US20040064138A1 - Atrial appendage remodeling device and method - Google Patents

Atrial appendage remodeling device and method Download PDF

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Publication number
US20040064138A1
US20040064138A1 US10/674,732 US67473203A US2004064138A1 US 20040064138 A1 US20040064138 A1 US 20040064138A1 US 67473203 A US67473203 A US 67473203A US 2004064138 A1 US2004064138 A1 US 2004064138A1
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atrial appendage
appendage
entering
electrocautery
pericardium
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James Grabek
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595—Cauterization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre

Definitions

  • the present invention relates generally to devices and techniques for remodeling the atrial appendage of a mammal. The process takes place through the pericardial space from an access point outside the pericardium or pericardial space.
  • the atrial appendage is an anatomic feature of the left atrium of the human heart. It is widely believed that atrial fibrillation results in a pooling of blood in the atrial appendage which results in clots.
  • the present invention teaches devices and methods of using the devices to remodel the atrial appendage from locations outside the heart but within the pericardial space.
  • the pericardial space is accessed via the chest wall below the rib cage and an endoscope is inserted. It is preferred to perform the process steps under visual guidance although robotic and other location technologies may be used in the alternative.
  • the preferred treatment for the appendage is “wet cautery” where the size and therefore the volume of the appendage is reduced.
  • An alternate preferred device cuts and cauterizes while removing the appendage.
  • Other surgical techniques are useful as well including conventional electrosurgery and cautery and conventional suture and staple techniques. In all instances the volume of the appendage is reduced and in some approaches tissue is removed as well.
  • FIG. 1 is a schematic diagram of the patient's chest cavity
  • FIG. 2 is a schematic diagram of pericardial access process and device
  • FIG. 3 is a schematic diagram of pericardial space visualization process and device
  • FIG. 4 is a schematic diagram of pericardial space electrocautery process and device
  • FIG. 5 is a schematic diagram of an electrocautery process and device
  • FIG. 6 is a schematic diagram of an electrocautery process and device
  • FIG. 7 is a schematic diagram of an endoscopic suture placement process
  • FIG. 8 is a schematic diagram of an endoscopic staple placement process.
  • FIG. 1 shows the patients heart 10 located within the patient's chest cavity 12 .
  • the ribs 14 and skin 16 show the boundary of the chest cavity 12 .
  • the left atrial appendage (LAA) 18 is exaggerated in size to facilitate the description of the invention.
  • the heart 10 chambers lie within the so-called pericardium 20 , which is shown in an exaggerated scale.
  • the pericardium 20 is a bag like structure that surrounds the heart. It is attached to the great vessels at the “top” of the heart and it completely encircles the ventricles and the atrium of the heart.
  • the pericardium 20 provides a low friction surface surrounding the heart that permits motion of the heart. In essence the pericardium allows the heart to “beat” without disturbing other near-by organs.
  • the processes of the invention permit the pericardium to remain “intact”. Although several opening to the pericardial space are illustrated it is emphasized that the smaller the number of “holes” in the pericardium are preferred.
  • FIG. 2 shows initial access to the pericardial space though the use of a pericardial access device 22 , which is described in more detail in U.S. Pat. No. 5,827,216 among others.
  • This patent is incorporated by reference herein and the commercially available device is sold under the trademark “Perducer”.
  • the Perducer is preferred but alternate devices such as that taught by U.S. Pat. No. 5,931,810 could be freely substituted for the Perducer device. If multiple access points are required for a particular patient the two devices may be used together.
  • the preferred device 22 has an aperture at its distal end 24 that allows aspiration of the pericardium 20 into the device.
  • An illustrative source of vacuum is shown as the physician operated syringe 26 .
  • the aspirated tissue drawn into the device 22 can be pierced by the needle 28 .
  • the needle 28 can be translated toward the aspirated tissue by pushing on the proximal end of the needle 28 .
  • a guidewire 30 can next be inserted through the lumen of the needle 28 .
  • the physician can withdraw the needle and use the guidewire to insert a catheter or other device.
  • the access procedure described may be repeated to provide for multiple access sites or locations into the pericardial space.
  • the device shown is preferred it should be recognized that other devices may be used as well.
  • FIG. 3 shows two access sites labeled 50 and 52 respectively.
  • a guide catheter 40 has been introduced into the pericardial space 42 .
  • This access site or port permits access by the endoscope 46 which includes a camera 48 and a display system 52 .
  • these devices provide a visualization system allows visual navigation and manipulation of additional surgical tools in the pericardium 20 .
  • this visualization system is not seen in the remaining drawings its use should be presumed and the deletion from the figure is done to clarify the remaining drawings.
  • most conventional endoscopes in use today have laparoscopic tool access ports built into the device and many steps of the invention can be carried out trough the scope rather than through a separate access site.
  • a typical atrial appendage reduction would require two sites, with one devoted to the introduction of a endoscope.
  • FIG. 4 shows a snare like electrocautery tool 60 introduced into the pericardial space 42 .
  • the distal loop 64 has been navigated visually to “lasso” the atrial appendage.
  • one end of the snare loop 64 is attached to a tubular body 63 while the other end is carried through the lumen of the tubular body 63 and attached to a sliding handle 15 .
  • a fixed handle 17 is attached to the tubular body 63 . Traction applied to the snare loop 64 by moving the sliding handle relative to the fixed handle 17 captures the appendage 18 .
  • the application of electrical energy (RF) from the electrocautery unit 70 can either remove or close the atrial appendage.
  • RF electrical energy
  • this closure process may be essentially bloodless and may be performed under direct visualization through the endoscope (FIG. 3).
  • This process is an example of “dry” cautery as opposed to “wet” cautery described in connection with FIG. 6.
  • the snare like device is preferred there are several commercially available products that can also be used for this step including the loop excision electrodes sold by ValleyLab of Colorado. In general, any specific surgeon may prefer to use other familiar tools for the process.
  • the electrosurgery unit 70 will be connected between the loop 64 and a patient ground depicted as 71 . The physician may activate the hand or foot switch 73 to dissect the appendage.
  • FIG. 5 shows the snare loop 64 isolating the atrial appendage 18 prior to the applicant of electrical energy.
  • the physician my grasp an insulator handle and the connection 19 may not be attached to the generator 70 until after the lasso procedure has been accomplished.
  • the loop electrocautery device is preferred it should be noted that the conventional unipolar or bipolar cautery scissors such as those illustrated as device 13 may be used to cut off the appendage.
  • FIG. 6 shows the use of “wet” electrocautery to “reduce” the atrial appendage.
  • the electrical catheter 80 is irrigated by a fluid flow of saline or other conductive fluid 81 .
  • This wet electrode applies the energy over a wider surface area as a consequence heat is supplied preferentially to the LAA. It is expected that the application of heat will cause the appendage to reduce in size substantially.
  • Fluid assisted electrocautery is known from U.S. Pat. No. 6,063,081 among others.
  • FIG. 7 shows an alternate method of closing off the atrial appendage.
  • a suture 90 has been formed into a loop 92 and passed over the atrial appendage.
  • a laparoscopic knot pusher 94 is passed down one leg of the suture 90 to place and tighten a knot formed in the suture.
  • the use of a suture may be preferred given the size and shape of the appendage 18 .
  • FIG. 8 illustrates an alternate closure device and process.
  • a laparoscopic stapler is used to place one or more staples to close off the atrial appendage.
  • the tool 98 has been used to place one staple seen as staple 97 closing off the appendage.

Abstract

The invention describes a method of treating a patient's left atrial appendage through the pericardial space. The process takes place through the pericardial space from an access point outside the pericardium or pericardial space.

Description

    FIELD OF THE INVENTION
  • The present invention relates generally to devices and techniques for remodeling the atrial appendage of a mammal. The process takes place through the pericardial space from an access point outside the pericardium or pericardial space. [0001]
    • BRIEF DESCRIPTION OF THE PRIOR ART
  • The atrial appendage is an anatomic feature of the left atrium of the human heart. It is widely believed that atrial fibrillation results in a pooling of blood in the atrial appendage which results in clots. [0002]
  • The surgical removal of the atrial appendage through a limited thoracotomy has been proposed by Johnson in U.S. Pat. No. 5,306,234. However, the surgical removal of the appendage remains problematic since the surgical intervention occurs under general anesthesia and is considered major surgery. It should also be realized that even a transluminal minimally invasive approach from inside the heart is problematic since such an approach requires an implantable closure device and has the risk of acute stroke. Typically any closure device left in contact with the interior of the heart is potentially a thromobogenic surface. [0003]
  • For these reasons among others there is a continuing need to improve techniques for occluding or removing the left atrial appendage. [0004]
    • SUMMARY
  • In contrast to the prior art, the present invention teaches devices and methods of using the devices to remodel the atrial appendage from locations outside the heart but within the pericardial space. In use, the pericardial space is accessed via the chest wall below the rib cage and an endoscope is inserted. It is preferred to perform the process steps under visual guidance although robotic and other location technologies may be used in the alternative. The preferred treatment for the appendage is “wet cautery” where the size and therefore the volume of the appendage is reduced. An alternate preferred device cuts and cauterizes while removing the appendage. Other surgical techniques are useful as well including conventional electrosurgery and cautery and conventional suture and staple techniques. In all instances the volume of the appendage is reduced and in some approaches tissue is removed as well.[0005]
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • The invention is illustrated in the figures where like reference numeral represent identical structure throughout the several views wherein: [0006]
  • FIG. 1 is a schematic diagram of the patient's chest cavity; [0007]
  • FIG. 2 is a schematic diagram of pericardial access process and device; [0008]
  • FIG. 3 is a schematic diagram of pericardial space visualization process and device; [0009]
  • FIG. 4 is a schematic diagram of pericardial space electrocautery process and device; [0010]
  • FIG. 5 is a schematic diagram of an electrocautery process and device; [0011]
  • FIG. 6 is a schematic diagram of an electrocautery process and device; [0012]
  • FIG. 7 is a schematic diagram of an endoscopic suture placement process; and [0013]
  • FIG. 8 is a schematic diagram of an endoscopic staple placement process.[0014]
    • DETAILED DESCRIPTION
  • FIG. 1 shows the [0015] patients heart 10 located within the patient's chest cavity 12. The ribs 14 and skin 16 show the boundary of the chest cavity 12. The left atrial appendage (LAA) 18 is exaggerated in size to facilitate the description of the invention. The heart 10 chambers lie within the so-called pericardium 20, which is shown in an exaggerated scale. The pericardium 20 is a bag like structure that surrounds the heart. It is attached to the great vessels at the “top” of the heart and it completely encircles the ventricles and the atrium of the heart. The pericardium 20 provides a low friction surface surrounding the heart that permits motion of the heart. In essence the pericardium allows the heart to “beat” without disturbing other near-by organs.
  • The processes of the invention permit the pericardium to remain “intact”. Although several opening to the pericardial space are illustrated it is emphasized that the smaller the number of “holes” in the pericardium are preferred. [0016]
  • FIG. 2 shows initial access to the pericardial space though the use of a [0017] pericardial access device 22, which is described in more detail in U.S. Pat. No. 5,827,216 among others. This patent is incorporated by reference herein and the commercially available device is sold under the trademark “Perducer”. The Perducer is preferred but alternate devices such as that taught by U.S. Pat. No. 5,931,810 could be freely substituted for the Perducer device. If multiple access points are required for a particular patient the two devices may be used together.
  • The [0018] preferred device 22 has an aperture at its distal end 24 that allows aspiration of the pericardium 20 into the device. An illustrative source of vacuum is shown as the physician operated syringe 26. The aspirated tissue drawn into the device 22 can be pierced by the needle 28. The needle 28 can be translated toward the aspirated tissue by pushing on the proximal end of the needle 28.
  • A [0019] guidewire 30 can next be inserted through the lumen of the needle 28. With the guidewire in the pericardial space, the physician can withdraw the needle and use the guidewire to insert a catheter or other device. The access procedure described may be repeated to provide for multiple access sites or locations into the pericardial space. Although the device shown is preferred it should be recognized that other devices may be used as well.
  • FIG. 3 shows two access sites labeled [0020] 50 and 52 respectively. A guide catheter 40 has been introduced into the pericardial space 42. This access site or port permits access by the endoscope 46 which includes a camera 48 and a display system 52. Together these devices provide a visualization system allows visual navigation and manipulation of additional surgical tools in the pericardium 20. Although this visualization system is not seen in the remaining drawings its use should be presumed and the deletion from the figure is done to clarify the remaining drawings. It should be noted that most conventional endoscopes in use today have laparoscopic tool access ports built into the device and many steps of the invention can be carried out trough the scope rather than through a separate access site. However, it is expected that a typical atrial appendage reduction would require two sites, with one devoted to the introduction of a endoscope.
  • FIG. 4 shows a snare like [0021] electrocautery tool 60 introduced into the pericardial space 42. The distal loop 64 has been navigated visually to “lasso” the atrial appendage. In the device seen in FIG. 4, one end of the snare loop 64 is attached to a tubular body 63 while the other end is carried through the lumen of the tubular body 63 and attached to a sliding handle 15. A fixed handle 17 is attached to the tubular body 63. Traction applied to the snare loop 64 by moving the sliding handle relative to the fixed handle 17 captures the appendage 18. The application of electrical energy (RF) from the electrocautery unit 70 can either remove or close the atrial appendage. It is important to note that this closure process may be essentially bloodless and may be performed under direct visualization through the endoscope (FIG. 3). This process is an example of “dry” cautery as opposed to “wet” cautery described in connection with FIG. 6. Although the snare like device is preferred there are several commercially available products that can also be used for this step including the loop excision electrodes sold by ValleyLab of Colorado. In general, any specific surgeon may prefer to use other familiar tools for the process. Typically, the electrosurgery unit 70 will be connected between the loop 64 and a patient ground depicted as 71. The physician may activate the hand or foot switch 73 to dissect the appendage.
  • FIG. 5 shows the [0022] snare loop 64 isolating the atrial appendage 18 prior to the applicant of electrical energy. In the figure the physician my grasp an insulator handle and the connection 19 may not be attached to the generator 70 until after the lasso procedure has been accomplished. Although the loop electrocautery device is preferred it should be noted that the conventional unipolar or bipolar cautery scissors such as those illustrated as device 13 may be used to cut off the appendage.
  • FIG. 6 shows the use of “wet” electrocautery to “reduce” the atrial appendage. In this procedure the [0023] electrical catheter 80 is irrigated by a fluid flow of saline or other conductive fluid 81. This wet electrode applies the energy over a wider surface area as a consequence heat is supplied preferentially to the LAA. It is expected that the application of heat will cause the appendage to reduce in size substantially. Fluid assisted electrocautery is known from U.S. Pat. No. 6,063,081 among others.
  • FIG. 7 shows an alternate method of closing off the atrial appendage. In this situation a [0024] suture 90 has been formed into a loop 92 and passed over the atrial appendage. A laparoscopic knot pusher 94 is passed down one leg of the suture 90 to place and tighten a knot formed in the suture. The use of a suture may be preferred given the size and shape of the appendage 18.
  • FIG. 8 illustrates an alternate closure device and process. In this figure a laparoscopic stapler is used to place one or more staples to close off the atrial appendage. In the figure the [0025] tool 98 has been used to place one staple seen as staple 97 closing off the appendage.

Claims (9)

What is claimed is:
1. A method for treating the atria appendage comprising:
entering the chest cavity with a surgical instrument creating a surgical opening;
introducing a pericardial access device through said opening;
entering the pericardial space between the pericardium and the heart;
navigating an electrosurgery device to the atrial appendage;
activating the electrosurgical device to remodel the atrial appendage.
2. The method of claim 2 wherein said navigating step is carried out under visual guidance through the endoscopic system.
3. The method of claim 1 wherein said electrosurgical device is a unipolar electrocautery scissors.
4. The method of claim 1 wherein said electrocautery device is a bipolar electrocautery scissors.
5. The method of claim 1 wherein said electrocautery device is a snare loop.
6. The method of claim 1 wherein said electrocautery device includes at least one saline electrode.
7. The method of shrinking the atrial appendage comprising the steps:
entering the chest cavity with a surgical instrument creating a surgical opening;
introducing a pericardial access device through said opening of the type having an extended catheter body with an aspiration lumen for connecting to the pericardium;
entering the pericardial space between the pericardium and the heart;
navigating an electrosurgery device of the type having at east one saline electrode, to the atrial appendage;
activating the electrosurgical device while irrigating the artrial appendage with saline from the electrosurgery device, to remodel the atrial appendage.
9. A method for treating the atrial appendage comprising:
entering the chest cavity with a surgical instrument creating a surgical opening;
introducing a pericardial access device through said opening;
entering the pericardial space between the pericardium and the heart;
navigating an endoscopic stapling device to the atrial appendage;
activating the stapling device to remodel the atrial appendage by closing off a portion of said atrial appendage.
10. An electrosurgery device for cutting tissue comprising:
an elongate tubular body;
a fixed handle attached to said tubular body;
a sliding handle adapted to slide along said tubular body and located proximate said fixed handle;
a snare having a first end connected to said tubular body and a second end attached to said movable handle, whereby motion of said movable handle manipulates the snare.
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