# US 12,004,939 B1 · Transcatheter growth devices and methods for Norwood, Glenn and Fontan therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,939 B1 - Document ID: US12004939B1 - Status: Granted - Kind: B1 - Application number: 18/532,943 - Filed: 2023-12-07 - Published: 2024-06-13 - Granted: 2024-06-11 - Earliest claimed: 2022-12-09 - Assignees: Renata Medical, Inc. - Applicants: Renata Medical, Inc. - Inventors: Corey Marshall; Eason Abbott; Dustin Armer; Jordan Roy; Evan Zahn; Rani Mahmoudi - Web page: https://patentgrep.com/patent/US12004939B1 ## CPC - A61F 2/064: {with special features to facilitate anastomotic coupling (anastomosis of natural blood vessels A61B17/11)} - A61F 2/848: having means for fixation to the vessel wall, e.g. barbs - A61F 2/07: Stent-grafts - A61F 2/852: Two or more distinct overlapping stents - A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other - A61F 2002/821: {Ostial stents} - A61F 2002/825: {having longitudinal struts} - A61F 2002/826: {more than one stent being applied sequentially} - A61F 2002/8486: {provided on at least one of the ends} - A61F 2002/91541: {Adjacent bands are arranged out of phase} - A61F 2002/91558: {connected peak to peak} - A61F 2220/0008: Fixation appliances for connecting prostheses to the body - A61F 2250/0065: telescopic - A61F 2250/0069: Sealing means - A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract A transcatheter growth device for treating congenital illnesses in infantile and other pediatric heart disease patients and methods for making and using the same. The growth device includes an elongated device frame with alternating annular growth cell members and spacing members that axially span proximal and distal end regions of the device frame. The growth cell members and spacing members define a radial periphery for the growth device. Each growth cell member can comprise a scaffolded growth cell member with first and second annular strut arrangements coupled via a growth cell junction to provide device frame flexibility. A retention member for engaging a selected lumen within a patient and a covering member for sealing the growth device, when deployed, are disposed at the device periphery. The growth device advantageously can be deployed for treating heart disease alone or in combination with one or more additional growth devices. ## Claims ### Claim 1 A transcatheter growth device for treating congenital illnesses in heart disease patients, comprising: a first elongated device frame having a first annular spacing member in axial alignment between a proximal annular growth cell member and a distal annular growth cell member and being in an implantation state for facilitating 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; a first covering member being disposed around the first device periphery of said first device frame; and one or more retention members being distributed about the first device periphery at the distal annular growth cell member and being configured to extend radially from the first device periphery and to engage a second lumen in communication with the first lumen when deployed, wherein said growth device is configured to be deployed within the first lumen with said first device frame being expanded from the implantation state to a first stable expanded state with the first device periphery supporting the first lumen and defining a central axial channel for promoting blood flow between the first and second lumens, said first covering member being configured to provide a radial seal at an intersection between the first and second lumens, and wherein said first device frame is configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state as the first lumen of the patient grows from a first dimension to a second dimension, the first device periphery supporting the first lumen with the second dimension. ### Claim 2 (depends on 1) The transcatheter growth device of claim 1, wherein said first device frame further comprises at least one intermediate annular spacing member alternating with at least one intermediate annular growth cell member being disposed in axial alignment between the first annular spacing member and the proximal annular growth cell member and cooperate to further define the first device periphery. ### Claim 3 (depends on 2) The transcatheter growth device of claim 2, wherein each of the proximal annular growth cell member, the distal annular growth cell member and each intermediate annular growth cell member includes a first annular strut arrangement and a second annular strut arrangement, wherein the first annular strut arrangement comprises a plurality of paired first growth cell struts with 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 coupled such that the distal end regions extend from the coupled proximal end regions, the distal end regions of adjacent paired first growth cell struts being coupled to form the first annular strut arrangement with a zigzag arrangement of the first growth cell struts, and wherein the second annular strut arrangement comprises a plurality of paired second growth cell struts with 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 coupled such that the distal end regions extend from the coupled proximal end regions, the distal end regions of adjacent paired second growth cell struts being coupled to form the second annular strut arrangement with a zigzag arrangement of the second growth cell struts. ### Claim 4 (depends on 3) The transcatheter growth device of claim 3, wherein the first annular spacing member and each intermediate annular spacing member comprises a plurality of elongated spacer member struts with 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 coupled with the coupled proximal end region of a corresponding one of the paired first growth cell struts of the first annular strut arrangement of a first adjacent annular growth cell member, each of the distal end regions of the spacer member struts being coupled with the coupled proximal end region of a corresponding one of the paired second growth cell struts of the second annular strut arrangement of a second adjacent annular growth cell member. ### Claim 5 (depends on 4) The transcatheter growth device of claim 4, wherein the first annular spacing member and each intermediate annular spacing member are configured to reduce foreshortening of a length of said first device frame during expansion from the implantation state to the first stable expanded state. ### Claim 6 (depends on 4) The transcatheter growth device of claim 4, wherein each of the proximal end regions of the spacer member struts are coupled with the coupled proximal end region of the corresponding one of the paired first growth cell struts of the first annular strut arrangement of the first adjacent annular growth cell member via a first intermediate coupling member, and wherein each of the distal end regions of the spacer member struts are coupled with the coupled proximal end region of the corresponding one of the paired second growth cell struts of the second annular strut arrangement of the second adjacent annular growth cell member via a second intermediate coupling member. ### Claim 7 (depends on 6) The transcatheter growth device of claim 6, wherein each first intermediate coupling member comprises a first flexible central body with a first coupling region for coupling with a corresponding coupled proximal end region of the selected one of the paired first growth cell struts of the first annular strut arrangement of the first adjacent annular growth cell member and a second coupling region for coupling with the proximal end region of a selected spacer member strut, and wherein each second intermediate coupling member comprises a second flexible central body with a first coupling region for coupling with a corresponding coupled proximal end region of the selected one of the paired second growth cell struts of the second annular strut arrangement of the second adjacent annular growth cell member and a second coupling region for coupling with the distal end region of the selected spacer member strut. ### Claim 8 (depends on 6) The transcatheter growth device of claim 6, wherein the first and second intermediate coupling members provide flexibility for said device frame. ### Claim 9 (depends on 3) The transcatheter growth device of claim 3, wherein the first annular strut arrangement and the second annular strut arrangement of one or more of the proximal annular growth cell member, a selected intermediate annular growth cell member and the distal annular growth cell member are coupled via said first covering member. ### Claim 10 (depends on 3) The transcatheter growth device of claim 3, wherein the coupled distal end regions of a predetermined one of the adjacent paired first growth cell struts of a selected annular growth cell member are coupled with the coupled distal end regions 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 coupling the first and second annular strut arrangements of the selected annular growth cell member. ### Claim 11 (depends on 10) The transcatheter growth device of claim 10, wherein the selected annular growth cell member comprises the distal annular growth cell member. ### Claim 12 (depends on 11) The transcatheter growth device of claim 11, wherein a retention member is coupled with the growth cell junction and configured to extend radially from the distal annular growth cell member and to engage the second lumen when deployed. ### Claim 13 (depends on 3) The transcatheter growth device of claim 3, wherein the coupled distal end regions of a predetermined one of the adjacent paired first growth cell struts of the proximal annular growth cell member are coupled with the coupled distal end regions 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 coupling the first and second annular strut arrangements of the proximal annular growth cell member, wherein the coupled distal end regions of a predetermined one of the adjacent paired first growth cell struts of the intermediate annular growth cell member are coupled with the coupled distal end regions 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 coupling the first and second annular strut arrangements of the intermediate annular growth cell member, and wherein the coupled distal end regions of a predetermined one of the adjacent paired first growth cell struts of the distal annular growth cell member are coupled with the coupled distal end regions 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 coupling the first and second annular strut arrangements of the distal annular growth cell member. ### Claim 14 (depends on 13) The transcatheter growth device of claim 13, wherein the first, second and third growth cell junctions provide flexibility for said device frame. ### Claim 15 (depends on 1) The transcatheter growth device of claim 1, wherein said device frame is formed from a self-expanding metal material. ### Claim 16 (depends on 1) The transcatheter growth device of claim 1, wherein said first covering member is disposed outside the first device periphery of said first device frame. ### Claim 17 (depends on 1) The transcatheter growth device of claim 1, wherein said first covering member is disposed around the first device periphery along an axial length of said first device frame between the proximal annular growth cell member and the distal annular growth cell member. ### Claim 18 (depends on 1) The transcatheter growth device of claim 1, wherein said first covering member comprises a fluid-impermeable material. ### Claim 19 (depends on 1) A transcatheter growth system for treating congenital illnesses in heart disease patients, comprising: said transcatheter growth device of claim 1; and a second transcatheter growth device being configured to cooperate with said transcatheter growth device and comprising: a second elongated device frame having a second annular spacing member in axial alignment between a proximal annular growth cell member and a distal annular growth cell member and being in an implantation state for facilitating 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 being disposed on the second device periphery of said second device frame; and a second covering member being disposed around the second device periphery of said second device frame, wherein said second growth device is configured to be deployed within the first lumen with said second device frame being expanded from the implantation state to a first stable expanded state with the second device periphery supporting the first lumen and defining a central axial channel for promoting blood flow between the first lumen and a third lumen in communication with the first lumen, said anchor member being configured to extend radially from the second device periphery and to engage the third lumen, said second covering member being configured to provide a radial seal at an intersection between the first and third lumens. ### Claim 20 (depends on 19) The transcatheter growth system of claim 19, wherein said second device frame further comprises at least one intermediate annular spacing member alternating with at least one intermediate annular growth cell member being disposed in axial alignment between the second annular spacing member and the proximal annular growth cell member of said second device frame and cooperate to further define the second device periphery. ### Claim 21 (depends on 20) The transcatheter growth system of claim 20, wherein each of the proximal annular growth cell member, the distal annular growth cell member and each intermediate annular growth cell member of said second device frame includes a first annular strut arrangement and a second annular strut arrangement, wherein the first annular strut arrangement comprises a plurality of paired first growth cell struts with 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 coupled such that the distal end regions extend from the coupled proximal end regions, the distal end regions of adjacent paired first growth cell struts being coupled to form the first annular strut arrangement with a zigzag arrangement of the first growth cell struts, and wherein the second annular strut arrangement comprises a plurality of paired second growth cell struts with 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 coupled such that the distal end regions extend from the coupled proximal end regions, the distal end regions of adjacent paired second growth cell struts being coupled to form the second annular strut arrangement with a zigzag arrangement of the second growth cell struts. ### Claim 22 (depends on 21) The transcatheter growth system of claim 21, wherein the coupled distal end regions of a predetermined one of the adjacent paired first growth cell struts of a selected annular growth cell member of said second device frame are coupled with the coupled distal end regions 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 coupling the first and second annular strut arrangements of the selected annular growth cell member. ### Claim 23 (depends on 22) The transcatheter growth system of claim 22, wherein the selected annular growth cell member comprises a selected intermediate annular spacing member of said second device frame. ### Claim 24 (depends on 23) The transcatheter growth system of claim 23, wherein said anchor member is coupled with the growth cell junction and configured to extend radially from the selected intermediate annular spacing member when deployed. ### Claim 25 (depends on 21) The transcatheter growth system of claim 21, wherein said second covering member is disposed around the second device periphery along an axial length of said second device frame between the distal annular growth cell member of said second device frame and said anchor member. ### Claim 26 (depends on 21) The transcatheter growth system of claim 21, wherein the distal annular growth cell member of said first device frame when deployed is configured to receive the distal annular growth cell member of said second device frame, said second device frame being in axial alignment with said first device frame with the proximal end region of said second device frame extending from the distal annular growth cell member of said first device frame. ### Claim 27 (depends on 26) The transcatheter growth system of claim 26, wherein said first and second device frame are configured to deploy in a telescoping arrangement for adjusting a distance between said retention members and said anchor member to conform with a predetermined distance between the second and third lumens of the patient. ### Claim 28 (depends on 21) The transcatheter growth system of claim 21, wherein said first device frame is further configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state and said second device frame is further configured to subsequently radially re-expand from the first stable expanded state to a second stable expanded state as the first lumen of the patient grows from a first dimension to a second dimension, the first and second device peripheries supporting the first lumen with the second dimension.