Methods and apparatus for accessing and stabilizing an area of the heart
First Claim
1. A suction tool for accessing the epicardium of the heart through an incision through the pericardium and into the pericardial space to implant an electrode of an epicardial cardiac lead within the myocardium or against the epicardium comprising:
- a suction tool body extending between a suction tool body proximal end and a suction tool body distal end; and
an elongated suction pad extending between a suction pad proximal end and a suction pad distal end, the suction pad proximal end attached to the suction tool body distal end, the suction pad shaped to have a suction cavity adapted to be applied against tissue, the suction cavity defined by an elongated, substantially concave suction cavity wall bounded by a suction cavity rim, a plurality of suction ports extending through the suction cavity wall into the suction cavity, the suction pad distal end shaped with a leader to fit through a pericardial incision and a tissue dilator to be inserted through the pericardial incision to facilitate advancement of the suction pad into the pericardial space, the suction tool body further comprising;
a suction lumen extending from a proximal suction fitting adapted to be coupled to a vacuum source and to the plurality of suction ports through which suction is applied to the pericardium to draw a pericardial bleb of the pericardium into the suction cavity when the suction cavity wall is applied against the pericardium and through which suction is applied to the epicardium to draw an myocardial bleb of the myocardium into the suction cavity when the suction pad is inserted through an incision of the pericardium into the suction cavity wall and applied against the epicardium; and
a working lumen extending between a working lumen proximal end opening and an working lumen distal end opening into the suction cavity, the working lumen adapted to receive a cutting instrument having a cutting element for cutting into the pericardial bleb to form a pericardial incision through which the suction pad can be advanced into the pericardial space, the working lumen further adapted to receive a cardiac lead having a distal electrode and a lead fixation mechanism for maintaining the distal electrode in contact with the myocardium.
1 Assignment
0 Petitions
Accused Products
Abstract
A tubular suction tool for accessing an anatomic surface or anatomic space and particularly the pericardium to access pericardial space and the epicardial surface of the heart to implant cardiac leads in a minimally invasive manner are disclosed. The suction tool incorporates a suction pad concave wall defining a suction cavity, a plurality of suction ports arrayed about the concave wall, and a suction lumen, to form a bleb of tissue into the suction cavity when suction is applied. The suction cavity extends along one side of the suction pad, so that the suction pad and suction cavity can be applied tangentially against a tissue site. The suction tool can incorporate light emission and video imaging of tissue adjacent the suction pad. A working lumen terminating in a working lumen port into the suction cavity enables introduction of tools, cardiac leads, and other instruments, cells, drugs or materials into or through the tissue bleb drawn into the suction cavity.
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Citations
24 Claims
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1. A suction tool for accessing the epicardium of the heart through an incision through the pericardium and into the pericardial space to implant an electrode of an epicardial cardiac lead within the myocardium or against the epicardium comprising:
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a suction tool body extending between a suction tool body proximal end and a suction tool body distal end; and
an elongated suction pad extending between a suction pad proximal end and a suction pad distal end, the suction pad proximal end attached to the suction tool body distal end, the suction pad shaped to have a suction cavity adapted to be applied against tissue, the suction cavity defined by an elongated, substantially concave suction cavity wall bounded by a suction cavity rim, a plurality of suction ports extending through the suction cavity wall into the suction cavity, the suction pad distal end shaped with a leader to fit through a pericardial incision and a tissue dilator to be inserted through the pericardial incision to facilitate advancement of the suction pad into the pericardial space, the suction tool body further comprising;
a suction lumen extending from a proximal suction fitting adapted to be coupled to a vacuum source and to the plurality of suction ports through which suction is applied to the pericardium to draw a pericardial bleb of the pericardium into the suction cavity when the suction cavity wall is applied against the pericardium and through which suction is applied to the epicardium to draw an myocardial bleb of the myocardium into the suction cavity when the suction pad is inserted through an incision of the pericardium into the suction cavity wall and applied against the epicardium; and
a working lumen extending between a working lumen proximal end opening and an working lumen distal end opening into the suction cavity, the working lumen adapted to receive a cutting instrument having a cutting element for cutting into the pericardial bleb to form a pericardial incision through which the suction pad can be advanced into the pericardial space, the working lumen further adapted to receive a cardiac lead having a distal electrode and a lead fixation mechanism for maintaining the distal electrode in contact with the myocardium. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A system for accessing the epicardium of the heart through an incision through the pericardium and into the pericardial space to implant an epicardial cardiac lead comprising:
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a suction tool comprising;
a suction tool body extending between a suction tool body proximal end and a suction tool body distal end; and
an elongated suction pad extending between a suction pad proximal end and a suction pad distal end, the suction pad proximal end attached to the suction tool body distal end, the suction pad shaped to have a suction cavity adapted to be applied against tissue, the suction cavity defined by an elongated, substantially concave suction cavity wall bounded by a suction cavity rim, a plurality of suction ports extending through the suction cavity wall into the suction cavity, the suction pad distal end shaped to form a tissue dilator to be inserted through an incision made through the pericardium to facilitate advancement of the suction pad into the pericardial space, the suction tool body further comprising a suction lumen extending from a proximal suction fitting adapted to be coupled to a vacuum source and to the plurality of suction ports suction through which suction is applied to the pericardium to draw a pericardial bleb of the pericardium into the suction cavity when the suction cavity wall is applied against the pericardium and through which suction is applied to the epicardium to draw an myocardial bleb of the myocardium into the suction cavity when the suction pad is inserted through an incision of the pericardium into the suction cavity wall and applied against the epicardium, and a working lumen extending between a working lumen proximal end opening and an working lumen distal end opening into the suction cavity; and
a cutting instrument having a cutting element adapted to be inserted through the working lumen for cutting into the pericardial bleb to form a pericardial incision through which the suction pad can be inserted into the pericardial space, whereby a cardiac lead having a distal electrode and a lead fixation mechanism for maintaining the distal electrode in contact with the myocardium can be inserted through the working lumen to fix the distal electrode in contact with the myocardium. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method of accessing the epicardium of the heart through an incision through the pericardium and into the pericardial space to implant an epicardial cardiac lead comprising:
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inserting a suction tool body extending between a suction tool body proximal end and a suction tool body distal end through a pathway in the body to dispose a suction pad of the suction tool in proximity to the epicardium, the suction pad extending between a suction pad proximal end and a suction pad distal end, the suction pad proximal end attached to the suction tool body distal end, the suction pad shaped to have a suction cavity adapted to be applied against tissue, the suction cavity defined by an elongated, substantially concave suction cavity wall bounded by a suction cavity rim, a plurality of suction ports extending through the suction cavity wall to a suction lumen extending through the suction tool body to the suction tool body proximal end, and a working lumen extending from the suction tool proximal end into the suction cavity;
applying the suction cavity against the pericardium;
applying suction through the suction lumen and the suction ports to the pericardium to draw a pericardial bleb of the pericardium into the suction cavity;
advancing a cutting instrument through the working lumen and cutting through the pericardial bleb to form a pericardial incision;
advancing the suction pad through the pericardial incision to dispose the suction cavity against the epicardium;
applying suction through the suction lumen and the suction ports to the epicardium to draw an myocardial bleb of the myocardium into the suction cavity;
advancing a cardiac lead having a distal fixation mechanism through the working lumen; and
fixing the distal fixation mechanism to the myocardial bleb. - View Dependent Claims (16, 17, 18, 19)
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20. A method of implanting an epicardial cardiac lead comprising:
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inserting a suction tool body extending between a suction tool body proximal end and a suction tool body distal end through a pathway in the body to dispose a suction pad of the suction tool in proximity to the epicardium, the suction pad extending between a suction pad proximal end and a suction pad distal end, the suction pad proximal end attached to the suction tool body distal end, the suction pad shaped to have a suction cavity adapted to be applied against tissue, the suction cavity defined by an elongated, substantially concave suction cavity wall bounded by a suction cavity rim, a plurality of suction ports extending through the suction cavity wall to a suction lumen extending through the suction tool body to the suction tool body proximal end, and a working lumen extending from the suction tool proximal end into the suction cavity;
forming a pericardial incision;
advancing the suction pad through the pericardial incision to dispose the suction cavity against the epicardium;
applying suction through the suction lumen and the suction ports to the epicardium to draw an myocardial bleb of the myocardium into the suction cavity;
advancing a cardiac lead having a distal fixation mechanism through the working lumen; and
fixing the distal fixation mechanism to the myocardial bleb. - View Dependent Claims (21, 22, 23, 24)
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Specification