Apparatus for Accurately Positioning an Endocaval Lead

Abstract

An electrical connector clamp for attaching to a distal end of a wire of a Central Venous Access Device (CVAD) including a first plate having a first side, a second side, a first edge, and a second edge. A second plate also is included having a third side, a fourth side, a third edge, and a fourth edge, wherein the first edge and the third edge are connected by a hinge that enables the first and second plates to pivot relative to each other, and the hinge enables the first side and the third side to come in contact. A latch holds the first side of the first plate against the third side of the second plate in a closed position. An electrically conductive material is on the first side of the first plate, and an electrical connector is on the second side of the first plate that is electrically connected to the electrically conductive material on the first side of the first plate. The first and third sides are to be pivoted together in the closed position around a wire to provide an electrical connection between the wire and the electrical connector.

Claims

1. An electrical connector clamp for attaching to a distal end of a stylet of a Central Venous Access Device (CVAD), comprising: a first plate having a first side, a second side, a first edge, and a second edge; a second plate having a third side, a fourth side, a third edge, and a fourth edge, wherein the first edge and the third edge are connected by a hinge that enables the first plate and second plate to pivot relative to each other, and the hinge enables the first side of the first plate and the third side of the second plate to come in contact when in a closed position; a latch for holding the first side of the first plate against the third side of the second plate in the closed position; electrically conductive material on the first side of the first plate; an electrical connector on the second side of the first plate that is electrically connected to the electrically conductive material on the first side of the first plate; and wherein the first side and third side are to be pivoted together in the closed position around a wire located between the first plate and third plate to provide to an electrical connection between the wire and the electrical connector.

2. The electrical connector clamp of claim 1, further comprising: electrically conductive material on the third side of the second plate.

3. The electrical connector clamp of claim 1, further comprising: electrically conductive material on the second side of the first plate that is electrically connected to the electrically conductive material on the first side and the electrical connector.

4. The electrical connector clamp of claim 1, wherein the electrical conductor is magnetically connected to the second side of the first plate.

5. The electrical connector clamp of claim 1, wherein the first plate has a planar configuration.

6. The electrical connector clamp of claim 1, wherein the second plate has a planar configuration.

7. The electrical connector clamp of claim 1, wherein the electrical conductor is male button connector.

8. The electrical connector clamp of claim 1, wherein the first plate and the second plate are constructed of a single material, and the hinge is formed by a crease between the first and second plates.

9. The electrical connector clamp of claim 1, further comprising: a wire located between the first and second plates in the closed position and electrically connected to the electrical connector.

10. The electronical connector clamp of claim 7, further comprising: a female button connector electronically attached to the mail button connector.

11. The electronical connector clamp of claim 1, further comprising: electrically conductive material on the second side of the first plate.

12. The electrical connector clamp of claim 1, wherein the latch is connected to the first plate.

13. The electrical connector clamp of claim 1, further comprising: a stylet wire located and secured between the first and third plates in the closed position.

14. The electrical connector of clamp claim 1, wherein the electrically conductive material is an electrically conductive metal.

15. An electrical connector clamp for attaching to a distal end of a stylet of a Central Venous Access Device (CVAD), comprising: a first plate having a first side, a second side, a first edge, and a second edge; a second plate having a third side, a fourth side, a third edge, and a fourth edge, wherein the first edge and the third edge are connected by a hinge that enables the first and second plates to pivot relative to each other, and the hinge enables the first side of the first plate and the third side of the second plate to come in contact when in a closed position; a latch for holding the first side of the first plate against the third side of the second plate in the closed position; the first side of the first plate has an electrically conductive surface; an electrical connector on the second side of the first plate that is electrically connected to the electrically conductive surface on the first side of the first plate; and wherein the first side and third side are to be pivoted together in the closed position around a wire located between the first plate and third plate to provide to an electrical connection between the wire and the electrical connector.

16. The electrical connector clamp of claim 15, wherein the first plate is constructed of metal having a conductive surface.

17. The electrical connector clamp of claim 15, wherein the first plate includes magnetic material, and the electrical connector is attached to the first plate by magnetism.

18. The electrical connector clamp of claim 15, wherein the first plate includes metal material, and the electrical connector is magnetic and attached to the first plate by magnetism.

19. The electrical connector clamp of claim 15, wherein the first plate and the second plate are constructed of unitary plastic, and the hinge is formed by a crease between the first plate and the second plate, and the first side of the first plate includes metal plating to create a conductive surface.

20. The electrical connector clamp of claim 15, wherein the first plate and the second plate are separate components.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1 is a prior art diagram of Einthoven's triangle, which provides an imaginary formation of three limb leads in a triangle used in electrocardiography;

[0049] FIG. 2 is a diagram of a patient's body illustrating the insertion of a PICC in accordance with the present invention;

[0050] FIG. 3 is drawing of a stylet for a catheter configured in accordance with the presenting invention;

[0051] FIG. 4 illustrates a spring engaged ECG electrode connector configured in accordance with the present invention;

[0052] FIG. 5a is a perspective view of the bottom of an ECG lead connector coverplate for a portable ECG monitor configured in accordance with the present invention;

[0053] FIG. 5b is a perspective view of the top of the ECG lead connector coverplate shown in FIG. 5a;

[0054] FIG. 5c is a perspective view of the top of the ECG connector coverplate shown in FIGS. 5a and 5b wherein connector leads are about to be connected to the coverplate;

[0055] FIG. 6 is a flowchart of a method of inserting a PICC line into a patient in accordance with a method of the present invention;

[0056] FIG. 7 is a flowchart of a method of inserting a dialysis line into a patient in accordance with a method of the present invention;

[0057] FIG. 8 is a perspective view of the electrical connector clamp or Scout connector configured in accordance with the present invention and in the open position; and

[0058] FIG. 9 is a perspective view of the electrical connector clamp shown in FIG. 8 in the closed position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] FIG. 2 illustrates the body 10 of a patient receiving a PICC 12 wherein the distal end 15 of the PICC 12 has been inserted to the proper location in the superior vena cava (SVC) 16 just above the heart 18. The SVC is formed at the junction of the right brachiocephalic 20 and the left brachiocephalic 22. Further illustrated above the heart 18 are the right jugular 24 and the left jugular 26. Also illustrated is the right subclavian 28 and the left subclavian 30. The left arm 32 and the right arm 34 are illustrated, wherein the PICC 12 is inserted into a vein of the right arm 34 at a venipuncture location 36. The positive (+) input to the monitor 52 is via electrode 38 which is connected to the left side of the chest 40 via electrical lead wire 31. The negative () input to the monitor 52 is via electrical lead wire 42 which is connected electrically directly to the proximal end 47 of the stylet 44. The stylet 44 is inserted into the catheter 46.

[0060] In accordance with the present invention, a Quickly Attached/Quickly Released (QA/QR) electrical connector, such as a male snap connector 48 (FIG. 3), is manufactured to be permanently connected to the proximal end 47 of the stylet 44. The male snap connector 48 can then be quickly connected to the female snap connector 50 which is electrically connected to an ECG/EKG monitor 52 having inputs 37. The stylet 44 is inserted into the catheter 46 and locked in position within the catheter by a screw lock 55 located on the hemostasis 56. After the stylet 44 is used to properly position the distal end of the catheter 46 within the SVC of the patient, the screw lock 55 is released, and the stylet 44 is removed from the catheter 44. The catheter is then secured in place with an IV connector mount 58, such as a microclave or end cap. The ECG lead connectors 48, 50 and 38 of the present invention can be utilized on any ECG monitor, but are preferably used on a small portable EGC monitor 52 to wait for a spike in the P-wave 54 when properly positioning the distal end 15 of the PICC 12 within a patient 10.

[0061] The ECG monitor 52 is preferably a small portable model, such as the Wellue Pulsebit EX personal ECG/EKG monitor sold by Viatom, based out of Guangdong, China. The Pulsebit is designed to wirelessly interface with a sophisticated ECG tracking chart and an analyzing program on a smartphone, such as the iPhone. Actually, any monitor can be utilized with the present invention as long as the monitor includes input leads for receiving and displaying input signals.

[0062] FIG. 3 illustrates a stylet 44 configured in accordance with the present invention. The proximal end 47 of the stylet 44 includes a male snap connector 48 for quickly and easily electrically connecting the stylet 44 to the negative input of an ECG monitor. While the illustrated quick connector 48 shown in FIG. 3 is a male snap connector, any quick electrical connector can also be utilized, such as an alligator clip, plug, etc. The quick connector 48 preferably is permanently secured to the distal end 47 of the stylet 44.

[0063] The stylet 44 is shown within a hemostasis valve with a T-port 56 and a dispenser tube 59 housing the stylet 44 before insertion into a catheter. The hemostasis valve 56 includes a screw lock 55 for securing the stylet 44 within the hemostasis valve 56 so as to extend a predetermined length beyond the hemostasis valve 56. This predetermined length 57 ensures the distal end 60 of the stylet 44 is located at the distal end of a catheter, but does not exit the distal end of a catheter within a patient. The hemostasis valve 56 is removed along with the stylet 44.

[0064] Also, in accordance with a further embodiment of the present invention, the stylet wire 44 is covered with a vinyl insulation 41, such as nylon, polyvinyl chloride or PTFe (polytetrafluoroethylene), specifically constructed to enable a specific PICC line, called the Hydropicc by Access Vascular, Inc., to function without interference or aspects in the monitoring of the P-wave when using the stylet 44 as a negative contact for an ECG monitor. This vinyl insulation 41 provides an significant improvement when using the stylet 44 as a negative contact as certain PICC lines are constructed mostly of water that carry an electrical charge on the surface of the PICC line, so any non-insulated surface of the stylet causes significant P-wave impedance, resulting in no change in the P-wave, which prevents a technician from properly positioning the distal end of the catheter using an ECG monitor.

[0065] FIG. 4 illustrates an electrical wire lead 63 including a QA/QR electrical connector. Here, the QA/QR electrical connector is a spring engaged hook clip 62 for quickly connecting to and releasing from the proximal end 47 of the stylet 44. This is another embodiment of the present invention that enables a negative lead of an ECG monitor to be quickly connected to the proximal end 47 of a stylet 44 using the spring engaged hook clip connector 62. This provides an alternative to the male snap connector 48 permanently connected to the proximal end 47 of the stylet 44 shown in FIGS. 2 and 3. The opposing end of the electrical lead 63 includes a male snap connector 64 for quickly connecting the electrical lead 63 to the negative input of an ECG monitor.

[0066] FIG. 5a is a perspective view of the bottom 72 of an ECG lead connector coverplate 70 configured in accordance with the present invention. The coverplate 70 is configured to securely fit over a portable ECG or EKG detection device 80, such as the KardiaMobile monitor manufactured and sold by AliveCor, Inc. or the Wellue DuoEK wearable EKG/ECG detection device, which includes Bluetooth capability for interfacing with a sophisticated EKG/ECG monitoring and analyzing application program on a smartphone, such as an iPhone. The coverplate 70 includes a right (R) electrical contact 74 and a left electrical contact 76 that directly contact the right 75 and left 77 electrical contacts, respectively, of the portable EKG detection device 80. The right and left electrical contacts 75 and 77, respectively, were originally configured as part of the Wellue DuoEK to place a finger on each of the right and left hand of a patient.

[0067] FIG. 5b illustrates the top 79 of the coverplate 70 which includes knobs or snap button connectors 82 and 84 corresponding to the right 74 and left 76 electrical contacts (FIG. 5a) on the bottom 72 of the coverplate 70.

[0068] FIG. 5c illustrates the coverplate 70 about to be snapped onto the electrical contacts 75 (R) and 77 (L) of the EKG detection device 80. The right (R) electrical contact 75 is to be connected to the proximal end 47 of the stylet 44 via the female snap button connector 71. The left (L) electrical contact 77 is to be connected to the left side of the patient 10 via the female snap button connector 73. The female snap button connector 71 is preferable used with the Scout lead to connect to the stylet 44. Of course, any type of quick attach and release connector can be used in place of the snap button connectors 71, 73, 82, 84.

[0069] The EKG detection device 80 then wirelessly transmits 88 detected EKG data to a smart phone 90 with a display screen to display EKG readings, such as an iPhone.

[0070] FIG. 6 is a flow chart setting forth steps of the present invention for inserting a PICC line. Beginning at start 100, the first step 102 is to locate a desired vein to insert a needle using ultrasound. Then in step 104 the technician inserts a needle into the desired vein. Next at step 106 a guidewire is inserted though the needle and into the vein, and then the needle is removed leaving the guidewire at step 108. A peel away sheath is then inserted over the guidewire and into the vein in step 110. Next at step 112 the guidewire is removed leaving the peal away sheath. At step 114 the distance from the venipuncture or insertion point of the needle to the SVC is measured. A catheter is then inserted into the peel away sheath with the premeasured stylet corresponding to the distance to the end of the catheter at step 116. The stylet is locked in place inside the catheter so the distal end of the stylet is located at the distal end of the cather, but does not exit the external end of the catheter. Next at step 118 an inducer or dilator is removed from the peel away sheath, leaving the sheath within the vein at the venipuncture. At step 120 the peel away sheath is removed, leaving the catheter within the vein.

[0071] In accordance with the present invention, at step 122 the Scout lead or a quick release connector is attached to the proximate end of the stylet to create or form a negative () connection lead for the ECG. At step 124 the distal end of the catheter is precisely located in the SVC by monitoring the P-wave, wherein the distal end of the stylet is located at and within the distal end of the catheter, thus enabling the ECG to precisely position the distal end of the catheter by monitory the distal end of the stylet. After the distal end of catheter is properly located within the SVC, the Scout lead or quick connector disconnected from the stylet and the stylet is removed in step 126. Next in step 128 an IV connector is connected to the proximal end of the catheter and is glued by adhesive to the skin of the patient adjacent to the venipuncture. The process for inserting the PICC in accordance with the present invention is terminated at step 130.

[0072] FIG. 7 is a flow chart of the process of inserting a dialysis catheter is accordance with the present invention. Beginning at start 150, the first step 152 is to locate the jugular vein using ultrasound and then insert a needle at step 154. At the next step 156 the technician inserts a guidewire through the needle and into the jugular vein. The needle is then removed leaving the guidewire at step 158. An introducer or dilator is inserted over the guidewire and into the jugular vein at step 160. Next at step 162 the dilator is removed, and the guidewire remains in the jugular vein. At step 164 the catheter is inserted over the guidewire and into the jugular vein, then at step 166 the guidewire is removed leaving the catheter in the jugular vein. At step 168 the distance from the venipuncture or insertion point of the needle to the SVC is externally measured. At step 170 a premeasured stylet corresponding to the distance from the venipuncture to the SVC is inserted into the catheter so at reach the distal end of the catheter, but not exit the distal end of the catheter.

[0073] In accordance with the present invention, at step 172 the Scout lead or a quick release connector is attached to the proximate end of the stylet to create or form a negative () connection lead for the ECG. At step 174 the distal end of the catheter is precisely located in the SVC by monitoring the P-wave, wherein the distal end of the stylet is located at and within the distal end of the catheter, thus enabling the ECG to precisely position the distal end of the catheter by monitory the distal end of the stylet. After the distal end of catheter is properly located within the SVC, the Scout lead or quick connector disconnected from the stylet and the stylet is removed in step 176. Next in step 178 an IV connector is connected to the proximal end of the catheter and is glued by adhesive to the skin of the patient adjacent to the venipuncture. The process for inserting the dialysis in the jugular vein in accordance with the present invention is terminated at step 180.

[0074] Referring now to FIGS. 8 and 9, illustrated are perspective views of an electrical connector clamp or Scout connector clamp 200 configured in accordance with the present invention. FIG. 8 illustrates the connector clamp 200 in the open position and FIG. 9 illustrates the connector clamp 200 in the closed position. The connector camp 200 includes a first plate 202 pivotally connected to a second plate 204 by a hinge 205. The hinge 205 can be a separate component or a crease formed between the first plate 202 and the second plate 204 that preferably is integrally formed out of the same single material, such as stainless steel or any conductive metal or a flexible material such as plastic. The first plate 202 preferably is planar and has a first planar side 206 and a second planar side 208. The first plate 202 further includes a first edge 210 and a second edge 212, wherein a latch 215 is connected to the second edge 212, and the hinge 205 is located on the first edge 210. The second plate 204 has a third planar side 214, a fourth planar side 216, a third edge 218, and a fourth edge 220. The plate 204 preferably is planar, and the third edge 218 is pivotally connected to the first edge 210 of the first plate 202.

[0075] An electrically conductive layer 222, such as copper, or a magnetic metal, preferably is attached to the first side 206 of the first plate 202, especially if the first plate 202 is not constructed of an electrically conductive material. The electrically conductive layer 222 can wrap around to the second side 208 of the first plate 202 to electrically connect to the electrical connector 224, wherein the electrical connector 224 is located on the second side 208 of the first plate 202. The electrical connector 224 preferably is a button connector, male or female. The electrical connector 224 can be magnetic and attached to the second side 208 of the first plate 202 by magnetism or other known electrically conductive means, such as soldering. The first plate 202 can be constructed of magnetic material to attach the electrical connector 224 to the first plate 202 by magnetism. The first plate 202 also can be constructed of a conductive material, thus eliminating the need for a conductive layer 222.

[0076] The second plate 204 also can include a conductive layer 222 on the third side 214 and the fourth side 216. The latch 215 on the second side 212 of the first plate 202 is configured to latch or grip the fourth edge 220 of the second plate 204 in the closed position, as shown in FIG. 9.

[0077] In accordance with the present invention, and as shown in FIG. 8, a wire 225 is to be placed between the first and second plates 202,204 and secured between the first and second plates 202,204 when the plates 202,204 are in the closed position, as shown in FIG. 9. The wire 225 also is electrically connected to the electrical connector 224 when the wire 225 is secured between the first and second plates 202,204 in the closed position. Another matching electrical connector 226, such as a female button connector, can then be connected to the electrical connector 224, thus establishing an electrical connection between the wire 225 and the electrical connector 226.

[0078] Assuming the wire 225 is the proximal end 47 of the stylet 44, an electrical connection can be made to an ECG monitor as discussed above.

[0079] While specific embodiments have been shown and described to point out fundamental and novel features of the invention as applied to the preferred embodiments, it will be understood that various omissions and substitutions and changes of the form and details of the invention illustrated and in the operation may be done by those skilled in the art, without departing from the spirit of the invention.