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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
• • 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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
• • 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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
• • 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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
  • A61M2039/064—Slit-valve

Definitions

• the present invention relates generally to the field of medical instruments, and more particularly to hemostasis seals for use during medical procedures.
• a guide catheter may be advanced through the patient's vasculature to a desired treatment location, such as the right atrium of the patient's heart, for delivery of a cardiac lead.
• a mechanism e.g., a hemostasis valve
• a hemostasis seal may be located at the proximal end of the guide catheter to control or inhibit the flow of blood out of the guide catheter lumen.
• a cardiac lead or other device e.g., a guide wire
• the seal inhibits blood flow around the lead.
• the present invention is a hemostasis seal configured to permit passage of a medical device.
• the seal includes a first resilient seal portion having a first proximal seal member with a first mating surface, a first projecting portion, and a first receiving portion.
• the seal also includes a second resilient seal portion having a second proximal seal portion with a second mating surface, a second projecting portion, and a second receiving portion.
• the first mating surface is configured to mate with the second mating surface to form a first fluid seal with respect to the medical device, in addition, the first and second projecting portions are adapted to mate with and sealingly engage the second and first receiving portions, respectively, to form a second fluid seal with respect to the medical device.
• the present invention is a hemostasis seal configured to permit passage of a medical device, and includes a first resilient seal portion with a first mating surface that includes a projecting portion; and a second resilient seal portion with a second mating surface configured to mate with the first mating surface.
• the second mating surface includes a receiving portion adapted to mate with the projecting portion.
• the seal is configured such that the first and second seal portions seal around substantially the entire circumferential surface of the medical device when it is passed between the first and second seal portions.
• FIG. 1 is a schematic cutaway view of a hub assembly for use in a medical procedure, such as a catheterization procedure, according to one embodiment of the present invention.
• FIGS. 2A and 2B show proximal and distal perspective views of an assembled seal according to one embodiment of the present invention.
• FIG. 3 shows perspective views of the mating first and second portions of the seal according to one embodiment of the present invention.
• FIG. 4 shows the first and second seal portions from a proximal plan view, according to one embodiment of the present invention.
• FIG. 5 shows the first and second seal portions from a distal plan view, according to one embodiment of the present invention.
• FIG. 6 is a partial cross-sectional view of the first seal portion according to one embodiment of the present invention.
• FIG. 7 is a perspective view of the sea! according to one embodiment of the present invention, showing the seal portions partially separated.
• FIG. 8 is a partial perspective view of the seal according to one embodiment of the present invention with a medical device passing therethrough.
• FIG. 9 is a partial proximal plan view of the seal, according to one embodiment of the present invention, with a medical device, such as a therapy lead, passing therethrough.
• a medical device such as a therapy lead
• FIG. 1 depicts, schematically, a hub assembly 10 for use in a medical procedure, such as a catheterization procedure, according to one embodiment of the present invention.
• the hub assembly 10 includes a body 12 having a lumen 16 therethrough, and a seal 50 according to one embodiment of the present invention.
• the lumen 16 is sized to permit passage of a medical device 18 such as, for example, a therapy lead, guiding catheter, or a guide wire.
• the seal 50 is retained within the hub body 12, and is adapted to maintain a substantially positive fluid seal around the medical device 18 that is passed through the lumen 16.
• the hub 10 may be coupled to another medical device 51 such as a catheter or introducer sheath.
• FIGS. 2A and 2B show proximal and distal perspective views of an assembled seal 50 according to one embodiment of the present invention.
• the seal 50 is, in one embodiment, generally cylindrical with a longitudinal axis 52 and a perimeter 53, and is composed of a first seal portion 56 and a mating second seal portion 58.
• the seal portions 56 and 58 are substantially equivalent in overall size and join at a proximal joint 64 and a distal joint 66 to form a proximal entrance area 70 and a distal exit area 76.
• the shape of the sea! 50 will be dictated by the configuration and requirements of the hemostasis valve, hub, or introducer sheath into which the seal 50 is inserted.
• the seal 50 is generally cylindrical with an outer diameter D of from about 0.250 inches to about 0.750 inches. In one embodiment, the diameter D is about 0.600 inches. In another embodiment, the diameter D is about 0.450 inches.
• the seal 50 may be made of polyisoprene.
• seal 50 other resilient materials may be used to form the seal 50, including, without limitation, silicone, latex, neoprene, and other rubber- based compounds as will be understood by those of ordinary skill in the art.
• the proximal entrance area 70 is generally conical and has an apex 78 near the longitudinal axis 52
• the distal exit area 76 is concave and may include a generally circular planar portion 82 disposed about and generally perpendicular to the longitudinal axis 52.
• the planar portion 82 has a diameter d of from about 0.030 inches to about 0.100 inches.
• the planar portion 82 has a diameter d of about 0.070 inches.
• the planar portion 82 has a diameter d of about 0.050 inches.
• the planar portion 82 may have a non-circular shape (e.g., rectangular, elliptical)
• FIG. 3 shows perspective views of the first and second seal portions 56 and 58, respectively. Additionally, FIGS. 4 and 5 are proximal (FIG. 4) and distal (FIG. 5) plan views of the seal portions 56 and 58.
• the first seal portion 56 includes a first proximal sealing member 114 having a first mating surface 118, a first projection 132, a first distal wall 134 defining a first recess 136, and a first planar subportion 140.
• the second seal portion 58 includes a second proximal sealing member 146 having a second mating surface 150, a second projection 162, a second distal wall 164 defining a second recess 166, and a second planar subportion 170.
• the recesses 136 and 166 are sized and shaped to receive the projections 132 and 162. In one embodiment, when the seal 50 is assembled, substantially all of the adjacent surfaces of the projections 132 and 162 and the recesses 166 and 136 are in sealing contact with one another.
• the first proximal sealing member 114 intersects the first projection 132
• the second proximal sealing member 146 intersects the second projection 162, at approximately 90 degree angles and at approximately the longitudinal axis 52.
• the proximal sealing members 114 and 146 overlap the distal joint 66 (see FIG. 2B), and the projections 132 and 162 overlap the proximal joint 64, at substantially all points other than the longitudinal axis 52.
• FIG. 6 is a partial cross-sectional view of the first seal portion
• the features of the second seal portion 58 are generally configured to have the same size and shape as the corresponding features of the first seal portion 56.
• the second proximal sealing member 146, the second projection 162, the second recess 166, and the second planar subportion 170 have generally the same dimensions and shape as the first proximal sealing member 114, the first projection 132, the first recess 136, and the first planar subportion 140, respectively.
• the proximal sealing members 114 and 146 are tapered radially inward, having a thickness t1 near the seal perimeter 53 and a thickness t2 near the apex 78.
• the thickness t1 may range from about 0.075 inches to about 0.175 inches
• the thickness X2 may range from about 0.005 inches to about 0.025 inches.
• the thickness t1 is about 0.125 inches and the thickness t2 is about 0.0075 inches.
• seal 50 of the present invention may be adapted to accommodate larger or smaller diameter medical devices as may be required for a particular procedure.

Landscapes

• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Materials For Medical Uses (AREA)
• Laser Surgery Devices (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Priority Applications (4)

Applications Claiming Priority (2)

Publications (2)

Family

ID=38004787

Family Applications (1)

Country Status (7)

Cited By (1)

Families Citing this family (32)

Family Cites Families (46)

• 2005
  • 2005-10-24 US US11/257,201 patent/US7731694B2/en not_active Expired - Fee Related
• 2006
  • 2006-10-23 AT AT06848407T patent/ATE499140T1/de not_active IP Right Cessation
  • 2006-10-23 DE DE602006020321T patent/DE602006020321D1/de active Active
  • 2006-10-23 WO PCT/US2006/060159 patent/WO2007067826A2/en not_active Ceased
  • 2006-10-23 EP EP06848407A patent/EP1951359B1/en not_active Not-in-force
  • 2006-10-23 ES ES06848407T patent/ES2359942T3/es active Active
  • 2006-10-23 JP JP2008536658A patent/JP5001290B2/ja not_active Expired - Fee Related
• 2010
  • 2010-05-17 US US12/781,433 patent/US8048033B2/en not_active Expired - Fee Related

Also Published As

Similar Documents

Legal Events