Transcatheter growth devices and methods for Norwood, Glenn, and Fontan treatments

Abstract

A transcatheter growth device for treating congenital heart disease in infants and other pediatric heart patients, and methods of making and using the same. The growth device includes an elongated device frame with alternating annular growth cell members and spacing members axially spanning the proximal and distal end regions of the device frame. The growth cell members and spacing members define the radial periphery of the growth device. Each growth cell member may include a scaffolded growth cell member having a first annular strut array and a second annular strut array connected via growth cell junctions to provide flexibility to the device frame. A retention member for engaging a selected lumen within the patient's body and a covering member for sealing the growth device upon deployment are disposed on the device periphery. The growth device can be advantageously deployed for the treatment of heart disease alone or in combination with one or more additional growth devices.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 431,616, filed December 9, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. [Technical Field]

[0002] Embodiments of the present disclosure relate generally to the field of medical devices, and more particularly, but not limited to, transcatheter grown Norwood, Glenn, and Fontan devices, including medical stents, shunts, and occlusion devices, for implantation in pediatric patients and subsequent expansion to adult vessel size. [Background technology]

[0003] Transcatheter and surgical shunts, stents, and occlusion devices have been used for many years to treat patients by diverting blood flow in a more hemodynamically favorable direction. Patients with congenital heart disease who suffer from common congenital disorders (or conditions), such as hypoplastic left heart syndrome, tricuspid atresia, and other single ventricle diseases, may currently undergo three stages of surgery throughout childhood to correct the common congenital conditions. If left untreated, these conditions can ultimately lead to serious cardiovascular problems or death.

[0004] For many years, the definitive treatment for these common congenital conditions has been surgical repair and creation using blood flow diverters, conduits, and shunts via open-heart surgery. However, such procedures are risky and prone to complications. However, open-heart surgery in newborns and other pediatric patients can have adverse developmental effects. Patients can undergo one or more of three-stage surgeries, either individually, in combination, or all three, in a typical approach to treat these common congenital conditions. The three-stage surgery is shown and described with reference to Figures 1A-D.

[0005] The first of the three-stage procedures these pediatric patients often undergo is the Norwood procedure, which is performed shortly after birth. The Norwood procedure, shown in Figure 1B, creates a single outflow vessel and valve that delivers oxygenated blood to the rest of the body and a large orifice between the atrial septum walls, allowing blood to mix and enter a single ventricle. A Blalock-Taussig (or BT) shunt or Sano shunt is surgically created to ensure adequate pressure in the patient's pulmonary artery. This shunt stabilizes blood flow while reducing cardiovascular strain on the congenital single ventricle. The Norwood procedure involves creating a resized aorta to pump blood to the patient's body.

[0006] The second surgery, the Glenn procedure, is performed when the patient is approximately 6 months old. The Glenn procedure is shown in Figure 1C. This procedure involves creating a shunt between the patient's pulmonary artery and superior vena cava (or SVC) to passively route deoxygenated blood to the lungs. Simultaneously with shunt creation, the SVC is occluded to prevent deoxygenated blood from flowing from the upper body to the single ventricle. The B–T or Sano shunt created during the previous Norwood procedure must also be occluded. The Glenn procedure passively routes deoxygenated blood from the upper body to the lungs, preparing the patient's anatomy for the third procedure, the Fontan procedure. In other words, the Glenn procedure allows the single ventricle to only pump blood to the body, allowing blood to passively fill the lungs for oxygenation.

[0007] Figure 1D shows the Fontan procedure, which is performed when a patient is between 2 and 6 years of age. This procedure is temporary and may allow all deoxygenated blood from the upper and lower body to passively flow to the lungs, where it can be converted to oxygenated blood. The Fontan procedure involves occluding the inferior vena cava (or IVC) from the right atrium, creating a conduit that directs blood from the IVC to the SVC. The Fontan procedure reroutes blood flow so that oxygen-rich blood and oxygen-poor blood do not mix.

[0008] All three procedures are invasive surgical procedures that result in healing times and pain for patients. Advances in transcatheter techniques and devices, such as balloon, shunt, and stent placement, have led to the development of devices and treatments that do not require these procedures, potentially reducing healing times and pain for patients with congenital heart disease. Transcatheter devices and techniques, particularly those that do not require open-heart surgery and cardiac bypass surgery, have been shown to reduce complications and mortality.

[0009] Furthermore, there are currently no commercially available options for performing the Norwood-Glenn-Fontan procedure using transvascular or transcatheter techniques, and no implant or catheter system specifically designed and implanted for neonates, infants, toddlers, young (or small) children, or other pediatric patients, and / or congenital patients diagnosed with single ventricle disease or other related conditions. Summary of the Invention [Problem to be solved by the invention]

[0010] In light of the above, there is a need for a transcatheter growth device and method for treating common congenital disorders in cardiac patients, particularly infants and other pediatric cardiac patients, that overcomes the aforementioned obstacles and deficiencies in currently available three-stage invasive surgical procedures. [Means for solving the problem]

[0011] The present disclosure relates to a transcatheter growth device for treating congenital heart disease in infants and other pediatric heart patients, as well as methods of making and using the same. The growth device includes an elongated device frame with alternating annular growth cell members and spacing members axially spanning the proximal and distal end regions of the device frame. The growth cell members and spacing members define the radial periphery of the growth device. Each growth cell member may include a scaffolded growth cell member having a first annular strut array and a second annular strut array connected via growth cell junctions to provide flexibility to the device frame. A retention member for engaging a selected lumen within the patient's body and a covering member for sealing the growth device upon deployment are disposed on the device periphery. The growth device can be advantageously deployed for the treatment of heart disease alone or in combination with one or more additional growth devices.

[0012] According to a first aspect disclosed herein, a transcatheter growth device for treating a congenital disease in a cardiac patient is described, the growth device comprising: a first elongated device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member, the first elongated device frame being in an implanted state to facilitate insertion into a first lumen of a patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a first radial device periphery; and The growth device can be configured to be deployed within a first lumen with the first device frame expanded from an implanted state to a first stable expanded state, the first device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a second lumen in communication with the first lumen.

[0013] In selected embodiments, the growth device of the first aspect can include a first covering member disposed around the first device periphery of the first device frame, and the first covering member can be configured to provide a radial seal at the intersection of the first and second lumens. The first covering member can be disposed, for example, outside the first device periphery of the first device frame. Additionally and / or alternatively, the first covering member can be disposed around the first device periphery along the axial length of the first device frame between the proximal and distal annular growth cell members. The first covering member can optionally include a fluid-impermeable material and / or a stretchable fabric material.

[0014] In some embodiments of the disclosed growth device of the first aspect, the first device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery.

[0015] At least one or each of the proximal annular growth cell member, the distal annular growth cell member, and each intermediate annular growth cell member can optionally include a first annular strut array and a second annular strut array. The first annular strut array can include, for example, a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected such that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts. Additionally and / or alternatively, the second annular strut array may include a plurality of paired second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent paired second growth cell struts being connected to form a second annular strut array having a zigzag arrangement of second growth cell struts.

[0016] In some embodiments of the disclosed growth device of the first aspect, the first annular spacing member and each intermediate annular spacing member can include a plurality of paired second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being coupled to a corresponding one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being coupled to a corresponding one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member. The first annular spacing member and each intermediate annular spacing member can be configured to reduce shortening in length of the first device frame during expansion, for example, from the implanted state to the first stable expanded state.

[0017] In some embodiments of the disclosed growth device of the first aspect, each of the proximal end regions of the spacer member struts may be connected via a first intermediate connector to a connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Additionally and / or alternatively, each of the distal end regions of the spacer member struts is connected via a second intermediate connector to a connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member.

[0018] In some embodiments of the disclosed growth device of the first aspect, each first intermediate link member can include a first flexible central body with a first connection region for connecting with a proximal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Each second intermediate link member can optionally include a second flexible central body with a first connection region for connecting with a distal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member. Advantageously, the first and second intermediate link members can provide flexibility to the device frame.

[0019] In some embodiments of the disclosed growth device of the first aspect, the first annular strut array and the second annular strut array of one or more of the proximal annular growth cell member, the selected intermediate annular growth cell member, and the distal annular growth cell member are connected via a first covering member.

[0020] In some embodiments of the disclosed growth device of the first aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of a selected annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member. The selected annular growth cell member can optionally include a distal annular growth cell member. Additionally and / or alternatively, a retention member can be connected to the growth cell junction and configured to extend radially from the distal annular growth cell member to engage with the second lumen upon deployment. The retention member can include, for example, a paddle, a hook, a tab, a spiral, or a combination thereof. The retention member can optionally be formed from a self-expanding metallic material.

[0021] In some embodiments of the disclosed growth device of the first aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the proximal annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first and second annular strut arrays of the proximal annular growth cell member. The first growth cell junction can advantageously provide flexibility to the device frame.

[0022] In some embodiments of the disclosed growth device of the first aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the intermediate annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first and second annular strut arrays of the intermediate annular growth cell member. The second growth cell junction can advantageously provide flexibility to the device frame.

[0023] In some embodiments of the disclosed growth device of the first aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the distal annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first and second annular strut arrays of the distal annular growth cell member. The third growth cell junction can advantageously provide flexibility to the device frame.

[0024] In some embodiments, the disclosed growth device of the first aspect can further include one or more retention members disposed on the first device periphery at the distal annular growth cell member and extending radially from the first device periphery and configured to engage the second lumen upon deployment. The retention members can optionally be distributed around the first device periphery at the distal annular growth cell member and / or can be formed from or include a self-expanding metallic material.

[0025] In some embodiments of the disclosed growth device of the first aspect, the device frame can be formed from a self-expanding metallic material.

[0026] In some embodiments of the disclosed growth device of the first aspect, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from a first stable expanded state to a second stable expanded state, with the first device periphery supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can be further configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first device periphery supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first device periphery supporting the first lumen having the fourth dimension.

[0027] In some embodiments, the disclosed growth device of the first aspect can be provided as part of a transcatheter growth system (or means) for treating congenital disorders in cardiac patients. The disclosed growth device of the first aspect can be configured to cooperate with a second transcatheter growth device. For example, the disclosed growth device of the first aspect can include a retention member disposed on the periphery of the first device at the distal annular growth cell member, extending radially from the distal annular growth cell member and configured to engage the second lumen upon deployment.

[0028] In selected embodiments, the second transcatheter growth device comprises: a second elongated device frame having a second annular spacing member axially aligned between the proximal and distal annular growth cell members and in an implanted state to facilitate insertion into the first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a second radial device periphery; anchor members disposed on the second device periphery of the second device frame; and / or a second covering member disposed around the second device periphery of the second device frame; and The second growth device can be configured to be deployed within the first lumen with the second device frame expanded from an implanted state to a first stable expanded state, the second device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a third lumen communicating with the first lumen, the anchor members configured to extend radially from the second device periphery to engage the third lumen, and the second covering member configured to provide a radial seal at the intersection of the first lumen and the third lumen.

[0029] In some embodiments of the first aspect, the second device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define a second device periphery.

[0030] At least one or each of the proximal annular growth cell member, the distal annular growth cell member, and each intermediate annular growth cell member of the second device frame can include, for example, a first annular strut array and a second annular strut array. The first annular strut array can optionally include a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected such that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts. Additionally and / or alternatively, the second annular strut array may include a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of second growth cell struts.

[0031] In some embodiments of the first aspect, a connected distal end region of a given one of adjacent paired first growth cell struts of a selected annular growth cell member of the second device frame is connected to a connected distal end region of a corresponding one of adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member, which optionally can include a selected intermediate annular spacing member of the second device frame.

[0032] In some embodiments of the first aspect, the anchoring members are capable of coupling with the growth cell junctions and are configured to extend radially from the selected intermediate annular spacing member upon deployment.

[0033] In some embodiments of the first aspect, the second covering member can be positioned around the second device periphery along the axial length of the second device frame between the distal annular growth cell member of the second device frame and the anchor member.

[0034] In some embodiments of the first aspect, the distal annular growth cell member of the first device frame can be configured to receive, when deployed, the distal annular growth cell member of the second device frame, the second device frame being axially aligned with the first device frame and a proximal end region of the second device frame extending from the distal annular growth cell member of the first device frame.

[0035] In some embodiments of the first aspect, the first and second device frames are configured to deploy in a telescoping configuration to adjust the distance between the retention member and the anchor member to match a predetermined distance between the second and third lumens of the patient.

[0036] In some embodiments of the first aspect, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the first stable expanded state to the second stable expanded state, with the first and second device peripheries supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can optionally be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the second stable expanded state to the third stable expanded state, with the first and second device peripheries supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first and second device peripheries supporting the first lumen having the fourth dimension.

[0037] According to a second aspect disclosed herein, there is disclosed a delivery catheter means for implanting and / or deploying the transcatheter growth device of the first aspect. In selected embodiments, the delivery catheter means may be configured to implant and / or deploy the transcatheter growth system (or means) of the first aspect.

[0038] According to a third aspect disclosed herein, there is disclosed a method of manufacturing a first transcatheter growth device for treating a congenital disease in a cardiac patient, the method comprising: disposing a first covering member around a first radial device periphery of a first elongate device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member and in an implanted state to facilitate insertion into a first lumen of a patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define the first device periphery; and The first growth device can be configured to be deployed within the first lumen with the first device frame expanded from an implanted state to a first stable expanded state, the first device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a second lumen communicating with the first lumen, and the first covering member configured to provide a radial seal at the intersection of the first lumen and the second lumen.

[0039] In some embodiments of the disclosed method of the third aspect, the first device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery. At least one or each of the proximal annular growth cell member, the distal annular growth cell member, and each intermediate annular growth cell member can include, for example, a first annular strut array and a second annular strut array. The first annular strut array can optionally include a plurality of pairs of first growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of first growth cell struts. Additionally and / or alternatively, the second annular strut array can include a plurality of pairs of second growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of second growth cell struts.

[0040] In selected embodiments, the first annular spacing member and each intermediate annular spacing member may include a plurality of paired second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being connected to the connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being connected to the connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member.

[0041] In selected embodiments, the first annular spacing member and each intermediate annular spacing member can be configured to reduce shortening of the length of the first device frame during expansion from the implanted state to the first stable expanded state. Each of the proximal end regions of the spacer member struts can be connected, for example, via a first intermediate connector, to a connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Additionally and / or alternatively, each of the distal end regions of the spacer member struts can be connected, for example, via a second intermediate connector, to a connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member.

[0042] In selected embodiments, each first intermediate link member can include a first flexible central body with a first connection region for connecting with a proximal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Additionally and / or alternatively, each second intermediate link member can include a second flexible central body with a first connection region for connecting with a distal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member. The first and second intermediate link members can advantageously provide flexibility to the device frame.

[0043] In some embodiments of the disclosed method of the third aspect, the first annular strut array and the second annular strut array of one or more of the proximal annular growth cell member, the selected intermediate annular growth cell member, and the distal annular growth cell member can be connected via a first covering member.

[0044] In some embodiments of the disclosed method of the third aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the selected annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member. The selected annular growth cell member can optionally include a distal annular growth cell member. Some embodiments of the disclosed method of the third aspect can further include connecting a retention member to the growth cell junction, the retention member extending radially from the distal annular growth cell member and configured to engage with the second lumen upon deployment. The retention member can include, for example, a paddle, a hook, a tab, a spiral, or a combination thereof. The retention member can optionally be formed from a self-expanding metallic material.

[0045] In some embodiments of the disclosed method of the third aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the proximal annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first and second annular strut arrays of the proximal annular growth cell member. The first growth cell junction can advantageously provide flexibility to the device frame.

[0046] In some embodiments of the disclosed method of the third aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the intermediate annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first and second annular strut arrays of the intermediate annular growth cell member. The second growth cell junction can advantageously provide flexibility to the device frame.

[0047] In some embodiments of the disclosed method of the third aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the distal annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first and second annular strut arrays of the distal annular growth cell member. The third growth cell junction can advantageously provide flexibility to the device frame.

[0048] In some embodiments, the disclosed method of the third aspect can further include disposing one or more retention members on the first device periphery at the distal annular growth cell member, the retention members extending radially from the first device periphery and configured to engage the second lumen upon deployment. Disposing the retention members can include distributing the retention members around the first device periphery at the distal annular growth cell member. The disclosed method of the third aspect can optionally further include forming the retention members from a self-expanding metallic material.

[0049] In some embodiments of the disclosed method of the third aspect, the device frame can be formed from a self-expanding metallic material. The step of disposing the first covering member can include disposing the first covering member outside the first device periphery of the first device frame and / or disposing the first covering member around the first device periphery along the axial length of the first device frame between the proximal and distal annular growth cell members. The first covering member can optionally comprise a fluid-impermeable material and / or a stretchable fabric material.

[0050] In some embodiments of the disclosed method of the third aspect, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state, with the first device periphery supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can optionally be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first device periphery supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first device periphery supporting the first lumen having the fourth dimension.

[0051] In some embodiments, the disclosed method of the third aspect can further include manufacturing a second transcatheter growth device for treating a congenital disorder in a cardiac patient in cooperation with the first transcatheter growth device. The first transcatheter growth device can include, for example, a retention member disposed on a periphery of the first device at the distal annular growth cell member and extending radially from the distal annular growth cell member and configured to engage the second lumen upon deployment.

[0052] In some embodiments, the step of manufacturing the second transcatheter growth device comprises: placing anchor members on a second radial device periphery of a second elongate device frame having a second annular spacing member axially aligned between the proximal and distal annular growth cell members and in an implanted state to facilitate insertion into the first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define the second device periphery; and / or disposing a second covering member around the second device periphery of the second device frame; and The second growth device can be configured to be deployed within the first lumen with the second device frame expanded from the implanted state to a first stable expanded state, the second device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a third lumen communicating with the first lumen, the anchor members configured to extend radially from the second device periphery to engage the third lumen, and the second covering member configured to provide a radial seal at the intersection of the first lumen and the third lumen.

[0053] In selected embodiments, the second device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define the second device periphery. At least one or each of the proximal, distal, and intermediate annular growth cell members of the second device frame can optionally include a first annular strut arrangement and a second annular strut arrangement. For example, the first annular strut array can include a plurality of pairs of first growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of first growth cell struts. Additionally and / or alternatively, the second annular strut array can include a plurality of pairs of second growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of second growth cell struts.

[0054] In selected embodiments, the connected distal end region of a given one of the adjacent paired first growth cell struts of the selected annular growth cell member of the second device frame can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member. The selected annular growth cell member can include, for example, a selected intermediate annular spacing member of the second device frame. Additionally and / or alternatively, the step of positioning the anchor member can include connecting the anchor member to the growth cell junction, the anchor member configured to extend radially from the selected intermediate annular spacing member upon deployment. The anchor member can optionally be covered with fabric or another suitable material to promote acute sealing, chronic ingrowth, and / or retention within the selected lumen of the patient.

[0055] In selected embodiments, the step of disposing the second covering member can include disposing the second covering member around the second device periphery along the axial length of the second device frame between the distal annular growth cell member of the second device frame and the anchor member. The distal annular growth cell member of the first device frame can be configured to receive the distal annular growth cell member of the second device frame when deployed, for example, with the second device frame in axial alignment with the first device frame and a proximal end region of the second device frame extending from the distal annular growth cell member of the first device frame. The first and second device frames can optionally be configured to deploy in a telescopic configuration to adjust the distance between the retention member and the anchor member to match a predetermined distance between the second and third lumens of the patient.

[0056] In selected embodiments, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the first stable expanded state to the second stable expanded state, with the first and second device peripheries supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can optionally be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first and second device peripheries supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first and second device peripheries supporting the first lumen having the fourth dimension.

[0057] According to a fourth aspect disclosed herein, there is disclosed a method of implanting a first transcatheter growth device for treating a congenital disease in a cardiac patient, the method comprising: inserting a first elongate device frame into a first lumen of a patient, the first device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member and in an implanted state to facilitate insertion into the first lumen of the patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a first radial device periphery, and a first covering member disposed about the first device periphery of the first device frame; and / or expanding the first device frame from the implanted state to a first stable expanded state, the first device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a second lumen in communication with the first lumen. and The first covering member is configured to provide a radial seal at the intersection of the first lumen and the second lumen.

[0058] In some embodiments of the disclosed method of the fourth aspect, the first device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery. At least one or each of the proximal annular growth cell member, the distal annular growth cell member, and each intermediate annular growth cell member can optionally include a first annular strut array and a second annular strut array. For example, the first annular strut array can include a plurality of pairs of first growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of first growth cell struts. Additionally and / or alternatively, the second annular strut array can include a plurality of pairs of second growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of second growth cell struts.

[0059] In some embodiments of the disclosed method of the fourth aspect, the first annular spacing member and each intermediate annular spacing member can include a plurality of paired second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being coupled to a coupled proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being coupled to a coupled proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member. The first annular spacing member and each intermediate annular spacing member can be configured to reduce shortening of the length of the first device frame during expansion of the first device frame. Each of the proximal end regions of the spacer member struts may be connected via a first intermediate connector to the connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Additionally and / or alternatively, each of the distal end regions of the spacer member struts is connected via a second intermediate connector to the connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member.

[0060] In selected embodiments, each first intermediate link member can include a first flexible central body with a first connection region for connecting with a proximal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of a first adjacent annular growth cell member. Additionally and / or alternatively, each second intermediate link member can include a second flexible central body with a first connection region for connecting with a distal end region of a selected spacer member strut and a second connection region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of a second adjacent annular growth cell member. The first and second intermediate link members can advantageously provide flexibility to the device frame to facilitate insertion of the first device frame.

[0061] In some embodiments of the disclosed method of the fourth aspect, the first annular strut array and the second annular strut array of one or more of the proximal annular growth cell member, the selected intermediate annular growth cell member, and the distal annular growth cell member can be connected via a first covering member.

[0062] In some embodiments of the disclosed method of the fourth aspect, a connected distal end region of a given one of an adjacent pair of first growth cell struts of a selected annular growth cell member can be connected to a connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member. The selected annular growth cell member can optionally include a distal annular growth cell member.

[0063] In some embodiments of the disclosed method of the fourth aspect, a retention member can be coupled with the growth cell junction and configured to extend radially from the distal annular growth cell member to engage the second lumen upon deployment. The retention member can include, for example, a paddle, a hook, a tab, a spiral, or a combination thereof. The retention member can optionally be formed from a self-expanding metallic material. In selected embodiments, the disclosed method of the fourth aspect can include allowing the retention member to self-expand.

[0064] In some embodiments of the disclosed method of the fourth aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the proximal annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first and second annular strut arrays of the proximal annular growth cell member. The first growth cell junction can advantageously provide flexibility to the device frame.

[0065] In some embodiments of the disclosed method of the fourth aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the intermediate annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first and second annular strut arrays of the intermediate annular growth cell member. The second growth cell junction can advantageously provide flexibility to the device frame.

[0066] In some embodiments of the disclosed method of the fourth aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of the distal annular growth cell member can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first and second annular strut arrays of the distal annular growth cell member. The third growth cell junction can advantageously provide flexibility to the device frame.

[0067] In some embodiments of the disclosed method of the fourth aspect, the step of expanding the first device frame can include radially extending one or more retention members disposed on the first device periphery at the distal annular growth cell member to engage the second lumen. The retention members can be, for example, distributed around the first device periphery at the distal annular growth cell member. The retention members can optionally be formed from a self-expanding metallic material.

[0068] In some embodiments of the disclosed method of the fourth aspect, the device frame can be formed from a self-expanding metallic material, and expanding the first device frame can include allowing the retention member to self-expand.

[0069] In some embodiments of the disclosed method of the fourth aspect, the first covering member can be disposed outside the first device periphery of the first device frame.

[0070] In some embodiments of the disclosed method of the fourth aspect, the first covering member can be positioned around the first device periphery along the axial length of the first device frame between the proximal annular growth cell member and the distal annular growth cell member.

[0071] In some embodiments of the disclosed method of the fourth aspect, the first covering member can include a fluid impermeable material.

[0072] In some embodiments of the disclosed method of the fourth aspect, the first covering member can include a stretchable textile material.

[0073] In some embodiments of the disclosed method of the fourth aspect, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state, with the first device periphery supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can optionally be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first device periphery supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first device periphery supporting the first lumen having the fourth dimension.

[0074] In some embodiments, the disclosed method of the fourth aspect can further include implanting a second transcatheter growth device that cooperates with the first transcatheter growth device to treat the congenital disease in a cardiac patient. The first transcatheter growth device can include, for example, a retention member disposed on a periphery of the first device at the distal annular growth cell member and extending radially from the distal annular growth cell member and configured to engage the second lumen upon deployment.

[0075] In selected embodiments of the disclosed method of the fourth aspect, the step of implanting the second transcatheter growth device comprises: inserting a second elongate device frame into a first lumen of the patient, the second device frame having a second annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member and in an implanted state to facilitate insertion into the first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a second radial device periphery, an anchor member disposed on the second device periphery of the second device frame, and a second covering member disposed around the second device periphery of the second device frame; and / or expanding the second device frame from the implanted state to a first stable expanded state, the second device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a third lumen in communication with the first lumen. and The anchoring member may extend radially from the second device periphery and be configured to engage the third lumen; and / or The second covering member may be configured to provide a radial seal at the intersection of the first lumen and the third lumen.

[0076] In selected embodiments, the step of inserting the second device frame may be performed after inserting the first device frame, and / or the step of expanding the second device frame may be performed after expanding the first device frame.

[0077] In selected embodiments of the disclosed method of the fourth aspect, the second device frame can include an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define the second device periphery. At least one or each of the proximal, distal, and intermediate annular growth cell members of the second device frame can optionally include a first annular strut array and a second annular strut array. For example, the first annular strut array can include a plurality of pairs of first growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired first growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of first growth cell struts. Additionally and / or alternatively, the second annular strut array can include a plurality of pairs of second growth cell struts, each having a proximal end region and a distal end region, the proximal end regions of the paired second growth cell struts being connected so that the distal end regions extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of second growth cell struts.

[0078] In selected embodiments of the disclosed method of the fourth aspect, the connected distal end region of a given one of the adjacent paired first growth cell struts of a selected annular growth cell member of the second device frame can be connected to the connected distal end region of a corresponding one of the adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member. The selected annular growth cell member can include, for example, a selected intermediate annular spacing member of the second device frame. An anchor member can optionally be connected to the growth cell junction and configured to extend radially from the selected intermediate annular spacing member upon deployment.

[0079] In selected embodiments of the disclosed method of the fourth aspect, the second covering member can be positioned around the second device periphery along the axial length of the second device frame between the distal annular growth cell member of the second device frame and the anchor member.

[0080] In selected embodiments of the disclosed method of the fourth aspect, inserting the second device frame can include positioning the distal annular growth cell member of the second device frame inside a central axial channel defined by the distal annular growth cell member of the first device frame, the second device frame being axially aligned with the first device frame, with a proximal end region of the second device frame extending from the distal annular growth cell member of the first device frame. The first and second device frames can be configured to deploy, for example, in a telescopic arrangement. In selected embodiments, the disclosed method of the fourth aspect can further include adjusting the distance between the retention member and the anchor member to match a predetermined distance between the second lumen and a third lumen of the patient.

[0081] In selected embodiments, as the patient's first lumen grows from a first dimension to a second dimension, the first device frame can be configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the first stable expanded state to the second stable expanded state, with the first and second device peripheries supporting the first lumen having the second dimension. As the patient's first lumen further grows from the second dimension to a third dimension, the first device frame can optionally be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first and second device peripheries supporting the first lumen having the third dimension. Additionally and / or alternatively, as the patient's first lumen further grows from the third dimension to a fourth dimension, the first device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, and the second device frame can be configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state, with the first and second device peripheries supporting the first lumen having the fourth dimension. [Brief explanation of the drawings]

[0082] [Figure 1A] Diagram showing the heart undergoing the three-stage procedure [Figure 1B] Diagram showing Norwood procedure [Figure 1C] Diagram showing Glenn surgery [Figure 1D] Diagram showing the Fontan procedure [Figure 2] FIG. 1 is a detailed view of an exemplary embodiment of a growth device for treating common congenital disorders in infants and other pediatric heart disease patients. [Figure 3A]FIG. 3 is a detailed view illustrating an exemplary embodiment of a growth cell member for the growth device of FIG. 2, in which a first pair of connected growth cell struts of the growth cell member connects with a second pair of connected growth cell struts to form a growth cell junction. [Figure 3B] FIG. 3B is a detailed view illustrating an exemplary alternative embodiment of the growth cell member of FIG. 3A, in which a first pair of connected growth cell struts of the growth cell member are separated from a second pair of connected growth cell struts to define an intermediate gap. [Figure 3C] Detail view of an exemplary embodiment of a proximal growth cell member for the growth device of FIG. 2. [Figure 3D] Detail view of an exemplary embodiment of a distal growth cell member for the growth device of FIG. 2. [Figure 3E] Detail view of an exemplary alternative embodiment of the growth device of FIG. 2, in which linked pairs of linked growth cell struts allow the growth device to be moved within the patient's internal anatomy. [Figure 4] Detail view of an exemplary embodiment of a spacing member for the growth device of FIG. 2. [Figure 5A] Detail view of an exemplary embodiment of a retention member for the growth device of FIG. 2. [Figure 5B] 5B is a detailed view illustrating an exemplary embodiment of the retention member of FIG. 5A, in which the retention member includes a hollow retention member with one or more stabilizing members. [Figure 5C] 5C is a detailed view illustrating an exemplary embodiment of the retaining member of FIG. 5B, in which the retaining member comprises a solid retaining member. [Figure 5D] 5B is a detailed view illustrating another exemplary alternative embodiment of the retention member of FIG. 5A, wherein the retention member includes one or more wing extension members. [Figure 5E] 5B is a detailed view illustrating yet another exemplary alternative embodiment of the retention member of FIG. 5A, wherein the retention member includes a forked distal end region. [Figure 5F] 5B is a detailed view illustrating yet another exemplary alternative embodiment of the retention member of FIG. 5A, wherein the retention member includes a circumferential retention member. [Figure 6]10 is a detailed view illustrating another exemplary alternative embodiment of the growth device of FIG. 2, wherein the growth device includes at least one anchor member. [Figure 7A] 7 is a detailed view illustrating an exemplary embodiment of an anchor member for the growth device of FIG. 6. [Figure 7B] 7B is a detailed view illustrating an exemplary embodiment of the anchor member of FIG. 7A, in which the anchor member includes a hollow anchor member with one or more stabilizing members. [Figure 7C] 7C is a detailed view illustrating an exemplary embodiment of the anchor member of FIG. 7B, wherein the anchor member comprises a solid anchor member. [Figure 7D] 7B is a detailed view illustrating another exemplary alternative embodiment of the anchor member of FIG. 7A, wherein the anchor member includes one or more wing extension members. [Figure 7E] 7B is a detailed view illustrating yet another exemplary alternative embodiment of the anchor member of FIG. 7A, wherein the anchor member includes a forked distal end region; [Figure 8] 10 is a detailed view illustrating yet another exemplary alternative embodiment of the growth device of FIG. 2, in which the growth device is implanted in a glen position within a patient's body. [Figure 9] FIG. 10 is a detailed view illustrating yet another exemplary alternative embodiment of the growth device of FIG. 2, in which the growth device is implanted in the Fontan position within a patient. [Figure 10A] 10 is a detailed view illustrating an exemplary alternative embodiment of the growing device of FIG. 9, in which the growing device cooperates with a second growing device; [Figure 10B] 10 is a detailed view illustrating an exemplary alternative embodiment of the growing device of FIG. 9, in which the growing device cooperates with a second growing device; [Figure 11A] 10A-B, in which the growth device includes a separate growth device; [Figure 11B] 11B is a top view of an exemplary alternative embodiment of the growth device of FIG. 11A, wherein the growth device comprises a nested growth device. [Figure 12A]11A-B, in which a second growth device is positioned within a first growth device at a first predetermined overlap distance. [Figure 12B] 11A-B, in which a second growth device is positioned within the first growth device at a second predetermined overlap distance. [Figure 13] 10A-B, in which a growth device implanted in the Fontan position cooperates with a third growth device implanted in the Glenn position within a patient. [Figure 14A] FIG. 10 is a detailed view illustrating an exemplary embodiment of a delivery catheter system for implanting and deploying the growth device of FIG. 2 at a selected implantation site within a patient's body. [Figure 14B] FIG. 10 is a detailed view illustrating an exemplary embodiment of a delivery catheter system for implanting and deploying the growth device of FIG. 2 at a selected implantation site within a patient's body. [Figure 14C] FIG. 10 is a detailed view illustrating an exemplary embodiment of a delivery catheter system for implanting and deploying the growth device of FIG. 2 at a selected implantation site within a patient's body. [Figure 14D] FIG. 10 is a detailed view illustrating an exemplary embodiment of a delivery catheter system for implanting and deploying the growth device of FIG. 2 at a selected implantation site within a patient's body. [Figure 14E] Detail views illustrating an exemplary alternative embodiment of the delivery catheter system of FIGS. 14A-D, in which a growth device is disposed on the delivery catheter system. [Figure 14F] Detail views illustrating an exemplary alternative embodiment of the delivery catheter system of FIGS. 14A-D, in which a growth device is disposed on the delivery catheter system. [Figure 14G] Detail views illustrating an exemplary alternative embodiment of the delivery catheter system of FIGS. 14A-D, in which a growth device is disposed on the delivery catheter system. [Figure 15A]FIG. 1 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device, in which the transcatheter growth device comprises a wireframe-based shunt with a coil device for docking to the patient's superior vena cava (or SVC). [Figure 15B] FIG. 1 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device, in which the transcatheter growth device comprises a wireframe-based shunt with a coil device for docking to the patient's superior vena cava (or SVC). [Figure 15C] FIG. 1 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device, in which the transcatheter growth device comprises a wireframe-based shunt with a coil device for docking to the patient's superior vena cava (or SVC). [Figure 15D] FIG. 1 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device, in which the transcatheter growth device comprises a wireframe-based shunt with a coil device for docking to the patient's superior vena cava (or SVC). [Figure 15E] FIG. 1 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device, in which the transcatheter growth device comprises a wireframe-based shunt with a coil device for docking to the patient's superior vena cava (or SVC). [Figure 16] Detail views illustrating an exemplary embodiment of the wire frame shunt of FIGS. 15A-E, with the wire frame shunt implant positioned within the anatomy of a patient. [Figure 17A] FIG. 1 is a detailed view of an exemplary embodiment of a transcatheter growth device, in which the device comprises a growth shunt with a fabric (or foam) sealing ring and a fixation ring at each end region. [Figure 17B] FIG. 1 is a detailed view of an exemplary embodiment of a transcatheter growth device, in which the device comprises a growth shunt with a fabric (or foam) sealing ring and a fixation ring at each end region. [Figure 18]Detail views illustrating the exemplary embodiment of the shunt implant of FIGS. 17A-B, in which the shunt implant is positioned within the anatomy of a patient. [Figure 19A] FIG. 10 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device comprising a dual-material shunt implant including a self-expanding metallic material such as nitinol and a balloon-expandable metallic material such as cobalt chrome, creating a balloon-expandable growth implant with fixation hooks or flares. [Figure 19B] FIG. 10 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device comprising a dual-material shunt implant including a self-expanding metallic material such as nitinol and a balloon-expandable metallic material such as cobalt chrome, creating a balloon-expandable growth implant with fixation hooks or flares. [Figure 19C] FIG. 10 is a detailed view illustrating an exemplary embodiment of a transcatheter growth device comprising a dual-material shunt implant including a self-expanding metallic material such as nitinol and a balloon-expandable metallic material such as cobalt chrome, creating a balloon-expandable growth implant with fixation hooks or flares. [Figure 20A] Detail views illustrating another embodiment of the dual frame shunt implant of FIGS. 19A-C, in which the dual frame shunt implant is configured to minimize shortening of the length of the transcatheter growth device during expansion. [Figure 20B] Detail views illustrating another embodiment of the dual frame shunt implant of FIGS. 19A-C, in which the dual frame shunt implant is configured to minimize shortening of the length of the transcatheter growth device during expansion. [Figure 21] FIG. 10 is a detailed view illustrating another alternative embodiment of a dual frame shunt implant, where the dual frame shunt implant is positioned within the patient's anatomy. [Figure 22A]Detail view showing an exemplary embodiment of a transcatheter growth device, wherein the transcatheter growth device comprises a single or dual material frame shunt implant with flat rings (or flanges) on one and / or both side regions of the shunt implant. [Figure 22B] Detail view showing an exemplary embodiment of a transcatheter growth device, wherein the transcatheter growth device comprises a single or dual material frame shunt implant with flat rings (or flanges) on one and / or both side regions of the shunt implant. [Figure 22C] Detail view showing an exemplary embodiment of a transcatheter growth device, wherein the transcatheter growth device comprises a single or dual material frame shunt implant with flat rings (or flanges) on one and / or both side regions of the shunt implant. [Figure 23A] FIG. 10 is a detailed view of an exemplary embodiment of a transcatheter growth device, in which the device comprises a dual-ring shunt connected by a fluid-impermeable fabric and optionally structurally supported by wire and / or cell arrays. [Figure 23B] FIG. 10 is a detailed view of an exemplary embodiment of a transcatheter growth device, in which the device comprises a dual-ring shunt connected by a fluid-impermeable fabric and optionally structurally supported by wire and / or cell arrays. [Figure 24A] Detailed diagrams illustrating selected techniques for visualizing the intersection of a patient's pulmonary artery (or PA) and superior vena cava (or SVC), including guidewires, fluoroscopic markers, and / or contrast-filled balloons. [Figure 24B] Detailed diagrams illustrating selected techniques for visualizing the intersection of a patient's pulmonary artery (or PA) and superior vena cava (or SVC), including guidewires, fluoroscopic markers, and / or contrast-filled balloons. [Figure 24C] Detailed diagrams illustrating selected techniques for visualizing the intersection of a patient's pulmonary artery (or PA) and superior vena cava (or SVC), including guidewires, fluoroscopic markers, and / or contrast-filled balloons. [Figure 25] Detail showing the use of one or more magnets to align the intersection of the SVC and PA. [Figure 26] Detailed diagram showing the selected crossing system for creating access from the SVC to the PA. [Figure 27] FIG. 10 is a detailed view of an exemplary embodiment of a transcatheter growth device, where the transcatheter growth device includes a coated end region to block flow from the SVC to the right atrium (or RA). [Figure 28] FIG. 1 is a detailed view of an exemplary embodiment of a transcatheter growth device, in which the device includes a three-way implant system for creating blood pathways from the SVC, PA, and the junction of the IVC and RA. [Figure 29] Detail view showing an exemplary embodiment of a transcatheter growth device in which the device includes a "trap door" mechanism, strategically blocking blood flow from the IVC-RA junction to the SVC until instructed to open the pathway. [Figure 30] Detailed view showing an exemplary embodiment of an IVC to SVC conduit implant system with fixation elements that help ensure no migration during growth. [Figure 31] Detail view showing an exemplary embodiment of an IVC to SVC partially covered conduit system including two implant rings and fabric and / or wire components to divert blood flow and provide structure. [Figure 32A] Detail view showing an exemplary embodiment of an implant device that diverts flow from the RA to the SVC. [Figure 32B] Detail view showing an exemplary embodiment of an implant device that diverts flow from the RA to the SVC. [Figure 32C] Detail view showing an exemplary embodiment of an implant device that diverts flow from the RA to the SVC. [Figure 33A] Detail view of an exemplary embodiment of a dual frame implant device for restricting blood flow within a PA. [Figure 33B]Detail view of an exemplary embodiment of a dual frame implant device for restricting blood flow within a PA. [Figure 33C] Detail view of an exemplary embodiment of a dual frame implant device for restricting blood flow within a PA. [Figure 33D] Detail view of an exemplary embodiment of a dual frame implant device for restricting blood flow within a PA. [Figure 34] Detail view illustrating an exemplary embodiment of an implant device for dilating a patent ductus arteriosus (PDA). [Figure 35] Detail views of exemplary embodiments of the dual frame implant device of FIGS. 33A-D and the implant device of FIG. 34, with the dual frame implant device and implant device positioned within the anatomy of a patient. DETAILED DESCRIPTION OF THE INVENTION

[0083] It should be noted that the figures are not drawn to scale, and that elements having similar structures or functions are represented by similar reference numerals throughout the figures for ease of explanation. It should also be noted that the figures are intended only to facilitate the description of the preferred embodiments. The figures do not illustrate every aspect of the described embodiments, nor do they limit the scope of the present disclosure.

[0084] Because the three-stage surgical procedures currently available for treating common congenital defects in patients with congenital heart disease are invasive, require long healing times, and cause pain to the patient, a transcatheter growing device and method for treating these common congenital defects may prove desirable and may provide the basis for broader applications, such as treating common congenital defects in infants and other pediatric heart disease patients. This result may be achieved, according to one embodiment disclosed herein, by a transcatheter growing device 1000 for treating common congenital defects in infants and other pediatric heart disease patients, as shown in FIG. 2.

[0085] In selected embodiments, the growth device 1000 allows patients with congenital heart disease that results in single ventricle function to function optimally with respect to adequate blood flow to peripheral tissues and the lungs. Various congenital disease conditions can be defined as single ventricle abnormalities, such as hypoplastic left heart syndrome, hypoplastic right ventricle syndrome, Ebstein's anomaly, tricuspid atresia, pulmonary atresia, etc. The growth device 1000 can also be advantageously applied to other congenital heart diseases that require rerouting of blood flow within the heart.

[0086] 2, an exemplary embodiment of a growth device 1000 is shown comprising an elongated device frame 1100. The device frame 1100 of FIG. 2 includes a plurality of annular growth cell members 1120 and one or more annular spacing members 1130. The growth cell members 1120 and spacing members 1130 define a periphery 1140 of the device frame 1100 and a proximal end region 1110 of the device frame 1100. P to the distal end region 1110 of the device frame 1100 D 2, each spacing member 1130 can be disposed between a pair of adjacent growth cell members 1120. In other words, the device frame 1100 can extend from the proximal end region 1110 to the P and distal end region 1110 D The device frame 1100 may include a series of alternating growth cell members 1120 and spacing members 1130 that may axially span between the growth cell members 1120 and spacing members 1130 and provide a radial periphery 1140 of the device frame 1100. The arrangement of growth cell members 1120 and spacing members 1130 may thereby define a central axial channel 1150 of the elongated device frame 1100.

[0087] The growth cell member 1120 shown in FIG. 2 may be, for example, a proximal end region 1110 of the device frame 1100. P proximal growth cell member 1120 disposed on P and a distal end region 1110 of the device frame 1100. D a distal growth cell member 1120 disposed on the distal growth cell member 1120;D The spacing member 1130 may include a proximal growth cell member 1120. P and distal growth cell member 1120 D In selected embodiments, the growth cell member 1120 may be positioned between the proximal growth cell member 1120 P and distal growth cell member 1120 D an intermediate growth cell member 1120 disposed between the I The first spacing member 1130 may include a proximal growth cell member 1120. P and intermediate growth cell member 1120 I and / or a second spacing member 1130 may be disposed between the intergrowth cell member 1120 I and distal growth cell member 1120 D Additionally and / or alternatively, growth cell members 1120 may be arranged such that each spacing member 1130 is spaced apart from an adjacent intermediate growth cell member 1120, as shown in FIG. I a plurality of intergrowth cell members 1120 disposed therebetween; I may include:

[0088] The growth cell members 1120 of the device frame 1100 can have uniform and / or different structures depending, for example, on the intended use of the growth device 1000, the implantation location of the growth device 1000 within the patient 100 (shown in FIG. 8 ), and / or the anatomy of the patient 100. In selected embodiments, the growth cell members 1120 can be formed from, but are not limited to, metals, metal alloys, polymers, biodegradable polymers, fabrics, and / or combinations of materials. An exemplary growth cell member 1120 is shown in FIG. 3A . Referring to FIG. 3A , the growth cell member 1120 is shown comprising a scaffolded growth cell member comprising a plurality of growth cell struts 1122, which can be arranged in a ring configuration to define an internal growth cell opening 1124 in the growth cell member 1120.

[0089] The growth cell struts 1122 can have a predetermined cell strut width and / or a predetermined cell strut thickness and / or can define one or more frame cells 1126. The cell strut width and / or cell strut thickness can be increased to increase the radial strength of the growth cell member 1120 and / or decreased to decrease the radial strength of the growth cell member 1120. The frame cells 1126 advantageously allow the growth device 1000 to be crimped into an implanted state having a predetermined initial size, shape, diameter, cross-section, or other dimensions, and expanded to a (stable) expanded state having a predetermined expanded size, shape, diameter, cross-section, or other dimensions.

[0090] Exemplary initial dimensions of the growth device 1000 include, but are not limited to, initial dimensions between 1 millimeter and 4 millimeters. The expanded state of the growth device 1000 can have a predetermined dimension between 10 millimeters and 30 millimeters, but is not limited to this. This allows the growth device 1000 to support a wide range of expansion ratios between the expanded state and the initial state. Based on the aforementioned exemplary dimensions, exemplary expansion ratio ranges can include ranges between 2 and 30. In selected embodiments, the implanted growth device 1000 can be configured to be deployed within a neonatal, infant, toddler, or other pediatric patient. For pediatric patients, the expanded state can be equivalent to the size of a congenital pediatric vessel.

[0091] In some embodiments, the device frame 1100 can comprise a balloon-expandable device frame 1100. In other embodiments, the device frame 1100 can comprise a self-expanding device frame using materials such as nitinol and other metal alloys. The device frame 1100 advantageously allows for further expansion as the patient grows. While shown and described in FIG. 3A as including uniform cell strut widths, uniform cell strut thicknesses, and / or uniform frame cells 1126 for illustrative purposes only, the growth cell struts 1122 can include uniform and / or varying cell strut widths, cell strut thicknesses, and / or frame cells 1126.

[0092] In selected embodiments, the growth cell struts 1122 may be provided as one or more pairs of growth cell struts 1122. Each pair of growth cell struts 1122 may optionally be paired with one or more other paired growth cell struts 1122 of the growth cell member 1120, as shown in FIG. 3A. The paired growth cell struts 1122 may include, for example, a first pair of growth cell struts 1122S, 1122T and a second pair of growth cell struts 1122U, 1122V. Each of the growth cell struts 1122S, 1122T, 1122U, 1122V may be provided in the proximal end region 1122. P and distal end region 1122 D may include:

[0093] Referring to the first pair of increment cell struts 1122S, 1122T, the proximal end region 1122 of the increment cell strut 1122S P The proximal end region 1122 of the growth cell strut 1122T P and distal end regions 1122 of the growth cell struts 1122S, 1122T. D The proximal end region 1122 P The proximal end regions 1122 of the second pair of growth cell struts 1122U, 1122V extend from Pcan be similarly connected, and the distal end regions 1122 of the growth cell struts 1122U, 1122V can also be connected. D The proximal end region 1122 P As shown in FIG. 3A, the distal end region 1122 of the first pair of growth cell struts 1122S may extend from D The distal end region 1122 of the second pair of growth cell struts 1122U D 1122T; while the distal end region 1122 of the first pair of growth cell struts 1122T D the distal end region 1122 of the second pair of growth cell struts 1122V D The first and second pairs of growth cell struts 1122S, 1122T, 1122U, 1122V can thereby define a first frame cell 1126S TUV.

[0094] The distal end region 1122 of the first pair of growth cell struts 1122S D Optionally, the distal end region 1122 of the second pair of growth cell struts 1122U D and / or the distal end region 1122 of the first pair of growth cell struts 1122T. D Optionally, the distal end region 1122 of the second pair of growth cell struts 1122V D In selected embodiments, the distal end region 1122 of the growth cell strut 1122S may be connected to D 3A, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122U is provided with D The distal end region 1122 of the growth cell strut 1122T can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122V, D can be separated from

[0095] Additionally and / or alternatively, the paired increment cell struts 1122 can include a third pair of increment cell struts 1122W, 1122X and a fourth pair of increment cell struts 1122Y, 1122Z. Each of the increment cell struts 1122W, 1122X, 1122Y, 1122Z is ​​located at the proximal end region 1122. P and distal end region 1122 D The proximal end region 1122 of the growth cell strut 1122W may include P is connected to the proximal end region 1122 P the distal end regions 1122 of the growth cell struts 1122W, 1122X extending from D a proximal end region 1122 of the growth cell strut 1122X, P The proximal end region 1122 of the fourth pair of growth cell struts 1122Y, 1122Z can be connected to the P can be similarly connected, and the distal end regions 1122 of the growth cell struts 1122Y, 1122Z can also be connected. D is connected to the proximal end region 1122 P As shown in FIG. 3A, the distal end region 1122 of the third pair of growth cell struts 1122W extends from D The distal end region 1122 of the fourth pair of growth cell struts 1122Y D while the distal end region 1122 of the third pair of growth cell struts 1122X may be disposed adjacent to the distal end region 1122 of the third pair of growth cell struts 1122X. D The distal end region 1122 of the fourth pair of growth cell struts 1122Z D The third and fourth pairs of growth cell struts 1122W, 1122X, 1122Y, 1122Z can thereby define second frame cells 1126WXYZ.

[0096] the distal end region 1122 of the third pair of growth cell struts 1122W; D The distal end region 1122 of the fourth pair of growth cell struts 1122Y D and / or the distal end region 1122 of the third pair of growth cell struts 1122X. DThe distal end region 1122 of the fourth pair of growth cell struts 1122Z D In selected embodiments, the distal end region 1122 of the growth cell strut 1122W may be connected to D 3A, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122Y is provided with D The distal end region 1122 of the growth cell strut 1122X can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122Z, D 3A, the first, second, third, and fourth pairs of growth cell struts 1122 are shown and described as being connected in a similar manner for purposes of example only, however, the growth cell struts 1122 may be connected in any suitable uniform and / or different manner.

[0097] The growth cell struts 1122 may be connected in any suitable manner to form a ring configuration of the growth cell member 1120. The distal end regions 1122 of adjacent growth cell struts 1122 D As shown in FIG. 3A, the distal end regions 1122 of the increment cell struts 1122T in the second pair of increment cell struts 1122S, 1122T may be connected. D and the distal end region 1122 of the growth cell strut 1122W in the third pair of growth cell struts 1122W, 1122X. D The distal end region 1122 of the growth cell strut 1122V in the second pair of growth cell struts 1122U, 1122V can be connected to each other. D and the distal end region 1122 of the growth cell strut 1122Y in the fourth pair of growth cell struts 1122Y, 1122Z. D can also be linked in the same way.

[0098] In selected embodiments, the connected distal end regions 1122 of the increment cell struts 1122T, 1122WD As shown in FIG. 3A, the distal end regions 1122 of the growth cell struts 1122V, 1122Y are connected. D The connected distal end regions 1122 of the growth cell struts 1122T, 1122W can be D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The connection between the growth cell struts 1122T, 1122W and the distal end regions 1122T, 1122W can be provided as growth cell junctions 1127. In other words, the connection between the growth cell struts 1122T, 1122W and the distal end regions 1122T, 1122W can be provided as growth cell junctions 1127. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D may intersect to form growth cell junctions 1127. The growth cell junctions 1127 may provide a mechanical (or physical) connection between the growth cell struts 1122T, 1122W and the growth cell struts 1122V, 1122Y to form the growth cell member 1120. Preferably, the growth cell junctions 1127 are formed at the joined distal end regions 1122 of the growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D A flexible connection can be provided between the

[0099] To aid in providing a flexible connection, the growth cell junctions 1127 can be provided as a connecting member, such as a flexible connecting member 1129. The flexible connecting member 1129 can include a flexible central body 1129C with first and second connecting regions 1129A, 1129B. The first connecting region 1129A can connect the connected distal end regions 1122T, 1122W of the growth cell struts 1122T, 1122W. D while the second connecting region 1164B can be configured to connect to the connected distal end regions 1122 of the increment cell struts 1122V, 1122Y. DAlthough the flexible central body 1129C can be provided in any suitable size, shape, or other configuration, the flexible central body 1129C is shown in FIG. 3A as defining a central opening 1129D to enhance the flexibility of the flexible connecting member 1129 and / or to provide a connecting area for an optional retaining member 1200 (shown in FIGS. 2 and 5A-E).

[0100] the connected distal end regions 1122 of the growth cell struts 1122 of the growth cell member 1120; D Each pair of growth cell struts 1122 may be connected via a respective growth cell junction 1127. Alternatively, the connected distal end regions 1122 of the growth cell struts 1122 may be connected via a respective growth cell junction 1127. D One or more pairs of the growth cell struts 1122 may be separated (or unconnected). D The separated pairs can help increase the flexibility of the growth cell members 1120 and, therefore, the flexibility of the device frame 1100.

[0101] 3B, for example, growth cell member 1120 is shown as including a fifth pair of growth cell struts 1122L, 1122M and a sixth pair of growth cell struts 1122N, 1122O. The fifth pair of growth cell struts 1122L, 1122M and the sixth pair of growth cell struts 1122N, 1122O may be provided in the manner described in more detail above with respect to the first pair of growth cell struts 1122S, 1122T and the second pair of growth cell struts 1122U, 1122V of FIG. 3A and may be configured to define a third frame cell 1126L MNO. The connected distal end regions 1122 of growth cell struts 1122M, 1122S may be configured to define a third frame cell 1126L MNO. D The connecting distal end regions 1122 of the growth cell struts 1122O, 1122U D The connected distal end regions 1122 of the growth cell struts 1122M, 1122S are shown separately. Dand the connected distal end regions 1122 of the growth cell struts 1122O, 1122U. D 3B, can form gaps, such as apical gaps 1128. In other words, the growth cell member 1120 can include multiple apical gaps 1128 disposed between adjacent frame cells 1126.

[0102] The apical gaps 1128 can advantageously allow bending and / or flexing of the device frame 1100 and, therefore, the growth device 1000. The flexibility of the device frame 1100 can be increased by increasing the size of at least one apical gap 1128 and / or decreased by decreasing the size of the apical gap 1128. As shown in FIG. 3E , for example, the growth cell junctions 1127 and apical gaps 1128 allow the device frame 1100 to move within curves and other geometries within a selected blood vessel or other lumen 120 of the patient 100.

[0103] In selected embodiments, the first pair of growth cell struts 1122S, 1122T, the third pair of growth cell struts 1122W, 1122X, and the fifth pair of growth cell struts 1122L, 1122M of Figures 3A-B can be linked to form a first annular strut array 1111A of linked growth cell struts 1122; while the second pair of growth cell struts 1122U, 1122V, the fourth pair of growth cell struts 1122Y, 1122Z, and the sixth pair of growth cell struts 1122N, 1122O of Figures 3A-B can be linked to form a second annular strut array 1111B of linked growth cell struts 1122. In other words, the growth cell struts 1122 associated with each of the first and second annular strut arrays 1111A, 1111B may be connected in a zigzag pattern to form a cylindrical shape.

[0104] The proximal end regions 1122 of a pair of adjacent growth cell struts 1122 PThe distal end regions 1122 of the pair of adjacent growth cell struts 1122 can be connected. D is connected to the proximal end region 1122 P The pairs of connected growth cell struts 1122 forming the V shape can be repeated around the circumference of the cylinder, with the distal end regions 1122 of the pairs of connected growth cell struts 1122 extending radially from the D are connected to form a repeating V-shaped (or Z-shaped) pattern. The first and second annular strut arrays 1111A, 1111B may be connected via growth cell junctions 1127 and / or may cooperate to define internal growth cell openings 1124 of the growth cell member 1120. As discussed above with reference to FIG. 3A, the growth cell junctions 1127 are formed by connecting the distal end regions 1122 of the connected growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The growth cell junction 1127 can thereby provide a flexible connection between the first and second strut annular arrangements 1111A, 1111B.

[0105] In the manner described in more detail above with reference to the device frame 1100 of Figure 2, the growth cell members 1120 may be coupled to one or more spacing members 1130. The growth cell members 1120 and spacing members 1130 may be coupled in any suitable manner. The spacing members 1130 may be, for example, coupled to the proximal end regions 1122 of the growth cell struts 1122 of selected growth cell members 1120. P As shown in FIG. 3A, the growth cell member 1120 can be connected to an intermediate growth cell member 1120. I a first spacing member 1130 connecting the first pair of connected proximal end regions 1122 of the growth cell struts 1122S, 1122T; P and the third pair of connected proximal end regions 1122 of the growth cell struts 1122W, 1122X. Pand a second spacing member 1130 is connected to the connected proximal end regions 1122 of the second pair of growth cell struts 1122U, 1122V. P and the fourth pair of connected proximal end regions 1122 of the growth cell struts 1122Y, 1122Z. P is linked to.

[0106] The growth cell member 1120, in selected embodiments, is a proximal growth cell member 1120, as shown in FIG. P Referring to FIG. 3C, the proximal growth cell member 1120 of the device frame 1100 may include P The proximal growth cell member 1120 can include a plurality of growth cell struts 1122 that define one or more frame cells 1126 and are arranged in a ring configuration to define ingrowth cell openings 1124 in the manner shown and described with reference to the growth cell member 1120 in FIG. 3A. P Each of the growth cell struts 1122 can optionally be paired with another growth cell strut 1122, as shown in FIG. 3C.

[0107] In the method described in more detail above with reference to FIG. 3A, the proximal growth cell member 1120 P The paired increment cell struts 1122 may include a first pair of increment cell struts 1122S, 1122T and a second pair of increment cell struts 1122U, 1122V. Each of the increment cell struts 1122S, 1122T, 1122U, 1122V may be located at the proximal end region 1122. P and distal end region 1122 D Referring to the first pair of increment cell struts 1122S, 1122T, the proximal end region 1122 of the increment cell strut 1122S may include P The proximal end region 1122 of the growth cell strut 1122T P and distal end regions 1122 of the growth cell struts 1122S, 1122T. D The proximal end region 1122 PThe proximal end regions 1122 of the second pair of growth cell struts 1122U, 1122V extend from P can be similarly connected, and the distal end regions 1122 of the growth cell struts 1122U, 1122V can also be connected. D The proximal end region 1122 P It can extend from

[0108] The distal end region 1122 of the first pair of growth cell struts 1122S D 3C, the distal end region 1122 of the second pair of growth cell struts 1122U. D The distal end region 1122 of the first pair of growth cell struts 1122T can be disposed adjacent to the D Similarly, the distal end region 1122 of the second pair of growth cell struts 1122V D The first and second pairs of growth cell struts 1122S, 1122T, 1122U, 1122V can thereby define a first frame cell 1126S TUV.

[0109] Optionally, distal end region 1122 of first pair of growth cell struts 1122S D The distal end region 1122 of the second pair of growth cell struts 1122U D while the distal end region 1122 of the first pair of growth cell struts 1122T may be connected to D the distal end region 1122 of the second pair of growth cell struts 1122V D In selected embodiments, the distal end region 1122 of the growth cell strut 1122S may be connected to D 3C, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122U is provided with D The distal end region 1122 of the growth cell strut 1122T can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122V, D can be separated from

[0110] Additionally and / or alternatively, the paired increment cell struts 1122 can include a third pair of increment cell struts 1122W, 1122X and a fourth pair of increment cell struts 1122Y, 1122Z. Each of the increment cell struts 1122W, 1122X, 1122Y, 1122Z is ​​located at the proximal end region 1122. P and distal end region 1122 D The proximal end region 1122 of the growth cell strut 1122W may include P is connected to the proximal end region 1122 P the distal end regions 1122 of the growth cell struts 1122W, 1122X extending from D a proximal end region 1122 of the growth cell strut 1122X, P The proximal end region 1122 of the fourth pair of growth cell struts 1122Y, 1122Z can be connected to the P can be similarly connected, and the distal end regions 1122 of the growth cell struts 1122Y, 1122Z can also be connected. D is connected to the proximal end region 1122 P As shown in FIG. 3C, the distal end region 1122 of the third pair of growth cell struts 1122W D The distal end region 1122 of the fourth pair of growth cell struts 1122Y D while the distal end region 1122 of the third pair of growth cell struts 1122X may be disposed adjacent to the distal end region 1122 of the third pair of growth cell struts 1122X. D The distal end region 1122 of the fourth pair of growth cell struts 1122Z D The third and fourth pairs of growth cell struts 1122W, 1122X, 1122Y, 1122Z can thereby define second frame cells 1126WXYZ.

[0111] the distal end region 1122 of the third pair of growth cell struts 1122W; D The distal end region 1122 of the fourth pair of growth cell struts 1122Y Dand / or the distal end region 1122 of the third pair of growth cell struts 1122X. D The distal end region 1122 of the fourth pair of growth cell struts 1122Z D In selected embodiments, the distal end region 1122 of the growth cell strut 1122W may be connected to D 3C, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122Y is provided with D The distal end region 1122 of the growth cell strut 1122X can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122Z, D 3C, although the first, second, third, and fourth pairs of growth cell struts 1122 are shown and described as being connected in a similar manner for purposes of example only, the growth cell struts 1122 may be connected in any suitable uniform and / or different manners.

[0112] The growth cell struts 1122 may be connected in any suitable manner to the proximal growth cell member 1120. P The distal end regions 1122 of adjacent growth cell struts 1122 may form a ring configuration. D As shown in FIG. 3C, the distal end regions 1122 of the increment cell struts 1122T in the second pair of increment cell struts 1122S, 1122T may be connected. D and the distal end region 1122 of the growth cell strut 1122W in the third pair of growth cell struts 1122W, 1122X. D The distal end regions 1122 of the increment cell struts 1122V in the second pair of increment cell struts 1122U, 1122V can be connected. D and the distal end region 1122 of the growth cell strut 1122Y in the fourth pair of growth cell struts 1122Y, 1122Z. D can also be linked in the same way.

[0113] In selected embodiments, the connected distal end regions 1122 of the increment cell struts 1122T, 1122W D The growth cell struts 1122V, 1122Y are connected to each other at the distal end regions 1122. D The connected distal end regions 1122 of the growth cell struts 1122T, 1122W can be D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The connection between the growth cell struts 1122T, 1122W and the growth cell junction 1127 can be provided as an in-growth cell junction 1127 in the manner shown and described in more detail above with reference to FIG. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D may intersect to form growth cell junctions 1127. The growth cell junctions 1127 may provide a mechanical (or physical) connection between the growth cell struts 1122T, 1122W and the growth cell struts 1122V, 1122Y to form the growth cell member 1120. Preferably, the growth cell junctions 1127 are formed at the joined distal end regions 1122 of the growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D and a flexible connection between the

[0114] To aid in providing a flexible connection, the growth cell junctions 1127 can be provided as a connecting member, such as a flexible connecting member 1129. The flexible connecting member 1129 can include a flexible central body 1129C with first and second connecting regions 1129A, 1129B. The first connecting region 1129A can connect the connected distal end regions 1122T, 1122W of the growth cell struts 1122T, 1122W. D while the second connecting region 1164B can be configured to connect to the connected distal end regions 1122 of the increment cell struts 1122V, 1122Y. DAlthough the flexible central body 1129C can be provided in any suitable size, shape, or other configuration, the flexible central body 1129C is shown in FIG. 3C as defining a central opening 1129D to enhance the flexibility of the flexible connecting member 1129 and / or to provide a connecting area for an optional retaining member 1200 (shown in FIGS. 2 and 5A-E).

[0115] the connected distal end regions 1122 of the growth cell struts 1122 of the growth cell member 1120; D Each pair of growth cell struts 1122 may be connected via a respective growth cell junction 1127. Alternatively, the connected distal end regions 1122 of the growth cell struts 1122 may be connected via a respective growth cell junction 1127. D One or more pairs of the growth cell struts 1122 may be separated (or unconnected). D The separated pairs can help increase the flexibility of the growth cell members 1120 and, therefore, the flexibility of the device frame 1100.

[0116] The growth cell member 1120 can include, for example, a fifth pair of growth cell struts 1122L, 1122M and a sixth pair of growth cell struts 1122N, 1122O. The fifth pair of growth cell struts 1122L, 1122M and the sixth pair of growth cell struts 1122N, 1122O can be provided in the manner described in more detail above with respect to the fifth pair of growth cell struts 1122L, 1122M and the sixth pair of growth cell struts 1122N, 1122O of FIG. 3B and can be configured to define a third frame cell 1126L MNO. The connected distal end regions 1122 of the growth cell struts 1122M, 1122S can be configured to define a third frame cell 1126L MNO. D The connecting distal end regions 1122 of the growth cell struts 1122O, 1122U D The connected distal end regions 1122 of the growth cell struts 1122M, 1122S are shown separately. D and the connected distal end regions 1122 of the growth cell struts 1122O, 1122U.D can form gaps, such as apical gap 1128, in the manner shown and described in more detail above with reference to FIG. 3B. In other words, growth cell member 1120 can include multiple apical gaps 1128 disposed between adjacent frame cells 1126. The apical gaps 1128 can advantageously allow bending and / or flexing of device frame 1100 and, therefore, growth device 1000. The flexibility of device frame 1100 can be increased by increasing the size of at least one apical gap 1128 and / or decreased by decreasing the size of the apical gap 1128.

[0117] In selected embodiments, a first pair of growth cell struts 1122S, 1122T, a third pair of growth cell struts 1122W, 1122X, and a fifth pair of growth cell struts 1122L, 1122M can be connected to form a first annular strut array 1111A of connected growth cell struts 1122; while a second pair of growth cell struts 1122U, 1122V, a fourth pair of growth cell struts 1122Y, 1122Z, and a sixth pair of growth cell struts 1122N, 1122O can be connected to form a second annular strut array 1111B of connected growth cell struts 1122. The first and second annular strut arrays 1111A, 1111B can be connected via growth cell junctions 1127 and / or can cooperate to define internal growth cell openings 1124 of the growth cell member 1120. The growth cell junctions 1127 are formed by connecting the distal end regions 1122 of the growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The growth cell junction 1127 can thereby provide a flexible connection between the first and second strut annular arrangements 1111A, 1111B.

[0118] In the manner described in more detail above with reference to the device frame 1100 of FIG. 2, the proximal growth cell member 1120 P The proximal growth cell member 1120 may be coupled to a spacing member 1130. P The spacing member 1130 may be coupled to the proximal growth cell member 1120 in any suitable manner. P The proximal end region 1122 of the selected growth cell strut 1122 P As shown in FIG. 3C, the spacing member 1130 may be connected to the connected proximal end regions 1122 of the second pair of growth cell struts 1122U, 1122V. P and the fourth pair of connected proximal end regions 1122 of the growth cell struts 1122Y, 1122Z. P It can be connected to the connecting part of.

[0119] Additionally and / or alternatively, the growth cell member 1120 may be a distal growth cell member 1120, as shown in FIG. 3D. D 3D, the distal growth cell member 1120 of the device frame 1100 may include D can include a plurality of growth cell struts 1122 that define one or more frame cells 1126 and are arranged in a ring configuration to define ingrowth cell openings 1124 in the manner shown and described with reference to the growth cell member 1120 of FIG. 3A. D Each of the growth cell struts 1122 can optionally be paired with another growth cell strut 1122, as shown in FIG. 3D.

[0120] In the method described in more detail above with reference to FIG. 3A, distal growth cell member 1120 D The paired increment cell struts 1122 may include a first pair of increment cell struts 1122S, 1122T and a second pair of increment cell struts 1122U, 1122V. Each of the increment cell struts 1122S, 1122T, 1122U, 1122V may be located at the proximal end region 1122.P and distal end region 1122 D Referring to the first pair of increment cell struts 1122S, 1122T, the proximal end region 1122 of the increment cell strut 1122S may include P The proximal end region 1122 of the growth cell strut 1122T P and distal end regions 1122 of the growth cell struts 1122S, 1122T. D The proximal end region 1122 P The proximal end regions 1122 of the second pair of growth cell struts 1122U, 1122V extend from P can be similarly connected, and the distal end regions 1122 of the growth cell struts 1122U, 1122V can also be connected. D The proximal end region 1122 P It can extend from

[0121] As shown in FIG. 3D, the distal end region 1122 of the first pair of growth cell struts 1122S D The distal end region 1122 of the second pair of growth cell struts 1122U D 1122T; while the distal end region 1122 of the first pair of growth cell struts 1122T D the distal end region 1122 of the second pair of growth cell struts 1122V D The first and second pairs of growth cell struts 1122S, 1122T, 1122U, 1122V can thereby define a first frame cell 1126S TUV.

[0122] The distal end region 1122 of the first pair of growth cell struts 1122S D Optionally, the distal end region 1122 of the second pair of growth cell struts 1122U D and / or the distal end region 1122 of the first pair of growth cell struts 1122T. D Optionally, the distal end region 1122 of the second pair of growth cell struts 1122V DIn selected embodiments, the distal end region 1122 of the growth cell strut 1122S may be connected to D 3D, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122U is provided with D The distal end region 1122 of the growth cell strut 1122T can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122V, D can be separated from

[0123] Additionally and / or alternatively, the paired increment cell struts 1122 can include a third pair of increment cell struts 1122W, 1122X and a fourth pair of increment cell struts 1122Y, 1122Z. Each of the increment cell struts 1122W, 1122X, 1122Y, 1122Z is ​​located at the proximal end region 1122. P and distal end region 1122 D The proximal end region 1122 of the growth cell strut 1122W may include P is connected to the proximal end region 1122 P the distal end regions 1122 of the growth cell struts 1122W, 1122X extending from D a proximal end region 1122 of the growth cell strut 1122X, P The proximal end region 1122 of the fourth pair of growth cell struts 1122Y, 1122Z can be connected to the P can be similarly connected, and the distal end regions 1122 of the growth cell struts 1122Y, 1122Z can also be connected. D is connected to the proximal end region 1122 P As shown in FIG. 3D, the distal end region 1122 of the third pair of growth cell struts 1122W D The distal end region 1122 of the fourth pair of growth cell struts 1122Y D while the distal end region 1122 of the third pair of growth cell struts 1122X may be disposed adjacent to the distal end region 1122 of the third pair of growth cell struts 1122X. DThe distal end region 1122 of the fourth pair of growth cell struts 1122Z D The third and fourth pairs of growth cell struts 1122W, 1122X, 1122Y, 1122Z can thereby define second frame cells 1126WXYZ.

[0124] the distal end region 1122 of the third pair of growth cell struts 1122W; D The distal end region 1122 of the fourth pair of growth cell struts 1122Y D and / or the distal end region 1122 of the third pair of growth cell struts 1122X. D The distal end region 1122 of the fourth pair of growth cell struts 1122Z D In selected embodiments, the distal end region 1122 of the growth cell strut 1122W may be connected to D 3D, the distal end region 1122 D The distal end region 1122 of the growth cell strut 1122Y is provided with D The distal end region 1122 of the growth cell strut 1122X can be separated from the D Optionally, distal end region 1122 D a distal end region 1122 of the growth cell strut 1122Z, D 3D, although the first, second, third, and fourth pairs of growth cell struts 1122 are shown and described as being connected in a similar manner for purposes of example only, the growth cell struts 1122 may be connected in any suitable uniform and / or different manner.

[0125] The growth cell struts 1122 may be connected in any suitable manner to the distal growth cell member 1120. D The distal end regions 1122 of adjacent growth cell struts 1122 may form a ring configuration. DAs shown in FIG. 3D, the distal end regions 1122 of the increment cell struts 1122T in the second pair of increment cell struts 1122S, 1122T may be connected. D and the distal end region 1122 of the growth cell strut 1122W in the third pair of growth cell struts 1122W, 1122X. D The distal end regions 1122 of the increment cell struts 1122V in the second pair of increment cell struts 1122U, 1122V can be connected. D and the distal end region 1122 of the growth cell strut 1122Y in the fourth pair of growth cell struts 1122Y, 1122Z. D can also be linked in the same way.

[0126] In selected embodiments, the connected distal end regions 1122 of the increment cell struts 1122T, 1122W D The growth cell struts 1122V and 1122Y are connected at their distal end regions 1122. D The connected distal end regions 1122 of the growth cell struts 1122T, 1122W can be D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The connection between the growth cell struts 1122T, 1122W and the growth cell junction 1127 can be provided as an in-growth cell junction 1127 in the manner shown and described in more detail above with reference to FIG. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D may intersect to form growth cell junctions 1127. The growth cell junctions 1127 may provide a mechanical (or physical) connection between the growth cell struts 1122T, 1122W and the growth cell struts 1122V, 1122Y to form the growth cell member 1120. Preferably, the growth cell junctions 1127 are formed at the joined distal end regions 1122 of the growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. Dand a flexible connection between the

[0127] To aid in providing a flexible connection, the growth cell junctions 1127 can be provided as a connecting member, such as a flexible connecting member 1129. The flexible connecting member 1129 can include a flexible central body 1129C with first and second connecting regions 1129A, 1129B. The first connecting region 1129A can connect the connected distal end regions 1122T, 1122W of the growth cell struts 1122T, 1122W. D while the second connecting region 1164B can be configured to connect to the connected distal end regions 1122 of the increment cell struts 1122V, 1122Y. D Although the flexible central body 1129C can be provided in any suitable size, shape, or other configuration, the flexible central body 1129C is shown in FIG. 3D as defining a central opening 1129D to enhance the flexibility of the flexible connecting member 1129 and / or to provide a connecting area for an optional retaining member 1200 (shown in FIGS. 2 and 5A-E).

[0128] the connected distal end regions 1122 of the growth cell struts 1122 of the growth cell member 1120; D Each pair of growth cell struts 1122 may be connected via a respective growth cell junction 1127. Alternatively, the connected distal end regions 1122 of the growth cell struts 1122 may be connected via a respective growth cell junction 1127. D One or more pairs of the growth cell struts 1122 may be separated (or unconnected). D The separated pairs can help increase the flexibility of the growth cell members 1120 and, therefore, the flexibility of the device frame 1100.

[0129] The growth cell member 1120 can include, for example, a fifth pair of growth cell struts 1122L, 1122M and a sixth pair of growth cell struts 1122N, 1122O. The fifth pair of growth cell struts 1122L, 1122M and the sixth pair of growth cell struts 1122N, 1122O can be provided in the manner described in more detail above with respect to the fifth pair of growth cell struts 1122L, 1122M and the sixth pair of growth cell struts 1122N, 1122O of FIG. 3B and can be configured to define a third frame cell 1126L MNO. The connected distal end regions 1122 of the growth cell struts 1122M, 1122S can be configured to define a third frame cell 1126L MNO. D The connecting distal end regions 1122 of the growth cell struts 1122O, 1122U D The connected distal end regions 1122 of the growth cell struts 1122M, 1122S are shown separately. D and the connected distal end regions 1122 of the growth cell struts 1122O, 1122U. D can form gaps, such as apical gap 1128, in the manner shown and described in more detail above with reference to FIG. 3B. In other words, growth cell member 1120 can include multiple apical gaps 1128 disposed between adjacent frame cells 1126. The apical gaps 1128 can advantageously allow bending and / or flexing of device frame 1100 and, therefore, growth device 1000. The flexibility of device frame 1100 can be increased by increasing the size of at least one apical gap 1128 and / or decreased by decreasing the size of the apical gap 1128.

[0130] In selected embodiments, a first pair of growth cell struts 1122S, 1122T, a third pair of growth cell struts 1122W, 1122X, and a fifth pair of growth cell struts 1122L, 1122M can be connected to form a first annular strut array 1111A of connected growth cell struts 1122; while a second pair of growth cell struts 1122U, 1122V, a fourth pair of growth cell struts 1122Y, 1122Z, and a sixth pair of growth cell struts 1122N, 1122O can be connected to form a second annular strut array 1111B of connected growth cell struts 1122. The first and second annular strut arrays 1111A, 1111B can be connected via growth cell junctions 1127 and / or can cooperate to define internal growth cell openings 1124 of the growth cell member 1120. The growth cell junctions 1127 are formed by connecting the distal end regions 1122 of the growth cell struts 1122T, 1122W. D and the connected distal end regions 1122 of the growth cell struts 1122V, 1122Y. D The growth cell junction 1127 can thereby provide a flexible connection between the first and second strut annular arrangements 1111A, 1111B.

[0131] In the manner described in more detail above with reference to the device frame 1100 of FIG. 2, the distal growth cell member 1120 D The distal growth cell member 1120 may be coupled to a spacing member 1130. D The distal growth cell member 1120 and the spacing member 1130 may be coupled in any suitable manner. D The proximal end region 1122 of the selected growth cell strut 1122 P As shown in FIG. 3D, the spacing member 1130 may be attached to the connected proximal end regions 1122 of the first pair of growth cell struts 1122S, 1122T. P and the third pair of connected proximal end regions 1122 of the growth cell struts 1122W, 1122X. PIt can be connected to the connecting part.

[0132] The spacing member(s) 1130 of the device frame 1100 can have a uniform and / or different structure. In selected embodiments, the spacing member(s) 1130 can be formed from, but are not limited to, a metal, a metal alloy, a polymer, a biodegradable polymer, a fabric, and / or a combination of materials. An exemplary spacing member 1130 is shown in FIG. 4. With reference to FIG. 4, the spacing member 1130 is shown as comprising a plurality of spacer member struts 1132 that can be arranged in a ring configuration to define an interior spacer member opening 1134 of the spacing member 1130. Each spacer member strut 1132 of the spacing member 1130 has a proximal end region 1132 P and distal end region 1132 D and a spacer member strut 1132. The spacer member struts 1132 can have a predetermined spacer member strut width, a predetermined spacer member strut thickness, and / or a predetermined spacer member strut length. The predetermined spacer member strut width, the predetermined spacer member strut thickness, and / or the predetermined spacer member strut length of the spacer member struts 1132 can include any suitable spacer member strut width, spacer member strut thickness, and / or spacer member strut length. Exemplary spacer member strut thicknesses can include, but are not limited to, 0.15 millimeters to 0.75 millimeters; while spacer member strut lengths can range between, but are not limited to, 5 millimeters to 50 millimeters or more. In selected embodiments, the spacing member 1130 can include cobalt chrome to provide radial strength to the spacing member 1130 itself.

[0133] To enhance the radial strength of spacer member struts 1132, spacer member struts 1132 preferably have a spacer member strut width that is 1 to 3 times the predetermined cell strut width of growth cell struts 1122 and / or a spacer member strut thickness that is 1 to 3 times the predetermined cell strut thickness of growth cell struts 1122. Although a uniform spacer member strut width and / or a uniform spacer member strut thickness is shown and described in Figure 4 for illustrative purposes only, spacer member struts 1132 can include uniform and / or varying spacer member strut widths and / or spacer member strut thicknesses.

[0134] 4, the spacer member struts 1132 can be axially aligned with the device frame 1100 and / or can be arranged in a substantially parallel configuration. The geometric configuration of the spacer member struts 1132 can advantageously allow the spacing members 1130 to expand as the growth cell members 1120 expand without experiencing foreshortening. This can reduce or eliminate foreshortening during expansion of the growth device 1000 via the spacer member struts 1132 of the spacing members 1130. In other words, the spacer member struts 1132 of the spacing members 1130 can reduce or eliminate the rate of foreshortening of the growth device 1000 throughout the operating range of the diameter, cross-section, or other dimension of the growth device 1000 from implantation to expansion.

[0135] Increasing the spacer member strut length of the spacer member struts 1132 may increase the growth device's 1000 resistance to rate of shortening across its length, but may decrease the overall radial strength of the growth device 1000. In contrast, spacer member struts 1132 with increased spacer member strut length may decrease the growth device's 1000 resistance to rate of shortening across its length, and may increase the overall radial strength of the growth device 1000. The spacer member strut lengths of the spacer member struts 1132 may be uniform and / or may vary among the spacing members 1130 of the growth device 1000. In other words, the spacer member strut length of a first spacing member 1130 of the growth device 1000 may be longer than the spacer member strut length of a second spacing member 1130 of the growth device 1000 and / or may be shorter than the spacer member strut length of a third spacing member 1130 of the growth device 1000. The spacer member strut length of the spacing member 1130 may depend, for example, on the intended use of the growth device 1000, the implantation location of the growth device 1000 within the patient 100 (shown in FIG. 8), and / or the anatomy of the patient 100.

[0136] The spacing member 1130 can be configured to couple with the first growth cell member 1120A and / or the second growth cell member 1120B in any suitable manner. P may be configured to couple with, for example, first growth cell member 1120A and / or the distal end region 1132 of spacer member strut 1132. D can be configured to couple with the second growth cell member 1120B. In selected embodiments, the proximal end region 1132 of the spacer member strut 1132 P is a distal end region 1122 of a growth cell strut 1122 associated with the first growth cell member 1120A. D while the distal end region 1132 of the spacer member strut 1132D 4, at the proximal end region 1122 of the growth cell strut 1122 associated with the second growth cell member 1120B. P It can be configured to be coupled to

[0137] The device frame 1100 includes a series of alternating growth cell members 1120 and a proximal end region 1110 of the device frame 1100, as described above with reference to FIG. P , 1110 D When the growth cell members 1120 include spacing members 1130 spanning axially therebetween, the in-growth cell openings 1124 of the growth cell members 1120 and the interior spacer member opening(s) 1134 of the spacing member(s) 1130 can cooperate to define a central axial channel 1150 of the elongated device frame 1100. In other words, the in-growth cell openings 1124 of the growth cell members 1120 and the interior spacer member opening(s) 1134 of the spacing member(s) 1130 can be axially aligned to provide the central axial channel 1150 of the elongated device frame 1100.

[0138] In selected embodiments, each spacing member 1130 can be directly coupled to an associated growth cell member 1120. Additionally and / or alternatively, one or more spacing members 1130 and associated growth cell members 1120 can be indirectly coupled via one or more optional intermediate connecting members, such as the illustrative intermediate connecting member 1160, as shown in FIG. 4. Each intermediate connecting member 1160 can include a flexible central body 1162 having first and second connecting regions 1164A, 1164B. The thickness of the flexible central body 1162 can be increased to decrease the flexibility of the intermediate connecting member 1160 and / or decreased to increase the flexibility of the intermediate connecting member 1160. As shown in FIG. 4, the flexible central body 1162 can have a fork or V-shape with two branches (or end regions) at which the first and second connecting regions 1164A, 1164B are located. The first coupling region 1164A can be configured to couple with an associated growth cell member 1120; while the second coupling region 1164B can be configured to couple with an associated spacing member 1130.

[0139] The flexible central body 1162 advantageously allows for a flexible connection between the associated growth cell members 1120 and the associated spacing members 1130. The device frame 1100 may be configured with a series of alternating growth cell members 1120 and a proximal end region 1110 of the device frame 1100, as described above with reference to FIG. P and distal end region 1110 D When the growth cell members 1120 include a spacing member 1130 axially spanning between the growth cell members 1120 and the spacing member 1130, the flexible connection between the growth cell members 1120 and the spacing member 1130 can increase the overall flexibility of the device frame 1100. The flexibility of the device frame 1100 can facilitate implantation, deployment, and / or expansion of the growth device 1000 within the body of a patient 100 (shown in FIG. 8 ) during use.

[0140] In some embodiments, the device frame 1100 can take any of a variety of forms with respect to strut design. The device frame 1100 can be designed with a diamond strut configuration to allow for appropriate crimp size, radial force, and a target diameter range. This diamond strut configuration can be a closed-cell design, with vertices connected to each level of the diamond row and intersecting to form respective strut junctions. Other embodiments can be an open-cell design without a diamond strut configuration. An open-cell design consists of cells that are disconnected from each other, allowing for flexibility in the frame. Another configuration for the device frame 1100 can be a chevron strut design, with straight connecting beams separating the strut vertices. A chevron strut design can advantageously limit strut shortening when the implant is expanded to a higher (or larger) diameter. This frame embodiment can consist of multiple frame struts extending continuously from the proximal side of the frame to the distal side of the frame. The expanded device frame 1100 can form a central axial channel 1150 for blood flow.

[0141] 2, growth device 1000 is shown as including one or more optional retention members 1200. Retention members 1200 are attached to the proximal end region 1110 of device frame 1100. P and / or distal end region 1110 D and can extend radially from the periphery 1140. In other words, the retention member 1200 can be positioned on the proximal growth cell member 1120 of the device frame 1100. P and / or distal growth cell member 1120 D and extend radially therefrom. In selected embodiments, the retention members 1200 can be distributed around the periphery 1140 of the device frame 1100. The retention members 1200 can be distributed in any predetermined configuration around the periphery 1140 of the device frame 1100, and can be evenly distributed around the periphery 1140, as shown in FIG.

[0142] The retention members 1200 provide positioning support during delivery via a delivery catheter system (or means) 2000 (shown in FIGS. 14A-D) and hold the growth device 1000 in place while connecting the blood flow of different blood vessels. The growth device 1000 can be configured, for example, for deployment within a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). Each retention member 1200 can be provided in any suitable manner. The retention members 1200 can be fabricated, for example, from a polymer, metal, or other suitable material. The retention members 1200 can comprise paddles, hooks, tabs, spirals, or other suitable shapes. In selected embodiments, the device frame 1100 can expand radially outward to form one or more retention members 1200. This expansion can occur by utilizing a balloon expansion system 2200 (shown in FIG. 14B) of the delivery catheter system 2000 when the device frame 1100 is made of a balloon-expandable material, such as stainless steel or cobalt chrome. Additionally and / or alternatively, the retention member 1200 can be molded to a self-expanding material, such as Nitinol. In some embodiments, the self-expanding retention member 1200 can be attached to a balloon-expandable shunt. This allows the self-expanding retention member 1200 to be molded perpendicular to the delivery catheter system 2000 and crimped shunt, thereby enabling catheter delivery and retention during deployment and post-inflation of the device frame 1100.

[0143] The retention members 1200 can be angled toward the proximal end region of the device frame 1100 and / or toward the distal end region of the device frame 1100, depending on the retention or sealing function required. In some embodiments, the retention members 1200 can comprise a single bar, loop, or other shape. One or more retention members 1200 can be positioned around the periphery 1140 of the device frame 1100. In selected embodiments, a self-expanding metal sheet can be formed into an "L" shape and attached to the periphery 1140 of the device frame 1100 as retention members 1200, forming vertical tabs that extend into a second blood vessel adjacent to the selected retention member 1200 after delivery via the delivery catheter system 2000. The delivery catheter system 2000 can include, for example, an outer sheath member 2100 (shown in FIG. 14A ) that can be unsheathed to expose the growth device 1000, thereby exposing the shaped vertical retention members 1200 for use in delivering the growth device 1000. In these embodiments, the retention member 1200 can be secured to an adjacent blood vessel, the retention member 1200 acts as an anchor in a second blood vessel of the patient, and the growth device 1000 can be pulled proximally using the delivery catheter system 2000.

[0144] In some embodiments, retention members 1200 for maintaining the growth device 1000 within the pulmonary artery 122 can be constructed of, but are not limited to, nitinol, cobalt chrome, stainless steel, or other metal alloys. The retention members 1200 can be attached to the device frame 1100 in any suitable manner, including, but not limited to, suturing, welding, riveting, lamination, and / or a separate mechanical lock. The retention members 1200 can be distributed around the periphery 1140 of the device frame 1100. In selected embodiments, the retention members 1200 can be distributed evenly and / or unevenly around the periphery 1140. The retention members 1200 can be oriented such that they can extend along the length of the second vessel.

[0145] Referring to FIG. 5A, the retention member 1200 includes a proximal end region 1210 for coupling with the periphery 1140 of the device frame 1100 (shown in FIGS. 2 and 5A-E). P and a distal end region 1210 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D The central retaining member body 1210 may include a proximal end region 1210 having P In selected embodiments, the central retaining member body 1210 can be configured to couple with selected growth cell joints 1127 (shown in FIG. 5B ) of the device frame 1100. For example, the central retaining member body 1210 can include engagement members 1250 for coupling with selected growth cell joints 1127. The central retaining member body 1210 can couple with the inner surface of the inner periphery 1140 (shown in FIGS. 2 and 5A-E ) of the device frame 1100 and / or the outer surface of the outer periphery 1140 of the device frame 1100. The central retaining member body 1210 can be coupled to the device frame 1100 in any suitable manner, including, but not limited to, sutures, wires, welds, adhesives, and / or adhesive polymer layers.

[0146] Proximal end region 1210 of central retention member body 1210 P 5B, the proximal end region 1210 can be flush coupled with the device frame 1100. In other words, the proximal end region 1210 P The central retention member body 1210 can be positioned in a parallel configuration relative to the periphery 1140 of the device frame 1100. The central retention member body 1210 can be positioned in a parallel configuration relative to the periphery 1140 of the device frame 1100. D The central retaining member body 1210 may include a curved member body such that the central retaining member body 1210 may extend at an angle from the periphery 1140 of the device frame 1100. In selected embodiments, the central retaining member body 1210 may include a curved member body such that the central retaining member body 1210 may extend at an angle from the periphery 1140 of the device frame 1100. D is the proximal end region 1210 P The member may include a curved member body portion 1230 such that the member is disposed at an angle relative to the curved member body portion 1230 .

[0147] Each retention member 1200 can be provided in any suitable size, shape, or other configuration. In selected embodiments, the retention member 1200 can include one or more stabilizing members 1240. When the retention member 1200 is coupled to the device frame 1100, each stabilizing member 1240 can be configured to engage with an adjacent growth cell strut 1122, as shown in FIG. 5B, to help increase the stability of the retention member 1200. In selected embodiments, the stabilizing member 1240 can be disposed around the engagement member 1250. In other words, the stabilizing member 1240 can extend proximally from the engagement member 1250 and / or can extend distally from the engagement member 1250. This allows the stabilizing member 1240 to engage with one or more growth cell struts 1122 adjacent to a selected growth cell junction 1127. The stabilizing member 1240 can be coupled to adjacent growth cell struts 1122 in any suitable manner, including, but not limited to, sutures, wires, welds, adhesives, and / or adhesive polymer layers. The sutures and / or wires can, for example, be wrapped around the stabilizing member 1240 and adjacent growth cell struts 1122.

[0148] The retention member 1200 of FIG. 5B includes a proximal end region 1210 for coupling with the periphery 1140 of the device frame 1100. P and a hollow distal end region 1210 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D In other words, the retention member 1200 may include a central retention member body 1210 having a distal end region 1210, as shown in FIG. D The central retention member body 1210 may include a hollow retention member having a distal end region 1210 defining a retention member opening 1220. In selected embodiments, the central retention member body 1210 may include a distal end region 1210 D is the proximal end region 1210 P The retention member opening 1220 may include a curved member body portion 1230 such that the retention member opening 1220 is disposed at an angle relative to the retaining member opening 1220. The retention member opening 1220 may be formed in any suitable manner.

[0149] The retention member 1200 can comprise, for example, a wire-based retention member. In other words, the central retention member body 1210 of the retention member 1200 can be formed from a wire or other thin rod that can be formed into a loop that defines the retention member opening 1220. When the retention member 1200 comprises a wire-based retention member, it can advantageously be easily compressed when the growth device 1000 is crimped into an implanted state and / or have a wide distal end region 1210 for engaging a selected lumen 120 of the patient 100 when the growth device 1000 is subsequently expanded to one of the stable expanded states. D The wide distal end region 1210 D can help prevent the retention member 1200 from twisting from side to side during implantation, deployment, and subsequent use.

[0150] Additionally and / or alternatively, the retention member 1200 may include a proximal end region 1210 for coupling with the periphery 1140 of the device frame 1100 (FIGS. 2 and 5A-E), as shown in FIG. 5C. P and a solid distal end region 1210 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D In selected embodiments, the central retaining member body 1210 may include a central retaining member body 1210 having a distal end region 1210 D is the proximal end region 1210 P 5B, the solid distal end region 1210 of the retention member 1200 may include a curved member body portion 1230 such that the retention member 1200 is disposed at an angle relative to the wire-based retention member 1200. D does not define a retention member opening 1220. D The retention member 1200 having the above structure can advantageously provide increased retention strength for engaging the selected lumen 120 of the patient 100 when the growth device 1000 is expanded to any of the stable expanded states.

[0151] When the growth device 1000 is deployed and / or expanded within the patient 100 (shown in FIG. 8 ), the retention member 1200 can engage a selected blood vessel or other lumen 120 (shown in FIG. 8 ) of the patient 100 and maintain the position of the growth device 1000 within the selected lumen 120. In other words, the retention member 1200 can help prevent the growth device 1000 from migrating out of the selected lumen 120. The retention member 1200 can advantageously be deployed along the length of the selected lumen 120. This allows the distal end region 1210 of the retention member 1200 to be secured to the selected lumen 120. D and / or the length of the distal end region 1210 D can be flush with the entrance surface of the selected lumen 120 of the patient 100. Additionally and / or alternatively, deployment of the retention member 1200 can advantageously help minimize occlusion of the selected vessel by the growth device 1000 by avoiding the natural bias of the growth device 1000 to move toward the center of the selected vessel.

[0152] The retention member 1200 may optionally include one or more wing extension members 1260, as shown in Figure 5D. In the manner described in more detail above with reference to Figures 5A-C, the retention member 1200 includes a proximal end region 1210 for coupling with the periphery 1140 of the device frame 1100 (shown in Figures 2 and 5A-E). P and a distal end region 1210 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D In selected embodiments, the central retaining member body 1210 may include a central retaining member body 1210 having a distal end region 1210 D is the proximal end region 1210 P Each wing extension member 1260 may include a curved member body portion 1230 such that it is disposed at a predetermined angle relative to the proximal end region 1210 of the retention member 1200. P1. The wing extension member 1260 can, for example, extend laterally from the engagement member 1250 of the retention member 1200. Advantageously, the wing extension member 1260 can include retention aids for connecting the retention member 1200 with the device frame 1100 (shown in FIGS. 2 and 5A-E). The wing extension member 1260 can also be attached to the distal end region 1210 of the retention member 1200. D This can also be useful in suppressing lateral deflection.

[0153] The retention member 1200 shown in FIG. 5E has a proximal end region 1210 for coupling with the periphery 1140 of the device frame 1100 (shown in FIGS. 2 and 5A-E). P and a forked distal end region 1210 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) in a patient 100 (shown in FIG. 8). D In other words, the distal end region 1210 of the retention member 1200 of FIG. D The central retention member body 1210 may have a fork or V-shape with two branches (or end regions) 1270 for engaging a selected blood vessel. Each of the branches 1270 may engage a separate portion of the selected blood vessel. In selected embodiments, the central retention member body 1210 may have a distal end region 1210 D is the proximal end region 1210 P The distal end region 1210 may include a curved member body portion 1230 such that the distal end region 1210 is disposed at a predetermined angle relative to the curved member body portion 1230. D Each branch 1270 of the can include a separate curved member body portion 1230, as shown in Figure 5E.

[0154] In selected embodiments, the retention member 1200 may include a circumferential retention member, as shown in FIG. 5F. When deployed, the retention member 1200 extends from the distal end region 1110 of the device frame 1100 for engagement with a selected blood vessel or other lumen 120 (shown in FIG. 8) of the patient 100 (shown in FIG. 8). D5F may include a retention member profile 1280 that may extend radially from the periphery 1140 of the device frame 1100. In other words, the retention member profile 1280 may include a solid profile that may extend radially from the periphery 1140 of the device frame 1100 when deployed. While shown in FIG. 5F as including a solid, oval-shaped retention member profile for illustrative purposes only, the retention member profile 1280 may have any suitable predetermined size, shape, diameter, or other dimensions. For example, the retention member profile 1280 may be based on the size, shape, or other geometry of a selected blood vessel or other lumen 120 of the patient 100.

[0155] Returning to Figure 2, the growth device 1000 can optionally include a covering member 1300. The covering member 1300 can advantageously provide radial sealing of the growth device 1000. For example, the covering member 1300 can seal the growth device 1000 at the intersection of a selected blood vessel and an intersecting source blood vessel of the patient 100. The covering member 1300 can optionally provide a seal for one or more walls of the source blood vessel.

[0156] The covering member 1300 can be provided in any suitable manner and is preferably blood-impermeable. In selected embodiments, the covering member 1300 can be made of fabric, one or more braids, one or more woven fabrics, and / or one or more polymers. If the covering member 1300 is made of fabric, the fabric can have a smooth surface free of wrinkles and folds throughout the entire diameter range of the growth device 1000. The covering member can include, for example, a stretchable fabric material that remains taut at each diameter configuration. The fabric can be tacked and deployable as the diameter expands. The fabric material can have a mechanical mechanism similar to a one-way tie or ratchet to help ensure that there is no slack in the fabric at lower diameter ranges. The fabric can be composed of polymer, rubber, or other bioinert materials.

[0157] The covering member 1300 can be coupled to or associated with the device frame 1100. As shown in Figure 2, for example, the covering member 1300 can be disposed around the periphery 1140 of the device frame 1100. The covering member 1300 can be disposed around the inner surface of the inner periphery 1140 of the device frame 1100 and / or around the outer surface of the outer periphery 1140 of the device frame 1100.

[0158] Additionally and / or alternatively, the covering member 1300 may be positioned between the proximal end region 1110 of the device frame 1100 depending on the intended use of the growth device 1000, the implantation location of the growth device 1000 within the patient 100 (as shown in FIG. 8 ), and / or the anatomy of the patient 100. P to the distal end region 1110 of the device frame 1100 D The device frame 1100 can extend fully or partially to, but not limited to, a length greater than 1 / 2 inch (3 mm). In selected embodiments, the device frame 1100 can include a covered frame portion 1112 (shown in FIG. 11A) and an uncovered frame portion 1114 (shown in FIG. 11A), with the covering member 1300 associated with the covered frame portion 1112 and not associated with the uncovered frame portion 1114. In some embodiments, the partial covering of the device frame 1100 of the growth device 1000 can be utilized to overlap or otherwise cooperate with a second growth device 1000B (shown in FIGS. 10A-B) to achieve a desired length range. The covering member 1300 can optionally encase the device frame 1100.

[0159] Advantageously, the covering member 1300 can compress and / or expand with the device frame 1100 from implantation to expansion throughout the entire operating range of diameter, cross-section, or other dimension of the growth device 1000. In other words, the covering member 1300 can compress when the growth device 1000 is crimped to an implanted state and / or expand when the growth device 1000 is expanded to one or more stable expanded states.

[0160] The thickness of the covering member 1300 can be thinned to help improve the crimp shape of the growth device 1000 in an implanted state, and / or thickened to help improve the expandability and / or structural integrity of the growth device 1000. The connection between the covering member 1300 and the device frame 1100 can preferably help ensure that the covering member 1300 remains connected to the device frame 1100 throughout the range of motion of the growth device 1000. The covering member 1300 can be, for example, but not limited to, laminated onto the device frame 1100, sutured to the device frame 1100, and / or compressed onto the device frame 1100.

[0161] 6, the growth device 1000 is shown as further including one or more anchor members 1400 for engaging selected vascular tissue and preventing migration of the growth device 1000 within the patient 100, and in selected embodiments may advantageously be utilized in the hepatic vein within the patient 100. The growth device 1000 of FIG. 6 may be provided in the manner described in more detail above with respect to FIGS. 2, 3A-E, and 4. For example, the growth device 1000 may comprise a device frame 1100 including a plurality of annular growth cell members 1120 and one or more annular spacing members 1130. The growth cell members 1120 and spacing members 1130 define a periphery 1140 of the device frame 1100 and are spaced apart from a proximal end region 1110 of the device frame 1100. P to the distal end region 1110 of the device frame 1100 D 6, each spacing member 1130 can be disposed between a pair of adjacent growth cell members 1120. In other words, the device frame 1100 can extend from the proximal end region 1110 to the P and distal end region 1110 DThe device frame 1100 may include a series of alternating growth cell members 1120 and spacing members 1130 that may axially span between the growth cell members 1120 and spacing members 1130 and provide a radial periphery 1140 of the device frame 1100. The arrangement of growth cell members 1120 and spacing members 1130 may thereby define a central axial channel 1150 of the elongated device frame 1100.

[0162] The growth device 1000 of FIG. 6 can optionally include one or more retention members 1200 for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of the patient 100 (shown in FIG. 8). Each retention member 1200 can be provided in the manner described in more detail above with respect to FIGS. 5A-E and can be attached to the proximal end region 1110 of the device frame 1100. P and / or distal end region 1110 D and can extend radially from the periphery 1140. In other words, the growth cell members 1120 can be positioned at the proximal end region 1110 of the device frame 1100. P proximal growth cell member 1120 disposed on P and a distal end region 1110 of the device frame 1100. P a distal growth cell member 1120 disposed on the distal growth cell member 1120; D and the retention member 1200 can include a proximal growth cell member 1120. P and / or distal growth cell member 1120 D and can extend radially therefrom.

[0163] Additionally and / or alternatively, the growth device 1000 of Figure 6 can include an optional covering member 1300 to provide radial sealing of the growth device 1000. The covering member 1300 can be provided in the manner described in more detail above with respect to Figure 2. As discussed herein, the covering member 1300 can be positioned at the proximal end region 1110 of the device frame 1100 depending on the intended use of the growth device 1000, the implantation location of the growth device 1000 within the patient 100 (as shown in Figure 8), and / or the anatomy of the patient 100. Pto the distal end region 1110 of the device frame 1100 D The covering member 1300 can optionally encase the device frame 1100 and / or include one or more abrasive regions (not shown) to promote ingrowth and / or retention of the growth device 1000 within the patient's 100 body.

[0164] In selected embodiments, any spacing members 1130 covered by the covering member 1300 may have spacer member struts 1132 with spacer member strut lengths that are less than (or shorter than) the spacer member strut lengths of the spacer member struts 1132 that comprise the uncovered spacing members 1130. The shorter spacer member struts 1132 of the covered spacing members 1130 may advantageously help ensure that the hepatic veins of the patient 100 are not covered by the in-growth cell members 1120 and / or the covering member 1300.

[0165] For example, if the growing device 1000 is utilized to treat one or more hepatic veins, at least one retention member 1200 can be deployed within a selected hepatic vein to prevent migration of the anchor member(s) 1400. The hepatic veins enter the inferior vena cava (or IVC) 124 near the transition 124B (shown in FIGS. 9 and 10A-B) between the inferior vena cava 124 and the right atrium 123 of the patient's 100 heart and must not be blocked. The retention member 1200 can advantageously help prevent the growing device 1000 from blocking the hepatic veins, which could be fatal to the patient 100. In selected embodiments, the retention member 1200 can be positioned within the uppermost hepatic vein of the patient 100 during implantation of the growing device 1000. This positioning of the retention member 1200 can help ensure that no portion of the growing device 1000 covered by the covering member 1300 is deployed over the hepatic veins of the patient 100.

[0166] The growth device 1000 of FIG. 6 similarly includes a proximal growth cell member 1120. P and distal growth cell member 1120 D an intermediate growth cell member 1120 disposed between the I The first spacing member 1130 may include a proximal growth cell member 1120. P and intermediate growth cell member 1120 I and / or a second spacing member 1130 may be disposed between the intergrowth cell member 1120 I and distal growth cell member 1120 D In selected embodiments, the growth cell members 1120 may be spaced apart by adjacent intermediate growth cell members 1120 with respective spacing members 1130 as shown in FIG. I a plurality of intergrowth cell members 1120 disposed therebetween; I may include:

[0167] As shown in FIG. 6, each anchor member 1400 is attached to a selected intergrowth cell member 1120 of the device frame 1100. I 11. The selected intergrowth cell member 1120 may be placed in I When the growth device 1000 includes multiple anchor members 1400, the anchor members 1400 can extend radially from the periphery 1140 of each intergrowth cell member 1120. I In selected embodiments, the anchor member 1400 may be positioned at the periphery 1140 of the common intergrowth cell member 1120. I The anchor members 1400 may be distributed around the periphery 1140 of the intergrowth cell member(s) 1120. I The adhesive may be distributed in any predetermined configuration around the periphery 1140, and may be distributed evenly around the periphery 1140, if desired.

[0168] The anchor members 1400 provide positioning support during delivery via a delivery catheter system 2000 (shown in FIGS. 14A-D) and retention of the growth device 1000 during connection of the blood flow of different blood vessels. The growth device 1000 can be configured, for example, for deployment within a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). Each anchor member 1400 can be provided in any suitable manner. The anchor members 1400 can be fabricated, for example, from a polymer, metal, or other suitable material. The anchor members 1400 can comprise paddles, hooks, tabs, spirals, or other suitable shapes. The anchor members 1400 can optionally be covered with fabric or another suitable material to promote acute sealing, chronic ingrowth, and / or retention within the selected lumen of the patient.

[0169] In selected embodiments, the device frame 1100 may expand radially outward to form one or more anchor members 1400. This expansion can occur by utilizing a balloon expansion system (or means) 2200 (shown in FIG. 14B) of the delivery catheter system 2000 if the device frame 1100 is made of a balloon-expandable material, such as stainless steel or cobalt chrome. Additionally and / or alternatively, the anchor members 1400 can be molded into a self-expanding material, such as nitinol. In some embodiments, the self-expanding anchor members 1400 can be attached to a balloon-expandable shunt. This allows the self-expanding anchor members 1400 to be molded perpendicular to the delivery catheter system 2000 and crimped shunt, thereby enabling catheter delivery and retention of the device frame 1100 during deployment and after inflation.

[0170] The anchor members 1400 can be angled toward the proximal end region of the device frame 1100 and / or toward the distal end region of the device frame 1100, depending on the required retention or sealing function. In some embodiments, the anchor members 1400 can comprise a single bar, loop, or other shape. One or more anchor members 1400 can be disposed around the periphery 1140 of the device frame 1100. In selected embodiments, a self-expanding metal sheet can be formed into an "L" shape and attached to the periphery 1140 of the device frame 1100 as anchor members 1400, forming vertical tabs that extend into a second blood vessel adjacent to the selected 120 after delivery via the delivery catheter system 2000. The delivery catheter system 2000 can include, for example, an outer sheath member 2100 (shown in FIG. 14A ) that can be unsheathed to expose the growth device 1000, thereby exposing the shaped vertical anchor members 1400 for use in delivering the growth device 1000. In these embodiments, the anchor member 1400 can be secured to an adjacent blood vessel, and the growth device 1000 can be pulled proximally using the delivery catheter system 2000, with the anchor member 1400 acting as an anchor within a second blood vessel of the patient.

[0171] In some embodiments, the anchor members 1400 for maintaining the growth device 1000 within the pulmonary artery 122 can be constructed of, but are not limited to, nitinol, cobalt chrome, stainless steel, or other metal alloys. The anchor members 1400 can be attached to the device frame 1100 in any suitable manner, including, but not limited to, suturing, welding, riveting, lamination, and / or a separate mechanical lock. The anchor members 1400 can be distributed around the periphery 1140 of the device frame 1100. In selected embodiments, the anchor members 1400 can be distributed evenly and / or unevenly around the periphery 1140. The anchor members 1400 can be oriented in a direction that allows them to extend along the length of the second vessel.

[0172] Referring to FIG. 7A, anchor member 1400 is attached to selected intergrowth cell member 1120. I proximal end region 1410 for coupling with periphery 1140 (shown in FIGS. 6 and 7B) P and a distal end region 1410 for engaging tissue adjacent a selected blood vessel 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D The central anchor member body 1410 may include a proximal end region 1410 having P In selected embodiments, the selected intergrowth cell member 1120 I The growth cell junctions 1126 may be configured to couple with selected growth cell junctions 1127 (shown in FIG. 7B).

[0173] For example, the central anchor member body 1410 can include an engagement member 1450 for connecting with a selected growth cell junction 1127. The central anchor member body 1410 can also connect with a selected intermediate growth cell member 1120. I 6 and 7B) and / or the inner surface of selected intergrowth cell members 1120 I The central anchor member body 1410 can be attached to the outer surface of the outer periphery 1140 of the selected interstitial growth cell member 1120 in any suitable manner, including but not limited to, with sutures, wires, welds, adhesives, and / or adhesive polymer layers. I can be linked with.

[0174] The proximal end region 1410 of the central anchor member body 1410 P 7B, the selected intergrowth cell member 1120 I In other words, the proximal end region 1410 P Selected intergrowth cell member 1120 I The central anchor member body 1410 can be disposed in a parallel configuration with respect to the peripheral edge 1140 of the distal end region 1410. D The selected intergrowth cell member 1120 IIn selected embodiments, the central anchor member body 1410 may include a curved member body such that the central anchor member body 1410 may extend at an angle from the peripheral edge 1140 of the distal end region 1410. D proximal end region 1410 P The member may include a curved member body portion 1430 such that the member is disposed at an angle relative to the curved member body portion 1430 .

[0175] Each anchor member 1400 can be provided in any suitable size, shape, or other configuration. In selected embodiments, the anchor member 1400 can include one or more stabilizing members 1440. The anchor member 1400 can be attached to a selected intergrowth cell member 1120. I When coupled with the growth cell junction 1127, each stabilization member 1440 can be configured to engage with an adjacent growth cell strut 1122, as shown in FIG. 7B , helping to increase the stability of the anchor member 1400. In selected embodiments, the stabilization member 1440 can be disposed around the engagement member 1450. In other words, the stabilization member 1440 can extend proximally from the engagement member 1450 and / or can extend distally from the engagement member 1450. This allows the stabilization member 1440 to engage one or more growth cell struts 1122 adjacent to a selected growth cell junction 1127. The stabilization member 1440 can be coupled with adjacent growth cell struts 1122 in any suitable manner, including, but not limited to, sutures, wires, welds, adhesives, and / or adhesive polymer layers. Sutures and / or wires can be wrapped around the stabilization member 1440 and adjacent growth cell struts 1122, for example.

[0176] The anchor member 1400 of FIG. 7B is attached to the selected intergrowth cell member 1120. I a proximal end region 1410 for coupling with the peripheral edge 1140 of the P and a hollow distal end region 1410 for engaging tissue adjacent a selected blood vessel 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). DIn other words, the anchor member 1400 may include a central anchor member body 1410 having a distal end region 1410, as shown in FIG. D The central anchor member body 1410 may include a hollow anchor member having a distal end region 1410 defining an anchor member opening 1420. In selected embodiments, the central anchor member body 1410 may include a distal end region 1410. D proximal end region 1410 P The anchor member openings 1420 may include a curved member body portion 1430 such that the anchor member openings 1420 are disposed at an angle relative to the anchor member openings 1420. The anchor member openings 1420 may be formed in any suitable manner.

[0177] The anchor member 1400 can comprise, for example, a wire-based anchor member. In other words, the central anchor member body 1410 of the anchor member 1400 can be formed from a wire or other thin rod that can be formed into a loop that defines the anchor member opening 1420. When the anchor member 1400 comprises a wire-based anchor member, it can advantageously be easily compressed when the growth device 1000 is crimped into an implanted state and / or have a wide distal end region 1410 for engaging selected vascular tissue of the patient 100 when the growth device 1000 is later expanded to one of the stable expanded states. D The wide distal end region 1410 D can help prevent anchor member 1400 from twisting from side to side during implantation, deployment, and subsequent use.

[0178] Additionally and / or alternatively, anchoring member 1400 may be attached to selected intergrowth cell members 1120, as shown in FIG. 7C. I proximal end region 1410 for coupling with periphery 1140 (shown in FIGS. 6 and 7B) P and a solid distal end region 1410 for engaging tissue adjacent a selected blood vessel 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D In selected embodiments, the central anchor member body 1410 may include a distal end region 1410. Dproximal end region 1410 P 7B, the solid distal end region 1410 of the anchor member 1400 may include a curved member body portion 1430 such that the solid distal end region 1410 of the anchor member 1400 is disposed at an angle relative to the wire-based anchor member 1400. D does not define an anchor member opening 1420. D The anchor member 1400 comprising can advantageously provide increased anchor strength for engaging selected vascular tissue when the growth device 1000 is expanded to any of the stable expanded states.

[0179] When the growth device 1000 is deployed and / or expanded within the patient 100 (shown in FIG. 8 ), the anchoring member 1400 can engage selected vascular tissue and maintain the position of the growth device 1000 within the patient 100. In other words, the anchoring member 1400 can help prevent the growth device 1000 from migrating from the selected lumen 120. The anchoring member 1400 can advantageously be deployed along the length of the selected lumen 120. This allows the distal end region 1410 of the anchoring member 1400 to be secured to the selected lumen 120. D and / or the length of the distal end region 1410 D can be flush with the entrance surface of the selected lumen 120 of the patient 100. Additionally and / or alternatively, deployment of the anchor member 1400 can advantageously help minimize occlusion of the selected vessel by the growth device 1000 by avoiding the natural bias of the growth device 1000 to move toward the center of the selected vessel.

[0180] The anchor member 1400 can optionally include one or more wing extension members 1460, as shown in Figure 7D. In the method described in more detail above with reference to Figures 7A-C, the anchor member 1400 can be attached to selected intergrowth cell members 1120. I proximal end region 1410 for coupling with periphery 1140 (shown in FIGS. 6 and 7B) Pand a distal end region 1410 for engaging tissue adjacent a selected blood vessel 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8). D In selected embodiments, the central anchor member body 1410 may include a distal end region 1410. D proximal end region 1410 P Each wing extension member 1460 may include a curved member body portion 1430 such that it is disposed at a predetermined angle relative to the proximal end region 1410 of the anchor member 1400. P The wing extension members 1460 can, for example, extend laterally from the engagement members 1450 of the anchor member 1400. Advantageously, the wing extension members 1460 can connect the anchor member 1400 to the selected intergrowth cell member 1120. I (shown in FIGS. 6 and 7B). Wing extension member 1460 may also be provided with a retention aid for coupling with distal end region 1410 of anchor member 1400. D This can also be useful in suppressing lateral deflection.

[0181] The anchor member 1400 shown in FIG. 7E is attached to the selected intergrowth cell member 1120. I proximal end region 1410 for coupling with periphery 1140 (shown in FIGS. 6 and 7B) P and a forked distal end region 1410 for engaging tissue adjacent a selected blood vessel 120 (shown in FIG. 8) in a patient 100 (shown in FIG. 8). D In other words, the distal end region 1410 of the anchor member 1400 of FIG. D The central anchor member body 1410 may have a fork or V-shape with two branches (or end regions) 1470 for engaging a selected vessel. Each of the branches 1470 may engage a separate portion of the selected vessel. In selected embodiments, the central anchor member body 1410 may have a distal end region 1410. D proximal end region 1410 PThe distal end region 1410 may include a curved member body portion 1430 such that the distal end region 1410 is disposed at a predetermined angle relative to the curved member body portion 1430. D Each branch 1470 of the can include a separate curved member body portion 1430, as shown in Figure 7E.

[0182] In use, the growth device 1000 can be crimped or compressed into an implanted state in a manner discussed in more detail herein. The growth device 1000 can have a predetermined initial size, shape, diameter, cross-section, or other dimensions when in the implanted state. Exemplary initial dimensions of the growth device 1000 include, but are not limited to, an initial dimension between 1 and 4 millimeters. The growth device 1000 can be crimped onto a delivery catheter system 2000 (shown in FIGS. 14A-D ), for example, at a size small enough to pass through the vasculature 110 (shown in FIG. 8 ) of a patient 100 (shown in FIG. 8 ) to a selected implantation site 130 (or other region of interest) (shown in FIG. 8 ) within a selected blood vessel or other lumen 120 (shown in FIG. 8 ) of the patient 100. Once at the selected implantation site 130, the growth device 1000 can be deployed to treat common congenital disorders in the patient 100.

[0183] The growth device 1000 in Figure 8 is shown deployed in a Glen position. Referring to Figure 8, the growth device 1000 can be placed in the superior vena cava (or SVC) 121 of a patient 100 via a delivery catheter system 2000 (shown in Figures 14A-D). The distal end region 1110 of the device frame 1100 D can extend from the superior vena cava 121 to the pulmonary artery (or PA) 122. In other words, the distal end region 1110 DThe growth device 1000 may extend from the delivery catheter system 2000 to engage at least one intravascular surface 122A of the pulmonary artery 122. ...

[0184] The growth device 1000 can be exposed by the delivery catheter system 2000 and prepared for expansion. A catheter expansion system of the delivery catheter system 2000, such as a balloon expansion system 2200 (shown in FIG. 14B), can be positioned within the central axial channel 1150 of the device frame 1100. The catheter expansion system can expand the device frame 1100 from an implanted state to a (stable) expanded state by inflating or otherwise increasing its size. In the expanded state, the device frame 1100 can engage at least one intravascular surface 121A of the superior vena cava 121 and stretch the tissue defining the tissue opening 121B at the intersection 121B of the superior vena cava 121 and the pulmonary artery 122. The growth device 1000 can have a predetermined expanded size, shape, diameter, cross-section, or other dimensions when in the expanded state. An exemplary expanded size, shape, diameter, cross-section, or other dimension of the growth device 1000 in the expanded state can be between 10 millimeters and 30 millimeters, but is not limited to this.

[0185] Once the device frame 1100 is expanded to the expanded state, the catheter expansion system contracts or reduces in size, allowing the delivery catheter system 2000 to be removed from the patient 100. The expanded growth device 1000 can remain engaged with the intravascular surface 121A of the superior vena cava 121 and can include sufficient radial strength to remain expanded without support from the catheter expansion system. The expanded state of the growth device 1000 shown in FIG. 8 allows blood to flow from the superior vena cava 121 to the pulmonary artery 122.

[0186] Advantageously, the covering member 1300 can radially seal the intersection 121B of the superior vena cava 121 and the pulmonary artery 122. In other words, the covering member 1300 can be configured to seal the stretched tissue opening created between the superior vena cava 121 and the pulmonary artery 122. Additionally and / or alternatively, the covering member 1300 can provide a seal on the intravascular surface 121A of the superior vena cava 121 to help ensure that all blood flow from the superior vena cava 121 is directed to the pulmonary artery 122.

[0187] After implantation is complete, the growth device 1000 can be re-expanded to a second, third, or other subsequent (stable) expanded state as the patient 100 grows. In other words, the growth device 1000 can be periodically re-expanded to accommodate an increase in the size of the selected lumen 120 of the patient 100. When implanted in a pediatric patient, the growth device 1000 can be re-expanded as the patient grows to sizes appropriate for older pediatric, teenage, and / or adult patients. The growth device 1000 can be expanded to, for example, a first expanded state of 14 millimeters and then re-expanded to a second expanded state of 18 millimeters, a predetermined dimension, as the patient grows. The growth device 1000 can later be further re-expanded to a third expanded state of 22 millimeters, a predetermined dimension, as the patient continues to grow. In other words, the growth device 1000 can cyclically change from a first expanded state to a second expanded state to a third expanded state, etc. as the diameter of the selected lumen 120 of the patient 100 increases.

[0188] The growth device 1000 can be re-expanded in any suitable manner. For example, the growth device 1000 can be re-expanded by the introduction of a catheter expansion system, similar to the expansion of the growth device 1000 during implantation. Additionally and / or alternatively, the growth device 1000 can comprise a self-growing growth device with a device frame 1100 formed, for example, from Nitinol or another shape-changing material. The growth device 1000 in the re-expanded state can remain engaged with the intravascular surface 121A of the superior vena cava 121 and comprise sufficient radial strength to maintain the expanded state.

[0189] The growing device 1000, in selected embodiments, can provide a shunt from the inferior vena cava (or IVC) 124 to the pulmonary artery (or PA) 122 during a Fontan procedure. Additionally and / or alternatively, the growing device 1000 can provide a shunt from the superior vena cava (or SVC) 121 to the pulmonary artery 122 during a Glenn procedure. For example, a shunt can be formed using a flexible stent graft to direct blood flow from the inferior vena cava 124 to the pulmonary artery 122 or from the superior vena cava 121 to the pulmonary artery 122. The shunt graft can have one or more retention mechanisms for fixation to the pulmonary artery 122, the superior vena cava 121, and / or the inferior vena cava 124. The shunt can advantageously allow for the creation of a lumen for directing blood flow. In selected embodiments, the shunt can be provided as a stent frame or other structure that can hold open blood vessels and other tissue areas to allow blood to move from one vessel to another. In some embodiments, the stent can hold open a vessel wall to create a lumen connection between blood in different vessels. One or more portions of the device frame 1100 can be attached to a vessel wall, for example, to support a lumen; while other portions of the device frame 1100 can be placed at the intersection of vessels to hold open other tissue material.

[0190] 9, the growth device 1000 is shown deployed in the Fontan position. The growth device 1000 can be positioned within the tissue of the right atrium 123 of the patient 100 via a delivery catheter system 2000 (shown in FIGS. 14A-D). The distal end region 1110 of the device frame 1100 D can extend from the tissue of the right atrium 123 to the pulmonary artery 122. In other words, the distal end region 1110 DThe growth device 1000 may extend from the delivery catheter system 2000 and engage at least one intravascular surface 122A of the pulmonary artery 122. ...

[0191] Proximal end region 1110 of device frame 1100 P 14B)。 The growth device 1000 can be exposed by the delivery catheter system 2000 and prepared for expansion. A catheter expansion system, such as a balloon expansion system 2200 (shown in FIG. 14B) of the delivery catheter system 2000, can be placed in the central axial channel 1150 of the device frame 1100. The catheter expansion system can be inflated or otherwise expanded in size to expand the device frame 1100 from the implanted state to the expanded state.

[0192] In the expanded state, the device frame 1100 can engage at least one interior surface 123A of the right atrium 123 (shown in FIG. 10A ) and / or at least one intravascular surface 124A of the inferior vena cava 124. The expanded device frame 1100 can stretch tissue defining a tissue opening at the intersection 123B of the right atrium 123 and the pulmonary artery 122 and / or tissue defining a transition 124B between the right atrium 123 and the inferior vena cava 124. The growth device 1000 can have a predetermined expanded size, shape, diameter, cross-section, or other dimension when in the expanded state. An exemplary expanded size, shape, diameter, cross-section, or other dimension of the growth device 1000 in the expanded state can be, but is not limited to, between 10 millimeters and 30 millimeters.

[0193] Once the device frame 1100 is expanded to the expanded state, the catheter expansion system contracts, or reduces in size, allowing the delivery catheter system 2000 (shown in FIGS. 14A-D ) to be removed from the patient 100. The expanded growth device 1000 can remain engaged with the inner surface 123A of the right atrium 123 and / or the intravascular surface 124A of the inferior vena cava 124 and can include sufficient radial strength to remain in the expanded state without support from the catheter expansion system. The covering member 1300 can advantageously radially seal the intersection 123B between the right atrium 123 and the pulmonary artery 122. The covering member 1300, in turn, can seal the stretched tissue opening created between the right atrium 123 and the pulmonary artery 122. Additionally and / or alternatively, the covering member 1300 may provide a seal at the transition 124B between the right atrium 123 and the inferior vena cava 124, thereby helping to direct blood flow through the transition 124B.

[0194] After implantation is complete, the growth device 1000 can be re-expanded to a second, third, or other subsequent stable re-expanded state as the patient 100 grows. In other words, the growth device 1000 can be periodically re-expanded to accommodate an increase in the size of the selected lumen 120 of the patient 100. The growth device 1000 can be re-expanded in any suitable manner. For example, the growth device 1000 can be re-expanded by the introduction of a catheter expansion system, similar to the expansion of the growth device 1000 during implantation. Additionally and / or alternatively, the growth device 1000 can comprise a self-growing growth device with a device frame 1100 formed, for example, from nitinol or another shape-changing material. The growth device 1000 in the re-expanded state can remain engaged with the inner surface 123A of the right atrium 123 and / or the intravascular surface 124A of the inferior vena cava 124 and include sufficient radial strength to maintain the re-expanded state.

[0195] Two or more growth devices 1000 can be configured for implantation in a patient 100. The growth devices 1000 can, in selected embodiments, include telescoping or retractable growth devices. The growth devices 1000 can advantageously work together to treat common congenital disorders in heart disease patients.

[0196] In selected embodiments, two separate growth devices 1000 can be interlocked to direct blood flow from the inferior vena cava 124 to the pulmonary artery 122. One of the growth devices 1000 can be positioned within the inferior vena cava 124 and can extend into the right atrium 123. Retention anchors can be attached to the surrounding vessels and / or the intravascular surface 124A of the inferior vena cava 124. A sealing mechanism can be located in the inferior vena cava 124 between the transition between the right atrium 123 and the hepatic vein 125. The growth device 1000 can be fully or partially covered by the covering member 1300. The other growth device 1000 can be positioned within the pulmonary artery 122 and can extend into the right atrium 123. This growth device 1000 can have a retention anchor in the pulmonary artery 122 to retain the growth device 1000 within the pulmonary artery 122.

[0197] In this embodiment, the growth device 1000 placed in the inferior vena cava 124 can be externally or internally mated with the growth device 1000 anchored in the pulmonary artery 122 via radial expansion or a separate mechanism. Both growth devices 1000 can be deployed at various lengths and can telescope or overlap each other to allow for treatment of various patient anatomical sizes. The separate growth devices 1000 may allow for a wider range of patient sizing because the amount of overlap can be adjusted. Advantageously, the overlapping feature of the growth device 1000 can be applied to the Glenn procedure as well, with a retention anchor placed in the pulmonary artery 122.

[0198] As shown in FIGS. 10A-B, for example, a first growth device 1000A has a proximal end region and a distal end region 1110.P , 1110 D The growth device 1000 may include a growth device 1000 having a first device frame 1110A with a first covering member 1300A and a first device frame 1110B with a first covering member 1300A. The first growth device 1000A is shown as having at least one retention member 1200 and being deployed in the Fontan position in the manner described in more detail above with reference to FIG. 9. A second growth device 1000B may similarly be configured for implantation in the patient 100. The second growth device 1000B may include a proximal end region and a distal end region 1110B. P , 1110 D The growth device 1000 may include a second device frame 1110B having a second covering member 1300B, and a second device frame 1110B having a second covering member 1300B. As shown in Figures 10A-B, one or more anchor members 1400 may be disposed on the second device frame 1110B.

[0199] When implanted in the patient 100 after the first growth device 1000A is implanted, the second growth device 1000B can be placed in the inferior vena cava 124 of the patient 100, as shown in Fig. 10A. The second growth device 1000B can extend through the inferior vena cava 124 and cooperate with the first growth device 1000A. When the second growth device 1000B is crimped into an implanted state, the distal end region 1110 of the second growth device 1000B D can be received within the central axial channel 1150 of the expanded first growth device 1000A. The second growth device 1000B can be radially aligned with the first growth device 1000A and can at least partially overlap the first growth device 1000A. This allows the first and second growth devices 1000A, 1000B to form a nested or telescopic growth device.

[0200] The second growth device 1000B is connected to the proximal end region 1110 of the first growth device 1000A. P and a proximal end region 1110 of the second growth device 1000B. PThe proximal end region 1110 of the second growth device 1000B can be positioned within the inferior vena cava 124 of the patient 100, as shown in FIG. P is preferably axially aligned with the inferior vena cava 124. As shown in Figure 10A, the position of the second growth device 1000B can be adjusted until the proximal end region 1110P of the second growth device 1000B is positioned adjacent to the transition 124B between the right atrium 123 and the inferior vena cava 124 and / or until at least one anchor member 1400 of the second growth device 1000B is positioned adjacent to the hepatic vein 125 of the patient 100.

[0201] In selected embodiments, the proximal end region 1110P of the second growth device 1000B can be axially aligned with the transition portion 124B; while the anchor member 1400 of the second growth device 1000B can be configured to engage with at least one intravascular surface 125A of the hepatic vein 125. The proximal end region 1110P of the second growth device 1000B, in other words, can be aligned with the hepatic vein 125 and the transition portion 124B. The engagement of the anchor member 1400 with the intravascular surface 125A of the hepatic vein 125 can help ensure the stability of the second growth device 1000B after deployment.

[0202] The second growth device 1000B can be exposed and prepared for expansion by a delivery catheter system 2000 (shown in FIGS. 14A-D). A catheter expansion system, such as a balloon expansion system 2200 (shown in FIG. 14B), of the delivery catheter system 2000 can be positioned within the central axial channel 1150 of the second device frame 1100B. The catheter expansion system can inflate or otherwise increase in size, thereby expanding the second device frame 1100 from an implanted state to an expanded state.

[0203] In the expanded state, the second growth device 1000B extends from the proximal end region 1110 of the first growth device 1000A, as shown in FIG. 10B. Pand / or at least one intravascular surface 124A of the inferior vena cava 124. The expanded second device frame 1100 can stretch tissue defining the transition 124B between the right atrium 123 and the inferior vena cava 124. The second growth device 1000B can have a predetermined expanded size, shape, diameter, cross-section, or other dimension when in the expanded state. An exemplary expanded size, shape, diameter, cross-section, or other dimension of the second growth device 1000B in the expanded state can be, but is not limited to, between 10 millimeters and 30 millimeters.

[0204] The anchoring member 1400 of the second growth device 1000B can engage with the intravascular surface 125A of the hepatic vein 125. The at least one retention member 1200 can optionally engage with the intravascular surface 124A of the inferior vena cava 124. Engagement by the anchoring member 1400 and / or retention member 1200 can help prevent migration of the second growth device 1000B.

[0205] Once the second device frame 1100B is expanded to the expanded state, the catheter expansion system contracts or decreases in size, allowing the delivery catheter system 2000 to be withdrawn from the patient 100. The second growth device 1000B in its expanded state is positioned at the proximal end region 1110 of the first growth device 1000A. P and / or the intravascular surface 124A of the inferior vena cava 124 and may include sufficient radial strength to remain in an expanded state without support from a catheter expansion system.

[0206] The second covering member 1300 can be associated with the covered frame portion 1112 (shown in FIG. 11A ) of the second device frame 1100B between the hepatic vein 125 and the transition 124B between the right atrium 123 and the inferior vena cava 124. In selected embodiments, the second covering member 1300B is associated only with the covered frame portion 1112 of the second device frame 1100B between the hepatic vein 125 and the transition 124B, thereby enabling the second covering member 1300B to form a seal with the stretched tissue between the hepatic vein 125 and the transition 124B.

[0207] After implantation is complete, the second growth device 1000B can be re-expanded to a second, third, or other subsequent stable re-expanded state as the patient 100 grows. In other words, the second growth device 1000B can be re-expanded periodically to accommodate an increase in the size of the selected lumen 120 of the patient 100. The second growth device 1000B can be re-expanded in any suitable manner. For example, the second growth device 1000B can be re-expanded by the introduction of a catheter expansion system, similar to the expansion of the growth device 1000 during implantation. Additionally and / or alternatively, the second growth device 1000B can comprise a self-growing growth device with a second device frame 1100B formed, for example, from nitinol or another shape-changing material. The second growth device 1000B in the re-expanded state can be configured to expand the proximal end region 1110 of the first growth device 1000A. P and / or the intravascular surface 124A of the inferior vena cava 124 and may include sufficient radial strength to remain in a re-expanded state.

[0208] The telescoping or telescopic structure of the growth device 1000 can allow for precise positioning of the second covering member 1300B of the second growth device 1000B. The second covering member 1300B can advantageously be precisely positioned regardless of anatomical variations between patients 100. The covered end segment 1112A (shown in FIG. 11B) of the covered frame portion 1112 (shown in FIGS. 11A-B) of the second growth device 1000B is positioned over the proximal end region 1110 of the first growth device 1000A. P In selected embodiments, the covered end segment 1112A of the second growth device 1000B can be configured to seal only the tissue between the hepatic vein 125 and the transition 124B between the right atrium 123 and the inferior vena cava 124. Because the distance between the hepatic vein 125 and the transition 124B can vary between patients, the nested growth devices 1000A, 1000B can advantageously be configured such that the covered end segment 1112A of the second growth device 1000B is positioned between the proximal end region 1110 of the first growth device 1000A. P Segment extension distance D extending from E (shown in FIG. 11B) can be configured to precisely adjust

[0209] Referring to FIG. 11A, a first growth device 1000A includes a proximal end region 1110 of a device frame 1110. P and distal end region 1110 D The first predetermined length L A In selected embodiments, the first device frame 1100A has a first predetermined length L A The retaining member 1200 and the distal end region 1110 of the first device frame 1110A are D The first covering member 1300A may include a distance between the proximal end region 1110 of the first device frame 1110A, as shown in FIG. P to the distal end region 1110 D It can span.

[0210] The second growth device 1000B similarly includes a proximal end region 1110 of the second device frame 1100B. P and distal end region 1110 D A second predetermined length L between B The second growth device 1000B may include a second device frame 1100B having a predetermined covered frame portion length L. The second covering member 1300B may be associated with the covered frame portion 1112 of the second device frame 1100B. The covered frame portion 1112 of the second growth device 1000B may include a second device frame 1100B having a predetermined covered frame portion length L. C and the length L C In selected embodiments, the distal end region 1110 of the second growth device 1000B D and the anchor member 1400. The remaining portion of the second growth device 1000B may include a distance between the predetermined uncovered frame portion length L U , preferably including the uncovered frame portion 1114 of the second growth device 1000B. In other words, the uncovered frame portion 1114 of the second growth device 1000B is preferably not covered with the covering member 1300.

[0211] When the first and second growth devices 1000A, 1000B are configured to be telescopically nested, the second covering member 1300B can overlap or otherwise cooperate with the first covering member 1300A. In other words, the second covering member 1300B can complement the first covering member 1300A to form a composite covering member. The composite covering member can have a predetermined composite covering member length L S As shown in FIG. 11B, the composite covering member length L S is the first predetermined length L of the first growth device 1000A. A and the covered end segment 1112A of the second growth device 1000B is positioned at the proximal end region 1110 of the first growth device 1000A. P Segment extension distance D extending from E The overlap length L between the nested first and second growth devices 1000A, 1000B may beO is the covered frame portion length L of the covered frame portion 1112 C and the segment expansion distance D of the covered end segment 1112A of the second growth device 1000B. E It can be constructed from the difference between

[0212] Composite covering member length L S can be advantageously adjusted to accommodate variations in patient anatomy. In other words, the covered end segment 1112A of the second growth device 1000B is positioned over the proximal end region 1110 of the first growth device 1000A. P Segment extension distance D extending from E The covered end segment 1112A of the second growth device 1000B can be configured to seal tissue between, for example, the hepatic vein 125 (shown in FIGS. 10A-B) and the transition 124B (shown in FIGS. 10A-B) between the inferior vena cava 124 and the right atrium 123 of the heart of a selected patient 100. The spacing between the hepatic vein 125 and the transition 124B can vary from patient to patient. The covered end segment 1112A of the second growth device 1000B can be configured to seal tissue between, for example, the hepatic vein 125 (shown in FIGS. 10A-B) and the proximal end region 1110 of the first growth device 1000A. P Segment extension distance D extending from E can be increased or decreased to suit the spacing between the hepatic vein 125 and the transition 124B for a particular patient 100.

[0213] The first and second growth devices can be implanted in a selected patient 100. The distal end region 1110 of the first growth device 1000A D and / or the retention member 1200 can be configured to engage the intravascular surface 122A (shown in FIGS. 10A-B) of the pulmonary artery 122 (shown in FIGS. 10A-B). In the manner described in more detail above with reference to FIGS. 10A-B, the anchor member 1400 of the second growth device 1000B can be configured to engage the intravascular surface 125A (shown in FIGS. 10A-B) of the hepatic vein 125 (shown in FIGS. 10A-B). Thus, the composite covering member length L of the nested growth devices 1000A, 1000B can beS may include the distance between the pulmonary artery 122 and the hepatic vein 125 of the patient 100. Since the distance between the pulmonary artery 122 and the hepatic vein 125 may vary from patient to patient, the composite covering member length L of the nested growth devices 1000A, 1000B may be adjusted accordingly. S can be advantageously adjusted to accommodate these variations.

[0214] 11B, a second growth device 1000B is shown housed within the first growth device 1000A to form a nested (or telescopic) growth device arrangement. The second growth device 1000B is positioned within the first growth device 1000A by a first predetermined overlap distance L. O1 In other words, the first predetermined overlap distance L O1 The distance at which the covered frame portion 1112 of the second growth device 1000B is disposed within the first growth device 1000A can include a distance at which the covered frame portion 1112 of the second growth device 1000B is disposed within the proximal end region 1110 of the first growth device 1000A. P From the segment expansion distance D E can only be extended.

[0215] As shown in FIG. 11B, the segment expansion distance D E is the predetermined covered frame portion length L of the covered frame portion 1112 of the second growth device 1000B. C and a first predetermined overlap distance L O1 Therefore, the total length L of the nested growth devices 1000A, 1000B can be T is the segment expansion distance D as shown in FIG. E and a first predetermined length L of the first growth device 1000A. AWhen the anchor member 1400 of the second growth device 1000B is disposed at the intersection of the covered frame portion 1112 and the uncovered frame portion 1114 of the second growth device 1000B as shown in FIGS. 11A-B, for example, the segment expansion distance D E can be determined based at least in part on the location of the hepatic vein 125 (shown in FIGS. 10A-B) of the patient 100 (shown in FIGS. 10A-B). In other words, the overall length L of the nested growth devices 1000A, 1000B T may include the sum of a first distance between the pulmonary artery 122 (shown in FIGS. 10A-B) and the inferior vena cava 124 (shown in FIGS. 10A-B), and a second distance between the hepatic vein 125 and a transition 124B (shown in FIGS. 10A-B) between the right atrium 123 (shown in FIGS. 10A-B) and the inferior vena cava 124 (shown in FIGS. 10A-B).

[0216] A numerical example illustrating an exemplary method for tailoring the nested growth devices 1000A, 1000B for implantation in a particular patient is shown and described with reference to Figures 12A-B. Referring to Figure 12A, a first growth device 1000A is positioned at a first predetermined length L of 40 millimeters. A The second growth device 1000B may also have a covered frame portion length L of 40 mm. C and an uncovered frame portion length L of 20 mm. U and an uncovered frame portion 1114 having a second predetermined length L of 60 mm. B can have:

[0217] The nested growth devices 1000A, 1000B can be configured for implantation in a first patient having a first distance of 60 millimeters between the pulmonary artery 122 (shown in FIGS. 10A-B) and the inferior vena cava 124 (shown in FIGS. 10A-B), and a second distance of 10 millimeters between the hepatic vein 125 (shown in FIGS. 10A-B) and the transition 124B (shown in FIGS. 10A-B) between the right atrium 123 (shown in FIGS. 10A-B) and the inferior vena cava 124 (shown in FIGS. 10A-B). The anchor member 1400 of the second growth device 1000B is positioned at the intersection between the covered frame portion 1112 and the uncovered frame portion 1114 of the second growth device 1000B, thereby extending the overall length L of the nested growth devices 1000A, 1000B. T may include the sum of a first distance of 60 mm between the pulmonary artery 122 and the inferior vena cava 124 and a second distance of 10 mm between the hepatic vein 125 and the transition portion 124B. Thus, the total length L of the nested growth devices 1000A, 1000B may be T In the first patient, it may comprise a length of 70 millimeters.

[0218] Segment expansion distance D E is the total length L T The first predetermined length L of the first growth device 1000A is 70 mm. A The covered frame portion 1112 has a covered frame portion length L C The proximal end region 1110 of the first growth device 1000A has a diameter of 40 mm. P From the segment expansion distance D E Since it extends by 30 mm, the overlap length L O is the length of the covered frame part L C and segment expansion distance D E This may include a difference of 10 mm.

[0219] The same nested growth devices 1000A, 1000B can be advantageously configured for implantation in a second patient, as shown in Figure 12B. The second patient may have a first distance of 40 millimeters between the pulmonary artery 122 (shown in Figures 10A-B) and the inferior vena cava 124 (shown in Figures 10A-B), and a second distance of 10 millimeters between the hepatic vein 125 (shown in Figures 10A-B) and the transition 124B (shown in Figures 10A-B) between the right atrium 123 (shown in Figures 10A-B) and the inferior vena cava 124 (shown in Figures 10A-B). The overall length L of Figure 12A T As described above with reference to the total length L of the nestable growth devices 1000A, 1000B for the second patient, T may include the sum of a first distance of 40 millimeters between the pulmonary artery 122 and the inferior vena cava 124 and a second distance of 10 millimeters between the hepatic vein 125 and the transition portion 124B. T can be equal to 50 millimeters.

[0220] Segment expansion distance D E is the total length L T a first predetermined length L of the first growth device 1000A of 50 mm; A The covered frame portion 1112 has a length L C The proximal end region 1110L of the first growth device 1000A has a length of 40 mm. C From the segment expansion distance D E Since it extends by 10 mm, the overlap length L O is the length of the covered frame part L C and segment expansion distance D E 30 mm.

[0221] The growth devices 1000 can be advantageously configured in any suitable number and / or arrangement for implantation in a patient 100. With reference to FIG. 13, for example, three growth devices 1000 are shown implanted in a patient 100. A first growth device 1000A and a second growth device 1000B can be configured as telescoping (or telescopic) growth devices and can be deployed in the Fontan position in the manner described in more detail above with reference to FIGS. 9 and 10A-B. Additionally, a third growth device 1000C can be implanted in the Glenn position, as shown and described herein with reference to FIG. 8.

[0222] As discussed herein, the growth device 1000 can be implanted and deployed at a selected implantation site 130 (or other region of interest) (shown in FIG. 8) within a selected blood vessel or other lumen 120 (shown in FIG. 8) of a patient 100 (shown in FIG. 8) via a delivery catheter system 2000. An exemplary delivery catheter system 2000 for implanting the nested growth devices 1000A, 1000B (shown in FIGS. 10A-B) is shown in FIGS. 14A-D. The delivery catheter system 2000 of FIGS. 14A-D can include a dual-balloon catheter system for streamlining the implantation and deployment of the nested growth devices 1000A, 1000B.

[0223] 14A, a delivery catheter system 2000 is shown comprising an enclosed delivery catheter system with an outer sheath member (or means) 2100. The outer sheath member 2100 can encase a first growth device 1000A (shown in FIG. 11A) and separate a second growth device 1000B (shown in FIG. 11A). Once introduced into a patient 100 (shown in FIGS. 10A-B), the outer sheath member 2100 can steer and guide the first and second growth devices 1000A, 1000B through the vasculature of the patient 100 to a selected implantation site 130 (or other region of interest) (shown in FIG. 8) within a selected blood vessel or other lumen 120 (shown in FIG. 8) of the patient 100.

[0224] Predetermined length L S1 The outer sheath member 2100 includes an elongated sheath member having a proximal end region 2100 P and a distal end region 2100 with a catheter insertion tip 2110. D The catheter insertion tip 2110 preferably comprises a smooth tip to facilitate passage of the delivery catheter system 2000 through the vasculature of the patient 100. The distal end region 2100 D is the first width W S1 while the catheter insertion tip 2110 can have a second width W S2 An exemplary length L of the outer sheath member 2100 can be S1 may include, but is not limited to, 65 centimeters. In selected embodiments, the distal end region 2100 D The first width W S1 can include a width of 10 French to 11 French, and the catheter insertion tip 2110 has a second width W of 9 French. S2 It has.

[0225] The balloon shaft member 2200 of the delivery catheter system 2000 is shown in Figures 14B-C. Referring to Figure 14B, the balloon shaft member 2200 is shown as including a first balloon member (or means) 2220 disposed distally from a second balloon member (or means) 2230. The first balloon member 2220 can be configured to expand a first growth device 1000A (shown in Figure 11A) at a selected implantation site 130 (or other region of interest) (shown in Figure 8) within the body of the patient 100 (shown in Figure 8), and the second balloon member 2230 can be configured to expand a second growth device 1000B (shown in Figure 11A) after the first growth device 1000A has been expanded. The balloon shaft member 2200 advantageously allows the first balloon member 2220 and the second balloon member 2230 to be expanded independently to allow for stepwise deployment of the first and second growth devices 1000A, 1000B.

[0226] In selected embodiments, the first balloon member 2220 has a second balloon length L of the second balloon member 2230. B2 The first balloon length L, which may be the same as or different from B1 Similarly, the first balloon member 2220 may have a second balloon width (or diameter) W 2230 that allows the second balloon member 2230 to be expanded. B2 The first balloon width (or diameter) W, which may be the same as or different from B1 The specific length and width of the first and second balloon members 2220, 2230 may depend, for example, on the anatomy of the patient 100. By way of non-limiting example, the first balloon member 2220 may have a first balloon length L of approximately 60 millimeters. B1 , and / or a first balloon width W of 10 to 12 mm B1 Additionally and / or alternatively, the second balloon member 2230 can have a second balloon length L of about 70 millimeters. B2 , and / or a second balloon width W between 12 and 14 mm B2 The present invention can have, but is not limited to, the following:

[0227] 14C, a balloon shaft member 2200 is shown disposed within the outer sheath member 2100. The balloon shaft member 2200 can include a balloon catheter tip 2210. As shown in FIG. 14C, the balloon catheter tip 2210 has a predetermined balloon tip width (or diameter) W BT An exemplary balloon tip width W BTThe thickness may include, but is not limited to, 0.018 inches (approximately 0.46 mm). The balloon catheter tip 2210 preferably mates with the catheter insertion tip 2110 (shown in FIG. 14A) of the outer sheath member 2100 (shown in FIG. 14A) to form a smooth transition to facilitate passage of the delivery catheter system 2000 through the vasculature of the patient 100. The self-expanding growth device 1000 can be delivered without the balloon shaft member 2200, but can be delivered with the balloon shaft member 2200 if additional deployment force is required.

[0228] In some embodiments of the delivery catheter system 2000, the first balloon member 2220 can deploy the first growth device 1000A within the pulmonary artery 122 or other blood vessel, followed by the second balloon member 2230 deploying the second growth device 1000B within the first growth device 1000A and the inferior vena cava 124 or superior vena cava 121. In this embodiment, the first and second balloon members 2220, 2230 can have different lengths and diameters depending on the target anatomy. For example, if the pulmonary artery 122 of the patient 100 has a smaller diameter than the inferior vena cava 124 or superior vena cava 121, the first balloon member 2220 can have a smaller diameter than the second balloon member 2230. The first and second growth devices 1000A, 1000B can be deployed together using a single delivery system with one or more balloon members 2220, 2230 and / or can be deployed independently via separate delivery systems.

[0229] When deployed via a single delivery system, the first growth device 1000A can be deployed uncovered, while the second growth device 1000B remains enclosed further within the delivery system. In this embodiment, after the first growth device 1000A is deployed, the delivery system can be advanced into the first growth device 1000A, whereupon the second growth device 1000B can be aligned and deployed within the first growth device 1000A and the inferior vena cava 124 or superior vena cava 121. Once the second growth device 1000B is deployed and in place, the balloon members 2220, 2230 can be removed by withdrawing the delivery system rearward from the first and second growth devices 1000A, 1000B.

[0230] In some embodiments, the growth device 1000 can be deployed using a tapered balloon member. If the pulmonary artery 122 is smaller than the inferior vena cava 124 or the superior vena cava 121, the portion of the tapered balloon member for deploying the first growth device 1000A in the pulmonary artery 122 can have a diameter smaller than the diameter of the portion of the tapered balloon member for deploying the second growth device 1000B in the inferior vena cava 124 or the superior vena cava 121.

[0231] In some embodiments, the balloon shaft member 2200 can have one or more tapered elements connected to the distal end region of the first balloon member 2220 and / or the second balloon member 2230, which can help reduce the likelihood of the first and second balloon members 2220, 2230 engaging the first and second growth devices 1000A, 1000B during removal of the delivery catheter system 2000. The tapered elements can be larger in diameter than the deflated first and second balloon members 2220, 2230, thereby allowing the tapered elements to interact with the first and second growth devices 1000A, 1000B rather than the first and second balloon members 2220, 2230 interacting with the growth devices 1000A, 1000B.

[0232] The delivery catheter system 2000, as shown in Figure 14D, can optionally include a pusher shaft member (or means) 2300. The pusher shaft member 2300 can advantageously help stabilize the first and second growth devices 1000A, 1000B (shown in Figures 10A-B) during deployment. In other words, the pusher shaft member 2300 can help ensure that the first and second growth devices 1000A, 1000B are maintained axially centered relative to the first and second balloon members 2220, 2230 (shown in FIG. 14B), respectively, when the first and second growth devices 1000A, 1000B are loaded into the delivery catheter system 2000 and / or as the first and second growth devices 1000A, 1000B are implanted and deployed at a selected implantation site 130 (shown in FIG. 8) within a selected lumen 120 (shown in FIG. 8) of the patient 100 (shown in FIG. 8).

[0233] Referring to FIG. 14D, the pusher shaft member 2300 includes a proximal end region 2300 P and distal end region 2300 D The proximal end region 2300 of the pusher shaft member 2300 is shown as including an elongated member having P may have a first predetermined width (or diameter) and / or distal end region 2300 D The area has a second predetermined width (or diameter) W P1 The second predetermined width (or diameter) W P1 can include any suitable width (or diameter), and in selected embodiments can include, but is not limited to, a width (or diameter) of about 8 French.

[0234] The pusher shaft member 2300 can define an internal channel 2310. As shown in FIG. 14D, the internal channel 2310 can extend from the proximal end region 2300 of the pusher shaft member 2300. P and distal end region 2300 DThe interior channel 2310 can have an interior width (or diameter) W P2 In selected embodiments, the interior channel 2310 may have an interior width W P2 can be configured to accommodate the balloon shaft member 2200 (shown in FIGS. 14B-C). In other words, the internal width W of the internal channel 2310 P2 is the first balloon width (or diameter) W of the first balloon member 2220 (shown in FIGS. 14B-C). B1 14B-C) and / or may have a second balloon width (or diameter) W of the second balloon member 2230 (shown in FIGS. 14B-C). B2 (shown in Figures 14B-C).

[0235] 14E-G show an exemplary embodiment of a delivery catheter system 2000 in which first and second growth devices 1000A, 1000B are disposed on a balloon expansion system 2200. Referring to FIG. 14E, for example, the outer sheath member 2100 of the delivery catheter system 2000 is shown retracted distally relative to the balloon catheter tip 2210, partially exposing the first growth device 1000A during implantation. The first growth device 1000A can be disposed on the first balloon member 2220 as described above with reference to FIGS. 14A-D. With the outer sheath member 2100 partially retracted, the retention member(s) 1200 of the first growth device 1000A can be partially exposed. The retention member(s) 1200 are shown in a straight or other implanted state to facilitate insertion into a selected blood vessel or other lumen 120 (shown in FIG. 8) of the patient 100 (shown in FIG. 8), with the retention member(s) 1200 shown in axial alignment with the first device frame 1100A.

[0236] As the outer sheath member 2100 continues to be retracted, the retention member(s) 1200 of the first growth device 1000A may be fully exposed and deployable, as shown in FIG. 14F. In other words, the retention member(s) 1200 may transition from an implanted state to a deployed state for engaging a selected blood vessel or other lumen 120 (shown in FIG. 8) of the patient 100 (shown in FIG. 8) in the manner described herein. Further retraction of the outer sheath member 2100 may expose the entire first growth device 1000A. FIG. 14G illustrates that the second growth device 1000B may be positioned over the second balloon member 2230 as described above with reference to FIGS. 14A-D and may likewise be fully exposed by further retraction of the outer sheath member 2100.

[0237] Once the first growth device 1000A is fully exposed, the first balloon member 2220 can be inflated or otherwise expanded in size to expand the first growth device 1000A from an implanted state to a (stable) expanded state, as described above with reference to Figures 14A-D. Additionally and / or alternatively, the second balloon member 2230 can be inflated or otherwise expanded in size to expand the second growth device 1000B from an implanted state to a (stable) expanded state. The first and second growth devices 1000A, 1000B can be inflated and otherwise deployed simultaneously and / or in any predetermined order.

[0238] In selected embodiments, the first growth device 1000A can be expanded before the second growth device 1000B is expanded. The first growth device 1000A can be expanded, for example, to an expanded state. The second growth device 1000B, in its implanted state, can then be placed within the central axial channel 1150 (shown in FIG. 2) of the expanded first growth device 1000A and expanded to its expanded state, as shown and described with reference to FIGS. 11B and 12A-B. This allows the periphery 1140 (shown in FIG. 2) of the expanded second device frame 1100B to engage with the periphery 1140 of the expanded first device frame 1100A, and the first and second growth devices 1000A, 1000B are deployed in a nested or telescopic arrangement.

[0239] Alternatively, the second growth device 1000B may be expanded before the first growth device 1000A is expanded. The second growth device 1000B can be expanded, for example, to an expanded state. The first growth device 1000A in the implanted state can then be placed within the central axial channel 1150 of the expanded second growth device 1000B and expanded to the expanded state, as shown and described with reference to Figures 11B and 12A-B. This allows the periphery 1140 of the expanded first device frame 1100A to engage with the periphery 1140 of the expanded second device frame 1100B, and the first and second growth devices 1000A, 1000B are deployed in a telescopic or expandable arrangement.

[0240] In some embodiments, the growth device 1000 can be delivered with a catheter less than 3 millimeters in diameter and expanded to a first expanded state corresponding to the size of congenital pediatric blood vessels. The growth device 1000 can be re-expandable as the patient grows to accommodate the patient's physical growth. For example, the growth device 1000 can be deployed to a diameter of 12 millimeters and re-expanded to accommodate vascular growth as the patient ages. The growth device 1000 can initially be deployed to an initial diameter ranging from 4 to 20 millimeters and then re-expanded to a diameter of 24 millimeters or greater. The growth device 1000 can hold various blood vessels open to maintain an open lumen for blood flow as the patient grows. Some embodiments of the growth device 1000 can have a covering member 1300 on the outer surface of the device frame 1100 that seals against the vessel wall and prevents blood flow around the growth device 1000.

[0241] In some embodiments, the delivery catheter system 2000 can be constructed of high durometer materials that facilitate implant deployment stability, delivery system control, and delivery system torque transmission.

[0242] Additional and / or alternative embodiments and / or features of the growth device 1000 are shown and described herein with reference to Figures 15-35. The growth device 1000 can be provided, for example, as a shunt device and / or a shunt graft.

[0243] In some embodiments of the Glenn and Fontan shunt grafts, the graft can be constructed with a single stent scaffold with interconnected regions to enhance the stability and flexibility of the graft. These interconnected regions can have suitable shapes, such as a "V" or "C" shape, and / or can eliminate stent cell connections or other mechanical features to enhance the flexibility of the shunt graft. The shunt graft scaffold can have a straight, vertical shape or vertically connected vertices, which can reduce the amount of shortening that occurs with shunt graft growth. In this embodiment, the shunt graft scaffold can be a single component that can span the entire length of the graft or a portion of the graft. The diameter of the shunt graft scaffold can be, but is not limited to, 2 millimeters to 24 millimeters or more. The shunt graft scaffold can be constructed from, but is not limited to, cobalt chromium, nitinol, stainless steel, or other metal alloys. In some embodiments, the shunt graft scaffold can have retention features to facilitate retention of the anchoring and sealing features. The retention features can be, but are not limited to, circular eyelets, rectangular tabs, stent struts, or some other mechanical lock. In some embodiments, the shunt graft scaffold can be made of thicker or thinner material to facilitate or limit the amount of recoil of the shunt graft after expansion.

[0244] In other embodiments, the shunt graft scaffold may be constructed from multiple individual stent components that may be supported using a flexible fabric rather than being mechanically attached to one another using metal or some other attachment mechanism. In this embodiment, the stents within the scaffold may be aligned and spaced apart to increase the flexibility of the overall shunt graft.

[0245] In some embodiments, the shunt graft can be covered with a fabric to seal the vessel wall at both the Glenn and Fontan locations. The fabric can be braided, woven, a flexible polymer, or some other material that seals the vessel and directs blood flow through the center of the shunt graft. The fabric can be made from a flexible material such as, but not limited to, expanded polytetrafluoroethylene (or PTFE), Dacron, polyethylene terephthalate (or PET), or some other biocompatible fabric. In this embodiment, the fabric can be compressed to a size of 2 millimeters in diameter with the shunt graft in place and can expand to a size of 24 millimeters in diameter.

[0246] In some embodiments, a shunt 3000 can be created from the superior vena cava 121 to the pulmonary artery 122 during a Glenn procedure. In other embodiments, a shunt 3000 can be created from the inferior vena cava 124 to the pulmonary artery 122 during a Fontan procedure. As shown in FIGS. 15-16 , for example, the shunt 3000 can be formed by using a wire frame (or coil) 3020 to hold blood vessels together and create a fluid pathway between the vessels. The coil 3020 of the shunt 3000 allows blood to travel from the superior vena cava 121 to the pulmonary artery 122. The diameter of the coil 3020 of the shunt 3000 can be, but is not limited to, 6 millimeters to 10 millimeters or more. The coil 3020 of the shunt 3000 can be expandable to accommodate the patient's growth by deploying a stent (not shown) within the coil 3020 of the shunt 3000. The coil 3020 of the shunt 3000 can then unwind and expand along with the stent. The wire frame and coil implant design can vary in pitch and diameter to achieve proper vessel sealing and fluid flow. Materials for wire frame embodiments can be constructed from, but are not limited to, metals and metal alloys, polymers, biodegradable polymers, metal alloys, and / or combinations of materials. This embodiment can have optional attachment features at the end regions to allow for deployment and retrieval within a delivery system catheter. Some embodiments can also have a flared or varying pitch and diameter throughout the coil and wire frame to allow for proper fixation to tangential vessels such as the pulmonary artery 122 and superior vena cava 121.

[0247] In some embodiments of the coil implant design, the end regions of the coil implant 3020 may be provided with a hook device 3021 that may provide adequate anchoring within the pulmonary artery 122. The hook device 3021 may vary from a partial circle to a full circle.

[0248] As shown in Figures 17-23, the Glenn and / or Fontan shunt 3000 may be an expandable frame with a single or dual material implant. Materials used for any of the frame components can range from, but are not limited to, nitinol, cobalt chrome, stainless steel, other metal alloys, medical-grade fabrics and foams, and polymers and biodegradable polymer materials. In some embodiments, the frame can include growth features that allow for subsequent expansion to accommodate patient and vascular growth. The diameter of the frame body 3062, 3070 can range from 1 millimeter to 20 millimeters or more (or any range therebetween). The second frame components 60, 65, 90 and materials can provide adequate fixation and connection between the connected superior vena cava 121 and pulmonary artery 122. This fixation function can optionally be achieved by flaring, hooks, outward radial force on the vessels, and / or barb features. These fixation features can be made from, but are not limited to, laser-cut hypotubes, wires, or other fixation mechanisms. Multi-frame implants can be connected to each other by various mechanisms 3061, 3063, 3091, including, but not limited to, suture attachments 3061, 3063, 3091, welding, mechanical locks, or adhesives. In multi-frame implants, some embodiments of the transcatheter growth device may consist of an exposed metal frame at the frame contacts, or a fabric or polymer spacer may be provided between the frames of the attachment. In some multi-material embodiments, implant-grade foam 3041 or fabric may be provided at the end regions of the metal frame to allow for fixation and sealing of the shunt 3000. In single-frame embodiments, the design may include a straight tubular frame or a tubular frame with flared ends at one or both end regions of the shunt and a straight center. These embodiments provide a shunt mechanism for single-ventricle patients that can be expanded to adult size. As shown in FIG. 20B, one or more selected struts of the shunt 3000 can be arranged in a chevron configuration.Selected struts in a chevron configuration can advantageously help resist foreshortening by connecting the apexes of the struts with beam members.

[0249] In some embodiments, the shunt implant 3000 is comprised of nitinol hooks connected by fabric, which can create a blood flow pathway from the superior vena cava 121 to the pulmonary artery 122 or from the inferior vena cava 124 to the pulmonary artery 122. These hooks can grasp the pulmonary artery 122, pulling the vessel toward the superior vena cava 121 and securing it in place. A second set of hooks can anchor to the wall of the superior vena cava 121 or the inferior vena cava 124. The fabric connecting the two hook sets 3060, 3065 or flange 3090 can be wire reinforced for structural stability and can expand to larger sizes.

[0250] In some embodiments, the shunt implant 3000 can be re-expanded and / or re-expanded to adult size with an active balloon inflation mechanism, or it can passively grow with the body. In some embodiments, the frame design allows the implant to reach a target diameter range without fracture while maintaining structural stability. Individual strut bodies can be designed with an S-shape to aid in strain distribution across the diameter range. Enlarged strut junctions can tolerate greater radial forces, and the radius of the strut connectors can be designed to allow for smaller crimps and a greater expansion range.

[0251] One embodiment of the implant 3000 for the Glenn procedure involves two separate implants and delivery catheter systems for delivering a shunt from the superior vena cava 121 to the pulmonary artery 122, followed by implantation of a superior vena cava 121 occlusion device. Figures 15-16 show an exemplary embodiment of a combined device that may achieve the desired results of both a superior vena cava 121 to pulmonary artery 122 shunt coil 3020 and superior vena cava 121 occlusion coils 3023, 3025 with a single implant. The shunt coil and the superior vena cava 121 occlusion coil may have a connector mechanism 3022. One embodiment shows a coil comprising a polymer such as polytetrafluoroethylene (PTFE) or another type of fabric material 3026 that can fold back on itself to occlude the superior vena cava when the coil 3020 is released from the catheter.

[0252] FIG. 23 illustrates a dual-ring implant 3000 that may include two or more rings and / or be connected by an impermeable fabric or polymer covering to allow blood flow from the superior vena cava 121 to the pulmonary artery 122. The ring implant 3000 may serve multiple purposes, including providing a re-expansion mechanism expandable to adult size. The implanted ring may also provide proper fixation by oversizing the superior vena cava 121. FIG. 23 illustrates ring expansion into the superior vena cava 121, diverting all blood flow from the superior vena cava 121 to the pulmonary artery 122 while blocking blood flow from the inferior vena cava 124 and / or right atrium 123. Some embodiments of this implanted ring system have a target location for re-entry for subsequent procedures to open blood flow pathways or other openings and connections from the inferior vena cava 124 and / or right atrium 123 to the superior vena cava 121. The covering of the implant system 3000 can be structurally reinforced with metal wires 3102 or polymer strands 3102 to ensure vascular patency. Some embodiments of this covering are braided strands, some are monofilament strands. One embodiment does not utilize a fabric or another polymer in the vessel, but rather utilizes two expandable implant rings 3100 that can be connected by fabric 3101 and / or isolated at the junction of the superior vena cava 121 and the pulmonary artery 122.

[0253] The expandable ring can be crimped to fit a 4 to 8 French catheter and can expand to 20 millimeters. The expandable ring can be flared or straight, and can have a slope. The flared end regions of the expandable ring can be created by utilizing the shape memory and superelastic properties of Nitinol, or can be created manually by balloon expansion, which inflates the end regions of the balloon to a larger diameter. The impermeable fabric 3101 advantageously allows complete blood diversion from the superior vena cava 121 to the pulmonary artery 122, sealing off the junction of the pulmonary artery 122 and the superior vena cava 121 from blood leakage.

[0254] 24-26 illustrate exemplary procedures and techniques that may provide access to the pulmonary artery 122 via the superior vena cava 121.

[0255] Some embodiments of superior vena cava 121-to-pulmonary artery 122 access illustrate various visualization techniques for providing guidance on the puncture location. This visual guidance can consist of a single guidewire 3110 inserted into the pulmonary artery 122 to fluoroscopically indicate the location where the pulmonary artery 122 and superior vena cava 121 intersect in the anatomy. Fluoroscopic markers 3113 can be used to further highlight the target area. These markers can be made of various materials, such as, but not limited to, gold, tantalum, platinum, or other metal alloys. Visual indicators can include the use of a balloon catheter 3112 inflated with contrast to visualize the entire pulmonary artery 122 vessel. Once the visual indicators are in place, the fluoroscopic imaging device can be oriented at various angles to obtain the optimal viewing position for superior vena cava 121-to-pulmonary artery 122 access.

[0256] 25, magnets 3121, 3143 can be utilized to precisely align the intersection of the superior vena cava 121 and the pulmonary artery 122. This can be accomplished by placing a first magnet 3121 in the pulmonary artery 122 and a second magnet 3123 in the superior vena cava 121. When the first magnet 3121 and the second magnet 3123 are close enough, the magnetic field attracts them together, indicating the location where access should be created. The magnets 3121, 3123 may be stand-alone catheters 3122, 3140 and / or may be integrated into a needle access catheter (not shown). Once a magnetic connection is established, a curved or straight needle (not shown) may be moved from the delivery system toward the pulmonary artery 122. Some embodiments of the magnets 3121, 3123 may include electromagnets 3121, 3143, and / or some magnets 3121, 3123 may include polar magnets. The magnet's activation state may be zeroed by passing a current through the electromagnet.

[0257] A puncture catheter can be advantageously utilized to puncture a vessel wall for catheter access, as shown in Figure 26. Figure 26 serves as an example of an embodiment that can be further tailored for various indications. In some embodiments, the catheter can have a steerable tip for positioning prior to puncture, and in other embodiments, the catheter can incorporate a pre-curve ranging from 10 degrees to 90 degrees or more.

[0258] In some embodiments, a puncture needle exiting the catheter to create the access is provided, with a precurve built into the design and manually actuated. The precurve for both the catheter and needle can be manually formed in the operating room prior to insertion into the patient. The needle used to create access from the superior vena cava 121 to the pulmonary artery 122 can have a location for connecting an electrode proximal to the handle. In selected embodiments, the electrode can be energized to generate thermal energy at the tip of the needle, facilitating puncture into the pulmonary artery 122 or other vessel wall. The needle material can be, but is not limited to, stainless steel, nitinol, or a durable polymer. A sealing cloth or foam can be provided around the needle body to ensure excessive bleeding does not occur after access is created.

[0259] In some embodiments of the puncture needle, the needle can be shaped like a corkscrew. A corkscrew-shaped needle allows the needle to be rotated in a circular motion to penetrate the vessel wall. In other embodiments, the needle can be shaped like a hook, allowing a force to be applied to the vessel to move it closer to the catheter. The needles of selected embodiments can be manually actuated, automatically actuated, or otherwise actuated.

[0260] 27, an implant occlusion system can be used to inhibit the flow of blood from the superior vena cava (or SVC) 121 into the right atrium (or RA) 123. The occlusion implant can include a metal frame 3140, 3142 with an impermeable fabric 3141 covering the entire one end region to help ensure that blood does not flow from the superior vena cava 121 into the right atrium 123.

[0261] Materials used for the SVC to RA occlusion implant can include, but are not limited to, nitinol, cobalt chrome, stainless steel, polymers, or biodegradable polymers. The frame used for the occlusion implant can allow for repeated re-expansion over the patient's lifetime.

[0262] A custom designed balloon can be used to expand the occlusion implant device. Additionally and / or alternatively, the implant may be self-expanding.

[0263] The impermeable fabric 3141 for diverting blood flow can be made from polyethylene terephthalate (or PET) or possibly a biodegradable polymer. The fabric can allow for tissue growth and healing. The fabric can have perforations in its design to allow for needle re-access at later stages of the procedure in the patient's life. The fabric can be stretchable to accommodate a wide range of deployment diameters. The fabric portion of the occlusion implant can have sealing foam or other sealing devices attached to the edges of the implant to prevent blood from leaking around the implant 3000.

[0264] In one embodiment, the occlusion implant device can have a foam or other sealing material 3141 filling the orifice in the frame. This allows the catheter components to pass through the foam and track properly. When the catheter components are removed, the foam can relax and block blood flow through the barrel of the implant. In other words, the foam or sealing material acts as a seal to block blood flow, but may also be able to open as the catheter passes through and reseal after the catheter is removed from the barrel of the device. This foam material may include PET or other polymeric materials that are released by heating. The foam may also have shape memory and superelastic properties. The density of the foam allows it to trap and clot blood, completely blocking blood flow from the barrel of the implant within a short period of time.

[0265] In some embodiments, the frame of the occlusion implant can be made of a biodegradable material that degrades over time and can provide a scaffold for tissue growth. This degradation can occur over a variety of time periods, and once the implant is fully degraded, the patient's anatomy can grow and develop completely autonomously. The biodegradable material provides the initial structure and radial strength of the occlusion implant and can degrade over time to form an occlusion without the biodegradable material.

[0266] To secure to the wall of the superior vena cava 121 or inferior vena cava 124, the occlusion implant can have one or more fixation mechanisms. One of these fixation mechanisms utilizes barbs or friction elements, such as textured fabric and metal. The occlusion implant can also utilize radial force and self-expansion or balloon-expanded oversizing as a fixation method. The implant can have flared end regions on one or both sides, which may provide improved fixation and potentially improved sealing capabilities. The SVC occlusion implant can also utilize a flanged RA ceiling to ensure no upward migration.

[0267] 28-32 illustrate various transcatheter Fontan techniques that appropriately divert blood flow from the inferior vena cava 124 to the superior vena cava 121 and pulmonary artery 122, completing a passive blood flow loop that delivers deoxygenated blood to the lungs.

[0268] Referring to FIG. 28 , a transcatheter Fontan approach is shown. The transcatheter Fontan approach can be similar to that used in abdominal aortic aneurysm (or AAA) grafts. The implant 3000 can be fully or partially covered by sewing an impermeable fabric to a frame or by electrospinning a fabric material. Embodiments of this Fontan implant system can be made of nitinol, cobalt chromium, stainless steel, polymer, or biodegradable polymer materials, either separately or bonded together, or can be a combination of multiple materials bonded together via fabric or other coverings.

[0269] One embodiment of the Fontan implant system can include the use of multiple expandable frame rings 3100 connected by an impermeable fabric or covering. One embodiment includes three expandable rings 3100. The fabric connections can be reinforced with metal or polymer wire to ensure structural integrity throughout the patient's lifetime. The three expandable rings can be re-expanded as the patient grows, adapting to adult vessel sizes. As part of the Fontan implant system, each ring can have a flange or flare 3151 to enhance fixation and blood sealing.

[0270] Some embodiments can include the use of a trapdoor mechanism that can open and close various blood flow paths, as shown in FIG. 29 . This trapdoor 3161 can include a movable blood flow blocking portion 3161 that can be actuated to block different areas. In one embodiment, the door blocks the superior vena cava 121 and then engages to block the right atrium (or RA) 123. The implant system can be implanted during the Glenn procedure and will have a closed flow path from the superior vena cava 121 to the right atrium 123. When the patient is ready to receive the Fontan passive blood flow configuration, the flow path will open, creating a direct fluid pathway between the inferior vena cava 124 and the superior vena cava 121, while simultaneously blocking blood flow to the right atrium 123.

[0271] In this embodiment, the trapdoor can have a variety of mechanical or material actuation mechanisms. One mechanism could be to hinge open the flow path using a wire supported by the catheter system. Another actuation mechanism could be to utilize the shape memory material properties of nitinol. Nitinol will deform to a closed configuration and exhibit a very high austenitic final temperature. By attaching an electrode probe to the nitinol trapdoor 3161 and applying an electrical current to the implant 3000, the nitinol can act as a one-way actuator and open the blood flow pathway.

[0272] Some embodiments include using a transcatheter Fontan conduit to channel blood from the inferior vena cava 124 to the superior vena cava 121. The Fontan conduit can be completely or partially covered with a blood-impermeable fabric such as PET. The conduit can also be made of two or more expandable rings 3100 partially or completely connected by fabric 3180. The fabric covering can advantageously eliminate blood flow from the inferior vena cava 124 to the right atrium 123. The two-ring implant system can have a wire or metal frame to structurally support the patency of the conduit.

[0273] In some embodiments, the Fontan conduit or blood flow guider implant is made from a biodegradable material, and the fabric can provide a scaffold for tissue growth, allowing the patient's anatomy to grow normally while the tissue growth stabilizes the blood flow obstruction.

[0274] In some embodiments, the Fontan conduit or flow directing implant may have configurable features and a frame design that allows it to be re-expanded to an adult size as the patient's anatomy develops, either manually by balloon expansion or passively expanded to accommodate the patient's anatomical growth.

[0275] In some embodiments, the Fontan conduit or flow guider implant may have fenestrations to allow increased pressure from the pulmonary artery 122 to be released into the right atrium 123. The fenestrations may be predetermined in size or may be made of an expandable material that can be expanded to an optimal size using a balloon or other mechanism. Fenestrations may be placed on both sides of the conduit or on only one side. If fenestrations are placed on only one side, the surgeon can rotate the system to their preference, allowing the fenestrations to either seal against the wall of the right atrium 123 or to occlude them. The fenestrations may have fluoroscopic marker bands to inform the surgeon of their location.

[0276] In some embodiments, the Fontan conduit or blood flow guider implant can include one or more fixation mechanisms to ensure that the implant 3000 does not move or migrate undesirably after it is deployed. Some of these fixation mechanisms include the use of radial force and overexpansion to ensure proper contact with the vessel wall. Other fixation mechanisms include the use of barbs or other sharp members to puncture and hold the vessel wall. In one embodiment, the fixation mechanism is shown having a protruding feature that extends into the right atrium 123 (which may contact the wall of the right atrium 123 if the implant system moves even slightly).

[0277] In some embodiments, the Fontan conduit or blood flow directing implant can take into account the need to avoid obstructing the hepatic veins 125, which are located below the right atrium 123 and in the inferior vena cava 124. This can be achieved by having an open cell design that provides optimal spacing to ensure unobstructed blood flow out of the hepatic veins 125.

[0278] Some embodiments illustrate other implant mechanisms for diverting blood flow from the inferior vena cava 124 to the superior vena cava 121 without the use of a Fontan conduit system. These flow-directing implants may involve the use of various barriers to block blood flow to the right atrium 123.

[0279] One embodiment involves isolating the right atrium 123 from the inferior vena cava 124 using a barb fixation element connected to an impermeable fabric 3190. The barbs can be positioned at the junction of the inferior vena cava 124 and the right atrium 123 and at the junction of the superior vena cava 121 and the right atrium 123, collinear with the IVC / SVC blood flow pathway and facing toward the septum at these junctions. The number and size of the barbs can be variable. The fixation element can be a tissue anchor comprised of a helicoil with a head for driving the anchor. The impermeable fabric can be stretchable to accommodate the increasing size of the right atrium 123 as the patient 100 grows. In selected embodiments, the fabric can have needles attached.

[0280] One embodiment involves the use of a flat disc 3193 that utilizes the tricuspid valve leaflets as the anchoring mechanism 3194. The flow directing implant may have one or more hooks 3194 that can effect leaflet capture on the biological tricuspid valve leaflets. Once the tricuspid valve leaflets are captured, the flow directing disc is suspended by a wire (or braid) 3195 and positioned at the junction of the inferior vena cava 124 and the right atrium 123, and the junction of the superior vena cava 121 and the right atrium 123. In selected embodiments, the sealing disc 3193 may be made from a nitinol braid or a polymeric material.

[0281] One embodiment includes the use of a covered ball or cage that can be placed in the right atrium 123 or right atrial appendage (or RAA) to allow for proper fixation. This embodiment can include making the implant larger in size and having a bulbous portion, allowing a smaller portion to be fixed in the superior vena cava 121 and a bulbous portion to be fixed in the RA or RAA to block blood flow.

[0282] One embodiment can include two disks that can block blood flow from the inferior vena cava 124 to the right atrium 123 and can be anchored to the wall of the right atrium 123. The flow directing implant can be made from a nitinol braid that is molded into two disks 3196, 3197 and / or can also be made from a shape memory polymer.

[0283] 33A-D can be used in a transcatheter Norwood procedure to restrict blood flow in the pulmonary artery 122. The implant can be made of a self-expanding outer frame 3203 and a balloon-expandable inner frame 3201 connected via a fabric connector 3202.

[0284] In some embodiments, the self-expanding outer frame 3203 can be a straight tube stent, a double flared stent, or a self-expanding braided design. The strut designs of the self-expanding outer frame 3203 and the balloon-expandable inner frame 3201 can be a diamond design or a chevron strut design as shown in other figures herein. The balloon-expandable inner frame 3201 can have the ability to expand to a wide range of diameters depending on the patient's growth and hemodynamic needs. The diameter of the balloon-expandable inner frame 3201 can range from less than 1 millimeter to 20 millimeters or more. The diameter of the self-expanding outer frame 3203 can range from less than 1 millimeter to 7 millimeters or more. The self-expanding outer frame 3203 can be designed with a particular wall thickness or strut design to be weaker than the balloon-expandable inner frame 3201, allowing the balloon-expandable inner frame 3201 to overwhelm the self-expanding outer frame 3203 if the inner frame expands more than the outer frame. The fabric connector 3202 can be made from PTFE or another type of fabric material and can be stretchable. The fabric connector 3202 can advantageously connect the two frames and / or provide a seal to prevent blood leakage.

[0285] 34 shows an implant design 3000 that can be used to expand a patent ductus arteriosus (or PDA). This PDA implant 3000 may have two expandable rings 3100 connected by an impermeable fabric 3152. The fabric may have wires embedded in it to provide structural support.

[0286] 35, one or more PA flow restrictors and PDA stents are shown implanted as a transcatheter Norwood procedure. Many of the embodiments described herein can be used in a transcatheter Norwood procedure.

[0287] Transvascular techniques can involve the introduction and implantation of shunts, occluders, or conduits in neonates using flexible catheters in a less invasive manner than open-heart surgery. In this technique, devices such as SVC-to-PA shunts, SVC occlusion devices, and / or Fontan flow restrictors or conduits are crimped onto the end of a flexible catheter and advanced through the patient's blood vessels until the specific device reaches the implantation site. The catheter-tip device is then expanded to a functional size at the target site, such as by inflating a balloon to which the implant is attached or by removing a self-expanding implant from a sheath. These implants can later be re-expanded to adult vascular size using a transcatheter balloon. This allows implants to be implanted in neonatal patients and expanded as needed throughout the patient's life.

[0288] The blood-impermeable covering allows for vascular ingrowth and blocks blood leakage from the implant system. The covering can be a fabric such as polyethylene terephthalate (or PET) or a fluoropolymer such as some polytetrafluoroethylene. The covering provides sealing and functionality across the entire range of diameters of the implant system frame and can expand with the frame as the patient grows. In selected embodiments, applying a blood-impermeable covering to the distal and proximal end regions of the stent frame can allow for proper expansion.

[0289] Flaring can be achieved in any suitable manner. One method is to use material properties to curve the tip of the end region(s) outward, or to use a balloon with an outwardly curved shape for expansion. Similar techniques can be used to prevent aneurysms by flaring one or both end regions inward. Similarly, blunting the end regions can prevent aneurysms. Blunt end regions can be created in implant designs by attaching circular eyelets or end regions of various sizes to reduce the sharpness of the frame.

[0290] As discussed above, the inventive concept encompasses many variations, and the optional features described above may be added to the embodiments disclosed herein, either alone or in various combinations as desired.

[0291] Advantageously, each embodiment described herein can have the ability to grow with the patient. In some cases, for neonates, infants, toddlers, young children, and other pediatric patients, all implants can be delivered through a 4 French or smaller delivery sheath. In other embodiments, for neonates, infants, toddlers, young children, and other pediatric patients, implants can be delivered through a 6 French or smaller sheath. Implants for children older than neonates, such as devices replacing the Fontan procedure, can be delivered through an 8 French or smaller delivery system. The same sizing applies to the delivery systems and conduits described herein. In some embodiments, the implants can grow in size naturally or via an actuating element, such as a balloon catheter, providing a lifelong therapeutic solution.

[0292] A further understanding of the nature and advantages of embodiments of the present disclosure will become apparent by reference to the remaining portions of the specification and the drawings.

[0293] In one embodiment, the catheter is advanced to the target site via the femoral vein or artery, depending on the endpoint. Other blood vessels in the patient can be utilized to properly track the delivery catheter to the desired site. Variations in the catheter material allow for proper tracking to the target site, even through challenging anatomy.

[0294] With regard to materials, the implant system can be made of a variety of materials known in the art as balloon-expandable stents, or in alternative embodiments, as self-expanding stents. By way of non-limiting example, the stent can be made of any suitable material, such as a metal or metal alloy, such as stainless steel, cobalt chrome, nitinol, or elgiloy, or a polymer. In self-expanding embodiments, the stent is made of a shape-memory material, such as nitinol.

[0295] The above has primarily been described in terms of balloon-expandable stent embodiments. However, the delivery devices shown and described herein can be modified for delivery of self-expanding implant systems within the scope of the present disclosure. That is, delivery of a self-expanding implant system to an implantation site can be performed percutaneously using a modified version of the delivery device of the present disclosure. Generally speaking, this involves providing a transcatheter assembly, which can include the delivery sheath and / or additional sheaths described above. These devices generally further include a delivery catheter, a balloon catheter, and / or a guidewire.

[0296] As used herein, phrases in the form of at least one of A, B, C, and D should be interpreted to mean one or more of A, one or more of B, one or more of C, and / or one or more of D. Similarly, phrases in the form A, B, C, or D should be interpreted to mean A or B or C or D. For example, phrases in the form A, B, C, or combinations thereof should be interpreted to mean A or B or C, or any combination of A, B, and / or C.

[0297] In view of the many embodiments to which the principles disclosed herein may be applicable, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the invention. Furthermore, it should be recognized that, for example, features discussed with reference to a particular embodiment may also be applied to other embodiments disclosed herein. Accordingly, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

[0298] The described embodiments are susceptible to various modifications and alternative forms, specific examples of which have been shown by way of example in the drawings and are herein described in detail. It is to be understood, however, that the described embodiments are not limited to the particular forms or methods disclosed, but rather, the disclosure covers all modifications, equivalents, and alternatives. [Explanation of symbols]

[0299] 1000 Growth Device 1100 Device Frames 1110 P proximal end region 1110 D Distal end region 1111 Circular strut arrangement 1120 Growth cell member 1122 Growth Cell Strut 1126 Frame Cell 1127 Growth cell junction 1128 Top gap 1129 Flexible connecting member 1130 Spacing member 1140 Periphery 1150 central axial channel 1200 Retaining member 1300 Covering materials 1400 Anchor member

Claims

1. A transcatheter grown device for treating a congenital heart defect in a patient, a first elongated device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member and in an implanted state to facilitate insertion into a first lumen of a patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a first radial device circumference; and a first covering member disposed around the first device periphery of the first device frame; It is equipped with The growth device is configured to be deployed within the first lumen with the first device frame expanded from the implanted state to a first stable expanded state, the first device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a second lumen communicating with the first lumen, and the first covering member configured to provide a radial seal at an intersection of the first lumen and the second lumen. Transcatheter growth devices.

2. 10. The transcatheter growth device of claim 1, wherein the first device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery.

3. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members each comprises a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; 3. The transcatheter growth device of claim 2.

4. 4. The transcatheter growth device of claim 3, wherein the first annular spacing member and each intermediate annular spacing member include a plurality of elongated spacer member struts, each spacer member strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired first growth cell struts of a first annular strut array of a first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired second growth cell struts of a second annular strut array of a second adjacent annular growth cell member.

5. 5. The transcatheter growth device of claim 4, wherein the first annular spacing member and each intermediate annular spacing member are configured to reduce shortening in length of the first device frame during expansion from the implanted state to the first stable expanded state.

6. each of the spacer member strut proximal end regions is connected via a first intermediate connecting member to a connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; and each of the spacer member strut distal end regions is connected via a second intermediate connecting member to a connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; 5. The transcatheter growth device of claim 4.

7. each first intermediate connecting member includes a first flexible central body with a first connecting region for connecting with a proximal end region of a selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; and each second intermediate connecting member includes a second flexible central body having a first connecting region for connecting with a distal end region of the selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; 7. The transcatheter growth device of claim 6.

8. 7. The transcatheter growth device of claim 6, wherein the first and second intermediate link members provide flexibility to the device frame.

9. 4. The transcatheter growth device of claim 3, wherein a first annular strut array and a second annular strut array of one or more of the proximal annular growth cell member, selected intermediate annular growth cell member, and the distal annular growth cell member are connected via the first covering member.

10. 4. The transcatheter growth device of claim 3, wherein a connected distal end region of a given one of an adjacent pair of first growth cell struts of a selected annular growth cell member is connected to a connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first and second annular strut arrays of the selected annular growth cell member.

11. 11. The transcatheter growth device of claim 10, wherein the selected annular growth cell member comprises the distal annular growth cell member.

12. 12. The transcatheter growth device of claim 11, wherein a retention member is coupled with the growth cell junction, extends radially from the distal annular growth cell member, and is configured to engage the second lumen upon deployment.

13. The transcatheter growth device of claim 12, wherein the retaining member comprises a paddle.

14. 13. The transcatheter growth device of claim 12, wherein the retaining member comprises a hook.

15. 13. The transcatheter growth device of claim 12, wherein the retaining member comprises a tab.

16. 13. The transcatheter growth device of claim 12, wherein the retention member comprises a spiral.

17. 13. The transcatheter growth device of claim 12, wherein said retention member is formed from a self-expanding metallic material.

18. 4. The transcatheter growth device of claim 3, wherein a connected distal end region of a given one of an adjacent pair of first growth cell struts of the proximal annular growth cell member is connected to a connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first and second annular strut arrays of the proximal annular growth cell member.

19. 20. The transcatheter growth device of claim 18, wherein the first growth cell junctions provide flexibility to the device frame.

20. 4. The transcatheter growth device of claim 3, wherein the connected distal end region of a given one of the adjacent pair of first growth cell struts of the intermediate annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent pair of second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first and second annular strut arrays of the intermediate annular growth cell member.

21. 21. The transcatheter growth device of claim 20, wherein the second growth cell junctions provide flexibility to the device frame.

22. 4. The transcatheter growth device of claim 3, wherein the connected distal end region of a given one of the adjacent pair of first growth cell struts of the distal annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent pair of second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first and second annular strut arrays of the distal annular growth cell member.

23. 23. The transcatheter growth device of claim 22, wherein the third growth cell junction provides flexibility to the device frame.

24. 24. The transcatheter growth device of any one of claims 1 to 23, further comprising one or more retention members disposed on the first device periphery at the distal annular growth cell member and extending radially from the first device periphery and configured to engage the second lumen upon deployment.

25. 25. The transcatheter growth device of claim 24, wherein the retention members are distributed around the first device periphery in the distal annular growth cell member.

26. 25. The transcatheter growth device of claim 24, wherein said retention member is formed from a self-expanding metallic material.

27. 24. The transcatheter growth device of any one of claims 1 to 23, wherein the device frame is formed from a self-expanding metallic material.

28. 24. The transcatheter growth device of any one of claims 1 to 23, wherein the first covering member is disposed outside the first device periphery of the first device frame.

29. 24. The transcatheter growth device of any one of claims 1 to 23, wherein the first covering member is disposed around the first device periphery along the axial length of the first device frame between the proximal and distal annular growth cell members.

30. 24. The transcatheter growth device of any one of claims 1 to 23, wherein the first covering member comprises a fluid impermeable material.

31. 24. The transcatheter growth device of any one of claims 1 to 23, wherein said first covering member comprises a stretchable textile material.

32. 24. The transcatheter growth device of any one of claims 1 to 23, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state as the patient's first lumen grows from a first dimension to a second dimension, and wherein the first device periphery supports the first lumen having the second dimension.

33. 33. The transcatheter growth device of claim 32, wherein the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state as the patient's first lumen further grows from the second dimension to a third dimension, with the first device periphery supporting the first lumen having the third dimension.

34. 34. The transcatheter growth device of claim 33, wherein the first device frame is further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first lumen further grows from the third dimension to a fourth dimension, and wherein the first device periphery supports the first lumen having the fourth dimension.

35. A transcatheter growth device for treating a congenital heart defect in a patient, comprising:

24. The transcatheter growth device of any one of claims 1 to 23, comprising a retention member disposed on the distal annular growth cell member on the first device periphery, extending radially from the distal annular growth cell member and configured to engage the second lumen upon deployment; and a second transcatheter growth device configured to cooperate with the transcatheter growth device, a second elongated device frame having a second annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member, the second elongated device frame being in an implanted state to facilitate insertion into the first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a second radial device circumference; an anchor member disposed on the second device periphery of the second device frame; and a second covering member disposed around a second device periphery of the second device frame; a second transcatheter growth device comprising: Including, the second growth device is configured to be deployed within the first lumen with the second device frame expanded from the implanted state to a first stable expanded state, the second device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a third lumen communicating with the first lumen, the anchor members extending radially from the second device periphery and configured to engage the third lumen, and the second covering member configured to provide a radial seal at an intersection of the first and third lumens. Transcatheter growth means.

36. 36. The transcatheter growth means of claim 35, wherein the second device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being disposed in axial alignment between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define the second device periphery.

37. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members of the second device frame each include a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; 37. The transcatheter growth means of claim 36.

38. 38. The transcatheter growth means of claim 37, wherein a connected distal end region of a given one of adjacent paired first growth cell struts of a selected annular growth cell member of the second device frame is connected to a connected distal end region of a corresponding one of adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first annular strut array and the second annular strut array of the selected annular growth cell member.

39. 39. The transcatheter growth means of claim 38, wherein said selected annular growth cell members comprise selected intermediate annular spacing members of said second device frame.

40. 40. The transcatheter growth means of claim 39, wherein the anchoring members are configured to couple with the growth cell junctions and extend radially from the selected intermediate annular spacing member when deployed.

41. 36. The transcatheter growth means of claim 35, wherein the second covering member is disposed around the second device periphery along the axial length of the second device frame between the distal annular growth cell member and the anchor member of the second device frame.

42. 36. The transcatheter growth means of claim 35, wherein the distal annular growth cell member of the first device frame is configured to receive the distal annular growth cell member of the second device frame when deployed, the second device frame is axially aligned with the first device frame, and a proximal end region of the second device frame extends from the distal annular growth cell member of the first device frame.

43. 43. The transcatheter growth means of claim 42, wherein the first and second device frames are configured to deploy in a telescoping configuration to adjust the distance between the retention member and the anchor member to conform to a predetermined distance between the second and third lumens of the patient.

44. 36. The transcatheter growth means of claim 35, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state and the second device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state as the patient's first lumen grows from a first dimension to a second dimension, and the first and second device peripheries support the first lumen having a second dimension.

45. 45. The transcatheter growth means of claim 44, wherein the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state and the second device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state as the patient's first lumen further grows from the second dimension to a third dimension, and the first and second device peripheries support the first lumen having a third dimension.

46. 46. ​​The transcatheter growth means of claim 45, wherein the first device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state and the second device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first lumen further grows from the third dimension to a fourth dimension, and the first and second device peripheries support the first lumen having a fourth dimension.

47. 24. A delivery catheter means for implanting a transcatheter growth device according to any one of claims 1 to 23.

48. 47. A delivery catheter means for implanting a transcatheter growing means according to any one of claims 35 to 46.

49. 1. A method of manufacturing a first transcatheter growth device for treating a congenital disease in a cardiac patient, comprising: disposing a first covering member around a first radial device periphery of a first elongate device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member and in an implanted state to facilitate insertion into a first lumen of a patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define the first device periphery; Including, the first growth device is configured to be deployed within the first lumen with the first device frame expanded from the implanted state to a first stable expanded state, the first device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a second lumen communicating with the first lumen, and the first covering member configured to provide a radial seal at an intersection of the first lumen and the second lumen. method.

50. 50. The method of claim 49, wherein the first device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery.

51. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members each comprises a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; 51. The method of claim 50.

52. 52. The method of claim 51 , wherein the first annular spacing member and each intermediate annular spacing member include a plurality of elongated spacer member struts, each spacer member strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired first growth cell struts of a first annular strut array of a first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired second growth cell struts of a second annular strut array of a second adjacent annular growth cell member.

53. 53. The method of claim 52, wherein the first annular spacing member and each intermediate annular spacing member are configured to reduce shortening in length of the first device frame during expansion from the implanted state to the first stable expanded state.

54. each of the spacer member strut proximal end regions connected via a first intermediate connecting member to a connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; and each of the spacer member strut distal end regions is connected via a second intermediate connecting member to a connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; 53. The method of claim 52.

55. each first intermediate connecting member includes a first flexible central body with a first connecting region for connecting with a proximal end region of a selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; each second intermediate connecting member includes a second flexible central body having a first connecting region for connecting with a distal end region of the selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; 55. The method of claim 54.

56. 55. The method of claim 54, wherein the first and second intermediate connecting members provide flexibility to the device frame.

57. 52. The method of claim 51, wherein the first annular strut array and the second annular strut array of one or more of the proximal annular growth cell member, the selected intermediate annular growth cell member, and the distal annular growth cell member are connected via the first covering member.

58. 52. The method of claim 51, wherein a connected distal end region of a given one of an adjacent pair of first growth cell struts of a selected annular growth cell member is connected to a connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first annular strut array and the second annular strut array of the selected annular growth cell member.

59. 59. The method of claim 58, wherein the selected annular growth cell member comprises the distal annular growth cell member.

60. 60. The method of claim 59, further comprising coupling a retention member to the growth cell junction, the retention member extending radially from the distal annular growth cell member and configured to engage the second lumen when deployed.

61. 61. The method of claim 60, wherein the retaining member comprises a paddle.

62. 61. The method of claim 60, wherein the retention member comprises a hook.

63. 61. The method of claim 60, wherein the retaining member comprises a tab.

64. 61. The method of claim 60, wherein the retaining member comprises a spiral.

65. 61. The method of claim 60, further comprising forming the retention member from a self-expanding metallic material.

66. 52. The method of claim 51, wherein the connected distal end region of a given one of an adjacent pair of first growth cell struts of the proximal annular growth cell member is connected to the connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first annular strut array and the second annular strut array of the proximal annular growth cell member.

67. 67. The method of claim 66, wherein the first growth cell joints provide flexibility to the device frame.

68. 52. The method of claim 51, wherein the connected distal end region of a given one of the adjacent pair of first growth cell struts of the intermediate annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent pair of second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first annular strut array and the second annular strut array of the intermediate annular growth cell member.

69. 69. The method of claim 68, wherein the second growth cell joints provide flexibility to the device frame.

70. 52. The method of claim 51, wherein the connected distal end region of a given one of the adjacent pair of first growth cell struts of the distal annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent pair of second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first annular strut array and the second annular strut array of the distal annular growth cell member.

71. 71. The method of claim 70, wherein the third growth cell joint provides flexibility to the device frame.

72. 72. The method of any one of claims 49 to 71, further comprising disposing one or more retention members on the first device periphery of the distal annular growth cell member, the retention members extending radially from the first device periphery and configured to engage the second lumen when deployed.

73. 73. The method of claim 72, wherein the step of positioning the retention members comprises distributing the retention members around the first device periphery in the distal annular growth cell member.

74. 73. The method of claim 72, further comprising forming the retention member from a self-expanding metallic material.

75. 72. The method of any one of claims 49 to 71, wherein the device frame is formed from a self-expanding metallic material.

76. 72. The method of any one of claims 49 to 71, wherein the step of positioning the first covering member comprises positioning the first covering member outside the first device periphery of the first device frame.

77. 72. The method of any one of claims 49 to 71, wherein the step of positioning the first covering member comprises positioning around the first device periphery along the axial length of the first device frame between the proximal annular growth cell member and the distal annular growth cell member.

78. 72. The method of any one of claims 49 to 71, wherein the first covering member comprises a fluid impermeable material.

79. 72. The method of any one of claims 49 to 71, wherein the first covering member comprises a stretchable textile material.

80. 72. The method of any one of claims 49 to 71, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state as the patient's first lumen grows from a first dimension to a second dimension, and the first device periphery supports the first lumen having the second dimension.

81. 81. The method of claim 80, wherein as the patient's first lumen further grows from the second dimension to a third dimension, the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first device periphery supporting the first lumen having the third dimension.

82. 82. The method of claim 81, wherein the first device frame is further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first lumen further grows from the third dimension to a fourth dimension, and the first device periphery supports the first lumen having the fourth dimension.

83. 72. The method of any one of claims 49 to 71, further comprising manufacturing a second transcatheter growth device for treating a congenital disease in the heart disease patient in cooperation with the first transcatheter growth device, wherein the first transcatheter growth device includes a retention member disposed on a periphery of the first device at the distal annular growth cell member, extending radially from the distal annular growth cell member, and configured to engage the second lumen upon deployment.

84. manufacturing the second transcatheter growth device, placing anchor members on a second radial device periphery of a second elongate device frame having a second annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member, the second elongate device frame being in an implanted state to facilitate insertion into a first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define the second device periphery; and placing a second covering member around a second device periphery of the second device frame; Including, the second growth device is configured to be deployed within the first lumen with the second device frame expanded from the implanted state to a first stable expanded state, the second device periphery supporting the first lumen and defining a central axial channel for facilitating blood flow between the first lumen and a third lumen communicating with the first lumen, the anchoring members extending radially from the second device periphery and configured to engage the third lumen, and the second covering member configured to provide a radial seal at an intersection of the first and third lumens.

84. The method of claim 83.

85. 85. The method of claim 84, wherein the second device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define the second device periphery.

86. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members of the second device frame each include a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; 86. The method of claim 85.

87. 87. The method of claim 86, wherein a connected distal end region of a given one of adjacent paired first growth cell struts of a selected annular growth cell member of the second device frame is connected to a connected distal end region of a corresponding one of adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first annular strut array and the second annular strut array of the selected annular growth cell member.

88. 88. The method of claim 87, wherein the selected annular growth cell member comprises a selected intermediate annular spacing member of the second device frame.

89. 90. The method of claim 88, wherein the step of positioning the anchor members includes coupling the anchor members with the growth cell junctions, the anchor members configured to extend radially from the selected intermediate annular spacing member when deployed.

90. 85. The method of claim 84, wherein the step of positioning the second covering member comprises positioning the second covering member around the second device periphery along the axial length of the second device frame between the distal annular growth cell member and the anchor member of the second device frame.

91. 85. The method of claim 84, wherein the distal annular growth cell member of the first device frame is configured to receive the distal annular growth cell member of the second device frame when deployed, the second device frame is axially aligned with the first device frame, and a proximal end region of the second device frame extends from the distal annular growth cell member of the first device frame.

92. 92. The method of claim 91, wherein the first and second device frames are configured to deploy in a telescoping configuration to adjust the distance between the retention member and the anchor member to conform to a predetermined distance between the second and third lumens of the patient.

93. 85. The method of claim 84, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state and the second device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state as the patient's first lumen grows from a first dimension to a second dimension, and the first and second device peripheries support the first lumen having a second dimension.

94. 94. The method of claim 93, wherein the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the second device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, as the patient's first lumen further grows from the second dimension to a third dimension, and the first and second device peripheries support the first lumen having a third dimension.

95. 95. The method of claim 94, wherein the first device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state and the second device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first lumen further grows from the third dimension to a fourth dimension, and the first and second device peripheries support the first lumen having a fourth dimension.

96. 1. A method of implanting a first transcatheter growth device for treating a congenital heart disease in a cardiac patient, comprising: inserting a first elongate device frame into a first lumen of a patient, the first device frame having a first annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member, the first device frame being in an implanted state to facilitate insertion into the first lumen of a patient, the first annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a first radial device periphery, and a first covering member disposed about the first device periphery of the first device frame; and expanding the first device frame from the implanted state to a first stable expanded state, wherein the first device periphery supports the first lumen and defines a central axial channel for facilitating blood flow between the first lumen and a second lumen in communication with the first lumen. Includes the first covering member is configured to provide a radial seal at an intersection of the first and second lumens. method.

97. 97. The method of claim 96, wherein the first device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the first annular spacing member and the proximal annular growth cell member and cooperating to further define the first device periphery.

98. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members each comprises a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; 98. The method of claim 97.

99. 99. The method of claim 98, wherein the first annular spacing member and each intermediate annular spacing member include a plurality of elongated spacer member struts, each spacer member strut having a proximal end region and a distal end region, each of the proximal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired first growth cell struts of a first annular strut array of a first adjacent annular growth cell member, and each of the distal end regions of the spacer member struts being connected to a connected proximal end region of a corresponding one of the paired second growth cell struts of a second annular strut array of a second adjacent annular growth cell member.

100. 100. The method of claim 99, wherein the first annular spacing member and each intermediate annular spacing member are configured to reduce shortening of the length of the first device frame during expansion of the first device frame.

101. each of the spacer member strut proximal end regions connected via a first intermediate connecting member to a connected proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; and each of the spacer member strut distal end regions is connected via a second intermediate connecting member to a connected proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; 100. The method of claim 99.

102. each first intermediate connecting member includes a first flexible central body with a first connecting region for connecting with a proximal end region of a selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired first growth cell struts of the first annular strut array of the first adjacent annular growth cell member; each second intermediate connecting member includes a second flexible central body having a first connecting region for connecting with a distal end region of the selected spacer member strut and a second connecting region for connecting with a corresponding connected proximal end region of a selected one of the paired second growth cell struts of the second annular strut array of the second adjacent annular growth cell member; The method of claim 101.

103. 102. The method of claim 101, wherein the first and second intermediate connecting members provide flexibility to the device frame to facilitate insertion of the first device frame.

104. 99. The method of claim 98, wherein the first annular strut array and the second annular strut array of one or more of the proximal annular growth cell member, the selected intermediate annular growth cell member, and the distal annular growth cell member are connected via the first covering member.

105. 99. The method of claim 98, wherein a connected distal end region of a given one of an adjacent pair of first growth cell struts of a selected annular growth cell member is connected to a connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first annular strut array and the second annular strut array of the selected annular growth cell member.

106. 106. The method of claim 105, wherein the selected annular growth cell member comprises the distal annular growth cell member.

107. 107. The method of claim 106, wherein a retention member is coupled to the growth cell junction, extends radially from the distal annular growth cell member, and is configured to engage the second lumen when deployed.

108. 108. The method of claim 107, wherein the retaining member comprises a paddle.

109. 108. The method of claim 107, wherein the retaining member comprises a hook.

110. 108. The method of claim 107, wherein the retaining member comprises a tab.

111. 108. The method of claim 107, wherein the retaining member comprises a spiral.

112. 108. The method of claim 107, wherein the retention member is formed from a self-expanding metallic material, and expanding the first device frame comprises allowing the retention member to self-expand.

113. 99. The method of claim 98, wherein the connected distal end region of a given one of an adjacent pair of first growth cell struts of the proximal annular growth cell member is connected to the connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the proximal annular growth cell member to form a first growth cell junction for connecting the first and second annular strut arrays of the proximal annular growth cell member.

114. 114. The method of claim 113, wherein the first growth cell joints provide flexibility to the device frame to facilitate insertion of the first device frame.

115. 99. The method of claim 98, wherein the connected distal end region of a given one of an adjacent pair of first growth cell struts of the intermediate annular growth cell member is connected to the connected distal end region of a corresponding one of an adjacent pair of second growth cell struts of the intermediate annular growth cell member to form a second growth cell junction for connecting the first and second annular strut arrays of the intermediate annular growth cell member.

116. 116. The method of claim 115, wherein the second growth cell joints provide flexibility to the device frame to facilitate insertion of the first device frame.

117. 99. The method of claim 98, wherein the connected distal end region of a given one of the adjacent pair of first growth cell struts of the distal annular growth cell member is connected to the connected distal end region of a corresponding one of the adjacent pair of second growth cell struts of the distal annular growth cell member to form a third growth cell junction for connecting the first annular strut array and the second annular strut array of the distal annular growth cell member.

118. 118. The method of claim 117, wherein the third growth cell joint provides flexibility to the device frame to facilitate insertion of the first device frame.

119. 119. The method of any one of claims 96 to 118, wherein the step of expanding the first device frame includes radially extending one or more retention members disposed on the first device periphery at the distal annular growth cell member to engage the second lumen.

120. 120. The method of claim 119, wherein the retention members are distributed around the first device periphery in the distal annular growth cell member.

121. 120. The method of claim 119, wherein the retention member is formed from a self-expanding metallic material.

122. 119. The method of any one of claims 96 to 118, wherein the device frame is formed from a self-expanding metal material, and expanding the first device frame comprises allowing the retention member to self-expand.

123. 119. The method of any one of claims 96 to 118, wherein the first covering member is positioned outside the first device periphery of the first device frame.

124. 119. The method of any one of claims 96 to 118, wherein the first covering member is positioned around the first device periphery along the axial length of the first device frame between the proximal annular growth cell member and the distal annular growth cell member.

125. 119. The method of any one of claims 96 to 118, wherein the first covering member comprises a fluid-impermeable material.

126. 119. The method of any one of claims 96 to 118, wherein the first covering member comprises a stretchable textile material.

127. 119. The method of any one of claims 96 to 118, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state as the patient's first lumen grows from a first dimension to a second dimension, and the first device periphery supports the first lumen having the second dimension.

128. 128. The method of claim 127, wherein as the patient's first lumen further grows from the second dimension to a third dimension, the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, with the first device periphery supporting the first lumen having the third dimension.

129. 129. The method of claim 128, wherein the first device frame is further configured to subsequently radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first lumen further grows from the third dimension to a fourth dimension, and the first device periphery supports the first lumen having the fourth dimension.

130. 119. The method of any one of claims 96 to 118, further comprising implanting a second transcatheter growth device cooperating with the first transcatheter growth device to treat a congenital disease in the heart disease patient, wherein the first transcatheter growth device includes a retention member disposed on a periphery of the first device at the distal annular growth cell member, extending radially from the distal annular growth cell member, and configured to engage the second lumen when deployed.

131. implanting the second transcatheter growth device comprises: inserting a second elongated device frame into the first lumen of the patient, the second device frame having a second annular spacing member axially aligned between a proximal annular growth cell member and a distal annular growth cell member, the second device frame being in an implanted state to facilitate insertion into the first lumen of the patient, the second annular spacing member, the proximal annular growth cell member, and the distal annular growth cell member cooperating to define a second radial device periphery, an anchor member disposed on the second device periphery of the second device frame, and a second covering member disposed around the second device periphery of the second device frame; and expanding the second device frame from the implanted state to a first stable expanded state, wherein the second device periphery supports the first lumen and defines a central axial channel for facilitating blood flow between the first lumen and a third lumen in communication with the first lumen. Including, the anchoring members extend radially from the second device periphery and are configured to engage the third lumen; and the second covering member is configured to provide a radial seal at an intersection of the first lumen and the third lumen. The method of claim 130.

132. 132. The method of claim 131, wherein the insertion of the second device frame occurs after the insertion of the first device frame.

133. 132. The method of claim 131, wherein the expansion of the second device frame is performed after the expansion of the first device frame.

134. 132. The method of claim 131, wherein the second device frame includes an alternating arrangement of at least one intermediate annular spacing member and at least one intermediate annular growth cell member, the alternating arrangement being axially aligned and disposed between the second annular spacing member and the proximal annular growth cell member of the second device frame and cooperating to further define the second device periphery.

135. the proximal annular growth cell member, the distal annular growth cell member, and each of the intermediate annular growth cell members of the second device frame each include a first annular strut array and a second annular strut array; the first annular strut array includes a plurality of pairs of first growth cell struts, each first growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of first growth cell struts being connected such that the distal end regions extend from the connected proximal end regions, and the distal end regions of adjacent pairs of first growth cell struts being connected to form the first annular strut array having a zigzag arrangement of the first growth cell struts; and the second annular strut array includes a plurality of pairs of second growth cell struts, each second growth cell strut having a proximal end region and a distal end region, the proximal end regions of the pairs of second growth cell struts being connected to extend from the connected proximal end region, and the distal end regions of adjacent pairs of second growth cell struts being connected to form the second annular strut array having a zigzag arrangement of the second growth cell struts; The method of claim 134.

136. 136. The method of claim 135, wherein a connected distal end region of a given one of adjacent paired first growth cell struts of a selected annular growth cell member of the second device frame is connected to a connected distal end region of a corresponding one of adjacent paired second growth cell struts of the selected annular growth cell member to form a growth cell junction for connecting the first annular strut array and the second annular strut array of the selected annular growth cell member.

137. 137. The method of claim 136, wherein the selected annular growth cell member comprises a selected intermediate annular spacing member of the second device frame.

138. 138. The method of claim 137, wherein the anchor members are configured to couple with the growth cell junctions and extend radially from the selected intermediate annular spacing member when deployed.

139. 132. The method of claim 131, wherein the second covering member is positioned around the second device periphery along the axial length of the second device frame between the distal annular growth cell member and the anchor member of the second device frame.

140. 132. The method of claim 131, wherein the step of inserting the second device frame includes the step of positioning the distal annular growth cell member of the second device frame inside the central axial channel defined by the distal annular growth cell member of the first device frame, wherein the second device frame is axially aligned with the first device frame and a proximal end region of the second device frame extends from the distal annular growth cell member of the first device frame.

141. 141. The method of claim 140, wherein the first and second device frames are configured to deploy in a telescopic arrangement.

142. 141. The method of claim 140, further comprising adjusting the distance between the retention member and the anchor member to match a predetermined distance between a second lumen and a third lumen of the patient.

143. 132. The method of claim 131, wherein the first device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state when the patient's first lumen grows from a first dimension to a second dimension, and the second device frame is configured to radially re-expand from the first stable expanded state to a second stable expanded state, and the first and second device peripheries support the first lumen having a second dimension.

144. 144. The method of claim 143, wherein as the patient's first lumen further grows from the second dimension to a third dimension, the first device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the second device frame is configured to subsequently radially re-expand from the second stable expanded state to a third stable expanded state, and the first and second device peripheries support the first lumen having the third dimension.

145. The method of claim 144, wherein the first device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state, and the second device frame is configured to radially re-expand from the third stable expanded state to a fourth stable expanded state as the patient's first internal lumen further grows from the third dimension to a fourth dimension, and the first and second device peripheries support the first internal lumen having a fourth dimension.

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