Expandable conduit-guide and a method for applying and positioning an expandable conduit-guide

• US 20070233172A1
• Filed: 01/31/2007
• Published: 10/04/2007
• Est. Priority Date: 03/30/2006
• Status: Active Grant

• Current Assignee: Thoratec LLC
• Original Assignee: Levitronix LLC (George N. Hatsopoulos, PhD)
• Inventors: Gellman, Barry N.
• Granted Patent: US 8,591,539 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

The invention relates to an expandable conduit-guide (1) providing a leak-tight conduit through a skin (3) between an inside of a corpus (2) and an outside of the corpus (2). Said conduit-guide (1) includes a body (100) encompassing a lumen (110) extending essentially axially along a center-line (120), and has a distal-end (130) to be positioned outside of the corpus (2), and a proximal-end (140) to be positioned inside of the corpus (2), so that a medical device (4) can be placed in and passed through the lumen (110) between the distal-end (130) and the proximal-end (140). The body (100) of the conduit-guide (1) is constructed from a braided-wire (150) so that the conduit-guide (1) is capable of actively expanding from a closed diameter (D1) to an opened diameter (D2) with the placement of the medical device (4) positioned within the lumen (1 10) and passively collapsing from the opened diameter (D2) to the closed diameter (D1) upon withdrawal of the medical device (4) under a spring load of the braided-wire (150). The invention is also related to a catheter-sheath (8) and a catheter-sheath-assembly (800) as well as to a method for applying and positioning an expandable conduit-guide (1), catheter-sheath (8) and a catheter-sheath-assembly (800) in accordance with the present invention.

Claims

1. An expandable conduit-guide providing a leak-tight conduit through a skin (3) between an inside of a corpus (2) and an outside of the corpus (2), said conduit-guide (1) including a body (100) encompassing a lumen (110) extending essentially axially along a center-line (120), and having a distal-end (130) to be positioned outside of the corpus (2), and having a proximal-end (140) to be positioned inside of the corpus (2), so that a medical device (4) can be placed in and passed through the lumen (110) between the distal-end (130) and the proximal-end (140) wherein the body (100) of the conduit-guide (1) is constructed from a braided-wire (150) characterized in that the conduit-guide (1) is capable of actively expanding from a closed diameter (D1) to an opened diameter (D2) with the placement of the medical device (4) positioned within the lumen (110) and passively collapsing from the opened diameter (D2) to the closed diameter (D1) upon withdrawal of the medical device (4) under a spring load of the braided-wire (150).

2. An expandable conduit-guide in accordance with claim 1, wherein a pre-determinable portion of the braided-wire (150) is covered by a flexible membrane (5) enabling the braided-wire (150) to articulate from the closed diameter (D1) to the opened diameter (D2) and the flexible membrane (5) sealing an interstitial space (151) resultant between the braid openings.

3. An expandable conduit-guide in accordance with claim 1, wherein in the applied state, a pre-determinable velour-portion (6) of the conduit-guide (1) emerging through the skin (3) of the corpus (2), is contained within a velour-like tube (61) to enable a tissue in-growth of the skin (3), in particular to reduce bacterial wicking about the wound and/or the velour material is knitted and/or woven polyester and/or the velour-portion (6) is bonded as a velour-tube (61) to an outside diameter of the conduit-guide (1).

4. An expandable conduit-guide in accordance with claim 1, wherein the proximal-end (140) of the conduit-guide (1) includes a bare-section (7) which does not contain the flexible membrane (5) in order to permit tissue in-growth about the braided-wire (150), in particular to provide a means for anchoring the conduit-guide (1) and/or the bare-section (7) ranges from 0″

to 0.5″

, in particular from 0″

to 0.1″

, preferably from 0″

to 0.25″

from a proximal tip of the conduit-guide (1).

5. An expandable conduit-guide in accordance with claim 1, wherein in the bare-section (7) the individual wire (152) is individually coated.

6. An expandable conduit-guide in accordance with claim 1, wherein a distal wire-end (131) is closed-ended, in particular closed-ended accomplished by a fold of the wire (152), and/or includes a welded joint end or a coating, especially a polymer coating joining the wire (152).

7. An expandable conduit-guide in accordance with claim 1, wherein the flexible membrane (5) is fabricated from polyurethane and/or vinyl and/or a thermoplastic rubber and/or a natural rubber and/or a thermoset material, in particular silicone and/or the flexible membrane (5) is dip molded and/or blown film and/or extruded and/or injection molded and/or pultruded and or assembled from flat stock as a separate component and/or assembled to the braided body (100) and/or the flexible membrane (5) is applied about the braided-wire (150) by dipping and/or by coating the braided-wire (150) with liquid polymer and/or the flexible membrane (5) is spray applied to the braided-wire (150).

8. An expandable conduit-guide in accordance with claim 1, wherein in a un-compressed state a lumen-diameter is between 0.1″

and 1″

, in particular between 0.25″ and

0.75″

, preferably about 0.5″ and

/or wherein the wire is braided to a loose pitch ranging from 0.5″

to 4″

, in particular from 0.75″

to 3″

, especially from 1″

to 2″ and

/or preferably a target length of the wire is 1.5″

pitch for a compressed diameter and/or wherein in a compressed state the lumen-diameter ranges from 0.03″

to 0.15″

, in particular from 0.06″

to 0.10″

, preferably about 0.08″

.

9. An expandable conduit-guide in accordance with claim 1;

wherein the number of wires utilized in the over-under braid ranges from 5 to 100 wires, in particular from 20 to 48 wires, preferably from 24 to 32 wires and/or wherein about half of the wires being left-hand wind and about half of the wires being right-hand wind and/or a wire-diameter of a strand is between 0.001″

to 0.02″

, in particular 0.003″

to 0.01, preferably about 0.005″ and

/or the wire is made of plastic, and/or made of a composite material, and/or made of a metal, especially made of a stainless steel, preferably made of at least ½

hard stainless steel.

10. An expandable conduit-guide in accordance with claim 1, wherein the conduit-guide (1) is pre-assembled at a diameter (D1, D3) into a catheter-sheath (8) and/or the catheter-sheath (8) includes a depth-marker, in particular a depth-marker-band for positioning a proximal-end (81) of the catheter-sheath (8) in the corpus (2) and/or the catheter-sheath (8) includes a pusher-device (82) for catheter-sheath (8) removal after positioning the conduit-guide (1) within the corpus (2).

11. A catheter-sheath for pre-assembling a conduit-guide (1) in accordance with claim 1.

12. A catheter-sheath in accordance with claim 11, including a pusher (82) for removal the conduit-guide (1) after positioning the conduit-guide (1) within an human or an animal corpus (2) and/or including a depth-marker, in particular a depth-marker-band for positioning a proximal-end (81) of the catheter-sheath (8) in the corpus (2).

13. A catheter-sheath-assembly including a catheter-sheath (8) in accordance with claim 11.

14. Method for applying and positioning an expandable conduit-guide (1) made in accordance with claim 1, and for positioning at least one of a catheter-sheath (8) and a catheter-sheath-assembly (800) within a human or an animal corpus (2) including the following steps:

providing a conduit-guide (1);

positioning a proximal-end (140) of the conduit-guide (1) in a wall (9) of a heart and/or a major vessel;

tunneling a distal-end (130) of the conduit-guide (1) through a skin (3) of the corpus (2) to externally communicate a lumen (110) of the conduit-guide (1);

and/or including the following steps;

providing a conduit-guide (1);

tunneling a distal-end (130) of the conduit-guide (1) through a skin (3) of the corpus (2) to externally communicate a lumen (110) of the conduit-guide (1).

positioning a proximal-end (140) of the conduit-guide (1) in a wall (9) of a heart and/or a major vessel.

15. Method in accordance with claim 14, wherein a medical device (4) is placed in and/or passed through the lumen (110) of the conduit-guide (1) and/or the conduit-guide (1) is actively dilated with the passage of the medical device (4) through the lumen (110).

16. Method in accordance with claim 14, wherein on removing the medical device (4) from the conduit-guide (1), the conduit-guide (1) is collapsed.

17. Method in accordance with claim 14, wherein the conduit-guide (1) is pre-assembled into a catheter-sheath (8) forming a catheter-sheath-assembly (800).

18. Method in accordance with claim 14, wherein the catheter-sheath-assembly (800) is placed within a corpus-cavity, a distal-end of the catheter-sheath-assembly (800) is tunneled to emerge out the desired percutaneous site of the corpus (2), a heart and/or an associated vessel, in particular a major vessel is entered by poking the catheter-sheath-assembly (800) and/or the conduit-guide (1) through a wall (9) of the heart and/or the associated vessel and/or a proximal-end (81) of the catheter-sheath-assembly (800) and/or of the conduit-guide (1) is positioned by using a depth-marker, in particular a depth-marker-band, provided about the catheter-sheath (8).

19. Method in accordance with claim 14, wherein the catheter-sheath (8) includes a pusher-device (82) and the catheter-sheath (8) is removed by the pusher-device (2) once the conduit-guide (1) is positioned within the corpus (2) and/or once the distal-end (130) of the conduit-guide (1) is externalized.

20. Method in accordance with claim 14, wherein the proximal-end (140) of the conduit-guide (1) is fixed by a suture at a wall (9) of the heart and/or of a associate vessel and/or at a tissue of the corpus (2).

21. Method in Accordance with claim 14, wherein the medical device (4) is a cannula (4), in particular a cardiac cannula (4) providing a blood conduit between a major blood vessel and/or an external device, in particular an Extracorporal Membrane Oxygenation and/or a Ventricular Assist Device and/or a circuit including a blood pump.

22. Method in accordance with of claim 14, wherein the medical device (4) is a scope (4) and/or a light (4) and/or a camera (4) and the conduit-guide (1) is provided as a conduit for performing a vision access required for diagnostic and/or therapeutic applications and/or for multi-purpose catheters with vision and/or therapeutic device access.

23. Method in accordance with claim 14, wherein an access to a kidney, a bladder, a G.I. tract, in particular to an intestine, a stomach, or an esophagus, to a thorax cavity or to a sinus is performed by the guide-conduit (1).