WO2009142598A1 - Disque barrière mécanique utilisé pour la cicatrisation d'une plaie - Google Patents

Disque barrière mécanique utilisé pour la cicatrisation d'une plaie Download PDF

Info

Publication number
WO2009142598A1
WO2009142598A1 PCT/SE2009/050586 SE2009050586W WO2009142598A1 WO 2009142598 A1 WO2009142598 A1 WO 2009142598A1 SE 2009050586 W SE2009050586 W SE 2009050586W WO 2009142598 A1 WO2009142598 A1 WO 2009142598A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrier disc
wound
disc according
barrier
rigid
Prior art date
Application number
PCT/SE2009/050586
Other languages
English (en)
Inventor
Martin Ugander
Malin MALMSJÖ
Original Assignee
Forskarpatent I Syd Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Forskarpatent I Syd Ab filed Critical Forskarpatent I Syd Ab
Publication of WO2009142598A1 publication Critical patent/WO2009142598A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/916—Suction aspects of the dressing specially adapted for deep wounds
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/918—Suction aspects of the dressing for multiple suction locations

Definitions

  • the present invention relates to a device to be used in topical negative pressure treatment of wounds, in particular sternotomy wounds.
  • sternotomy wound In cardiac surgery, e.g., by-pass operation of the heart, the sternum is cut lengthwise, and quite often the left pleura is opened as well. This gene- rates a so called sternotomy wound. Following surgery, the sternotomy wound is closed with sternal wires and left to heal. In a number of patients, about 1 to 5 % of those undergoing cardiac surgery including sternotomy, an infection called mediastinitis occurs. Such post-sternotomy mediastinitis occurs in particular in a risk group of patients, such as those suffering from di- abetes mellitus, low left ventricular ejection fraction, obesity, renal failure, and three-vessel disease.
  • the NPWT technique entails applying negative pressure to a wound in a controlled manner.
  • a wound dressing in the form of a sterile polyurethane foam is placed between the sternal edges, but not below the level of the sternum, in order not to affect hemodynamic and respiratory function.
  • a second layer of foam is often placed subcutaneously and secured with a running suture to the surrounding skin. This facilitates the application of the adhesive drape and reduces the risk of accidental movement of the device. Drainage tubes are inserted into the foam. The wound is then sealed with a transparent adhesive drape. The drainage tubes are connected to a purpose-built vacuum pump and a canister for collection of effluents. Initially, a low pressure (e.g.
  • -50 mmHg is applied to allow adjustment of the foam as the air is eva- cuated. If the wound geometry and foam contraction are considered satisfactory, a pressure of -125 mmHg is applied. Air leakage is known to dry out the wound and can be prevented by additional draping. Most of the patients can be extubated and mobilized immediately after NPWT application. Revisions and dressing changes are performed regularly, e.g. three times a week, under aseptic conditions and general anesthesia. The sternal wound can be closed and rewired when the infection has resolved, typically after 1-3 weeks of NPWT treatment. The method is simple and effective and is believed to combine the benefits of closed and open wound treatment to create an environment that promotes wound healing.
  • WO 2007/123451 discloses a treatment using an implantable, disposable barrier disc to be used in the negative pressure treatment of wounds with underlying organs or vital structures such as sternotomy wounds, abdominal wounds, or neurosurgical wounds in particular sternotomy wounds whereby the barrier disc consists of a rigid material withstanding a pressure of -50 mmHg without causing deformation to the barrier, and that the barrier is perforated to allow drainage of wound fluid through said barrier disc.
  • the barrier disc consists of a rigid material withstanding a pressure of -50 mmHg without causing deformation to the barrier, and that the barrier is perforated to allow drainage of wound fluid through said barrier disc.
  • US 2008/0058684 discloses a method wherein a negative pressure is applied post-surgically to avoid movement of an organ or tissue, wherein an open cell structure is used to distribute the pressure around the organ or tissue.
  • the present invention related to a barrier disc and a method that can be used for the same purposes and in the same way as disclosed in WO 2007/123451 and US 2008/0058684.
  • the present invention eliminates the risk for serious damage to underlying organs or vital tissue, including heart rupture, at NPWT treatment of different wounds, including sternotomy wounds.
  • the present invention provides an implantable barrier disc, to be used in negative pressure therapy of a wound, which barrier disc is formed of a rigid material withstanding a pressure of at least -20 mmHg without undergoing major deformation and which barrier disc consists at least partly of an impermeable material.
  • This barrier disc partly hinders pressure transduction from the vacuum source of the negative pressure treatment means and a wound interface dressing material to any underlying organ or tissue, thereby protecting these structures from the effects of negative pressure.
  • Fig. 1 shows a perspective view of one embodiment of the invention
  • 1 denotes generally a substantially rectangular flat barrier disc made of a biocompatible material.
  • the barrier is made of impermeable material and has as a rigid structure.
  • the barrier disc In order to fit a sternotomy wound the barrier disc has a width of 10 to 15 cm and a length of 15 to 25 cm depending of the size of the patient.
  • the barrier disc has preferably a thickness of 1 to 3 mm. Barrier discs for use with other wounds can be sized appropriately.
  • the barrier disc optionally has a less rigid edge 5.
  • Fig. 2 shows a perspective view of another embodiment of the inven- tion; again 1 denotes generally a substantially rectangular flat barrier disc made of a biocompatible material.
  • One part of the barrier disc 2 is made of impermeable material and has as a rigid structure.
  • Another part of the barrier disc 3 is made of a permeable material.
  • the pores 4 in this part have the function of allowing for passage of wound fluid being sucked from the interior of the wound to the drainage of the wound into the drainage tubes.
  • the barrier disc optionally has a less rigid edge 5.
  • the barrier disc according to the invention is intended to be used in Negative Pressure Therapy or Negative Pressure Wound Therapy (NPWT or TNP treatment). This kind of therapy and the problems associated therewith is explained in more detail in US 2008/0058684 in paragraphs [0003]-[0022].
  • the barrier disc can be used for all types of wounds where there is an underlying organ or tissue that needs to be protected. Examples of such wounds are sternotomy wounds, abdominal wounds, neurosurgical wounds and wounds resulting from vascular surgery. Examples of the organs and tissues that need protection are heart and lungs in the case of sternotomy wounds, intestines in the case of abdominal wounds, brain in the case of cranial or neurosurgical wounds and blood vessels in the case of vascular surgery.
  • the organ or vital tissues underlying the wound e.g. the heart and surrounding structures in the case of a sternotomy wound
  • the barrier disc prevents i.e. right ventricular rupture from being wedged by the, many times, sharp edges of the sternum.
  • the heart in particular the right ventricle, lung tissue and the by-pass grafts will be protected from the sternal edges.
  • the barrier can protect the impairment of heart function via suction of the right ventricular free wall up into the gap between the sternal edges.
  • the present invention also hinders the effects of the negative pressure per se on the underlying organs or vital tissue. This may be of particular importance in connection with abdominal surgery, since negative pressure on the intestines may result in ischemia, formation of fistulas or adhesions. It may also be of particular importance in connection with vascular surgery of neurosurgery, when the negative pressure may cause ischemia.
  • the part of the barrier disc that is impermeable is then placed above the organ or vital tissue that is to be protected.
  • the size of this impermeable area is therefore dependent on what organ or vital tissue it is to be placed over. It may be preferable that it has a size sufficient to cover the whole or- gan.
  • At least part of the barrier disc must have a tight structure which means that it must be impermeable. This means that the negative pressure applied to the outward facing side when the barrier disc is in use in a patient shall not be able to transduce through the barrier disc and affect the underly- ing organ or vital structure. However, such an impermeable disc or impermeable part of the disc will still allow drainage of exudates from its outer/upper side in close relationship to the wound edges.
  • the size of the impermeable part varies depending on what organ or vital structure it is intended to protect. The size of the whole barrier disc depends on what kind of wound it is to be used for.
  • a suitable barrier disc for a sternotomy wound has a width of 10 to 15 cm and a length of 15 to 25 cm depending of the size of the patient.
  • the barrier disc has preferably a thickness of 1 to 3 mm.
  • Barrier discs for use with other wounds are sized appropriately, based on the size of the wound, the size of the patient and/or the size of the organ(s) or vital tis- sue it is intended to protect.
  • the barrier disc may be for example essentially rectangular or essentially round.
  • the form or shape of the barrier disc depends on the shape of the wound and/or the shape of the organ(s) or vital tissue it is intended to protect. According to some embodi merits the whole barrier disc is impermeable which means that it has a tight structure.
  • a part of the barrier disc is impermeable or has a tight structure while another part of the barrier disc is permeable in order to allow passage of wound fluids being sucked from the interior of the wound to the outside when the negative pressure are applied, in the same way as explained in WO 2007/123451 i.a. on page 4, lines 8-13 and page 4, line 21 - page 5, line 12.
  • the permeable part of the barrier disc may be perforated in the way that has already been taught in WO 2007/123451.
  • the permeable part of the barrier disc consists of an open porous structure material, as explained in more detail below.
  • the barrier disc shall be rigid. However, it shall not be completely stiff. The disc must be so rigid that it withstands a pressure amounting to -20 mmHg or -50 mmHg, preferably to -75 mmHg, more preferably -100 mmHg, still more preferably -150 mmHg, more preferably -200 mmHg and even up to -250 mmHg without undergoing major deformation.
  • the negative pressure the barrier disc needs to withstand depends on the type of wound it is to be used for.
  • Major deformation in this context means that the barrier disc loses it disc shape and is bent into another shape.
  • the barrier disc ac- cording to the invention essentially keeps it disc shape when exposed to the negative pressure, in order to avoid that it is sucked up in between the edges of the wound, such as the sternal edges in case of a sternotomy when it is exposed to a negative pressure.
  • the barrier disc should be somewhat flexible to allow bending to some extent or a slight deformation when exposed to the negative pressure, so that the barrier disc adopts to the internal shape of the structure wherein the wound is situated, for example in the case of a sternotomy, to the internal shape of the sternum.
  • the material forming the disc may be a ceramic, open porous structure material, a rigid gauze open porous structure material, a rigid mesh open porous structure material, or a rigid foam open porous structure material.
  • a gauze material this may be made of natural fiber, such as cotton, or a synthetic fiber. In either case the fiber may have been made rigid by coating it with a polymer providing such rigidity.
  • the porosity of the open porous rigid structure material may be anything from a few microns to several hundred microns, i.e., anything that allows a flow of wound fluid there through.
  • the implantable disc is disposable or degradable.
  • the edges 5 of the barrier disc 1 are preferably of a less rigid structure. Thus these more flexible edges are allowed to adapt themselves to the inner side of the deep wound, such as the inner part of the sternum, and to provide a sealing of the barrier disc between the wound edges and the deeper structures inside the wound.
  • part of the barrier disc 3 is perforated by means of its open porous structure. These porosities 4 have the function of allowing for passage of wound fluid being sucked from the interior of the wound to the drainage of the wound into the drainage tubes.
  • the drainage is made possible by the vacuum applied onto the top of the barrier disc by means of one or more suction tubes applied to a vacuum source, such as a vacuum pump.
  • a wound interface dressing material may be attached to the top surface of the barrier disc 1.
  • the barrier disc is then attached to the wound dressing in order to insure that the barrier disc remains fixed in relation to the wound geometry.
  • the wound dressing may be attached via a thread having a length of about the thickness of the sternum.
  • the wound dressing foam material normally has an open pore struc- ture of 400 to 600 ⁇ m.
  • Another way of ensuring that the barrier disc remains fixed in relation to the wound geometry is to suture the edges of the disc to surrounding structures, such as the pleuras in the case of a sternotomy wound. Besides preventing the barrier disc from being misplaced, this also prevents the lungs from being sucked up in between the edges of the sternal wound.
  • the invention is exemplified in more detail below with reference to a sternotomy wound.
  • the invention is not limited to sternotomy wound. It can also be applied to other types of wounds, such as abdominal wounds, neurosurgical wounds etc, as mentioned above.
  • the barrier disc 1 is applied underneath the sternum to cover the sternal edges and anterior of the barrier disc is a wound interface dressing that distributes the negative pressure to the wound surface, or as being a part of the barrier disc assembly on top of and over the sternal wound.
  • Non-collapsible evacuation tubes are connected to the wound and the wound is sealed with adhesive drape is inserted into the center of the sternal foam layer and sutured in place. The superficial foam layer is sutured to the surrounding subcutaneous tissue and a skin protector is applied.
  • the tubes are positioned 5 cm apart to facilitate application of adhesive draping around the tubes.
  • the foam In a relaxed state the foam should protrude 1 to 2 cm over the edge of skin to allow volume reduction during vacuum therapy.
  • the foam layer is then secured subcutaneously with a running suture to the surrounding skin edge.
  • a second tube is normally inserted into the middle of this foam layer and sutured.
  • a skin barrier disc protector (such as Cavilon; 3M Healthcare, St. Paul, MN) is applied and the open wound is sealed with a transparent adhesive drape (KCI, Copenhagen, Denmark). The drape overlaps the wound margins by 5 cm.
  • the two drainage tubes are positioned 5 cm apart to facilitate application of the draping.
  • the two drainage tubes from the closed wound are connected to a vacuum source (VAC pump unit; KCI, Copenhagen, Denmark).
  • This vacuum source set to deliver a continuous or intermittent pressure of -25 to -250mnnHg. Initially -50 mmHg is applied as it allows adjust- ment of the foam as the air is evacuated. If the wound geometry and foam contraction are considered to be satisfactory the pump unit is programmed to deliver -125 mm Hg continuous pressure. At this pressure no further adjustment can be carried out since the compressed foam will be firm.
  • a canister in the pump unit collects exudate from the wound.
  • the wound dressings are changed regularly, e.g. every 3 rd day, under aseptic conditions and under general anesthesia. Bone and soft tissue necrosis is demarked by lack of granulation tissue on the sternal edges and complementary revisions are made during dressing change surgery.

Abstract

La présente invention porte sur un disque barrière implantable devant être utilisé dans le traitement par pression négative de plaies, telles que des plaies de sternotomie. Le disque barrière est constitué d'un matériau sensiblement rigide qui supporte une pression de -20 mm de mercure sans déformation majeure et comporte au moins une partie imperméable devant être placée sur un organe ou un tissu vital pour le protéger de l'exposition à l'ouverture de la plaie et à la pression négative.
PCT/SE2009/050586 2008-05-23 2009-05-20 Disque barrière mécanique utilisé pour la cicatrisation d'une plaie WO2009142598A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0801217 2008-05-23
SE0801217-1 2008-05-23

Publications (1)

Publication Number Publication Date
WO2009142598A1 true WO2009142598A1 (fr) 2009-11-26

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PCT/SE2009/050586 WO2009142598A1 (fr) 2008-05-23 2009-05-20 Disque barrière mécanique utilisé pour la cicatrisation d'une plaie

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013012381A1 (fr) 2011-07-19 2013-01-24 Shieldheart Medtech Ab Stabilisateur, disque d'arrêt et un pansement de plaie comprenant un stabilisateur, procédé de commande de la position d'un pansement de plaie ou d'un disque d'arrêt, et procédé pour faciliter le drainage d'un pansement de plaie ou d'un disque d'arrêt lors du traitement d'une plaie sous pression négative
US8926574B2 (en) 2010-11-25 2015-01-06 Paul Hartmann Ag Wound dressing for negative-pressure therapy

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003057071A2 (fr) * 2001-12-26 2003-07-17 Hill-Rom Services, Inc. Emballage de pansement sous vide
WO2007123451A1 (fr) * 2006-04-26 2007-11-01 Forskarpatent I Syd Ab Barrière mécanique dans la cicatrisation des plaies
US20080058684A1 (en) * 2006-09-04 2008-03-06 Martin Ugander Surgical method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003057071A2 (fr) * 2001-12-26 2003-07-17 Hill-Rom Services, Inc. Emballage de pansement sous vide
US20050010153A1 (en) * 2001-12-26 2005-01-13 Lockwood Jeffrey S Vaccum bandage packing
WO2007123451A1 (fr) * 2006-04-26 2007-11-01 Forskarpatent I Syd Ab Barrière mécanique dans la cicatrisation des plaies
US20080058684A1 (en) * 2006-09-04 2008-03-06 Martin Ugander Surgical method

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8926574B2 (en) 2010-11-25 2015-01-06 Paul Hartmann Ag Wound dressing for negative-pressure therapy
WO2013012381A1 (fr) 2011-07-19 2013-01-24 Shieldheart Medtech Ab Stabilisateur, disque d'arrêt et un pansement de plaie comprenant un stabilisateur, procédé de commande de la position d'un pansement de plaie ou d'un disque d'arrêt, et procédé pour faciliter le drainage d'un pansement de plaie ou d'un disque d'arrêt lors du traitement d'une plaie sous pression négative
CN103702710A (zh) * 2011-07-19 2014-04-02 心脏防护医疗技术公司 在负压伤口治疗中的稳定器、包括稳定器的隔离片及伤口敷料、用于控制伤口敷料或隔离片的位置的方法、以及用于促进从伤口敷料或隔离片引流的方法
EP2734260A1 (fr) * 2011-07-19 2014-05-28 Shieldheart Medtech AB Stabilisateur, disque d'arrêt et un pansement de plaie comprenant un stabilisateur, procédé de commande de la position d'un pansement de plaie ou d'un disque d'arrêt, et procédé pour faciliter le drainage d'un pansement de plaie ou d'un disque d'arrêt lors du traitement d'une plaie sous pression négative
EP2734260A4 (fr) * 2011-07-19 2015-04-22 Shieldheart Medtech Ab Stabilisateur, disque d'arrêt et un pansement de plaie comprenant un stabilisateur, procédé de commande de la position d'un pansement de plaie ou d'un disque d'arrêt, et procédé pour faciliter le drainage d'un pansement de plaie ou d'un disque d'arrêt lors du traitement d'une plaie sous pression négative

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