AU7157100A - Anesthesia docking station - Google Patents

Description

"C CHuI.-II-uu .I d ;La v ies u oi i is on u av e 61 3 925428 ;51 3 2542808 22/ 37 TRUE COPY P/00/01 1 29/5/91 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIEFICATION STANDARD PATENT

(ORIGINAL)

Name of Applicant: Actual Inventor: Address for Service: Invention Title: Children's Medical Center Corporation, of 55 Shattuck Street, Boston, Massachusetts 02115, United States of America Stephen B CORN DAVIES COLLISON CAVE, Patent Attorneys, of 1 Little Collins Street, Melbourne, Victoria 3000, Australia.

"Anesthesia Docking Station" The following statement is a full description of this invention, including the best method of performing it known to us: RECEIVED TIME 13, NOV. 16:23 PITTM 4 O. 61 PRINT TIME KNOV. 6:13 u I i ,La 3 i a V I r c II I 3V 3H&0O4UDO J JI 61 3 92542808 -2- Background of the Invention The present invention relates to a device for improving connection to a patient of an anesthesia-delivering catheter and an infusion source for the anesthesia.

Epidural and continuous spinal anesthesia are common anesthetic techniques used in operating rooms, hospital wards and in pain clinics. Such anesthetic techniques also find use by outpatients in homes for the treatment of chronic pain. Anesthesia is delivered to a patient through a thin, flexible catheter, the distal end of which penetrates the patient's body to deliver the anesthesia to a desired location, usually the epidural space. The proximal end of the catheter typically is connected to an infusion line that communicates with an infusion 15 source for delivering the anesthesia to the catheter.

Currently, anesthesia is often delivered simply by joining together the infusion line and catheter and taping the joined unit to a tongue depressor, allowing the catheter to extend over the patient's shoulder and along the patient's back to a desired insertion point.

Such a connection arrangement is not satisfactory as it can often lead to catheter kinking or disconnection, possibly resulting in contamination of the epidural system and/or inadequate delivery of anesthesia. The increased use of epidural anesthesia in ambulating patients has resulted in an increased incidence of catheter disconnection, kinking and breaking, and system contamination.

Another potential hazard encountered with the use of such anesthesia delivery systems is the inadvertent injection into the epidural catheter system of substances intended for intravenous or other sites. Such errors can have life threatening consequences.

U.S. Patent No. 3,794,032 (Derouineau) discloses a connecting device in the form of a cuff mountable on a patient for effecting tranfusions or perfusions to a patient. The connecting device comprises a support base, mountable to the patient, and an adapter mechanism mounted on the support base. The adapter mechanism has at least one inlet port in fluid communication with an outlet port that is connectable to a catheter. A valve is present on the adapter mechanism to regulate flow between inlet and outlet ports.

Accordingly, there is a need for a more secure and reliable anesthesia delivery system that effectively joins an infusion source to an epidural catheter system.

RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14.NOV. 6:12 I il u 1 0 -1 1 U U 61 3 92542808 01 4 4 b 4 Z b U 6 24/ U7 P1.%ORBW7OMI- dadx-i Nwumbv, -3- It is thus an object of the invention to provide a system for safely and effectively delivering spinal and epidural anaesthesia, or to at least provide a useful alternative to known systems or devices.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

0 *0 0 0 000 RECEIVED TIME 13. NOV. 16:23 PITTM 4 O. 61 PRINT TIME 14.NOV, 6:12 61 3 92542808 PiMO~ lDBW i670o -l .div.oc-1N cr 2mbr. Wl -4- Summary of the Invention The invention provides a device for joining an infusion line to an anaesthesia-delivering catheter, having a support base and an adapter mechanism mounted on a first surface of the support base, the adapted mechanism having at least a first port adapted to communicate with an infusion line, a second port in fluid communication with the first port and adapted to communicate with an anaesthesia-delivering catheter, and optionally a valve means for regulating flow between the first and second ports; the device being characterized by a catheter line connected at one end to the second port and at the other end adapted to communicate with said anaesthesia-delivering catheter, and comprising strain relief means for relieving tensile strain on said anaesthesiadelivering catheter.

15 Preferably, a bottom or second surface of the support base includes a double sided adhesive material to facilitate mounting of the device to a patient.

9 The device is useful in the delivery of epidural and continuous spinal anaesthesia as it provides a secure connection between the infusion line and the catheter 20 system and may also be comfortably affixed to a patient. This facilitates greater patient mobility, while at the same time reducing the risk of catheter breakage, catheter disconnection and catheter kinking. The device also enhances patient safety because the reduced risk of catheter breakage and catheter disconnection also reduces the risk of infection due to contamination of the epidural system.

Tensile strain on the anaesthesia catheter can be relieved by providing an adapter line which connects between the second port and the proximal end of the anaesthesia-delivering catheter. The adapter line preferably is stretchable or expandable conduit having sufficient inner diameter to accommodate fluid flow. Preferably, the adapter line is a stretchable line having a coiled region.

RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14. NOV. 6 12 1. I iiu i U V o U I Iu i l I 1aun a ve i ;J Z d UB 25/ 37 61 3 92542808 PMaFRA HiMU rlyA-9Ndi 1Nov em M -4A Tensile strain on the other catheter may also be reduced without connecting a stretchable adapter line between the second port and the catheter. In such an embodiment the proximal end of the catheter can be connected directly to the second port.

Further, a length of a proximal end of the catheter is engaged by flanges or stanchions mounted on opposite ends of the top support base. In this way, slack can be created in the catheter line to relieve any tensile strain. Alternatively, a zone can be formed on the surface of the support base to engage a portion of a proximal length of the catheter to create slack in the catheter line.

In another embodiment the device further includes a third port in fluid communication with the first and second ports. The third port facilitates the delivery of medicaments anaesthetics) to the anaesthesia-delivering catheter.

g 4 RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14, NOV. 6 12 61 3 92542808 P:.0P!x\DBwi7091 div.sl.l3 Nowcmbe,. Brief Description of the Drawings Figure I is a perspective view illustrating an anaesthesia docking station of an embodiment of the present invention while in use by a patient.

Figure 2 is a perspective of the anaesthesia docking station shown in Figure 1.

Figure 3 is an alternative anaesthesia docking station useful with an embodiment of the present invention.

*9*ooS S. 10 Detailed Description of the Preferred Embodiments The following description is by way of example only.

As shown in Figure 1, anaesthesia docking system 10 of the invention comprises a docking station 12 that can be affixed to a patient 14. The system 15 comprises an infusion source (not shown) communicated through an infusion line 18 to the docking station 12. The infused fluid, such as anaesthesia-containing fluid, is :communicated to a catheter line 22, the distal end thereof which delivers anaesthesia to the epidural of the subarachoid space of the patient. The system is best adapted for use in the S: delivery of epidural anaesthesia and continuous spinal anaesthesia.

Referring to Figures 1 and 2, docking station 12 comprises a support base 26 having mounted thereon an adapter mechanism 28. Preferably, the adapter mechanism 28 is mounted upon a flange 31 such that it is positioned above the surface 29 of support base 26. The adapter mechanism 28 includes a first port 30 adapted to communicate with infusion line 18 and a second port 32 adapted to communicate with catheter 22. A third port 34 (shown in Figure 2) may also be mounted on the adapter mechanism28, intermediate first port 30 and second port 32. Third port 34 can be used to deliver medicament to the catheter line 22. Ideally, port 34 includes at a top portion thereof a selfclosing seal RECEIVED TIME 13, NOV. 16:23 PRINT TIME 14.NOV, 6:12 -uu, i. io ,uavies o i i son .ave ;61 3 32b42808 28/ 37 61 3 92542808 P.WPelDBM70I.9-" div.d:- 13 Novnmbe. WO As illustrated in Figure 2, the first port 30 may be mounted on flexible fluid communication line 36 that extends between port 30 and the adapter mechanism 28.

Preferably, at least a portion of line 36 includes a coiled region 38 that enables extension of the line 36. Alternatively, port 30 can be mounted directly on adapter mechanism 28 as shown in Figure 3.

The proximal end of catheter 22 can be connected directly to second port 32 as illustrated in Figure 3. Alternatively, as illustrated in Figure 2, the proximal end of S..O catheter 22 can be connected to port 32 through a catheter adapter line 40. Catheter adapter line 40 has a proximal end 42 with a connector 44, such as a luer lock, friction fit connector, or

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:*So 0 RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14. NOV. 6:12 c u 1 o-1 -uu i t: ;uavies o li son cave ;61 3 3Zb42BOB 29/ 37 61 3 92542808 -6threaded connector, for mounting to port 32. The distal end 46 of catheter adapter line includes a standard connector 48 for mounting to catheter 22. Catheter adapter line preferably is manufactured from a medically compatible polymeric material and has an inner diameter sufficient to accommodate fluid flow. Catheter adapter line 40 preferably includes a coiled region 50 that enables extension of line 40 and movement of catheter 22 without placing undue tensile strain on either catheter line 40 or catheter line 22. The length of catheter line 40 may vary depending upon requirements of a given application. Generally, however, the line is approximately 16 inches in length and coiled region 50 enables catheter adapter line 40 to be extended to at least 3 to 5 times its normal length.

The adapter mechanism 28 preferably includes a valve 52, such as a stopcock, infusion port, or a similar device, to regulate fluid flow between the first and third ports and the second port.

15 Support base 26 is a rigid or flexible member having a shape and dimensions suitable to its intended application. This support member may, for example, be rectangular, oval or circular in shape. A suitable rectangular base 26 can have dimensions of about 1 1/2 x 3 1/2 inches. One having ordinary skill in the art will appreciate that the dimensions of the support base may be modified as necessary. A bottom surface 54 of support base 26 20 preferably includes an adhesive material or other means of mounting the support base to the skin of a patient. Preferably, a cushioned, two-sided adhesive 56 is placed on the bottom surface 54 of support base 26. A removable release sheet 58 preferably protects the adhesive surface of the adhesive layer 56 before use.

Figure 3 illustrates docking station 60, forming an alternative embodiment of the invention. As illustrated, adapter mechanism 70 is secured by way of mounting flange 31 to a top surface 29 of support base 26. The adapter mechanism includes a first port second port 32 and third port 34. The three ports mounted upon the adapter mechanism 70 in alternative docking station 60 serve the same purpose as the corresponding ports in docking station 12. However, port 30 communicates directly with catheter line 22. Docking station also includes two stanchions 62 mounted on opposite ends of docking station Stanchions 62 are adapted to engage a proximal portion of catheter line 22 to provide slack in the catheter line and thus relieve any tensile strain on the catheter line 22. In one embodiment, one stanchion may comprise a U-shaped flange 64 while the other comprises a vertical member 66 having a central aperture 68 disposed therein. As illustrated, the catheter may engage flange 64 and be threaded through aperture 68 of member 66 before being directed to a desired location on a patient's body. The threading of the catheter line through aperture 68 enables a desired amount of slack to be created in catheter line 22.

RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14.NOV. 6:12 4 c 11 u I I1-U1, I I~ 1 0 U V I e f O L. 0 o150n kdVt 61 3 92542808 ;01 11 JZ:)4zdUd 3 U/ 3 7 M'OPERDBW67091-9S i.4oc43 NOWMWe, ZO -7- Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "fcomprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

RECEIVED TIME 13, NOV. 16:23 PITTM 4 O. 61 PRINT TIME 14.NOV. 6:12

Claims (14)

1. A device for joining an infusion line to an anaesthesia-delivering catheter, having a support base and an adapter mechanism mounted on a first surface of the support base, the adapter mechanism having at least a first port adapted to communicate with an infusion line, a second port in fluid communication with the first port and adapted to communicate with an anaesthesia-delivering catheter, and optionally a valve means for regulating flow between the first and second ports; 10 the device being characterized by a catheter line connected at one end to the second S""port and at the other end adapted to communicate with said anaesthesia-delivering catheter, and comprising strain relief means for relieving tensile strain on said anaesthesia- delivering catheter.

2. The device of claim 1, characterized in that said strain relief means comprises a coiled stretchable conduit.

3. The device of claim 1, characterized in that said strain relief means comprises flanges or stanchions mounted on opposite ends of the support base, said flanges or stanchions being adapted to engage a proximal portion of the catheter line to create slack therein, thereby relieving tensile strain on the anaesthesia-delivering catheter.

4. The device of claim 1 or 2, characterized in that said catheter line comprises an adapter line which connects between the second port and the proximal end of said anaesthesia-delivering catheter and which has said strain relief means for relieving tensile strain on the anaesthesia-delivering catheter. The device of claim 4, characterized in that said adapter line is connectable at a distal end to a connector at a proximal end of said anaesthesia-delivering catheter and is attached at a proximal end to said second port. RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14.NOV. 6:12 eZ U11UI IuI. -UuI I 1.1 0 ;Ldv ies

5 OI i s 5o n i V a v ebl J Zb4ZUUS 32/ 37 61 3 925428 P.IM W601 divwoc.B Nov=W,1 ZM -9-

6. The device of any one of the preceding claims, characterized by further comprising another strain relief means disposed between the first port and the infusion line for relieving tensile strain on the infusion line, at least a portion of the second strain relief means being secured to the first surface of the support base.

7. The device of any one of the preceding claims, characterized in that a second surface of the support base has mounted thereon a two-sided adhesive one surface of which is adapted to be adhered to a patient. 10

8. The device of any one of the preceding claims, characterized in that the first port connects to the infusion line by way of a luer lock, fiction fit, or threaded connector and/or the second port connects to the anaesthesia-delivering catheter by way of a luer lock, friction fit, or a threaded connector.

9. The device of any one of the preceding claims, characterized in that the adapter mechanism further comprises a third port, in fluid communication with thle first and second ports the third port being adapted to facilitate the delivery of medicaments to the anaesthesia-delivering catheter.

10. The device of any onc of the preceding claims, characterized in that said adapter line connected between the catheter and the second port and/or adapter line between the infusion source and the first port is an extensible adapter line.

11. The device of any one of the preceding claims, characterized in that the first port is integrally secured to an extensible fluid flow line in fluid communication with the adapter mechanism and the second port.

12. The device of any one of claims 6 to 11, characterized in that said other strain relief means comprises a coiled, stretchable conduit. RECEIVED TIME 13. NOV. 16:23 PITTM 4 O. 61 PRINT TIME 14. NOV. 6 12 ne enu il-uu; i ;U avies o i son cave 61 3 92542808 ;51 3 S2b42808 33/ 37

13. The device of any one of the preceding claims characterized in that the support base is adapted to adhere to the body of the patient.

14. The device of any one of the preceding claims, characterized in that the device further comprises said valve means for regulating flow between the first and second ports. A device substantially as hereinbefore described with reference to the accompanying drawings. a DATED this 13 h day of November 2000 Children's Medical Center Corporation By its Patent Attorneys DAVIES COLLISON CAVE RECEIVED TIME 13. NOV. 16:23 PRINT TIME 14.NOV, 6:11