SYSTEMS AND METHODS FOR ACCESSING THE LUMEN OF A VESSEL

• US 20120259219A1
• Filed: 04/05/2011
• Published: 10/11/2012
• Est. Priority Date: 04/05/2011
• Status: Active Grant

• Current Assignee: Houston Medical Robotics, Inc.
• Original Assignee: Houston Medical Robotics, Inc.
• Inventors: Sheldon, Jeffery J., Smith, Kenneth R., Dannecker, Bruce W., Goodwin, Katherine E., Lacey, Joseph M.
• Granted Patent: US 8,945,011 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/14 Echo-tomography
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4444 related to the probe
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/587 Calibration phantoms models for medical purposes G09B23/28
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0111 : Aseptic insertion devices
• CPC Class Codes: A61M 25/0113 : Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0606 : "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/065 : Guide needles
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/09041 : Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

An apparatus for accessing the lumen of a vessel. The apparatus includes a reusable handheld device and a disposable cartridge. The reusable handheld device includes a imaging device attachment utilized to secure an image capturing instrument, an arm coupled to the imaging device attachment, and a depth scale coupled to the arm, wherein the depth scale provides a scale indicating an insertion depth. The disposable cartridge attaches to the reusable handheld device. The disposable cartridge includes a sheath, needle or guidewire coupled to the disposable cartridge. The sheath or needle extends to the insertion depth when fully advanced, thereby allowing the sheath, needle, or guidewire to access the lumen of a vessel.

Claims

1. An apparatus for accessing the lumen of a vessel, the apparatus comprising:

a reusable handheld device, wherein the reusable handheld device comprises,

a imaging device attachment, wherein the imaging device attachment is utilized to secure an image capturing instrument to the reusable handheld device;

an arm coupled to the imaging device attachment, wherein the arm provides a cartridge attachment; and

a depth scale providing a scale indicating an insertion depth; and

a disposable cartridge attached to the arm of the reusable handheld device, wherein the disposable cartridge houses a needle, sheath, or guidewire that advances to the insertion depth indicated on the depth scale to access the lumen of the vessel.

2. The apparatus of claim 1, wherein the reusable handheld device further comprises a thumb wheel coupled to the arm, wherein rotation of the thumb wheel adjust the insertion depth of the sheath.

3. The apparatus of claim 1, wherein the disposable cartridge further comprises:

a needle slider slidably attached to the disposable cartridge, wherein the needle slider is coupled to the needle in the disposable cartridge; and

a sheath slider slidably attached to the disposable cartridge, wherein the sheath slider is coupled to the sheath in the disposable cartridge.

4. The apparatus of claim 3, further comprising:

a slider stop bar coupled to the needle slider, wherein the slider stop bar advances with the needle slider; and

a slide stop attached to the reusable handheld device, wherein advancing the needle slider a predetermined amount advances a tip of the needle to the insertion depth, and when the needle slider is advanced the predetermined amount, the slider stop bar contacts the slide stop to prevent the needle slider from advancing beyond the predetermined amount.

5. The apparatus of claim 3, wherein the disposable cartridge further comprises a lock bar that prevents movement of the needle slider and sheath slider.

6. The apparatus of claim 1, further comprising an alignment cartridge with a stylet and a stylet slider, wherein the alignment cartridge is attached to the arm of the reusable handheld device in place of the disposable cartridge, and the alignment cartridge is utilized to check a first alignment of the reusable handheld device.

7. The apparatus of claim 1, further comprising an alignment cube with at least one target vessel, wherein the reusable handheld device is placed on the alignment cube to check a second alignment of the imaging device secured to the reusable handheld device.

8. The apparatus of claim 7, wherein the alignment cube provides a first target wire and a second target wire, wherein the first target wire is arranged vertically through a center of the target vessel in the alignment cube, and the second target wire is arranged horizontally through the center of the target vessel and the second target wire intersects the first target wire.

9. The apparatus of claim 1, further comprising a screen overlay with a vertical line provided in the center of the screen overlay.

10. A method for accessing the lumen of a vessel, the method comprising the steps of:

attaching an image capturing instrument to an imaging device attachment of a reusable handheld device;

attaching a disposable cartridge to a reusable handheld device, wherein the reusable handheld device comprises,

the imaging device attachment for securing an image capturing instrument to the reusable handheld device;

an arm coupled to the imaging device attachment, wherein the arm provides a cartridge attachment; and

a depth scale providing a scale indicating an insertion depth of the sheath;

placing the reusable handheld device on a desired vessel location;

determining a depth of the vessel with an imaging device;

adjusting the insertion depth to the depth determined utilizing the depth scale on the reusable handheld device;

advancing a first slider in the disposable cartridge a predetermined distance, wherein the first slider advances a needle or sheath to the depth determined with the imaging device.

11. The method of claim 10, wherein the image capturing instrument is an ultrasound transducer and the imaging device is an ultrasound imaging device.

12. The method of claim 10, wherein the insertion depth is adjusted by rotating a thumb wheel coupled to the arm of the reusable handheld device.

13. The method of claim 10, further comprising the step of:

advancing a second slider in the disposable cartridge, wherein the second slider advances the needle to the depth determined with the imaging device;

advancing a guidewire through the needle into the vessel; and

retracting the first and second slider into the disposable cartridge.

14. The method of claim 10, further comprising the step of checking a first alignment of the reusable handheld device, wherein the first alignment is checked with an alignment cartridge providing a stylet and a stylet slider.

15. The method of claim 10, further comprising the step of checking a second alignment of the imaging device, wherein the second alignment is checked with an alignment cube providing at least one target vessel.

16. The method of claim 15, wherein the alignment cube provides a first target wire and a second target wire, wherein the first target wire is arranged vertically through a center of the target vessel in the alignment cube, and the second target wire is arranged horizontally through the center of the target vessel and the second target wire intersects the first target wire.

17. The method of claim 16, further comprises the step of adjusting the imaging device to a desired position in which the second target wire is displayed as a horizontal line on a display of the imaging device;

and

securing the imaging device in the desired position on the reusable handheld device.

18. The method of claim 10, further comprising the step of placing a screen overlay on a display of the imaging device.

19. An apparatus for accessing the lumen of a vessel, the apparatus comprising:

a reusable handheld device, wherein the reusable handheld device comprises,

a body providing an image device attachment and an arm; and

a depth scale providing a scale indicating an insertion depth; and

a disposable cartridge attached to the reusable handheld device, wherein the disposable cartridge comprises,

a sheath slidably coupled to the disposable cartridge, wherein the sheath extends to the insertion depth when advanced;

a needle slidably coupled to the disposable cartridge, wherein the needle extends to the insertion depth when advanced; and

a guidewire coupled to the disposable cartridge, wherein the guidewire passes through the center of the needle and the sheath.

20. The apparatus of claim 19, further comprising:

a boom arm connected to the arm, wherein the boom arm has an adjustable height, and the adjustable height determines the insertion depth.

21. The apparatus of claim 20, wherein a needle extension length of the needle is variable.

22. The apparatus of claim 20, wherein an attachment point between the disposable cartridge and boom arm is adjustable.

23. The apparatus of claim 19, further comprising:

a boom arm with a fixed height, wherein the boom arm is connected to the arm and the disposable cartridge.

24. The apparatus of claim 21, wherein a needle extension length of the needle is variable.

25. The apparatus of claim 21, wherein an attachment point between the disposable cartridge and boom arm is adjustable.

26. The apparatus of claim 21, wherein an angle between the disposable cartridge and boom arm is adjustable.

27. The apparatus of claim 24, wherein a needle extension length of the needle is variable.

28. The apparatus of claim 24, wherein an attachment point between the disposable cartridge and boom arm is adjustable.