WO2005089341A2 - Method and device for coronary artery bypass - Google Patents

Method and device for coronary artery bypass Download PDF

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Publication number
WO2005089341A2
WO2005089341A2 PCT/US2005/008652 US2005008652W WO2005089341A2 WO 2005089341 A2 WO2005089341 A2 WO 2005089341A2 US 2005008652 W US2005008652 W US 2005008652W WO 2005089341 A2 WO2005089341 A2 WO 2005089341A2
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WO
WIPO (PCT)
Prior art keywords
heart
posterior
surgery
pericardial space
inferior
Prior art date
Application number
PCT/US2005/008652
Other languages
French (fr)
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WO2005089341A3 (en
Inventor
Brian S. Bull
Original Assignee
Bull Brian S
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 Bull Brian S filed Critical Bull Brian S
Publication of WO2005089341A2 publication Critical patent/WO2005089341A2/en
Publication of WO2005089341A3 publication Critical patent/WO2005089341A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/36—Surgical swabs, e.g. for absorbency or packing body cavities during surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover

Definitions

  • CABG Coronary artery bypass grafting
  • Exposure of the patient's blood to the internal surfaces of the CPB circuit can, however, activate the patient's blood so that clotting is initiated, thereby forming fibrin microclots which are returned to the patient's circulation.
  • fibrin microclots There are at least two sequelae to the formation of fibrin microclots, first, bleeding can occur due to clotting factor consumption and to the coating of platelets by fibrin breakdown products, and second, the fibrin microclots can themselves cause microvascular occlusion
  • Several techniques are used to minimize the formation of microclots, including heparinization of the internal surfaces of the CPB circuit, and manufacturing of the CPB circuit components from plastics with improved biocompatibility.
  • the heart is lifted to the top of the pericardial space (that is, the heart is moved anteriorly in the pericardial space) and fixed in position temporarily using one or more than one cotton-fiber fabric laparotomy sponge.
  • the laparotomy sponge itself becomes part of the cardio-pulmonary bypass (CPB) circuit because the surgeon squeezes the laparotomy sponge when it becomes blood-soaked, and aspirates the recovered blood directly through a large mesh filter into the CPB circuit.
  • CPB cardio-pulmonary bypass
  • a surgical sponge useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the surgical sponge substantially comprising a fabric comprising biocompatible, manufactured monofilament fibers.
  • the manufactured monofilament fibers comprise a polymer material.
  • the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
  • the fabric is woven.
  • the surgical sponge comprises a plurality of layers of fabric.
  • a kit for performing a surgical or medical procedure comprises a sterilized surgical sponge according to claim 1 sealed within a package.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery is provided.
  • the method comprises, (a) providing a surgical sponge according to the present invention and (b) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • a method for performing a cardiothoracic surgery comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a surgical sponge according to the present invention; and (c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the surgical sponge; and (c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • a method for performing a cardiothoracic surgery there is provided.
  • the method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the surgical sponge; (d) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery is provided.
  • the device comprises a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart.
  • the form comprises two lateral arms having proximal ends and distal ends, and a central connecting portion connecting the proximal ends of the two lateral arms.
  • the distal ends of the arms flare outward.
  • the material is non-woven.
  • the material comprises a polymer material.
  • the material is selected from the group consisting of an aramid, a para- aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
  • the device further comprises, within the material, a substance that is readily deformable at room temperature and pressure.
  • the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder, and combinations of the preceding.
  • the device further comprises an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the device.
  • a kit for performing a surgical or medical procedure comprises a sterilized device according to the present invention sealed within a package.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery is provided.
  • the method comprises, (a) providing a device according to the present invention; and (b) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space.
  • a method for performing a cardiothoracic surgery comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a device according to the present invention; (c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the device; and (c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • a method for performing a cardiothoracic surgery comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the device; and (c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • the method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the device; (d) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • the means comprises a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart.
  • the material is non-woven.
  • the material comprises a polymer material.
  • the material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
  • the means further comprises, within the material, a substance that is readily deformable at room temperature and pressure.
  • the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder and combinations of the preceding.
  • the means further comprises an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the means.
  • a kit for performing a surgical or medical procedure comprises a sterilized means according to the present invention within a package.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery comprises, (a) providing a means according to the present invention; and (b) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space.
  • a method for performing a cardiothoracic surgery comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a means according to the present invention; and (c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery is provided.
  • the method comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the means; and (c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • a method for performing a cardiothoracic surgery comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the means; and (c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • the method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the means; (d) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery.
  • the surgery is a coronary artery bypass graft surgery.
  • Figure 1 is a partial, top perspective, view of a device according to the present invention useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery
  • Figure 2 is a partial, top perspective, view of a device, according to another embodiment of the present invention
  • Figure 3 is a top perspective view of a device, according to another embodiment of the present invention
  • Figure 4 is a lateral perspective view of the device shown in Figure 3
  • Figure 5 is a top perspective view of a device, according to another embodiment of the present invention
  • Figure 6 is a partial cutaway, lateral perspective view of the device shown in Figure 5 taken al ,ng line 6-6
  • Figure 7 is a cutaway, top perspective, view of one embodiment of a kit for performing a surgical or medical procedure according to the present invention
  • Figure 8 is a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the
  • a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair.
  • the device is a surgical sponge according to the present invention.
  • the device comprises a substance that is readily deformable at room temperature and pressure, such as a substance in the form of filaments, gas, gel, liquid, particles, or powder.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair.
  • each method comprises providing a device according to the present invention, and placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • the term “surgical sponge” means a device according to the present invention, as compared to the term “laparotomy sponge” which means a device known in the prior art.
  • the use of the term “surgical sponge” to indicate a device according to the present invention is not, however, intended indicate that the device is limited to use in any particular type of surgery.
  • the term “natural fiber” means any fiber that exists as such in the natural state (the definition as given in the Textile Products Identification Act, 15 U.S.C. ⁇ 70).
  • the term "manufactured fiber” means any fiber derived by a process of manufacture from any substance which, at any point in the manufacturing process, is not a fiber (the definition as given in the Textile Products Identification Act, 15 U.S.C. ⁇ 70).
  • the term “fabric” means any material woven, knitted, felted, or otherwise produced from, or in combination with, any natural or manufactured fiber. Both the surgical sponge of the present invention and the laparotomy sponges known in the prior art comprise fabric.
  • biocompatible is used to designate a material (such as a fabric) specifically selected to decrease the tendency of blood exposed to the material to clot, and to decrease the tendency of platelets and neutrophils exposed to the material to activate.
  • Cotton-fiber fabric as used in the laparotomy sponges of the prior art, is actually selected to increase the tendency of blood exposed to the material to clot.
  • sterilizable and variations of the term, such as “sterilized” means capable of being sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas, techniques which do not render the device being sterilized as unfit for its intended purpose.
  • the term "substantially” means at least about 90% .
  • the present invention is a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair.
  • the device comprises one or more than one characteristic that is advantageously different from presently used laparotomy sponges.
  • the device of the present invention comprises two or more than two characteristics that are advantageously different from presently used laparotomy sponges.
  • the device is a surgical sponge according to the present invention.
  • the characteristics that distinguish the device of the present invention from the presently used laparotomy sponges will now be disclosed in detail, initially with respect to a surgical sponge according to the present invention, but with the understanding that the characteristics can also be applied to the other devices of the present invention, as will be understood by those with skill in the art with reference to this disclosure.
  • the first characteristic that distinguishes the surgical sponge of the present invention from the presently used laparotomy sponges is that the surgical sponge comprises a material, such as a fabric, that is more biocompatible than fabric made from cotton-fiber fabric or other natural fibers, such that anticoagulated blood exposed to the surgical sponge does not tend to clot in the time required to perform a surgical procedure, such as coronary artery bypass grafting, to the extent that it would when exposed to cotton-fiber fabric; and platelets and neutrophils exposed to the surgical sponge do not tend to activate to the extent that they would when exposed to cotton- fiber.
  • a surgical procedure such as coronary artery bypass grafting
  • the surgical sponge of the present invention comprises a fabric substantially made from biocompatible, manufactured fiber.
  • the manufactured fiber comprises a polymer material, with or without additives such as plasticizers.
  • the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as for example, Nomex ® or Kevlar ® .
  • the second characteristic that distinguishes the device according to the present invention, such as a surgical sponge of the present invention, from presently used laparotomy sponges is that the surgical sponge comprises fabric having a much smaller total surface area that is exposed to a patient's bodily fluids in use than the presently used cotton-fiber fabric, laparotomy sponges.
  • a cotton-fiber fabric, laparotomy sponge is typically in the shape of a square having dimensions of between about 40 cm and 50 cm on each side, and typically comprises four layers of about 900 cotton-fiber strands, where each strand has a length the same as the side length of laparotomy sponge.
  • Each strand comprises about 50 ribbon-like, filaments having cross-sectional dimensions of about 26 ⁇ M in width by about 5.5 ⁇ M in height thus yielding a surface area for each filament of approximately 2.85 x 10 "5 M 2 . Therefore, the total area of a cotton-fiber fabric, laparotomy sponge having dimensions of 45 cm on each side is about 5.1 M 2 . By contrast, the total internal surface area of a typical CPB circuit is only about 0.8 M 2 . This is exclusive of the membrane oxygenator, whose approximately 2 M 2 surface is designed to be compatible with blood. Hence, the typical surface area of a single cotton-fiber fabric laparotomy sponge is between about 3 and 5 times the total internal surface area of the CPB circuit, exclusive of the membrane oxygenator.
  • the surgical sponge of the present invention substantially comprises monofilament strands, rather than strands comprising bundles of smaller filaments.
  • Surgical sponges of the present invention comprising fabric made substantially of monofilaments made of biocompatible manufactured fibers synergistically decrease the occurrence of microclots and the activation of platelets and neutrophils.
  • the device is a surgical sponge 10 comprising a woven fabric 12 of monofilaments 14.
  • the device is a surgical sponge 10 comprising a plurality of layers of fabric 12 of monofilaments 14.
  • another device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair.
  • the device 20 comprises a generally U- shaped structure having a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart.
  • the device 20 comprises two lateral arms 22 having proximal ends 24 and distal ends 26, and a central connecting portion 28 connecting the proximal ends 24 of the lateral arms 22.
  • the distal ends 26 of the arms 22 flare outward slightly.
  • both the wall of the lateral arms 22 and the connecting portion 28 is concave toward the center of the device 20.
  • the device 20 is produced in a variety of sizes, thereby allowing the surgeon to select a size most suitable to the size of the patient in which the device is being used.
  • the device generally has maximum external dimensions of approximately 11 cm (from the farthest extent of the central connecting portion 28 to the distal ends 26 of the lateral arms 22) by 6 cm (the distance from the farthest extent of one lateral arm 22 to the other arm 22) by 2 cm (thickness).
  • the "a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart” means that the device will fit in the pericardial bed without putting damaging pressure on the heart or surrounding structures, such as, for example, by sharp edges, seams or protrusions that would puncture living tissue, such as the heart or associated structures.
  • the device 20 comprises a biocompatible material.
  • the material is non- woven, in order to decrease the total surface area of the device that is exposed to a patient's bodily fluids in use compared to the presently used cotton-fiber fabric, laparotomy sponges.
  • the material is a polymer.
  • the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as, for example, Nomex ® or Kevlar ® .
  • the device 20 can be sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas.
  • another device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair.
  • the device comprises a substance that is readily deformable at room temperature (about 20 °C to 25 °C) and pressure (about 1 atmosphere), such as a substance is in the form of filaments, gas, gel, liquid, particles, or powder and combinations of the preceding, such as for example air, water, saline, frozen saline "slush,” gelatin, tightly coiled plastic filaments, sand, beads and viscous solutions of biocompatible long chain polysaccharides, such as mannitol.
  • the material is non-toxic, to prevent injury to the patient if the material is accidently allowed to contact the patient's living tissue.
  • the device 30 comprises a fluid or gel proof covering 32 surrounding a cavity 34 for holding a substance 36 that is readily deformable at room temperature and pressure within the covering 32, to make the device 30 more flexible and less potentially damaging to living tissue.
  • the device 30 comprises an outlet valve 38, to allow a surgeon to express some of the substance 36 in the cavity 34 to decrease the total volume of the device 30 and allow the device 30 to deform so as to take a more appropriate shape for the use intended.
  • the shape of the device 30 can vary and still be within the scope of the present invention.
  • the device 30 can be substantially rectangular, as shown in Figure 3 and Figure 4.
  • the covering 32 of the device 30 comprises a biocompatible material.
  • the material is non-woven, in order to decrease the total surface area of the device that is exposed to a patient's bodily fluids in use compared to the presently used cotton-fiber fabric, laparotomy sponges.
  • the material is a polymer.
  • the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as for example, Nomex ® or Kevlar ® .
  • the device 30 can be sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas.
  • a kit for performing a surgical or medical procedure comprises a container having a sterilized device according to the present invention sealed within the kit.
  • the device can be any device according to the present invention, as will be understood by those with skill in the art with reference to this disclosure.
  • the container is unsealed, such as for example by peeling back a top layer on the container to expose the device within, or by removing one end of the container to expose the device within.
  • the device is then removed from the container for use.
  • the kit 40 comprises a container 42 comprising a sterilized surgical sponge 10 according to the present invention sealed within the container 42 to maintain the sterility of the surgical sponge 10 until the container 42 is unsealed.
  • Figure 8 there is shown a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the present invention.
  • the kit 40 comprises a container 42 comprising a device 20 according to the present invention sealed within the container 42 to maintain the sterility of the device 20 until the container 42 is unsealed.
  • the kit 40 comprises a container 42 comprising a device 30 according to the present invention sealed within the container 42 to maintain the sterility of the device 30 until the container 42 is unsealed.
  • a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair.
  • the method comprises providing a device according to the present invention. Then, the device is placed posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
  • the method comprises providing a kit according to the present invention, unsealing the package, and removing the sterilized device.
  • the device is a surgical sponge ' ?cording to the present invention.
  • the device is a device such as the device 20 or device 30 according to the present invention.
  • the method can also comprise expressing some of the substance to decrease the volume of the device and allow the device to deform so as to take a more appropriate shape for the use intended.
  • this method does not require a change in the techniques presently being used by surgeons, other than substituting the device of the present invention for the cotton-fiber fabric, laparotomy sponge.
  • a method of performing cardiothoracic surgery such as coronary artery bypass grafting and heart valve repair.
  • the method comprises creating an opening into the cardiothoracic cavity. Then, a device according to the present invention is provided.
  • the device is placed posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space. Then, the surgery is completed.
  • the method comprising providing a kit according to the present invention, unsealing the package, and removing the sterilized device.
  • the device is a surgical sponge according to the present invention.
  • the device is a device such as the device 20 or device 30 according to the present invention. If the device is at least partially filled with substance, the method can also comprise expressing some of the substance to decrease the volume of the device and allow the device to deform so as to take a more appropriate shape for the use intended.
  • this method does not require a change in the techniques presently being used by surgeons, other than substituting the device of the present invention for the cotton-fiber fabric, laparotomy sponge.

Abstract

A device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. A method for performing a cardiothoracic surgery. A kit for performing a surgical or medical procedure.

Description

METHOD AND DEVICE FOR CORONARY ARTERY BYPASS
CROSS-REFERENCE TO RELATED APPLICATIONS The present Application claims the benefit of United States Provisional Patent Application 60/554,056, titled "Method and Device for Coronary Artery Bypass," filed March 16, 2004, the contents of which are incorporated in this disclosure by reference in their entirety . BACKGROUND Coronary artery bypass grafting (CABG) is a commonly performed surgical procedure used to treat decreased coronary artery blood flow due to partially occluded coronary arteries. During the procedure, the patient is connected to a coronary artery bypass (CPB) circuit that reoxygenates and repressurizes the patient's blood. Exposure of the patient's blood to the internal surfaces of the CPB circuit can, however, activate the patient's blood so that clotting is initiated, thereby forming fibrin microclots which are returned to the patient's circulation. There are at least two sequelae to the formation of fibrin microclots, first, bleeding can occur due to clotting factor consumption and to the coating of platelets by fibrin breakdown products, and second, the fibrin microclots can themselves cause microvascular occlusion Several techniques are used to minimize the formation of microclots, including heparinization of the internal surfaces of the CPB circuit, and manufacturing of the CPB circuit components from plastics with improved biocompatibility. Further, during coronary artery bypass grafting, the heart is lifted to the top of the pericardial space (that is, the heart is moved anteriorly in the pericardial space) and fixed in position temporarily using one or more than one cotton-fiber fabric laparotomy sponge. Disadvantageously, however, when a laparotomy sponge is used for this purpose in a patient whose blood is fully anticoagulated, the laparotomy sponge itself becomes part of the cardio-pulmonary bypass (CPB) circuit because the surgeon squeezes the laparotomy sponge when it becomes blood-soaked, and aspirates the recovered blood directly through a large mesh filter into the CPB circuit. Laparotomy sponges are not designed for inclusion in the CPB circuit. Exposure of blood to the cotton-fibers of the laparotomy sponge can cause even anticoagulated blood to clot and subsequently defibrinate, that is, transform plasma fibrinogen to fibrin which is deposited on the sponge. Additionally, exposure of blood to the cotton-fibers of the laparotomy sponge can activate platelets and neutrophils. Therefore, there is a need for a new method and device for performing a cardiothoracic surgery, such as a coronary artery bypass, that is not associated with these disadvantages. SUMMARY According to one embodiment of the present invention, there is provided a surgical sponge useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the surgical sponge substantially comprising a fabric comprising biocompatible, manufactured monofilament fibers. In one embodiment, the manufactured monofilament fibers comprise a polymer material. In another embodiment, the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride. In one embodiment, the fabric is woven. In one embodiment, the surgical sponge comprises a plurality of layers of fabric. According to another embodiment of the present invention, there is provided a kit for performing a surgical or medical procedure. The kit comprises a sterilized surgical sponge according to claim 1 sealed within a package. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a surgical sponge according to the present invention and (b) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a surgical sponge according to the present invention; and (c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the surgical sponge; and (c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the surgical sponge; (d) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. According to another embodiment of the present invention, there is provided a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The device comprises a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart. In one embodiment, the form comprises two lateral arms having proximal ends and distal ends, and a central connecting portion connecting the proximal ends of the two lateral arms. In another embodiment, the distal ends of the arms flare outward. In another embodiment, the material is non-woven. In another embodiment, the material comprises a polymer material. In another embodiment, the material is selected from the group consisting of an aramid, a para- aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride. In another embodiment, the device further comprises, within the material, a substance that is readily deformable at room temperature and pressure. In another embodiment, the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder, and combinations of the preceding. In another embodiment, the device further comprises an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the device. According to another embodiment of the present invention, there is provided a kit for performing a surgical or medical procedure. The kit comprises a sterilized device according to the present invention sealed within a package. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a device according to the present invention; and (b) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a device according to the present invention; (c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the device; and (c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the device; (d) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. According to another embodiment of the present invention, there is provided means useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the means comprises a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart. In one embodiment, the material is non-woven. In another embodiment, the material comprises a polymer material. In one embodiment, the material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride. In one embodiment, the means further comprises, within the material, a substance that is readily deformable at room temperature and pressure. In another embodiment, the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder and combinations of the preceding. In one embodiment, the means further comprises an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the means. According to another embodiment of the present invention, there is provided a kit for performing a surgical or medical procedure. The kit comprises a sterilized means according to the present invention within a package. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a means according to the present invention; and (b) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a means according to the present invention; and (c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (d) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery. The method comprises, (a) providing a kit according to the present invention; (b) unsealing the package and removing the means; and (c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. The method comprises, (a) creating an opening into the cardiothoracic cavity; (b) providing a kit according to the present invention; (c) unsealing the package and removing the means; (d) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and (e) completing the surgery. In one embodiment, the surgery is a coronary artery bypass graft surgery. FIGURES These and other features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying figures where: Figure 1 is a partial, top perspective, view of a device according to the present invention useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery; Figure 2 is a partial, top perspective, view of a device, according to another embodiment of the present invention; Figure 3 is a top perspective view of a device, according to another embodiment of the present invention; Figure 4 is a lateral perspective view of the device shown in Figure 3; Figure 5 is a top perspective view of a device, according to another embodiment of the present invention; Figure 6 is a partial cutaway, lateral perspective view of the device shown in Figure 5 taken al ,ng line 6-6; Figure 7 is a cutaway, top perspective, view of one embodiment of a kit for performing a surgical or medical procedure according to the present invention; Figure 8 is a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the present invention; and Figure 9 is a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the present invention. DESCRIPTION According to one embodiment of the present invention, there is provided a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. In one embodiment, the device is a surgical sponge according to the present invention. In another embodiment of the present invention, the device comprises a substance that is readily deformable at room temperature and pressure, such as a substance in the form of filaments, gas, gel, liquid, particles, or powder. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. According to another embodiment of the present invention, there is provided a method for performing a cardiothoracic surgery. In one embodiment, each method comprises providing a device according to the present invention, and placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. The device and method of the present invention will now be disclosed in greater detail. As used in this disclosure, the term "comprise" and variations of the term, such as "comprises" and "comprises," are not intended to exclude other additives, components, integers or steps. As used in this disclosure, the term "surgical sponge" means a device according to the present invention, as compared to the term "laparotomy sponge" which means a device known in the prior art. The use of the term "surgical sponge" to indicate a device according to the present invention is not, however, intended indicate that the device is limited to use in any particular type of surgery. As used in this disclosure, the term "natural fiber" means any fiber that exists as such in the natural state (the definition as given in the Textile Products Identification Act, 15 U.S.C. § 70). As used in this disclosure, the term "manufactured fiber" means any fiber derived by a process of manufacture from any substance which, at any point in the manufacturing process, is not a fiber (the definition as given in the Textile Products Identification Act, 15 U.S.C. § 70). As used in this disclosure, the term "fabric" means any material woven, knitted, felted, or otherwise produced from, or in combination with, any natural or manufactured fiber. Both the surgical sponge of the present invention and the laparotomy sponges known in the prior art comprise fabric. As used in this disclosure, the term "biocompatible" is used to designate a material (such as a fabric) specifically selected to decrease the tendency of blood exposed to the material to clot, and to decrease the tendency of platelets and neutrophils exposed to the material to activate. Cotton-fiber fabric, as used in the laparotomy sponges of the prior art, is actually selected to increase the tendency of blood exposed to the material to clot. As used in this disclosure, the term "sterilizable" and variations of the term, such as "sterilized" means capable of being sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas, techniques which do not render the device being sterilized as unfit for its intended purpose. As used in this disclosure, the term "substantially" means at least about 90% . In one embodiment, the present invention is a device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. In a preferred embodiment, the device comprises one or more than one characteristic that is advantageously different from presently used laparotomy sponges. In another preferred embodiment, the device of the present invention comprises two or more than two characteristics that are advantageously different from presently used laparotomy sponges. In a particularly preferred embodiment, the device is a surgical sponge according to the present invention. The characteristics that distinguish the device of the present invention from the presently used laparotomy sponges will now be disclosed in detail, initially with respect to a surgical sponge according to the present invention, but with the understanding that the characteristics can also be applied to the other devices of the present invention, as will be understood by those with skill in the art with reference to this disclosure. The first characteristic that distinguishes the surgical sponge of the present invention from the presently used laparotomy sponges is that the surgical sponge comprises a material, such as a fabric, that is more biocompatible than fabric made from cotton-fiber fabric or other natural fibers, such that anticoagulated blood exposed to the surgical sponge does not tend to clot in the time required to perform a surgical procedure, such as coronary artery bypass grafting, to the extent that it would when exposed to cotton-fiber fabric; and platelets and neutrophils exposed to the surgical sponge do not tend to activate to the extent that they would when exposed to cotton- fiber. Cotton-fiber fabric is specifically used for the manufacture of laparotomy sponges because the fabric tends to promote clotting, a property useful in most surgeries where blood is not recovered from the surgical site and reintroduced into the patient. In one embodiment, the surgical sponge of the present invention comprises a fabric substantially made from biocompatible, manufactured fiber. In a preferred embodiment, the manufactured fiber comprises a polymer material, with or without additives such as plasticizers. In a particularly preferred embodiment, the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as for example, Nomex® or Kevlar®. The second characteristic that distinguishes the device according to the present invention, such as a surgical sponge of the present invention, from presently used laparotomy sponges is that the surgical sponge comprises fabric having a much smaller total surface area that is exposed to a patient's bodily fluids in use than the presently used cotton-fiber fabric, laparotomy sponges. For example, a cotton-fiber fabric, laparotomy sponge is typically in the shape of a square having dimensions of between about 40 cm and 50 cm on each side, and typically comprises four layers of about 900 cotton-fiber strands, where each strand has a length the same as the side length of laparotomy sponge. Each strand comprises about 50 ribbon-like, filaments having cross-sectional dimensions of about 26 μM in width by about 5.5 μM in height thus yielding a surface area for each filament of approximately 2.85 x 10"5 M2. Therefore, the total area of a cotton-fiber fabric, laparotomy sponge having dimensions of 45 cm on each side is about 5.1 M2. By contrast, the total internal surface area of a typical CPB circuit is only about 0.8 M2. This is exclusive of the membrane oxygenator, whose approximately 2 M2 surface is designed to be compatible with blood. Hence, the typical surface area of a single cotton-fiber fabric laparotomy sponge is between about 3 and 5 times the total internal surface area of the CPB circuit, exclusive of the membrane oxygenator. Further, multiple laparotomy sponges are frequently used under the heart during coronary artery bypass grafting, increasing exposure of the patient's blood to cotton-fiber in the laparotomy sponge and increasing the chance of creating microclots. Therefore, in order to decrease the effective surface area where blood is exposed, in a preferred embodiment, the surgical sponge of the present invention substantially comprises monofilament strands, rather than strands comprising bundles of smaller filaments.
Substituting a monofilament strand of equivalent cross sectional area for the multifilament cotton-fiber strand reduces the surface area of the surgical sponge exposed to the patient's blood by about 90% as compared with the presently used cotton-fiber fabric, laparotomy sponge of the same overall dimensions. Surgical sponges of the present invention comprising fabric made substantially of monofilaments made of biocompatible manufactured fibers synergistically decrease the occurrence of microclots and the activation of platelets and neutrophils. Referring now to Figure 1 and Figure 2, there are shown, respectively, a partial, top perspective, view of a device, according to one embodiment of the present invention (Figure 1); and a partial, top perspective, view of a device, according to another embodiment of the present invention (Figure 2). As can be seen in Figure 1, in one preferred embodiment, the device is a surgical sponge 10 comprising a woven fabric 12 of monofilaments 14. In another preferred embodiment, as shown in Figure 2, the device is a surgical sponge 10 comprising a plurality of layers of fabric 12 of monofilaments 14. According to another embodiment of the present invention, there is provided another device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. Referring now to Figure 3 and Figure 4, there are shown, respectively, a top perspective view (Figure 3), and a lateral perspective view of the device shown in Figure 3 (Figure 4). As can be seen in Figure 3 and Figure 4, the device 20 comprises a generally U- shaped structure having a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart. The device 20 comprises two lateral arms 22 having proximal ends 24 and distal ends 26, and a central connecting portion 28 connecting the proximal ends 24 of the lateral arms 22. In one embodiment, as shown in Figure 3 and Figure 4, the distal ends 26 of the arms 22 flare outward slightly. In one embodiment, as shown in Figure 3 and Figure 4, both the wall of the lateral arms 22 and the connecting portion 28 is concave toward the center of the device 20. In a preferred embodiment, the device 20 is produced in a variety of sizes, thereby allowing the surgeon to select a size most suitable to the size of the patient in which the device is being used. By way of example only, in one embodiment, the device generally has maximum external dimensions of approximately 11 cm (from the farthest extent of the central connecting portion 28 to the distal ends 26 of the lateral arms 22) by 6 cm (the distance from the farthest extent of one lateral arm 22 to the other arm 22) by 2 cm (thickness). As will be understood by those with skill in the art with reference to this disclosure, the "a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart" means that the device will fit in the pericardial bed without putting damaging pressure on the heart or surrounding structures, such as, for example, by sharp edges, seams or protrusions that would puncture living tissue, such as the heart or associated structures. In a preferred embodiment, the device 20 comprises a biocompatible material. In another preferred embodiment, the material is non- woven, in order to decrease the total surface area of the device that is exposed to a patient's bodily fluids in use compared to the presently used cotton-fiber fabric, laparotomy sponges. In a preferred embodiment, the material is a polymer. In a particularly preferred embodiment, the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as, for example, Nomex® or Kevlar®. In a preferred embodiment, the device 20 can be sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas. According to another embodiment of the present invention, there is provided another device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair, and configured to replace the laparotomy sponge presently used to move the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. In one embodiment, the device comprises a substance that is readily deformable at room temperature (about 20 °C to 25 °C) and pressure (about 1 atmosphere), such as a substance is in the form of filaments, gas, gel, liquid, particles, or powder and combinations of the preceding, such as for example air, water, saline, frozen saline "slush," gelatin, tightly coiled plastic filaments, sand, beads and viscous solutions of biocompatible long chain polysaccharides, such as mannitol. In a preferred embodiment the material is non-toxic, to prevent injury to the patient if the material is accidently allowed to contact the patient's living tissue. Referring now to Figure 5 and Figure 6, there are shown, respectively, a top perspective view of one embodiment of the device (Figure 5); and a partial cutaway, lateral perspective view of the device shown in Figure 5 taken along line 6-6 (Figure 6). As can be seen in Figure 5, the device 30 comprises a fluid or gel proof covering 32 surrounding a cavity 34 for holding a substance 36 that is readily deformable at room temperature and pressure within the covering 32, to make the device 30 more flexible and less potentially damaging to living tissue. In a particularly preferred embodiment, the device 30 comprises an outlet valve 38, to allow a surgeon to express some of the substance 36 in the cavity 34 to decrease the total volume of the device 30 and allow the device 30 to deform so as to take a more appropriate shape for the use intended. As will be understood by those with skill in the art, the shape of the device 30 can vary and still be within the scope of the present invention. For example, In one embodiment, the device 30 can be substantially rectangular, as shown in Figure 3 and Figure 4. In a preferred embodiment, the covering 32 of the device 30 comprises a biocompatible material. In another preferred embodiment, the material is non-woven, in order to decrease the total surface area of the device that is exposed to a patient's bodily fluids in use compared to the presently used cotton-fiber fabric, laparotomy sponges. In a preferred embodiment, the material is a polymer. In a particularly preferred embodiment, the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride, such as for example, Nomex® or Kevlar®. In a preferred embodiment, the device 30 can be sterilized using standard techniques available in a hospital or clinical setting such as by autoclave and by gas. According to another embodiment of the present invention, there is provided a kit for performing a surgical or medical procedure. The kit comprises a container having a sterilized device according to the present invention sealed within the kit. The device can be any device according to the present invention, as will be understood by those with skill in the art with reference to this disclosure. In use, the container is unsealed, such as for example by peeling back a top layer on the container to expose the device within, or by removing one end of the container to expose the device within. The device is then removed from the container for use. Referring now to Figure 7, there is shown a cutaway, top perspective, view of one embodiment of the kit for performing a surgical or medical procedure according to the present invention. As can be seen, the kit 40 comprises a container 42 comprising a sterilized surgical sponge 10 according to the present invention sealed within the container 42 to maintain the sterility of the surgical sponge 10 until the container 42 is unsealed. Referring now to Figure 8, there is shown a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the present invention. As can be seen, the kit 40 comprises a container 42 comprising a device 20 according to the present invention sealed within the container 42 to maintain the sterility of the device 20 until the container 42 is unsealed. Referring now to Figure 9, there is shown a cutaway, top perspective, view of another embodiment of a kit for performing a surgical or medical procedure according to the present invention. As can be seen, the kit 40 comprises a container 42 comprising a device 30 according to the present invention sealed within the container 42 to maintain the sterility of the device 30 until the container 42 is unsealed. According to another embodiment of the present invention, there is provided a method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. In one embodiment, the method comprises providing a device according to the present invention. Then, the device is placed posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space. In a preferred embodiment, the method comprises providing a kit according to the present invention, unsealing the package, and removing the sterilized device. In a preferred embodiment, the device is a surgical sponge ' ?cording to the present invention. In a preferred embodiment, the device is a device such as the device 20 or device 30 according to the present invention. If the device is at least partially filled with substance, the method can also comprise expressing some of the substance to decrease the volume of the device and allow the device to deform so as to take a more appropriate shape for the use intended. Advantageously, this method does not require a change in the techniques presently being used by surgeons, other than substituting the device of the present invention for the cotton-fiber fabric, laparotomy sponge. According to another embodiment of the present invention, there is provided a method of performing cardiothoracic surgery, such as coronary artery bypass grafting and heart valve repair. In one embodiment, the method comprises creating an opening into the cardiothoracic cavity. Then, a device according to the present invention is provided. Next, the device is placed posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space. Then, the surgery is completed. In a preferred embodiment, the method comprising providing a kit according to the present invention, unsealing the package, and removing the sterilized device. In a preferred embodiment, the device is a surgical sponge according to the present invention. In a preferred embodiment, the device is a device such as the device 20 or device 30 according to the present invention. If the device is at least partially filled with substance, the method can also comprise expressing some of the substance to decrease the volume of the device and allow the device to deform so as to take a more appropriate shape for the use intended. Advantageously, this method does not require a change in the techniques presently being used by surgeons, other than substituting the device of the present invention for the cotton-fiber fabric, laparotomy sponge. Although the present invention has been discussed in considerable detail with reference to certain preferred embodiments, other embodiments are possible. Therefore, the scope of the appended claims should not be limited to the description of preferred embodiments contained in this disclosure. All references cited herein are incorporated by reference to their entirety.

Claims

WHAT IS CLAIMED IS: 1. A surgical sponge useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the surgical sponge substantially comprising a fabric comprising biocompatible, manufactured monofilament fibers.
2. The surgical sponge of claim 1, where the manufactured monofilament fibers comprise a polymer material.
3. The surgical sponge of claim 2, where the polymer material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
4. The surgical sponge of claim 1, where the fabric is woven.
5. The surgical sponge of claim 1, comprising a plurality of layers of fabric.
6. A kit for performing a surgical or medical procedure, the kit comprising a sterilized surgical sponge according to claim 1 sealed within a package.
7. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a surgical sponge according to claim 1 ; and b) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
8. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a surgical sponge according to claim 1 ; and c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and d) completing the surgery.
9. The method of claim 8, where the surgery is a coronary artery bypass graft surgery.
10. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a kit according to claim 6; b) unsealing the package and removing the surgical sponge; and c) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
11. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a kit according to claim 6; c) unsealing the package and removing the surgical sponge; d) placing the surgical sponge posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericard:ιl space; and e) completing the surgery.
12. The method of claim 11, where the surgery is a coronary artery bypass graft surgery.
13. A device useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the device comprising a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart.
14. The device of claim 13, where the form comprises two lateral arms having proximal ends and distal ends, and a central connecting portion connecting the proximal ends of the two lateral arms.
15. The device of claim 14, where the distal ends of the arms flare outward.
16. The device of claim 13, where the material is non- woven.
17. The device of claim 13, where the material comprises a polymer material.
18. The device of claim 15, where the material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
19. The device of claim 13, further comprising, within the material, a substance that is readily deformable at room temperature and pressure.
20. The device of claim 19, where the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder, and combinations of the preceding.
21. The device of claim 17, further comprising an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the device.
22. A kit for performing a surgical or medical procedure, the kit comprising a sterilized device according to claim 13 sealed within a package.
23. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a device according to claim 13; and b) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space.
24. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a device according to claim 13; c) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and d) completing the surgery.
25. The method of claim 24, where the surgery is a coronary artery bypass graft surgery.
26. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a kit according to claim 22; b) unsealing the package and removing the device; and c placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
27. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a kit according to claim 22; c) unsealing the package and removing the device; d) placing the device posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and e) completing the surgery.
28. The method of claim 27, where the surgery is a coronary artery bypass graft surgery.
29. Means useful for moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the means comprising a biocompatible, sterilizable material in a form configured to fit in the pericardial bed between the posterior surface of the heart and the structures normally positioned immediately posterior to the posterior surface of the heart.
30. The means of claim 29, where the material is non-woven.
31. The means of claim 29, where the material comprises a polymer material.
32. The means of claim 29, where the material is selected from the group consisting of an aramid, a para-aramid, a nylon, a polyester, a poly-paraphenylene terephthalamide and a polyvinyl chloride.
33. The means of claim 29, further comprising, within the material, a substance that is readily deformable at room temperature and pressure.
34. The means of claim 33, where the substance is selected from the group consisting of filaments, gas, gel, liquid, particles, powder and combinations of the preceding.
35. The means of claim 29, further comprising an outlet valve, to allow a surgeon to express some of the substance to decrease the volume of the means.
36. A kit for performing a surgical or medical procedure, the kit comprising a sterilized means according to claim 29 sealed within a package.
37. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a means according to claim 29; and b) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space.
38. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a means according to claim 29; and c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and d) completing the surgery.
39. The method of claim 38, where the surgery is a coronary artery bypass graft surgery.
40. A method of moving the heart anteriorly in the pericardial space during cardiothoracic surgery, the method comprising: a) providing a kit according to claim 34; b) unsealing the package and removing the means; and c) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space.
41. A method for performing a cardiothoracic surgery, the method comprising: a) creating an opening into the cardiothoracic cavity; b) providing a kit according to claim 36; c) unsealing the package and removing the means; d) placing the means posterior to or inferior to, or both posterior to or inferior to the heart in the pericardial space, thereby moving the heart anteriorly in the pericardial space; and e) completing the surgery.
42. The method of claim 41 , where the surgery is a coronary artery bypass graft surgery.
PCT/US2005/008652 2004-03-16 2005-03-15 Method and device for coronary artery bypass WO2005089341A2 (en)

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