Source: https://patents.google.com/patent/US20150223839A1/en
Timestamp: 2019-12-13 15:37:39
Document Index: 101874447

Matched Legal Cases: ['Application No. 61', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

US20150223839A1 - Apparatus and methods for cutting an atrial wall - Google Patents
US20150223839A1
US20150223839A1 US14/560,512 US201414560512A US2015223839A1 US 20150223839 A1 US20150223839 A1 US 20150223839A1 US 201414560512 A US201414560512 A US 201414560512A US 2015223839 A1 US2015223839 A1 US 2015223839A1
US14/560,512
US9808283B2 (en
ANATOPICA Inc
2014-12-04 Application filed by HeartWare Inc filed Critical HeartWare Inc
2014-12-04 Priority to US14/560,512 priority patent/US9808283B2/en
2015-05-01 Assigned to SCR, INC. reassignment SCR, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ANATOPICA, INC.
2015-05-01 Assigned to HEARTWARE, INC. reassignment HEARTWARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SCR, INC.
2015-05-01 Assigned to SCR, INC. reassignment SCR, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SPENCE, PAUL A., TOMPKINS, LANDON
2015-05-01 Assigned to ANATOPICA INC. reassignment ANATOPICA INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ACLAND, Robert
2015-08-13 Publication of US20150223839A1 publication Critical patent/US20150223839A1/en
2017-11-07 Publication of US9808283B2 publication Critical patent/US9808283B2/en
238000005520 cutting process Methods 0 abstract description title 295
230000001746 atrial Effects 0 description title 216
The present application claims priority to and benefit of U.S. Provisional Patent Application No. 61/911,678, entitled “Apparatus and Methods for Cutting an Atrial Wall,” filed Dec. 4, 2013, the disclosure of which is incorporated herein by reference in its entirety.
As used herein, the words “proximal” and “distal” refer to direction closer to and away from, respectively, an operator of a medical device. Thus, for example, the end of the device contacting the patient's body would be the distal end of the device, while the end opposite the distal end would be the proximal end of the device. Moreover, a portion of an anatomical structure can be considered as a reference to describe a position closer to or away from the portion of the anatomical structure. For example, an end of the superior vena cava that is closest to the heart would be the proximal end of the superior vena cava, while the end opposite the proximal end would be the distal end.
The term “substantially” when used in connection with “cylindrical,” “linear,” and/or other geometric relationships is intended to convey that the structure so defined is nominally cylindrical, linear or the like. As one example, a portion of a support member that is described as being “substantially linear” is intended to convey that, although linearity of the portion is desirable, some non-linearity can occur in a “substantially linear” portion. Such non-linearity can result from manufacturing tolerances, or other practical considerations (such as, for example, the pressure or force applied to the support member). Thus, a geometric construction modified by the term “substantially” includes such geometric properties within a tolerance of plus or minus 5% of the stated geometric construction. For example, a “substantially linear” portion is a portion that defines an axis or center line that is within plus or minus 5% of being linear.
As used herein, the term “stiffness” relates to an object's resistance to deflection, deformation, and/or displacement by an applied force. For example, a wire or support member with greater stiffness is more resistant to deflection, deformation and/or displacement when exposed to a force than a wire or support member having a lower stiffness. Similarly stated, a support member having a higher stiffness can be characterized as being more rigid than a support member having a lower stiffness. In some embodiments, the stiffness of an object can be characterized by the object's linear stiffness. Linear stiffness can be characterized in terms of the amount of force applied to the object and the resulting distance through which a first portion of the object deflects, deforms, and/or displaces with respect to a second portion of the object. When characterizing the linear stiffness of an object, the deflected distance may be measured as the deflection of a portion of the object different than the portion of the object to which the force is directly applied. Said another way, in some objects, the point of deflection is distinct from the point where force is applied.
The embodiments and methods described herein can be used to facilitate the placement of a ventricular assist device system (referred to herein as a “VAD”) that can be at least partially implanted into a portion of the body of a patient to assist the function of the heart. For example, FIG. 1 illustrates a VAD 10 that is in fluid communication with a heart 1. For reference and as shown in FIG. 1, the heart 1 includes and/or otherwise defines a left atrium 2, a right atrium 4, a left ventricle 6 and a right ventricle 7. The left atrium 2 and the right atrium 4 are separated by a septum 5. The left atrium 2 includes a wall 3 that defines a dome of the left atrium 2. The heart 1 is in fluid communication with the superior vena cava 8 (which provides blood flow into the right atrium 4) and the aorta 9 (which receives blood flow from the left ventricle 6). The heart 1 is described herein for reference and is not meant to be an exhaustive description of the heart 1. Therefore, the simplified discussion of the heart 1 is provided for context as it pertains to the embodiments described herein.
The methods described herein include making an incision in the left atrial wall 3 (referred to herein as “atrial wall”) through which the inlet flow cannula 13 (also referred to herein as “inflow cannula”) can be inserted. Although the atrial wall is shown in FIG. 1 as being the dome of the left atrium, the methods and apparatus described herein can be suitable for any target tissue, such, for example, other regions of the atrium, and other portions of the anatomy unrelated to the heart. For example, in some embodiments, the methods and apparatus described herein can be used to incise the septum of the heart in, for example, a right atrial approach procedure.
Referring now to FIGS. 6-14, a support member 110 and a cutting device 120 are shown, according to an embodiment. The support member 110 can be any suitable device that can provide support to or backing for the atrial wall 3 to facilitate the incising of the atrial wall 3. For example, in some embodiments, the support member 110 can be shape memory device that can be transitioned between a first configuration (e.g., FIGS. 6-8) and a second configuration (e.g., FIG. 9). In some embodiments, the support member 110 can be formed from, for example, a nickel-titanium alloy or the like such as Nitinol™. In some embodiments, the support member 110 can be substantially cylindrical with a diameter between, for example, about 500 micrometers (μm) and about 3 millimeters (mm). In other embodiments, the support member 110 can have a diameter less than 500 μm. In still other embodiments, the support member 110 can have a diameter that is greater than 3 mm. The size of the diameter of the support member 110 can be such that the support member 110 is sufficiently stiff to pierce the atrial wall 3, as described in further detail herein. In some embodiments, the diameter of the support member 110 can vary along the length of the support member to facilitate piercing of the atrial wall 3. Said another way, in some embodiments a distal end portion of the support member 110 can be tapered. In some embodiments, a distal end portion of the support member 110 can form a cutting edge. The cutting edge can include, for example, a tapered tip, sharp point and/or series of serrations. In this manner, the support member 110 can be configured to pierce the atrial wall 3.
The support member 110 includes a proximal end portion 111, a distal end portion 112 and a central portion 113 therebetween. The proximal end portion 111 can be referred to as a guide portion, and the distal end portion 112 can include or be referred to as a contact portion. As shown in FIGS. 6-8, when in the first configuration, the distal end portion 112 of the support member 110 is non-linear. More specifically, as shown, when in the first configuration, the distal end portion 112 of the support member 110 forms a substantially annular ring that can be positioned inside the left atrium and pulled up (e.g., pulled outward or retracted) against the atrial wall 3 to provide a backing for and/or to otherwise support the atrial wall 3, as described in further detail herein. Similarly stated, when in the first configuration, the contact portion 112 of the support member 110 is configured to contact a surface of the atrium and substantially surround the proximal end portion 111. In this manner, the, contact portion 112 can limit in at least one direction the movement of the atrial wall 3 when a cutting force or pressure is applied thereto. In some embodiments, when in the first configuration, the contact portion 112 can create a taut cutting and/or pressure site (also referred to herein as a “target portion”) of the atrial wall 3. For example, the contact portion 112 can deform the atrial wall 3 (or any suitable organ wall) in a radial direction from the center point (i.e., away from where a puncture member or support member penetrates, punctures, or otherwise applies pressure to). In this manner, the atrial wall 3 can be moved into and/or held in a preferable position when a cutting force or pressure is applied thereto. In some instances, this can reduce the puncturing forces to penetrate the atrial wall 3. In some instances, the “stretching” of the atrial wall 3 can minimize and/or eliminate any “bunching” of the atrial wall 3 that may otherwise occur, and instead can produce a surface layer having a substantially constant thickness. In this manner, the contact portion 112 can cause movement of and/or stabilize at least a portion of the atrial wall 3 such that at least the portion of the atrial wall 3 is in a preferable position during the piercing and/or cutting.
Additionally, the curved transition of the central portion 113 is positioned such that the linear portion of the support member 110 (i.e., a portion that is coaxial with and/or includes the proximal end portion 111) extends a distance ‘d’ beyond the contact portion 112 (see e.g., FIG. 6). This arrangement allows the proximal end portion 111 and/or the linear portion to define a path along which a cutting tool or other device can be moved. More particularly, because the guide path extends on either side of the annular ring defined by the contact portion 112, a cutting tool can be moved through the entire tissue wall and into a chamber (e.g., the atrium 3) defined by the tissue wall (e.g., the dome), as shown below in FIGS. 13 and 14. Said another way, a cutting tool can be moved about or along the guide path of the support member 110 from one side of the contact portion 112 (e.g., external to the tissue wall), to a second side of the contact portion 112 (e.g., inside the chamber). In this manner, the cutting tool can be moved beyond the contact portion 112 of the support member 110. Similarly stated, the contact portion 112 substantially surrounds (or circumscribes) the guide path defined by the support member 110. This allows the cutting tool to be moved along the guide path through the full cutting procedure, including the portion of the movement that occurs within the interior region of the organ.
As shown in FIG. 11, with the distal end portion 112 of the support member 110 advanced beyond the atrial wall 3, the support member 110 can be retracted to an extent that places the annular ring formed by the distal end portion 112 in contact with an inner surface of the atrial wall 3. Thus, the distal end portion 112 of the support member 110 can be used as a “backer” for the cutting device 120 that can pierce the atrial wall 3 and pass through the annular ring formed by the distal end portion 112, as described in further detail herein. Similarly stated, in use, the contact portion 112 is placed into contact with the inner surface of the atrial wall 3 to maintain the position of and/or limit movement of the atrial wall during the cutting operation.
As shown in FIGS. 12-14, at least the proximal end (or guide) portion 111 of the support member 110 can define a path along which the cutting device 120 can move. More particularly, the proximal end portion 111 of the support member 110 can be substantially linear and can be configured to engage a portion of the cutting device 120, thereby acting as, for example, a guide wire or the like. The cutter device 120 can be any suitable device. For example, as shown in FIG. 12, the cutter device 120 includes a proximal end portion 121 and a distal end portion 122. The distal end portion 123 can include, for example, a set of blades, wires, sutures, strings, plugs, edges, and/or the like that can be configured to cut or incise a target tissue (e.g., the atrial wall 3). In some instances, the cutting device 122 can be slidably disposed about the proximal end portion 111 of the support member 110. In this manner, the cutting device 120 can be moved in the distal direction to place the blades 123 in contact with the atrial wall 3, as indicated by the arrow D in FIG. 13. The arrangement of the blades 123 of the cutting device 120 can be such that as the cutting device 120 is advanced relative to the atrial wall 3, the size of the incision is increased. In some instances, substantially the entirety of the blades 123 can be advanced through the atrial wall 3, as indicated by the arrow E in FIG. 14. Moreover, with the support member 110 in contact with an inner surface of the atrial wall 3, the support member 110 can exert a reaction force in response to an upward force exerted on the proximal end portion 111, as shown by arrows D′ (FIG. 13) and E′ (FIG. 14). In this manner, deformation of the atrial wall 3 can be minimized and the atrial wall 3 can be cut to define a desired incision that can receive, for example, a portion of an inlet flow cannula of a VAD (e.g., the inlet flow cannula 13 of the VAD 10 in FIG. 1), which can then be coupled the atrial wall 3 (e.g., via sutures, adhesives, and/or the like).
Although the support member 110 is described above as transitioning from the second configuration to the first configuration in response to being advanced beyond an introducer catheter 105, in other embodiments, a support member can be configured to transition between the first configuration and the second configuration when any suitable transitioning criterion is satisfied. For example, in some embodiments, a support member can be configured to transition between the first configuration and the second configuration (or vice versa) in response to a current, tension force, compression force, and/or the like. In some embodiments, the support member 110 can be constructed from a shape memory material that can transition between a first configuration and a second configuration in response to an applied heat. For example, in some embodiments, the support member 110 can be constructed from a material that can have a transition temperature below that of the nominal bodily temperature (i.e., about 98 degrees Fahrenheit (° F.)). Thus, when the support member 110 is maintained at or below the transition temperature (e.g., maintained at or below, for example, 85° F.), the support member 110 is maintained in the second configuration. When, after a sufficient period of time, the support member 110 is heated above the transition temperature (e.g., as a result of being disposed in the body), the support member 110 can then transition to the first (or collapsed) configuration (see e.g., FIGS. 6-8). In some embodiments, a support member can be configured to transition between a series of configuration (e.g., more than two configurations). For example, in the embodiments where the support member 110 is formed from a shape memory material that transitions in response to an applied heat, the support member 110 can transition between any number of configurations to control the rate of transition and/or the like. In this manner, potential damage to bodily tissue as a result of the support member 110 rapidly transitioning from the first configuration to the second configuration can be reduced and/or eliminated.
More specifically, the distal end portion 412 and the suction force collectively can create a taut cutting and/or pressure site (also referred to herein as a “target portion”) of the atrial wall 3. For example, the distal end portion 412 can deform the atrial wall 3 (or any suitable organ wall) in a radial direction from the center point (i.e., away from where a puncture member or support member penetrates, punctures, or otherwise applies pressure to). In this manner, the atrial wall 3 can be moved into and/or held in a preferable position when a cutting force or pressure is applied thereto. In some instances, this can reduce the puncturing forces to penetrate the atrial wall 3. In some instances, the “stretching” of the atrial wall 3 can minimize and/or eliminate any “bunching” of the atrial wall 3 that may otherwise occur, and instead can produce a surface layer having a substantially constant thickness. In this manner, the distal end portion 412 can cause movement of and/or stabilize at least a portion of the atrial wall 3 such that at least the portion of the atrial wall 3 is in a preferable position during the piercing and/or cutting.
As shown in FIGS. 18-20, the support member 410 can be placed in contact with the atrial wall 3 to support the atrial wall 3 during a cutting procedure. For example, as shown in FIGS. 18 and 19, the support member 410 can be moved in a distal direction to place a distal surface of the support member 410 in contact with a surface of the atrial wall 3, as indicated by the arrow F in FIG. 19. Once in contact with the atrial wall 3, the vacuum source (not shown in FIGS. 17-20) can be actuated to produce a negative pressure in the inner volume 416, as described above. The negative pressure can exert a suction force on the atrial wall 3 that is sufficient to couple, at least temporarily, the support member 410 to the atrial wall 3. Moreover, the suction force can be sufficient to maintain the coupling between the support member 410 and the atrial wall 3 when a suitable external force is exerted upon the support member 410 and/or the atrial wall 3. For example, in some instances, it may be desirable to gently pull on the support member 410, as shown by the arrow F′, to increase an amount of tension in the atrial wall 3. The increase in tension in the atrial wall 3 can aid in resisting deformation of the atrial wall 3 during a cutting event.
As shown in FIG. 20, when the desired amount of suction is applied to the atrial wall 3 and the desired amount of tension is applied to the atrial wall 3, the cutting device 420 can be moved in the distal direction relative to the support member 410 to pierce and/or cut the atrial wall 3. More specifically, as shown in FIGS. 18-20, the cutting device includes a proximal end portion 421 and a distal end portion 422. The proximal end portion 421 of the cutting device 420 can be manipulated by a user (e.g., a doctor, surgeon, physician, technician, etc.) to move the cutting device 420 relative to the support member 410. The distal end portion 422 of the cutting device 420 can be any suitable cutting member. For example, in some embodiments, the distal end portion 422 of the cutting device 420 can be substantially similar to the distal end portion 122 of the cutting device 120 (FIGS. 12-14). Thus, the cutting device 420 can be moved in the distal direction to cut the atrial wall 3, as indicated by the arrow G in FIG. 20. The coupling of the support member 410 to the atrial wall 3 can be such that as the distal end portion 422 of the cutting device 420 is advanced in the distal direction, the deflection of the atrial wall 3 prior to the distal end portion 422 of the cutting device 420 cutting the atrial wall 3 is minimized. Similarly stated, the support member 410 can maintain the position of the atrial wall 3 during the cutting operation. Thus, the cutting device 420 can produce a substantially clean cut without undo tearing of the atrial wall 3, which can be exacerbated by movement of the atrial wall 3. Once the cutting device 420 cuts the atrial wall 3, the vacuum source can be switched to an “off” position and the negative pressure maintain the coupling between support member 410 and the atrial wall 3 is removed. Thus, the support member 410 can be retracted from the atrial wall 3.
More specifically, the distal end portion 512 and the suction force collectively can create a taut cutting and/or pressure site (also referred to herein as a “target portion”) of the atrial wall 3. For example, the distal end portion 512 can deform the atrial wall 3 (or any suitable organ wall) in a radial direction from the center point (i.e., away from where a puncture member or support member penetrates, punctures, or otherwise applies pressure to). In this manner, the atrial wall 3 can be moved into and/or held in a preferable position when a cutting force or pressure is applied thereto. In some instances, this can reduce the puncturing forces to penetrate the atrial wall 3. In some instances, the “stretching” of the atrial wall 3 can minimize and/or eliminate any “bunching” of the atrial wall 3 that may otherwise occur, and instead can produce a surface layer having a substantially constant thickness. In this manner, the distal end portion 512 can cause movement of and/or stabilize at least a portion of the atrial wall 3 such that at least the portion of the atrial wall 3 is in a preferable position during the piercing and/or cutting.
FIG. 36 is a flowchart illustrating a method 1250 of coupling, for example, an inlet flow cannula of a VAD to a wall of the heart, according to an embodiment. The method 1250 includes coupling, at least temporarily, a support member adjacent to a target tissue, at 1251. The support member is configured to support the target tissue and to define a path along which a cutting device can move. For example, in some embodiments, the support member can be a wire formed from a shape memory alloy such as Nitinol™. In such embodiments, the support member can be substantially similar to or the same as, for example, the support members 110 (FIGS. 6-14), 210 (FIG. 15), and/or 310 (FIG. 16). In this manner, a distal end portion of the support member can be transitioned between a first configuration and a second configuration to form, for example, a substantially annular ring that can be placed in contact with, for example, a surface of an atrial wall. The substantially annular ring formed by the distal end portion of the support member can be placed in contact with the atrial wall to limit an amount of deflection and/or deformation of the atrial wall when exposed to an external force.
With the superior vena cava and/or the aorta moved to a desired position relative to the heart, a support member is at least temporarily coupled to the wall of the atrium such that movement of the wall in at least one direction is limited, at 1352. For example, as described above, the support member is configured to support the target tissue and to define a path along which a cutting device can move. For example, in some embodiments, the support member can be a wire formed from a shape memory alloy such as Nitinol™. In such embodiments, the support member can be substantially similar to or the same as, for example, the support members 110 (FIGS. 6-14), 210 (FIG. 15), and/or 310 (FIG. 16). In this manner, a distal end portion of the support member can be transitioned between a first configuration and a second configuration to form, for example, a substantially annular ring that can be placed in contact with, for example, a surface of an atrial wall. For example, in some instances, the distal end portion of the support member can be inserted, at least partially, through the atrial wall (e.g., the dome wall 3 of the left atrium 2 of the heart 1 in FIG. 1) and once disposed in the atrium, can be transitioned (e.g., via a application or removal of force, heat, current, and/or the like) from the first configuration to the second configuration to form the annular ring. The substantially annular ring formed by the distal end portion of the support member can be placed in contact with an interior surface of the atrial dome wall to limit an amount of deflection and/or deformation of the atrial dome wall when exposed to an external force.
FIG. 38 is a flowchart illustrating a method 1450 of piercing an organ wall, according to an embodiment. The method 1450 includes introducing into a first opening in an organ wall (e.g., atrial wall 3) a support member when the support member is in a collapsed configuration, at 1451. The support member, for example, can be a wire formed from a shape memory alloy such as Nitinol™. The support member can be substantially similar to or the same as, for example, the support members 110 (FIGS. 6-14), 210 (FIG. 15), and/or 310 (FIG. 16).
For example, in some embodiments, the contact portion 112 can deform the atrial wall 3 (or any suitable organ wall) in a radial direction from the center point (i.e., away from where a puncture member or support member penetrates, punctures, or otherwise applies pressure to). In this manner, the atrial wall 3 can be moved into and/or held in a preferable position or configuration when a cutting force or pressure is applied thereto. In some instances, this can reduce the puncturing forces to penetrate the atrial wall 3. In some instances, the “stretching” of the atrial wall 3 can minimize and/or eliminate any “bunching” of the atrial wall 3 that may otherwise occur, and instead can produce a surface layer having a substantially constant thickness. In this manner, the contact portion 112 can cause movement of and/or stabilize at least a portion of the atrial wall 3 such that at least the portion of the atrial wall 3 is in a preferable position during the piercing and/or cutting.
FIG. 39 is a flowchart illustrating a method 1550 of piercing an organ wall, according to an embodiment. The method 1550 includes removably coupling a support member to a wall of an organ (e.g., atrial wall 3), at 1551, such that movement of the wall in at least one direction is limited. In this manner, the support member can be placed in contact with the atrial wall to limit an amount of deflection and/or deformation of the atrial wall when exposed to an external force, and/or promote a taut target portion (or surface) of the atrial wall for a piercing and/or cutting procedure. The support member, for example, can be a wire formed from a shape memory alloy such as Nitinol™. The support member can be substantially similar to or the same as, for example, the support members 110 (FIGS. 6-14), 210 (FIG. 15), and/or 310 (FIG. 16).
US14/560,512 2013-12-04 2014-12-04 Apparatus and methods for cutting an atrial wall Active 2035-02-20 US9808283B2 (en)
US14/560,512 US9808283B2 (en) 2013-12-04 2014-12-04 Apparatus and methods for cutting an atrial wall
US15/728,857 US20180028227A1 (en) 2013-12-04 2017-10-10 Apparatus and methods for cutting an atrial wall
US15/728,857 Continuation US20180028227A1 (en) 2013-12-04 2017-10-10 Apparatus and methods for cutting an atrial wall
US20150223839A1 true US20150223839A1 (en) 2015-08-13
US9808283B2 US9808283B2 (en) 2017-11-07
US14/560,512 Active 2035-02-20 US9808283B2 (en) 2013-12-04 2014-12-04 Apparatus and methods for cutting an atrial wall
US15/728,857 Pending US20180028227A1 (en) 2013-12-04 2017-10-10 Apparatus and methods for cutting an atrial wall
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Owner name: ANATOPICA INC., KENTUCKY
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Owner name: SCR, INC., KENTUCKY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SPENCE, PAUL A.;TOMPKINS, LANDON;REEL/FRAME:035550/0667
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SCR, INC.;REEL/FRAME:035550/0649
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ANATOPICA, INC.;REEL/FRAME:035550/0662