GB2378137A - A stent comprising a framework of shape memory metal - Google Patents

A stent comprising a framework of shape memory metal Download PDF

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Publication number
GB2378137A
GB2378137A GB0118606A GB0118606A GB2378137A GB 2378137 A GB2378137 A GB 2378137A GB 0118606 A GB0118606 A GB 0118606A GB 0118606 A GB0118606 A GB 0118606A GB 2378137 A GB2378137 A GB 2378137A
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United Kingdom
Prior art keywords
prosthesis
catheter
medical
knitted
medical prosthesis
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Withdrawn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
GB0118606A
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GB0118606D0 (en
Inventor
John Reece Jenkins
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Individual
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Individual
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Filing date
Publication date
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Priority to GB0118606A priority Critical patent/GB2378137A/en
Publication of GB0118606D0 publication Critical patent/GB0118606D0/en
Publication of GB2378137A publication Critical patent/GB2378137A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • DTEXTILES; PAPER
    • D04BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04BKNITTING
    • D04B1/00Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B1/14Other fabrics or articles characterised primarily by the use of particular thread materials
    • D04B1/16Other fabrics or articles characterised primarily by the use of particular thread materials synthetic threads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • DTEXTILES; PAPER
    • D10INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10BINDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00Medical; Hygiene
    • D10B2509/06Vascular grafts; stents

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Textile Engineering (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A medical prosthesis 3 comprising a tubular framework knitted from a single strand of shape memory metal. The wire may be warp knitted or weft knitted by means of a lock stitch or tuck stitch. The shape memory metal may be nitinol and exhibit thermal shape recovery properties at body temperature. The stent may be of uniform dimension along its length, or may be frusto conical or possess a sheath cover extending along its entire length. The prosthesis may be coated in bioactive substances <I>e.g</I> antibiotics, anti-thrombogenic agents, monoclonal antibodies, steroids. A method of emplacing the stent comprising loading it within a catheter, restricting flow through a blood vessel ahead of the stent by inflating a balloon, withdrawing the catheter allowing the stent to expand and removing the deflated balloon through the expanded stent.

Description

<Desc/Clms Page number 1>
Improvements in and Relating to a Medical Prosthesis The present invention relates to improvements in and relating to a medical prosthesis. In particular, the invention relates to tubular medical prostheses of the kind known as stents. Such medical prostheses are used for a number of purposes. They may be inserted into a body passageway, such as an artery, and may be used to maintain such a passageway in an open condition. In addition, such medical prostheses may be used to reinforce, and in some cases substitute for body passageways.
Such medical prostheses are typically inserted into a human body by a catheter. When the medical prosthesis is in position, a balloon carried by the catheter is expanded within the medical prosthesis to expand the medical prosthesis to fit the walls of the body passageway.
In the manufacture of medical prostheses it is known to co-knit two strands of material together, one of which is a metal strand that defines the tubular strength of the prosthesis so formed. An example of this is described in US 4 366 504.
It is also known to produce a medical prosthesis from shape memory alloys such nitinol. One such medical prosthesis has been sold under the name CRAGGSTENT. The prosthesis was constructed from a monofilament wire of generally zig zag configuration. The abutting peaks of adjacent wire portions were secured with sutures. However, it is understood that there was an undesirable tendency for the sutures to break when the prosthesis in use within a human body.
According to a first aspect of the invention, a tubular medical prosthesis comprises a single strand of shape memory metal knitted into a tubular framework.
It is an advantage of the present invention that it provides for a robust construction of a tubular medical prosthesis from a single strand of shape memory metal that is not prone to unravelling within a human body.
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Preferably, the strand is weft knitted to form the framework. More preferably, the strand is weft knitted by means of a tuck stitch or a lock stitch.
Alternatively, the strand is warp knitted to form the framework.
Preferably, the shape memory metal exhibits thermal shape recovery properties at human body temperatures. Preferably the shape memory metal is nitinol.
Preferably the tubular metal prosthesis is provided with a sheath cover. More preferably, the sheath cover extends over the entire length of the prosthesis.
Preferably, the prosthesis is of uniform dimension along its length. Alternatively, the prosthesis may be frusto-conical in form.
Preferably, the prosthesis is coated with a bioactive substance, such as an anti-thrombogenic agent, steroids, antimicrobials, antibiotics, monoclonal antibodies, antifibrosis agents, or the like.
A method of locating a medical prosthesis according to the first aspect of the present invention comprises the steps of loading the prosthesis within a catheter; inserting both the catheter and the prosthesis into a body passageway; positioning the catheter adjacent a site at which the prosthesis is to be located; locating a catheter balloon ahead of the catheter; expanding the catheter balloon to restrict a blood flow through the body passageway; advancing the prosthesis to the site at which the prosthesis is to be located; withdrawing the catheter from the prosthesis; allowing the prosthesis to expand; deflating the catheter balloon; withdrawing the balloon through the expanded prosthesis; and removing the balloon and catheter from the body passageway.
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The invention will now be described, by way of example only, with reference to the accompanying drawings, in which :Figure 1 shows in simplified form an enlarged side view of a plain loop weft knitted fabric; Figures 2 to 5 illustrate steps in a process for locating a medical prosthesis in accordance with the present invention; Figure 6 shows an enlarged view of a three wale loop tuck stitch; Figure 7 shows an enlarged view of a three course tuck stitch Figure 8 shows an enlarged view of a plain tuck stitch 1/1; Figure 9 shows an enlarged view of a plain tuck stitch 1/1 showing a repeat pattern; Figures 10 to 12 show a tubular framework, an outer sleeve and part-sectional view of a medical prosthesis in accordance with the present invention; Figures 13a and 13b show an enlarged perspective view of a medical prosthesis in accordance with the present invention of frusto-conical form and provided with a sleeve; and Figures 14,15 and 16 shows a bifurcated construction of a medical prosthesis in accordance with the present invention and how this may be used with a further medical prosthesis in accordance with the present invention to construct a larger medical prosthesis within a human body.
Referring first to Figure 1, there may be seen an enlarged side view of a plain loop weft knitted fabric. Such a fabric can be formed from a single strand of fibre 2. All of the component knitted loops are of the same sort and meshed in the same manner. Further details of the stiches referred to in this document may be found in various textile reference books, including"Knitting"by Harry Wignall published by Pitman & Sons in 1964. Such fabrics can readily be knitted in tubular form by known tubular knitting machines. By providing a tubular knitting machine with a thread of shape memory metal, such as nitinol, a tubular product is formed which may be used as a medical prosthesis in accordance with the present invention.
It is preferred that the medical prosthesis be knitted as a weft knitted fabric since such fabrics have as an advantage a resistance to laddering in that such fabrics do not unravel upon a loop
<Desc/Clms Page number 4>
of the fabric becoming broken. It will be appreciated that such resistance to unravelling when in situ within the human body is a highly desirable characteristic.
Referring now to Figures 2 to 5, there may be seen a number of steps in a process for locating a medical prosthesis 3 comprising a knitted skeleton or framework 4 of a shape memory metal in accordance with the present invention in an artery to provide support for the artery in the region of an aneurysm 6.
The medical prosthesis 3 is located in a catheter 8 which is introduced in a manner known in the art into a body passageway such as an artery 14 of a patient to be treated. The medical prosthesis 3 is located towards a leading edge of the catheter 8 by means of a retainer 10. A probe and associated balloon 12 are located ahead of the knitted framework 4 with the probe extending from the balloon back through the catheter 8.
Once in the position shown in Figure 2, in which the knitted framework 4 is located in the region of the aneurysm 6, the balloon 12 is expanded at a location slightly forward of the aneurysm 6. The balloon 12 expands to the healthy issue of the body passageway 14 to restrict or halt a flow of blood through the body passageway.
Once the balloon 12 has been expanded to the extent required, the catheter 8 is drawn back over the retainer 10 (Figure 3). This has the effect of removing the catheter 8 from around the knitted framework 4 of the medical prosthesis 3. At this stage, the knitted framework 4 becomes exposed to the blood of the patient. This has the effect of warming the shape memory metal of the knitted framework 4 causing the knitted framework 4 to adopted an expanded configuration.
Once the catheter 8 has been fully retracted allowing the knitted framework 4 to be fully exposed and expanded (Figure 4), the balloon 12 may be deflated thereby allowing full blood flow to resume (represented by the arrows in Figure 5). A constant flow of blood will allow the knitted framework 4 of the medical prosthesis 3 to maintain the expanded configuration within the body passageway. As may be seen from Figures 4 and 5, the knitted framework
<Desc/Clms Page number 5>
4 is of sufficient length that in the expanded configuration the knitted framework 4 presses against the healthy tissue to each side of the aneurysm thereby locating and maintaining the medical prosthesis 3 in position.
Once the balloon has been deflated and the knitted framework 4 allowed to adopt the expanded configuration, the balloon 12 and probe may be withdrawn through the knitted framework 4 and removed from the body of the patient together with the retainer 10 and the catheter 8.
The medical prosthesis 3 may also be knitted by other weft knitting stiches, such as those illustrated in Figures 7 to 10. Alternatively, the medical prosthesis 3 may also be knitted by single strand warp knitting techniques. In each case, the single strand may comprise one or more filaments of shape memory metal.
The strand of shape memory metal may be provided with a coating of a bioactive substance, such as an anti-thrombogenic agent, steroids, antimicrobials, antibiotics, monoclonal antibodies, antifibrosis agents, or the like. The bioactive substance may in this way provide for slow release drug delivery system.
The medical prosthesis 3 may be provided at the ends therof with a radio opaque marker.
Such a marker conveniently takes the form of a platinum marker provided on the knitted framework 4.
In an alternate embodiment, the medical prosthesis 3 is provided with a sheath cover or sleeve 16. The sleeve 16 is formed from any suitable material. The sleeve 16 will need to be biocompatable and able to expand with the knitted framework of the medical prosthesis 3.
The sleeve 16 may conveniently be formed as a woven or knitted covering ofDACROIST, a speciality yam manufactured by DuPont.
The sleeve 16 may extend beyond an entire length of the knitted framework (Figurel2), along the entire length of the knitted framework or along only a part of the length of the
<Desc/Clms Page number 6>
knitted framework 4 (Figure13a). Where the sleeve 16 extends beyond an entire length of the knitted framework 4, the sleeve 16 may be folded back within the knitted framework 4 to form a hem 18 about an end of the knitted framework 4 (Figure 13b).
Medical prostheses 20 offrusto-conical form may be manufactured (Figures 13a and 13b).
Such medical prostheses have particular utility in situations in which a body passageway having a marked reduction in diameter along its length requires repair or support.
The use of known circular knitting techniques means that a medical prostheses 30 of bifurcated form (Figure 14) can also be manufactured. Typically, a first framework of fabric is knitted, with a second framework being linked to a portion of the first framework.
The first medical prosthesis 30 of Figure 14 is provided with a limb 32 of tapered section.
The limb 32 is provided with sheath cover 34 having a fold forming a hem 36 in the region of the tapered section. A second medical prosthesis 40 may subsequently be introduced into the tapered section of the limb 32 (Figure 15).
As may be seen from Figure 16, the framework of the further medical prosthesis 40 is constructed such that upon adopting the expanded configuration one end is provided with a reverse taper 42 which is retained within the tapered section of the limb 32 of the first medical prosthesis 30.

Claims (13)

  1. Claims 1. A medical prosthesis comprising a single strand of shape memory metal knitted into a tubular framework.
  2. 2. A medical prosthesis according to claim 1, in which the strand is weft knitted to form the framework.
  3. 3. A medical prosthesis according to claim 2, in which the strand is weft knitted by means of a tuck stitch or a lock stitch.
  4. 4. A medical prosthesis according to claim 1, in which the strand is warp knitted to form the framework.
  5. 5. A medical prosthesis according any previous claim, in which the shape memory metal exhibits thermal shape recovery properties at human body temperatures.
  6. 6. A medical prosthesis according any previous claim, in which the shape memory metal is nitinol.
  7. 7. A medical prosthesis according any previous claim, in which the tubular metal prosthesis is provided with a sheath cover.
  8. 8. A medical prosthesis according to claim 7, in which the sheath cover extends over the entire length of the prosthesis.
  9. 9. A medical prosthesis according any previous claim, in which the prosthesis is of uniform dimension along its length.
  10. 10. A medical prosthesis according to any of claims 1 to 8, in which the prosthesis may be frusto-conical in form.
    <Desc/Clms Page number 8>
  11. 11. A medical prosthesis according any previous claim, in which the medical prosthesis is coated with a bioactive substance, such as an anti-thrombogenic agent, steroids, antimicrobials, antibiotics, monoclonal antibodies, antifibrosis agents, or the like.
  12. 12. A tubular medical prosthesis substantially as described herein with reference to and as illustrated in one or more of the accompanying drawings.
  13. 13. A method of locating a medical prosthesis according to any previous claim comprises the steps of loading the prosthesis within a catheter;
    1--+1, 4-e C-+ C+e,-arA +1, inserting both the catheter and the prosthesis into a body passageway ; positioning the catheter adjacent a site at which the prosthesis is to be located; locating a catheter balloon ahead of the catheter; expanding the catheter balloon to restrict a blood flow through the body passageway; advancing the prosthesis to the site at which the prosthesis is to be located; withdrawing the catheter from the prosthesis; allowing the prosthesis to expand; deflating the catheter balloon; withdrawing the balloon through the expanded prosthesis ; and removing the balloon and catheter from the body passageway.
GB0118606A 2001-07-31 2001-07-31 A stent comprising a framework of shape memory metal Withdrawn GB2378137A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB0118606A GB2378137A (en) 2001-07-31 2001-07-31 A stent comprising a framework of shape memory metal

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB0118606A GB2378137A (en) 2001-07-31 2001-07-31 A stent comprising a framework of shape memory metal

Publications (2)

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GB0118606D0 GB0118606D0 (en) 2001-09-19
GB2378137A true GB2378137A (en) 2003-02-05

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2068761A1 (en) * 2006-08-18 2009-06-17 William, a Cook Australia Pty. Ltd. Stent graft extension
US9005274B2 (en) 2008-08-04 2015-04-14 Stentys Sas Method for treating a body lumen
US9192492B2 (en) 2005-02-17 2015-11-24 Jacques Seguin Device allowing the treatment of bodily conduits at an area of a bifurcation
US10531867B2 (en) 2017-02-13 2020-01-14 Muath Alanbaei Sinus venosus atrial septal defect treatment device
US11395644B2 (en) 2017-02-13 2022-07-26 Gulf Medical Technologies Sinus venosus atrial septal defect treatment device
EP4279037A3 (en) * 2018-04-09 2024-02-21 Boston Scientific Scimed, Inc. Stent

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994001056A1 (en) * 1992-07-13 1994-01-20 Boston Scientific Corporation Tubular medical prosthesis
WO1994012136A1 (en) * 1992-10-13 1994-06-09 Boston Scientific Corporation Stents for body lumens exhibiting peristaltic
WO1997042878A1 (en) * 1996-05-14 1997-11-20 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US6161399A (en) * 1997-10-24 2000-12-19 Iowa-India Investments Company Limited Process for manufacturing a wire reinforced monolayer fabric stent
GB2355728A (en) * 1999-10-27 2001-05-02 Anson Medical Ltd Tubular medical implants and methods of manufacture

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994001056A1 (en) * 1992-07-13 1994-01-20 Boston Scientific Corporation Tubular medical prosthesis
WO1994012136A1 (en) * 1992-10-13 1994-06-09 Boston Scientific Corporation Stents for body lumens exhibiting peristaltic
WO1997042878A1 (en) * 1996-05-14 1997-11-20 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US6161399A (en) * 1997-10-24 2000-12-19 Iowa-India Investments Company Limited Process for manufacturing a wire reinforced monolayer fabric stent
GB2355728A (en) * 1999-10-27 2001-05-02 Anson Medical Ltd Tubular medical implants and methods of manufacture

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9192492B2 (en) 2005-02-17 2015-11-24 Jacques Seguin Device allowing the treatment of bodily conduits at an area of a bifurcation
EP2068761A1 (en) * 2006-08-18 2009-06-17 William, a Cook Australia Pty. Ltd. Stent graft extension
EP2068761B1 (en) * 2006-08-18 2019-02-13 Cook Medical Technologies LLC Stent graft extension
US9005274B2 (en) 2008-08-04 2015-04-14 Stentys Sas Method for treating a body lumen
US10531867B2 (en) 2017-02-13 2020-01-14 Muath Alanbaei Sinus venosus atrial septal defect treatment device
US11395644B2 (en) 2017-02-13 2022-07-26 Gulf Medical Technologies Sinus venosus atrial septal defect treatment device
EP4279037A3 (en) * 2018-04-09 2024-02-21 Boston Scientific Scimed, Inc. Stent
US11986407B2 (en) 2018-04-09 2024-05-21 Boston Scientific Scimed, Inc. Stent

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