KIT AND METHOD OF REDUCING HUMAN ERROR DURING IMPLANTED INFUSION PUMP REFILLING
Method of safely refilling an implanted infusion pump. The method includes contacting a withdrawn fluid with a protein-detecting composition, detecting whether the protein-detecting composition experiences a reaction, and performing a refilling procedure if no reaction is detected.
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The instant application is a PCT International Application claiming the benefit of U.S. nonprovisional application Ser. No. 15/935,894 filed on Mar. 26, 2018, the disclosure of which is hereby expressly incorporated by reference thereto in its entirety.
BACKGROUND OF THE INVENTION 1. Field of the InventionThis invention relates to a kit or system for more safely filling an implanted infusion pump, for example, by determining or detecting whether “pocket fill” has occurred. The invention also includes a method of determining or detecting whether pocket-fill has occurred and/or of more safely filling an implanted infusion pump. The implanted infusion pump may be of the type that dispenses baclofen.
2. Discussion of Background InformationImplantable infusion pumps are generally safe and effective forms of treatment for approved uses. An example of the same is described in U.S. Pat. No. 7,044,932 to BORCHARD et al., the entire disclosure of which is herein expressly incorporated by reference. However, one of the safety concerns of implantable infusion pumps is human error during the pump refill process.
One type of error that can occur in a refill process is that the health care professional fails to inject the medicine into the designated reservoir of the infusion pump, and instead, injects the medicine into the human tissues surrounding the infusion pump. This can result in a number of safety concerns for the patient depending on the type of medicine used for injection.
Errors in the context of the invention include those associated with underdose, overdose, and adverse events. In addition, such errors can likely lead to either an overdose (injection of too much medicine directly into the body) or under-dose, leading potentially to withdrawal reactions (from the lack of medication reaching the pump and resultant delivery target, resulting in a complete withdrawal of medication from the patient when the reservoir becomes empty). These errors are referred to as “pocket fills” referring to the injection of some or all of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket or area under the skin where the pump is placed, which may include a pocket of fluid that often surrounds foreign objects implanted into the body. This can lead to a series of serious medical events, which could include death. One should also appreciate that, for some pumps, one cannot readily determine (or directly measure) the volume of fluid that actually makes it into the pump reservoir.
Implantable infusion pumps have been designed to ensure the highest level of safety when delivering medicine within the human body. In order to maintain that safety, the pumps have been engineered to ensure that exposure to foreign materials (anything other than medicine which was specifically developed for this use) is minimized to prevent pump malfunction or infection. These efforts have led to pump systems that are highly effective in preventing unintended exposure to protein inside the pump reservoir.
Foreign objects, such as implantable infusion pumps, can be disruptive to the human body. In an effort to protect the body from the foreign object, the immune system may respond by surrounding the foreign object with fat, collagen, and/or vasculature in an effort to create a barrier between the foreign object and the body. In doing so, the body may create fluid pockets that directly surround the pump and these fluids are filled with a variety of things, including proteins.
Post implantation, the infusion pump requires periodic refilling of the drug product intended for targeted delivery via the infusion pump.
The infusion pump refill procedure is typically broken into five sub-procedures as follows:
-
- 1. Patient prep—this involves getting the patient into a good position to conduct the procedure. Cleaning the site overlaying the infusion pump in preparation for a subcutaneous injection, and preparing the sterile field with the instruments (syringes, needles, medicine, etc.) that will be used in the procedure (generally described in the infusion pump refill kit instructions—which can be provided or otherwise available such as from a website).
- 2. Placing a needle into the pump reservoir—this is the procedure in which the health care professional attempts to secure a direct line with a needle into the designated septum of the infusion pump reservoir, which occurs via subcutaneous injection. This process is often challenging and the health care professional may supplement their own training and skill with other detection techniques, including but not limited to the use of ultrasound.
- 3. Withdrawing the remaining drug in the reservoir—before refilling the pump, the pump must be completely empty as the refills are typically designated to fill the full volume of the pump reservoir. This is also an opportunity for physicians to identify how much medication was left in the pump and compare it to what was expected to be leftover (based on information available in the pump and in some devices, extractable through a handheld, wireless programming device). This is the primary method of physicians identifying if they have hit a “pocket” or if they have been able to access the pump reservoir. If a physician were to hit a “pocket” they may extract a clear fluid as well, potentially due to the lack of vasculature directly surrounding the pump.
- 4. Refilling the pump—this is when the health care professional injects the new medication into the pump via subcutaneous injection through the designated pump septum. This is also the place where a health care professional might inject the medication instead into a “pocket”, delivering the medication inadvertently directly into the patient subcutaneously.
- 5. Removal, cleanup, reprogramming—after the pump is filled, the pump is reprogrammed for administration of the newly placed drug, typically using the same hand-held device and the patient is cleaned for discharge.
At each time in which the pump is filled or refilled, there is a risk that the pump will not be filled correctly, as explained above. There remains a need in the field to improve the safety at the filling and refilling stage.
SUMMARY OF THE INVENTIONThe invention aims to improve the safety of treating with implantable infusion pump technology by providing an embodiment that would allow health care practitioners or trained assistants, when performing the withdrawing stage (as related to pump filling or refilling), to access the fluid that they are extracting from the body and to prevent the filling or refilling stage until there is assurance that the pump reservoir has been correctly located.
Embodiments of the invention include methods of testing the fluid that has been removed from the body with a color-changing composition that, upon contact with the withdrawn fluid, can detect the existence of proteins. If no color change occurs, the health care professional will have an indication that they have correctly accessed the pump reservoir. This method can be employed as part of the pump refill kit and can be performed by physicians, hospital personnel, ancillary healthcare practitioners or trained staff.
Non-limiting embodiments of the invention include:
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- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface allowing the syringe to connect thereto and to receive therein the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface allowing the syringe to connect thereto and to receive therein the withdrawn fluid. A label or tag is arranged on or associated with the bag or container to provide a visual indicator to the user. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. This color may be configured to match a color on the adjoining label or tag that visually indicates to a user that the fluid has tested positive for containing protein. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected. The tag may contain another color indicator associated with a negative test result, i.e., if the color of the fluid matches the color on the tag, the tested withdrawn fluid does not contain protein (or contains protein in an amount below the detection threshold),
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A needle, medical tubing for accessing the pump reservoir, and a valve device for selectively stopping flow through the tubing.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface allowing the syringe to connect thereto and to receive therein the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
- A package or container for containing and storing the above-noted items.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A needle, medical tubing for accessing the pump reservoir, and a valve device for selectively stopping flow through the tubing.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface allowing the syringe to connect thereto and to receive therein the withdrawn fluid. A label or tag is arranged on or associated with the bag to provide a visual indicator to the user. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. This color will generally match a color on the tag that visually indicates to a user that the fluid has tested positive for containing protein. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected. The tag may contain another color indicator associated with a negative test result, i.e., if the color of the fluid matches the color on the tag, the tested withdrawn fluid does not contain protein (or contains protein in an amount below the detection threshold).
- A package or container for containing and storing the above-noted items which can include instructions or information for obtaining instructions elsewhere such as from a website.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A needle, medical tubing for accessing the pump reservoir, and a valve device for selectively stopping flow through the tubing.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface with integral one-way valve (or device containing the same) allowing the syringe to connect thereto and to receive therein the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
- A package or container for containing and storing the above-noted items.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a syringe for withdrawing fluid.
- A needle, medical tubing for accessing the pump reservoir, and a valve device for selectively stopping flow through the tubing.
- A bag or container containing a color-changing composition such as biuret and having a connecting interface with integral one-way valve allowing the syringe to connect thereto and to receive therein the withdrawn fluid. A label or tag is arranged on or associated with the bag to provide a visual indicator to the user. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. This color will generally match a color on the label, tag or instructions that visually indicates to a user that the fluid has tested positive for containing protein. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected. The tag may contain another color indicator associated with a negative test result, i.e., if the color of the fluid matches the color on the tag, the tested withdrawn fluid does not contain protein (or contains protein in an amount below the detection threshold).
- A package or container for containing and storing the above-noted items.
Non-limiting embodiments of the invention include, among other things:
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- A fluid-withdrawing device such as a non-needle or non-luer-lock type syringe for withdrawing fluid;
- A one-way valve for connecting the injection device to a container or bag; and
- A bag or container containing a color changing composition such as biuret in either liquid form or as a coating disposed inside the container or bag. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device such as a needle or needle-luer-lock type syringe for withdrawing fluid; and
- A vial, bottle, bag or container containing a color changing composition such as biuret in either liquid form or as a coating disposed inside the container or bag. A portion of the container, such as the container wall or a pierceable cap, allows for the needle to pass there-through to introduce the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device having a needle for withdrawing fluid; and
- A vial containing a color changing composition such as biuret in either liquid form or as a coating disposed inside the vial. A portion of the vial such as a pierceable cap allows for the needle to pass there-through to introduce between 2 to 6 milliliters the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
Non-limiting embodiments of the invention include:
-
- A fluid-withdrawing device having a needle for withdrawing fluid. The fluid-withdrawing device contains therein a color changing composition such as biuret in either powder form, liquid form or as a coating disposed inside and can receive therein between 1 and 10 milliliters the withdrawn fluid. If the introduced withdrawn fluid contains protein, it will cause the color changing composition to change color upon contact therewith. If the introduced fluid does not contain protein (or contains protein in an amount below the detection threshold), no color change will be detected.
The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:
The figures are intended to show basic features, functioning and aid in understanding and may or may not show features or details which are utilized in commercial embodiments.
The present invention is further described in the detailed description which follows, in reference to exemplary embodiments.
As shown in
As is shown in
A user will typically connect the syringe 40 to the interface 20 as shown in
A. No color change (or a change below a threshold value);
B. A color change indicative of protein detection. Examples include a change from clear or translucent to violet, or a change from blue or light blue to violet (but the actual color is not critical, and can be any color whose appearance may be observed, either through the naked eye or with machine assistance);
C. A color change indicative of a medicine contained in the infusion pump; and
D. A color change indicative of a medicine and a protein contained in the infusion pump.
In the case of A, where no color change occurs, this can provide a visual indication that no protein was detected in the fluid WF. The user can thus be assured that the withdrawn fluid is from the pump reservoir and not from a pocket fill injection. If the pump reservoir has not yet been emptied, this can now be completed and the infusion pump refilled. Note that while “no color change” is referred to here, this of course encompasses a situation in which a color change occurs but is minor and is considered to be below a threshold value.
In the case of B, where a color change indicates protein detection has occurred, this will provide a visual indication that protein was detected in the fluid WF. The user can thus be informed that an error was made in that the withdrawn fluid is likely from a pocket fill location rather than from the pump reservoir. The user thus knows not to attempt refilling of the infusion pump and to instead attempt again to correctly locate the pump reservoir. This can occur by the obtaining another needle, locating the pump reservoir and injecting the needle in that location. The withdrawn fluid from this new location can be tested using a new syringe 40 and a new container 10 containing the protein-detecting composition 30. In this case, the original syringe 40, container 10, tubing and needle can be safely discarded.
In the case of C, where a color change occurs detecting only a medicine, this can provide a visual indication that no protein was detected in the fluid WF. The user can thus be assured that the withdrawn fluid is from the pump reservoir and not from a pocket fill injection. If the pump reservoir has not yet been emptied, this can now be completed and the infusion pump refilled.
In the case of D, where a color change indicates protein detection and medicine detection has occurred, this will provide a visual indication that both medicine and protein was detected in the fluid WF. The user can thus be informed that something is wrong with the implanted pump. The area of tissue around the pump should not contain any significant amount of medicine and the pump reservoir should not contain any protein. The user thus knows not to attempt refilling of the infusion pump and to instead take corrective action(s).
Alternatively, in the embodiment of
Alternatively, the embodiment of
In further embodiments, the areas FI, SI and TI can include indicia providing further indication or positive or negative test results such as a plus “+” sign and a minus “−” sign, a check indicator, etc., or other indicators for better or more clearly providing an indication to the user.
As shown in
In the exemplary embodiment of
As shown in
As shown in
As shown in
As shown in
With reference to
In stage 200, a user accesses a test kit having a container 10 similar to that shown in
In stages 300 and 400, a user connects the syringe containing the withdrawn fluid to the container 10 and injects the withdrawn fluid similar to that shown in
In stages 500-700, a user visually detects whether the composition 30 experiences a color change and takes action consistent therewith such as performing a refilling procedure as in stage 600 or starting over in stage 700.
Non-Limiting Examples of Protein-Detecting CompositionProtein-sensing dyes (Biuret test for example) were developed and have been used to identify a number of protein-related disorders and are commonly used to identify protein in urine. Some tests have become complex and are sensitive to certain types of protein, others provide more general recognition of the presence of protein. Protein-detecting compositions generally produce a visually observable reaction on reacting with protein. Examples include, but are not limited to, the Bradford protein assay, which is based on Coomassie Brilliant Blue G-250, and the use of which results in an observable color shift. Preferably, the composition includes a Biuret solution.
Biuret protein test is a well-established test to qualitatively detect this presence of proteins. It generally includes a reagent made up of potassium iodide, potassium sodium tartrate, copper sulfate, and sodium hydroxide. It is based on the cupric ions in the alkaline solution reacting with the peptide bonds of the protein and polypeptides to produce a violet colored complex.
Cu+++Protein→OH−Cu-Protein complex
Numerous examples of protein-sensing dyes and tests are known in the art, and are not set forth herein for the sake of brevity. However, the inventors do not believe the choice of dye or test is a limiting aspect of the invention, as any type could be used according to the invention. Particular types of biuret reaction tests are described, for example, by Gornall et al., in The Journal of Biological Chemistry, Vol. 177, pages 751-766, Feb. 1, 1949, and Weichselbaum, in American Journal of Clinical Pathology, Vol. 10, pages 40-49, March 1946, the entire disclosures of both of which are incorporated by reference herein. Commercially available products are also available. There are various advantages and disadvantages to different tests, relating for example, to the speed and sensitivity of the reaction, and color of the reaction product, but the choice of particular test method is not critical.
The invention contemplates various protein-detecting compositions which can change color upon contact with protein. This includes a change from clear or light blue to violet as well as other changes. Although acceptable results can be obtained when a certain volume or amount of withdrawn fluid is placed into contact with a certain volume or amount of the protein-detecting composition and ratio ranges of between 1 to 1 (withdrawn fluid to protein-changing composition) and 1 to 2 (withdrawn fluid to protein-changing composition) can provide acceptable results, the invention contemplates other ratio ranges. In addition, the invention can be implemented with a certain or threshold amount of withdrawn fluid such as 1 milliliter and with a predetermined range or amount of protein-detecting composition such as between 2 and 6 milliliters. A preferred embodiment of the present invention includes the use of at least 4 milliliters, with 4 milliliters of withdrawn fluid mixed therewith.
The protein-detecting compositions used in the present invention may be in dry form such as powder form or in liquid form. For example, in dry form, the separate dry elements of the reaction mixture can be included, and then rely on the liquid from the biological fluid to dissolve the elements for the reaction to occur. Alternatively, for example, a liquid composition may be dried (after dissolving the various components in a solvent), and the dried composition may be mixed and re-dissolved in biological fluid. Or the protein-detecting composition may be in liquid form, which can be mixed with the biological fluid to be tested for protein. Various combinations and modifications will be readily apparent to skilled persons after reviewing the present specification.
Note that the protein-detecting compositions are intended to provide a basis for determining whether a composition includes a sufficient amount of protein to be a cause for concern. The inventors of course recognize the any injection into human tissue will almost necessarily introduce some protein into or onto a needle tip, which can be detected by the protein-detecting compositions. Thus, the inventors contemplate that some protein in a sample may be unavoidable, and contemplate that a threshold color change may determined through a standard concentration curve to determine what level of protein is considered to be a cause for concern. While not wishing to be bound to any particular concentration, a concentration of protein of about 30 mg/ml or higher in the withdrawn fluid will generally be considered as evidence that the needle has been inserted into human fluid, i.e., outside the pump reservoir.
The inventors certainly also recognize that certain human conditions might result in a normally higher or lower concentration of protein in serum. For example, liver disease, acute infection, or immunodeficiency can result in low serum albumin concentration; and other diseases such as paraproteinemia (caused by certain leukemias and lymphomas), Hodgkin's lymphoma, and leukemia can result in an increase in immunoglobulins. The presence of such conditions can be taken into account by the practitioner in determining whether a color change in the protein-detecting test should be considered cause for concern.
ExamplesDevelopment of a qualitative colour test for proteins in abdominal body fluid.
Sensitivity to be reached 0.03 g/mL=30 mg/mL.
The value of 30 mg/ml was determined as the target value based on reported levels of total protein in peritoneal fluid (normally exudate material is >3.0 g/dl with transudate <3.0 g/dl).
Objective(1) Develop formulation for peritoneal fluid
(2) Define appropriate Biuret solution to protein fluid ratio
(3) Define protein operating range and limit of detection for the Biuret solution
(5) Verify stability of the solution
(6) Use of control samples with the Biuret solutions
(1) Biuret reagent development
Three different Biuret solutions were tested—with all solutions sensitive enough to visualize 30 mg/mL of protein. Gornall and Weichselbaum refer to the sources of biuret found in a literature search.
(1.1) Biuret Formulations
-
- Gornall biuret solution. See
FIG. 29 . - Weichselbaum biuret solution. See
FIG. 30 . - Modified biuret test solution. See
FIG. 31 .
- Gornall biuret solution. See
(1.2) Formulation performance
For this the various Biuret solutions above were evaluated against visual colour and spectrophotometrically.
Gornall. See
Conclusion: The BSA calibration curve is linear until about 2.5 mg/ml. For this reason, only the 0-2.5 mg/ml curve was used to calculate concentrations. The total protein concentration found is 77 mg/ml (120% recovery). The target concentration of 30 mg/ml is clearly visible.
The Weichselbaum solution performance was compared again against the Gornall See
Conclusion: The Weichselbaum Biuret solution reaches a higher OD value than the Gornall solution. Also the Weichselbaum signal develops in time more than the Gornall signal.
SolutionThe solution performance was tested and compared against the two previous solution types. See
Conclusion: the biuret solution results in a good performance A very low background and good colour intensity @(10 mg/ml, OD 0.710).
(2) Evaluation of the performance of different ratios of biuret reagent solutions with BSA calibrators in different protein:biuret ratios: 1:3, 1:2, 1:1, 2:1, 3:1. See
Conclusion: There is a wide range of color changing ratios versus the typically specified 1:1 preferred biuret ratio. This allows for a single volume of biuret fill with a range of potential pump aspiration volumes and still provide valid results
(3) Protein operating range and limit of detection determination
(3.1) From the above section 1.2 an operational range of 1.0 to 10.0 mg/ml was established for all Biuret solutions. However, the % CV was best for the solution with a relatively low background and hence less variability.
Further linearity studies were carried out listed below these confirmed the linear range. See
Conclusion: Linearity and hence range was demonstrated from 1.0 mg/ml to 10.0 mg/ml. LOD of 0.1 mg/ml was determined.
(3.2) Also a visual study was conducted with laboratory personnel to determine when an end point (color change) could be visually detected and to see what concentration of protein this corresponded to. The spectrophotometric method was used a reference.
Conclusion (without showing all data): At the concentration of 1 mg/ml, all laboratory personnel (n=6) could visually detect the colour change.
(4) Stability
Stability was initially carried out on Gornall and Weichelbaum solutions. After this initial study and evaluation, the Weichelbaum reagent was not as stable and further stability was not continued for this solution.
Stability studies were carried out on the solutions at various conditions.
Conclusion (data not shown): The solutions all demonstrate acceptable stability.
(5) Control samples (including drug)
(5.1) Baclofen as a negative control
Lioresal (baclofen(2.0 mg/ml)) was used as a negative control to determine if the use influenced a false positive result. See
Conclusion: Baclofen solution alone (ie. Aspirate in a real world setting) does not create a color change and therefore a false-positive.
Conclusion from all examples:
Each of the various biuret solutions exhibited acceptable performance.
Claims
1. A method of safely refilling an implanted infusion pump, the method comprising:
- contacting a withdrawn fluid with a protein-detecting composition;
- detecting whether the protein-detecting composition experiences a reaction; and
- performing a refilling procedure if no reaction is detected.
2. The method of claim 1, wherein the reaction is a color change.
3. The method of claim 1, further comprising, before the contacting, injecting the withdrawn fluid into a container containing the protein-detecting composition.
4. The method of claim 1, further comprising, before the contacting, connecting a syringe containing the withdrawn fluid to a container containing the protein-detecting composition.
5. A protein detection kit usable with implanted infusion pumps, said kit comprising:
- at least one container containing a protein-detecting composition and comprising an interface for allowing fluid to be introduced and an indicating mechanism for providing an indicator indicative of protein detection.
6. The kit of claim 5, wherein the container is at least partially transparent or translucent.
7. The kit of claim 5, wherein the container is a vial.
8. The kit of claim 5, wherein the container is a medical bag.
9. The kit of claim 5, wherein the interface is directly connectable with a syringe.
10. The kit of claim 5, wherein the interface contains a standard connecting interface connectable with a standard connecting interface of a syringe.
11. The kit of claim 10, wherein the standard connecting interface is a luer-lock interface.
12. The kit of claim 5, wherein the indicator is a visual indicator mechanism is a label or tag containing at least one color area that substantially or significantly matches a color that the protein-detecting composition changes to when contacted by protein.
13. The kit of claim 5, further comprising at least one syringe.
14. The kit of claim 5, further comprising at least one section of medical tubing.
15. The kit of claim 5, further comprising at least one needle.
16. The kit of claim 6, wherein the protein-detecting comprising comprises a biuret solution.
17. A method of using the kit of claim 6, the method comprising:
- introducing withdrawn fluid into a container containing a protein-detecting composition; and
- determining whether aspirate is protein-rich fluid, signifying that the aspiration needle is not in the pump septum.
18. A method of using the kit of claim 5, the method comprising:
- introducing withdrawn fluid into a container containing a protein-detecting composition; and
- refilling an implanted infusion pump after determining that proper placement of needle in the pump septum.
19. A method of using the kit of claim 5, the method comprising:
- introducing withdrawn fluid into a container containing a protein-detecting composition; and
- detecting whether a color change has occurred in the protein-detecting composition.
20. A method of using the kit of claim 5, the method comprising:
- introducing withdrawn fluid into a container containing a protein-detecting composition; and
- detecting a color change in the protein-detecting composition.
21. A method of refilling an implanted infusion pump, the method comprising:
- accessing a container containing a protein-detecting composition;
- connecting a syringe containing withdrawn fluid to the container;
- injecting the withdrawn fluid into the container;
- detecting whether the protein-detecting composition experiences a color change; and
- performing a refilling procedure if no color changes occurs.
22. A method of safely refilling an implanted infusion pump, the method comprising:
- locating a reservoir refill septum of the implanted infusion pump; and
- preventing inadvertent injection into subcutaneous tissue,
- wherein the preventing comprises: withdrawing fluid while attempting to fill or refill a reservoir of the implanted infusion pump; after the withdrawing, contacting the fluid with a protein-detecting composition to determine whether the protein-detecting composition experiences a reaction.
23. The method of claim 22, wherein the method further comprises:
- accessing a container containing the protein-detecting composition;
- connecting a syringe containing the fluid to the container;
- injecting the fluid into the container;
- detecting whether the protein-detecting composition experiences a color change; and
- performing a refilling procedure only after the detecting.
Type: Application
Filed: Mar 25, 2019
Publication Date: May 6, 2021
Applicant: SAOL INTERNATIONAL LIMITED (HAMILTON)
Inventors: David PENAKE (Atlanta, GA), Sharon HAMM (Odessa, FL), Martin REYNELL (Dublin)
Application Number: 17/041,886