Failsafe percutaneous wound barrier

• US 10,231,721 B2
• Filed: 09/16/2015
• Issued: 03/19/2019
• Est. Priority Date: 06/24/2010
• Status: Active Grant

• Current Assignee: St. Croix Surgical Systems, LLC
• Original Assignee: St. Croix Surgical Systems, LLC
• Inventors: Nowakowski, Sr., Karol Leon
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US14/756,544
• Publication Number:
  US 20170065284A1
• Time in Patent Office: 1,280 Days
• Field of Search: 606213, 606214
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00884 enhancing wound closure

Abstract

Provided are approaches to establish a failsafe barrier to internal bleeding from percutaneous wounds to protect a patient from failed wound closure devices or related complications due to a variety of contributing factors such as state of systemic anticoagulation, errors in surgical procedure, variability in patient anatomy, and the like. Systems include a clotting agent to encase, and thus isolate, substantially the entire wound access area from the rest of the patient and an instrument, such as an intravascular introducer sheath, inserted through a wound at an access site on a vessel, for delivering the clotting agent to the entire enveloping tissue region around the accessed area as a mold cavity to be filled with the clotting agent. With benefits of patient safety, user simplicity, and low healthcare cost driving the effort, autologous whole blood is the preferred injected agent.

Claims

1. A method for delivering a tissue forming fluid to internal bleeding pathways, the method comprising:

delivering, by an apparatus, the tissue forming fluid through skin of a patient via an access path to a subcutaneous region surrounding a vessel in a body of the patient while the tissue forming fluid is in flowable form, wherein

the tissue forming fluid comprises clotting material including autologous whole blood;

filling the subcutaneous region with the tissue forming fluid;

maintaining a position of at least a portion of the apparatus for a period of time to allow the tissue forming fluid to at least partially solidify into a tissue mass, wherein

the tissue mass is capable of being reabsorbed by the body of the patient over time, and

upon at least partial solidification, the tissue mass comprises a core pin channel impression in the form of the portion of the apparatus; and

removing the apparatus from the access path, wherein, upon removal, the core pin channel impression provides a channel for directing any bleeding out to the skin of the patient, thereby providing a failsafe mechanism to avoid internal bleeding.

2. The method of claim 1, wherein the apparatus comprises a cannula for providing fluid communication between a source of the tissue forming fluid and the subcutaneous region via the access path.

3. The method of claim 1, wherein the apparatus comprises a sheath.

4. The method of claim 3, wherein maintaining a position of the apparatus comprises maintaining the position of the sheath while utilizing the sheath for a subsequent intravascular medical procedure.

5. The method of claim 1, wherein the apparatus comprises a dilator for minimizing disruption of wounded tissue along the access path.

6. The method of claim 1, wherein the apparatus comprises a pressure gauge for identifying fullness of the subcutaneous region.

7. The method of claim 1, wherein the apparatus comprises a syringe containing the tissue forming fluid.

8. The method of claim 1, further comprising filling a portion of the access path with the tissue forming fluid, thereby enabling closure of the access path.

9. The method of claim 1, wherein:

the vessel comprises a wound; and

filling the subcutaneous region with the tissue forming fluid comprises encasing the wound and the vessel.

10. The method of claim 1, wherein the subcutaneous region comprises internal bleeding pathways bounded by at least one of loose connective tissue, muscle, and cutaneous tissue.

11. The method of claim 1, wherein the core pin channel impression extends from an access opening in the vessel to the skin of the patient.

12. The method of claim 1, further comprising, after removing the apparatus, applying compression, thereby collapsing the core pin channel impression.

13. The method of claim 1, further comprising, after removing the apparatus, introducing another instrument into the core pin channel impression for performing an additional medical procedure.

14. A method for percutaneously closing a wound, the method comprising:

establishing, using an apparatus, an access path to a percutaneous vessel through skin of a patient;

placing a clotting agent in internal bleeding pathways surrounding the percutaneous vessel while in flowable form;

maintaining a position of at least a portion of the apparatus for a period of time to allow the clotting agent to at least partially solidify into a tissue cast, wherein

the tissue cast is formed within internal bleeding cavities surrounding the percutaneous vessel,

the tissue cast is formed in part of autologous whole blood, and

the tissue cast, after solidification,

is capable of being reabsorbed by the patient'"'"'s body over time, and

comprises a core pin casting cavity in the form of the portion of the apparatus; and

removing the apparatus from the access path, wherein, upon removal, the core pin casting cavity provides a channel for directing any bleeding out to the skin of the patient, thereby providing a failsafe mechanism to avoid internal bleeding.

15. The method of claim 14, wherein the tissue cast is formed within a percutaneous region defined by one or more of interstitial loose connective tissue, blood vessels, cutaneous tissue, and muscle tissue.

16. The method of claim 14, wherein the core pin casting cavity provides access through the skin of a patient for a procedural instrument.

17. The method of claim 14, wherein the core pin casting cavity provides access for deploying a wound closure.

18. The method of claim 14, wherein the core pin casting cavity is collapsed for providing wound closure.

19. The method of claim 14, wherein the apparatus comprises an indicator for allowing controlled adjustment of the clotting agent.