Medical insertion device with hemostatic valve

• US 5,911,710 A
• Filed: 05/03/1997
• Issued: 06/15/1999
• Est. Priority Date: 05/02/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Glens Falls Corp. (AngioDynamics, Inc.)
• Original Assignee: Schneider/Namic
• Inventors: Gertner, Michael, Lambrecht, Gregory, Lamson, Theodore, Barry, Robert
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/850,265
• Time in Patent Office: 773 Days
• Field of Search: 604/246, 604/249, 604/256, 604/283, 604/164, 604/167, 604/169
• US Class Current: 604/249
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/066 Septum-like element
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A medical insertion device that reduces the drag force exerted on an elongated member such as a catheter that is inserted through the device, increases maneuverability of the elongated member throughout the procedure in which the device is used and provides hemostasis. The device comprises a sheath housing and shuttle housing; the shuttle housing moves relative to the sheath housing. An elastomeric valve that contains an openable radial slit is provided in the sheath housing and provides hemostasis until the shuttle housing is biased towards the sheath housing. When the shuttle housing is biased forward, a generally tubular shuttle tube in the shuttle housing opens the slit in the elastomeric valve. The device is constructed so that, within the shuttle housing, hemostasis is provided after the shuttle tube has biased the elastomeric valve open.

Claims

1. A medical insertion device for introducing an elongated member into a vascular system and facilitating maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a housing having an interior lumen extending therethrough;

a sheath tube attached to a distal end of the housing, the sheath tube having a distal end adapted for insertion into the vascular system;

a first elastomeric valve secured within the interior lumen of the housing and having an openable slit therein;

a shuttle tube having proximal and distal ends and an interior passageway, the interior passageway being in fluid communication with the interior lumen of the housing, the shuttle tube being capable of biasing the first elastomeric valve open; and

means for maintaining hemostasis when the shuttle tube biases the first elastomeric valve open, the means for maintaining hemostasis being coupled to the shuttle tube, wherein the means for maintaining hemostasis comprises a Tuohy-Borst valve having an opening that is changeable in size so as to engage an outer diameter of the elongated member, the elongated member being inserted through the device.

2. A medical insertion device for introducing an elongated member into a vascular system and facilitating maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a housing having an interior lumen extending therethrough;

a sheath tube attached to a distal end of the housing, the sheath tube having a distal end adapted for insertion into the vascular system;

a first elastomeric valve secured within the interior lumen of the housing and having an openable slit therein;

a shuttle tube having proximal and distal ends and an interior passageway, the interior passageway being in fluid communication with the interior lumen of the housing, the shuttle tube being capable of biasing the first elastomeric valve open; and

means for maintaining hemostasis when the shuttle tube biases the first elastomeric valve open, the means for maintaining hemostasis being coupled to the shuttle tube, wherein the means for maintaining hemostasis comprises a fluid bearing.

3. A medical insertion device that introduces an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a first housing having proximal and distal ends and an interior lumen extending therethrough;

a sheath tube attached to the distal end of the first housing, the sheath tube having a distal end adapted for insertion into the vascular system;

an elastomeric valve secured within the first housing and having an openable slit through the valve;

a second housing having proximal and distal ends, the second housing being connectable to the first housing and being adapted to move reciprocally relative to the first housing, the second housing having an entrance port located at its proximal end and an interior lumen extending therethrough, in fluid communication with the entrance port;

a shuttle tube having proximal and distal ends and an interior passageway and being secured within the second housing, the distal end of the shuttle tube selectively biasing the elastomeric valve open so that the interior passageway is in fluid communication with the interior lumen of the first housing; and

means for providing hemostasis secured within the interior lumen of the second housing and located proximally of the shuttle tube, such that when the second housing is moved toward the distal end of the first housing, the shuttle tube biases the elastomeric valve open and the means for providing hemostasis provides hemostasis, wherein the valve comprises a Tuohy-Borst valve having an opening that is in fluid communication with the interior passageway of the shuttle tube and the entrance port, the opening being changeable in size so as to engage an outer diameter of the elongated member, the elongated member being inserted through the device.

4. A medical insertion device that introduces an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a first housing having proximal and distal ends and an interior lumen extending therethrough;

a sheath tube attached to the distal end of the first housing, the sheath tube having a distal end adapted for insertion into the vascular system;

an elastomeric valve secured within the first housing and having an openable slit through the valve;

a second housing having proximal and distal ends, the second housing being connectable to the first housing and being adapted to move reciprocally relative to the first housing, the second housing having an entrance port located at its proximal end and an interior lumen extending therethrough, in fluid communication with the entrance port;

a shuttle tube having proximal and distal ends and an interior passageway and being secured within the second housing, the distal end of the shuttle tube selectively biasing the elastomeric valve open so that the interior passageway is in fluid communication with the interior lumen of the first housing; and

means for providing hemostasis secured within the interior lumen of the second housing and located proximally of the shuttle tube, such that when the second housing is moved toward the distal end of the first housing, the shuttle tube biases the elastomeric valve open and the means for providing hemostasis provides hemostasis, wherein the means for providing hemostasis comprises a fluid bearing.

5. A medical insertion device that introduces an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a first housing having proximal and distal ends and an interior lumen extending therethrough;

a sheath tube attached to the distal end of the first housing, the sheath tube having a distal end adapted for insertion into the vascular system;

an elastomeric valve secured within the first housing and having an openable slit through the valve;

a second housing having proximal and distal ends, the second housing being connectable to the first housing and being adapted to move reciprocally relative to the first housing, the second housing having an entrance port located at its proximal end and an interior lumen extending therethrough, in fluid communication with the entrance port;

a shuttle tube having proximal and distal ends and an interior passageway and being secured within the second housing, the distal end of the shuttle tube selectively biasing the elastomeric valve open so that the interior passageway is in fluid communication with the interior lumen of the first housing; and

means for providing hemostasis secured within the interior lumen of the second housing and located proximally of the shuttle tube, such that when the second housing is moved toward the distal end of the first housing, the shuttle tube biases the elastomeric valve open and the means for providing hemostasis provides hemostasis, wherein the device further comprises a locking mechanism disposed on at least one of the first housing and the second housing, the locking mechanism being selectively operable to restrict movement of the second housing relative to the first.

6. A medical insertion device that introduces an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a sheath housing comprising a sheath hub, a sheath cap, and a sheath valve, the sheath hub being secured to the sheath cap such that an interior lumen is formed within, the sheath valve being secured in the interior lumen and having an openable slit extending through the valve;

a sheath tube attached to a distal end of the sheath housing, the sheath tube having a distal end adapted for insertion into the vascular system;

a shuttle housing that is connectable to the sheath housing and adapted to move relative to the sheath housing, the shuttle housing having proximal and distal ends and comprising a shuttle body and shuttle cap, the shuttle body having proximal and distal ends, the shuttle cap having proximal and distal ends and being secured to the proximal end of the shuttle body, the shuttle body and shuttle cap forming a hollow interior when secured together;

an entrance port located at the proximal end of the shuttle housing,

a shuttle tube having proximal and distal ends and an interior passageway and being secured within the hollow interior of the shuttle housing, the distal end of the shuttle tube selectively biasing the elastomeric valve open so that the interior passageway is in fluid communication with the interior lumen of the sheath housing; and

a shuttle valve secured within the hollow interior of the shuttle housing and located proximally of the shuttle tube such that when the shuttle housing movably engages the sheath housing, the shuttle tube biases the sheath valve open and the shuttle valve provides hemostasis, wherein the shuttle valve comprises a Tuohy-Borst valve having an opening that is changeable depending upon the outer diameter of the elongated member inserted through the device.

7. A medical insertion device that introduces an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a sheath housing comprising a sheath hub, a sheath cap, and a sheath valve, the sheath hub being secured to the sheath cap such that an interior lumen is formed within, the sheath valve being secured in the interior lumen and having an openable slit extending through the valve;

a sheath tube attached to a distal end of the sheath housing, the sheath tube having a distal end adapted for insertion into the vascular system;

a shuttle housing that is connectable to the sheath housing and adapted to move relative to the sheath housing, the shuttle housing having proximal and distal ends and comprising a shuttle body and shuttle cap, the shuttle body having proximal and distal ends, the shuttle cap having proximal and distal ends and being secured to the proximal end of the shuttle body, the shuttle body and shuttle cap forming a hollow interior when secured together;

an entrance port located at the proximal end of the shuttle housing,

a shuttle tube having proximal and distal ends and an interior passageway and being secured within the hollow interior of the shuttle housing, the distal end of the shuttle tube selectively biasing the elastomeric valve open so that the interior passageway is in fluid communication with the interior lumen of the sheath housing; and

a shuttle valve secured within the hollow interior of the shuttle housing and located proximally of the shuttle tube such that when the shuttle housing movably engages the sheath housing, the shuttle tube biases the sheath valve open and the shuttle valve provides hemostasis, wherein the device further comprises a locking mechanism disposed on at least one of the first housing and the second housing, the locking mechanism being selectively operable to restrict movement of the second housing relative to the first.

8. A medical insertion device that assists introduction of an elongated member into a vascular system and facilitates maneuverability of the elongated member through the vascular system while providing hemostasis, the device comprising:

a housing comprising proximal and distal ends and having an interior lumen;

a shuttle tube secured within the interior lumen and having an interior passageway;

a means for providing hemostasis located in the interior lumen, the means for providing hemostasis including a fluid bearing;

wherein the device is used to bias open a valve in a second medical insertion device so as to facilitate maneuverability of the elongated member through the second medical insertion device and provide hemostasis.

9. A method for introducing an elongated member into a vascular system and facilitating the maneuverability of the elongated member through the vascular system while maintaining hemostasis, the method comprising the steps of:

(a) accessing a vascular system of a patient with a needle;

(b) inserting a first guide wire into the needle and into the vascular system;

(c) withdrawing the needle from the vascular system, leaving the guide wire in the vascular system;

(d) placing a medical insertion device over the guide wire and sliding a distal end of the device over the guide wire until the distal end of the device is in the vascular system, wherein the device comprises;

(I) a housing having proximal and distal ends and an entrance port and an interior lumen extending therethrough;

(ii) a sheath tube attached to the distal end of the housing and being inserted into the vascular system;

(iii) an elastomeric valve secured within the interior lumen of the housing and having an openable slit therein;

(iv) a shuttle tube having proximal and distal ends and an interior passageway, the interior passageway being in fluid communication with the interior lumen of the housing, the shuttle tube being capable of biasing the elastomeric valve open, and

(v) means for providing hemostasis;

(e) withdrawing the first guide wire;

(f) placing the elongated member over a second guide wire and inserting the elongated member and second guide wire into the entrance port of the housing and guiding them through the device and into the vascular system; and

(g) biasing the shuttle tube forward so that it opens the slit in the elastomeric valve.

10. The method according to claim 9, wherein the method further comprises biasing the shuttle tube away from the sheath valve, thus causing the slit in the elastomeric valve to close around the elongated member and guide wire.

11. A method for introducing an elongated member into a vascular system and facilitating the maneuverability of the elongated member through the vascular system while maintaining hemostasis, the method comprising:

(a) accessing a vascular system of a patient;

(b) providing a medical insertion device in fluid communication with the vascular system, the medical insertion device including a valve assembly comprising;

(i) a housing having proximal and distal ends and an entrance port and an interior lumen extending therethrough;

(ii) a first elastomeric valve secured within the interior lumen of the housing and having an openable slit therein;

(iii) a shuttle tube having proximal and distal ends and an interior passageway, the interior passageway being in fluid communication with the interior lumen of the housing, the shuttle tube being capable of biasing the first elastomeric valve open; and

(iv) means for providing hemostasis;

(c) inserting the elongated member into the entrance port of the housing and guiding it through the device; and

(d) biasing the shuttle tube forward so that it opens the slit in the first elastomeric valve.

12. The method according to claim 11, wherein the means for providing hemostasis includes an opening having an inner diameter that is slightly smaller than an outer diameter of the elongated member.

13. The method according to claim 12, wherein the means for providing hemostasis comprises an O-ring valve.

14. The method according to claim 11, wherein the shuttle tube has an outer surface including a series of alternating flattened and curved surfaces along a longitudinal axis.

15. The method according to claim 11, wherein the shuttle tube includes a tapered distal tip.

16. The method according to claim 11, wherein the insertion device is formed as a y-adapter having first and second prongs, one of the first and second prongs including the valve assembly.

17. The method according to claim 11, wherein the means for providing hemostasis comprises a second elastomeric valve.