Apparatus and Method for Vascular Access

Abstract

In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

1 . A transcutaneous ultrasound vascular access guiding system comprising:
 an elongate body having a handle;   a guide on the elongate body configured to receive a vascular access device;   a single element ultrasound device on the elongate body configured to provide A-Mode imaging, Doppler and correlation-based blood velocity estimation;   a processor to process and correlate ultrasound information from the single element ultrasound device; and   a system for information output based on the output of the processor.   
     
     
         2 . The device of  claim 1  further comprising: a lens positioned to control the single element ultrasound beam shape. 
     
     
         3 . The device of  claim 1  further comprising a lens positioned on the ultrasound device configured to provide a matching layer between the ultrasound transducer and the skin. 
     
     
         4 . The device of  claim 1  constructed as a single-use device. 
     
     
         5 . The device of  claim 1  wherein the information output is a scrolling chart. 
     
     
         6 . The device of  claim 1  wherein the Doppler information can be bidirectional. 
     
     
         7 . The device of  claim 1  wherein the Doppler acquisition can be pulsed wave or continuous wave. 
     
     
         8 . The device of  claim 1  wherein the guide attached to the imaging device is configured to guide one of the endovascular device selected from the group consisting of:
 a needle;   a stylet;   a catheter; and   an introducer.   
     
     
         9 . The device of  claim 8  further comprising: an adaptor to match the outer diameter of the endovascular guided device to the inner diameter of the guide. 
     
     
         10 . The device of  claim 8  wherein the endovascular device is configured to slide or move with respect to the imaging device as to provide single hand deployment capability of the endovascular guided device. 
     
     
         11 . A method of accessing a blood vessel comprising the steps of: 
       preparing sterile vascular access site on patient's skin;
 sliding a vascular access device in the device guide, flush aligning with the tip of the imaging element, and locking in position; 
 positioning the assembly on the patient's skin on the sterile site without the use of ultrasound gel; 
 orienting the assembly like a flashlight until the desired vessel can be seen on the scrolling chart display; 
 advancing the endovascular element into the vasculature by sliding the guide element over the imaging device; and 
 monitoring the advancement of the endovascular device towards the desired target by using at least one element from a list including A-mode imaging, Doppler flow information, and correlation-based blood flow information. 
 
     
     
         12 . An endovascular device comprising:
 an elongate body;   an element on or in the elongate body configured to generate, emit or produce sound waves; and   a device to control the generation, emission or production of sound waves from the element.   
     
     
         13 . The device of  claim 12  wherein the element is placed on or in the elongate body. 
     
     
         14 . The device of  claim 12  wherein the device to control operates by pushing and pulling wires manually. 
     
     
         15 . The device of  claim 12  wherein the device to control is actuated by motorized movement of moving connective parts. 
     
     
         16 . The device of  claim 12  wherein the device to control generation of the element is actuated by delivering a gas through a lumen on or in the elongate body. 
     
     
         17 . The device of  claim 12  wherein the sound generating elements may be actuated by delivering fluid through a lumen of the endovascular device. 
     
     
         18 . The device of  claim 12  wherein the sound generating elements may be actuated through interaction with the blood or an anatomical site. 
     
     
         19 . The device of  claim 12  wherein sound waves are generated by rubbing notched or serrated components. 
     
     
         20 . The device of  claim 12  wherein sound waves may be generated by hitting a stylet against a solid member in order to generate a repetitive ping. 
     
     
         21 . The device of  claim 12  wherein sound waves may be generated by a moving membrane. 
     
     
         22 . The device of  claim 12  wherein sound waves may be generated by a moving membrane configured to amplify sound. 
     
     
         23 . The device of  claim 12  wherein a device lumen is configured to amplify sound. 
     
     
         24 . An auscultation system comprising:
 one or more sound sensitive elements;   a sound processor in communication with the one or more sound sensitive elements; and   an information output device in communication with the sound processor.   
     
     
         25 . The system of  claim 24  wherein the sound processor is configured such that a plurality of auscultation devices can be synchronized to provide acoustic triangulation for accurate detection of an endovascular sound source. 
     
     
         26 . A guiding method for endovascular devices comprising the steps of:
 positioning one or more sound sensitive elements on a patient's chest;   inserting a sound emitting endovascular device into the patient's vasculature;   emitting sounds from the endovascular device; and   detecting the sounds from the emitting step with the sound sensitive elements.   
     
     
         27 . The method of  claim 26  wherein the emitting step is performed continuously, intermittently or on demand. 
     
     
         28 . The method of  claim 26  wherein the sound intensity measured in the detecting step is used to estimate the distance between the sound emitting endovascular device and the one or more sound sensitive elements. 
     
     
         29 . The method of  claim 26  further comprising: triangulating the sounds from the detecting step to locate the sound emitting endovascular device with respect to the one or more sound sensitive elements. 
     
     
         30 . A method to locate an endovascular device comprising an ultrasound sensor using one or more transcutaneous ultrasound systems, comprising the steps of:
 introducing an endovascular member containing an ultrasound sensor into the vasculature of a body;   sending and receiving ultrasound waves in the vasculature using the ultrasound sensor;   placing one or more transcutaneous ultrasound systems on the patient's body;   detecting the interference between the endovascular ultrasound device and the transcutaneous ultrasound systems using either the endovascular sensor or with any of the transcutaneous systems; and   notifying the user when interference has been detected such the user becomes aware of the presence of the endovascular device in the field of view of the transcutaneous systems.   
     
     
         31 . The method of  claim 30  wherein the endovascular device is configured to emit ultrasound signals. 
     
     
         32 . The method of  claim 30  wherein the endovascular device is configured to receive ultrasound signals. 
     
     
         33 . The method of  claim 30  wherein the transcutaneous ultrasound system is configured to emit ultrasound signals. 
     
     
         34 . The method of  claim 30  wherein the transcutaneous ultrasound system is configured to receive ultrasound signals. 
     
     
         35 . The method of  claim 30  wherein the transcutaneous ultrasound system is configured as an ultrasound imaging scan head connecting to an ultrasound imaging system. 
     
     
         36 . The method of  claim 30  wherein the information in the detecting step from several transcutaneous ultrasound systems is used for triangulating and/or locating the endovascular ultrasound sensor. 
     
     
         37 . The method of  claim 30  wherein the endovascular ultrasound device is connected to the one or more transcutaneous system such as to allow synchronization of transmitting and receiving ultrasound waves in the same region of the body. 
     
     
         38 . An endovascular device, comprising:
 an elongate body sized for insertion into the vasculature;   a sensor on the distal end of the elongate body; and   a structure on or in the elongate body to move its tip from an inner blood vessel wall while maintaining the blood stream flow when the endovascular device is in a blood vessel.   
     
     
         39 . The device of  claim 38 , the elongate body further comprising:
 a distal segment that is flexible and made of metal or polymer, and the polymer may be reinforced to increase tensile strength.   
     
     
         40 . The device of  claim 38  wherein the structure is a star shaped balloon on or about the elongate body. 
     
     
         41 . The device of  claim 38  wherein the structure is a 2 piece displaced asymmetrical shaped balloon. 
     
     
         42 . The device of  claim 38  wherein the structure is a deployable circular braid. 
     
     
         43 . The device of  claim 38  wherein the structure is a deployable balloon. 
     
     
         44 . The device of  claim 38  wherein the structure comprises:
 strips cut in the elongate body material; and   deployed to move the endovascular device from a wall using a deployment member.   
     
     
         45 . The device of  claim 38  wherein the structure comprises a deployable basket. 
     
     
         46 . An endovascular device, comprising:
 an elongate body sized for insertion into the vasculature;   a sensor on the distal end of the elongate body; and   a structure configured to align the elongate body tip or the sensor with the blood stream while maintaining the blood stream flow.   
     
     
         47 . The endovascular device of  claim 46  wherein the structure comprises axial alignment facilitated by a tether component attached to the elongate body. 
     
     
         48 . The device of  claim 46  wherein the alignment with the blood stream is provided by a star shaped balloon. 
     
     
         49 . The device of  claim 46  wherein the structure for alignment with the blood stream is provided by a 2 piece displaced asymmetrical shaped balloon. 
     
     
         50 . The device of  claim 46  wherein the structure for the alignment with the blood stream is provided by a deployable circular braid. 
     
     
         51 . The device of  claim 46  wherein the structure for the alignment with the blood stream is provided by a deployable balloon. 
     
     
         52 . The device of  claim 46  wherein the structure for the alignment with the blood stream is provided by strips cut in the elongate body material and deployed using a deployment member. 
     
     
         53 . The device of  claim 46  wherein the structure for the alignment with the blood stream is provided by a deployable basket. 
     
     
         54 . A securement device for an endovascular member which provides electrical and optical sensor connectors and actuation elements to connect and control sensors and devices attached at the distal end of the endovascular members. 
     
     
         55 . A system for tracking clinical procedures and workflow, comprising:
 a workflow processor;   an input interface;   an output interface;   a code reader;   a communication component; and   a database interface.   
     
     
         56 . The system of  claim 55  wherein the workflow processor stores information about procedure times, device information, patient and operator information, calculates parameters of the procedure like time duration and elapsed time between activities, and provides statistical data analysis of such parameters. 
     
     
         57 . The system of  claim 55  wherein information about the endovascular procedure is input into the system through a dedicated user interface guiding data acquisition. 
     
     
         58 . The system of  claim 55  wherein the output interface presents results of procedure workflow analysis. 
     
     
         59 . The system of  claim 55  wherein the code reader can be an RFID reader, a bar code reader or a reader of any computer readable label. 
     
     
         60 . The system of  claim 55  wherein the communication component can communicate over a wired network or a wireless network with a hospital information system. 
     
     
         61 . The system of  claim 55  wherein the communication component can communicate with other systems for tracking clinical procedures and establish a network of such systems. 
     
     
         62 . The system of  claim 55  wherein the database interface allows the procedure and workflow information to be archived. 
     
     
         63 . A method for tracking clinical procedures and workflow, comprising:
 entering a time when a consult request is received;   entering a time when a work step is started; and   entering a time when a work step is finished.   
     
     
         64 . The method of  claim 63  where the work step comprises the following activities:
 gathering patient data;   transporting to a case;   obtaining patient consent;   gaining vascular access;   placing an endovascular device or any other type of device;   providing therapy through the endovascular device;   removing or securing an endovascular device;   ordering or waiting for x-ray or other confirmatory imaging modality;   repositioning a device based on input from an imaging modality; and   documenting that an endovascular device is ready for use.