US20080167620A1 - Disposable infusion device facilitating tissue fold formation for cannula deployment and method - Google Patents

Disposable infusion device facilitating tissue fold formation for cannula deployment and method Download PDF

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Publication number
US20080167620A1
US20080167620A1 US11/651,425 US65142507A US2008167620A1 US 20080167620 A1 US20080167620 A1 US 20080167620A1 US 65142507 A US65142507 A US 65142507A US 2008167620 A1 US2008167620 A1 US 2008167620A1
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US
United States
Prior art keywords
cannula
base
skin
base member
fold
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/651,425
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English (en)
Inventor
John M. Adams
Clifton A. Alferness
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Calibra Medical LLC
Original Assignee
Seattle Medical Technology
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seattle Medical Technology filed Critical Seattle Medical Technology
Priority to US11/651,425 priority Critical patent/US20080167620A1/en
Assigned to SEATTLE MEDICAL TECHNOLOGIES reassignment SEATTLE MEDICAL TECHNOLOGIES ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ADAMS, JOHN M., ALFERNESS, CLIFTON A.
Priority to PCT/US2008/000320 priority patent/WO2008086007A1/fr
Assigned to CALIBRA MEDICAL, INC. reassignment CALIBRA MEDICAL, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SEATTLE MEDICAL TECHNOLOGIES, INC.
Publication of US20080167620A1 publication Critical patent/US20080167620A1/en
Priority to US12/205,655 priority patent/US7713258B2/en
Assigned to CALIBRA MEDICAL, INC. reassignment CALIBRA MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ADAMS, JOHN, ALFERNESS, CLIFTON A.
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters

Definitions

  • Insulin delivery has been dominated by subcutaneous injections of both long acting insulin to cover the basal needs of the patient and by short acting insulin to compensate for meals and snacks.
  • Recently, the development of electronic, external insulin infusion pumps has allowed the continuous infusion of fast acting insulin for the maintenance of the basal needs as well as the compensatory doses (boluses) for meals and snacks.
  • These infusion systems have shown to improve control of blood glucose levels.
  • these pumps are electronically controlled and must be programmed to supply the desired amounts of basal and bolus insulin. This prevents many patients from accepting this technology over the standard subcutaneous injections.
  • a convenient form of insulin treatment which does not require significant programming or technical skills to implement to service both basal and bolus needs.
  • a treatment would be carried out by an infusion device that is simple to use and mechanically driven negating the need for batteries and the like. It would also be preferable if the infusion device could be directly attached to the body and not require any electronics to program the delivery rates.
  • the insulin is preferably delivered through a small, thin-walled tubing (cannula) through the skin into the subcutaneous tissue similar to technologies in the prior art.
  • Cannula deployment to support insulin delivery Another problem is with cannula deployment to support insulin delivery. Cannula deployment to support delivery of the insulin beneath the patient's skin must be made easy and convenient. This is not as easy as it seems because cannula deployment, as generally and currently performed in the art, requires insertion of a cannula-carrying needle into the patient and then retraction of only the needle to leave the cannula in place beneath the patient's skin.
  • the pain associated with the injection may be reduced by forming a fold in the skin at the injection site prior to the injection.
  • the fold of skin can also increase the probability that only soft tissue will be affected during the injection.
  • the forming of such a skin fold when the needle is also being driven through an associated device, such as in infusion device, for example, to deliver a cannula to a deployed position extending from the device to beneath the skin is not readily possible. The reason for this is that in such cases, the device is already adhered to the skin and covers the injection site, making it virtually impossible to form a desired skin fold to receive the needle and cannula.
  • the present invention addresses these and other issues toward providing a simple, practical, reliable and relatively pain-free deployment of a cannula beneath the skin to support insulin delivery.
  • the invention provides a medical device comprising a base having a base surface and a flexible layer member.
  • the flexible layer member has a first surface adjacent the base surface and a second surface adapted to be adhered to a patient's skin.
  • the first surface has a first portion adhered to a portion of the base surface and a second portion adherable to the base surface.
  • the base surface and the flexible layer member may be arranged to permit a cannula to pass there through from the base.
  • the base may be arranged to permit a cannula to pass through the first portion of the first surface.
  • the base may include a septum within the base surface to permit a cannula to pass through the first portion of the first surface.
  • the second portion of the first surface may include a layer of adhesive and a removable cover overlying the layer of adhesive.
  • the second portion of the first surface may include first and second areas on opposite sides of the first portion.
  • the base surface and the flexible layer member are preferably arranged to permit a cannula to pass there through from the base.
  • the base may be further arranged to permit a cannula to pass through the first portion of the first surface.
  • the base may include a septum within the base surface to permit a cannula to pass there the first portion of the first surface.
  • the first and second areas of the first surface may each include a layer of adhesive and a removable cover overlying the layer of adhesive.
  • the invention may further provide a method of deploying a cannula of a disposable infusion device.
  • the method comprises the steps of adhering, to a skin surface, a base member having a port for receiving a cannula, forming a skin fold having skin surfaces sloping away from opposite sides of the base member and driving a cannula through the port of the base member while maintaining the skin fold and thereafter releasing the skin fold.
  • the step of forming the skin fold may include compressing soft tissue beneath and on opposite sides of the base member.
  • the adhering step may include adhering a first portion of the base member to the skin surface before forming the skin fold and adhering an additional portion of the base member to the skin surface after releasing the skin fold.
  • the additional portion of the base member may be a portion of the base member remaining to be adhered to the skin surface.
  • the method may further include the step of releasably attaching to the base member a cannula driver having a cannula and a drive mechanism for driving the cannula from the cannula driver into and through the port of the base member.
  • the driving step may then include actuating the drive mechanism to drive the cannula into and through the base member port.
  • the method may include the further step of removing the cannula driver from the base member after the cannula has been driven through the base member port to a deployed position extending from the base member to beneath the skin.
  • the step of forming the skin fold may include compressing soft tissue beneath and on opposite sides of the base member.
  • the adhering step may include the steps of adhering a first portion of the base member to the skin surface before forming the skin fold and adhering an additional portion of the base member to the skin surface after releasing the skin fold.
  • the additional portion of the base member may be a portion of the base member remaining to be adhered to the skin surface.
  • FIG. 1 is a perspective view of a disposable infusion device according to an embodiment of the invention together with a cannula driver that provides the infusion device with a cannula for the delivery of a liquid medicant;
  • FIG. 2 is perspective view of the cannula driver of FIG. 1 detachably received by the infusion device of FIG. 1 before the device is adhered to the skin;
  • FIG. 3 is a perspective view of the infusion device and cannula driver of FIG. 1 after the device is adhered to the skin;
  • FIG. 4 is a perspective view of the infusion device and cannula driver of FIG. 1 after the device is adhered to the skin and as a skin fold is formed to receive a cannula from the cannula driver;
  • FIG. 5 is a perspective view of the infusion device and cannula driver of FIG. 1 as a needle and cannula are driven into the skin fold according to an embodiment of the invention
  • FIG. 6 is a perspective view of the infusion device and cannula driver of FIG. 1 after the needle has been retracted from the cannula back into the cannula driver and as an adhesive is exposed to the device to more completely secure the device with respect to the skin in accordance with an embodiment of the invention;
  • FIG. 7 is a perspective view of the infusion device of FIG. 1 after the cannula driver has been removed from the infusion device and the cannula has been fully deployed to facilitate the delivery of insulin through the cannula to beneath the skin.
  • the infusion system 10 generally includes an infusion device 100 and a cannula driver 200 .
  • the device 100 includes a septum 110 for both receiving a cannula to be deployed and receiving boluses of insulin with a needle syringe, for example.
  • the device 100 further includes a body 120 having a base 130 and a flexible member 140 .
  • the base 130 has a base surface 132 and the flexible member 140 includes a first surface 142 adjacent the base surface 132 of the device base 130 and a second surface 144 adapted to be adhered to the skin.
  • the flexible member 140 carries three protective strips 150 , 152 , and 154 . Each strip has a respective tab 150 a , 150 2 , and 154 a to facilitate its removal.
  • the first strip 150 when removed, exposes a layer of adhesive for use in adhering the second surface 144 of the flexible member 140 to the patient's skin.
  • the second and third strips 152 and 154 when removed, expose an adhesive on the first surface 142 of the flexible member to the base surface 132 of the device.
  • the strips 152 and 154 cover outer regions of the flexible member first surface 142 leaving a center region 146 already adhered to the base surface 132 of the device base 130 .
  • the strips 152 and 154 may be removed to expose the adhesive in the outer regions of the first surface 142 of the flexible member 140 to the base surface 132 of the device 130 . This permits the entire base surface 132 to be adhered to the flexible member 140 to more fully stabilize the device 100 on the patient's skin after cannula deployment.
  • the device 100 further includes a pair of actuator buttons of which one such button 112 may be seen in FIG. 1 .
  • the device 100 is preferably arranged so that only concurrent depression of the actuator buttons results in insulin being dispensed to the patient.
  • the cannula driver 200 is arranged to be detachably received on the infusion device 100 to facilitate deployment of a cannula from the device 100 .
  • the driver 200 includes a plurality of projections 202 that are arranged to align with and be frictionally received by a like plurality of recesses 114 within the body 120 of the infusion device 100 .
  • the projections 202 and the recesses 114 are correspondingly arranged to serve the further function of aligning the cannula driver 200 with the infusion device 100 for cannula deployment.
  • the cannula driver 200 still further includes an actuator button 220 .
  • a mechanism (not shown) within the cannula driver is released to first drive a cannula carried on a cannula needle through the device 100 to a deployed position and then retract the needle back into the cannula driver 200 leaving the cannula deployed and ready to provide insulin to the patient.
  • a mechanism (not shown) within the cannula driver is released to first drive a cannula carried on a cannula needle through the device 100 to a deployed position and then retract the needle back into the cannula driver 200 leaving the cannula deployed and ready to provide insulin to the patient.
  • FIGS. 2-7 illustrate a manner in which the infusion device 100 may be deployed on a patient's skin according to an embodiment of the present invention for providing a liquid medicant, such as insulin, to the patient.
  • a liquid medicant such as insulin
  • FIG. 2 it may be seen that the cannula driver 200 has been detachably received by the infusion device 100 .
  • the strip 150 is partly removed, as by the pulling of the tab 150 a , to expose the adhesive coated second surface 144 of the flexible member 140 to be adhered to the patient's skin.
  • a port 160 that communicates with the septum 110 of the infusion device 100 .
  • the port 160 permits the cannula to be deployed to pass through the base 130 of the device 100 and the flexible member 140 into its deployed position as will be seen subsequently.
  • the port is located equidistant and in between the tabs 152 a and 154 a so that the cannula passes through the central region 146 ( FIG. 1 ) of the first surface 142 of the flexible member 140 already adhered to the device 100 .
  • FIG. 3 shows the infusion system 10 after the strip 150 is removed and the second surface 144 of the flexible member 140 is adhered to the patient's skin 12 . It may be noted that the tabs 152 a and 154 a are still in place and that their corresponding strips have not yet been removed.
  • FIG. 4 shows a next step in the deployment process. Since the strips 152 and 154 have not yet been removed, the outer regions of the first surface of the flexible member 140 are not adhered to the base surface 132 of the device 100 . Thus, the outer regions of the flexible member 140 remain flexible to facilitate the formation of a skin fold 14 of soft tissue on opposite sides of the device 100 . More particularly, and as may be seen in FIG. 4 , the fold of soft tissue is formed by the compression of soft tissue on opposite sides of the central region of the base surface 132 so that the surface of the skin 12 slopes away from opposite sides of the central region of the base surface 132 . The patient is now ready to actuate the cannula driver 200 .
  • FIG. 5 shows the cannula driver 200 being actuated.
  • the actuator button 220 is depressed with the other hand.
  • This causes a cannula/needle assembly 170 to be driven from the cannula driver 200 and through the device 100 to cause the assembly 170 to project from the device 100 to beneath the patient's skin 12 .
  • the formed skin fold 14 the pain associated with the assembly driving is reduced and the probability of affecting only soft tissue is greatly enhanced.
  • the assembly 170 is seen with the cannula 174 being carried by a needle 172 . Once the assembly is positioned as shown, the needle 172 is withdrawn from the cannula 174 and preferably transported back to the cannula driver 200 for safe sharps disposal.
  • FIG. 6 shows strip 154 being removed by the pulling on its corresponding tab 154 a .
  • the strip 152 may be removed in the same manner. This exposes the adhesive on the outer regions of the flexible member first surface 142 to the base surface 132 .
  • the outer regions of the first surface 142 of the flexible member 140 may now be brought into engagement with the base surface 132 of the infusion device 100 to more completely stabilize the device 100 on the patient's skin 12 .
  • the cannula driver 200 may now be separated from the infusion device 100 .
  • the infusion device 100 will now be fully deployed as shown in FIG. 7 .
  • the second surface 144 of the flexible member 140 is solidly adhered to the skin 12 .
  • the first surface 142 of the flexible member 140 is solidly adhered to the base surface 132 of the infusion device 100 .
  • the device 100 is fully stabilized on the patient's skin 12 .
  • the cannula extends from the device 100 beneath the skin 12 in a fully deployed position. Depression of the actuator buttons 112 will now cause insulin to be provided to the patient through the deployed cannula 174 .

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US11/651,425 2007-01-08 2007-01-09 Disposable infusion device facilitating tissue fold formation for cannula deployment and method Abandoned US20080167620A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US11/651,425 US20080167620A1 (en) 2007-01-09 2007-01-09 Disposable infusion device facilitating tissue fold formation for cannula deployment and method
PCT/US2008/000320 WO2008086007A1 (fr) 2007-01-08 2008-01-09 Dispositif d'infusion jetable favorisant la formation d'un pli de tissu pour le déploiement d'une canule et procédé
US12/205,655 US7713258B2 (en) 2007-01-09 2008-09-05 Disposable infusion device facilitating tissue fold formation for cannula deployment and method

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US11/651,425 US20080167620A1 (en) 2007-01-09 2007-01-09 Disposable infusion device facilitating tissue fold formation for cannula deployment and method

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US12/205,655 Active US7713258B2 (en) 2007-01-09 2008-09-05 Disposable infusion device facilitating tissue fold formation for cannula deployment and method

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US20090048578A1 (en) 2009-02-19

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