EP2830696A1 - Gaine d'introducteur ayant une tige à paroi mince - Google Patents

Gaine d'introducteur ayant une tige à paroi mince

Info

Publication number
EP2830696A1
EP2830696A1 EP13769139.0A EP13769139A EP2830696A1 EP 2830696 A1 EP2830696 A1 EP 2830696A1 EP 13769139 A EP13769139 A EP 13769139A EP 2830696 A1 EP2830696 A1 EP 2830696A1
Authority
EP
European Patent Office
Prior art keywords
introducer sheath
wire
shaft
annealed
coating
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.)
Withdrawn
Application number
EP13769139.0A
Other languages
German (de)
English (en)
Other versions
EP2830696A4 (fr
Inventor
Robert E. Fischell
Tim A. Fischell
David R. Fischell
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.)
FISCHELL INNOVATIONS LLC
Original Assignee
FISCHELL INNOVATIONS LLC
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
Priority claimed from US13/431,526 external-priority patent/US8591495B2/en
Application filed by FISCHELL INNOVATIONS LLC filed Critical FISCHELL INNOVATIONS LLC
Publication of EP2830696A1 publication Critical patent/EP2830696A1/fr
Publication of EP2830696A4 publication Critical patent/EP2830696A4/fr
Withdrawn legal-status Critical Current

Links

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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/02—Inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • 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
    • A61M2039/0653—Perforated disc

Definitions

  • This invention is in the field of devices to assist in the placement of catheters through the skin to treat certain coronary and peripheral vascular disorders.
  • FIG. 1 is a top view of an introducer sheath having a pressure sensitive adhesive pad located at the distal end of the strain relief that is attached to the proximal end of the introducer sheath shaft.
  • FIG. 2 is an end view of the sheath at Section 2-2 of FIG. 1 .
  • FIG. 3 is a top view of an alternative embodiment of the present invention wherein the adhesive pad is attached to the bottom surface of the hemostasis valve.
  • FIG. 4A is a cross section at "A-A" of FIG. 3 showing the construction of the adhesive pad and the hemostasis valve.
  • FIG. 4B is a cross section at "B-B" of FIG. 3 showing the construction of the adhesive pad and the hemostasis valve.
  • FIG. 5 is a cross section of the wrist at the site of the hemostasis valve with an adhesive wrap connected to the bottom surface of the hemostasis valve, the adhesive wrap being placed around a patient's wrist.
  • FIG. 6 is a cross section of the wrist at the site of the hemostasis valve with an adhesive wrap connected to the top surface of the hemostasis valve, the adhesive wrap being placed around a patient's wrist.
  • FIG. 7 is a cross section of a distal portion of a thin-walled shaft of an introducer sheath utilizing two helices of different metal alloys each helix having a specific characteristic that is advantageous for the design and functioning of the sheath.
  • FIG. 8 is a drawing of still another embodiment of the present invention sheath having a corkscrew-like, self-taping wire for affixing the proximal end of the sheath at the insertion site.
  • FIG. 9 is a longitudinal cross-section of portions of another embodiment of a thin-walled introducer sheath.
  • Still another problem experienced by physicians who insert vascular sheaths is the complication of accidental sheath withdrawal from the vascular entry site during the procedure, particularly when a catheter is withdrawn from the sheath.
  • This complication can be minimized by adhesively attaching the proximal end of the sheath to the skin with an adhesive as described herein. Also, making the proximal portion of the shaft of the sheath (portion in the subcutaneous tissue) less lubricious. And by decreasing the frictional force exerted on the sheath's hemostasis valve during catheter removal decrease the propensity for the sheath to be inadvertently pulled out of the blood vessel.
  • One feature of some embodiments of the present disclosure is a novel attachment means located near the proximal end of the sheath. This attachment means is designed to facilitate rapid attachment and detachment of the proximal end of the sheath to the patient's skin.
  • One embodiment of the present disclosure is an introducer sheath that is improved by having an adhesive pad located at or near the sheath's proximal end that detachably attaches the introducer sheath to the patient's skin without requiring any additional parts that come from a separate sterile package such as a needle and a suture.
  • one embodiment of the present disclosure is an adhesive pad located at the distal end of the strain relief section of the shaft of the introducer sheath in close proximity to the hemostasis valve that is located at the proximal end of the introducer sheath.
  • the adhesive pad has a pressure sensitive adhesive on one side that is covered by a removable plastic cover sheet which is removed to expose the pressure sensitive adhesive surface of the adhesive pad in order to attach the introducer sheath to the skin. Either before or after the shaft of the introducer sheath is placed through the skin, the thin plastic (or paper) cover sheet that covers the pressure sensitive adhesive is removed.
  • the pressure sensitive adhesive pad is then pushed firmly against the skin thereby firmly attaching the sheath to the patient's skin without requiring a sutured connection.
  • One aspect of some embodiments of the present disclosure is an adhesive pad that can be placed at a location that is in close proximity to the hemostasis valve located at the proximal end of the introducer sheath.
  • the adhesive pad is retained at the distal end of the strain relief where it is joined to the proximal end of the shaft of the introducer sheath. If there is no strain relief, then the adhesive pad can be attached to the distal end of the hemostasis valve which is pushed against the skin when the introducer sheath is fully inserted into the patient's vascular system.
  • an adhesive pad is attached to the bottom surface of the hemostasis valve.
  • the adhesive pad is joined to the bottom surface of the hemostasis valve through a spongy material that allows the pressure sensitive adhesive to more readily cover any skin surface even if it is somewhat irregular.
  • Still another embodiment utilizes a pressure sensitive adhesive pad that is attached to the hemostasis valve and also wrapped around the patient's wrist. This design would be particularly applicable for the placement of the introducer sheath into the radial artery in the arm.
  • Another embodiment of the present disclosure is a diaphragm for the hemostasis valve that has a lubricity coating so as to minimize the frictional force that occurs when a catheter is either advanced or pulled back through the diaphragm of the hemostasis valve. This feature allows a catheter to be inserted into or removed from the patient's blood vessel with less resistance thus reducing the tendency to pull the introducer sheath out of that blood vessel during catheter removal.
  • This lack of lubricity coating along a proximal portion of the shaft of the sheath will tend to create some resistance to accidental sheath removal from its vascular entry site during catheter removal from the sheath.
  • suture is now the only means that is used to make the attachment of the proximal end of an introducer sheath to the skin.
  • the present disclosure eliminates the extra time required to open a separate package containing the needle and suture material, and the time required to place the suture through the introducer sheath and into the skin.
  • the present disclosure eliminates the penetration of the skin that can be somewhat uncomfortable for the patient and increases the possibility of infection. Still further, the cost of the needle and suture in a sterile pack is avoided. It is believed that suturing for retention of the sheath will require about 2 minutes of time for the operator.
  • Another aspect of the present disclosure is the construction of the tubular shaft of the introducer sheath.
  • the shaft of the sheath would employ a thin-walled, flat wire helical coil to be fabricated from a shape memory alloy such as Nitinol to prevent the possibility of kinking of the tubular shaft of the introducer sheath.
  • a cobalt chromium alloy e.g.; L605
  • This novel design would be very advantageous for providing a thin-walled shaft for the sheath that is also radiopaque and reasonably economical to build. It is also envisioned that just using cobalt chromium alloy flat wires wound two at a time onto an inner Teflon layer and then coated in plastic could be an excellent design.
  • Still another embodiment of the presently disclosed sheath includes an attachment component with a helical round wire having a sharpened distal end.
  • the helical wire which is in the form of a corkscrew, would have a handle that can be used to rotate the helical wire so that it can attach the proximal end of the sheath to the skin. This would provide an alternate means to attach and detach the sheath from the skin without the need for a separate suture.
  • one object of the present disclosure is to provide a means to secure the proximal end of an introducer sheath to a patient's skin without the use of a suture, this means being integrated into the proximal region of the introducer sheath.
  • Another object of the present disclosure is to secure the proximal end of an introducer sheath to a patient's skin by means of a pressure sensitive adhesive pad without the use of a suture.
  • Still another object of this disclosure is to secure the proximal end of an introducer sheath to the skin without using a needle and suture so as to eliminate the discomfort that may be felt by the patient when a needle is used to penetrate his or her skin.
  • Still another object of this disclosure is to attach the proximal end of an introducer sheath to the patient's skin using a pressure sensitive adhesive pad attached to the hemostasis valve thereby eliminating the possibility of an infection where suture material penetrates the patient's skin.
  • Still another object of this disclosure is to place a lubricious coating on most of the outer surface of the shaft of the introducer sheath that passes through the patient's skin except for a comparatively short region that is in close proximity to the hemostasis valve at the proximal end of the introducer sheath.
  • Still another object of this disclosure is to have a shaft for the introducer sheath that has an outside diameter that is at least one French size smaller than commercially available introducer sheaths having the same inside diameter, so as to minimize bleeding complications at the vascular entry site.
  • Still another object of this disclosure is to have a shaft for the introducer sheath that uses at least two separate, thin-walled, flat wire, helical structures made from at least two different metals, this thin-walled structure having plastic materials on its inside and outside surfaces.
  • Still another object of this disclosure is to have a shaft for the introducer sheath that uses a thin-walled, flat wire, helical structure made from a shape memory alloy such as Nitinol so as to prevent kinking of the thin-walled sheath when it is inserted in the patient's vascular system, the thin-walled structure having plastic materials on its inside and outside surfaces.
  • a shape memory alloy such as Nitinol
  • Still another object of this disclosure is to have a method for reducing the need for a blood transfusion after an interventional procedure using an introducer sheath by reducing the outside diameter of the tubular shaft that passes through the patient's skin to access the patient's vascular system.
  • Still another object of this disclosure is to decrease the frictional force that is required as a guiding catheter is either advanced forward or pulled out of the introducer sheath by the use of a lubricity agent placed onto the diaphragm of the hemostasis valve.
  • Yet another object of the present disclosure is to have a helical wire with a handle that is attached to the proximal end of the sheath where the wire is advanced like a corkscrew to attach and detach the proximal end of the sheath to the patient's skin to reduce the time otherwise needed to get and attach a separate suture.
  • catheters, sheaths, dilators, guidewires, and other treatment devices are often used in connection with minimally invasive treatments and therapies, such as minimally invasive therapies within the human vasculature.
  • minimally invasive treatments and therapies such as minimally invasive therapies within the human vasculature.
  • the disclosure below refers specifically to the placement and use of such devices to access and treat disorders within the vasculature. Notwithstanding any specific examples and references, the current disclosure is applicable to any treatment involving placement of elongated devices within body lumens.
  • a physician inserts an introducer sheath through the skin of a patient to access the patient's vascular system.
  • a physician may place an introducer sheath through the skin to access the femoral artery at the groin or the radial artery at the wrist.
  • such sheaths are configured with small diameters to reduce the risk of bleeding and other complications once the sheath is removed following therapy. Because the inside diameter of a sheath is dictated, in some procedures, by the size of the instruments to be passed through that sheath, in some instances the outside diameter of a sheath can be decreased by minimizing the wall thickness of the sheath.
  • Thin-walled sheaths may be prone to kinking and other deformation that prevents or hinders use of the sheath in therapy.
  • a metal scaffolding structure for example, a helical wire structure, can be integrated within the wall of the sheath to prevent kinking of the sheath.
  • scaffolding reinforced sheathes include heat- treated scaffolding structures to further minimize wall thickness and reduce kinking.
  • the scaffolding structure provides resistance to kinking, while heat treating the scaffolding structure reduces the tendency of the structure to deform, thus requiring a minimal amount of plastic in the wall to retain the scaffolding.
  • the tip of the sheath is also formed with the plastic components of the sheath wall.
  • phrases “connected to,” “coupled to,” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction.
  • Two components may be coupled to each other even though they are not in direct contact with each other.
  • two components may be coupled to each other through an intermediate component.
  • proximal and distal refer to opposite ends of a medical device.
  • the proximal end of a medical device is the end nearest to a practitioner while the practitioner is using or manipulating the device, while the distal end is the opposite end.
  • the proximal end of a catheter or sheath used in minimally invasive vascular treatment is the end accessible to a practitioner during use, while the distal end is disposed within a patient's vascular system when the sheath is placed into such a patient.
  • the "axial direction" of an elongate component refers to a direction along the center axis of the elongated component.
  • FIG. 1 is a top view of a first embodiment of the present invention which is an introducer sheath 10 that has a tubular shaft 1 1 and a hemostasis valve fitting 12 located at the proximal end of the introducer sheath 10.
  • a hydrophilic lubricious coating could be applied to the either or both the interior and exterior surfaces of the shaft 1 1 . However, it is conceived to not extend the lubricious surface to where it passes through the patient's skin.
  • the darkened region 1 1A in FIG. 1 could be the only surface of the shaft 1 1 that is not covered with a lubricious coating. For example, the lubricious exterior coating might extend only to within approximately 1 .0 to 2 cm.
  • the length of the region without a lubricious coating would be less than 5.0 cm. In that way, there is some increase in the tendency of the shaft 1 1 to be retained in the position where it is placed through the skin.
  • a side arm 14 of the introducer sheath 10 would have a cylindrical tube 15 which has a two-way stop cock 16 located at the proximal end of the tube 15.
  • the valve handle 19 of the stop cock 16 can be used to select between either one of the two Luer fittings 17 or it can close off the distal end of the side arm 14.
  • the side arm 14 is used to flush out the introducer sheath 10 before its placement into a blood vessel of a human subject and to inject medications after an interventional procedure is completed.
  • the stop cock 16 can be closed so as to disallow any leakage of blood through the side arm 14 after the introducer sheath 10 is placed into the patient's vascular system.
  • an adhesive pad 20 is placed around the shaft 1 1 at the distal end of the strain relief 18.
  • the adhesive pad 20 has a main body 24 onto which is attached a pressure sensitive adhesive 25 (as seen in FIG. 1 ) that is covered by a removable plastic cover sheet 26 having removal tabs 23A and 23B (as seen in FIG. 2).
  • the plastic sheet 26 is split along the line 23C so that it can he easily removed from each side of the shaft 1 1 .
  • the pressure sensitive adhesive 25 is placed upon the surface of the main body 24 which main body is ideally a spongy material that is covered by a thin plastic cover sheet 21 that is fixedly attached to the spongy material of the main body 24.
  • the tab 22 of the plastic covering 21 is used to remove the adhesive pad 20 from the patient's skin at the conclusion of the medical procedure. By the omission of an adhesive on the tab 22, it is easier for the operator to remove the adhesive pad 20 from the patient's skin at the completion of the procedure when the introducer sheath 10 is to be removed from the patient's body.
  • the cover sheet 26 is shown having two pieces in FIG. 1 it could be formed as one piece or 3 or more pieces. It could also be made of regular paper, waxed paper or paper with a plastic coating.
  • the adhesive pad 20 can be angled with respect to the longitudinal direction defined by the tube 1 1 so that the adhesive pad 20 can be more easily attached to the skin even if the tube 1 1 is inserted through the skin at an angle other than 90 degrees.
  • FIGS. 1 and 2 Another advantage of the design of FIGS. 1 and 2 is that the adhesive will cover the hole in the skin where the shaft 1 1 of the sheath 10 penetrates the skin. This covering will tend to prevent any bleeding that might otherwise occur at the place where the shaft 1 1 is placed through the patient's skin.
  • FIG. 1 also shows a suture tab 13 placed onto the side of the hemostasis valve 12.
  • the present invention conceives of having this suture tab 13 located at the proximal end of the introducer sheath to be used if for any reason that the adhesive pad 20 fails to adequately adhere to the patient's skin.
  • the present invention conceives of the combination of an adhesive pad 20 with a backup of a suture tab 13 in some instances.
  • FIGS. 1 and 2 show the adhesive pad 20 at a location in close proximity to the hemostasis valve 12 and wrapped around the shaft 1 1 , it is also conceived that the adhesive pad be could be placed at other locations at or near the proximal end of the introducer sheath 10.
  • the present invention envisions an adhesive pad placed around the shaft 1 1 and fixedly attached to the distal surface of the hemostasis valve fitting 12 without any strain relief being used, in some embodiments.
  • FIGS. 3, 4A, 4B, 5 and 6 illustrate alternative embodiments of the present invention each of which has an adhesive pad that is located at the proximal end of the introducer sheath with the adhesive pad attached to the hemostasis valve. It is also conceived that the adhesive layer 25 could be impregnated and elute an antibiotic medication to reduce the probability of infection at the insertion site.
  • FIG. 3 is a top view of an alternative embodiment of the present invention which is an introducer sheath 30 having an adhesive pad 40 attached to the bottom surface of the hemostasis valve 32.
  • FIG. 3 shows a suture tab 33 that can be used with a suture as an alternative means for the operator to attach the proximal end of the introducer sheath 30 to the patient's skin.
  • FIG. 3 also shows that the introducer sheath shaft 31 and side arm 35 are each placed into the hemostasis valve 32 that has a front entrance port 37 (as seen in FIGS. 4A and 4B).
  • a diaphragm 36 As seen in FIG. 4B, within the hemostasis valve 32 is a diaphragm 36 through which a guiding catheter or similar catheter can be placed.
  • the purpose of the diaphragm 36 is to prevent the back backward flow of blood whether or not any catheter is placed through the diaphragm 36.
  • a diaphragm 36 could be treated with a lubricious, typically hydrophilic, coating such as those used on the outer surface of some introducer sheaths.
  • the adhesive pad 40 includes a spongy pad 41 , a tab 42 to remove the adhesive pad 40 from the patient's skin after the procedure is completed and a tab 43 that is used to pull a plastic cover sheet 46 off of the pressure sensitive adhesive 45.
  • the use of a comparatively thick and spongy adhesive pad 41 allows the hemostasis valve 32 to be more effectively joined by the pressure sensitive adhesive 45 to a surface of the skin that could be somewhat irregular.
  • the plastic sheet 46 that covers the pressure sensitive adhesive 45 is removed just before the adhesive pad 40 is attached to the patient's skin. It is also conceived that the spongy pad 41 could be impregnated and elute an antibiotic medication to reduce the probability of infection.
  • FIG. 5 is a cross section of an introducer sheath 50 showing a hemostasis valve 52 that has an adhesive pad 51 attached to its bottom surface.
  • the adhesive pad 51 could be partially or completely wrapped around the patient's wrist to secure the introducer sheath 50 to the patient's wrist.
  • FIG. 6 is a cross section of an introducer sheath 60 showing a hemostasis valve 62 that has an adhesive pad 61 attached to its top surface.
  • the adhesive pad 61 could be partially or completely wrapped around the patient's wrist to secure the introducer sheath 60 to the patient's wrist.
  • FIG. 7 is another feature of an embodiment of the present invention showing a sheath shaft 70 of a novel, thin-walled design which has a distal opening 71 and a tapered distal end 72.
  • the shaft 70 should be as thin-walled as can be achieved.
  • the shaft 70 could be fabricated from two or more thin-walled, flat-wire, metal helical coils 73 and 74 with plastic material on either or both of its interior and exterior surfaces.
  • the inner plastic layer 76 might typically be made from PTFE or any similar Teflon-like, slippery material.
  • the outer plastic layer 75 could typically be Pebax or any similar polymer.
  • the helical metal coils 73 and 74 would be fabricated from flat wires that would optimally be approximately 1 to 3 mils in thickness and about 10 to 30 mils in width. The space between coils would be between 1 and 30 mils with the optimal spacing being between one tenth and nine tenths of the wire's width.
  • the metal for each of the coils 73 and 74 could be stainless steel, a shape memory alloy or a cobalt chromium alloy (such as L605) or any equivalent metal alloy.
  • a key feature of the shaft 70 is that the flat wires 73 and 74 would be made from different metal alloys. Although FIG. 7 shows two helices of flat wire 73 and 74, it should be understood that as many as four separate flat wires could be used for the shaft 70.
  • At least one of the flat wires would be stainless steel because that is an inexpensive metal alloy. If radiopacity is desired for the shaft, then at least one of the two to four wires would be made from a very dense metal alloy such as the cobalt-chromium alloy L605. If a shape memory alloy is desired to increase resistance against kinking of the sheath, then the metal alloy Nitinol could be used for at least one of the flat wires for the shaft 70. The Nitinol would be treated to maintain its helical shape at a temperature that is below body temperature and preferably below room temperature. The advantage of Nitinol is that in its superelastic state above the transition temperature, such a shaft 70 would be non-kinking even though it would have a very thin wall.
  • An optimum design to achieve radiopacity with minimum cost would be to have one helical coil fabricated from a cobalt-chromium alloy flat wire and one to three additional coils would be made from stainless steel to minimize the coat of the shaft material.
  • An optimum design to avoid kinking of the shaft would use one helix of Nitinol and a second helix of stainless steel to minimize cost of the shaft material.
  • the outside diameter of such a shaft 70 would be very much smaller than the outside diameter of any existing introducer sheath having the same inside diameter.
  • An optimum thickness for the shaft 70 would be less than 7 mils and still better, it would be approximately 5 mils in thickness.
  • a very small diameter wire with a circular cross section could he used instead of the flat wire to form the helical structure to support the tubular shaft or the introducer sheath.
  • the flat wire could be formed as a braid which is two flat wire helical coils that are interlaced.
  • the present invention conceives that this thin-walled wire structure with such an extremely small wall thickness constitutes a significant improvement over the prior art.
  • What the present invention claims, in some embodiments, is a new concept of thin-walled introducer sheaths whose outside diameter is at least 1 .0 French size smaller than any other introducer sheath of comparable inside diameter and optimally a full 1 .5 French size smaller outside diameter.
  • Such a reduction in the outside diameter of the introducer sheath's shaft 70 can significantly reduce bleeding at the patient's groin which bleeding can require that the patient requires a blood transfusion.
  • the present invention claims a method for decreasing the percentage of patients who require a blood transfusion after an introducer sheath has been used to access the patient's vascular system, in some embodiments.
  • This method includes forming of a thin-walled, flat-wire, helical coil within the sheath with the helical coils made from two different metal alloys onto which a plastic material is placed onto each side of these helical coils.
  • the method also includes the step of forming the wall thickness of a tubular shaft 70 to be less than 7 mils and as small as 5 mils.
  • the final aspect of this method is to use such a thin-walled tubular shaft as part of an introducer sheath that is used to access a patient's vascular system.
  • FIG. 8 is a sketch of still another embodiment of the present invention sheath 80 having a corkscrew-like, self-taping wire 82 with handle 86 and connector 84 for affixing the proximal end of the sheath 80 to the skin near the insertion site.
  • the sheath 80 also includes hemostasis valve 89, shaft 81 , side arm 87 with valve 88 and Luer attachment port 86.
  • the handle 86 and corkscrew 82 could be rotated by 90 degrees from the position shown in FIG. 80 in order to more readily attach the corkscrew 82 to the patient's skin. It is also envisioned that to save time, instead of a corkscrew wire 82 and handle 86, the integrated attachment means could be a needle and suture cord that could be attached to the hemostasis valve so as to not require a separate suture
  • FIG. 9 is a longitudinal cross-section of portions of one embodiment of a thin-walled introducer sheath.
  • the sheath includes an elongated, hollow shaft 90 with a distal opening 91 located at the distal end of the shaft 90.
  • the shaft further includes an inner coating 96, an outer coating 95, and one or more scaffolding coils 93, 94 are disposed between the inner 96 and outer 95 coatings.
  • the scaffolding coils 93, 94 may only be coated on the inside or on the outside diameter of the coils.
  • the inner coating 96, the outer coating 95, and the scaffolding coils 93, 94 may be configured such that the total wall thickness of the shaft 90 is minimized.
  • the scaffolding coils 93 are configured to provide strength, provide enhanced radiopacity, and to resist kinking and other deformation.
  • the outer coating 95 is further configured to seal the structure and to confine the coils 93, 94 to prevent them from unwinding or losing their shapes.
  • the inner coating 96 is formed of a polymer such as polytetrafluoroethylene (PTFE), for example.
  • PTFE polytetrafluoroethylene
  • other plastics including plastics with relatively low coefficients of friction, may also be used.
  • the inner coating 96 is configured as a low friction coating, facilitating the passage of elongated instruments through the shaft 90.
  • one or more helical coils 93, 94 are coupled to the inner coating 96.
  • a sheath may include only a single helical coil or include multiple helical coils, such as, for example, two, three, or four total helical coils.
  • each helical coil is composed of a single helically wound coil of wire.
  • any shape, configuration, or type of scaffolding structure is within the scope of this disclosure.
  • the helical coils 93, 94 are referred to above as “wire” structures, it is within the scope of this disclosure to form these scaffolding structures from any material, including metals, polymers, and fibers, including organic and inorganic fibers.
  • the "wires" or strands of material within the scope of this disclosure may be flat, or may have a cross-sectional profile which is substantially circular, elliptical, rectangular, square, or multisided.
  • the helical coils 93, 94 are metal wires wound in helical shapes about the inner coating 96.
  • the distance between adjacent coils on each helix is from about 0.001 inch to about 0.100 inch, in some embodiments.
  • Certain embodiments within the scope of this disclosure include more than one helically wound wire; in some such instances the helices intersect, while in others they are substantially parallel.
  • two helical wires could be interlaced, or wound in opposite directions, forming a braided wire structure around the diameter of an introducer sheath.
  • the coils 93, 94 are formed of flat wires wound in helical shapes which do not intersect.
  • the wires are from about 0.001 inch to about 0.005 inch thick, including from about 0.001 inch to about 0.004 inch thick or from about 0.001 inch to about 0.003 inch thick.
  • the coils 93, 94 are from about 0.005 inch to about 0.030 inch in width.
  • the shaft 90 includes two helical coils 93, 94 which are substantially evenly spaced along the length of the helices.
  • the distance between the two helically wound wires 93, 94 is from about one 0.0005 inch to about 0.060 inch.
  • the distance between helices is proportional to the width of the wires, including embodiments where the distance is from about one-tenth to about twice the width of the wires.
  • the flat wire helices 93, 94 are formed of metal wires, including embodiments where the wires 93, 94 are stainless steel, a shape memory alloy such as Nitinol, and/or a highly radiopaque metal alloy such as a cobalt chromium alloy such as the alloy L605.
  • FIG. 9 includes a first helical coil 93 which, in some embodiments, is formed of a relatively inexpensive material such as stainless steel and a second helical coil 94 which, in some embodiments, is formed from a radiopaque material such as a cobalt chromium alloy.
  • a shaft 90 includes four total coils, three formed of stainless steel and one formed of a cobalt chromium alloy. Such a combination of materials may be utilized to create an introducer sheath shaft with desired properties of stiffness, resiliency, and radiopacity while also minimizing the material cost of the introducer sheath.
  • one or more coils are formed of a shape memory alloy such as Nitinol.
  • a shape memory alloy is configured to increase resistance to kinking in some embodiments.
  • the Nitinol is treated to maintain its shape, for example, a helical shape, at temperatures below body temperature and/or below room temperature.
  • Nitinol or other shape memory alloys may be used to reduce the incidence of kinking, due at least in part to the superelastic state of shape memory alloys above their transition temperatures.
  • one or more Nitinol wires may be used in conjunction with one or more stainless steel wires to create a sheath with desired properties while minimizing cost.
  • the wire scaffolding structures 93, 94 are coated with an outer coating 95.
  • the outer coating 95 forms the outside structure of the shaft 90 of an introducer sheath.
  • the outer coating 95 is formed of a polymer, such as Pebax, for example.
  • the outer coating 95 forms the outer structure of the shaft 90 as well as functions to confine the coils 93, 94 in some embodiments.
  • the outer coating 95 may be configured to prevent scaffolding structures comprising helical coils from expanding, unwinding, or otherwise undesirably deforming.
  • metal wires may have significant residual stresses introduced when the wire was formed.
  • some metal wires are formed by drawing, or pulling the wire through a die. Drawing wires can introduce internal stresses as the material is cold worked. Cold worked wires can be hard, brittle, or tend to unravel once formed into a helical shape. Thus, in some embodiments, cold worked wires require a thicker outer coating 95 to contain the coil, once the coil is incorporated into a sheath. Accordingly, in some embodiments, the wire coils 93, 94 are heat treated to a substantially soft condition so as to reduce hardness and residual stresses that result from cold working the material.
  • metal wires are annealed before being shaped into helical coils having the desired coil spacing and diameter.
  • Use of annealed coils decreases the required thickness of the outer coating 95 in some embodiments, because annealing can decrease forces which would tend to unwind the coil or force the coil outward so as to deform the outer coating 95.
  • annealing refers to any heat treating process (including processes comprising heating and cooling the material) configured to remove internal stresses and/or make the material less brittle.
  • the term does not require the metal to be treated at any specific temperature or for any specific amount of time.
  • metal is annealed within the meaning of this definition if the heat treatment is configured to remove any amount of cold-work-related residual stresses or hardness; it is not required that the annealing process remove all such stresses or hardness.
  • use of annealed coils 93, 94 is used to reduce the overall diameter of an introducer sheath shaft 90, because the required thickness of the outer coating 95 may be minimized.
  • the wall thickness of the shaft 90 are less than 0.010 inch thick, including embodiments where the wall thickness is less than 0.005 inch.
  • annealed coils in connection with the other disclosure provided herein, enables the production of a thin-walled introducer sheath 90 with an outside diameter from about 1 .0 or 1 .5 French size smaller than an introducer sheath of comparable inside diameter formed by other methods.
  • an introducer sheath is formed by first obtaining wire material to be formed into coils. The wire is then annealed to remove residual stresses introduced when the wire was formed. The annealed wire is then formed into the desired shape, for example helical coils 93, 94. In some instances the wire is so formed by wrapping the wire only onto the inner coating 96. For example, a single, flat wire may be wound in a single layer onto an inner coating 96 formed of a lubricous polymer. Additionally, in some embodiments, one or more additional wires are subsequently wound onto the inner coating 96. Continuing with the prior example, once the first flat wire is wound onto the inner coating 96, a second flat wire could be wound onto the inner coating 96.
  • wires of at least two different metal alloys could be wound onto the inner coating 96 at the same time.
  • as many as four separate flat wires are disposed in substantially parallel helices.
  • as many as four flat wires are disposed within the same layer of the sheath, and the as many as four wires do not cross or overlap each other.
  • the helices of two to four wires may be opposed such that the wires form a crossing pattern or weave.
  • a fifth, a sixth, or more wires can be added to this exemplary embodiment, including embodiments where none of the wires overlap.
  • the wires are annealed in a furnace or oven before the wires are formed into coils 93, 94 on the inner coating 96.
  • the entire length of wire is annealed.
  • the wires are annealed within a furnace while the wire is surrounded by an inert gas, such as nitrogen.
  • each type of wire is annealed under different conditions, such as at different temperatures and different times for heat treating and cooling.
  • flat wire stainless steel can be annealed by heating the wire to a temperature of about 1 ,200 degrees Fahrenheit for at least ten minutes, then slowly cooling the wire to room temperature.
  • radiopaque flat wires such as cobalt chromium
  • some radiopaque flat wires are annealed at temperatures between about 1 ,400 degrees and about 1 ,600 degrees Fahrenheit, then slowly cooled to room temperature.
  • the wires are annealed in large batches, then smaller portions of the wire are used to form individual introducer sheathes.
  • use of a furnace or oven to anneal the wires causes the entire length of the wire to be annealed.
  • the wires are annealed to a soft condition so that they do not push out against the outer coating 95 which could distort that outer coating.
  • the wires Once the wires have been formed onto the inner coating 96, they become work hardened when they are formed into a helix. This work hardening after they have initially been annealed to soften the wires 93, 94 helps to strengthen the wall of the shaft 90.
  • the introducer sheath further includes a tapered distal tip 92 that surrounds the distal opening 91 .
  • the tapered distal tip 92 can be shaped by heat forming the outer coating 95 of the introducer sheath.
  • the tapered distal tip 92 is integrally formed with the outer coating 95. The taper facilitates passage of the introducer sheath through the skin or other tissue of a patient in some instances.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne une gaine d'introducteur à paroi mince. Dans certains modes de réalisation, la gaine d'introducteur comprend des composants de support structuraux, tels que des fils, utilisés en liaison avec un revêtement interne polymère, un revêtement externe polymère, ou les deux. En outre, dans certains modes de réalisation, les composants de fil sont recuits pour réduire les contraintes et la dureté associées au travail à froid. L'utilisation de composants recuits peut permettre une réduction de l'épaisseur du revêtement externe polymère dans certaines applications.
EP13769139.0A 2012-03-27 2013-03-26 Gaine d'introducteur ayant une tige à paroi mince Withdrawn EP2830696A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/431,526 US8591495B2 (en) 2011-02-23 2012-03-27 Introducer sheath with thin-walled shaft
PCT/US2013/033840 WO2013148652A1 (fr) 2012-03-27 2013-03-26 Gaine d'introducteur ayant une tige à paroi mince

Publications (2)

Publication Number Publication Date
EP2830696A1 true EP2830696A1 (fr) 2015-02-04
EP2830696A4 EP2830696A4 (fr) 2015-10-28

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WO (1) WO2013148652A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015103187A1 (de) 2014-03-11 2015-09-17 Smartpolymer Gmbh Schwer entflammbare Cellulose-Formkörper, hergestellt nach einem Direktlöseverfahren
CN120022505B (zh) * 2025-04-23 2025-08-05 湖南省华芯医疗器械有限公司 一种导引结构、输尿管鞘及输尿管插入装置

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5380304A (en) * 1991-08-07 1995-01-10 Cook Incorporated Flexible, kink-resistant, introducer sheath and method of manufacture
US5423774A (en) * 1994-05-17 1995-06-13 Arrow International Investment Corp. Introducer sheath with irregular outer surface
US6824553B1 (en) * 1995-04-28 2004-11-30 Target Therapeutics, Inc. High performance braided catheter
US5927345A (en) * 1996-04-30 1999-07-27 Target Therapeutics, Inc. Super-elastic alloy braid structure
US6638245B2 (en) * 2001-06-26 2003-10-28 Concentric Medical, Inc. Balloon catheter
AU2003277361A1 (en) * 2002-10-10 2004-05-04 Micro Therapeutics, Inc. Wire braid-reinforced microcatheter
US8377035B2 (en) * 2003-01-17 2013-02-19 Boston Scientific Scimed, Inc. Unbalanced reinforcement members for medical device
EP1620158B1 (fr) * 2003-04-25 2008-09-03 Cook Incorporated Catheter d'administration
US7905877B1 (en) * 2006-05-12 2011-03-15 Micrus Design Technology, Inc. Double helix reinforced catheter

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EP2830696A4 (fr) 2015-10-28

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