method according to claim 1, wherein the method further comprises, subsequently to the activating of the user control to distally advance the driving assembly, activating the user control to proximally retract the driving assembly, the proximal retraction having a proximal-mode first phase and a proximal-mode second phase,

the proximal-mode first phase retracting the needle proximally into the surgical tool while the needle is rotationally stationary with respect to the longitudinal axis of the surgical tool, and

the proximal-mode second phase rotating the needle in a second rotational direction opposite to the first rotational direction.

8. The method according to claim 7, wherein activating the user control comprises executing the proximal-mode first and second phases of the proximally-directed motion in a single smooth motion of the user control.

9. The method according to claim 7, wherein activating the user control comprises sliding a slide-bar coupled to the driving assembly of the surgical tool.

10. The method according to claim 9, wherein activating the user control comprises executing the proximal-mode first and second phases of the proximal retraction of the driving assembly in a single smooth proximally-directed motion of the slide-bar.

11. Apparatus comprising:

a surgical tool shaped to define a lumen and comprising a handle disposed at a proximal end of the surgical tool;

a driving assembly disposed within the handle and comprising proximal and distal portions, the proximal and distal portions being slidably coupled to each other; and

a needle slidably disposed within the lumen of the surgical tool and coupled to the proximal portion of the driving assembly such that (i) during distal advancement of the driving assembly with respect to the handle the needle is advanced distally within the lumen of the surgical tool, the needle being rotationally stationary with respect to a longitudinal axis of the surgical tool, and (ii) subsequently to the needle being advanced distally within the lumen of the surgical tool, distal advancement of the distal portion of the driving assembly with respect to the proximal portion of the driving assembly rotates the needle in a first rotational direction around the longitudinal axis of the surgical tool.

12. The apparatus according to claim 11, wherein (i) during proximal retraction of the driving assembly with respect to the handle the needle is retracted proximally within the lumen of the surgical tool, the needle being rotationally stationary with respect to the longitudinal axis of the surgical tool, and (ii) subsequently to the needle being retracted proximally within the lumen of the surgical tool, proximal retraction of the distal portion of the driving assembly with respect to the proximal portion of the driving assembly rotates the needle in a second rotational direction that is opposite to the first rotational direction.

13. The apparatus according to claim 11, wherein:

the proximal portion of the driving assembly is shaped to define a thread along at least a portion of the proximal portion,

the distal portion of the driving assembly is shaped to define a protrusion, and

the proximal and distal portions of the driving assembly are arranged such that (a) the protrusion and the thread engage with one another and (b) engagement between the protrusion and the thread as the distal portion of the driving assembly is advanced distally with respect to the proximal portion of the driving assembly rotates the needle in the first rotational direction around the longitudinal axis of the surgical tool.

14. The apparatus according to claim 11, wherein:

the proximal portion of the driving assembly is shaped to define a protrusion,

the distal portion of the driving assembly is shaped to define a thread along at least a portion of the distal portion, and

the proximal and distal portions of the driving assembly are arranged such that (a) the protrusion and the thread engage with one another and (b) engagement between the protrusion and the thread as the distal portion of the driving assembly is advanced distally with respect to the proximal portion of the driving assembly rotates the needle in the first rotational direction around the longitudinal axis of the surgical tool.

15. The apparatus according to claim 11, wherein:

the proximal portion of the driving assembly is shaped to define a first thread along at least a portion of the proximal portion,

the distal portion of the driving assembly is shaped to define a second thread along at least a portion of the distal portion, and

the proximal and distal portions of the driving assembly are arranged such that (a) the first and second threads engage one another, and (b) engagement between the first and second threads as the distal portion of the driving assembly is advanced distally with respect to the proximal portion of the driving assembly rotates the needle in the first rotational direction around the longitudinal axis of the surgical tool.

16. The apparatus according to claim 15, wherein engagement between the first and second threads as the distal portion of the driving assembly is retracted proximally with respect to the proximal portion of the driving assembly rotates the needle in the second rotational direction.

17. The apparatus according to claim 15, wherein:

the proximal portion of the driving assembly is shaped to define (a) an inner core, the first thread being around a distal length of the inner core, and (b) an outer surface surrounding a proximal length of the inner core, the outer surface being shaped to define a protrusion extending laterally with respect to the longitudinal axis of the surgical tool, and

the distal portion of the driving assembly comprises a hollow shaft element slidably coupled to the proximal portion of the driving assembly such that prior to distal advancement of the distal portion with respect to the proximal portion, the distal length of the inner core is disposed along the hollow shaft element.

18. The apparatus according to claim 17, wherein prior to distal advancement of the distal portion with respect to the proximal portion, the distal length of the inner core is disposed within the hollow shaft element, the second thread being on an inside surface of the hollow shaft element.

19. The apparatus according to claim 17, wherein:

the handle is shaped to define at least one protruding stop on an inner wall of the handle, and

the apparatus further comprises a user control coupled to the driving assembly and arranged such that a first activation of the user control (a) advances the driving assembly distally within the surgical tool such that (i) the needle is advanced distally within the lumen and (ii) the protrusion engages the at least one protruding stop to lock the proximal portion in place, and (b) subsequently advances the distal portion of the driving assembly distally with respect to the proximal portion of the driving assembly, wherein engagement between the first and second threads as the distal portion is advanced distally with respect to the proximal portion causes rotation of the proximal portion around the longitudinal axis of the surgical tool in the first directional rotation, thereby causing rotation of the needle in the first rotational direction.

20. The apparatus according to claim 19, wherein the user control is arranged such that a second activation of the user control (a) retracts the driving assembly proximally such that the needle is retracted proximally within the lumen and (b) subsequently retracts the distal portion of the driving assembly proximally with respect to the proximal portion of the driving assembly, wherein engagement of the first and second threads as the distal portion is retracted proximally with respect to the proximal direction causes rotation of the proximal portion around the longitudinal axis of the surgical tool in the second rotational direction, thereby causing rotation of the needle in the second rotational direction.

21. The apparatus according to claim 19, wherein the user control comprises a slide-bar coupled to the driving assembly and configured to be advanced by a user distally with respect to the handle to cause the first activation and to be retracted by the user proximally with respect to the handle to cause the second activation.