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Medtronic Hepatic Artery Infusion Pump

Dry Hepatic Arterial Infusion Pump

Medtronic Extended Infusion set How to change the reservoir

The HAI pump will continue to flow regardless of medication being instilled in the drug chamber therefore, the main chamber needs to be maintained at specific time frames to avoid the pump going dry. Without medication infusing, blood in the hepatic artery could back up into the catheter and clot. Possible explanations for a dry pump include patients delayed return for pump maintenance, fevers, travel at high altitude, or use of heat on the pump, which increases the rate of infusion of medication.

Upon accessing a pump and noting no residual fluid, the nurse should reposition the needle. Another clinician can assist with repositioning and correcting needle placement. An additional technique to confirm needle placement is to attach and instill a 10 ml normal saline syringe. If the normal saline returns into the syringe when the plunger is released, it confirms that the needle position is accurate because the pressure in the pump is pushing the normal saline back, evidence of a dry pump.

The only exception to allowing the pump to run dry is when the patient is at the end of life. When a patient is admitted to hospice and no further treatment is being considered, the pump may be left to run dry and not be refilled.

Hepatic Artery Infusion Program At Duke University

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Recruitment Status : Withdrawn First Posted : August 13, 2020Last Update Posted : July 19, 2021
Condition or disease
Metastatic Colon CancerLiver CancerIntrahepatic Cholangiocarcinoma Device: Medtronic Synchromed II pump Not Applicable

Eligible patients will have the following procedures performed during this study.

  • On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
  • During the hospital stay, patients will have:

  • Daily physical examination to evaluate for the development of complications
  • Daily blood tests to evaluate blood cell counts and liver function
  • Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
  • Assessment of side effects
  • Clinic visits and study activities will take place every 2 weeks after surgery, and include:

    HAI includes:

    Intera 3000 Hai Pump Features

    Designed and approved for hepatic artery infusion

    • Delivers chemotherapy directly to the blood vessel that supplies the tumors in the liver.
    • The only FDA approved implantable pump for HAI therapy.
    • Beaded catheter designed to deliver floxuridine to the artery that supplies blood to the liver metastases
    • FDA approved for delivering glycerin, providing 6 to 8 weeks between refills when on drug holiday

    Designed for reliable, accurate drug administration

    • Simple continuous flow pump
    • Inexhaustible power supply using body heat to power the pump
    • Refill cycles are consistent and predictable
    • Raised septum designed to make refill needle placement easy

    Designed for simple long-term maintenance and support

    • Easy for doctors and nurses to refill the pump
    • Extended refill periods of 6 to 8 weeks when not on active treatment
    • No motors, rotors, or gears that could stall or fail
    • MRI conditional

    Over 25 years of safe use, with more than 10,000 pumps implanted.*

    Note: *The Intera 3000 Hepatic Artery Infusion Pump was previously marketed as the Model 3000 Series Pump and Codman® 3000 Series Pump. Disclaimer: Codman is a registered trademark of Integra LifeSciences Corporation. Intera Oncology is not endorsed by, affiliated with, or sponsored by Integra LifeSciences Corporation.

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    Improving Patient Access And Outcomes

    While hepatic arterial infusion has only been available at a handful of centers, Dr. Lidsky hopes that will change as a result of the FDA approval. He co-leads a consortium of programs from around the world to perform studies that further demonstrate the HAI pumps effectiveness and to better identify the right candidates for the procedure. The goals of the consortium are to further improve HAI outcomes, help launch new HAI centers, and make the pump more widely available to patients, he said.

    Imaging Of Hai Pump Flow

    Commercially Available Reservoir Options for Intrathecal Drug Delivery ...

    Pump imaging studies can be performed any time after surgical insertion, before the start of HAI therapy. At our institution, these studies are performed between 12 and 16 days postoperatively to allow the pump pocket swelling to subside. The pump is typically accessed under sterile conditions in our nuclear medicine departmentspecifically, the camera room where the patient undergoes imaging. However, in patients who have a body mass index higher than 30 kg/m2 or in whom the pump is difficult to palpate, fluoroscopic guidance or US is used to cannulate the CAP . Once access is established, 5 mCi of 99mTc-MAA is administered through the pump. Immediately following this injection , anterior and posterior planar images of the upper abdomen and lungs are acquired. The time between the radiopharmaceutical injection and image acquisition is minimized to avoid breakdown of 99mTc-MAA and accumulation of free pertechnetate, which may be mistaken for EHP because it distributes to the gastric mucosa, the renal parenchyma, or less frequently the spleen.

    Figure 4a.Figure 4b.Figure 5a.Figure 5b.Figure 6a.Figure 6b.Figure 6c.Figure 6d.

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    How Synchromedtm Ii Works

    The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed II pump reservoir. At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting pressure on the reservoir. The pressure helps advance the drug into the SynchroMed II pump tubing.

    The peristaltic action of the SynchroMed II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter access port, and implanted catheter, to the infusion site.

    The catheter access port allows injection of the drug into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the SynchroMed II pump mechanism and goes through the catheter port into the implanted catheter to the infusion site.

    Hepatic Arterial Infusion Pump With Challenging Access

    Pump placement in the abdomen is dependent on the patients normal vascular anatomy. Patients with excessive abdominal adipose tissue should have their pump placed above the muscle layer near the ribs. The supine position is best for accessing pumps because a flatter position ensures easier septum palpation . If the septum still remains difficult to find, a blind stick can be attempted by palpating and visualizing the outer perimeter of the pump, then marking with a pen where the center appears to be. Once the needle penetrates the skin, it is easier to feel the septum with the needle. The manufacturer prefilled kits include two 1.5-inch non-coring Huber needles however, 2-inch needles should be available if needed. If these strategies are unsuccessful, the patient can be accessed under fluoroscopy for refill procedure by an interventional radiologist.

    ACCESSING A HEPATIC ARTERIAL INFUSION PUMP

    Note. Copyright 2017 by Memorial Sloan Kettering Cancer Center. All rights reserved.

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    Surgical Placement Of The Intrahepatic Pump

    A surgeon from the Liver Cancer Center will:

    • Make an incision on the right side of your abdomen under your ribs
    • Place a small metal pump in a pocket under your skin
    • Guide the thin tubing from the pump into a side branch of the hepatic artery
    • Fill the pump with heparinized saline, so the tubing does not clot off

    Medtronic’s Implantable Drug Pump Approved In Us:

    Medtronic Extended Infusion set How to change the Set

    This article was originally published in Clinica

    Executive Summary

    Medtronic has received US FDA approval for its IsoMed constant-flow infusion system, an implantable drug pump for the treatment of colorectal liver cancer. The pump is surgically placed under the skin of the abdomen and delivers cancer-fighting medication directly to the liver, assisted by a catheter that runs from the pump to the hepatic artery. The system can also deliver morphine sulphate directly into spinal fluid as a treatment for chronic back pain, said the Minneapolis, Minnesota-based company.

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    Codman Catheter/synchromed Pump Hepatic Artery Chemotherapy For Unresectable Colorectal Metastases/intrahepatic Cholangiocarcinoma

    The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
    Recruitment Status : Terminated First Posted : February 19, 2020Results First Posted : January 17, 2023Last Update Posted : January 17, 2023
    Condition or disease

    Phase
    Bile Duct NeoplasmsColorectal Neoplasms Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.Drug: Hepatic artery infusion pump floxuridine and dexamethasoneDrug: Systemic chemotherapy for colorectal liver metastasesDrug: Systemic chemotherapy for intrahepatic cholangiocarcinoma Not Applicable
  • Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
  • 30-day Postoperative Serious Adverse Events Related to Pump Implantation Tabulation of CTCAE serious adverse events attributed to pump implantation
  • Overall Response Rate at 6 Months RECIST v1.1 will be used to assess overall response rate at 6 months.
  • Imaging Of Hai Pumprelated Complications

    Complications related to HAI pump therapy are relatively common. In a large study involving more than 500 patients who underwent HAI pump therapy , technical complications were reported in 22% of patients.

    Figure 7a. Various expected imaging appearances of HAI catheter positions in four patients with metastatic CRC. Coronal oblique contrast-enhanced CT image shows the high-attenuation catheter tip completely filling the GDA lumen. The GDA is not visible this is an expected appearance. Coronal oblique three-dimensional reconstruction of a contrast-enhanced CT angiogram in a second patient shows the catheter tip pointing retrograde toward the GDAcommon hepatic artery junction, again without any visible GDA. Axial and sagittal contrast-enhanced CT images in a third patient show the catheter tip appearing to extend slightly into the common hepatic artery toward the posterior wall this finding is seen to best advantage in d. Coronal contrast-enhanced CT image and three-dimensional reconstruction of a contrast-enhanced CT angiogram in a fourth patient show the catheter tip positioned just outside the GDA takeoff, with a few millimeters of GDA still visible and slightly more peripheral than is typically seen but still in an acceptable position.

    Figure 7a.Figure 7b.Figure 7c.Figure 7d.Figure 7e.Figure 7f.

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    When To Call Your Healthcare Provider

    • Have a fever of 100.4 °F or higher.
    • Have any signs of infection at your pump site, such as tenderness, drainage, or redness.
    • Have swelling over your pump site.
    • Cant go to a scheduled refill appointment. Your pump may not work properly if you miss an appointment.
    • Hear any alarms coming from your pump.
    • Cant go to a scheduled refill appointment.
    • Have any questions or concerns.

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    Arterial Embolization for Salvage of Hepatic Artery Infusion Pumps ...

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    Intrahepatic Pump Therapy Treatment

    • Two weeks after the surgery, the pump is refilled in your medical oncologists office and the chemotherapy begins.
    • The pump holds two-weeks’ worth of chemotherapy and slowly delivers 1 mL per day into the liver.
    • The pump is refilled once every two weeks. The refill is usually painless and only takes 10 minutes.
    • In general, the chemotherapy is given for a two-week period, followed by two weeks of rest with heparinized saline .
    • Your team of doctors will determine how long you’ll need treatment.

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    Background And Efficacy Of Hai

    HAI pumps were first introduced in the 1980s , although the adoption of these devices has taken several decades. Implementation of HAI treatment programs has been slow in part because of the complexity of caring for these patients. Multiple specialists are needed to implant the pump, manage patients surgically and medically, properly dose the drugs, and avoid toxicity. Complication rates in the early years of pump therapy were high, slowing the adoption of this treatment . However, with effective communication, experienced multidisciplinary teams are now able to more effectively deliver therapy , and specialized centers are increasingly starting to consider HAI as an established treatment option to use in combination with concurrent systemic chemotherapy . As a result, evidence supporting pump efficacy has mounted, and HAI pump placement is now considered in several different scenarios, including as an adjuvant therapy, to convert unresectable disease to resectable disease, as a treatment for unresectable colorectal liver metastasis , and as a treatment for unresectable ICC.

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    Security Screening And Radiologic Imaging

    The Codman 3000 Infusion Pump is detectable with walk-through and handheld wand metal detectors. Patients are given an identification card from the manufacturer to present to security at screenings. The HAI pump is safe for use in all radiologic imaging machines, including magnetic resonance imaging, computed tomography, and x-ray.

    Imaging studies are routinely performed to monitor treatment response and progression of disease. In some cases, the imaging will reveal other HAI pump complications, such as an aneurysm or a bleed at the tip of the catheter. An aneurysm is a dilation of the hepatic artery where the catheter lies. A bleed at the tip of the catheter can be visualized on the scan as a pooling of blood. The patient may present with weakness and low hemoglobin. Both complications require emergent intervention to embolize the artery. If embolization is unsuccessful, the pump may need to be permanently removed or emptied and not refilled to prevent further damage to the artery.

    Duke Surgeons Expertise With Hai Pumps

    Medtronic MiniMed – How to insert the Medtronic MiniMed Quick-set infusion set – diabetes therapy

    Drs. Lidsky and Allen and their Duke colleagues have implanted more than 100 pumps in people with liver metastases from colorectal cancer since they started offering the procedure in conjunction with whole-body chemotherapy in late 2018. In many cases, they also work alongside Duke surgical oncologist Sabino Zani, MD, who uses minimally invasive techniques, including robotic surgical approaches to implant the pump. The minimally invasive approach, which requires smaller incisions than traditional surgery, allows people to spend less time in the hospital, and recover faster.

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    Changes In Atmospheric Pressure And Increased Body Temperature

    The rate of the HAI pump is increased by higher altitude and body temperature. The only indicator of the rate of infusion is measuring the residual volume. There are no alarms to alert the patient that the fluid level is getting low. This should be taken into consideration when patients are traveling or live at higher altitudes because drug doses and refill schedules need to be adjusted. Patients should be educated on the importance of maintaining normal body temperature and avoid using heating pads, electric blankets, saunas, or hot tubs. Scuba diving will affect the flow rate and should be avoided. Air travel is permitted with pressurized cabins. Some limitations of having an HAI pump can be frustrating for patients, requiring emotional support to understand the rationale for the restrictions. Patients who miss their scheduled appointments may be putting the pump at risk for running dry and becoming occluded.

    Chemo Pump For Liver Mets Discontinued: What To Do

    Roxanne Nelson, BSN, RN

    May 29, 2018

    After several months of experiencing abdominal discomfort, Erin Michael Kelly finally made an appointment with his primary care practitioner. After undergoing liver ultrasonography and then colonoscopy, he was faced with a rather bleak diagnosis.

    Kelly, who is senior director of content analytics at Medscape LLC, had stage IV colon cancer with extensive metastasis to his liver.

    When the findings were first reviewed with an oncologist, Kelly was told that he had about 6 months to 2 years left to live. “The main issue was not so much the primary tumor in the colon as the fact that it had spread extensively throughout my liver,” he explained. “So, I was not considered a candidate for liver surgery at that point.”

    But that was back in November 2011, right before Thanksgiving. Today, 6 and a half years later, Kelly is alive and kicking. He still has cancer and is undergoing treatment, but he has beaten the initial odds given to him.

    Much of the credit for his prolonged survival, he believes, goes to a device known as the Codman pump, a perioperative hepatic arterial infusion pump, which allows for high doses of chemotherapy to be delivered directly to the liver. The treatment worked so well that Kelly became a candidate for surgery and underwent a liver resection in August 2012. “Without that pump the surgery would not have been possible,” he said.

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