|Publication number||USRE35192 E|
|Application number||US 08/319,148|
|Publication date||Mar 26, 1996|
|Filing date||Oct 6, 1994|
|Priority date||Nov 13, 1990|
|Publication number||08319148, 319148, US RE35192 E, US RE35192E, US-E-RE35192, USRE35192 E, USRE35192E|
|Inventors||H. William Reese|
|Original Assignee||Phoenix Surgical Products, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (13), Referenced by (17), Classifications (7), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
.Iadd.This application is a continuation of 08/078,632, filed Jun. 21, 1993, and is now abandoned, which is a reissue of 07/611,976, filed Nov. 13, 1990, and is U.S. Pat. No. 5,078,679. .Iaddend.
1. Field of the Invention
This invention is related in general to the field of drug infusions and, in particular, to the area of administration of post-operative anesthesia. The invention provides a novel technique and equipment to inject liquid anesthetics directly into the surgical site on a continuous basis.
2. Description of the Prior Art
Post-operative pain normally requires the injection of anesthetic medication into the area affected by the surgical procedure in order to alleviate the patient's discomfort and facilitate a successful recovery. Typically, care providers inject a liquid anesthetic directly into the surgical site for a number of days after the operation. This procedure necessitates a new needle puncture in an already sensitive area with each administration, with the obvious result of pain exacerbation and an increased potential for infection. Alternatively, post-operative pain can be alleviated with the administration of narcotics, but this approach is generally not favored because of their side effects.
When an anesthetic is administered locally, normally the dosage at each injection is reduced over a period of a few days after the operation because of the decreasing level of discomfort and the corresponding smaller need for anesthesia. This requires that accurate records be kept to avoid confusion concerning the type of medication and dosages used at each time. Therefore, in addition to the pain and trauma inflicted to the patient by the repeated needle punctures, the potential for error is increased because of the recurring human involvement. Thus, there is a need for an infusion apparatus designed to administer the total dosage of anesthetic required for post-operative treatment on a continuous and progressively decreasing basis through a single injection site in the surgical wound.
One objective of this invention is the development of a device for the administration of post-operative anesthesia locally and through a single injection site. This is obtained by providing a catheter that is introduced into the surgical wound and is used as the sole channel for infusing the required amount of pain relieving medication.
Another objective of the invention is an apparatus that dispenses the medication on a continuous basis. Thus, this device involves a spring-loaded syringe capable of holding the entire dosage of anesthetic required to be infused during the course of treatment and of delivering it continuously as a result of constant pressure applied by a spring on the syringe plunger.
A further goal of the invention is the gradual decrease of the rate of delivery of anesthetic according to a predetermined administration schedule. Therefore, the rate of flow out of the syringe is controlled by a specially designed length of micro-bore tubing and a variable pressure spring that result in the desired rate of delivery.
Yet another goal of the invention is a unit that can be set up as part of the post-operative procedure and left in place during the entire period of administration. To that end, the apparatus includes a catheter placement needle to provide access to the surgical site through a single procedure, and an injection port for charging the spring-loaded syringe with the total dosage of required medication.
A final objective is the easy and economical manufacture of the device according to the above stated criteria. This is achieved by using commercially available components and materials, modified only to the extent necessary to fit the requirements of the invention.
Therefore, according to these and other objectives, the present invention describes an apparatus for administering post-operative anesthesia directly to the surgical site through a catheter introduced into the site during the post-operative procedure. The flow of medication into the catheter is regulated by a micro-bore cannula that insures delivery at very small rates. The plunger of a spring-loaded syringe creates the pressure that causes the medication to flow through the cannula and catheter into the wound. Because of the spring's nonlinear characteristics within the range of stroke of the plunger, the pressure exerted on the liquid gradually decreases with the expansion of the spring. By appropriately sizing the spring and the inside diameter of the cannula, a device is developed that administers the required dosages of anesthetic continuously and at decreasing rates.
Various other purposes and advantages of the invention will become clear from its description in the specifications that follow and from the novel features particularly pointed out in the appended claims. Therefore, to the accomplishment of the objectives described above, this invention consists of the features hereinafter illustrated in the drawings, fully described in the detailed description of the preferred embodiment and particularly pointed out in the claims. However, such drawings and description disclose but one of the various ways in which the invention may be practiced.
FIG. 1 is a schematic representation of the apparatus of this invention as used to administer medication to a patient.
FIG. 2 is a cross-section of an elevational view of one embodiment of the spring-loaded syringe shown in FIG. 1.
FIG. 3 is a representative plot of the cumulative volume of medication administered by the apparatus of the invention as a function of time.
This invention consists of the application of simple mechanical principles in combination with known structural components to achieve a practical and economical design for an infusion device with the properties described above. The main point of the invention lies in the recognition of the advantages involved with the continuous administration of post-operative anesthesia and the fact that it can be achieved in an optimal manner by gradually reducing the delivery rate according to a desired, predetermined schedule.
Referring to the drawings, wherein like parts are designated throughout with like numerals and symbols, FIG. 1 illustrates the apparatus 10 of this invention with its several components assembled for use. A spring-loaded syringe 20, integrally connected through its tip 26 to standard medical tubing 31, is used both as reservoir and pump. In the preferred embodiment of the invention, a 50 cc syringe is employed because that capacity corresponds with the normal requirements of total anesthetic administration during the post-operative period. As illustrated in more detail in FIG. 2, the plunger 22 of the syringe is connected in working relationship with a spring 30 that exerts pressure in the direction of discharge. As the syringe is filled with medication by injection through an apposite injection port 34, the stopper 23 of the plunger 22 is pushed in an outward direction in the barrel 24, and the spring 30 is compressed and loaded into a charged position for exerting pressure on the liquid. When the outlet pressure of the syringe is released, the spring pressure causes the medication to flow out of the syringe continuously until the syringe becomes empty at the end of the plunger's stroke.
According to basic principles of physics, the pressure exerted by an ideal spring within its normal operating range is directly proportional to its elastic force; this, in turn, is directly proportional to the spring's linear compression. In practice, therefore, the pressure exerted on the plunger's stopper decreases approximately linearly as the spring 30 expands, producing a progressively decreasing flow rate of medication out of the syringe.
The medication tubing 31 attached to the syringe is equipped with a luer-lock or similar fitting 32 for connection with the other components of the invention. Directly downstream is an injection port 34 mounted on a Y fitting, provided for use in the process of charging the syringe 20 with medication, as mentioned above, followed by a flow controller 36. The flow controller consists of a micro-bore cannula of a specific inside diameter and length to provide the necessary flow restriction and pressure drop for producing, in cooperation with the syringe 20, the desired flow rate of anesthetic to the patient. The flow controller 36 is obviously placed downstream of the injection port 34 to avoid interference with the process of charging the syringe. Through another luer-lock or similar fitting, the flow controller 36 is connected to a medication catheter 38 that is provided for placement into the surgical site S. Finally, a hypodermic needle 40 is provided for use during the procedure of placing the catheter 38 into the site S through a puncture P in the skin of the patient.
In order to determine the precise specifications of the spring 30 and of the micro-bore cannula contained in the flow controller 36, experiments were conducted with medications currently used in anesthesia. For example, the drugs marketed by Winthrop Pharmaceuticals under the trademark "Marcaine" (0.25% HCl solution) and by Astra Pharmaceutical Products, Inc. under the name "Xylocane" (1% HCl solution) were tested over a three-day period of administration. The syringe 20 was charged with 50 ml of medication, well within the maximum recommended dosage for safety, and various sizes of springs and cannulae were used in the apparatus of the invention in order to determine experimentally what combination would provide the required delivery rates. It was found that a spring capable of producing an initial pressure of 12 psi, decreasing to 5 psi with 5 ml of liquid left in the syringe, in combination with a cannula 1/4 inch long with an inside diameter of 0.0016 inches, produces the desired clinical rate for these drugs. Specifically, over a period of ten tests, the anesthetic was delivered through the system at a rate of 23.4 ml (±3.5 ml) during the first 24 hour period, 14.1 ml (±2.1 ml) during the second 24 hour period, and 10.0 ml (±1.5 ml) during the third 24 hour period. These rates are considered clinically optimal for post-operative anesthesia. FIG. 3 illustrates in graphical form the cumulative volume of medication administered to the patient in a typical run.
Referring to the mode of operation of this invention, the following steps are performed. The appropriate amount of medication is loaded into the spring-loaded syringe 20 with a regular injection syringe and needle through the port 34 according to standard safety procedure to avoid air entrainment. The point of the hypodermic needle 40 is pushed from inside the surgical wound S to penetrate away from the site to be medicated, and then pushed outside through the skin at a point P as far away from the site as possible. The end of the catheter 38 is inserted into the needle and threaded through it all the way to the surgical site, as illustrated in FIG. 1. Then, the needle is pulled out leaving the catheter in place in the surgical site, carefully avoiding introducing it into the epidural space. Finally, the syringe 20 is connected to the catheter through the flow controller 36 for the delivery of the medication. The catheter can safely remain in place for up to three days, which is considered a normal period of post-operative anesthetic treatment.
With the exception of the spring-loaded syringe, all the components described above constitute standard medical equipment currently available in commerce. For example, a standard injection port and luer-lock fittings were used; the medication tubing was medical grade flexible PVC tubing; the catheter was 8 inch long and 22 gauge; and the placement needle was a standard 18 gauge hypodermic needle. The spring-loaded syringe was obtained by mounting a standard spring in a regular syringe so that it produced the necessary pressure against the plunger's stopper, as illustrated in FIG. 2.
While the embodiment shown in the figures features the specific shapes therein described, the invention can obviously take other shapes with equivalent functionality and utility. In fact, any shape for any of the components that retains the functional characteristics described above provides an acceptable apparatus to practice the invention. The capacity of the spring-loaded syringe and the size of all other components can be varied in obvious ways to produce different flow rates without affecting the scope of this disclosure. Similarly, a variety of other components could be introduced by one skilled in the art to fit the particular needs of specific applications. Various changes in the details, steps and materials that have been described may be made by those skilled in the art within the principles and scope of the invention herein illustrated and defined in the appended claims. Therefore, while the present invention has been shown and described herein in what is believed to be the most practical and preferred embodiment, it is recognized that departures can be made therefrom within the scope of the invention, which is therefore not to be limited to the details disclosed herein but is to be accorded the full scope of the claims so as to embrace any and all equivalent apparatus and methods.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3598119 *||Feb 2, 1970||Aug 10, 1971||Charles A White||Continuous paracervical anesthesia method and device|
|US3854477 *||Apr 6, 1973||Dec 17, 1974||S Smith||Apparatus and method for the application of a continuous somatic nerve block|
|US4381006 *||Nov 10, 1980||Apr 26, 1983||Abbott Laboratories||Continuous low flow rate fluid dispenser|
|US4597754 *||Feb 7, 1984||Jul 1, 1986||Minnesota Mining And Manufacturing Company||Long capillary tube hose assembly for fluid dispensing device|
|US4813926 *||May 2, 1988||Mar 21, 1989||Sherwood Medical Company||Medical suction device with air vent and fixed restrictor|
|US4813937 *||Feb 29, 1988||Mar 21, 1989||Vaillancourt Vincent L||Ambulatory disposable infusion delivery system|
|US4863429 *||Jun 30, 1987||Sep 5, 1989||Baldwin Brian E||Syringe driver/syringe/tube connecting set fluid delivery arrangement, and tube connecting sets therefor|
|US4874386 *||May 15, 1987||Oct 17, 1989||Sta-Set Corporation||Fluid dispensing device|
|US4966585 *||May 31, 1988||Oct 30, 1990||Gangemi Ronald J||Infusion apparatus|
|US4997420 *||Dec 28, 1989||Mar 5, 1991||Lefevre Robert J||Portable drug delivery device including pump with tapered barrel|
|US5069668 *||Jul 12, 1990||Dec 3, 1991||Boydman Scott A||Patient controlled analgesia system|
|US5084021 *||Nov 2, 1990||Jan 28, 1992||Baldwin Brian E||Patient controlled infusion apparatus and method|
|US5106376 *||Jul 3, 1990||Apr 21, 1992||B. Braun Melsungen Ag||Anaesthesia set|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6306432||Sep 8, 1997||Oct 23, 2001||Chiron Corporation||High and low load formulations of IGF-I in multivesicular liposomes|
|US6348043||Jun 21, 2000||Feb 19, 2002||Mckinley Medical, Lllp||Multi-dose infusion pump providing minimal flow between doses|
|US6428529 *||Sep 16, 1997||Aug 6, 2002||Skyepharma Inc.||Epidural administration of therapeutic compounds with sustained rate of release|
|US6802823||Aug 22, 2001||Oct 12, 2004||Breg, Inc.||Medication delivery system having selective automated or manual discharge|
|US7214221||Mar 26, 2003||May 8, 2007||Becton, Dickinson And Company||Multi-stage fluid delivery device and method|
|US7309333 *||Sep 2, 2004||Dec 18, 2007||Breg, Inc.||Medication delivery system having selective automated or manual discharge|
|US8182835||May 22, 2012||Pacira Pharmaceuticals, Inc.||Sustained-release liposomal anesthetic compositions|
|US8834921||May 21, 2012||Sep 16, 2014||Pacira Pharmaceuticals, Inc.||Sustained-release liposomal anesthetic compositions|
|US9192575||Mar 6, 2013||Nov 24, 2015||Pacira Pharmaceuticals, Inc.||Sustained-release liposomal anesthetic compositions|
|US9205052||Mar 15, 2013||Dec 8, 2015||Pacira Pharmaceuticals, Inc.||Sustained-release liposomal anesthetic compositions|
|US20020039596 *||Nov 13, 1998||Apr 4, 2002||Hartoun Hartounian||Production of multivesicular liposomes|
|US20050033262 *||Sep 2, 2004||Feb 10, 2005||Mason Jeffrey T.||Medication delivery system having selective automated or manual discharge|
|US20060078606 *||Apr 1, 2005||Apr 13, 2006||Skyepharma Inc.||Sustained-release liposomal anesthetic compositions|
|US20080097317 *||Aug 25, 2006||Apr 24, 2008||Jeffery Alholm||Infusion pump|
|US20100100038 *||Oct 15, 2009||Apr 22, 2010||Symbios Medical Products, Llc||Electronic flow control|
|WO2003082371A2 *||Mar 26, 2003||Oct 9, 2003||Becton, Dickinson And Company||Multi-stage fluid delivery device and method|
|WO2003082371A3 *||Mar 26, 2003||Feb 2, 2006||Becton Dickinson Co||Multi-stage fluid delivery device and method|
|U.S. Classification||604/512, 604/135, 604/93.01, 604/121|
|Sep 26, 1996||AS||Assignment|
Owner name: H. WILLIAM REESE, D.P.M., ARIZONA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SGARLATO LABORATORIES, INC., A CORP. OF CA;REEL/FRAME:008535/0263
Effective date: 19960816
|Dec 12, 1996||AS||Assignment|
Owner name: REESE, H. WILLIAM, ARIZONA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SGARLATO LABORATORIES, INC., A CALIFORNIA CORPORATION;REEL/FRAME:008296/0187
Effective date: 19960816
|Jun 21, 1999||FPAY||Fee payment|
Year of fee payment: 8
|Jul 7, 2003||FPAY||Fee payment|
Year of fee payment: 12