Patent Description:
Cardiac pacing may be utilized to stimulate the heart. Currently, two distinct approaches to implantation of medical devices for cardiac pacing are performed: (<NUM>) transvenous access of the endocardium or (<NUM>) direct surgical access to the epicardial surfaces. When it becomes necessary to implant a cardiac pacemaker in small children or patients with congenital heart defects, however, cardiologists and surgeons are presented with a unique set of challenges. These patients are often too small for insertion of pacemaker leads through a transvenous approach and congenital anomalies of the heart or venous system may complicate or prevent transvenous lead placement. Further to small body habitus and limited venous capacitance, other contraindications to transvenous pacing may include intracardiac shunts, venous obstruction, endocarditis, mechanical tricuspid valve, and complex venous anatomy resulting in an inability to access the right heart endocardium. Moreover, patients with congenital heart disease and device-dependent primary electrical diagnoses are likely to require multiple invasive procedures over the course of a lifetime with attendant cumulative risk of venous occlusion, therefrom.

For instance, cardiac resynchronization therapy for left ventricular failure and dyssynchrony may be performed via transvenous approach in adults and older children with structurally normal hearts. However, in smaller patients or those with particular forms of congenital heart disease that result in structurally abnormal hearts, epicardial pacing remains the conventional technique.

Significantly elevating risks to the patient, epicardial lead placement requires gaining direct surgical access to the heart via a significantly invasive approach including sternotomy and thoracotomy. Post-operative recovery, therefore, typically entails multiple days in an intensive care unit with commensurate costs and risks. Patients undergoing sternotomy may also be at increased risk of intrathoracic adhesions and heightened subsequent operative risk of reentry injury, should the need for reoperation or exploration arise. In such cases, fibrotic tissue must be fully dissected in order to reach viable cardiac tissue for acceptable pacing thresholds, thus complicating reoperation and hindering successful outcomes.

Most of the approved technologies used to implant devices for managing cardiac rhythm disease, are delivered via transvenous approach and rely on patient vasculature for navigation under intermediate exposure to fluoroscopy. For pediatric, single ventricle, and abnormal vasculature patients, however, a transvenous approach is not feasible due to anatomical restrictions in navigation. This patient population, typically subjected to either thoracotomy or equivalent procedure to expose the heart and allow direct access to the pericardium, may benefit from a minimally invasive approach to implantation of epicardial devices as described in the present disclosure.

<CIT> discloses an apparatus for transcutaneous delivery of a medical therapy, comprising a shell, a core concentrically disposed within the shell including one or more working channels, a proximal flange disposed at a proximal end of the shell and a distal flange disposed at a distal end of the shell.

The foregoing "Background" description is for the purpose of generally presenting the context of the disclosure. Work of the inventors, to the extent it is described in this background section, as well as aspects of the description which may not otherwise qualify as prior art at the time of filing, are neither expressly or impliedly admitted as prior art against the present invention.

The invention is defined by claims <NUM>, <NUM> and <NUM>. Surgical methods are not claimed. The present disclosure relates to an apparatus for transcutaneous delivery of a medical therapy, comprising a shell, a core, concentrically disposed within the shell, including one or more working channels, the one or more working channels including a first working channel and a second working channel, a proximal flange disposed at a proximal end of the shell, and a distal flange disposed at a distal end of the shell, wherein the first working channel and the second working channel are offset by a triangulation angle, the triangulation angle describing a relative arrangement of a longitudinal axis of the first working channel and a longitudinal axis of the second working channel, and wherein an aperture of the first working channel is larger than an aperture of the second working channel.

According to an embodiment, the present disclosure further relates to a method of manufacturing an apparatus for transcutaneous delivery of a medical therapy, comprising forming, via a subtractive manufacturing modality, a shell having a proximal flange disposed at a proximal end of the shell and a distal flange disposed at a distal end of the shell, forming, via the subtractive manufacturing modality, a core including one or more working channels, the one or more working channels including a first working channel and a second working channel, and positioning the core concentrically within the shell, wherein the first working channel and the second working channel are offset by a triangulation angle, the triangulation angle describing a relative arrangement of a longitudinal axis of the first working channel and a longitudinal axes of the second working channel, and wherein an aperture of the first working channel is larger than an aperture of the second working channel.

According to an embodiment, the present disclosure further relates to a method of manufacturing an apparatus for transcutaneous delivery of a medical therapy, comprising forming, via an additive manufacturing modality, a shell having a proximal flange disposed at a proximal end of the shell and a distal flange disposed at a distal end of the shell, and forming, via the additive manufacturing modality, a core disposed concentrically within the shell and including one or more working channels, the one or more working channels including a first working channel and a second working channel, wherein the first working channel and the second working channel are offset by a triangulation angle, the triangulation angle describing a relative arrangement of a longitudinal axis of the first working channel and a longitudinal axes of the second working channel, and wherein an aperture of the first working channel is larger than an aperture of the second working channel.

The terms "a" or "an", as used herein, are defined as one or more than one. The term "plurality", as used herein, is defined as two or more than two. The term "another", as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open language). Reference throughout this document to "one embodiment", "certain embodiments", "an embodiment", "an implementation", "an example" or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

According to an embodiment, the present disclosure relates to an apparatus for use in a surgical field. While preferred embodiments are disclosed, herein, it can be understood that the presented embodiments are merely exemplary and may be embodied in other forms. Therefore, the specific design, features, and functionality of the disclosed are not to be interpreted as limiting, but to serve a basis for the claims, and to educate one skilled in the art as to the functionality of the embodiments with respect to performing a task in any surgical field. Further, it can be appreciated that the following drawings are described in order to draw attention to specific features of the present disclosure and are not intended to, in each instance, be exhaustive descriptions of functionality. To this end, and for the purposes of teaching, the preferred embodiments, in a non-limiting manner, are directed to device anchoring, triangulation of tools in the surgical field, and methods to accommodate therapies of various sizes.

According to an embodiment, the present disclosure relates to an apparatus for accessing a pericardial space, referred to herein as an access apparatus. With reference to <FIG>, an access apparatus <NUM> comprises a shell <NUM>, a spacer <NUM>, a core <NUM>, a first working channel <NUM> and a second working channel <NUM> of one or more working channels, a proximal flange <NUM>, and a distal flange <NUM>. In an embodiment, the distal flange <NUM> may be disposed at a distal end of the core <NUM> or at the distal end of the shell <NUM>. With reference to <FIG>, a core flange <NUM> may be disposed between the core <NUM> and the proximal flange <NUM>. Further, a plug <NUM> may be attached to the core <NUM> via a tether <NUM>. In an embodiment, the plug <NUM> may be substantially cylindrical and may have an aperture <NUM>. The aperture <NUM> of the plug <NUM> may be of a diameter configured to decrease an aperture of one of the one or more working channels in order to, for example, allow passage of and retention of a surgical instrument of reduced diameter. In another embodiment, one or more plugs <NUM> may be attached to the core <NUM> via a corresponding one or more tethers <NUM>. Each of the one or more plugs <NUM> may be configured to modify an aperture of one of the one or more working channels, in a manner similar to that described above for a single plug <NUM>.

According to an embodiment, the plug <NUM> tethered to the core <NUM> may be a valve to control movement of equipment. In another embodiment, the aperture of the plug <NUM> tethered to the core <NUM> may be a valve in order to accommodate a variety of differently-sized tools.

According to an embodiment, to ensure insufflation of the patient and to allow unimpeded access to the surgical field, the access apparatus <NUM> may anchored transcutaneously to the chest wall of the patient.

In an embodiment in accordance with the present claimed invention, the access apparatus <NUM> may be in one of two states: an insertion state or a locked state. In the insertion state, the distal flange <NUM> may be folded into the shell <NUM> of the access apparatus <NUM> and held in position by the spacer <NUM>, which maintains a distance between the proximal flange <NUM> and a surface of the core <NUM>. Following insertion, and in order to secure the access apparatus <NUM> transcutaneously across the integument of a patient, the spacer <NUM> may be removed and the core <NUM> may be pushed through the shell <NUM>. Upon sufficient travel of the core <NUM> through the shell <NUM>, the distal flange <NUM> may be forced out of the shell <NUM> and into a relaxed form, as shown in <FIG>, within the body of the patient. In an embodiment, the distal flange <NUM> may act to secure the access apparatus <NUM> transcutaneously, with the distal flange <NUM> being inside the patient, thereby preventing movement of the access apparatus <NUM> by forces that may be applied from inside of or outside the patient. Concurrently, and in an embodiment, the proximal flange <NUM> may secure the access apparatus <NUM> to an external surface of the skin of the patient, thereby similarly preventing movement of the access apparatus <NUM> by forces that may be applied from inside of or outside the patient.

According to an embodiment, the access apparatus <NUM> may be fabricated from a variety of materials suitable for medical devices including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polyurethane, or a combination thereof.

In another embodiment, and in order to secure the access apparatus <NUM> transcutaneously, the distal flange <NUM> may be a mutable flange, deployable under pre-determined situations. The distal flange <NUM> may be fabricated from a shape-memory alloy selected from a group including but not limited to copper-aluminum-nickel and nickel-titanium, or alloys of zinc, copper, gold, and iron. To this end, the distal flange <NUM> may be deformed in an insertion state but relaxed to a pre-deformed state upon physiologic heating in the locked state. In an example, the deformed state of the distal flange <NUM> may be a straightened state, wherein, upon being pushed transcutaneously, the distal flange <NUM> may return to a relaxed state, or bent state, thus securing the access apparatus <NUM> to the chest wall of the patient.

Alternatively, the deformable, or mutable, nature of the distal flange <NUM> may be achieved by fabrication via materials that may be modified through application of external energy, including ultrasound, magnetism, or electricity, via mechanical action including but not limited to springs, or via naturally-deformable materials including but not limited to rubber, polysiloxane, and polydimethylsiloxane.

According to an embodiment, the access apparatus of the present disclosure, and the distal flange, therein, may be fabricated from the same material. Further, the distal flange may be fabricated integrally within the shell of the access apparatus, as shown in <FIG>. Accordingly, <FIG> is a schematic featuring a distal flange of an apparatus for accessing a pericardial space. According to an exemplary embodiment of the present disclosure, an access apparatus <NUM> may comprise a core <NUM>, a shell <NUM>, and one or more distal flanges integrally disposed at a distal end of the shell <NUM>. In an embodiment, the one or more distal flanges are one or more flaps <NUM>. During insertion, as shown in <FIG> the one or more flaps <NUM> may be deformed within a sleeve <NUM> in order to enable rapid and easy insertion within the patient. Upon insertion, however, the sleeve <NUM> may be removed from the access apparatus <NUM>. As a result, the deformable, or mutable, one or more flaps <NUM> may return to an original, pre-deformed position, thus securing the distal portion of the access apparatus <NUM> transcutaenously.

According to an embodiment, the one or more flaps <NUM> may be mutable, deployable under pre-determined situations. To this end, the one or more flaps <NUM> may be fabricated from a shape-memory alloy selected from a group including but not limited to copper-aluminum-nickel and nickel-titanium, or alloys of zinc, copper, gold, and iron. Further, the one or more flaps <NUM> may be deformed in a straightened state when in an insertion state but return to a pre-deformed, bent state upon being in a locked state.

Alternatively, the deformable nature of the one or more flaps <NUM> may be achieved by fabrication via materials that may be modified through application of external energy, including ultrasound, magnetism, or electricity, via mechanical action including but not limited to springs, or via naturally-deformable materials including but not limited to rubber, polysiloxane, and polydimethylsiloxane.

Moreover, in an embodiment, the one or more flaps <NUM> may be fabricated via a combination of the above-described materials. To this end, and as shown in the cross-sectional schematics of <FIG>, and <FIG>, an access apparatus <NUM> may comprise a sleeve <NUM> having one or more orienting slots <NUM> and a core <NUM> having one or more tines <NUM> embedded therein. In an embodiment, the sleeve <NUM> may be fabricated from a variety of materials suitable for medical devices including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polyurethane, or a combination thereof. In another embodiment, the core <NUM> may be fabricated from a combination of deformable materials including but not limited to shape-memory alloys, materials that may be modified via application of external energy, including ultrasound, magnetism, or electricity, materials that may be modified via mechanical action including but not limited to springs, or naturally-deformable materials including but not limited to rubber, polysiloxane, and polydimethylsiloxane. In an example, the core <NUM> may be fabricated from polysiloxane and the one or more tines <NUM> may be shape-memory alloys. The one or more tines <NUM> may be disposed within the polysiloxane core <NUM> and may extend from a central portion of the core <NUM> to a distal portion of the core <NUM>, ending in a distal flange <NUM>. As shown in <FIG>, the core <NUM> may be in a locked state, wherein the shape-memory alloy of the one or more tines <NUM> are in a pre-deformed, bent shape. Alternatively, the core <NUM> may be in an insertion state, wherein the one or more tines <NUM> are in a deformed, straightened state. Specifically, as shown in <FIG>, the core <NUM> may be fitted within the sleeve <NUM> such that one or more orienting posts (not shown) of the core <NUM> are secured within the one or more orienting slots <NUM> and the one or more tines <NUM> are deformed in order to fit within the sleeve <NUM>. Following insertion of the access apparatus <NUM> within the patient, the sleeve <NUM> may be removed and the one or more tine <NUM> may return to a pre-deformed, bent shape, as shown in <FIG>. In returning to the pre-deformed shape, the one or more tines <NUM> may form the distal flange <NUM>, securing the access apparatus <NUM> transcutaenously. The process of shifting from the insertion state to the locked state may be reversible.

According to an embodiment, the above-combination of soft materials and rigid materials within the core <NUM> ensure insufflation when the access apparatus <NUM> is positioned transcutaneously. To this end, as shown in <FIG>, the access apparatus <NUM> may be fabricated from a combination of soft materials and rigid materials. In an embodiment, the access apparatus <NUM> may be comprised of a network of tines <NUM> embedded within a polymeric material. In an example, the network of tines <NUM> may be comprised of a network of shape-memory alloys selected from the group including but not limited to copper-aluminum-nickel and nickel-titanium, or alloys of zinc, copper, gold, and iron, while the polymeric material may be fabricated from a material including but not limited to polysiloxane and polydimethylsiloxane. The orientation and arrangement of the one or more tines <NUM> of the network of tines <NUM> may be determined according to a desired shape of the access apparatus <NUM> in an insertion state and in a locked state. Through implementation of the above-described combination approach, the access apparatus <NUM> is able to exist in the insertion state and the locked state, wherein the insertion state comprises a deformed state and the locked state comprises a pre-deformed state. Upon insertion, the access apparatus <NUM> may return to the pre-deformed state, thus securing the access apparatus <NUM> transcutaneously via a mutable, distal flange <NUM> and a proximal flange <NUM>.

According to an embodiment of the present disclosure, and in order to secure an access apparatus to the chest wall, the access apparatus may employ a folding geometry. <FIG> are schematics featuring a folding feature of an apparatus for accessing a pericardial space, in an insertion state and a locked state, respectively. Specifically, <FIG> is an access apparatus <NUM> comprising a core <NUM> and a shell <NUM>. The shell <NUM>, extending from a proximal portion of the access apparatus <NUM> to a distal portion of the access apparatus <NUM>, may comprise one or more slits <NUM> of a pre-determined geometry. The one or more slits <NUM> of a pre-determined width may extend along a longitudinal axis of the access apparatus <NUM> for a pre-determined length. One or more struts <NUM> are positioned between each of the one or more slits <NUM> and comprise one or more biasing features <NUM>. The spacing, thickness, and depth of each of the above-described features, combined with the geometry of the one or more slits <NUM>, may influence the shape of an access tool. To this end, each of the one or more biasing features <NUM> may preferentially deform the one or more struts <NUM> outwardly, as shown in <FIG>, upon a pushing force or a pulling force at a proximal end of the access apparatus <NUM>. In the insertion state, the one or more struts <NUM> may be substantially perpendicular to an extracorporeal surface <NUM> of the access apparatus <NUM>. Upon insertion, however, the one or more struts <NUM> deform at the one or more biasing features <NUM>, resulting in the access apparatus <NUM> being in the locked state and forming a distal flange <NUM> for securing the access apparatus <NUM> transcutaneously. In an embodiment, the locked state may be achieved by engaging a screw and thread mechanism that pulls the distal flange <NUM> toward the proximal end of the access apparatus <NUM>, thus deforming the one or more struts <NUM>.

According to another embodiment, and as shown in <FIG>, a mutable, distal flange <NUM> of an access apparatus <NUM> may be an inflatable flange <NUM> that is selectively or permanently fixed to a distal portion of the access apparatus <NUM>. Adjacent to a first working channel <NUM> and a second working channel <NUM>, an inlet <NUM>, in fluid communication with an outlet <NUM>, provides a conduit between the extracorporeal space and the inside of the patient. In an embodiment, the inlet <NUM> may be disposed at a variety of positions within the access apparatus <NUM> such that a transcutaneous conduit is provided. This conduit may be accessed to provide a fluid to the inflatable flange <NUM>. <FIG> is an illustration of the access apparatus <NUM> in an insertion state, wherein the inflatable flange <NUM> may be deflated. <FIG>, therefore, is an illustration of the access apparatus <NUM> in a locked state, according to an exemplary embodiment of the present disclosure. Following insertion, a fluid, gas, liquid, or otherwise, may be provided to the inflatable flange <NUM> via the inlet and outlet of the access apparatus <NUM>. In an embodiment, the inlet <NUM> may be configured to be compatible with a syringe such that a user may inflate the inflatable flange <NUM> via sterile fluid. Once in an inflated state, the inflatable flange <NUM> secures the access apparatus <NUM> transcutaneously.

According to an embodiment, and in an effort to enhance visualization of the surgical field, the present disclosure describes a plurality of approaches for triangulation.

<FIG> are illustrations of an access apparatus <NUM> comprising one or more working channels configured for triangulation of a surgical camera and surgical instruments such that a surgical procedure may be directly visualized. Triangulation of the above-described tools may be accomplished via orientation of one or more working channels within the access apparatus <NUM>. In an embodiment, each of the one or more working channels of the access apparatus <NUM> extend along a substantially longitudinal axis such that access is provided transcutaneously. In an embodiment, a first working channel <NUM> is positioned relative to a second working channel <NUM> such that a relative angle is formed between the two. The relative angle may be defined, in part, by one or more planes encapsulating one or more longitudinal axes of the one or more working channels. In an example, as shown in <FIG>, an angle formed between the first working channel <NUM> and the second working channel <NUM>, housing a camera <NUM> and a surgical instrument <NUM>, respectively, may form a triangulation angle <NUM>. In an embodiment, and in order to further facilitate observation of the surgical procedure, the surgical camera <NUM> may be configured with a deflectable lens <NUM>. In another embodiment, the surgical camera <NUM> may be deflectable or rigid with a set viewing angle large enough to observe the surgical procedure, such as the set viewing angle of an oblique-viewing surgical camera. In an example, the surgical camera <NUM> may be a deflectable camera with a deflection angle between <NUM>° and <NUM>°.

According to an embodiment of the present disclosure, the triangulation angle <NUM> may be between <NUM>° and <NUM>°. In another embodiment, the triangulation angle <NUM> may be between <NUM>° and <NUM>°. In an example, the triangulation angle <NUM> may be <NUM>°. The triangulation angle <NUM> may be fixed or may be variable according to the demands of a surgical procedure. In an example, the triangulation angle <NUM> may be modified from <NUM>° to begin a surgical procedure to <NUM>° by completion of the surgical procedure. Moreover, the triangulation angle <NUM> may be adjusted before, during, or after use in the surgical procedure.

According to an embodiment, the above-described surgical camera may refer to a camera positioned distal to the access apparatus <NUM> or may refer to a camera coupled to an endoscope, the endoscope extending through the access apparatus <NUM> and into the surgical field, and positioned proximal to the access apparatus <NUM>. Surgical camera, camera, and endoscope may, therefore, be used interchangeably to describe a visualization implementation in the present disclosure. Further, it can be appreciated that the above-described visualization implements are merely representative of a variety of implementations providing visualization of a surgical field.

According to an embodiment, the one or more working channels are arranged within the access apparatus <NUM> such that the first working channel <NUM> and the second working channel <NUM> allow for instrument access and visualization of the surgical area. In an embodiment, the first working channel <NUM> and the second working channel <NUM> are substantially parallel. In another embodiment, the first working channel <NUM> and the second working channel <NUM> are askew.

According to an embodiment, the one or more working channels may be fabricated from a rigid material, a soft material, or a combination thereof, selected from a group including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polysiloxane, polyurethane, or a combination thereof. In an embodiment, the one or more working channels may be fabricated from a rigid material in order to secure the orientation of the surgical camera <NUM> relative to the surgical instrument <NUM>. In another embodiment, the one or more working channels may be fabricated from a soft material such that a user may be granted flexibility, within the context of the triangulation angle <NUM>, in independently moving surgical tools or therapies within the one or more working channels.

According to an embodiment of the present disclosure, the functional arrangement of the one or more working channels may be encapsulated within an extracorporeal apparatus, as shown in <FIG>. Specifically, an access apparatus <NUM> may comprise a first working channel <NUM> and a second working channel <NUM> disposed on a surface of a proximal flange <NUM>. In an embodiment, the access apparatus <NUM> may be extracorporeal, as shown in <FIG>, wherein each of one or more surgical instruments may be passed through a corresponding one or more working channels in order to penetrate the skin of a patient. To this end, the access apparatus <NUM> may serve as a guide in order to direct each of the one or more surgical instruments to a correct location within the surgical field to ensure visualization of a surgical field. Further, the one or more working channels may be coupled such that a motion of the first working channel <NUM> results in a duplicated motion of the second working channel <NUM>, or vice versa. The above-described coupled motion may ensure that a first surgical instrument passed through the first working channel <NUM> may be continuously visualized by a second surgical instrument passed through the second working channel <NUM>. Alternatively, the one or more channels may not be coupled such that control of the corresponding one or more surgical instruments may be independent.

According to an embodiment of the present disclosure, the first working channel <NUM> and the second working channel <NUM> may be arranged such that they may be related by a triangulation angle <NUM>. The triangulation angle <NUM> may be between <NUM>° and <NUM>°. In another embodiment, the triangulation angle <NUM> may be between <NUM>° and <NUM>°. In an example, the triangulation angle <NUM> may be <NUM>°.

According to an embodiment of the present disclosure, an ideal access apparatus may have the capacity to accommodate surgical instruments, visualization tools, and medical therapies of a variety of shapes and sizes.

With reference again to <FIG>, in an exemplary embodiment, an access apparatus may comprise one or more working channels having a corresponding one or more diameters. The corresponding one or more diameters of the one or more working channels provide flexibility to a user regarding surgical instrument selection. In an embodiment, the one or more working channels may be sized according to a dimension of a largest predicted therapy, wherein, via an additive approach, the access apparatus may further comprise features configured to reduce the dimensions of the one or more working channels, when appropriate. To this end, in an exemplary embodiment, the access apparatus may further comprise one or more plugs coupled to a corresponding one or more tethers, wherein the one or more plugs are of varying dimension such that, when inserted within a corresponding one of the one or more working channels, a diameter of a working channel is reduced. In an embodiment, one or more plugs may be tethered to the access apparatus. In another embodiment, the diameter of the one or more working channels may be reduced by another mechanism including but not limited to a one-way valve, a silicone insert, or other compliant material, or a shape-memory alloy such as nitinol.

Moreover, the one or more working channels may be sized according to a dimension of a smallest predicted therapy, wherein the access apparatus further comprises features to increase the dimensions of the one or more working channels. In an embodiment, the above-described approach may be integrated into the access apparatus, tethered to the access apparatus, or implemented as a standalone component compatible for use with the access apparatus.

In another, exemplary embodiment, an access apparatus may have a feature allowing the access apparatus to separate into components, via a reductive approach, wherein the component separation increases a dimension of one of the one or more working channels or otherwise improves functionality of the access apparatus. Component separation may occur prior to, during, or following a surgical procedure. Specifically, component separation may allow use of a surgical instrument or surgical therapy substantially larger than either of the one or more working channels, for example, a leadless pacemaker or similarly sized medical device. Alternatively, component separation may be used to remove the access apparatus from the patient following implantation of a surgical instrument.

To this end, <FIG> is an illustration of a component separation feature, wherein a core is configured to separate from a shell <NUM> of an access apparatus <NUM>. According to an exemplary embodiment of the present disclosure, through separation of the core <NUM> from the shell <NUM> of the access apparatus <NUM>, a modular working channel <NUM> of substantially increased dimensions may be created from a first working channel <NUM> and a second working channel <NUM>. The modular working channel <NUM>, as shown in <FIG>, may be configured to permit utilization of surgical instruments or surgical therapies of increased dimensions including but not limited leadless pacemakers or other similarly sized cardiac therapies.

According to an embodiment, the core <NUM> of the access apparatus <NUM> may be fabricated from a rigid material, a soft material, or a combination thereof. In an embodiment, the core <NUM> may be fabricated from a rigid material selected from a group including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, and polyurethane, wherein the rigid material is configured to separate in order to expose one or more modular working channels <NUM>.

In another embodiment, the core <NUM> may be fabricated from a soft material selected from a group including but not limited to rubber, polysiloxane, and polydimethylsiloxane, wherein the soft material is configured to be turn or cut in order to expose one or more modular working channels <NUM>. In an example, the core <NUM> may fit entirely within the shell <NUM>, as shown in <FIG>, or may be comprised of one or more features, including but not limited to a proximal flange, to prevent the core <NUM> from being pressed through the shell <NUM> as surgical instruments are passed through the one or more working channels of the access apparatus <NUM>.

According to another embodiment, and as shown in <FIG>, an access apparatus <NUM> may comprise a coupling mechanism for control of component separation. The coupling mechanism may be selected from a group including but not limited to key and hole, wherein one or more sets of keys and sets of holes, disposed on an internal surface of the access apparatus <NUM>, may be coupled in order to prevent component separation. In an embodiment, one or more holes <NUM> and one or more keys <NUM> may be disposed on an internal surface of the access apparatus <NUM>, as shown in <FIG>. The one or more keys <NUM> may be configured to couple with the one or more holes <NUM>. In an example, the one or more keys <NUM> and the one or more holes <NUM> may be substantially cylindrical and configured for a frictional fit.

In an exemplary embodiment, a force may be applied to an extracorporeal surface of the access apparatus <NUM> having a first working channel <NUM> and a second working channel <NUM>, thus separating the access apparatus <NUM> into two components along a division line <NUM> and exposing the longitudinal dimension of the one or more working channels, as shown in <FIG>. In another exemplary embodiment, the access apparatus <NUM> may be configured to hinge along a substantially longitudinal axis of the access apparatus <NUM>. Moreover, the access apparatus <NUM> may be configured such that, following component separation, the access apparatus <NUM> may be reassembled, as needed. Alternatively, a separation process may be a destructive process such that the components of the access apparatus <NUM> may not be rejoined.

According to an embodiment, the access apparatus <NUM> may be fabricated from a rigid material, a soft material, or a combination thereof, selected from a group including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polysiloxane, polyurethane, or a combination thereof.

According to another embodiment, the access apparatus may comprise one or more division lines <NUM>, as shown in <FIG>. In an example, a division line <NUM> may be a perforation in a side of an access apparatus <NUM>, allowing the access apparatus <NUM> to be separated into more than one component along the division line <NUM>. In another example, as shown in <FIG>, the division line <NUM> may be a physical slit formed in the access apparatus <NUM>. In an embodiment, wherein the division line <NUM> is a physical slit, the access apparatus <NUM> may be fabricated from a rigid material, a soft material, or a combination thereof, selected from a group including but not limited to polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polysiloxane, polyurethane, or a combination thereof. In an example, the access apparatus <NUM> may be fabricated from a rigid material and the division line <NUM> may extend through a sufficient length of the access apparatus <NUM> such that a force applied by a hand, a surgical tool, or other mechanism, may be sufficient to separate the access apparatus <NUM> into a plurality of components. In another example, the access apparatus <NUM> may be fabricated from a soft material and a retaining mechanism, as shown in <FIG>, may be used to prevent separation of the plurality of components of the access apparatus <NUM> under applied force, allowing surgical instruments to pass through. To this end, the retaining mechanism, a retaining ring <NUM>, maintains structural rigidity of the access apparatus <NUM> during insertion of a surgical instrument. Further, <FIG> illustrates a core <NUM> of the access apparatus <NUM> wherein the retaining ring <NUM> may be positioned circumferentially such that the access apparatus <NUM> does not separate along a division line <NUM>.

According to another embodiment of the present disclosure, an access apparatus <NUM> may be fabricated such that a plurality of components may be separated via pulling. As shown in <FIG>, the access apparatus <NUM> may comprise a core <NUM> and a shell <NUM>. Upon insertion of the access apparatus <NUM>, standard surgical instruments and surgical cameras may be introduced to the surgical window via a first working channel <NUM> and a second working channel <NUM> disposed within the core <NUM>. In so much as a larger dimension surgical instrument need be used, the core <NUM> may be pulled apart from the shell <NUM>, thus exposing a modular working channel <NUM> able to accept larger therapies or other implantable therapies such as a leadless pacemaker. In an example, during an initial phase of a surgical procedure for implanting a leadless pacemaker, the first working channel <NUM> and the second working channel <NUM> may be utilized in order to access the pericardial space. Once accessed, the core <NUM> of the access apparatus <NUM> may be removed such that a leadless pacemaker may be inserted into the pericardial space modular working channel <NUM>.

The above-described access apparatus may be used for delivery therapies to the heart wherein access to the pericardial space must be gained. To this end, <FIG> describes a process by which the pericardial space may be accessed, and a medical therapy implanted, via implementation of an embodiment of the access apparatus of the present disclosure, with reference to <FIG>. First, an incision may be made below the xiphoid process of the patient S1450, a cartilaginous tissue at an inferior aspect of the sternum in developing humans. Next, the rigid shell of the access apparatus may be positioned within the incision S1451. Following removal of the spacer of the access apparatus S1452, the core of the access apparatus may be depressed, thus deploying the distal flange S1453 or, in an embodiment, a mutable flange. A trocar may then be passed through a larger, first working channel of the access apparatus and used to puncture the diaphragm of the patient S1454. Insufflation may then be provided through the trocar to create a surgical volume S1455. Next, a camera may be placed down the trocar and used to visualization the heart of the patient S1456. A needle may passed through the second working channel of the access apparatus and advanced into the pericardial space of the heart S1457. A guidewire may then be passed down the needle S1458, thus allow the needle to be removed from the pericardial space S1459. Via the guidewire, a dilator and sheath may be passed into the pericardial space S1460. With the sheath in position, the dilator and guidewire may be removed from the pericardial space S1461. A medical therapy or, for instance, cardiac therapy, may be advanced through the sheath and positioned within the pericardial space, as confirmed via direct visualization S1462. The cardiac therapy may then be fixated within the pericardial space S1463. Once implanted, the sheath may first be removed from the pericardial space S1464, followed by removal of the core of the access apparatus from the shell via force exerted on a proximal flange of the access apparatus S1465. Lastly, the shell of the access apparatus may be removed from the patient S1466, the access apparatus may be removed from the patient S1467 and the incision may be closed S1468.

The above-described implementation of an embodiment of the access apparatus for delivery of a medical therapy employs a process that, with modification, may be applied to a variety of processes. Specifically, and in order to minimize risk, the process of <FIG>, with modification, may be applied to increasingly minimally-invasive therapies.

According to an embodiment, and in order to, for example, deliver certain cardiac therapies to the surgical field, a minimally-invasive, percutaneous approach may be used. To this end, as shown in <FIG>, an access apparatus <NUM> may comprise one or more working channels coupled via a pin <NUM>, or hinge, disposed at a distance from a trocar <NUM>. In an embodiment, the pin <NUM> is disposed at a distance from the trocar <NUM> along a surface of a first working channel <NUM> adjacent to a second working channel <NUM>. As a result of this coupling, and the functionality pursuant therefrom, the second working channel <NUM> and the first working channel <NUM> may be moved simultaneously. Concurrently, surgical instruments or surgical therapies inserted through the one or more working channels may be utilized and moved independently. Moreover, and in order to provide triangulation of a surgical instrument with, for instance, a camera inserted through the first working channel <NUM>, the second working channel <NUM> may be angulated from the first working channel <NUM>, about the pin <NUM>, by a triangulation angle <NUM>. The triangulation angle <NUM> may be adjusted in order to accommodate visualization of a variety of surgical therapies and surgical instruments.

According to an embodiment, and in order to achieve the triangulation angle <NUM>, the location of the pin <NUM> may be moved proximally or distally along the length of the first working channel <NUM>. In another embodiment, the pin <NUM> may be locked such that any of a variety of angles of the triangulation angle <NUM> may be achieved.

In an exemplary embodiment, the first working channel <NUM> and the second working channel <NUM> may be arranged about the pin <NUM> such that the triangulation angle <NUM> may be between <NUM>° and <NUM>°. In another embodiment, the triangulation angle <NUM> may be between <NUM>° and <NUM>°. In an example, the triangulation angle <NUM> may be <NUM>°.

Following insertion of a camera through a trocar, and, for instance, positioning a second working channel relative to a first working channel for visualization of the surgical field, the pericardial space may be accessed. In a generic embodiment, and as shown in <FIG>, <FIG>, and <FIG>, the pericardial space may accessed via coaxially-positioned needle <NUM> and camera <NUM> via an access apparatus. The camera <NUM> may be a rigid, flexible, or deflectable camera with a fixed or adjustable viewing angle <NUM>, as shown in <FIG>, of between <NUM>° and <NUM>°, in order to view the needle <NUM> within the surgical field.

According to an embodiment, and in order to access the pericardial space, the needle <NUM> may first be placed through the access apparatus. Next, the camera <NUM> may be placed within the needle <NUM> and adjusted to a depth such that a safe access tip <NUM> of the needle <NUM> may be visualized within the surgical field of view <NUM>. <FIG> is a graphical illustration of the surgical field of view, and pericardial sac therein, as visualized via the camera. A locking feature may fix the position of the camera <NUM> relative to the needle <NUM>. Once fixed, the needle <NUM> may be advanced in order to puncture the pericardial sac of a heart <NUM> and be inserted in to the pericardial space. The safe access tip <NUM> of the needle <NUM> ensures puncture of the pericardial sac without rupture of the epicardial surface. According to an embodiment, the safe access tip <NUM> is fabricated from a soft, compliant material. In another embodiment, the safe access tip <NUM> is outfitted with a tactile sensor, coupled to necessary processing circuitry, to determine a force applied to the safe access tip <NUM> and to prevent force application at a level which may penetrate the epicardial surface of the heart <NUM>. The camera <NUM> may then be removed and a guidewire may be inserted through the needle <NUM> and placed within the pericardial space. Via the Seldinger technique, surgical therapies, such as leadless pacemakers, may be delivered to the pericardial space over the inserted guidewire.

According to an embodiment, the above-described camera may refer to a camera positioned distal to the access apparatus or may refer to a camera coupled to an endoscope, the endoscope extending through the access apparatus and into the surgical field, and positioned proximal to the access apparatus. Surgical camera, camera, and endoscope may, therefore, be used interchangeably to describe a visualization implementation in the present disclosure. Further, it can be appreciated that the above-described visualization implements are merely representative of a variety of implementations providing visualization of a surgical field.

Further to the above-described generic embodiment, a variety of percutaneous approaches for delivering cardiac therapies while providing direct visualization may be implemented. As a result, access to the pericardial space may be gained while eliminating incisions, thus enhancing safety and procedural efficacy. Each of the below-described approaches are grounded in the importance of visualization and confirming, during a surgical procedure, the location of surgical instruments including but not limited to sheaths and dilators, thereby reducing the risks of heart puncture and improving lead fixation at the heart apex.

To this end, and according to an embodiment, <FIG> is a schematic of a modified dilator <NUM> that may contain a guidewire <NUM> and a camera <NUM> within a single lumen. The lumen of the dilator <NUM> may be separable into a plurality of lumens to allow for the physical separation of the guidewire <NUM>, the camera <NUM>, or other tools, either along the entire lumen or at particular segments. After the guidewire <NUM> has been inserted into the pericardial space, the dilator <NUM> may be pre-marked with locations indicating two different positions. A first position <NUM>, or Position <NUM>, may indicate when the dilator <NUM> is completely through a sheath <NUM> and a distal tip of the dilator <NUM> is projecting from the sheath <NUM>, shown in <FIG>. In the above-described configuration, the camera <NUM> is at the distal tip of the dilator <NUM> and provides direct visualization and confirmation of the location of the dilator <NUM>. Position <NUM><NUM> may be the first location that is visualized for the sheath and dilator complex <NUM>.

In order to confirm the location of the sheath, the dilator may be moved to a second position <NUM>, or Position <NUM>, along the guidewire <NUM>, as shown in <FIG>. Position <NUM><NUM> is the tip of the narrowest part of the sheath <NUM>. There may be one or more markings on the dilator <NUM> indicating each of the two positions. Furthermore, the sliding mechanism of the dilator <NUM> may be facilitated with an adapter or retracting mechanism to move the dilator <NUM> from the first position <NUM> to the second position <NUM>. In addition, an adapter or a modification in the sheath and dilator complex <NUM> may be used to allow the camera <NUM> and the guidewire <NUM> to move together or separately.

Throughout the duration of the procedure, visualization may be provided by a camera <NUM> within the dilator <NUM>. As described above, in another embodiment, the camera <NUM> may be a camera coupled to an endoscope, the endoscope extending in the surgical field. After confirmation of locations of the sheath <NUM> and the dilator <NUM>, the camera <NUM> and the guidewire <NUM> may be removed from the pericardial space via retraction of the dilator <NUM> from the sheath <NUM>. The sheath <NUM>, breakable in an example, may then be used to introduce a pacemaker lead into the heart.

According to an embodiment, the dilator <NUM> may be fabricated from a variety of materials including but not limited to stainless steel, polyethylene terephthalate, polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polyurethane, or a combination thereof, and may be fabricated via a variety of techniques including but not limited to extrusion molding, blow molding, injection molding, and machining. Similarly, the sheath <NUM> may be fabricated from a variety of materials including but not limited to stainless steel, polyethylene terephthalate, polyvinylidene fluoride, polyethylene, polypropylene, polydimethylsiloxane, parylene, polyamide, polytetrafluoroethylene, poly(methyl methacrylate), polyimide, polyurethane, or a combination thereof, and may be fabricated via a variety of techniques including but not limited to extrusion molding, blow molding, injection molding, and machining.

Additional modifications to the dilator <NUM> may include changes in the cap and the lumen in order to introduce the camera <NUM> into the dilator <NUM>. In an exemplary embodiment, the camera <NUM> may have a different entrance into the lumen via additional branching of the dilator <NUM>.

<FIG> is a flowchart of the above-described approach. First, access to the pericardial space may be gained through a camera down a needle stick. The camera may then be removed from the lumen of the needle and a guidewire may be inserted into the pericardial space. After removing the needle from the pericardial space, the camera may be inserted into the dilator and moved to a first position. A dilator and sheath complex may then be pushed over the guidewire and into the pericardial space. The location of the dilator may be confirmed through direct visualization at the first position. Next, the dilator tip may be moved to a second position. The dilator, the camera, and the guidewire may then be removed from the pericardial space, leaving the sheath in position. A cardiac therapy may then be delivered into the pericardial space via the sheath and the position thereof may be visually confirmed via camera within the lumen of the cardiac therapy.

According to another embodiment, the camera for direct visualization may be located within the delivery sheath and external to the dilator, as shown in <FIG>, and in contrast the embodiment of <FIG>, wherein the camera must be moved between a first position and a second position for visual confirmation. To this end, an end of a camera <NUM> may be placed at an end of a widest portion of a sheath <NUM>, referred to herein as a third position <NUM>. A tapering segment of the sheath <NUM> may consist of a clear material <NUM> or window that allows for the camera <NUM> to view a tip of a dilator <NUM>. Alterations to the tip length of the dilator <NUM> may be made to ensure visibility of the tip of the dilator <NUM> from the camera <NUM> at the third position <NUM>. Moreover, the tapered segments of the sheath <NUM> and the dilator <NUM> may be lengthened or shortened to facilitate movement of procedural tools and to ensure proper dilation within the tissues.

In implementing the above-described embodiment, and following gaining access to the pericardial space, guidewire insertion, and needle removal, the camera <NUM> may be inserted into the sheath and dilator complex <NUM> through an opening <NUM> in the side of the sheath <NUM>. In an example, the camera <NUM> may be inserted through the sheath's handle, into additional branches, or extended out of the cap of the dilator <NUM>. The sheath and dilator complex <NUM> may then be introduced into the pericardial space via a guidewire. Visualization of the tip of the dilator <NUM> from the third position <NUM> may result in the confirmation of the sheath and dilator complex <NUM> within the pericardial space. After the location of the dilator <NUM> and the sheath <NUM> has been confirmed, the dilator <NUM> and guidewire may be removed from the pericardial space. Subsequently, a pacemaker lead may be introduced into the pericardial space via the sheath <NUM> and fixated to the heart.

<FIG> is a flowchart of the above-described approach. First, access to the pericardial space may be gained through a camera down a needle stick. Once access to the pericardial space has been gained, the camera may be removed via the lumen of the needle and replaced by a guidewire inserted into the pericardial space. Once the guidewire is positioned, the needle may be removed. According to <FIG>, the camera may be inserted into its position within the sheath and dilator complex. The sheath and dilator complex may then be pushed over the guidewire and into the pericardial space. Visual confirmation of the location of the sheath and dilator complex may be performed at the third position. Once confirmed, the dilator and the guidewire may be removed from the pericardial space, thus allowing cardiac therapies to be delivered to the pericardial space via the sheath. Positioning of the cardiac therapy may be visually confirmed via camera within the lumen of the cardiac therapy.

According to another embodiment, access of the pericardial space may be gained analytically. To this end, markings and measurements may be disposed on a guidewire, a dilator, and a sheath to ensure that procedural tools are in appropriate locations. <FIG> is an illustrated flowchart of this approach. First, access to the pericardial space may be gained through a camera down a needle stick S2390.

Once access to the pericardial space has been established, the camera may be removed from the needle while the needle remains in position within the pericardial space S2391. Next, the length of the needle inserted into the skin is calculated by determining a difference between a length of the needle outside the incision site from a known total length of the needle S2392. In another embodiment, the needle may have ruler markings S2393. Once the length of the needle inserted into the skin has been calculated, a guidewire may be inserted into the needle such that the guidewire reaches the tip of the needle at the entrance to the pericardial space S2394. This may be accomplished by defining a pre-marked location on the guidewire indicating the length of the needle. Then, the guidewire may be pushed into the pericardial space S2395. Because the length of the guidewire being inserted into the pericardial space may be of interest, the guidewire length may be noted by additional gradations, markings, or pre-markings provided before the surgery indicating a length of the guidewire that should be inserted into the pericardial space or may be marked on the guidewire during the operation. After the insertion of the guidewire into the pericardial space, the sheath and dilator complex are placed onto the guidewire and pushed to a position such that the tip of the dilator touches the skin S2396. In order to allow the tip of the dilator to be placed at the entrance of the pericardial space, the sheath and dilator may include measurements or markings on a visible side. Therefore, the dilator and sheath may be pushed to the entrance of the pericardial space according to a previously determined length of the needle underneath the skin S2397. A length of the dilator and sheath complex that may be inserted into the pericardial space may be a pre-determined length, such as the length of the needle, in order to ensure insertion of the sheath within the pericardial space S2398. In another embodiment, additional markings may be made on the sheath and dilator complex to ensure a pre-determined length of the sheath and dilator complex be inserted within the pericardial space. Finally, the guidewire and dilator may be removed from the pericardial space, allowing for access to the pericardial space via the sheath.

<FIG> is a flowchart of the above-described approach. First, access to the pericardial space may be gained through a camera down a needle stick. Next the camera may be removed while the needle stick remains such that a length of the needle underneath the skin may be determined. To this end, the length of the needle underneath the skin may be calculated as a difference between the total length of the needle and the length of the needle outside of the skin, wherein the total length of the needle is a known value. Moreover, the needle stick may have measurement markings indicating the length of the needle underneath the skin. Next, a guidewire may be inserted into the needle such that it is positioned at a tip of the needle. In an embodiment, this length may indicated by markings on the guidewire. Subsequently, the guidewire may be pushed into the pericardial space. A sheath and dilator complex may be moved over the guidewire and up to the skin. Then, the sheath and dilator complex may be pushed to the pericardial entrance according to the calculated length of the needle underneath the skin. From this position, the sheath and dilator complex may be inserted into the pericardial space. The guidewire and dilator may then be removed and cardiac therapies may be delivered into the pericardial space via the sheath. Positioning of the cardiac therapy may be visually confirmed via camera within the lumen of the cardiac therapy.

According to another embodiment, percutaneous access to the pericardial space may be gained via a preloaded access tool, thus eliminating the need for a guidewire. A generalized flowchart of this approach is shown in <FIG>. Initially, appropriate access tools may be preloaded on a fiber scope, the appropriate access tools including but not limited to a needle, a sheath and dilator complex, a sheath, and other procedural tools for promoting safety and efficacy.

Once preloaded, therapies may be delivered to the pericardial space via the following approach. Initially, pericardial access may be obtained through direct visualization via a camera down a needle stick. The needle may then be removed from the dilator and sheath complex such that the dilator and sheath complex may be used to access the pericardial space. To this end, the needle may be removed in variety of ways.

In a first embodiment, and as shown in <FIG>, a needle <NUM> longer than a sheath and dilator complex <NUM> may be deployed in order to remove the needle <NUM> from the back of the sheath and dilator complex <NUM> via applied force. In a second embodiment, the dilator and sheath complex <NUM> may be fabricated to be shorter than a standard needle length such that the needle <NUM> extends beyond the dilator and sheath complex <NUM> when it is preloaded. In a third embodiment, a needle <NUM> may be split along at least one division line <NUM> when force is applied at a hub, allowing the needle <NUM> to be removed from cabling of a camera <NUM>, as shown in <FIG>. In the third embodiment, following removal of the needle <NUM> from a dilator and sheath complex, the needle <NUM> may be slid backwards along the camera <NUM> and secured by clamping a hub <NUM> to the camera <NUM>, thus preventing the needle <NUM> from sliding back within the dilator and sheath complex, as shown in <FIG>. In a fourth embodiment, a needle <NUM> may be embedded within a dilator <NUM> with over molding such that pericardial access may be obtained with a needle and dilator assembly, as shown in <FIG>. The dilator and needle assembly <NUM> may then be removed, simultaneously, from a sheath <NUM>.

Following any of the above described approaches, comprising access of the pericardial space via a needle and removal of the needle from a dilator and sheath complex, the dilator and sheath complex and other procedural tools may be advanced into the pericardial space over a camera. A distance the dilator and sheath complex may move over cabling of the camera may depend on the initial location of the dilator and sheath complex. For example, the dilator and sheath complex may initially be positioned at a distance from the camera tip and need to be slid over the cabling of the camera into the pericardial space. As the dilator and sheath complex <NUM> is pushed towards the tip of the camera <NUM>, the camera <NUM> may serve as a guide into the pericardial space of a heart <NUM>, as shown in <FIG>. The camera <NUM> may then be inserted within the pericardial space for direct visualization, thus assisting in confirmation of the procedural tools, as well as efficacy and safety. Modifications to the dilator and sheath complex <NUM> may include changes in thickness, diameter, degree of tapering, and length. Next, when the dilator and sheath complex, and other procedural tools, are within the pericardial space, the camera may be removed via the dilator and sheath complex. A pacemaker lead may then be inserted into the pericardial space through a lumen of the dilator and sheath complex. In an embodiment, insertion of the pacemaker lead may involve direct visualization via insertion of a camera within the lumen of the pacemaker lead, as shown in <FIG>. Direct visualization in this manner may improve configuration of the location of the sheath <NUM> within the pericardial space, resulting in the removal of the camera <NUM> from the sheath <NUM> and the insertion of the pacemaker lead <NUM>. In an embodiment, the pacemaker lead <NUM> may contain a camera within its lumen providing visualization when entering the pericardial space. In another embodiment, the camera <NUM> initially used for visualization may be subsequently placed within the pacemaker lead <NUM> for implantation. Additional adapters may be used to either prevent or encourage movement of the camera within the pacemaker lead, including camera rotation. Once the pacemaker lead is within the pericardial space, it may be fixated into the heart.

According to another embodiment, the pacemaker lead may be inserted by placing a camera down the lumen of the pacemaker lead, wherein a needle has been preloaded with the pacemaker lead. After gaining access to the pericardial space through direct visualization via the camera within the needle, the pacemaker lead may be advanced into the pericardial space. The needle may then be broken along two division lines in order to remove it from the pacemaker lead and camera.

<FIG> is a flowchart of the above-described embodiments. First, a camera may be preloaded with requisite procedural tools including but not limited to a needle, a sheath and dilator complex, a sheath, and other procedural tools. Next, percutaneous access may be gained via camera positioned down the lumen of a needle stick. The needle may be removed from the tip of the camera and placed in a different position via a variety of means, including but not limited to a longer needle, a sliding mechanism with a modified needle cap or connector, a breakable needle, and a repositioned dilator. In an embodiment, the breakable needle may separable along a perforation line or other biasing feature. The sheath and dilator complex may then be moved over the camera and into the pericardial space. After the camera is removed from the pericardial space and the sheath, the camera may be placed inside the pacemaker lead and inserted into the pericardial space via the sheath. Subsequently, the pacemaker lead may be fixated into the heart.

Obviously, numerous modifications and variations are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

Claim 1:
An apparatus (<NUM>) for transcutaneous delivery of a medical therapy, comprising:
a shell (<NUM>);
a core (<NUM>), concentrically disposed within the shell, including one or more working channels, the one or more working channels including a first working channel (<NUM>) and a second working channel (<NUM>);
a proximal flange (<NUM>) disposed at a proximal end of the shell; and
a distal flange (<NUM>) disposed at a distal end of the shell,
wherein the first working channel (<NUM>) and the second working channel (<NUM>) are offset by a triangulation angle, the triangulation angle describing a relative arrangement of a longitudinal axis of the first working channel (<NUM>) and a longitudinal axis of the second working channel (<NUM>),
wherein an aperture of the first working channel (<NUM>) is larger than an aperture of the second working channel (<NUM>), and
wherein the distal flange (<NUM>) is configured to be folded into the shell (<NUM>) and held in position by a spacer (<NUM>) in an insertion state, the spacer (<NUM>) maintaining a distance between the proximal flange (<NUM>) and a surface of the core (<NUM>).