Vein closure and injection kits and methods

• US 8,632,520 B2
• Filed: 11/09/2006
• Issued: 01/21/2014
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Otley, Clark C.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/093,114
• Publication Number:
  US 20090222003A1
• Time in Patent Office: 2,630 Days
• Field of Search: 604/218, 604/158, 604/164.01, 600/373, 600/461, 606/158, 606/41, 606/45, 606/46, 606/194
• US Class Current: 604/507
• CPC Class Codes: A61B 17/0057 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 sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Kits, apparatus, devices and methods for treating varicose veins caused by an incompetent venous junction (e.g., the saphenofemoral and/or saphenopopliteal junctions) are disclosed. The kits may include a sheath, a vein closure device, and an injection device. Alternatively, a vein closure device may include an integral injection channel and injection device. Methods may include injecting a vein with a sclerosing agent through a needle that extends in a direction that is not aligned with a longitudinal axis of a sheath or shaft.

Claims

1. A vein closure and injection kit for delivering sclerosing agent into a vein, the kit comprising:

a sclerosing agent;

an elongated sheath comprising a proximal end and a distal end defining a longitudinal axis extending along the elongated sheath from the proximal end to the distal end, the elongated sheath comprising;

a main channel extending along the longitudinal axis from the proximal end to the distal end of the elongated sheath, wherein the main channel comprises an entry port at the proximal end of the elongated sheath and an exit port at the distal end of the elongated sheath, wherein a device extending out of the main channel from the exit port is directed along the longitudinal axis;

an injection channel extending from the proximal end of the elongated sheath towards the distal end of the elongated sheath, wherein a proximal portion of the injection channel extends along the longitudinal axis to a bend at which the injection channel defines an injection direction that is not aligned with the longitudinal axis, whereby an injection device extending out of the injection channel from an injection port is directed along the injection direction;

a vein closure device operable through the main channel of the elongated sheath, wherein the vein closure device comprises an actuator that protrudes from the entry port of the main channel and a closure mechanism protruding from the exit port of the main channel during closure of a vein using the vein closure device; and

an injection device operable through the injection channel of the elongated sheath, wherein the injection device comprises a needle protruding from the injection port of the injection channel, wherein the needle is configured to deliver the sclerosing agent into a vein.

2. A kit according to claim 1, wherein the injection direction forms an injection angle with the longitudinal axis that is greater than five (5) degrees.

3. A kit according to claim 1, wherein the injection port is located in a side wall of the elongated sheath, and wherein the injection port is located proximally of the exit port of the main channel.

4. A kit according to claim 1, wherein the kit further comprises a dissecting instrument operable through the main channel of the elongated sheath, wherein the dissecting instrument comprises a dissecting end that protrudes from the exit port of the main channel during dissection of tissue using the dissecting instrument.

5. A kit according to claim 1, wherein the vein closure device comprises movable jaws comprising an open configuration and a closed configuration, wherein the injection direction lies in a plane that extends between the movable jaws when the movable jaws are in the open configuration.

6. A kit according to claim 1, wherein the elongated sheath comprises an ultrasonically visible material.

7. A kit according to claim 6, wherein the ultrasonically visible material is in the form of a coating.

8. A kit according to claim 1, wherein the vein closure device comprises an ultrasonically visible material.

9. A kit according to claim 1, wherein the vein closure device comprises a suture ligation device.

10. A kit according to claim 1, wherein the vein closure device comprises a clip ligation device.

11. A kit according to claim 1, wherein the vein closure device comprises an electrosurgical ablation device.

12. A kit according to claim 1, wherein the injection device comprises a syringe body and plunger attached to a proximal end of the needle, and further wherein the injection device is slidably mounted on the elongated sheath, whereby advancing the syringe body in the distal direction along the elongated sheath advances the needle out of the injection port.

13. A kit according to claim 1, wherein the elongated sheath comprises an imaging channel extending along the elongated sheath, wherein the imaging channel comprises a viewing port proximate the distal end of the elongated sheath.

14. A kit according to claim 13, wherein the kit further comprises a vision/imaging system adapted to use the imaging channel, whereby a practitioner can visually monitor operation of the vein closure device at the distal end of the elongated sheath.

15. A kit according to claim 1, wherein the kit further comprises a sclerosing agent that comprises sodium tetradecyl sulfate.

16. A method of treating saphenofemoral junction incompetence, the method comprising:

advancing a distal end of an elongated sheath to a position proximate an incompetent saphenofemoral junction using a dissecting instrument located within a main channel of the elongated sheath;

advancing a vein closure device through the main channel to the distal end of the elongated sheath;

grasping the saphenous vein at a location distal to the saphenofemoral junction;

advancing a needle out of an injection port of an injection channel of the elongated sheath, wherein the injection channel defines an injection direction that is not aligned with a longitudinal axis of the elongated sheath, whereby the needle extends out of the injection channel from the injection port along the injection direction; and

injecting a sclerosing agent into the saphenous vein at an injection site that is distal of the location at which the saphenous vein is grasped, wherein the injecting is performed using the needle advanced out of the injection port.

17. A method according to claim 16, wherein the injection direction forms an injection angle with the longitudinal axis that is greater than five (5) degrees.

18. A method according to claim 16, further comprising closing the saphenous vein at a location distal of the saphenofemoral junction and proximal of the injection site using the vein closure device.

19. A method according to claim 16, further comprising withdrawing the needle into the injection channel after the injecting.

20. A method according to claim 16, further comprising withdrawing the vein closure device and the elongated sheath.

21. A method according to claim 16, further comprising visually monitoring the positioning of the elongated sheath, dissecting instrument, vein closure device, and needle using ultrasonic energy.

22. A method according to claim 16, wherein the sclerosing agent that comprises sodium tetradecyl sulfate.

23. A method according to claim 16, wherein the needle advanced out of the injection port enters the saphenous vein from outside the saphenous vein.

24. A vein closure and injection kit for delivering sclerosing agent into a vein, the kit comprising:

a sclerosing agent;

an elongated sheath comprising a proximal end and a distal end defining a longitudinal axis extending along the elongated sheath from the proximal end to the distal end, the elongated sheath comprising;

a main channel extending along the longitudinal axis from the proximal end to the distal end of the elongated sheath, wherein the main channel comprises an entry port at the proximal end of the elongated sheath and an exit port at the distal end of the elongated sheath, wherein a device extending out of the main channel from the exit port is directed along the longitudinal axis;

an injection channel extending from the proximal end of the elongated sheath towards the distal end of the elongated sheath, wherein a proximal portion of the injection channel extends along the longitudinal axis to a bend at which the injection channel defines an injection direction that is not aligned with the longitudinal axis, whereby an injection device extending out of the injection channel from an injection port is directed along the injection direction;

a vein closure device operable through the main channel of the elongated sheath, wherein the vein closure device comprises an actuator that protrudes from the entry port of the main channel and a closure mechanism protruding from the exit port of the main channel during closure of a vein using the vein closure device; and

an injection device operable through the injection channel of the elongated sheath, wherein the injection device comprises a needle protruding from the injection port of the injection channel, wherein the needle is configured to deliver the sclerosing agent into a vein distal from the vein closure device;

wherein the vein closure device comprises movable jaws that move between an open configuration and a closed configuration, wherein movement of the movable jaws defines a plane, and wherein the injection direction extends away from the plane.