PERICARDIAL ACCESS DEVICE

• US 20150313633A1
• Filed: 07/07/2014
• Published: 11/05/2015
• Est. Priority Date: 05/05/2014
• Status: Active Application

• Current Assignee: Rainbow Medical Ltd.
• Original Assignee: Rainbow Medical Ltd.
• Inventors: GROSS, Yossi, SOHN, Zev, KARDOSH, Michael, KISHON, Amir, SADAN, Ido, YALOM, Jonathan, GINO, Omri
• Application Number:
  US14/324,457
• Publication Number:
  US 20150313633A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 1/00094 Suction openings
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00137 End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
• CPC Class Codes: A61B 1/00179 for off-axis viewing
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/0623 for off-axis illumination
• CPC Class Codes: A61B 1/0669 at proximal end of an endoscope
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/126 provided with means for cleaning in-use
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• 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 17/3423 : Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3468 : for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00247 : Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/00907 : for light
• CPC Class Codes: A61B 2017/0092 : for X-rays
• CPC Class Codes: A61B 2017/12004 : for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors
• CPC Class Codes: A61B 2017/320048 : Balloon dissectors
• CPC Class Codes: A61B 2017/3419 : Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2017/3456 : blunt
• CPC Class Codes: A61B 2017/3484 : Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3486 : Balloon
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself

Abstract

Apparatus and methods are described, including apparatus comprising a longitudinal guide member comprising a blunt distal end having an outer surface at least part of which is transparent. The guide member is advanced distally toward a heart of a subject. A sheath is shaped and sized to surround the guide member and shaped to define an at least partially distally-facing suction port at a distal end of the sheath. A portion of a pericardium of the heart is drawn through the suction port and into the sheath, when the suction port is distal to the guide member. A puncturing element punctures the portion of the pericardium while the portion of the pericardium is in the sheath, and a puncturing-element-restraining element inhibits passage of a distal tip of the puncturing element out of the distal end of the sheath. Other applications are also described.

Claims

1. Apparatus comprising:

a longitudinal guide member (a) comprising a blunt distal end having an outer surface at least part of which is transparent, and (b) configured to be advanced distally toward a heart of a subject;

a sheath shaped and sized to surround the guide member and shaped to define an at least partially distally-facing suction port at a distal end of the sheath, the apparatus being configured to facilitate drawing a portion of a pericardium of the heart through the suction port and into the sheath, when the suction port is distal to the guide member;

a puncturing element configured to puncture the portion of the pericardium while the portion of the pericardium is in the sheath; and

a puncturing-element-restraining element shaped and positioned with respect to the puncturing element to inhibit passage of a distal tip of the puncturing element out of the distal end of the sheath.

2. The apparatus according to claim 1, wherein at least part of the outer surface the distal end of the guide member is dome-shaped.

3. The apparatus according to claim 1,

wherein the guide member is a guide tube having a proximal end,

wherein the distal end is a distal end of the guide tube, and

wherein the guide tube is shaped to define a guide-tube lumen between the proximal and distal ends of the guide tube.

4. The apparatus according to claim 3, further comprising an imaging sensor disposed within the guide-tube lumen.

5. The apparatus according to claim 3, wherein the guide-tube lumen has a diameter of 4-15 mm.

6. The apparatus according to claim 3, wherein a radius of curvature at a distalmost point of the distal end of the guide tube is less than a radius of the guide tube.

7. The apparatus according to claim 6, wherein the radius of curvature at the distalmost point of the distal end of the guide tube is 30-60% of the radius of the guide tube.

8. The apparatus according to claim 1, wherein the guide member is a shaft shaped to define one or more longitudinal channels therealong.

9. The apparatus according to claim 1, further comprising a puncturing-element tube, wherein the puncturing element is sized and shaped to be passable through the puncturing-element tube and out of a distal end of the puncturing-element tube.

10. The apparatus according to claim 9, wherein the distal end of the puncturing-element tube defines a face that is not perpendicular to a local central longitudinal axis of the puncturing-element tube.

11. The apparatus according to claim 9,

wherein the distal end is shaped to define a puncturing-element-tube hole therein, and

wherein the puncturing-element tube is disposed such that the puncturing-element tube is in contact with a perimeter of the puncturing-element-tube hole.

12. The apparatus according to claim 11, wherein the puncturing-element-tube hole has a diameter of 0.2-2 mm.

13. The apparatus according to claim 11, wherein the puncturing-element-tube hole has a diameter of 2-5 mm.

14. The apparatus according to claim 9, wherein the puncturing-element tube is disposed between the guide member and the sheath.

15. The apparatus according to claim 9, wherein the puncturing-element tube is a puncturing-element-and-suction tube configured to facilitate the drawing of the portion of the pericardium through the suction port of the sheath by application of suction through the puncturing-element-and-suction tube.

16. The apparatus according to claim 1, wherein the puncturing element is disposed between the guide member and the sheath.

17. The apparatus according to claim 1, further comprising a suction tube configured to facilitate the drawing of the portion of the pericardium through the suction port of the sheath by application of suction through the suction tube.

18. The apparatus according to claim 17, wherein a distal end of the suction tube defines a face that is not perpendicular to a local central longitudinal axis of the suction tube.

19. The apparatus according to claim 17, wherein the suction tube is disposed between the guide member and the sheath.

20. The apparatus according to claim 17,

wherein the distal end is shaped to define a suction-tube hole therein, and

wherein the suction tube is disposed such that a distal end of the suction tube is in contact with a perimeter of the suction-tube hole.

21-174. -174. (canceled)