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Device and methods for subcutaneous delivery of high viscosity fluids

A delivery device and subcutaneous infusion technology, applied in the direction of subcutaneous injection equipment, equipment introduced into the body, and medical equipment

Inactive Publication Date: 2011-10-26
HALOZYME INC (US)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Unfortunately, methods and devices for the subcutaneous delivery of viscous fluid therapeutic agents to subcutaneous tissue have not been described, such devices allow for the administration of a large number of different viscous fluid therapeutic agents as well as large volumes of fluid

Method used

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  • Device and methods for subcutaneous delivery of high viscosity fluids
  • Device and methods for subcutaneous delivery of high viscosity fluids
  • Device and methods for subcutaneous delivery of high viscosity fluids

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Flow Analysis of Infusion Devices

[0057] This example illustrates flow rate characteristics for various infusion set designs.

[0058] For flow rate analysis of various infusion set configurations, such as image 3 system shown. A mechanically driven syringe pump is connected to the pressure transducer via tubing with variable length and inner diameter. To measure the high pressure inline, an analog manometer is placed between the pressure sensor and the collecting beaker. Inline low pressure can be measured using a transducer connected to a pressure sensor and interpreted by a computer.

[0059] The test reagents utilized in the experiment included sterile water, 10%, 15%, 20% human IgG (Carimune TM ) solution, and 10% and 20% human IgG (GammaGard TM ) solution. Human IgG was incorporated into the test solution to provide viscosity to the solution.

[0060] Identify key parameters for infusion set design to achieve desired flow rates and determine inline param...

Embodiment 2

[0106] Flow Analysis of Infusion Devices

[0107] This example illustrates flow rate characteristics for various infusion set designs. Using the infusion set having the characteristics shown in Table 15, the test was carried out in the same manner as described in Example 1.

[0108] Table 15. Analysis of Custom-Designed Infusion Devices

[0109]

[0110] *Indicates a non-customized infusion set for reference

[0111] Using the infusion set design shown in Table 14, at two different flow rates, using different percentages of human IgG (Carimune TM ) solution of the flow analysis results in Image 6 with 7 shown in .

[0112] Image 6 is a graphical representation of the inline pressures generated by various infusion sets represented in Table 15. At a flow rate of 4.0 mL / min, different percentages of human IgG (Carimune TM )The solution. The top three lines represented in the plan view correspond to an infusion set with a 27Ga needle. The three lines in the middle s...

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Abstract

The present invention provides infusion devices and methods for subcutaneous delivery of high viscosity fluids. The devices and methods described are innovative subcutaneous infusion systems that allow for the rapid delivery of viscous therapeutic fluids while avoiding adverse side effects and promoting patient comfort. The devices and methods described are also useful for rapid delivery of high volumes of therapeutic fluids.

Description

technical field [0001] The present invention relates generally to the field of subcutaneous infusion of fluids, and more particularly to infusion devices and methods for the subcutaneous delivery of highly viscous therapeutic fluids. Background technique [0002] The standard method for delivering therapeutic fluids to a patient's body is by injection or infusion. Intravenous delivery of therapeutic fluids involves applying the fluid directly into the patient's circulating blood stream by puncturing a patient's blood vessel, for example with an injection needle. Each year, practitioners properly place more than 25,000,000 intravenous catheters in US hospitals alone. Regardless, intravenous placement requires skill, and patients often experience failed attempts due to skin pigmentation, vascular sclerosis, fragility, collapse making access through the vein difficult, or hypertrophy or vagal response due to compression. Furthermore, catheter complications include malfunction...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M5/00
CPCA61M5/1452A61M5/158A61M2005/1581A61M2202/0468A61M5/14A61M5/162A61M5/168
Inventor 戴维·康莫尼卡·塞佩达
Owner HALOZYME INC (US)
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