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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B2050/002—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers having adhesive means, e.g. an adhesive strip
• • 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
  • A61M2005/14264—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with means for compensating influence from the environment
• • 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
  • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
• • 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
  • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking

Definitions

• Body-wearable medical device comprising a sealing element
• the present invention relates to a body-wearable medical device comprising a first housing portion and a second housing portion, the first housing portion having a female portion and the second housing portion having a male portion, the male portion is at least partially inserted into the female portion thereby defining a circumferential clearance gap, wherein a circumferential sealing element is arranged in the circumferential clearance gap between the female portion and the male portion.
• a body-wearable medical device is a small, relatively lightweight device that during its use is carried along by a patient. Thus, the body-wearable medical device is exposed to the same various environmental conditions and stress as the patient. Sometimes the body-wearable medical device is concealed by clothing, sometimes not. In order to prevent a malfunction caused by an ingress of dust, water, and/or humidity the circumferential sealing provided within the circumferential gap between the female portion and the male portion.
• the body-wearable medical device may not only be exposed to dust, water and humidity, but also to forces and stress caused by the patient’s movements and activities.
• forces and stress exert on the body-wearable medical device that may cause a temporary deformation of the first housing portion and/or the second housing portion. Due to the temporary deformation of the first housing portion and/or the second housing portion, the width of the circumferential clearance gap between the female portion and the male portion may alter. A change of the width of the clearance gap may negatively affecting the sealing between the female portion and the male portion as provided by the sealing element.
• a body-wearable medical device comprising an improved sealing that is less prone to failure by stress and forces exerting on the bodywearable medical device.
• At least one of the above objects is solved by a body-wearable medical device as outlined above, wherein the female portion and the male portion are fixed to each other by a circumferential fixation glue that is arranged in the circumferential clearance gap between the female portion and the male portion next to the circumferential sealing element.
• the circumferential fixation glue helps to keep the position of the first housing portion relative to the second housing portion.
• the circumferential fixation glue at least partially fills the clearance gap between the female portion and the male portion.
• the circumferential fixation glue helps to prevent that part of the female portion and part of the male portion are displaced from each other by stress or forces exerting on the body-wearable medical device. Thereby, the clearance gap is less likely deformed and the sealing element maintains its sealing function.
• the sealing element is a sealing glue having a smaller elastic modulus than the fixation glue.
• the purpose of the fixation glue is to keep the female portion and the male portion within their relative position, while the sealing glue prevents an ingress of at least one of water, dust, splash water and humidity.
• the sealing glue itself helps to keep the female portion and the male portion within their relative position.
• the flexibility of the sealing glue helps to balance some deformations of the clearance gap that may be caused by stress and/or forces acting on the body-wearable medical device.
• the sealing glue is a polyurethane adhesive.
• the polyurethane adhesive has a hardness of more than or equal to Shore A40 and lower than or equal to Shore A50.
• the polyurethane adhesive has a hardness of Shore A42.
• the polyurethane adhesive has a viscosity of more than or equal to 30.000 millipascal-second, preferable more than or equal to 40.000 mPas, but lower than or equal to 90.000 mPas, preferably lower than or equal to 80.000 mPas.
• the fixation glue is a low odor acrylic adhesive.
• the full cure time is 8 to 24 hours, and having a shear strength of more than or equal to 20.000 MPa and lower than or equal to 30.000 MPa.
• the acrylic adhesive can have a shear strength of 28.959 MPa.
• the sealing element comprises an O-ring that is arranged in the circumferential gap between the female portion and the male portion and that circumscribes the male portion.
• the O-ring is an elastic plastic ring circumscribing the male portion within the circumferential gap between the female portion and the male portion.
• the O-ring can form the sealing element as a standalone element, but can also form the sealing element together with the sealing glue.
• the O-ring is a reinforcement of the sealing element while the sealing glue helps to keep the sealing element in close sealing contact with the male portion and the female portion.
• the O-ring may additionally or alternatively form a barrier that is arranged next to the fixation glue and that helps to prevent the sealing glue from futher ingressing into the housing.
• the fixation glue discontinuously circumscribes the male portion in the circumferential clearance gap between the female portion and the male portion.
• the fixation glue can continuously or discontinuously circumscribe the male portion at least partially filling the clearance gap between the male portion and the female portion.
• a discontinuously circumscribing fixation glue comprises multiple distinct fixation glue elements that are separated from each other along the circumference of the male portion within the clearance gap.
• Each of the distinct fixation glue elements is in contact with the male portion and the female portion thereby fixing the male portion and the female portion together.
• the sum of length of each of the distinct fixation glue elements is larger than 40% of the circumferential length of the male portion along the line of the distinct fixation glue elements.
• the sum of length of each of the distinct fixation glue elements is larger than 50% of the circumferential length of the male portion along the line of the distinct fixation glue elements.
• the sum of length of each of the distinct fixation glue elements can be smaller than 80% or 70% of the circumferential length of the male portion along the line of the distinct fixation glue elements.
• the discontinuously circumscribing fixation glue is evenly distributed along the circumference of the male portion. Accordingly, the distinct fixation glue elements are evenly distributed along the circumferential length of the male portion within the clearance gap.
• the circumferential clearance gap is formed by a circumferential recess of the male portion and/or a circumferential recess of the female portion.
• the clearance gap can be formed by a recess in the male portion that extends along the circumference of the male portion.
• the clearance gap can be formed by a recess in the female portion that extends along the inner circumference of the female portion.
• the clearance gap can be formed by both, a recess in the female portion extending along the inner circumference of the female portion facing the male portion and a recess in the male portion extending along the outer circumference of the male portion facing the female portion.
• the male portion comprises a free-end portion facing away from the first housing portion, wherein the sealing element is located closer to the free-end portion than the fixation glue.
• the sealing element is arranged closer to the free-end portion than the fixation glue.
• the sealing element forms an outer boundary while the fixation glue is arranged inward relative to the sealing element.
• the sealing element can comprise a sealing glue or can be formed by a sealing glue.
• the first housing portion and the second housing portion form a watertight compartment.
• the sealing element forms a watertight sealing preventing an ingress of water through the clearance gap between the male portion and the female portion.
• the circumferential clearance gap forms a circular, a rectangular, a quadratic or elliptic shape circumscribing the male portion.
• the respective circular, rectangular, quadratic or elliptic shape circumscribing the male portion is formed by an inner wall portion of the female portion that faces the male portion.
• the inner wall portion of the female portion forms an outer boundary of the circumferential clearance gap.
• the rectangular or elliptic shape that, in a cross-sectional view of the body-wearable medical device, is formed by the circumferential clearance gap comprises a first extension in one direction and a second extension in a second direction, wherein the first extension is at least 1 .5 times larger than the second extension in the second direction. In an embodiment, the first extension is at least 2 times larger than the second extension in the second direction. In an embodiment, the first extension is at least s times larger than the second extension in the second direction. The first direction and second direction are perpendicular to each other.
• the body-wearable medical device is a drug delivery device, in particular an insulin delivery device, such as for example an insulin pen or an insulin infusion pump.
• the bodywearable medical device can be a continuous glucose monitoring device or a body-wearable medical device that is configured for analyzing bodily fluids.
• the body-wearable medical device can comprise a plaster and/or an adhesive layer that is configured for temporarily adhering the body-wearable medical device to a patient’s body.
• the body-wearable medical device can comprise a transcutaneous element such as for example a cannula, a probe or a sensor. The probe configured for retrieving bodily fluids, while the sensor is configured for analyzing bodily fluids.
• Figure 1 shows a schematic longitudinal view of a body-wearable medical device according to an embodiment of the present invention
• Figure 2 shows a schematic cross-sectional view of the body-wearable medical device according to figure 1 ;
• Figure 3 shows a schematic longitudinal view of a body-wearable medical device according to a further embodiment of the present invention.
• Figure 4 shows a schematic cross-sectional view of the body-wearable medical device according to figure 3.
• Figures 1 and 2 show a body-wearable medical device 1 according to a first embodiment of the present invention.
• Figure 1 shows a schematic longitudinal view of the body-wearable medical device 1
• figure 2 shows a schematic cross-sectional view of the body-wearable medical device 1 along line A- A.
• the body-wearable medical device 1 comprises a first housing portion 2 and a second housing portion 3.
• the first housing portion 2 comprises a female portion 2a and the second housing portion 3 comprises a male portion 3a.
• the male portion 3a is at least partially inserted into the female portion 2a, i.e. the female portion 2a forms a receiving portion for accommodating the male portion 3a of the second housing portion 3.
• a clearance gap 4 is provided between the male portion 3a and the female portion 2a, wherein the clearance gap 4 circumscribes the male portion 3a.
• the clearance gap 4 is at least partially formed by a circumferential recess 3b of the male portion 3a and a circumferential recess 2b of the female portion 2a.
• the circumferential recess 3b of the male portion 3a and the circumferential recess 2b of the female portion 2a are facing each other.
• the female portion 2a and the male portion 3a are fixed to each other by a fixation glue 6 that is evenly distributed within the clearance gap 4 along the circumference of the male portion 3a.
• a sealing element 5 here a sealing glue, is provided within the clearance gap 4.
• the sealing element 5 is continuously distributed along the circumference of the male portion 3a and in sealing contact with the female portion 2a and the male portion 3a.
• the second housing portion 3 i.e. the housing portion comprising the male portion 3a, comprises a free-end 3c portion that is facing away from the first housing portion 2, i.e. the housing portion comprising the female portion 2a.
• the sealing element 5 is arranged closer to the free-end 3c portion than the fixation glue 6. In a direction of insertion of the male portion 3a into the female portion 2b, the sealing element 5 forms an outer boundary while the fixation glue 6 forms an inner fixation means for holding the male portion 3a in fixed position relative to the female portion 2a.
• the first housing portion 2 and the second housing portion 3 together form a watertight compartment 8.
• FIG. 3 shows a longitudinal view of the body-wearable medical device 1
• figure 4 shows a cross- sectional view of the body-wearable medical device 1 along line B-B.
• the body-wearable medical device 1 according figures 3 and 4 differs from the body-wearable medical device 1 according to the embodiment of figures 1 and 2 by having a different configuration of the fixation glue 6.
• the fixation glue 6 discontinuously circumscribes the male portion 3a within the circumferential gap 4 between the female portion 2a and the male portion 3a.
• the fixation glue 6 is formed by multiple fixation glue elements that are evenly distributed along the circumference of the male portion 3a.
• fixation glue elements forming the fixation glue 6 are indicated in the cross-sectional view of figure 4 in broken line for illustrative purposed only as the fixation glue elements are arranged underneath the sealing element 5 and would not be visible in the cross-section along line B-B.
• the circumferential clearance gap 4 forms a rectangular-like shape having a first extension 9 in a first direction and a second extension 10 in a second direction.
• the first extension is at least 1.5 times, here 2 times, larger than the second extension 10 in the second direction.
• the first direction and the second direction are perpendicular to each other.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Hematology (AREA)
• Vascular Medicine (AREA)
• Anesthesiology (AREA)
• Surgery (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Gasket Seals (AREA)
• Professional, Industrial, Or Sporting Protective Garments (AREA)
• Endoscopes (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Related Child Applications (1)

Publications (1)

Family

ID=80447252

Family Applications (1)

Country Status (8)

Citations (4)

• 2022
  • 2022-02-10 EP EP22156022.0A patent/EP4226957A1/en active Pending
• 2023
  • 2023-02-08 WO PCT/EP2023/053036 patent/WO2023152148A1/en not_active Ceased
  • 2023-02-08 JP JP2024547513A patent/JP2025504234A/ja active Pending
  • 2023-02-08 CN CN202380021182.8A patent/CN118678977A/zh active Pending
  • 2023-02-08 IL IL314623A patent/IL314623A/en unknown
  • 2023-02-08 KR KR1020247026611A patent/KR20240142457A/ko active Pending
  • 2023-02-09 TW TW112104589A patent/TW202345920A/zh unknown
• 2024
  • 2024-08-08 US US18/798,437 patent/US20240398499A1/en active Pending

Patent Citations (4)

Also Published As

Similar Documents

Legal Events