US20070010793A1 - Method and system for accessing a pericardial space - Google Patents
Method and system for accessing a pericardial space Download PDFInfo
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- US20070010793A1 US20070010793A1 US11/159,705 US15970505A US2007010793A1 US 20070010793 A1 US20070010793 A1 US 20070010793A1 US 15970505 A US15970505 A US 15970505A US 2007010793 A1 US2007010793 A1 US 2007010793A1
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- shaft
- cavity
- needle
- distal end
- pericardium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
Definitions
- the present invention relates to medical devices and methods for accessing an anatomical space of the body. More specifically, the invention relates to devices and methods for accessing the pericardial space of the heart in a minimally-invasive manner.
- the human heart is enveloped within a tissue structure referred to as the pericardium, which comprises two major parts.
- the inner layer of the pericardium lies immediately over the myocardium (heart muscle) and is referred to as the visceral pericardium or epicardium.
- the outer layer, forming a sac around the visceral pericardium, is referred to as the parietal pericardium.
- Normally these two layers lie in close contact with each other and are separated only by a thin layer of pericardial fluid, which allows the heart to move within the parietal sac with minimal friction.
- the potential space between the visceral and parietal pericardia is referred to as the pericardial space.
- the visceral pericardium is commonly referred to as the epicardium and the parietal pericardium is commonly referred to as the pericardium. This naming convention will be used herein.
- pericardial space Access to the pericardial space is necessary for a variety of medical procedures, including treatment of infections, injuries, and heart defects.
- cardiac rhythm management systems such as pacemakers, implantable pulse generators, and implantable cardioverter defibrillators include electrode bearing leads for sensing and stimulating the heart. These leads can be deployed from inside or outside the heart. In the latter case, the pericardial space is typically traversed to reach the epicardium for lead implantation and attachment.
- the present invention is a device for accessing a pericardial space of a heart.
- the device includes a shaft that extends from a proximal end to a distal end and defines a cavity disposed near the distal end.
- the shaft further includes a suction lumen terminating in at least one distal suction port located within the cavity.
- a hollow needle extends through the shaft and is fixed in position relative to a longitudinal axis of the shaft. The needle has a sharp distal end protruding into the cavity toward a heart surface at an angle with respect to a longitudinal axis of the shaft.
- the present invention is a device for accessing a pericardial space of a heart and includes a shaft extending from a proximal end to a distal end, and having a suction lumen terminating in at least one distal suction port near the distal end and an inflation lumen.
- An inflatable member is positioned near a distal end of the shaft and has a collapsed configuration and an inflated configuration that defines a cavity. The inflatable member is in communication with the inflation lumen.
- the device includes a hollow needle adapted for advancement through the shaft into the cavity.
- the present invention is a method of accessing the pericardial space in which a distal end of a shaft is maneuvered to the pericardial surface.
- An inflatable member disposed at the distal end of the shaft is inflated to an inflated configuration defining a cavity adjacent the pericardial surface.
- Suction is applied within the cavity to draw the pericardium into the cavity and create an enlarged region.
- the pericardium within the cavity is pierced to access the pericardial space and a payload is inserted through the pierced pericardium and into the pericardial space.
- FIG. 1 is a schematic view of a pericardial access system, according to one embodiment of the invention, in relation to a heart.
- FIG. 2 is a side sectional view of a pericardial access system, according to one embodiment of the invention, in relation to the anatomic layers of the heart.
- FIG. 3 is a flowchart detailing a method of accessing the pericardial space using the pericardial access system of FIG. 2 .
- FIG. 4 is a side sectional view of the pericardial access system of FIG. 2 in which negative pressure has been applied.
- FIG. 5 is a side sectional view of the pericardial access system of FIG. 2 in which the pericardium has been pierced.
- FIG. 6 is a perspective view of the underside of a pericardial access system in accordance with another embodiment of the present invention.
- FIG. 7 is a flowchart detailing a method of accessing the pericardial space using the pericardial access system of FIG. 6 .
- FIG. 8 is a side sectional view of the pericardial access system of FIG. 6 in relation to the anatomic layers of the heart in which the inflatable member is deflated.
- FIG. 9 is a side sectional view of the pericardial access system of FIG. 8 in which the inflatable member is inflated.
- FIG. 10 is a side sectional view of the pericardial access system of FIG. 8 in which negative pressure has been applied.
- FIG. 11 is a side sectional view of the pericardial access system of FIG. 8 in which a needle has been advanced to pierce the pericardium.
- FIG. 12 is a side sectional view of the pericardial access system of FIG. 8 in which a guidewire has been introduced into the pericardial space.
- FIG. 13 is a perspective view of a pericardial access system in accordance with another embodiment of the present invention.
- FIG. 14 is a side sectional view of the pericardial access system of FIG. 13 .
- FIG. 15 is an end view of a shaft of the pericardial access system of FIG. 13 .
- FIG. 1 is a general schematic illustration of a pericardial access device 10 , in accordance with a first embodiment of the present invention, in relation to a heart 20 .
- the pericardial access device 10 is positioned adjacent a pericardium 22 of the heart 20 .
- a pericardial space 24 lies opposite the pericardium 22 and is bounded by an epicardium 26 on its far side. The epicardium 26 contacts a myocardium 28 on the side opposite the pericardial space 24 .
- the pericardial access device 10 may be employed for accessing the pericardial space 24 to facilitate a variety of procedures, including those requiring a minimally invasive approach to the heart 20 .
- Such procedures include, for example, epicardial lead placement, cellular myoplasty, transmyocardial revascularization, epicardial ablation, closed chest coronary anastomosis, epicardial/myocardial drug delivery, diagnoses and pericardicentesis (draining pericardial fluid).
- the device 10 includes a shaft 12 and a needle 14 fixed in relation to a longitudinal axis of the shaft 12 (i.e., the needle 14 is prevented from moving longitudinally within the shaft 12 ).
- the shaft 12 extends from a proximal end (not shown) to a distal end 16 provided with an atraumatic tip 17 .
- the shaft 12 is sized so that the distal end 16 can be brought into proximity with the pericardium 22 while the proximal end is accessible from outside of the chest cavity.
- the shaft 12 includes a cavity or recessed region 18 having a depth, d, disposed near the distal end 16 , preferably somewhat proximal relative to the distal tip 17 of the shaft 12 .
- a suction lumen 30 extends from a proximal port (not shown) near the proximal end of the shaft adapted for connecting to a source of negative pressure to a suction port 32 disposed at the recessed region 18 of the shaft 12 .
- the cavity or region 18 includes a plurality of ports 32 distributed at various locations to optimize the suction force applied to the pericardium 22 .
- the cavity 18 is defined by a substantially concave cavity wall. In other embodiments, the cavity 18 has other shapes and configurations.
- the needle 14 is a hollow tubular structure defining an inner bore 33 and having a sharp distal tip 36 .
- the needle tip 36 protrudes into the recessed region 18 of the shaft 12 a fixed distance and, in one embodiment, is angled downwardly, or towards the pericardium 22 . However, the needle 14 extends downwardly no further than the depth, d, of the cavity 18 , such that the needle tip 36 is wholly located within the cavity 18 . This prevents the needle tip 36 from snagging on tissue as the pericardial access device 10 is advanced to the heart 20 .
- the needle 14 includes an access port 34 in fluid communication with the needle bore 33 .
- the access port 34 is located near the needle tip 36 and is positioned within the cavity 18 of the shaft 12 .
- the needle bore 33 and access port 34 are adapted for slidably receiving medical instruments, for example, guidewires, and/or fluids or gases.
- the needle 14 extends from about 0.5 to about 3 mm into the cavity 18 .
- the needle 14 extends downwardly toward the heart at an angle of from about 15 to about 60 degrees with respect to a longitudinal axis of the shaft 12 .
- the suction lumen 30 encompasses generally the entire interior of the shaft 12 , and the needle 14 is positioned within the suction lumen 30 , as is shown in FIG. 2 .
- the shaft 12 includes a secondary lumen separate from the suction lumen 30 for receiving the needle 14 (see for example FIG. 6 ), or the needle 13 is integrally formed within the shaft 12 .
- FIG. 3 is a flowchart detailing a method 100 of accessing the pericardial space 24 using the pericardial access system 10 of FIG. 2 according to one embodiment of the present invention.
- the shaft 12 is inserted into the chest by, for example, a sub-xiphoid insertion route, and maneuvered to the pericardium 22 of the heart 20 so that the recessed region 18 is positioned adjacent the pericardium 22 (block 102 ).
- Suction or negative pressure is applied to the suction port 32 via the suction lumen 30 , drawing the pericardium 22 into the recessed region 18 , as is shown in FIG. 4 , forming what is known as a pericardial bleb.
- the negative pressure is sufficient to cause the pericardium 22 to engage the stationary and protruding needle tip 36 , such that the needle tip 36 is caused to penetrate the pericardium 22 (block 106 ), as shown in FIG. 4 .
- the depth, d, of the cavity 18 is sufficient that when the pericardium 22 is drawn upwardly, the needle tip 36 not only penetrates the pericardium 22 , but also the access port 34 extends into the pericardial space 24 .
- a payload, such as a guidewire 38 is inserted through the access port 34 via the needle bore 33 and into the pericardial space 24 within the recessed region 18 (block 108 ), as shown in FIG. 5 .
- the negative pressure is removed, allowing the pericardium 22 to withdraw to a normal position, disengaging from the needle tip 36 (block 110 ).
- the shaft 12 is withdrawn from the pericardium 22 (block 112 ), with the guidewire 38 remaining in the pericardial space 24 .
- the guidewire 38 may be employed to facilitate the delivery of other instruments, for example, cardiac pacing leads.
- the needle 14 may be employed to drain off excess fluid from the pericardial space 24 .
- the pericardial space 24 is accessed without piercing the epicardium 26 .
- the needle tip 36 is in a fixed position in relation to the recessed region 18 , there is no danger of over inserting the needle 14 or of the needle 14 inadvertently snagging on tissues.
- it is unnecessary to advance the needle 14 into position after suctioning to the pericardium 22 there is no risk of dislodging the suction port 32 from the pericardium 22 .
- FIG. 6 is a bottom perspective view of a pericardial access device 200 according to another embodiment of the present invention.
- the pericardial access device 200 includes a shaft 202 and a needle 204 slidably disposed within the shaft 202 (see FIGS. 8-12 ).
- the shaft 202 extends from a proximal end (not shown) to a distal end 206 and includes an inflation lumen 208 and a suction lumen 210 .
- the inflation lumen 208 extends from a proximal end adapted for connection to a source of air or fluid pressure (not shown) to a distal end 212 in fluid communication with an inflatable member 214 .
- Inflatable member 214 may be toroidal or ring-shaped, and is disposed on the shaft 202 proximal to an atraumatic distal tip 216 of the shaft 202 .
- the shaft includes a slight recess 215 sized to receive the inflatable member 214 when in a deflated configuration.
- Inflatable member 214 may have a variety of other shapes, and recess 215 may have a variety of configuration to accommodate inflatable member 214 .
- inflatable member 214 may be elliptical, egg-shaped, elongated, or asymmetric. Particular shapes may be chosen to facilitate forming a sealing engagement with a surface of the heart.
- the suction lumen 210 extends from a proximal end adapted for connection to a source of suction or negative pressure (not shown) to a distal end 218 in fluid communication with a suction port 220 .
- the suction port 220 is disposed on the shaft 202 proximal to the distal tip 216 of the shaft 202 and in particular is positioned within the circumference of the inflatable member 214 , such that the inflatable member 214 generally surrounds the suction port 220 .
- the shaft 202 may include multiple suction lumens terminating at various locations within the circumference of the inflatable member 214 .
- the shaft 202 further includes a secondary lumen 222 having a distal port 224 disposed adjacent the suction port 220 within the circumference of the inflatable member 214 .
- the secondary lumen 222 and the suction lumen 210 are one in the same (Not shown; see generally the embodiment of FIG. 2 ).
- the secondary lumen 222 is adapted for slidably receiving the needle 204 , as is shown in FIGS. 8-12 .
- FIG. 7 is a flowchart detailing a method 250 of accessing the pericardial space 24 using the pericardial access device 200 of FIG. 6 , according to one embodiment of the present invention.
- the shaft 202 is inserted into the chest using, for example, a sub-xiphoid insertion route, and the distal end 206 is brought into proximity with the pericardium 22 so that the inflatable member 214 is positioned adjacent the pericardium 22 (block 252 ), as shown in FIG. 8 .
- the inflatable member 214 is inflated, forming a toroidal or cylindrical-shaped ring adjacent the pericardium 22 (block 254 ).
- the inflated inflatable member 214 defines an open space or cavity 230 adjacent the pericardium 22 and causes the suction port 220 to be spaced above the pericardium 22 . Negative pressure is then applied to the suction lumen 210 , causing the pericardium 22 to be drawn upwardly into the cavity 230 (block 256 ), as shown in FIG. 10 , forming what is known as a pericardial bleb. This increases the volume of a region 234 of the pericardial space 24 adjacent the inflatable member 214 .
- the needle 204 is advanced through the secondary lumen 220 to penetrate the pericardium 22 and enter the enlarged pericardial space 234 (block 258 ), as shown in FIG. 11 .
- a payload such as a guidewire 238
- the needle 204 is removed and the payload is introduced directly through the secondary lumen 222 .
- needle 204 is withdrawn (block 262 ) and the negative pressure is eliminated, allowing the pericardium 22 to retract (block 264 ).
- the inflation fluid or gas is reduced or removed, deflating the inflatable member (block 266 ).
- the pericardial access system 200 may then be removed from the heart 20 (block 268 ), leaving the payload in place.
- the pericardial access device 200 displays a lower profile.
- the inflatable member 214 defines a pericardial bleb, as is shown in FIG. 10 , suitable for facilitating a variety of procedures.
- the inflatable member 214 may be inflated to an intermediate configuration defining a cavity of a different volume or configuration than in the fully inflated configuration. This allows the user to control the size or configuration of the region 234 .
- the secondary lumen 222 may be formed with varying angles adapted to point the needle 204 toward the pericardium 22 .
- the angle may be greater or lower to increase or decrease the amount of force needed to penetrate the pericardium 22 , or to facilitate navigation of the needle 204 therethrough.
- the needle 204 extends from a proximal end (not shown) to a sharp distal end 226 .
- Needle 204 is hollow and terminates in a distal port 230 at or proximally adjacent to the distal end 226 .
- the needle 204 may be adapted for receiving a payload such as a medical instrument, for example, a guidewire, or a fluid or gas.
- FIGS. 13-15 show a pericardial access device 300 in accordance with another embodiment of the present invention.
- the pericardial access device 300 includes a tubular body 302 having an inner suction lumen 304 and a hollow needle 306 disposed within the suction lumen 304 .
- the needle is held in position by a flange structure 308 made up of a needle flange 310 extending about a proximal portion 312 of the needle 306 and a retention flange 314 extending inwardly from an inner wall 316 of the shaft 302 .
- An outer diameter OD of the needle flange 310 is greater than an inner diameter ID of the retention flange 314 .
- the needle flange 310 engages the retention flange 314 and prevents further longitudinal displacement of the needle 306 with respect to the shaft 302 . However, the needle 306 is free to rotate.
- a secondary retention flange 322 is positioned proximal to and spaced apart from the retention flange 314 .
- the needle flange 310 is positioned therebetween to prevent inadvertent proximal displacement of the needle 306 .
- the needle 306 includes a secondary needle flange and the needle flange 310 and secondary needle flange are disposed on opposite sides of a single retention flange 314 .
- the retention flange 314 and secondary flange 322 are made up of multiple individual flanges 324 spaced apart from one another, defining spaces 326 .
- Spaces 326 provides a passage for vacuum or suction to be applied throughout the suction lumen 304 .
- the needle flange 310 is positioned on the needle 306 such that the distal end 318 of the needle 306 is recessed by a distance D from the access port 320 of the shaft 302 , forming a cavity or recessed space 328 between the distal end 320 of the shaft 302 and the distal end 318 of the needle 306 .
- the access port 320 of the shaft 302 is engaged to a surface of the pericardium 22 and suction is applied.
- the shaft 302 , and thus needle 306 is preferably positioned relative to the pericardium 22 to form an angle of about 90 degrees with respect to the pericardium 22 .
- the access port 320 of the shaft 302 is sealed to the pericardium 22 , and a portion of the pericardium 22 adjacent the access port 320 is drawn into the cavity 328 forming a pericardial bleb (not shown).
- the distance D is such that the portion of the pericardium 22 drawn into the cavity 328 engages the distal end 318 of the needle 306 and is pierced by the needle 306 .
- the needle 302 can be rotated to facilitate piercing. Payloads, such as guidewires, can then be fed through the needle 306 into an enlarged space between the pericardium 22 and epicardium 26 to access the pericardial space 24 therebetween.
- a pericardial access device may be used for a variety of procedures, including, for example, epicardial lead placement, cellular myoplasty, epicardial ablation, drug delivery, blind pericardial access, endoscopic pericardial access and endoscopic dissection of tissue reflections or adhesions. It can also be used for entering other spaces between anatomic tissue layers, including the peritoneum, vascular sheaths (for treatment of carotid disease or iliac/femoral artery disease) and the dura.
- a pericardial access system requires only a single surgical access point to locate the pericardium 22 , form an enlarged region of pericardial space, and deliver a medical instrument into the pericardial space 24 without damaging the underlying tissues.
Abstract
A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.
Description
- The present invention relates to medical devices and methods for accessing an anatomical space of the body. More specifically, the invention relates to devices and methods for accessing the pericardial space of the heart in a minimally-invasive manner.
- The human heart is enveloped within a tissue structure referred to as the pericardium, which comprises two major parts. The inner layer of the pericardium lies immediately over the myocardium (heart muscle) and is referred to as the visceral pericardium or epicardium. The outer layer, forming a sac around the visceral pericardium, is referred to as the parietal pericardium. Normally these two layers lie in close contact with each other and are separated only by a thin layer of pericardial fluid, which allows the heart to move within the parietal sac with minimal friction. The potential space between the visceral and parietal pericardia is referred to as the pericardial space. The visceral pericardium is commonly referred to as the epicardium and the parietal pericardium is commonly referred to as the pericardium. This naming convention will be used herein.
- Access to the pericardial space is necessary for a variety of medical procedures, including treatment of infections, injuries, and heart defects. For example, cardiac rhythm management systems such as pacemakers, implantable pulse generators, and implantable cardioverter defibrillators include electrode bearing leads for sensing and stimulating the heart. These leads can be deployed from inside or outside the heart. In the latter case, the pericardial space is typically traversed to reach the epicardium for lead implantation and attachment.
- Part of the challenge in accessing the pericardial space stems from its minimal thickness. When making an incision or perforation in the pericardium, it is preferable to avoid also puncturing the underlying epicardium and damaging the myocardium or a coronary vessel. The close proximity of the epicardium to the pericardium makes this difficult. Another important consideration is the trend toward minimally-invasive surgical techniques, which generally are associated with a host of advantages including lower costs and fewer complications.
- There is a need in the art for improved, efficacious methods and devices for penetrating the pericardium and thereby accessing the pericardial space, which minimize the risk of damaging other heart tissues. There is a further need for such methods and devices that are compatible with minimally-invasive surgical techniques.
- According to one embodiment, the present invention is a device for accessing a pericardial space of a heart. The device includes a shaft that extends from a proximal end to a distal end and defines a cavity disposed near the distal end. The shaft further includes a suction lumen terminating in at least one distal suction port located within the cavity. A hollow needle extends through the shaft and is fixed in position relative to a longitudinal axis of the shaft. The needle has a sharp distal end protruding into the cavity toward a heart surface at an angle with respect to a longitudinal axis of the shaft.
- According to another embodiment, the present invention is a device for accessing a pericardial space of a heart and includes a shaft extending from a proximal end to a distal end, and having a suction lumen terminating in at least one distal suction port near the distal end and an inflation lumen. An inflatable member is positioned near a distal end of the shaft and has a collapsed configuration and an inflated configuration that defines a cavity. The inflatable member is in communication with the inflation lumen. Finally, the device includes a hollow needle adapted for advancement through the shaft into the cavity.
- According to still another embodiment, the present invention is a method of accessing the pericardial space in which a distal end of a shaft is maneuvered to the pericardial surface. An inflatable member disposed at the distal end of the shaft is inflated to an inflated configuration defining a cavity adjacent the pericardial surface. Suction is applied within the cavity to draw the pericardium into the cavity and create an enlarged region. The pericardium within the cavity is pierced to access the pericardial space and a payload is inserted through the pierced pericardium and into the pericardial space.
- While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
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FIG. 1 is a schematic view of a pericardial access system, according to one embodiment of the invention, in relation to a heart. -
FIG. 2 is a side sectional view of a pericardial access system, according to one embodiment of the invention, in relation to the anatomic layers of the heart. -
FIG. 3 is a flowchart detailing a method of accessing the pericardial space using the pericardial access system ofFIG. 2 . -
FIG. 4 is a side sectional view of the pericardial access system ofFIG. 2 in which negative pressure has been applied. -
FIG. 5 is a side sectional view of the pericardial access system ofFIG. 2 in which the pericardium has been pierced. -
FIG. 6 is a perspective view of the underside of a pericardial access system in accordance with another embodiment of the present invention. -
FIG. 7 is a flowchart detailing a method of accessing the pericardial space using the pericardial access system ofFIG. 6 . -
FIG. 8 is a side sectional view of the pericardial access system ofFIG. 6 in relation to the anatomic layers of the heart in which the inflatable member is deflated. -
FIG. 9 is a side sectional view of the pericardial access system ofFIG. 8 in which the inflatable member is inflated. -
FIG. 10 is a side sectional view of the pericardial access system ofFIG. 8 in which negative pressure has been applied. -
FIG. 11 is a side sectional view of the pericardial access system ofFIG. 8 in which a needle has been advanced to pierce the pericardium. -
FIG. 12 is a side sectional view of the pericardial access system ofFIG. 8 in which a guidewire has been introduced into the pericardial space. -
FIG. 13 is a perspective view of a pericardial access system in accordance with another embodiment of the present invention. -
FIG. 14 is a side sectional view of the pericardial access system ofFIG. 13 . -
FIG. 15 is an end view of a shaft of the pericardial access system ofFIG. 13 . - While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
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FIG. 1 is a general schematic illustration of apericardial access device 10, in accordance with a first embodiment of the present invention, in relation to aheart 20. As shown in greater detail in the sectional side view ofFIG. 2 , thepericardial access device 10 is positioned adjacent apericardium 22 of theheart 20. Apericardial space 24 lies opposite thepericardium 22 and is bounded by anepicardium 26 on its far side. Theepicardium 26 contacts amyocardium 28 on the side opposite thepericardial space 24. Thepericardial access device 10 may be employed for accessing thepericardial space 24 to facilitate a variety of procedures, including those requiring a minimally invasive approach to theheart 20. Such procedures include, for example, epicardial lead placement, cellular myoplasty, transmyocardial revascularization, epicardial ablation, closed chest coronary anastomosis, epicardial/myocardial drug delivery, diagnoses and pericardicentesis (draining pericardial fluid). - As shown in
FIG. 2 , thedevice 10 includes ashaft 12 and aneedle 14 fixed in relation to a longitudinal axis of the shaft 12 (i.e., theneedle 14 is prevented from moving longitudinally within the shaft 12). Theshaft 12 extends from a proximal end (not shown) to adistal end 16 provided with anatraumatic tip 17. Theshaft 12 is sized so that thedistal end 16 can be brought into proximity with thepericardium 22 while the proximal end is accessible from outside of the chest cavity. Theshaft 12 includes a cavity or recessedregion 18 having a depth, d, disposed near thedistal end 16, preferably somewhat proximal relative to thedistal tip 17 of theshaft 12. Asuction lumen 30 extends from a proximal port (not shown) near the proximal end of the shaft adapted for connecting to a source of negative pressure to asuction port 32 disposed at the recessedregion 18 of theshaft 12. In other embodiments, the cavity orregion 18 includes a plurality ofports 32 distributed at various locations to optimize the suction force applied to thepericardium 22. In one embodiment, thecavity 18 is defined by a substantially concave cavity wall. In other embodiments, thecavity 18 has other shapes and configurations. - The
needle 14 is a hollow tubular structure defining aninner bore 33 and having a sharpdistal tip 36. Theneedle tip 36 protrudes into the recessedregion 18 of the shaft 12 a fixed distance and, in one embodiment, is angled downwardly, or towards thepericardium 22. However, theneedle 14 extends downwardly no further than the depth, d, of thecavity 18, such that theneedle tip 36 is wholly located within thecavity 18. This prevents theneedle tip 36 from snagging on tissue as thepericardial access device 10 is advanced to theheart 20. Theneedle 14 includes anaccess port 34 in fluid communication with the needle bore 33. Theaccess port 34 is located near theneedle tip 36 and is positioned within thecavity 18 of theshaft 12. The needle bore 33 andaccess port 34 are adapted for slidably receiving medical instruments, for example, guidewires, and/or fluids or gases. In one embodiment, theneedle 14 extends from about 0.5 to about 3 mm into thecavity 18. In one embodiment, theneedle 14 extends downwardly toward the heart at an angle of from about 15 to about 60 degrees with respect to a longitudinal axis of theshaft 12. - As illustrated in
FIG. 2 , thesuction lumen 30 encompasses generally the entire interior of theshaft 12, and theneedle 14 is positioned within thesuction lumen 30, as is shown inFIG. 2 . In other embodiments, theshaft 12 includes a secondary lumen separate from thesuction lumen 30 for receiving the needle 14 (see for exampleFIG. 6 ), or the needle 13 is integrally formed within theshaft 12. -
FIG. 3 is a flowchart detailing amethod 100 of accessing thepericardial space 24 using thepericardial access system 10 ofFIG. 2 according to one embodiment of the present invention. Theshaft 12 is inserted into the chest by, for example, a sub-xiphoid insertion route, and maneuvered to thepericardium 22 of theheart 20 so that the recessedregion 18 is positioned adjacent the pericardium 22 (block 102). Suction or negative pressure is applied to thesuction port 32 via thesuction lumen 30, drawing thepericardium 22 into the recessedregion 18, as is shown inFIG. 4 , forming what is known as a pericardial bleb. This increases the volume of thepericardial space 24 at the recessed region 18 (block 104). The negative pressure is sufficient to cause thepericardium 22 to engage the stationary and protrudingneedle tip 36, such that theneedle tip 36 is caused to penetrate the pericardium 22 (block 106), as shown inFIG. 4 . The depth, d, of thecavity 18 is sufficient that when thepericardium 22 is drawn upwardly, theneedle tip 36 not only penetrates thepericardium 22, but also theaccess port 34 extends into thepericardial space 24. A payload, such as aguidewire 38, is inserted through theaccess port 34 via the needle bore 33 and into thepericardial space 24 within the recessed region 18 (block 108), as shown inFIG. 5 . - Upon completion of the procedure, the negative pressure is removed, allowing the
pericardium 22 to withdraw to a normal position, disengaging from the needle tip 36 (block 110). Finally, theshaft 12 is withdrawn from the pericardium 22 (block 112), with theguidewire 38 remaining in thepericardial space 24. Theguidewire 38 may be employed to facilitate the delivery of other instruments, for example, cardiac pacing leads. Alternately, rather than delivering a payload (block 108) theneedle 14 may be employed to drain off excess fluid from thepericardial space 24. - In this manner, the
pericardial space 24 is accessed without piercing theepicardium 26. As theneedle tip 36 is in a fixed position in relation to the recessedregion 18, there is no danger of over inserting theneedle 14 or of theneedle 14 inadvertently snagging on tissues. Furthermore, because it is unnecessary to advance theneedle 14 into position after suctioning to thepericardium 22, there is no risk of dislodging thesuction port 32 from thepericardium 22. -
FIG. 6 is a bottom perspective view of apericardial access device 200 according to another embodiment of the present invention. Thepericardial access device 200 includes ashaft 202 and aneedle 204 slidably disposed within the shaft 202 (seeFIGS. 8-12 ). Theshaft 202 extends from a proximal end (not shown) to adistal end 206 and includes aninflation lumen 208 and asuction lumen 210. Theinflation lumen 208 extends from a proximal end adapted for connection to a source of air or fluid pressure (not shown) to adistal end 212 in fluid communication with aninflatable member 214.Inflatable member 214 may be toroidal or ring-shaped, and is disposed on theshaft 202 proximal to an atraumaticdistal tip 216 of theshaft 202. The shaft includes aslight recess 215 sized to receive theinflatable member 214 when in a deflated configuration.Inflatable member 214 may have a variety of other shapes, andrecess 215 may have a variety of configuration to accommodateinflatable member 214. For example,inflatable member 214 may be elliptical, egg-shaped, elongated, or asymmetric. Particular shapes may be chosen to facilitate forming a sealing engagement with a surface of the heart. - The
suction lumen 210 extends from a proximal end adapted for connection to a source of suction or negative pressure (not shown) to adistal end 218 in fluid communication with asuction port 220. Thesuction port 220 is disposed on theshaft 202 proximal to thedistal tip 216 of theshaft 202 and in particular is positioned within the circumference of theinflatable member 214, such that theinflatable member 214 generally surrounds thesuction port 220. In one embodiment, theshaft 202 may include multiple suction lumens terminating at various locations within the circumference of theinflatable member 214. Theshaft 202 further includes asecondary lumen 222 having adistal port 224 disposed adjacent thesuction port 220 within the circumference of theinflatable member 214. Alternately, thesecondary lumen 222 and thesuction lumen 210 are one in the same (Not shown; see generally the embodiment ofFIG. 2 ). Thesecondary lumen 222 is adapted for slidably receiving theneedle 204, as is shown inFIGS. 8-12 . -
FIG. 7 is a flowchart detailing amethod 250 of accessing thepericardial space 24 using thepericardial access device 200 ofFIG. 6 , according to one embodiment of the present invention. Theshaft 202 is inserted into the chest using, for example, a sub-xiphoid insertion route, and thedistal end 206 is brought into proximity with thepericardium 22 so that theinflatable member 214 is positioned adjacent the pericardium 22 (block 252), as shown inFIG. 8 . As shown inFIG. 9 , theinflatable member 214 is inflated, forming a toroidal or cylindrical-shaped ring adjacent the pericardium 22 (block 254). The inflatedinflatable member 214 defines an open space orcavity 230 adjacent thepericardium 22 and causes thesuction port 220 to be spaced above thepericardium 22. Negative pressure is then applied to thesuction lumen 210, causing thepericardium 22 to be drawn upwardly into the cavity 230 (block 256), as shown inFIG. 10 , forming what is known as a pericardial bleb. This increases the volume of aregion 234 of thepericardial space 24 adjacent theinflatable member 214. - At this point, the
needle 204 is advanced through thesecondary lumen 220 to penetrate thepericardium 22 and enter the enlarged pericardial space 234 (block 258), as shown inFIG. 11 . A payload, such as aguidewire 238, may then be delivered through theneedle port 230 into theenlarged region 234 of the pericardial space 24 (block 260), as shown inFIG. 12 . Alternatively, theneedle 204 is removed and the payload is introduced directly through thesecondary lumen 222. Following completion of the procedure,needle 204 is withdrawn (block 262) and the negative pressure is eliminated, allowing thepericardium 22 to retract (block 264). Optionally, the inflation fluid or gas is reduced or removed, deflating the inflatable member (block 266). Thepericardial access system 200 may then be removed from the heart 20 (block 268), leaving the payload in place. - When the
inflatable member 214 is in a deflated configuration, for example, during insertion and removal, thepericardial access device 200 displays a lower profile. When inflated and after suction is applied, theinflatable member 214 defines a pericardial bleb, as is shown inFIG. 10 , suitable for facilitating a variety of procedures. Furthermore, theinflatable member 214 may be inflated to an intermediate configuration defining a cavity of a different volume or configuration than in the fully inflated configuration. This allows the user to control the size or configuration of theregion 234. - Although the
secondary lumen 222 is shown inFIGS. 8-12 as having a nearly right angle curve proximal to theport 224, thesecondary lumen 222 may be formed with varying angles adapted to point theneedle 204 toward thepericardium 22. The angle may be greater or lower to increase or decrease the amount of force needed to penetrate thepericardium 22, or to facilitate navigation of theneedle 204 therethrough. As shown inFIGS. 8 and 11 , theneedle 204 extends from a proximal end (not shown) to a sharpdistal end 226.Needle 204 is hollow and terminates in adistal port 230 at or proximally adjacent to thedistal end 226. Theneedle 204 may be adapted for receiving a payload such as a medical instrument, for example, a guidewire, or a fluid or gas. -
FIGS. 13-15 show apericardial access device 300 in accordance with another embodiment of the present invention. Thepericardial access device 300 includes atubular body 302 having aninner suction lumen 304 and ahollow needle 306 disposed within thesuction lumen 304. - The needle is held in position by a
flange structure 308 made up of aneedle flange 310 extending about aproximal portion 312 of theneedle 306 and aretention flange 314 extending inwardly from aninner wall 316 of theshaft 302. An outer diameter OD of theneedle flange 310 is greater than an inner diameter ID of theretention flange 314. In this manner, theneedle 306 is positioned or inserted within thesuction lumen 304 such that a pointeddistal end 318 of theneedle 306 is positioned towards an open distal end oraccess port 320 of theshaft 302. Theneedle flange 310 engages theretention flange 314 and prevents further longitudinal displacement of theneedle 306 with respect to theshaft 302. However, theneedle 306 is free to rotate. Asecondary retention flange 322 is positioned proximal to and spaced apart from theretention flange 314. Theneedle flange 310 is positioned therebetween to prevent inadvertent proximal displacement of theneedle 306. In other embodiments, theneedle 306 includes a secondary needle flange and theneedle flange 310 and secondary needle flange are disposed on opposite sides of asingle retention flange 314. - As is shown in
FIG. 14 , theretention flange 314 andsecondary flange 322 are made up of multipleindividual flanges 324 spaced apart from one another, definingspaces 326.Spaces 326 provides a passage for vacuum or suction to be applied throughout thesuction lumen 304. - The
needle flange 310 is positioned on theneedle 306 such that thedistal end 318 of theneedle 306 is recessed by a distance D from theaccess port 320 of theshaft 302, forming a cavity or recessedspace 328 between thedistal end 320 of theshaft 302 and thedistal end 318 of theneedle 306. Thus, in a similar manner as described with respect to the pericardial access device generally shown inFIGS. 2-5 , theaccess port 320 of theshaft 302 is engaged to a surface of thepericardium 22 and suction is applied. Theshaft 302, and thus needle 306, is preferably positioned relative to thepericardium 22 to form an angle of about 90 degrees with respect to thepericardium 22. Theaccess port 320 of theshaft 302 is sealed to thepericardium 22, and a portion of thepericardium 22 adjacent theaccess port 320 is drawn into thecavity 328 forming a pericardial bleb (not shown). The distance D is such that the portion of thepericardium 22 drawn into thecavity 328 engages thedistal end 318 of theneedle 306 and is pierced by theneedle 306. Theneedle 302 can be rotated to facilitate piercing. Payloads, such as guidewires, can then be fed through theneedle 306 into an enlarged space between thepericardium 22 andepicardium 26 to access thepericardial space 24 therebetween. - A pericardial access device according to any of the preceding embodiments may be used for a variety of procedures, including, for example, epicardial lead placement, cellular myoplasty, epicardial ablation, drug delivery, blind pericardial access, endoscopic pericardial access and endoscopic dissection of tissue reflections or adhesions. It can also be used for entering other spaces between anatomic tissue layers, including the peritoneum, vascular sheaths (for treatment of carotid disease or iliac/femoral artery disease) and the dura. A pericardial access system according to any of the preceding embodiments requires only a single surgical access point to locate the
pericardium 22, form an enlarged region of pericardial space, and deliver a medical instrument into thepericardial space 24 without damaging the underlying tissues. - Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.
Claims (20)
1. A device for accessing a pericardial space of a heart, the device comprising:
a shaft extending from a proximal end to a distal end, the shaft defining a cavity disposed near the distal end, and a suction lumen terminating in at least one distal suction port located within the cavity; and
a hollow needle extending through the shaft and fixed in position relative to a longitudinal axis of the shaft, the needle having a sharp distal end protruding into the cavity downwardly toward a heart surface at an angle with respect to a longitudinal axis of the shaft.
2. The device of claim 1 further comprising a guidewire adapted for advancing through a bore of the needle.
3. The device of claim 1 wherein the suction lumen terminates in a plurality of distal suction ports.
4. The device of claim 1 wherein the needle extends a distance of from about 0.5 to about 3 mm into the cavity.
5. The device of claim 1 wherein the angle is between about 15 and about 60 degrees.
6. The device of claim 1 wherein the angle is about 90 degrees.
7. The device of claim 1 wherein the cavity has a generally concave configuration with respect to the heart surface.
8. The device of claim 1 further comprising a flange structure formed on an inner wall of the shaft adapted to prevent longitudinal movement of the needle relative to the shaft and permit rotational movement of the needle relative to the shaft.
9. A device for accessing a pericardial space of a heart, the device comprising:
a shaft extending from a proximal end to a distal end, the having a suction lumen terminating in at least one distal suction port near the distal end and an inflation lumen;
an inflatable member positioned near a distal end of the shaft, the inflatable member having a collapsed configuration and an inflated configuration defining a cavity, the inflatable member in communication with the inflation lumen; and
a hollow needle adapted for advancement through the shaft into the cavity.
10. The device of claim 9 further comprising a secondary lumen terminating in an access port located within the cavity.
11. The device of claim 10 wherein the needle is adapted for advancement through the secondary lumen.
12. The device of claim 9 wherein the inflatable member is ring or toroidal-shaped.
13. The device of claim 9 wherein the inflatable member is inflatable to at least a first intermediate configuration.
14. The device of claim 9 wherein the suction lumen terminates in a plurality of suction ports.
15. The device of claim 9 wherein the shaft further defines a recess adapted to hold the inflatable member while in the collapsed configuration.
16. A method of accessing the pericardial space, the method comprising:
maneuvering a distal end of a shaft to the pericardial surface;
inflating an inflatable member disposed at the distal end of the shaft to an inflated configuration defining a cavity adjacent the pericardial surface;
applying suction within the cavity to draw the pericardium into the cavity and create an enlarged region;
piercing the pericardium within the cavity to access the pericardial space; and
inserting a payload through the pierced pericardium and into the pericardial space.
17. The method of claim 16 wherein piercing the pericardium further includes advancing a hollow needle having a sharp distal end through the shaft to the cavity.
18. The method of claim 16 wherein inserting the payload further includes advancing a guidewire through the needle and into the enlarged region.
19. The method of claim 16 further comprising removing the suction to release the pericardium from the cavity.
20. The method of claim 16 wherein inflating the inflatable member further includes inflating the inflatable member to an intermediate configuration.
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US13/540,362 US8603031B2 (en) | 2005-06-23 | 2012-07-02 | Method and system for accessing a pericardial space |
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