Multiplanar ultrasonic vascular imaging device, system incorporating same, method of use and protective sheath

• US 20040236224A1
• Filed: 06/21/2004
• Published: 11/25/2004
• Est. Priority Date: 02/05/2002
• Status: Active Grant

• Current Assignee: Bradley J. Stringer, Cameron P. Ford, Douglas A. Christensen, Gary A. Simmons, Robert W. Evensen, Shayne Messerly
• Original Assignee: Bradley J. Stringer, Cameron P. Ford, Douglas A. Christensen, Gary A. Simmons, Robert W. Evensen, Shayne Messerly
• Inventors: Messerly, Shayne, Christensen, Douglas A., Ford, Cameron P., Stringer, Bradley J., Simmons, Gary A., Evensen, Robert W.
• Granted Patent: US 7,214,191 B2
• Time in Patent Office: Days
• US Class Current: 600/461
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61B 8/145 characterised by scanning multiple planes
• CPC Class Codes: A61B 8/42 Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

An apparatus, method and system for cannulation of blood vessels. The apparatus comprises a sensor assembly including two linear transducer arrays oriented perpendicular to each other to form a “T” shape, to provide ultrasound images of at least one blood vessel in a portion of a patient'"'"'s body in two perpendicular planes. The sensor assembly may be disposed within an elongated, flexible, protective sheath and secured to a frame to facilitate orientation of the sensor assembly on the patient and guidance of a needle towards a desired target vessel during the cannulation procedure. The sensor assembly may also include associated structure to cooperate with a reference location element to place, align and secure the sensor assembly to the patient'"'"'s skin at a desired location.

Claims

1. A kit of disposable components for use with a nondisposable sensor assembly including a housing carrying at least one transducer, the kit comprising:

an elongated, flexible protective sheath having an open end and a closed end;

a frame element configured to engage at least a portion of the housing; and

a cover configured to engage at least a portion of the frame element.

2. The kit of claim 1, wherein the cover includes a needle guide at one end thereof.

3. The kit of claim 1, wherein the cover includes markings on an exterior surface thereof indicative of two opposing directions of blood flow.

4. The kit of claim 1, further comprising a set of longitudinal grid markings and a set of cross-sectional grid markings perpendicular to the set of longitudinal grid markings on an exterior surface of the cover.

5. The kit of claim 1, further including a reference location element configured to be secured to skin of a patient and for cooperative placement of the cover thereover for movable affixation of the sensor assembly thereto.

6. The kit of claim 1, further comprising a quantity of sterile acoustic transmission gel, cotton gauze pads, cotton swabs, user guide and cautionary statement.

7. The kit of claim 1, wherein the flexible protective sheath further comprises:

a single tubular body of polymer film configured in a toroidal shape comprising a rolled double layer of polymer material defining a closed end pouch extending transversely thereto on one side thereof and a skirt of polymer film extending on a foot side of the toroidal shape from an interior of the toroidal shape about an exterior of the toroidal shape and extending transversely thereto on another side of the toroidal shape opposite the closed end pouch; and

the kit further comprises a tray configured to support the flexible protective sheath with the closed end pouch resting therein and the skirt facing upward.

8. A protective sheath for use in enclosing a nonsterile sensor element and in a packaged configuration, comprising:

a tubular body comprising a polymer film and having a closed end and a first open end;

the first open end being everted back over a portion of the tubular body until the everted, first open end is proximate the closed end to provide a doubled layer of polymer film and a second open end;

wherein the doubled layer of polymer film is rolled outwardly from the second open end, forming a toroidal shape with a foot comprising the closed end extending transversely therefrom and a skirt of polymer film defining the everted first open end extends about an outer periphery of the toroidal shape on an opposite side thereof from the foot.

9. The protective sheath of claim 8, further including at least one pull tab secured to the skirt of polymer film proximate the everted first open end.

10. A protective sheath for use in enclosing a nonsterile sensor element and in a packaged configuration, comprising:

a single tubular body of polymer film configured in a toroidal shape comprising a rolled double layer of polymer material defining a closed end pouch extending transversely thereto on one side thereof and a skirt of polymer film extending on a foot side of the toroidal shape from an interior of the toroidal shape about an exterior of the toroidal shape and extending transversely thereto on another side of the toroidal shape opposite the closed end pouch.

11. The protective sheath of claim 10, further including at least one pull tab secured to the skirt of polymer film.

12. A method of configuring a protective sheath for use in enclosing a nonsterile sensor element, comprising:

providing a tubular body comprising a polymer film and having a closed end and a first open end;

everting the first open end back over a portion of the tubular body until the everted first open end is proximate the closed end to provide a doubled layer of polymer film and a second open end;

rolling the doubled layer of polymer film outwardly from the second open end to form a toroidal shape with a foot comprising the closed end extending transversely therefrom; and

pulling a skirt of polymer film defining the everted first open end about an outer periphery of the toroidal shape to lie on an opposite side thereof from the foot.

13. The method of claim 12, further comprising introducing a sensor element having a cable element extending therefrom into the foot through a mouth defined by the skirt of polymer film and through the toroidal shape and pulling the skirt of polymer film along the cable element to extend the protective sheath therealong from the sensor element located in the foot.

14. The method of claim 12, further comprising pulling the skirt of polymer film using, at least in part, at least one pull tab secured to the skirt of polymer film proximate the everted first open end.