WO2019108941A1 - Memory catheter - Google Patents

Memory catheter Download PDF

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Publication number
WO2019108941A1
WO2019108941A1 PCT/US2018/063321 US2018063321W WO2019108941A1 WO 2019108941 A1 WO2019108941 A1 WO 2019108941A1 US 2018063321 W US2018063321 W US 2018063321W WO 2019108941 A1 WO2019108941 A1 WO 2019108941A1
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WO
WIPO (PCT)
Prior art keywords
memory
catheter
support structure
hollow tube
shape
Prior art date
Application number
PCT/US2018/063321
Other languages
French (fr)
Inventor
Komen BROWN
Original Assignee
Generations International Asset Management Company Llc D/B/A International Private Bank
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Generations International Asset Management Company Llc D/B/A International Private Bank filed Critical Generations International Asset Management Company Llc D/B/A International Private Bank
Publication of WO2019108941A1 publication Critical patent/WO2019108941A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0089Chemotherapy developing heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • A61F2007/126Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266Shape memory materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1017Peritoneal cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Definitions

  • the present description relates in general to surgical tools and methods, and more particularly to, for example and without limitation, memory catheters
  • Hyperthermic Intraperitoneal Chemotherapy is performed immediately after cytoreduction, and involves circulating heated chemotherapy in the patient’s peritoneal cavity (abdomen) for about 90-120 minutes.
  • the HIPEC procedure is designed to attempt to kill any remaining cancer cells that cannot be seen.
  • the chemotherapy solution is then removed and the incision closed.
  • peritoneal carcinomatosis or peritoneal cancer patients with peritoneal carcinomatosis or peritoneal cancer, tumors of the appendix or colon, ovarian cancer, uterine cancer, mucinous mtra-abdominal tumors, peritoneal tumors (mesothelioma), and any cancers located in or affecting the abdominal or peritoneal region benefit from HIPEC This procedure can be highly effective for this patient population, which historically has had only several months to live.
  • the description provided in the background section should not be assumed to be prior art merely because it is mentioned in or associated with the background section.
  • the background section may include information that describes one or more aspects of the subject technology.
  • a memory catheter in accordance with various aspects of the disclosure, includes a hollow tube with a proximal end and a distal end, a memory support structure that controls a shape of the hollow tube, and a plurality of openings along a length of the hollow tube at the distal end.
  • a method for providing hyperthermic mtraperitoneal chemotherapy includes inserting a memory' catheter into a peritoneal cavity of a patient.
  • the memory' catheter includes a hollow- tube with a proximal end and a distal end, a memory support structure that controls a shape of the hollow' tube, and a plurality of openings along a length of the hollow' tube at the distal end.
  • the method also includes providing a hyperthermic mtraperitoneal chemotherapy fluid into the peritoneal cavity of the patient via the plurality of openings.
  • FIG. 1 illustrates a cross-sectional view' of a memory catheter, in accordance with various aspects of the disclosure.
  • FIG. 2 illustrates a memory catheter in use in a patient cavity, in accordance with various aspects of the disclosure.
  • FIG. 3 illustrates a cross-sectional perspective view' of a length of a hollow tube of a memory' catheter with openings, during introduction of a medical fluid through the openings, in accordance with various aspects of the disclosure.
  • FIG. 4 illustrates a cross-sectional perspective view of a length of a hollow tube of a memory catheter with openings, during removal of a medical fluid through the openings, in accordance with various aspects of the disclosure.
  • FIG. 5 illustrates a cross-sectional view of a portion of a memory catheter having a memory' support member embedded within catheter tubing, in accordance with various aspects of the disclosure.
  • FIG. 6 illustrates a cross-sectional view' of a portion of a memory catheter having a memory support member disposed on an external surface of catheter tubing, in accordance with various aspects of the disclosure.
  • FIG. 7 illustrates a cross-sectional view of a portion of a memory catheter having a memory support member disposed on an inner surface of catheter tubing, in accordance with various aspects of the disclosure.
  • FIGS. 8-12 illustrate a memory catheter during various stages of insertion into a patient cavity, m accordance with various aspects of the disclosure.
  • FIG. 13 illustrates a fully inserted memory catheter during administration of fluids, in accordance with various aspects of the disclosure.
  • FIG. 14 illustrates a cross-sectional view of a single-branch memory catheter, in accordance with various aspects of the disclosure.
  • FIG 15 illustrates a cross-sectional view of another single-branch memory catheter, in accordance with vari ous aspects of the disclosure.
  • FIG 16 is a flow chart of illustrative operations that can be performed for Hyperthermic Intraperitoneal Chemotherapy (H1PEC) using a memory catheter, in accordance with various aspects of the disclosure.
  • H1PEC Hyperthermic Intraperitoneal Chemotherapy
  • not all of the depicted components in each figure may be required, and one or more implementations may include additional components not shown in a figure. Variations in the arrangement and type of the components may be made without departing from the scope of the subject disclosure. Additional components, different components, or fewer components may be utilized within the scope of the subject disclosure.
  • a memory catheter may have a hollow tube and a memory support structure for the hollow tube that curves the hollow tube into a desired shape for a particular procedure.
  • An input port is provided at a proximal end of the hollow tube, and one or more openings are provided at a distal end of the hollow tube.
  • the hollow tube may have multiple distal ends on multiple braches.
  • a memory catheter can be inserted laparoscopicaliy into a patient cavity and placed into a desired location in the patient cavity using, at least in part, a memory configuration of the memory catheter.
  • a medical fluid can then be introduced into the desired location in the patient cavity via the openings at the distal end of the tube m that location.
  • FIG. 1 shows a memory catheter in cross-section, in accordance with aspects of the invention.
  • a memory catheter 100 is provided that includes a hollow tube 102 with a proximal end 105 and multiple distal ends 107.
  • Memory ' catheter 100 also includes a memory' support structure 114 that controls a shape of hollow tube 102.
  • memory catheter 100 also includes openings 118 along a portion (e.g., a length 1 15) of the hollow tube102 at each of distal ends 107 to facilitate the distribution or uptake of a medical fluid such as a chemotherapy fluid within a patient.
  • Hollow tube 102 may be a contiguous hollow ' tube that is shaped by memory' support structure 114, rather than (for example) a multi-piece tubing set with transition pieces such as elbow ' pieces, to allow more flexibility ' during insertion and better flow of fluids therethrough.
  • Memory support structure 114 may be formed from a shape memory material and may be coupled to hollow tube 102 such that, in a least the first memory configuration that is illustrated in FIG. 1, memory support structure 1 14 curves hollow' tube 102 into a C-shape.
  • hollow tube 102 includes a first branch 106 and a second branch 108, each extending in opposing directions from a proximal portion 103 of hollow' tube 102.
  • each of branches 106 and 108 in the configuration of FIG. 1 includes a portion of a lumen 104 that forms the hollow' portion of hollow' tube 102.
  • lumen 104 extends from an input port at proximal portion 103 and splits at a first curve 110 m each of branches 106 and 108, extending to the distal ends 107 of both branches 106 and 108.
  • openings 118 can extend from lumen 104 through to the exterior surface of tube 102.
  • Lumen 104 can extend to the distal ends 107, as indicated, such that fluid can flow directly into and/or out of the distal ends 107 in addition to openings 118, or distal ends 107 can be closed so that fluid only flows into and/or out of lumen 104 through openings 118.
  • each of branches 106 and 108 includes a second curve 112 that, in combination, generate the C-shape of hollow tube 102.
  • each of curves 112 is a soft ninety-degree curve between substantially perpendicular straight portions of the tube.
  • the curvature that forms the C-shape for hollow tube 102 can be achieved with a curve that achieves about a ninety-degree change in direction, but over a longer portion of the tube than that shown in the FIG. 1 and/or a curve that is not ninety degrees.
  • curves 112 can extend along any portion of tube 102 including, in one example, from curves 110 all the way to distal ends 107 such that hollow tube 102 does not include any straight portions.
  • the C-shaped configuration of hollow tube 102 may be a memory configuration of the tube.
  • a memory configuration may be a configuration that memory' support structure 114 is programmed to return to following a deformation to a second configuration.
  • Memory' support structure 114 may be programmed to return to a C-shaped configuration (e.g., the configuration shown in FIG. 1) from a second configuration at any temperature, or responsive to a change in temperature.
  • the second configuration can be a second memory configuration that is a stable configuration that can be maintained without application of an external force, or can be another configuration that is not a memory configuration (e.g., a configuration that is unstable and from which memory support structure 1 14 will return to the memory configuration of FIG. 1 without application of external forces).
  • hollow tube 102 and memory support structure 1 14 can be deformed from the memory configuration shown in FIG. 1 to a second configuration in which bends 1 10 and 112 are straightened, and in which both of branches 106 and 108 are linear and parallel for insertion through a port in a trocar.
  • memory support structure 114 may return to the memory configuration of FIG. 1 to cause hollow tube 102 to return to a C- shape within a patient cavity.
  • Memory support structure 114 may be formed from any suitable shape memory material, such as a shape-memory polymer (e.g., a polyurethane polymer including inorganic polydimethylsiloxane (PDMS) segments) or a shape-memory metal (e.g., a shape-memory alloy such as nickel-titanium), that can be programmed to be stable m at least the C-shaped configuration.
  • a shape-memory polymer e.g., a polyurethane polymer including inorganic polydimethylsiloxane (PDMS) segments
  • PDMS polydimethylsiloxane
  • a shape-memory metal e.g., a shape-memory alloy such as nickel-titanium
  • Hollow tube 102 may be formed from a biocompatible, flexible polymeric material such as polyethylene glycol (PEG).
  • the biocompatible, flexible polymeric material of hollow tube 102 may be a non-memory material such that the shape memory behavior of memory catheter 100 is provided by memory support structure 114, or the biocompatible, flexible polymeric material may have shape memory features (e.g., to provide the shape memory' behavior of memory catheter 100 m combination with memory support structure 114 or without the need for a separate shape memory' structure).
  • memory' support structure 114 is attached to a surface of hollow' tube 102.
  • memory' support structure 114 is embedded within the polymeric material of hollow tube 102 (e.g., to prevent exposure to the patient).
  • Hollow' tube 102 may have a total length (e.g., between distal ends 107 along the length of the tube) of between about fifteen centimeters and about forty-five centimeters.
  • the portions 115 of hollow tube 102 at each distal end 107 i.e., the portions that include openings118
  • openings 118 may be provided along the entire length of hollow' tube 102 or along any contiguous or non-contiguous portion of hollow tube 102.
  • Openings 1 18 may be uniformly' distributed on hollow' tube 102, or may be formed in groups or along one or more sides of hollow tube 102 (e.g., to cause fluid to be dispersed in desired direction or at a desired location from memory catheter 100.
  • FIG. 2 illustrates memory catheter 100 in use during a laparoscopic HIPEC procedure.
  • memory catheter 100 may be compatible with any of various commercially available multi-port trocars such as trocar 200 having ports 202, 204, and 208.
  • the memory catheters disclosed herein allow one patient port to be used for two catheters (e.g., a fluid-input catheter in a first trocar port and a fluid- removal catheter in a second trocar port), as compared with other operational scenarios in which two separate trocars (and two separate incisions) are provided, one for each of two catheters.
  • a C-shaped memory catheter 100 can be inserted into a peritoneal cavity of a patient 201 via a trocar port 202 such that proximal portion 103 is exposed external to port 202 and branches 106 and 108 are disposed respectively in thoracic and pelvic locations to ensure even chemotherapy distribution in the laparoscopic HIPEC procedure.
  • memory catheter 100 can help ensure that the entire peritoneal cavity is exposed to chemotherapy, while reducing or eliminating the conventional need for shaking the patient during the procedure.
  • Memory catheter 100 may be anatomically shaped with a porous basket- type feature having openings 118 at each distal end 107, which can be more effective for introduction, distribution, and/or removal of medical fluids, such as fluids for chemotherapy, to and/or from patient cavities (e.g., as compared to a conventional curled structure of a Tenckhoff catheter, which can also be difficult to place m a desired location through a trocar port.
  • medical fluids such as fluids for chemotherapy
  • trocar 200 is inserted m a single incision port 207, and ports 202, 204, and 208 of trocar 200 may include a port 204 (e.g., about a 5 millimeter port) for a camera 206, an outflow' port 208 (e.g., about a 12 millimeter port) for an outflow catheter, and an inflow port 202 (e.g., about a 5 millimeter port) for an inflow memory' catheter 100 as illustrated.
  • the outflow catheter (not shown in FIG. 2) can be inserted while the inflow' catheter is in place or after the inflow catheter is removed.
  • branches 106 and 108 may be separate inflow and outflow branches of a common memory catheter.
  • FIG. 2 also shows how other surgical instruments such as forceps 210 can be used in combination with memory' catheter 100 during HIPEC procedures.
  • FIGS. 3 and 4 respectively, illustrate outflow' and inflow of a medical fluid, such as a HIPEC fluid, from a portion 115 at distal end 107 of a memory catheter 100.
  • a medical fluid such as a HIPEC fluid can be introduced into a patient cavity such as a pelvic or thoracic portion of a patient peritoneal cavity via fluid flow from openings 118 (as indicated by arrow's 300) and/or a distal end of lumen 104 (as indicated by arrow 302).
  • the medical fluid may be introduced into lumen 104 at an input port at the proximal end 105 of proximal portion 103 and flow' through lumen 104 to openings 1 18.
  • FIG. 3 illustrates outflow' and inflow of a medical fluid, such as a HIPEC fluid, from a portion 115 at distal end 107 of a memory catheter 100.
  • a medical fluid such as a HIPEC fluid can be introduced into a patient cavity such as a pelvi
  • a medical fluid such as a HIPEC fluid can be removed from a patient cavity such as a pelvic or thoracic portion of a patient peritoneal cavity via fluid flow into openings 1 18 (as indicated by- arrows 400) and/or a distal end of lumen 104 (as indicated by arrow' 402).
  • memor catheters 100 can be adapted for inflow and/or outflow of chemotherapy agents (e.g., fluid, gas, mist, etc.).
  • chemotherapy agents e.g., fluid, gas, mist, etc.
  • memory' catheters 100 may be provided that are sized and shaped for inflow of a medical fluid.
  • An inflow memory catheter 100 may have a cross-sectional diameter in a range from 1 about millimeter (mm) to about 10 mm, and may have an overall length of between about 15 centimeters (cm) and about 45 cm.
  • the distal end(s) 107 of an inflow memory catheter 100 may include openings 118 (e.g., holes) distributed along approximately the distal 5 cm to 15 cm (e.g., portions 115).
  • an outflow' memory catheter 100 may have a cross-sectional diameter of between about 10 mm and about 20 mm.
  • the outflow memory catheter 100 may have an overall length (e.g., between distal ends 107 along the length of hollow tube 102) of between about 15 cm and about 45 cm.
  • the distal end(s) 107 of the outflow' memory catheter 100 may include openings 118 (e.g., holes) distributed along approximately the distal 5 cm to 20 cm of the hollow' tube (e.g., portions 115).
  • FIG. 5 shows a lateral cross section of memory catheter 100 along a diameter of hollow' tube 102, in the configuration in which memory support structure 1 14 is embedded in the polymer material of hollow tube 102.
  • memory support structure 114 may be a strip of shape memory' material such as a memory' metal strip or a strip of any other material which can achieve a memory' function.
  • the memory function of the strip of memory material places the hollow' tube into at least one memory' configuration with a shape that approximates a“C” (e.g., an arcuate shape, a partial ring shape, etc.).
  • memory support structure 114 may be a rod embedded within the polymer of hollow tube 102 and having a round, square, or other cross-sectional shape that does not follow the curvature of hollow' tube 102.
  • memory support structure 114 may alternatively be attached to an exterior surface 600 of hollow' tube 102 as shown in FIG 6, or to an internal surface 700 (within lumen 104) as shown in FIG 7.
  • Memory support structure 114 can be attached to external surface 600 or internal surface 700 using a biocompatible adhesive or can be otherwise attached (e.g., by ultrasonic welding or other procedures) to a surface of hollow tube 102.
  • Embedding memory' support structure 114 within the material of hollow' tube 102 prevents exposure of patient tissues to shape memory materials and prevents exposure of the shape memor materials to medical fluids.
  • Memory support structure 1 14 is deformable to a second configuration that is different from the first memor configuration illustrated in FIGS. 1 and 2, to facilitate insertion of memory catheter 100 into a port 202 in a trocar 200 for insertion into a patient cavity.
  • FIGS. 8-12 show various stages of deformation of memory catheter 100 during insertion of memory' catheter 100 through a port in a trocar 200.
  • memory catheter 100 has been deformed from the memory' configuration shown m FIGS. 1 and 2, to a substantially linear configuration in which branches 106 and 108 have been straightened for insertion through a port in trocar 200.
  • memory' catheter 100 has been pushed through trocar 200 such that a portion of both of the distal ends 107 is through trocar 200 and memory support structure 110 has caused the distal ends to bend outward forming bends 110 in branches 106 and 108.
  • portions 115 have extended, due to memory support structure 1 14, in substantially opposing directions from trocar 200.
  • memory support structure 114 begins to form curves 112 that form the C- shape of memory catheter 100.
  • proximal portion 103 remains within the port in trocar 200, and branches 106 and 108 are fully beyond trocar 200 (e.g , and within a patient cavity) and have returned to the C-shape of FIGS. 1 and 2 with bends 110 and 1 12 as described above.
  • memory' support structure 114 may cause memory catheter 100 to return to the C-shape of FIG. 12 at room temperature (e.g., between about 50 and about 90 degrees Fahrenheit) and at the temperature of the human body (e.g., between about 95 and about 105 degrees Fahrenheit), or memory support structure 114 may cause memor catheter 100 to have a first memory configuration having the C-shape of FIG.
  • memor ⁇ ' support structure 114 when exposed to the heat in a patient cavity (e.g., when the temperature of memory support structure is at or near the temperature of the human body) and to have a different memory configuration (e.g., the configuration shown in FIG 8) when the memory' support structure 114 is at a different temperature (e.g., a temperature higher or lower than between about 95 and about 105 degrees Fahrenheit).
  • memor ⁇ ' support structure 114 may be heated to approximately 100 degrees Fahrenheit (F) to allow deformation to the configuration of FIG. 8 and may return to the configuration of FIG. 12 (e.g., as illustrated m FIGS. 9-11) as the memor ⁇ ' support structure cools to the about 98.6 degree (F) internal temperature of the human body.
  • an external fluid line 1302 can be connected via a connector 1300 to proximal portion 103.
  • a medical fluid such as a HIPEC fluid can be introduced from external fluid line 1302 into proximal portion 103.
  • the medical fluid flows within the lumen 104 (not shown in FIG. 13) of memory catheter 100 and out through openings 118 as indicated by arrows 1305 to facilitate the distribution or uptake of the medical fluid within a patient.
  • each memor ⁇ ' catheter 100 (e.g., whether implemented as an inflow memory catheter or an outflow memory catheter) is a C-shaped catheter having two branches 106 and 108 for introduction and removal of a medical fluid from the pelvic and thoracic regions of the peritoneal cavity (e.g., at the same time).
  • a memory' catheter having a memory support structure and distal openings can be provided with more than two branches, or with a single branch.
  • FIGS. 14 and 15 show examples, respectively, of an inflow memory catheter 100 A and an outflow memory catheter 100B.
  • each of inflow memory catheter 100A and outflow memory catheter 100B have a single branch (e.g., branches 106 and 108 respectively).
  • Inflow memory catheter 100A and outflow memory catheter 1003B can be used in two ports of a trocar (e.g., ports 202 and 208) simultaneously, such that a medical fluid flows into a patient cavity via the openings 118 in branch 106 of inflow memory catheter 100A, and is removed via openings 118 in branch 108 of outflow memory' catheter 100B.
  • a trocar e.g., ports 202 and 208
  • each of inflow memory catheter 100A and outflow' memory catheter 100B include a memory support structure 1 14 that extends at least partially into proximal portion 103 to cause the hollow tube 102 of each memory catheter to have a first bend 110 and a second bend 1 12 to facilitate placement at a desired location within a patient cavity.
  • FIG. 16 Illustrative operations that may be performed for delivering a medical fluid to a patient cavity using a memory catheter as described herein are shown in FIG. 16.
  • a memory catheter such as memory catheter 100, 100A, or 100B having a memory support structure 114, an input port at a proximal end 105, and a plurality of openings 118 at a distal end 107 is provided.
  • a trocar such as trocar 200 having a port such as port 202, 204, or 208 is provided in a patient incision.
  • the memory catheter 100 is inserted into patient peritoneal cavity via the port (e.g., port 202), the memory support structure 114 causing the memory catheter 100 to form a C-shape in the patient peritoneal cavity (see, e.g., FIGS. 1 and 2).
  • the memory support structure 114 changes shape and curves a hollow tube 102 of the memory catheter into the C-shape within the peritoneal cavity.
  • the C-shape may have a (e.g., first) branch 108 in a pelvic portion of the peritoneal cavity and a (e.g., second) branch 106 in a thoracic portion of the peritoneal cavity '.
  • the memory' support structure may be formed from a shape memory' metal embedded within a material of the hollow tube, in some examples.
  • a hyperthermic intraperitonea! chemotherapy fluid may be provided into the patient peritoneal cavity via the openings 118 at the distal end 107 of the memory catheter
  • the hyperthermic intraperitoneal chemotherapy fluid may be removed from the patient peritoneal cavity' via the openings 118 at the distal end 107 of the memory catheter 100 or another memory catheter (e.g., via an additional plurality of openings 118 in outflow memory catheter 100B or another multi-branch C-shape memory catheter)
  • Headings and subheadings, if any, are used for convenience only and do not limit the invention.
  • the word exemplary, or“e.g.,” is used to mean serving as an example or illustration. To the extent that the term include, have, or the like is used, such term is intended to be inclusive m a manner similar to the term comprise as comprise is interpreted when employed as a transitional word in a claim. Relational terms such as first and second and the like may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.
  • phrases such as an aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, an embodiment, the embodiment, another embodiment, some embodiments, one or more embodiments, a configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof and alike are for convenience and do not imply that a disclosure relating to such phrase(s) is essential to the subject technology or that such disclosure applies to all configurations of the subject technology.
  • a disclosure relating to such phrase(s) may apply to all configurations, or one or more configurations.
  • a disclosure relating to such phrase(s) may provide one or more examples.
  • a phrase such as an aspect or some aspects may refer to one or more aspects and vice versa, and this applies similarly to other of the foregoing phrases.
  • a phrase“at least one of’ preceding a series of items, with the terms“and” or“or” to separate any of the items, modifies the list as a whole, rather than each member of the list.
  • the phrase“at least one of’ does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items.
  • each of the phrases“at least one of A, B, and C” or“at least one of A, B, or C” refers to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
  • a term coupled or the like may refer to being directly coupled. In another aspect, a term coupled or the like may refer to being indirectly coupled.
  • top, bottom, front, rear, side, horizontal, vertical, proximal, distal, and the like refer to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, such a term may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

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Abstract

A memory catheter is disclosed. A memory catheter may include medical tubing having an internal lumen, a memory support structure attached to the medical tubing that causes the medical tubing to have at least one memory configuration shape, and openings at a distal end of the medical tubing that allow fluid to flow from the lumen through the openings. The memory configuration shape may be a C-shape that facilitates providing hyperthermic intraperitoneal chemotherapy.

Description

MEMORY CATHETER
TECHNICAL FIELD
[01] The present description relates in general to surgical tools and methods, and more particularly to, for example and without limitation, memory catheters
BACKGROUND OF THE DISCLOSURE
[02] Hyperthermic Intraperitoneal Chemotherapy (BIFEC) is performed immediately after cytoreduction, and involves circulating heated chemotherapy in the patient’s peritoneal cavity (abdomen) for about 90-120 minutes. The HIPEC procedure is designed to attempt to kill any remaining cancer cells that cannot be seen. The chemotherapy solution is then removed and the incision closed. Patients with peritoneal carcinomatosis or peritoneal cancer, tumors of the appendix or colon, ovarian cancer, uterine cancer, mucinous mtra-abdominal tumors, peritoneal tumors (mesothelioma), and any cancers located in or affecting the abdominal or peritoneal region benefit from HIPEC This procedure can be highly effective for this patient population, which historically has had only several months to live.
[03] At present, laparoscopic HIPEC procedures are clinically challenging. Despite the fact that the procedure can be conducted with just two catheters, that is, an inflow catheter and an outflow catheter, accurate placement and chemotherapy distribution, together with catheter migration prevention remain problematic. Current catheters used for HIPEC are straight, which results in areas of dead space, where chemotherapy does not touch the peritoneal tissue. Extensive shaking of the patient throughout the procedure is commonly used to attempt to drive chemotherapy to these areas. However, patient shaking is time-consuming and can have limited effectiveness in many scenarios.
[04] The description provided in the background section should not be assumed to be prior art merely because it is mentioned in or associated with the background section. The background section may include information that describes one or more aspects of the subject technology. SUMMARY
[05] I he following is a brief summary, not intended to identify specific elements or to delineate the scope thereof. Its sole purpose is to present concepts in a simplified form as a prelude to the more detailed description.
[06] In accordance with various aspects of the disclosure, a memory catheter is provided that includes a hollow tube with a proximal end and a distal end, a memory support structure that controls a shape of the hollow tube, and a plurality of openings along a length of the hollow tube at the distal end.
[07] In accordance with other aspects of the disclosure, a method for providing hyperthermic mtraperitoneal chemotherapy is disclosed, the method includes inserting a memory' catheter into a peritoneal cavity of a patient. The memory' catheter includes a hollow- tube with a proximal end and a distal end, a memory support structure that controls a shape of the hollow' tube, and a plurality of openings along a length of the hollow' tube at the distal end. The method also includes providing a hyperthermic mtraperitoneal chemotherapy fluid into the peritoneal cavity of the patient via the plurality of openings.
BRIEF DESCRIPTION OF THE DRAWINGS
[08] FIG. 1 illustrates a cross-sectional view' of a memory catheter, in accordance with various aspects of the disclosure.
[09] FIG. 2 illustrates a memory catheter in use in a patient cavity, in accordance with various aspects of the disclosure.
[010] FIG. 3 illustrates a cross-sectional perspective view' of a length of a hollow tube of a memory' catheter with openings, during introduction of a medical fluid through the openings, in accordance with various aspects of the disclosure.
[011] FIG. 4 illustrates a cross-sectional perspective view of a length of a hollow tube of a memory catheter with openings, during removal of a medical fluid through the openings, in accordance with various aspects of the disclosure.
[012] FIG. 5 illustrates a cross-sectional view of a portion of a memory catheter having a memory' support member embedded within catheter tubing, in accordance with various aspects of the disclosure. [013] FIG. 6 illustrates a cross-sectional view' of a portion of a memory catheter having a memory support member disposed on an external surface of catheter tubing, in accordance with various aspects of the disclosure.
[014] FIG. 7 illustrates a cross-sectional view of a portion of a memory catheter having a memory support member disposed on an inner surface of catheter tubing, in accordance with various aspects of the disclosure.
[015] FIGS. 8-12 illustrate a memory catheter during various stages of insertion into a patient cavity, m accordance with various aspects of the disclosure.
[016] FIG. 13 illustrates a fully inserted memory catheter during administration of fluids, in accordance with various aspects of the disclosure.
[017] FIG. 14 illustrates a cross-sectional view of a single-branch memory catheter, in accordance with various aspects of the disclosure.
[018] FIG 15 illustrates a cross-sectional view of another single-branch memory catheter, in accordance with vari ous aspects of the disclosure.
[019] FIG 16 is a flow chart of illustrative operations that can be performed for Hyperthermic Intraperitoneal Chemotherapy (H1PEC) using a memory catheter, in accordance with various aspects of the disclosure.
[020] In one or more implementations, not all of the depicted components in each figure may be required, and one or more implementations may include additional components not shown in a figure. Variations in the arrangement and type of the components may be made without departing from the scope of the subject disclosure. Additional components, different components, or fewer components may be utilized within the scope of the subject disclosure.
DETAILED DESCRIPTION
[021] The detailed description set forth below is intended as a description of various implementations and is not intended to represent the only implementations in which the subject technology may be practiced. As those skilled in the art would realize, the described implementations may be modified in various different ways, all without departing from the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.
[022] In accordance with aspects of the subject technology, memory catheters are disclosed herein. A memory catheter may have a hollow tube and a memory support structure for the hollow tube that curves the hollow tube into a desired shape for a particular procedure. An input port is provided at a proximal end of the hollow tube, and one or more openings are provided at a distal end of the hollow tube. In some implementations, the hollow tube may have multiple distal ends on multiple braches.
[023] A memory catheter can be inserted laparoscopicaliy into a patient cavity and placed into a desired location in the patient cavity using, at least in part, a memory configuration of the memory catheter. A medical fluid can then be introduced into the desired location in the patient cavity via the openings at the distal end of the tube m that location.
[024] FIG. 1 shows a memory catheter in cross-section, in accordance with aspects of the invention. As shown in FIG. 1, a memory catheter 100 is provided that includes a hollow tube 102 with a proximal end 105 and multiple distal ends 107. Memory' catheter 100 also includes a memory' support structure 114 that controls a shape of hollow tube 102. As shown, memory catheter 100 also includes openings 118 along a portion (e.g., a length 1 15) of the hollow tube102 at each of distal ends 107 to facilitate the distribution or uptake of a medical fluid such as a chemotherapy fluid within a patient. Hollow tube 102 may be a contiguous hollow' tube that is shaped by memory' support structure 114, rather than (for example) a multi-piece tubing set with transition pieces such as elbow' pieces, to allow more flexibility' during insertion and better flow of fluids therethrough.
[025] Memory support structure 114 may be formed from a shape memory material and may be coupled to hollow tube 102 such that, in a least the first memory configuration that is illustrated in FIG. 1, memory support structure 1 14 curves hollow' tube 102 into a C-shape. In the example C-shape memory configuration shown in FIG. 1 , hollow tube 102 includes a first branch 106 and a second branch 108, each extending in opposing directions from a proximal portion 103 of hollow' tube 102. As shown, each of branches 106 and 108 in the configuration of FIG. 1 includes a portion of a lumen 104 that forms the hollow' portion of hollow' tube 102. In this example, lumen 104 extends from an input port at proximal portion 103 and splits at a first curve 110 m each of branches 106 and 108, extending to the distal ends 107 of both branches 106 and 108. As indicated in FIG. 1, openings 118 can extend from lumen 104 through to the exterior surface of tube 102. Lumen 104 can extend to the distal ends 107, as indicated, such that fluid can flow directly into and/or out of the distal ends 107 in addition to openings 118, or distal ends 107 can be closed so that fluid only flows into and/or out of lumen 104 through openings 118.
[026] In the example of FIG. 1, each of branches 106 and 108 includes a second curve 112 that, in combination, generate the C-shape of hollow tube 102. In this configuration, each of curves 112 is a soft ninety-degree curve between substantially perpendicular straight portions of the tube. However, it should be appreciated that the curvature that forms the C-shape for hollow tube 102 can be achieved with a curve that achieves about a ninety-degree change in direction, but over a longer portion of the tube than that shown in the FIG. 1 and/or a curve that is not ninety degrees. For example, curves 112 can extend along any portion of tube 102 including, in one example, from curves 110 all the way to distal ends 107 such that hollow tube 102 does not include any straight portions.
[027] The C-shaped configuration of hollow tube 102 may be a memory configuration of the tube. A memory configuration may be a configuration that memory' support structure 114 is programmed to return to following a deformation to a second configuration. Memory' support structure 114 may be programmed to return to a C-shaped configuration (e.g., the configuration shown in FIG. 1) from a second configuration at any temperature, or responsive to a change in temperature. The second configuration can be a second memory configuration that is a stable configuration that can be maintained without application of an external force, or can be another configuration that is not a memory configuration (e.g., a configuration that is unstable and from which memory support structure 1 14 will return to the memory configuration of FIG. 1 without application of external forces).
[028] For example, hollow tube 102 and memory support structure 1 14 can be deformed from the memory configuration shown in FIG. 1 to a second configuration in which bends 1 10 and 112 are straightened, and in which both of branches 106 and 108 are linear and parallel for insertion through a port in a trocar. After insertion through the port, memory support structure 114 may return to the memory configuration of FIG. 1 to cause hollow tube 102 to return to a C- shape within a patient cavity.
[029] Memory support structure 114 may be formed from any suitable shape memory material, such as a shape-memory polymer (e.g., a polyurethane polymer including inorganic polydimethylsiloxane (PDMS) segments) or a shape-memory metal (e.g., a shape-memory alloy such as nickel-titanium), that can be programmed to be stable m at least the C-shaped configuration. Hollow tube 102 may be formed from a biocompatible, flexible polymeric material such as polyethylene glycol (PEG). The biocompatible, flexible polymeric material of hollow tube 102 may be a non-memory material such that the shape memory behavior of memory catheter 100 is provided by memory support structure 114, or the biocompatible, flexible polymeric material may have shape memory features (e.g., to provide the shape memory' behavior of memory catheter 100 m combination with memory support structure 114 or without the need for a separate shape memory' structure). In some configurations, memory' support structure 114 is attached to a surface of hollow' tube 102. In other configurations, memory' support structure 114 is embedded within the polymeric material of hollow tube 102 (e.g., to prevent exposure to the patient).
[030] Hollow' tube 102 may have a total length (e.g., between distal ends 107 along the length of the tube) of between about fifteen centimeters and about forty-five centimeters. The portions 115 of hollow tube 102 at each distal end 107 (i.e., the portions that include openings118) may extend from the corresponding distal end 107 (e.g., toward proximal end 105 along the length of the tubing) a distance of between about five centimeters and about twenty centimeters. In another example, openings 118 may be provided along the entire length of hollow' tube 102 or along any contiguous or non-contiguous portion of hollow tube 102. Openings 1 18 may be uniformly' distributed on hollow' tube 102, or may be formed in groups or along one or more sides of hollow tube 102 (e.g., to cause fluid to be dispersed in desired direction or at a desired location from memory catheter 100.
[031] Memory catheter 100 of FIG. 1 can be particularly helpful in laparoscopic HIPEC procedures. FIG. 2 illustrates memory catheter 100 in use during a laparoscopic HIPEC procedure. As shown in FIG. 2, memory catheter 100 may be compatible with any of various commercially available multi-port trocars such as trocar 200 having ports 202, 204, and 208. In this way, in some operational scenarios, the memory catheters disclosed herein allow one patient port to be used for two catheters (e.g., a fluid-input catheter in a first trocar port and a fluid- removal catheter in a second trocar port), as compared with other operational scenarios in which two separate trocars (and two separate incisions) are provided, one for each of two catheters.
[032] As shown in FIG. 2, a C-shaped memory catheter 100 can be inserted into a peritoneal cavity of a patient 201 via a trocar port 202 such that proximal portion 103 is exposed external to port 202 and branches 106 and 108 are disposed respectively in thoracic and pelvic locations to ensure even chemotherapy distribution in the laparoscopic HIPEC procedure. In this way, memory catheter 100 can help ensure that the entire peritoneal cavity is exposed to chemotherapy, while reducing or eliminating the conventional need for shaking the patient during the procedure. Memory catheter 100 may be anatomically shaped with a porous basket- type feature having openings 118 at each distal end 107, which can be more effective for introduction, distribution, and/or removal of medical fluids, such as fluids for chemotherapy, to and/or from patient cavities (e.g., as compared to a conventional curled structure of a Tenckhoff catheter, which can also be difficult to place m a desired location through a trocar port.
[033] In the example of FIG. 2, trocar 200 is inserted m a single incision port 207, and ports 202, 204, and 208 of trocar 200 may include a port 204 (e.g., about a 5 millimeter port) for a camera 206, an outflow' port 208 (e.g., about a 12 millimeter port) for an outflow catheter, and an inflow port 202 (e.g., about a 5 millimeter port) for an inflow memory' catheter 100 as illustrated. The outflow catheter (not shown in FIG. 2) can be inserted while the inflow' catheter is in place or after the inflow catheter is removed. In other examples, branches 106 and 108 may be separate inflow and outflow branches of a common memory catheter. FIG. 2 also shows how other surgical instruments such as forceps 210 can be used in combination with memory' catheter 100 during HIPEC procedures.
[034] FIGS. 3 and 4, respectively, illustrate outflow' and inflow of a medical fluid, such as a HIPEC fluid, from a portion 115 at distal end 107 of a memory catheter 100. As illustrated in FIG. 3, a medical fluid such as a HIPEC fluid can be introduced into a patient cavity such as a pelvic or thoracic portion of a patient peritoneal cavity via fluid flow from openings 118 (as indicated by arrow's 300) and/or a distal end of lumen 104 (as indicated by arrow 302). The medical fluid may be introduced into lumen 104 at an input port at the proximal end 105 of proximal portion 103 and flow' through lumen 104 to openings 1 18. As illustrated in FIG. 4, a medical fluid such as a HIPEC fluid can be removed from a patient cavity such as a pelvic or thoracic portion of a patient peritoneal cavity via fluid flow into openings 1 18 (as indicated by- arrows 400) and/or a distal end of lumen 104 (as indicated by arrow' 402).
[035] Accordingly, memor catheters 100 can be adapted for inflow and/or outflow of chemotherapy agents (e.g., fluid, gas, mist, etc.). For example, memory' catheters 100 may be provided that are sized and shaped for inflow of a medical fluid. An inflow memory catheter 100 may have a cross-sectional diameter in a range from 1 about millimeter (mm) to about 10 mm, and may have an overall length of between about 15 centimeters (cm) and about 45 cm. The distal end(s) 107 of an inflow memory catheter 100 may include openings 118 (e.g., holes) distributed along approximately the distal 5 cm to 15 cm (e.g., portions 115). In another example, an outflow' memory catheter 100 may have a cross-sectional diameter of between about 10 mm and about 20 mm. The outflow memory catheter 100 may have an overall length (e.g., between distal ends 107 along the length of hollow tube 102) of between about 15 cm and about 45 cm. The distal end(s) 107 of the outflow' memory catheter 100 may include openings 118 (e.g., holes) distributed along approximately the distal 5 cm to 20 cm of the hollow' tube (e.g., portions 115).
[036 In the example of memory catheter 100 shown in the top cross-section in FIG. 1, memory support structure 114 is embedded within the material of hollow' tube 102. FIG. 5 shows a lateral cross section of memory catheter 100 along a diameter of hollow' tube 102, in the configuration in which memory support structure 1 14 is embedded in the polymer material of hollow tube 102. As shown in FIG. 5, memory support structure 114 may be a strip of shape memory' material such as a memory' metal strip or a strip of any other material which can achieve a memory' function. The memory function of the strip of memory material places the hollow' tube into at least one memory' configuration with a shape that approximates a“C” (e.g., an arcuate shape, a partial ring shape, etc.). The strip of material shown in FIG. 5 is curved along the curvature of hollow tube 1 02 and extends partially around the circumference of hollow' tube 102. However, this is merely illustrative and other configurations of memory support structure 1 14 can be used without departing from the spirit of the invention. For example, memory support structure 114 may be a rod embedded within the polymer of hollow tube 102 and having a round, square, or other cross-sectional shape that does not follow the curvature of hollow' tube 102.
[037] Moreover, memory support structure 114 may alternatively be attached to an exterior surface 600 of hollow' tube 102 as shown in FIG 6, or to an internal surface 700 (within lumen 104) as shown in FIG 7. Memory support structure 114 can be attached to external surface 600 or internal surface 700 using a biocompatible adhesive or can be otherwise attached (e.g., by ultrasonic welding or other procedures) to a surface of hollow tube 102. Embedding memory' support structure 114 within the material of hollow' tube 102 prevents exposure of patient tissues to shape memory materials and prevents exposure of the shape memor materials to medical fluids.
[038] Memory support structure 1 14 is deformable to a second configuration that is different from the first memor configuration illustrated in FIGS. 1 and 2, to facilitate insertion of memory catheter 100 into a port 202 in a trocar 200 for insertion into a patient cavity. FIGS. 8-12 show various stages of deformation of memory catheter 100 during insertion of memory' catheter 100 through a port in a trocar 200.
[039] In the example of FIG. 8, memory catheter 100 has been deformed from the memory' configuration shown m FIGS. 1 and 2, to a substantially linear configuration in which branches 106 and 108 have been straightened for insertion through a port in trocar 200.
[040] In the example of FIG. 9, memory' catheter 100 has been pushed through trocar 200 such that a portion of both of the distal ends 107 is through trocar 200 and memory support structure 110 has caused the distal ends to bend outward forming bends 110 in branches 106 and 108. As memory catheter 100 is inserted further through trocar 200 as illustrated in FIG. 10, portions 115 have extended, due to memory support structure 1 14, in substantially opposing directions from trocar 200.
[041] As memory'· catheter 100 is inserted still further through trocar 200 as illustrated in FIG. I I, memory support structure 114 begins to form curves 112 that form the C- shape of memory catheter 100. In the example of FIG. 12, only proximal portion 103 remains within the port in trocar 200, and branches 106 and 108 are fully beyond trocar 200 (e.g , and within a patient cavity) and have returned to the C-shape of FIGS. 1 and 2 with bends 110 and 1 12 as described above.
[042] As described above, memory' support structure 114 may cause memory catheter 100 to return to the C-shape of FIG. 12 at room temperature (e.g., between about 50 and about 90 degrees Fahrenheit) and at the temperature of the human body (e.g., between about 95 and about 105 degrees Fahrenheit), or memory support structure 114 may cause memor catheter 100 to have a first memory configuration having the C-shape of FIG. 12 when exposed to the heat in a patient cavity (e.g., when the temperature of memory support structure is at or near the temperature of the human body) and to have a different memory configuration (e.g., the configuration shown in FIG 8) when the memory' support structure 114 is at a different temperature (e.g., a temperature higher or lower than between about 95 and about 105 degrees Fahrenheit). In one example, memor}' support structure 114 may be heated to approximately 100 degrees Fahrenheit (F) to allow deformation to the configuration of FIG. 8 and may return to the configuration of FIG. 12 (e.g., as illustrated m FIGS. 9-11) as the memor}' support structure cools to the about 98.6 degree (F) internal temperature of the human body.
[043] As illustrated in FIG. 13, once branches 106 and 108 of memory catheter 100 have been fully inserted through trocar 200 and are disposed in desired locations in a patient cavity (e.g., as illustrated in FIG. 2), an external fluid line 1302 can be connected via a connector 1300 to proximal portion 103. As indicated by arrow 1303, a medical fluid such as a HIPEC fluid can be introduced from external fluid line 1302 into proximal portion 103. The medical fluid flows within the lumen 104 (not shown in FIG. 13) of memory catheter 100 and out through openings 118 as indicated by arrows 1305 to facilitate the distribution or uptake of the medical fluid within a patient.
[044] In the examples of FIGS. I, 2, and 8-13, each memor}' catheter 100 (e.g., whether implemented as an inflow memory catheter or an outflow memory catheter) is a C-shaped catheter having two branches 106 and 108 for introduction and removal of a medical fluid from the pelvic and thoracic regions of the peritoneal cavity (e.g., at the same time). However, in other examples, a memory' catheter having a memory support structure and distal openings can be provided with more than two branches, or with a single branch.
[045] For example, FIGS. 14 and 15 show examples, respectively, of an inflow memory catheter 100 A and an outflow memory catheter 100B. In the examples of FIGS. 14 and 1 5, each of inflow memory catheter 100A and outflow memory catheter 100B have a single branch (e.g., branches 106 and 108 respectively). Inflow memory catheter 100A and outflow memory catheter 1003B can be used in two ports of a trocar (e.g., ports 202 and 208) simultaneously, such that a medical fluid flows into a patient cavity via the openings 118 in branch 106 of inflow memory catheter 100A, and is removed via openings 118 in branch 108 of outflow memory' catheter 100B. In the examples of FIGS. 14 and 15, each of inflow memory catheter 100A and outflow' memory catheter 100B include a memory support structure 1 14 that extends at least partially into proximal portion 103 to cause the hollow tube 102 of each memory catheter to have a first bend 110 and a second bend 1 12 to facilitate placement at a desired location within a patient cavity. [046] Illustrative operations that may be performed for delivering a medical fluid to a patient cavity using a memory catheter as described herein are shown in FIG. 16.
[047] At block 1600, a memory catheter such as memory catheter 100, 100A, or 100B having a memory support structure 114, an input port at a proximal end 105, and a plurality of openings 118 at a distal end 107 is provided.
[048] At block 1602, a trocar such as trocar 200 having a port such as port 202, 204, or 208 is provided in a patient incision.
[049] At block 1604, the memory catheter 100 is inserted into patient peritoneal cavity via the port (e.g., port 202), the memory support structure 114 causing the memory catheter 100 to form a C-shape in the patient peritoneal cavity (see, e.g., FIGS. 1 and 2). As the memory catheter is inserted into the patient peritoneal cavity, the memory support structure 114 changes shape and curves a hollow tube 102 of the memory catheter into the C-shape within the peritoneal cavity. The C-shape may have a (e.g., first) branch 108 in a pelvic portion of the peritoneal cavity and a (e.g., second) branch 106 in a thoracic portion of the peritoneal cavity'. The memory' support structure may be formed from a shape memory' metal embedded within a material of the hollow tube, in some examples.
[050] At block 1606, a hyperthermic intraperitonea! chemotherapy fluid may be provided into the patient peritoneal cavity via the openings 118 at the distal end 107 of the memory catheter
[051] At block 1608, the hyperthermic intraperitoneal chemotherapy fluid may be removed from the patient peritoneal cavity' via the openings 118 at the distal end 107 of the memory catheter 100 or another memory catheter (e.g., via an additional plurality of openings 118 in outflow memory catheter 100B or another multi-branch C-shape memory catheter)
[052] A reference to an element in the singular is not intended to mean one and only one unless specifically so stated, but rather one or more. For example,“a” module may refer to one or more modules. An element proceeded by“a,”“an,”“the,” or“said” does not, without further constraints, preclude the existence of additional same elements.
[053] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word exemplary, or“e.g.,” is used to mean serving as an example or illustration. To the extent that the term include, have, or the like is used, such term is intended to be inclusive m a manner similar to the term comprise as comprise is interpreted when employed as a transitional word in a claim. Relational terms such as first and second and the like may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.
[054] Phrases such as an aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, an embodiment, the embodiment, another embodiment, some embodiments, one or more embodiments, a configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof and alike are for convenience and do not imply that a disclosure relating to such phrase(s) is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. A disclosure relating to such phrase(s) may apply to all configurations, or one or more configurations. A disclosure relating to such phrase(s) may provide one or more examples. A phrase such as an aspect or some aspects may refer to one or more aspects and vice versa, and this applies similarly to other of the foregoing phrases.
[055] A phrase“at least one of’ preceding a series of items, with the terms“and” or“or” to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase“at least one of’ does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, each of the phrases“at least one of A, B, and C” or“at least one of A, B, or C” refers to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
[056] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary approaches. Unless explicitly stated otherwise, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in different order. Some of the steps, operations, or processes may be performed simultaneously . The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented. These may be performed in serial, linearly, in parallel or in different order it should be understood that the described instructions, operations, and systems can generally be integrated together in a single software/hardware product or packaged into multiple software/hardware products.
[057] In one aspect, a term coupled or the like may refer to being directly coupled. In another aspect, a term coupled or the like may refer to being indirectly coupled.
[058] Terms such as top, bottom, front, rear, side, horizontal, vertical, proximal, distal, and the like refer to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, such a term may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
[059] The disclosure is provided to enable any person skilled m the art to practice the various aspects described herein. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.
[060] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C §112, sixth paragraph, unless the element is expressly recited using the phrase“means for” or, in the case of a method claim, the element is recited using the phrase“step for”.
[061] The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and the various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the claims reflect, inventive subject matter lies m less than all features of a single disclosed configuration or operation. The claims are hereby incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.
[062] The claims are not intended to be limited to the aspects described herein, hut are to be accorded the full scope consistent with the language of the claims and to encompass all legal equivalents. Notwithstanding this, none of the claims are intended to embrace subject matter that fails to satisfy the requirements of the applicable patent lawr, nor should they be interpreted in such a way.

Claims

WHAT IS CLAIMED IS:
1. A memor catheter comprising:
a hollow tube with a proximal end and a distal end;
a memory support structure that controls a shape of the hollow' tube; and
a plurality of openings along a length of the hollow' tube at the distal end.
2. The memory' catheter of claim 1, wherein the plurality of openings extend from a lumen within the hollow tube to an exterior surface of the hollow tube.
3. The memory' catheter of claim 1, wherein the memory support structure comprises a shape memory material coupled to the hollow tube that, m a least a first memory' configuration, curves the hollow- tube into a C-shape.
4. The memory catheter of claim 3, wherein, in the C-shape, the hollow' tube comprises a first branch and a second branch, each extending in opposing directions from a proximal portion of the hollow tube, and each comprising a portion of a lumen that extends from an input port at the proximal portion.
5. The memory' catheter of claim 3, wherein the memory' support structure is deformable to a second configuration that is different from the first memory configuration to facilitate insertion of the memory catheter into a port in a trocar for insertion into a patient cavity.
6. The memory catheter of claim 5, wherein the memory support structure is configured to return to the first memory configuration, after deformation to the second configuration and after insertion through the port, without application of an external force.
7. The memory- catheter of claim 6, wherein the memory support structure is configured to return to the first memory configuration responsive to exposure to heat within the patient cavity.
8. The memory catheter of claim 3, wherein the shape memory material comprises a shape memory metal.
9. The memory catheter of claim 1, wherein the hollow tube is formed from a
biocompatible, polymeric material.
10. The memory catheter of claim 9, wherein the memory support structure is embedded within the biocompatible, polymeric material.
11. The memory' catheter of claim 1, wherein the memory support structure is formed on an exterior surface of the hollow tube.
12. The memory catheter of claim 1, wherein the memory' support structure is disposed on a surface of an internal lumen within the hollow tube.
13. The memory' catheter of claim 1 , wherein the hollow' tube has a total length of between about fifteen centimeters and about forty-five centimeters.
14. The memory catheter of claim 13, wherein the length of the hollow tube at the distal end that includes the plurality of openings extends from the distal end a distance of between about five centimeters and about twenty centimeters.
15. The memory catheter of claim 1, wherein the hollow tube has a cross-sectional diameter of between about one millimeter and about twenty millimeters.
16. The memory catheter of claim 1 , wherein the memory catheter comprises a C- shape memory catheter configured for hyperthermic mtraperitoneal chemotherapy.
17. A method for providing hyperthermic intraperitoneal chemotherapy, the method comprising:
inserting a memory catheter into a peritoneal cavity of a patient, the memory catheter comprising:
a hollow tube with a proximal end and a distal end,
a memory support structure that controls a shape of the hollow tube, and a plurality of openings along a length of the hollow tube at the distal end; and providing a hyperthermic intraperitoneal chemotherapy fluid into the peritoneal cavity- of the patient via the plurality- of openings.
18. The method of claim 17, wherein, as the memory catheter is inserted into the peritoneal cavity, the memory- support structure changes shape and curves the hollow- tube into a C-shape within the peritoneal cavity, the C-shape having a first branch in a pelvic portion of the peritoneal cavity and a second branch in a thoracic portion of the peritoneal cavity.
19. The method of claim 18, wherein the memory support structure comprises a shape memory- metal embedded within a material of the hollow tube.
20. The method of claim 19, further comprising removing the hyperthermic intraperitoneal chemotherapy fluid from the peritoneal cavity of the patient via the plurality of openings of the hollow tube or via an additional plurality of openings m an additional hollow tube of an additional memory catheter.
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Cited By (1)

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