US-12622686-B2 - Surgical vessel closing pressure device

US12622686B2US 12622686 B2US12622686 B2US 12622686B2US-12622686-B2

Abstract

Various embodiments include a vessel clamping pressure device that is configured to receive suture threads extending from the closure of a vascular vessel of a patient, and maintaining tension on suture threads between the patient and the vessel clamping pressure device to apply pressure to the patient so as to apply a clamping pressure to the vascular vessel to facilitate clotting.

Inventors

Auston LOCKE

Assignees

CATHETER PRECISION, INC.

Dates

Publication Date: 20260512
Application Date: 20220718

Claims (11)

1 . A method of closing an incision in a vascular vessel in a patient, comprising: closing the incision in the vascular vessel using sutures threads, and extending the suture threads from an entrance incision in the patient; inserting an extent of the suture threads extending from the entrance incision into a vessel clamping pressure device, wherein the vessel clamping pressure device comprises: a pressure applying surface with a surface slit, wherein the pressure applying surface is configured to contact the skin of the patient and is formed with a thickness extending in a first direction configured to extend directly away from the skin of the patient when in contact therewith, wherein the surface slit extends through the thickness of the pressure applying surface in the first direction, wherein the surface slit also extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface in a second direction lateral to the first direction, a central shaft with a shaft slit, wherein the central shaft extends away from the pressure applying surface in the first direction from a first side of the central shaft that connects to the pressure applying surface to a second side of the central shaft that is opposed to the first side, wherein the shaft slit extends through the central shaft from the first side to the second side and is open along a lateral side of the central shaft that extends between the first side and the second side, and a spindle located within the central shaft, the spindle including a spindle slit, wherein inserting the extent of the suture threads comprises inserting the extent of the suture threads to extend through the surface slit, shaft slit, and spindle slit; tensioning the suture threads between the vessel clamping pressure device and the patient; leaving the vessel clamping pressure device on the entrance incision for a clotting period; and after the clotting period, releasing tension on the suture threads and cutting the sutures threads below the vessel clamping pressure device.
2 . The method of claim 1 , wherein tensioning the suture threads between the vessel clamping pressure device and the patient comprises: pulling on the suture threads extending from the vessel clamping pressure device while pressing the pressure applying surface against skin of the patient; and changing an orientation of the spindle relative to the central shaft to maintain tension on the suture threads.
3 . The method of claim 2 , wherein changing the orientation of the spindle relative to the central shaft comprises rotating the spindle around an axis extending in a third direction approximately 90 degrees from the first direction.
4 . The method of claim 1 , wherein tensioning the suture threads between the vessel clamping pressure device comprises: rotating the spindle in the vessel clamping pressure device to pull the vessel clamping pressure device against the patient to apply pressure to the entrance incision in the patient.
5 . The method of claim 1 , wherein inserting the extent of the suture threads into the vessel clamping pressure device comprises positioning the vessel clamping pressure device such that the pressure applying surface is oriented toward the entrance incision.
6 . The method of claim 1 , wherein the clotting period is between 5 minutes and 30 minutes, and wherein releasing tension on the suture threads comprises rotating the spindle to realign the surface slit, shaft slit, and spindle slit.
7 . A surgical vessel closing pressure device, comprising: a pressure applying surface configured to contact a patient's skin or intermediate materials on the patient's skin at an incision site, wherein the pressure applying surface is formed with a thickness extending in a first direction configured to extend directly away from the skin of the patient when in contact therewith, wherein the pressure applying surface includes a first slit extending therethrough, wherein the first slit extends through the thickness of the pressure applying surface in the first direction, wherein the first slit also extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface in a second direction lateral to the first direction; a central shaft coupled to the pressure applying surface, wherein the central shaft extends away from the pressure applying surface in the first direction from a first side of the central shaft that connects to the pressure applying surface to a second side of the central shaft that is opposed to the first side, wherein the central shaft includes a second slit extending therethrough, wherein the second slit extends through the central shaft from the first side to the second side and is open along a lateral side of the central shaft that extends between the first side and the second side; and a spindle adjustably located within the central shaft and rotatable about a longitudinal axis of the spindle, the spindle including a third slit extending through the spindle laterally relative to the longitudinal axis, wherein the first, second, and third slits are configured to be selectively alignable and misalignable by rotation of the spindle to respectively allow insertion of suture threads into the first, second, and third slits and bind the suture threads by adjusting an orientation of the spindle to maintain tension between the device and a vascular vessel.
8 . The device of claim 7 , wherein the first, second, and third slits are configured to align when the spindle is in a first rotational position to allow suture threads to be inserted therein.
9 . The device of claim 8 , wherein the first, second, and third slits are configured to misalign when the spindle is rotated to a second rotational position to bind the suture threads between a spindle interior portion and the central shaft.
10 . The device of claim 7 , wherein the pressure applying surface is wider than the central shaft.
11 . The device of claim 7 , wherein the pressure applying surface and the central shaft are integrally formed as a single structure.

Description

RELATED APPLICATION This application claims the benefit of priority to U.S. Provisional Patent Application 63/314,030 entitled “SURGICAL VESSEL CLOSING PRESSURE DEVICE” filed Feb. 25, 2022, the entire contents of which are hereby incorporated by reference for all purposes. BACKGROUND Currently, there are a number of medical procedures that involve inserting a catheter through the skin into a vascular vessel (e.g., a vein or artery) to gain access to various organs in the body. In such procedures, the skin is cut and the vessel is “cut down”, allowing an introducer port to be inserted. Through this port, a catheter can be inserted. The most common procedures inserting a catheter into a vascular vessel are cardiac electrophysiology procedures and structural heart procedures. Examples of structural heart procedures involve inserting an artificial heart valve or a left atrial appendage closure device through a percutaneous access in the femoral artery. A challenge faced in medical procedures including vascular vessel percutaneous access involves closing up the vessel and the incision site in the skin once the catheter and introducer are pulled out. Products have been designed to address this challenge, and can be utilized during the procedure. One such device is called “Perclose®”, and is marketed by Abbott Laboratories, Inc., while another more recently introduced device labeled for both arterial and venous access sites is called “Vascade®” marketed by Cardiva Medical, Inc., a unit of Haemonectics Corporation. While such vascular closure products assist in the closure process, one significant problem remains, which is continual bleeding at the insertion site. Such bleeding is compounded in some cases by anticoagulant therapy that some patients take as a routine therapy. To address this problem, a care giver must stay with the patient until the bleeding has stopped. Pressure is applied to the site, with some weighted bags, or most often by the care giver applying pressure with two or three fingers, for a time period of twenty minutes or more. The patient cannot be moved off the surgery table and to the recovery area during this time. As a result, the surgery room is occupied after surgery is completed, resulting in potentially less procedure throughput during any one day. SUMMARY Various embodiments include devices for applying continued pressure to vascular vessel (e.g., an artery or vein) following intravascular procedure. Various embodiments may include a pressure applying surface coupled to a mechanism for maintaining tension on suture threads extending from the closure of the vascular vessel. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments, and together with the general description given above and the detailed description given below, serve to explain the features of the various embodiments. FIG. 1A is a perspective view of a vessel clamping pressure device according to some embodiments. FIGS. 1B and 1C are cross-sectional views of a vessel clamping vessel clamping pressure device according to some embodiments. FIG. 1D is a cross-sectional view of the embodiment of a vessel clamping pressure device illustrated in FIG. 1C showing a portion of the device from a different viewing angle. FIGS. 1E-1H are cross-sectional views of a vessel clamping vessel clamping pressure device showing an alternative configuration of a suture thread clamping mechanism according to some embodiments. FIG. 2A is a perspective view of a vessel clamping pressure device according to some embodiments. FIG. 2B is a cross-sectional view of a vessel clamping vessel clamping pressure device according to some embodiments. FIG. 2C is a perspective view of a vessel clamping pressure device according to another embodiment. FIGS. 2D-2I are perspective views of alternative configurations a spindle for a vessel clamping pressure device according to some embodiments. FIG. 3 is a cross-sectional view of a vessel clamping pressure device illustrating use on a patient according to some embodiments. FIGS. 4A-4D are perspective views of some alternative configurations of a vessel clamping pressure device according to some embodiments. FIGS. 5A and 5B are process flow diagrams of example methods for using a vessel clamping pressure device according to some embodiments. FIGS. 6 and 7 are perspective views of a prototype vessel clamping pressure device according to some embodiments. FIG. 8 is a side view of a vessel clamping pressure device according to another embodiments. FIGS. 9 and 10 are perspective views of the vessel clamping pressure device of the embodiment shown in FIG. 8. FIG. 11 is perspective view of a spindle component of the vessel clamping pressure device of the embodiment shown in FIG. 8. DETAILED DESCRIPTION Various embodiments will be described in detail with reference to the accompanying drawings. Wherever possible, t