INTRODUCER ASSEMBLY

• US 20130046241A1
• Filed: 09/13/2012
• Published: 02/21/2013
• Est. Priority Date: 03/15/2010
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: Okamura, Ryo, Mouri, Takayuki, Kuniyasu, Junko
• Granted Patent: US 9,174,036 B2
• Time in Patent Office: Days
• US Class Current: 604/171
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An introducer assembly is composed of an introducer sheath and a dilator which have been previously integrated with each other to permit the hemostatic valve to exhibit its hemostatic function over an extended period of time without significantly adversely affecting the inherent function of the dilator tube. The introducer assembly includes a dilator tube passing through a passage of a hemostatic valve. The introducer assembly has a deforming member arranged between the hemostatic valve and a cap. As the cap is pushed toward the proximal end surface of a sheath hub for engagement with the sheath hub, the cap presses the hemostatic valve and applies a compressive force to the hemostatic valve in such a direction as to close the passage.

Claims

1. An introducer assembly comprising:

an introducer sheath comprised of a sheath tube possessing a proximal end, a sheath huh attached to the proximal end of the sheath tube and possessing a proximal end portion, and a hemostatic valve attached to the proximal end portion of the sheath huh, the hemostatic valve possessing a through passage for a catheter to pass through;

a dilator comprised of a dilator tube and a dilator hub, the dilator tube possessing a proximal end, the dilator hub being attached to the proximal end of the dilator tube;

a cap positioned between the sheath hub and the dilator hub, the cap possessing a through-hole;

the dilator tube passing through the through-hole of the cap and passing through the through passage of the hemostatic valve;

the cap being positioned in a first position in which an engaging member on the cap and the sheath hub are spaced from one another, the cap being axially movable in a distal direction to a second position in which the engaging member on the cap and the sheath hub engage one another to hold the cap at the second position; and

a deforming member positioned between the hemostatic valve and the cap to press the hemostatic valve as the cap is moved to the second position to apply a compressive force to the hemostatic valve that causes closure of the passage in the hemostatic valve.

2. The introducer assembly as defined in claim 1, further comprising a holding member which holds the cap at the first position by temporarily fixing the cap to the sheath hub or the dilator hub.

3. The introducer assembly as defined in claim 1, further comprising a connecting member which detachably connects the dilator hub to the cap, the connecting member connecting the dilator hub to the cap with a force smaller than the force of the engaging member that holds the cap at the second position.

4. The introducer assembly as defined in claim 1, wherein the cap possesses an end surface facing an end surface of the hemostatic valve, and the deforming member is either a pressing part projecting from the end surface of the cap or a bulging part projecting from the end surface of the hemostatic valve.

5. The introducer assembly as defined in claim 1, wherein the passage is an open through hole before the dilator tube is passed through the passage while the hemostatic valve is under no-load condition which exists before the deforming member presses the hemostatic valve.

6. The introducer assembly as defined in claim 1, wherein the hemostatic valve has an inclined part which projects toward the cap in a sloping manner.

7. The introducer assembly as defined in claim 1, wherein the hemostatic valve includes one side facing the cap and an opposite side, the passage in the hemostatic valve being comprised of first and second slits which intersect each other, the first slit opening to the one side of the hemostatic valve and not opening to the opposite side, and the second slit opening to the opposite side and not opening to the one side.

8. The introducer assembly as defined in claim 1, wherein the dilator tube is positioned in the sheath tube with a space existing between an inner peripheral surface of the sheath tube and an outer peripheral surface of the dilator tube, the dilator tube possessing a side wall surrounding an interior of the dilator tube, and a through opening passing through the side wall of the dilator tube intermediate the proximal and distal ends of the dilator tube to communicate the interior of the dilator tube with the space to permit a fluid in the space to flow into the dilator tube, the fluid being supplied to the introducer sheath while the introducer sheath and the dilator are integrated with each other.

9. The introducer assembly as defined in claim 1, further comprising a packaging member in which is packed the introducer assembly while the dilator tube is passing through the through-hole of the cap and through the through passage of the hemostatic valve.

10. An introducer assembly comprising:

an introducer sheath comprised of a sheath tube possessing a proximal end, a sheath hub attached to the proximal end of the sheath tube and possessing a proximal end portion and an axis extending in an axial direction, and a hemostatic valve attached to the proximal end portion of the sheath hub, the hemostatic valve possessing a through passage for a catheter to pass through;

a dilator comprised of a dilator tube and a dilator hub, the dilator tube possessing a proximal end and a distal end, the dilator hub being attached to the proximal end of the dilator tube;

the dilator tube passing through the through passage of the hemostatic valve, the dilator being movable in a proximal direction relative to the introducer sheath so that the dilator tube is removed from the through passage of the hemostatic valve;

a deforming member positioned between the sheath hub and the hemostatic valve, the deforming member being movable in a moving direction intersecting the axial direction of the sheath hub, after the dilator tube is removed from the through passage of the hemostatic valve as a result of the dilator being moved in the proximal direction relative to the introducer sheath, to press the hemostatic valve in a manner applying a compressive force to the hemostatic valve which closes the passage; and

an engaging member positioned to be engaged by the sheath hub so that with the sheath hub in engagement with the engagement member the engaging member continues to press the hemostatic valve in a manner applying the compressive force to the hemostatic valve which closes the passage.

11. The introducer assembly as defined in claim 10, wherein the deforming member includes first and second pressing members located at oppositely positioned portions of the hemostatic valve so that the hemostatic valve is interposed between the first and second pressing members, the first and second pressing members being movable towards each to press the hemostatic valve and apply the compressive force.

12. The introducer assembly as defined in claim 10, wherein the hemostatic valve includes one surface facing in a direction toward the sheath tube and an opposite surface facing in a direction opposite the sheath tube, the one surface of the hemostatic valve possesses a groove extending in a direction perpendicular to the moving direction of the deforming member and possessing a concave cross section along the moving direction of the deforming member, the through passage being positioned in the groove.

13. The introducer assembly as defined in claim 10, further comprising a pinching member, and wherein the hemostatic valve includes one surface facing in a direction toward the sheath tube and an opposite surface facing in a direction opposite the sheath tube, the hemostatic valve being positioned between the pinching member and a supporting surface of the sheath hub on which the hemostatic valve is supported, the pinching member contacting the opposite surface of the hemostatic valve so that the hemostatic valve is held between the pinching member and the supporting surface of the sheath hub.

14. The introducer assembly as defined in claim 10, wherein the dilator hub is axially movable relative to the sheath hub and toward the sheath tube, a portion of the sheath hub engaging the engaging member as the dilator hub axially moves relative to the sheath hub, and further comprising a connecting member detachably connecting the dilator hub to the sheath hub when the dilator hub axially moves relative to the sheath hub and toward the sheath tube, the deforming member pressing the hemostatic valve to apply the compressive force to the hemostatic valve which closes the passage.

15. The introducer assembly as defined in claim 10, wherein the dilator tube is positioned in the sheath tube with a space existing between an inner peripheral surface of the sheath tube and an outer peripheral surface of the dilator tube, the dilator tube possessing a side wall surrounding an interior of the dilator tube, and a through opening passing through the side wall of the dilator tube intermediate the proximal and distal ends of the dilator tube to communicate the interior of the dilator tube with the space to permit a fluid in the space to flow into the dilator tube, the fluid being supplied to the introducer sheath while the introducer sheath and the dilator are integrated with each other.

16. The introducer assembly as defined in claim 10, further comprising a packaging member in which is packed the introducer assembly while the dilator tube is passing through the through-hole of the cap and through the through passage of the hemostatic valve.

17. An introducer assembly comprising

an introducer sheath comprised of a sheath tube possessing a proximal end, a sheath hub attached to the proximal end of the sheath tube and possessing a tapering interior part tapering in a narrowing manner toward the sheath tube, and a hemostatic valve positioned in the tapering interior part and possessing a through passage for a catheter to pass through;

a dilator comprised of a dilator tube possessing a proximal end and a dilator hub attached to the proximal end of the dilator tube, the dilator tube also possessing a distal end;

a cap possessing a through-hole and positioned between the sheath hub and the dilator hub;

the dilator tube passing through the through-hole of the cap and passing through the through passage of the hemostatic valve;

the cap being positioned in a first position in which an engaging member on the cap and the sheath hub are spaced from one another, the cap being axially movable in a distal direction to a second position in which the engaging member on the cap and the sheath hub engage one another to hold the cap at the second position; and

a deforming member positioned between the hemostatic valve and the cap to move the hemostatic valve in the distal direction toward a distal end of the tapering interior part as the cap is axially moved toward the second position, with movement of the hemostatic valve in the distal direction toward the distal end of the tapering part applying a compressive force to the hemostatic valve in a direction closing the passage.

18. The introducer assembly as defined in claim 17, wherein the sheath hub possesses an axis extending in an axial direction, and further comprising a pressing member arranged between an outer peripheral side surface of the hemostatic valve and the tapering interior part, and pressing the hemostatic valve in a direction intersecting the axial direction of the sheath hub as the sheath hub is moved in the distal direction by the deforming member.

19. The introducer assembly as defined in claim 18, wherein the pressing member is an elastic member which deforms under compression in the direction intersecting the axial direction of the sheath hub as the pressing member moves toward the distal end of the tapering interior part, thereby pressing the hemostatic valve.

20. The introducer assembly as defined in claim 18, wherein the pressing member is comprised of pinching members arranged in pairs with the hemostatic valve held between the pairs of pinching members in the direction intersecting the axial direction of the sheath hub, the pinching members forming each pair of pinching members moving closer to each other to press the hemostatic valve in the direction intersecting the axial direction of the sheath hub as the pinching members move to the distal end of the tapering interior part.

21. The introducer assembly as defined in claim 17, further comprising a regulating member on the tapering interior part of the sheath hub which regulates the movement of the hemostatic valve in the distal direction toward the distal end of the tapering interior part.

22. The introducer assembly as defined in claim 17, wherein the dilator tube is positioned in the sheath tube with a space existing between an inner peripheral surface of the sheath tube and an outer peripheral surface of the dilator tube, the dilator tube possessing a side wall surrounding an interior of the dilator tube, and a through opening passing through the side wall of the dilator tube intermediate the proximal and distal ends of the dilator tube to communicate the interior of the dilator tube with the space to permit a fluid in the space to flow into the dilator tube, the fluid being supplied to the introducer sheath while the introducer sheath and the dilator are integrated with each other.

23. The introducer assembly as defined in claim 17, further comprising a packaging member in which is packed the introducer assembly while the introducer sheath and the dilator are previously integrated with each other.