Device for creating temporary access and then closure

• US 9,610,097 B2
• Filed: 01/30/2014
• Issued: 04/04/2017
• Est. Priority Date: 08/23/2011
• Status: Active Grant

• Current Assignee: Milo, Simcha
• Original Assignee: Milo, Simcha
• Inventors: Milo, Simcha
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US14/168,890
• Publication Number:
  US 20140148786A1
• Time in Patent Office: 1,160 Days
• Field of Search: 606185, 606213
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00353 one mechanical instrument performing multiple functions, e.g. cutting and grasping channel for multiple instruments A61B2017/3445; instrument channel A61B2017/22072; replaceable heads A61B2017/2931; suction A61M1/00
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

Devices (11, 111) for providing temporary access to the ventricle of the heart and then closing such an access passage when the operation demanding such access has been completed. These devices include an anchor (13, 113) with a wire spiral (19, 119) for implantation in the tissue wall of the heart and a handle (15, 115) detachably connected to the anchor. The handle provides an axial passageway in which a hollow needle (27, 127) is slidably and stably received. With the anchor in juxtaposition with the apex of the heart, the pointed end of the hollow needle is inserted into the ventricle, and its presence traversing the wall of the heart provides a stable axis about which the wire spiral (19, 119) can be rotated to seat the anchor in precise circumscribing fashion about the hollow needle (27, 127).

Claims

1. A device for providing temporary access to the heart through a tissue wall of the heart, the device comprising:

an anchor having a ring-shaped body having a central opening and at least one wire spiral having a pointed distal end and having a proximal end that is connected to said body, the at least one wire spiral being shaped for juxtaposition with the exterior surface of the wall of the heart and the at least one wire spiral having a distal tubular region of substantially constant diameter and a frustoconical proximal region that decreases from the distal tubular region,

a detachable handle having a base formed with a central aperture and an interconnection means linking said base to said anchor,

said handle including an elongated guide section that is formed with an elongated central passageway open at opposite ends,

an elongated, hollow needle having a pointed tip for insertion through the wall of the heart so as to enter the heart, the needle being slidably received in said elongated central passageway, and

means securing said hollow needle to said guide section for limiting the distance said hollow needle can be axially moved within said guide section while locating said pointed tip so that it penetrates the heart wall before said wire spiral makes contact with the exterior surface of the wall of the heart,

whereby, once said needle is caused to penetrate into the heart, the device can be readily attached to the heart wall by screwing the wire spiral into the tissue wall of the heart via rotation relative to an axis coinciding with said needle, so that the device will then provide access to the heart along a guide wire that extends through said anchor, the guide wire being insertable through the lumen of the hollow needle before the hollow needle is withdrawn.

2. The access device according to claim 1 wherein said anchor includes a plurality of wire spirals connected to said ring-shaped body with their pointed distal ends spaced generally equiangularly with respect to one another.

3. The access device of claim 2 wherein each of said wire spirals has an arc length between about 400°

and 700°

.

4. The access device of claim 2 wherein two, three or four wire spirals are connected to said body, the wire spirals having proximal sections that grow greater in diameter in the distal direction.

5. The access device of claim 1 wherein said wire spiral is formed of wire having an axial thickness less than one-third of axial open distance between adjacent turns of the spiral in the distal tubular section.

6. The access device of claim 1 wherein said wire spiral is formed of wire of noncircular cross section that is contoured so as to have an inward-facing surface of a breadth at least about twice its radial thickness so as to promote inward compression of the heart wall tissue when the device is rotated to cause said anchor body to abut against the exterior surface of the wall of the heart.

7. The access device of claim 1 wherein said anchor body comprises a generally flat ring having angularly spaced apertures.

8. The access device of claim 7 wherein said interconnection means of said detachable handle is formed to press-fit with said anchor body at said apertures and wherein said handle main body has openings at equiangularly spaced locations.

9. The access device according to claim 8 in combination with a removal tool formed with parts for protrusion through said openings in said handle base to effect detachment of said handle base from said anchor.

10. The access device of claim 7 in combination with a cap for mating with said anchor body to close its central opening and seat against the wall of the heart upon conclusion of a surgical operation requiring such temporary access.

11. The access device according to claim 1 wherein said elongated guide section has a distal end that is formed for rotative engagement and disengagement with either the opening of said ring-shaped body or said central aperture of said handle base.

12. The access device according to claim 11 wherein said ring-shaped body has a threaded central opening, wherein said distal end of said elongated guide section has mating threads that interengage therewith, and wherein a separate cap for closing the central opening also has mating threads and is shaped surround the proximal surface of said ring-shaped body.

13. The access device of claim 1 wherein said at least one wire spiral has a conical proximal section and a tubular distal section, the tubular section extending for at least about ⅓

of the axial length of said wire spiral.

14. A device for providing temporary access to a ventricle of the heart through a wall at an apex of the heart, the device comprising:

an anchor having a ring-shaped body having a central opening and at least one wire spiral having a pointed distal end and having a proximal end that is connected to said body, the at least one wire spiral being shaped for juxtaposition with an exterior surface of the apex of the heart and the at least one wire spiral having a conical proximal section and a tubular distal section of substantially constant diameter,

a detachable handle having a base formed with a central aperture and an interconnection means linking said base to said anchor,

said handle including an elongated guide section that is formed with an elongated central passageway open at opposite ends,

an elongated, hollow needle having a pointed tip for insertion through the wall of the heart so as to enter a ventricle thereof, the needle being slidably received in said elongated central passageway, and means securing said hollow needle to said guide section for limiting the distance said hollow needle can be axially moved within said guide section while locating said pointed hp so that it penetrates the heart tissue before said wire spiral makes contact with the heart outer surface,

whereby, once said needle is caused to penetrate into the heart ventricle, the device can be readily attached to the heart wall at the apex by screwing the wire spiral into the tissue wall of the heart via rotation relative to an axis coinciding with said needle, so that the device will then provide access to the heart ventricle along a guide wire that extends through said anchor, the guide wire being insertable through the lumen of the hollow needle before the hollow needle is withdrawn;

wherein said anchor includes a plurality of wire spirals connected to said ring-shaped body with their pointed distal ends spaced generally equiangularly with respect to one another, and wherein two, three or four wire spirals are connected to said body, the wire spirals having proximal sections that grow greater in diameter in the distal direction;

wherein said wire spirals each have a conical proximal section and a tubular distal section, the tubular section extending for at least about A of the axial length of sad wire spiral.

15. A device for providing a temporary access opening into a human heart and then closing such access opening, the device comprising:

an anchor comprising a wire spiral formed of at least two spiral sections each having a pointed distal end, with proximal ends of said spiral sections inter-connected relative to one another, the wire spiral being shaped for juxtaposition with the exterior surface of the heart,

a detachable handle having a central passageway that is aligned axially of the wire spiral, said handle and said anchor being formed for detachable interconnection with each other, and

an elongated, hollow needle having a pointed tip for insertion through a wall of the heart so as to enter a cavity therewithin, said handle central passageway positioned to guide movement of said hollow needle axially within said wire spiral,

whereby said needle is slidable within said handle and once having entered the heart provides an axis about which said wire spiral can be screwed into the wall of the heart about said needle,

wherein said wire spiral is so shaped that it has a distal tubular region of substantially constant diameter and a frustoconical proximal region that decreases from the distal tubular region such that the anchor has a first position, spaced a first distance relative to the wall of the heart, whereby the distal tubular region is positioned to allow for dilation of the tissue wall to form an access opening in the tissue wall, and the anchor also has a second position, closer to the wall of the heart as compared to the first distance, whereby the anchor can selectively close the access opening by further rotating the wire spiral so that the tissue is progressively compressed radially inward using the frustoconical proximal region of the wire spiral.