CA2500475A1 - System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure - Google Patents

System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure Download PDF

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Publication number
CA2500475A1
CA2500475A1 CA002500475A CA2500475A CA2500475A1 CA 2500475 A1 CA2500475 A1 CA 2500475A1 CA 002500475 A CA002500475 A CA 002500475A CA 2500475 A CA2500475 A CA 2500475A CA 2500475 A1 CA2500475 A1 CA 2500475A1
Authority
CA
Canada
Prior art keywords
blood vessel
distal end
introduces
hemostasis
sheath
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002500475A
Other languages
French (fr)
Other versions
CA2500475C (en
Inventor
Eduardo Chi Sing
Mark Ashby
Luis Urquidi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sub Q Inc
Original Assignee
Sub-Q, Inc.
Eduardo Chi Sing
Mark Ashby
Luis Urquidi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sub-Q, Inc., Eduardo Chi Sing, Mark Ashby, Luis Urquidi filed Critical Sub-Q, Inc.
Publication of CA2500475A1 publication Critical patent/CA2500475A1/en
Application granted granted Critical
Publication of CA2500475C publication Critical patent/CA2500475C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00672—Locating means therefor, e.g. bleed back lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00898—Material properties expandable upon contact with fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth

Abstract

A system allows the hemostasis promoting material (20) to be delivered to a blood vessel puncture site (108) by fluid pressure. The system allows the hemostasis promoting material (20) to be delivered through an introducer sheath (10) which is already in place within a tissue tract. This system includes a control tip (14) which is insertable through the introducer sheath (10) to locate and occlude the blood vessel puncture (108), and a hydration chamber (12) for receiving and delivering the hemostasis promoting material (20) to the blood vessel puncture site (108). The system accurately locates the blood vessel wall (106) at a puncture site (108) and for properly placing a hemostasis plug (20) over the puncture site (108).

Claims (39)

1. A system for delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:
an introduces sheath having a proximal end and a distal end configured to be inserted into a blood vessel puncture;
a hydration chamber configured to receive and hydrate a pledget of hemostasis promoting material, the hydration chamber having a distal end configured to be connected to the proximal end of the introduces sheath and a proximal end configured to be connected to a syringe; and a control tip including a tube having a first diameter and an enlarged distal tip having a second diameter larger than the first diameter, the tube configured to extend from an interior of the hydration chamber through the distal end of the hydration chamber, through the introduces, and out the distal end of the introduces.
2. The system of Claim 1, wherein the control tip has a proximal end extending through a side of the hydration chamber between the proximal and distal ends of the hydration chamber.
3. The system of Claim 1, wherein the control tip has a central lumen extending from a distal end to a proximal end of the control tip configured to receive a guidewire.
4. The system of Claim 1, wherein the enlarged distal tip of the control tip extends beyond the distal end of the introduces sheath when the distal end of the hydration chamber is engaged with the proximal end of the introduces sheath.
5. The system of Claim 1, wherein the hydration chamber has a first inner diameter, a second inner diameter, and a tapered portion between the first and second inner diameters for compressing the hemostasis promoting material.
6. The system of Claim 5, wherein the second inner diameter is substantially the same as an inner diameter of the introducer sheath.
7. The system of Claim 1, further comprising an exhaust vent in fluid connection with a distal end of the introduces sheath for providing a bleed back indication of position.
8. The system of Claim 7, wherein the exhaust vent is located at the proximal end of the introduces sheath.
9. The system of Claim 8, wherein the exhaust vent is configured to be opened and closed by at least one of a cap, a valve, and a stopcock.
10. The system of Claim 7, wherein the exhaust vent is located in the distal end of the hydration chamber.
11. The system of Claim 10, wherein the exhaust vent is configured to be opened and closed by at least one of a cap, a valve, and a stopcock.
12. The system of Claim 1, wherein the control tip is fixed to the hydration chamber.
13. A system for delivering sponge material to a blood vessel puncture to facilitate hemostasis, the system comprising:
an introduces sheath having a proximal end and a distal end configured to be inserted into a blood vessel puncture;
a hydration chamber configured to received and hydrate a pledget of sponge material, the hydration chamber having a proximal end and a distal end configured to be connected to the proximal end of the introduces sheath;
a syringe connectable to the proximal end of the hydration chamber for delivering the sponge material through the sheath by fluid pressure;;
and means for preventing the injected sponge material from entering an interior of the blood vessel.
14. The system of Claim 13, wherein the means for preventing the injected sponge material from entering an interior of the blood vessel is a control tip including a tube having a first diameter and an enlarged distal tip having a second diameter larger than the first diameter, the tube configured to extend from an interior of the hydration chamber through the distal end of the hydration chamber, through the introduces and out the distal end of the introduces.
15. The system of Claim 13, wherein the second diameter of the control tip is smaller than an inner diameter of the introduces sheath.
16. A system for determining a location of a blood vessel puncture for delivery of a hemostasis promoting material to the blood vessel puncture to facilitate hemostasis, the system comprising:
an introduces sheath having a lumen, a proximal end, and a distal end configured to be inserted into a blood vessel puncture;

a hemostasis promoting material delivery system having a connector for forming a fluid tight connection with the proximal end of the introduces sheath; and a bleed back exhaust tube having a first end in fluid communication with the lumen of the introduces sheath and a second end positioned to deliver blood to an exterior of the system to provide a visual indication of the location of the distal end of the introduces sheath, wherein the bleed back exhaust tube has an inner diameter of less than 2mm.
17. The system of Claim 16, wherein the bleed back exhaust tube is connected to the introduces sheath.
18. The system of Claim 16, wherein the bleed back exhaust tube is on the hemostasis promoting material delivery system.
19. The system of Claim 16, wherein the hemostasis promoting material delivery system comprises:
a hydration chamber configured to receive and hydrate a pledget of hemostasis promoting material, the hydration chamber having a distal end configured to be connected to the proximal end of the introduces sheath and a proximal end configured to be connected to a syringe; and a control tip including a tube having a first diameter and an enlarged distal tip having a second diameter larger than the first diameter, the tube configured to extend from an interior of the hydration chamber through the distal end of the hydration chamber, through the introduces, and out the distal end of the introduces.
20. A method of promoting hemostasis of a blood vessel puncture, the method-comprising:
injecting a sponge material through an introduces sheath by fluid pressure from a proximal end of the introduces sheath located outside of the body to a distal end of the introduces sheath positioned within a tissue tract extending from the skin to a puncture in a blood vessel; and positioning the injected sponge material at a location outside of a lumen of the blood vessel to promote hemostasis of the blood vessel puncture
21. The method of Claim 20, wherein the step of positioning the injected sponge material at a location outside of the lumen of the blood vessel is performed by inserting a control tip through the puncture in the blood vessel wall and at least partially into the blood vessel to control blood flow through the puncture in the blood vessel wall and positioning the sponge material adjacent to an outer surface of the blood vessel wall at the puncture site with the control tip still at least part in the puncture in the blood vessel wall.
22. The method of Claim 20, wherein the sponge material is transported through the entire length of the introduces sheath by fluid pressure without the use of a plunger.
23. A method of promoting hemostasis of a blood vessel puncture, the method comprising:
positioning an introduces sheath in a tissue tract extending from the skin of a patient into a blood vessel;
performing an intravascular procedure through the introduces sheath positioned in the tissue tract;

connecting a hemostasis promoting material delivery system to the introduces sheath without removing the introduces sheath; and delivering the hemostasis promoting material through the introduces sheath to the tissue tract by fluid pressure.
24. The method of Claim 23, further comprising a step of withdrawing the introduces sheath to place a distal end of the introduces sheath at a delivery position within the tissue tract, wherein the step of withdrawing the introduces is performed after connecting the hemostasis promoting material delivery system to the introduces sheath and before delivering the hemostasis promoting material
25. The method of Claim 24, further comprising a step of providing bleed back to determine the delivery position for the distal end of the introduces sheath.
26. A system for delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:
a hemostasis promoting material delivery system containing a hemostasis promoting material; and a connector positioned on a distal end of the hemostasis promoting material delivery system, the connector configured to form a removable fluid tight seal with an introduces sheath by connecting to a flange of the introduces sheath.
27. The system of Claim 26, wherein the connector is configured for connection to an internal flange of the introduces sheath.
28. The system of Claim 26, wherein the connector is configured for connection to an external flange of the introduces sheath.
29. A system for delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:

an introducer sheath having a proximal end;
a pledget handling system configured to receive a pledget of hemostasis promoting material, the pledget handling system having a distal end configured to be connected to the proximal end of the introducer sheath and a proximal end configured to be connected to a syringe, said pledget handling system including a valve;
and a control tip.
30. A system according to claim 29 wherein said valve is constructed to allow the user to control the flow of fluid from the distal end of the pledget handling system.
31. A system according to claim 29 wherein said valve is constructed to allow the user to control the flow of fluid into the distal end of said pledget handling system.
32. A system according to claim 29 wherein said valve is constructed to allow the user to permit fluid to flow from the distal end of said pledget handling system while preventing the pledget from traveling out of said hydration system in order to stage a pledget while simultaneously allowing blood to flow into a bleed back tube which is coupled to the distal end of said pledget handling system.
33. A method of promoting hemostasis of a blood vessel puncture using a pledget handling system which includes a valve, the method comprising:
locating a sponge material inside the pledget handling system;
setting the valve to a first position and hydrating the sponge material;
thereafter setting the valve to a second position and staging the sponge material;
thereafter setting the valve to a third position and injecting the sponge material to a location within a tissue tract extending from the skin to a puncture in a blood vessel to promote hemostasis of the blood vessel puncture.
34. A method according to claim 33 wherein when the valve is in the first position the valve prevents fluid from flowing from the distal end of the pledget handling system.
35. A method according to claim 33 wherein the step of hydrating the sponge material includes applying pressurized fluid to the sponge material.
36. A method according to claim 33 wherein when the valve is in the second position the valve allows fluid to flow from the pledget handling system at a controlled rate while preventing the sponge material from traveling out of the pledget handling system.
37. A method according to claim 33 wherein when the valve is in the second position the valve allows blood to flow through a bleed back valve.
38. A system for delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:
an introduces sheath having a proximal end;
a pledget handling system configured to receive a pledget of hemostasis promoting material, the pledget handling system having a distal end configured to be connected to the proximal end of the introduces sheath and a proximal end configured to be connected to a syringe, said pledget handling system including a coupling system to couple said introduces sheath to said pledget handling system; and a control tip.
39. A system for delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:
an introduces sheath having a proximal end;
a pledget handling system configured to receive a pledget of hemostasis promoting material, the pledget handling system having a distal end configured to be connected to the proximal end of the introduces sheath and a proximal end configured to be connected to a syringe, said pledget handling system including a bleed back control system; and a control tip.
CA2500475A 2002-09-26 2003-09-26 System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure Expired - Fee Related CA2500475C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/256,493 US7008440B2 (en) 2001-11-08 2002-09-26 System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
US10/256,493 2002-09-26
PCT/US2003/030514 WO2004028588A2 (en) 2002-09-26 2003-09-26 Blood vessel puncture hemostatisis delivery systems

Publications (2)

Publication Number Publication Date
CA2500475A1 true CA2500475A1 (en) 2004-04-08
CA2500475C CA2500475C (en) 2011-05-24

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CA2500475A Expired - Fee Related CA2500475C (en) 2002-09-26 2003-09-26 System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure

Country Status (6)

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US (1) US7008440B2 (en)
EP (1) EP1556098A4 (en)
JP (2) JP4478024B2 (en)
AU (1) AU2003276995A1 (en)
CA (1) CA2500475C (en)
WO (1) WO2004028588A2 (en)

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EP1556098A2 (en) 2005-07-27
WO2004028588A2 (en) 2004-04-08
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AU2003276995A1 (en) 2004-04-19
US20040019328A1 (en) 2004-01-29
JP2006500990A (en) 2006-01-12
US7008440B2 (en) 2006-03-07
EP1556098A4 (en) 2010-03-10
JP4478024B2 (en) 2010-06-09
AU2003276995A8 (en) 2004-04-19
CA2500475C (en) 2011-05-24
JP5026535B2 (en) 2012-09-12

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