US20200206481A1 - Methods for delivery of therapeutic materials to treat cancer - Google Patents
Methods for delivery of therapeutic materials to treat cancer Download PDFInfo
- Publication number
- US20200206481A1 US20200206481A1 US16/685,950 US201916685950A US2020206481A1 US 20200206481 A1 US20200206481 A1 US 20200206481A1 US 201916685950 A US201916685950 A US 201916685950A US 2020206481 A1 US2020206481 A1 US 2020206481A1
- Authority
- US
- United States
- Prior art keywords
- catheter
- bile duct
- port
- occluder
- lumen
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
- A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2210/00—Anatomical parts of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1042—Alimentary tract
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/30—Blood pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
Abstract
Disclosed is a localized method for treatment of cancer including the steps of providing a drug delivery catheter; navigating the catheter to the bile duct; and delivering a therapeutic agent into the bile duct. According to one aspect of the method, the drug delivery catheter is a multi-occlusion balloon catheter. The multi-occlusion balloon catheter may include at least two balloons. The multi-occlusion balloon catheter may optionally include a pressure transducer between the balloons to optimize delivery technique.
Description
- This application is a continuation of U.S. application Ser. No. 15/351,922, filed Nov. 15, 2016, which is a continuation-in-part of U.S. application Ser. No. 14/958,415, filed Dec. 3, 2015, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 14/870,833, filed Sep. 30, 2015, now U.S. Pat. No. 9,463,304, which is a continuation of U.S. patent application Ser. No. 14/293,603, filed Jun. 2, 2014, now U.S. Pat. No. 9,457,171, which claims priority to and the benefit U.S. Provisional Patent Application No. 61/830,218, filed Jun. 3, 2013, and which is also a continuation-in-part of U.S. patent application Ser. No. 12/958,711, filed Dec. 2, 2010, now U.S. Pat. No. 8,821,476, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/265,845, filed Dec. 2, 2009, each of the disclosures of which is incorporated herein by reference in its entirety.
- The embodiments described herein relate generally to methods for delivering a therapeutic material to treat pancreatic cancer.
- Pancreatic cancer is considered an almost chemoresistant tumor. The ineffective result of systemic chemotherapy is at least in part due to an insufficient drug concentration within the tumor because of dose-limited toxicity in bone marrow and epithelial tissue. Since systemic chemotherapy is limited its effectiveness, localized therapy can be desirable for advanced pancreatic cancer patients. For example, one such treatment can include local intra-arterial delivery of chemotherapy. Intra-arterial infusion allows higher drug concentration to reach the tumor, overcoming the problem of poor blood flow to tumor mass in comparison to healthy tissue. Furthermore, intra-arterial chemotherapy can also take advantage of the first pass effect of chemotherapeutics, generating higher-level drug concentrations at the tumor cell membrane and therefore, enhancing cellular drug uptake as compared to intravenous infusion. Lastly, local delivery can reduce systemic side effects.
- Such a chemotherapy treatment is usually administered through catheters placed in the celiac/hepatic artery or portal vein, however, a best mode of catheter placement has yet to be established. The tumor response rates of pancreatic arterial infusion chemotherapy can range widely, for example, from 7% to 65%, at least in part due to efficacy of drug delivery where anticancer drugs were administered via the celiac artery without assessment of drug distribution. Thus, a need exists for improved methods for delivering a treatment such as a biologic agent and/or drug formation to target tissue of the pancreas, as well as hepatic tumors and cholangiocarinoma.
- Disclosed is a localized method for treatment of cancer, comprising the steps of:
- providing a drug delivery catheter; navigating the catheter to the bile duct; delivering a therapeutic agent into the bile duct.
- According to one aspect of the aforementioned method, wherein the drug delivery catheter is a multi-occlusion balloon catheter. The multi-occlusion balloon catheter may comprise at least two balloons. The multi-occlusion balloon catheter may optionally include a pressure transducer between the balloons to optimize delivery technique.
- According to one aspect of the aforementioned method, the therapeutic agent is selected from the group (5-fluorouracil (5-FU), Aldesleukin, Axitinib, Bleomycin, Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, doxorubicin liposomal non-pegylated (un-coated), doxorubicin liposomal pegylated (PEG coated), Floxuridine, Gemcitabine Hydrochloride, Irinotecan Hydrochloride Liposome, Lanreotide Acetate, leucovorin (antidote to folic acid antagonist used with 5FU), Methotrexate, Mitomycin, Mitoxantrone, Nivolumab, Olaparib, Oxaliplatin, Sorafenib Tosylate, Temsirolimus, Thiotepa, Topotecan Hydrochloride, Vinblastine Sulfate, vincristine sulfate).
- According to one aspect of the aforementioned method, the navigating step includes navigating the catheter using ERCP.
- According to one aspect of the aforementioned method, the navigating step includes navigating the catheter to the bile duct percutaneously.
- According to one aspect of the aforementioned method, the localized method is used to treat pancreatic cancer.
- According to one aspect of the aforementioned method, the localized method is used to treat at least one of hepatic tumors and cholangiocarinoma.
-
FIG. 1 is an illustration of a pancreas and related structure in a human; -
FIGS. 2 and 3 are schematic illustrations of a multi-occlusion catheter insertion device according to an embodiment, in a first configuration and a second configuration, respectively; -
FIG. 4 is a side view of a multi-occlusion catheter insertion device according to an embodiment, shown in a dilated configuration; -
FIG. 5 is a side view of a portion of the multi-occlusion catheter insertion device of -
FIG. 4 ; and -
FIGS. 6-11 are each a cross-sectional view of a different portion of the multi-occlusion catheter insertion device ofFIG. 4 , taken along lines 6-6, 7-7, 8-8, 9-9, 10-10, and 11-11, respectively, inFIG. 5 . -
FIG. 12 is a side view of a multi-occlusion catheter insertion device according to an embodiment. -
FIG. 13 is a side view of a portion of the multi-occlusion catheter insertion device ofFIG. 12 . -
FIGS. 14-19 are each a cross-sectional view of a different portion of the multi-occlusion catheter insertion device taken along lines 14-14, 15-15, 16-16, 17-17, 18-18, and 19-19, respectively, inFIG. 13 . -
FIG. 20 is a top view of a multi-occlusion catheter insertion device according to an embodiment, in a first configuration. -
FIG. 21 is a side view of a handle included in the multi-occlusion catheter insertion device ofFIG. 20 . -
FIG. 22 is a top view of a handle included in the multi-occlusion catheter insertion device ofFIG. 20 . -
FIG. 23 is an enlarged cross-sectional view of a portion of the handle ofFIG. 21 , indicated by the region X1 and taken along the line 23-23 inFIG. 22 . -
FIG. 24 is a cross-sectional view of a portion of the multi-occlusion catheter insertion device ofFIG. 20 , taken along the line 24-24. -
FIG. 25 is an enlarged cross-sectional view of a portion of the handle ofFIG. 21 , indicated by the region X2 and taken along the line 25-25 inFIG. 22 . -
FIG. 26 is a cross-sectional view of a portion of the multi-occlusion catheter insertion device ofFIG. 20 , taken along the line 26-26. -
FIG. 27 is a cross-sectional view of a portion of the multi-occlusion catheter insertion device ofFIG. 20 , taken along the line 27-27. -
FIG. 28 is a cross-sectional view of a portion of the multi-occlusion catheter insertion device ofFIG. 20 , taken along the line 28-28. -
FIG. 29 is a top view of the multi-occlusion catheter insertion device ofFIG. 20 in a second configuration. -
FIG. 30 is an illustration of a portion of the multi-occlusion catheter insertion device of -
FIG. 20 in use within a portion of a body. -
FIG. 31 is a flowchart illustrating a method for treating the pancreas, according to an embodiment. - Methods described herein can be used, for example, for the insertion and manipulation of a multi-occlusion catheter device to deliver a therapeutic agents to the bile duct for treatment of pancreatic cancer or other localized cancer. Tumors localized around the bile duct (cancer of the pancreatic head, primary and secondary liver tumors, and cholangiocarcinoma) may benefit from localized delivery through the bile duct itself. The bile duct can be exogenously accessed through an endoscopic retrograde cholangiopancreatogram (ERCP) catheter, one can envision delivery of a double balloon catheter into the bile duct using established ERCP technique. After localizing the double balloon catheter to the area of bile duct involved/adjacent to the tumor, that area of bile duct is isolated by inflating the two balloon elements. Chemotherapeutic elements are then infused between the two balloons. By increasing the pressure between two balloon elements to exceed the interstitial tissue pressure, in a diffusion dependent manner, the chemotherapeutic agent will then diffuse out the wall of the bile duct and into the tissue.
- By monitoring and/or adjusting the pressure between the balloons, one can change the penetration depth of the chemotherapy into the tissue.
- According to some embodiments, a therapeutic material for treatment of pancreatic cancer or other localized cancer is delivered into the bile duct using the multi-occlusion catheter. The gall bladder is connected to the pancreas via the common bile duct.
- Localized delivery to the site of the tumor has advantages for both maximizing local drug concentration at the tumor site, and decreasing systemic side effects/toxicity. Thus the approach disclosed herein may avoid some of the toxicity related side effects of delivering chemotherapy drugs directly to the pancreas and may enable the use of more concentrated dosage of chemotherapy drugs. It should be understood that therapeutic particles may be substituted for or used in conjunction with chemotherapy drugs. Moreover, it should be understood that in some cases it may be useful to place a stent to open the bile duct prior to delivering the chemotherapy and/or therapeutic agent.
- By way of example, such a use can include navigating a catheter such as a multi-occlusion catheter to the target anatomy using conventional percutaneous approaches or the same approach used for endoscopic retrograde cholangiopancreatogram (ERCP), isolating the bile duct, and then exogenously introducing therapeutic cells/agents/biologics into the isolated area, via an infusion port of the catheter. In such fashion, the cells/agents biologics can be delivered to the bile duct with high efficiency. In some embodiment, a device with two sliding balloon catheters can be used to isolate bile duct. The isolated area can then be perfused with cells/therapeutic agents via an infusion port disposed between the two balloon catheters. In some embodiments, the devices described herein can be arranged such that a user can manipulate a portion of the device substantially single handedly, to allow for accurate delivery of a biological agent and/or drug formulation to an isolated segment or portion of an organ.
- This application incorporates by reference to co-pending U.S. application Ser. No. 14/958,415 filed on December 3, 2015.
- In some embodiments, an apparatus includes a handle, an inner catheter, an outer catheter, an actuator, a first occlusion element, and a second occlusion element. The inner catheter is coupled to the handle and the first occlusion element is coupled to the inner catheter. The inner catheter defines an inner catheter lumen that is configured to receive a guidewire. The outer catheter is coupled to the housing and the second occlusion element is coupled to the outer catheter. The outer catheter defines a first lumen that is in fluid communication with a distal opening and is configured to introduce a therapeutic agent through the distal opening into the bile duct. The outer catheter defines a second lumen that is configured to receive at least a portion of the inner catheter.
- The actuator is coupled to the handle and is configured to move the outer catheter relative to the handle. The second occlusion element is disposed proximal to the first occlusion element and a distance therebetween is adjustable when the outer catheter is moved relative to the handle by the actuator.
- In some embodiments, an apparatus includes a handle, an inner catheter, an outer catheter, a first occlusion element, a second occlusion element, and an actuator. The inner catheter is coupled to the handle and the first occlusion element is coupled to the inner catheter. The outer catheter is coupled to the housing and the second occlusion member is coupled to the outer catheter. The outer catheter defines a first lumen that is in fluid communication with a distal opening and that is configured to introduce a therapeutic agent therethrough and into the bile duct. The outer catheter defines a second lumen that is configured to receive at least a portion of the inner catheter. The second occlusion element is disposed proximal of the first occlusion element. The actuator is coupled to the handle and is configured to move the outer catheter relative to the handle between a first position in which the second occlusion element is at a first distance from the first occlusion element and a second position in which the second occlusion element is at a second distance from the first occlusion element, with the second distance being greater than the first distance.
- In some embodiments, a system and/or device(s) is provided for endovascular introduction of therapeutic materials selectively to the bile duct for the treatment of pancreatic cancer. In some embodiments, a device and/or system can include, for example, an inner catheter having a distal retractable occlusion element and an inner catheter lumen adapted and configured to introduce a guidewire, and an outer catheter having a distal retractable occlusion element, an infusion lumen adapted and configured to introduce therapeutic materials to the bile duct, and a lumen for slidably receiving the inner catheter. In such an embodiment, the distal retractable occlusion element of the outer catheter can be positioned proximal to the distal retractable occlusion element of the inner catheter; and a sealing element can be included that is configured to selectively isolate or seal an end of the outer catheter to prevent therapeutic materials from entering into the lumen of the outer catheter in which the inner catheter is slidably disposed.
- In some embodiments, a selective sealing element can include, for example, a ring, a membrane, or any other suitable element configured to prevent loss of therapeutic material into the lumen of the outer catheter in which the inner catheter is disposed. The lumen provided in the inner catheter can be configured to perfuse a distal organ beyond the targeted isolation region of the artery.
- In some embodiments, a distance between the proximal retractable occlusion element and the selective sealing element can be configured for external adjustment, thus allowing a user to customize the isolated area (between the two occlusion elements) to better target the bile duct during delivery of biologics. The proximal retractable occlusion element and the selective sealing element can have a cross-sectional diameter, for example, between 2-12 mm.
- In some embodiments, the devices and methods described herein can be used for isolating the perfusion area of the gall bladder for introduction of chemotherapy for treatment of pancreatic cancer, hepatic tumors and cholangiocarinoma or other therapeutic agents targeted to the pancreas.
- As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof.
- As used herein, the term “set” can refer to multiple features or a singular feature with multiple parts. For example, when referring to a set of ports, the set of ports can refer to a single port or to multiple ports.
- As used herein, the words “proximal” and “distal” refer to a direction closer to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient's body (e.g., contacting the patient's body or disposed within the patient's body) would be the distal end of the medical device, while the end opposite the distal end and closest to, for example, the user of the medical device, would be the proximal end of the medical device. Said another way, the distal end portion is the end that is located furthest from a point of reference, such as an origin or a point of attachment. For example, the distal end portion would be the end farthest away from a user's hand. The proximal end portion, thus, would be the position nearer to a point of reference such as an origin, i.e., the user's hand.
- Table 1 is a list of chemotherapy drugs which may be delivered to the bile duct according to the method of the present invention.
-
TABLE 1 Trade Common Solvents/ # Drug Name(s) Indication(s) Diluents 1 5-fluorouracil 5FU, Breast, Liver, water (5-FU) Flourouracil, Pancreatic, Adrucil Stomach 2 Aldesleukin Proleukin Kidney water 3 Axitinib Inlyta Kidney water 4 Bleomycin Blenoxane Cervical, water Testicular 5 Carboplatin Paraplatin Ovarian water 6 Cetuximab Erbitux Colorectal, water Head, Neck 7 Cisplatin Platinol-AQ Bladder, Liver, water Ovarian, Pancreatic, Testicular 8 Cyclo- Cytoxan Breast, Ovarian, water phosphamide Pancreatic 9 Dacarbazine DTIC-Dome Pancreatic water 10 Doxorubicin Adriamycin, Breast, Liver, water Hydrochloride Rubex, Ovarian, (pH = 3) Caelyx Pancreatic, Stomach 11 doxorubicin Myocet Breast, Liver, water liposomal, non- Ovarian, (pH = 3) pegylated (un- Pancreatic, coated) Stomach 12 doxorubicin Doxil Breast, Liver, water liposomal, Ovarian, (pH = 3) pegylated (PEG Pancreatic, coated) Stomach 13 Floxuridine FUDR Liver, Pancreatic water 14 Gemcitabine Hospira, Breast, Ovarian, water Hydrochloride Gemcitab, Pancreatic (pH = 3) Gemzar 15 Irinotecan Onivyde, Pancreatic water Hydrochloride Camptosar (pH = 3) Liposome 16 Lanreotide Somatuline Pancreatic water Acetate 17 leucovorin Depot Pancreatic water or (antidote to folic oral acid antagonist used with 5FU) 18 Methotrexate Otrexup, Breast, water Rheumatrex, Pancreatic Trexall 19 Mitomycin Mutamycin, Liver, water MMC, Pancreatic, Mitomycin C, Stomach Mitozytrex 20 Mitoxantrone Novantrone Pancreatic water 21 Nivolumab Opdivo Kidney water 22 Olaparib Lynparza Ovarian water 23 Oxaliplatin Elotaxin Pancreatic water 24 Sorafenib Nexavar Kidney water Tosylate 25 Temsirolimus Torisel Kidney water 26 Thiotepa Bladder, water Ovarian 27 Topotecan Hycamtin Cervical, water Hydrochloride Ovarian (pH = 3) or oral 28 Vinblastine Velban, Breast, water Sulfate Velsar Pancreatic, Testicular 29 vincristine Alcrist, Pancreatic water sulfate Biocristin, Oncocristin- AQ, VCR -
FIG. 1 illustrates theliver 10, thegall bladder 20, and thepancreas 30 situated within an abdominal cavity (not shown) of a mammal (e.g., a human). Thepancreas 30 is a gland organ which is part of the digestive and endocrine system of vertebrates. Thepancreas 30 is both an endocrine gland producing hormones, including insulin, glucagon, and somatostatin, as well as an exocrine gland, secreting pancreatic juice containing digestive enzymes that pass to the small intestine. These enzymes help in the further breakdown of the carbohydrates, protein, and fat in the chyme. - As shown, the common bile duct leads from the gall bladder to the
pancreas 30. -
FIGS. 2 and 3 are schematic illustrations of a multi-occlusioncatheter insertion device 100 useful for delivering therapeutic agents to the bile duct for treatment of pancreatic cancer. The multi-occlusion catheter insertion device 100 (also referred to herein as “device”) can be arranged to allow for substantially single handed use to, for example, isolate a segment of a bodily lumen such as the buke duct, thereby allowing a procedure to be performed within the isolated segment and/or allowing a targeted delivery of a biological or therapeutic agent. Thedevice 100 includes ahandle 110, anactuator 150, afirst catheter 160, and asecond catheter 170. Thehandle 110 can be any suitable shape, size, or configuration. For example, in some embodiments, thehandle 110 can have a shape and size that are configured to enhance the ergonomics of thedevice 100. As described in further detail herein, thehandle 110 can be grasped by a user to insert a portion of thefirst catheter 160 and a portion of thesecond catheter 170 into a bodily lumen of a patient and can be manipulated to move, inflate, deflate, adjust, and/or otherwise reconfigure the portion of thefirst catheter 160 and the portion of thesecond catheter 170 within the bodily lumen. For example, thesecond catheter 170 can be moved relative to thefirst catheter 160, or vice-versa, to adjust a distance between afirst occlusion element 168 coupled to a distal end portion of thefirst catheter 160 and asecond occlusion element 178 coupled to a distal end portion of thesecond catheter 170. Thedevice 100 can be used to isolate a segment of the bile duct within the space defined between thefirst occlusion element 168 and thesecond occlusion element 178. Thus, a procedure can then be performed within the isolated segment such as for example, delivering a therapeutic agent to the isolated segment. - The
handle 110 has aproximal end portion 111 and adistal end portion 112. As described in further detail herein, thehandle 110 can be arranged to enclose, house, and/or be disposed about a portion of thefirst catheter 160 and thesecond catheter 170. For example, thefirst catheter 160 and thesecond catheter 170 can each be coupled to thehandle 110. Afirst port 120 and a second port 125 (collectively referred to herein as a first set of ports 128) are each disposed at theproximal end portion 111 of thehandle 110. Thefirst port 120 and thesecond port 125 can each define a lumen (not shown inFIGS. 2 and 3 ). In some embodiments, thefirst port 120 and thesecond port 125 can be formed monolithically or integrally with thefirst catheter 160. Thefirst port 120 and thesecond port 125 can be any suitable size, shape, or configuration. For example, in some embodiments, thefirst port 120 and thesecond port 125 can extend from theproximal end portion 111 of thehousing 110 such that at least a portion of thefirst port 120 and thesecond port 125 is accessible outside of thehandle 110. Although not shown inFIGS. 2 and 3 , thefirst port 120 and thesecond port 125 can each be physically and fluidically coupled to a device, mechanism, and/or the like, such as, for example, a source of an inflation medium as described in more detail below. For example, in some embodiments, thefirst port 120 and thesecond port 125 can each include a Luer-Lok® or the like that can physically and fluidically couple thefirst port 120 and/or thesecond port 125 to such a device. As described in further detail herein, the first set ofports 128 can be in fluid communication with at least a portion of thefirst catheter 160 to place at least the portion of thefirst catheter 160 in fluid communication with a device (e.g., a source of an inflation medium) coupled to thehandle 110 via thefirst port 120 and/or thesecond port 125. For example, the lumen of thefirst port 120 can be in fluid communication with a first lumen defined by thefirst catheter 160 and the lumen of thesecond port 125 can be in fluid communication with a second lumen defined by thefirst catheter 160. - The
distal end portion 112 of thehandle 110 includes athird port 130, afourth port 135, and a fifth port 140 (collectively referred to herein as a second set of ports 143). The second set ofports 143 can be any suitable arrangement such as, for example, described above with reference to the first set ofports 128. For example, thethird port 130, thefourth port 135, and thefifth port 140 can each define a lumen (not shown inFIGS. 2 and 3 ) and can each include a Luer-Lok® or the like that can physically and fluidically couple thethird port 130, thefourth port 135, and/or thefifth port 140 to any suitable attachment, device, mechanism, and/or the like. For example, thethird port 130, thefourth port 135, and/or thefifth port 140 can each be coupled to an external device such as a device supplying a therapeutic agent, a device supplying an inflation medium or a device supplying an irrigation solution as described in more detail below with reference to, for example,device 400. In some embodiments, the second set ofports 143 includes thefifth port 140 and only one of thethird port 130 and thesecond port 135. - As described in further detail herein, the second set of
ports 143 can be in fluid communication with at least a portion of thesecond catheter 170 to place at least the portion of thesecond catheter 170 in fluid communication with such external devices coupled to thehandle 110 via thethird port 130, thefourth port 135, and/or thefifth port 140. For example, thethird port 130 and/or thefourth port 135 can be coupled to and in fluid communication with a first lumen defined by thesecond catheter 170, and thefifth port 140 can be coupled to and in fluid communication with a second lumen defined by thesecond catheter 170. In some embodiments, thethird port 130, thefourth port 135, and/or thefifth port 140 can be monolithically or integrally formed with thesecond catheter 170. Moreover, the second set ofports 143 can be coupled to or operably coupled to theactuator 150 as described in more detail herein. - The first catheter 160 (also referred to herein as “inner catheter”) and the second catheter 170 (also referred to herein as “outer catheter”) can be any suitable catheter device. For example, in some embodiments, the
first catheter 160 and thesecond catheter 170 are multi-lumen catheters. As shown inFIG. 2 , thefirst catheter 160 has aproximal end portion 161 and adistal end portion 162. Theproximal end portion 161 of thefirst catheter 160 is disposed within a portion of thehandle 110. More specifically, theproximal end portion 161 of thefirst catheter 160 can be fixedly disposed within the portion of thehandle 110 to place thefirst catheter 160 in fluid communication with one or more of theports ports 128. In some embodiments, thefirst catheter 160 can define a first lumen that can be physically and fluidically coupled to thefirst port 120 and a second lumen that can be physically and fluidically coupled to thesecond port 125. In other embodiments, a first catheter can be coupled to the handle and can be operably coupled to a first port and a second port (e.g.,ports 120, 125) via an intervening structure such as, for example, flexible tubing or the like. In this manner, thefirst port 120 can be placed in fluid communication with a first lumen (not shown inFIGS. 2 and 3 ) defined by thefirst catheter 160, as described in further detail herein. Similarly, thesecond port 125 can be placed in fluid communication with a second lumen (not shown inFIGS. 2 and 3 ) defined by thefirst catheter 160. In some embodiments, thesecond port 125 and the second lumen of thefirst catheter 160 can receive a guidewire or the like, as described in further detail herein. - The
distal end portion 162 of thefirst catheter 160 extends beyond a distal end portion of thehandle 110 and includes theocclusion member 168. Theocclusion member 168 can be any suitable device or mechanism that is configured to selectively limit, block, obstruct, or otherwise occlude a bodily lumen in which theocclusion member 168 is disposed. For example, in some embodiments, theocclusion member 168 can be an inflatable balloon or the like that can be transitioned between a collapsed (e.g., deflated) configuration and an expanded (e.g., inflated) configuration. In some embodiments, the arrangement of thefirst catheter 160 and thehandle 110 can be such that thefirst port 120 is in fluid communication with theocclusion member 168. Thus, in use, thefirst port 120 can be fluidically coupled to a device that can supply a pressurized fluid (e.g., air, inert gas, or liquid) to theocclusion member 168 to transition theocclusion member 168 between a collapsed configuration and an expanded configuration, as described in further detail herein. - The
second catheter 170 of thedevice 100 has aproximal end portion 171 and adistal end portion 172. As shown inFIGS. 2 and 3 , thesecond catheter 170 is movably disposed about a portion of thefirst catheter 160. More specifically, thesecond catheter 170 can be, for example, a multi-lumen catheter and can be arranged such that thefirst catheter 160 is movably disposed within a first lumen (not shown inFIGS. 2 and 3 ) defined by thesecond catheter 170. Theproximal end portion 171 can be movably disposed within thehandle 110 such that a portion of thesecond catheter 170 is in fluid communication with the second set ofports 143. In some embodiments, thesecond catheter 170 can be physically and fluidically coupled to thethird port 130 and thefourth port 135, and/or thefifth port 140. In other embodiments, the second catheter can be disposed within a handle and can be operably coupled to one or more ports via an intervening structure such as, for example, flexible tubing or the like. In this manner, thethird port 130 and/or thefourth port 135 can be placed in fluid communication with the second lumen (not shown inFIGS. 2 and 3 ) defined by thesecond catheter 170, as described in further detail herein; thefifth port 140 can be placed in fluid communication with a third lumen (not shown inFIGS. 2 and 3 ) defined by thesecond catheter 170, as described in further detail herein. - The
distal end portion 172 of thefirst catheter 170 extends beyond a distal end portion of thehandle 110 and includes anocclusion member 178. Theocclusion member 178 can be any suitable device or mechanism that is configured to selectively limit, block, obstruct, or otherwise occlude a lumen in which theocclusion member 178 is disposed. For example, in some embodiments, theocclusion member 178 can be substantially similar to theocclusion member 168 of thefirst catheter 160. In some embodiments, the arrangement of thesecond catheter 170 and thehandle 110 can be such that thethird port 130 and/or thefourth port 135 is in fluid communication with theocclusion member 178. Thus, in use, thethird port 130 and/or thefourth port 135 can be fluidically coupled to a device that can supply a pressurized fluid (e.g., air, inert gas, or liquid) to theocclusion member 178 to transition theocclusion member 178 between a collapsed configuration and an expanded configuration, as described in further detail herein. In some embodiments, at least a portion of theocclusion member 178 can be selectively permeable to allow a biological agent to pass therethrough. Although not shown inFIGS. 2 and 3 , in some embodiments, thedistal end portion 172 of thesecond catheter 170 can define one or more openings. In such embodiments, thefifth port 140 can be fluidically coupled to a device that can supply irrigation, therapeutic material or agents, biological agents, and/or the like to a volume or region disposed between theocclusion member 168 of thefirst catheter 160 and theocclusion member 178 of thesecond catheter 170. - As described above, the
actuator 150 of thedevice 100 can be operably coupled to the second set ofports 143. For example, in some embodiments, theactuator 150 is included in and/or coupled to thehandle 110 and arranged relative to the second set ofports 143 to be operably coupled thereto. Theactuator 150 can be any suitable device, mechanism, assembly, etc. that is movable between a first position relative to thehandle 110, associated with thedevice 100 in the first configuration (FIG. 2 ), and a second position relative to thehandle 110, associated with thedevice 100 in the second configuration (FIG. 3 ). Furthermore, with theactuator 150 operably coupled to the second set ofports 143, theactuator 150 can be operable in moving the second set ofports 143 between a first position relative to the handle 110 (e.g., the distal position) and a second position relative to the handle 110 (e.g., the proximal position), as indicated by the arrow AA inFIG. 3 . Thus, when thesecond catheter 170 is coupled to the second set ofports 143, theactuator 150 can also move thesecond catheter 170 relative to thehandle 110 and/or relative to thefirst catheter 160 as described in more detail below. - In some embodiments, the
actuator 150 can be a push or pull slide that can move within a track (not shown inFIGS. 2 and 3 ) defined by thehandle 110. In other embodiments, theactuator 150 can be coupled to an energy storage device (e.g., a spring, compressed gas, etc.) that is configured to move theactuator 150. For example, theactuator 150 can include a push button that allows a spring to transition from a compressed configuration towards an uncompressed configuration to move theactuator 150 relative to thehandle 110. In other embodiments, a portion of theactuator 150 can be rotated to move theactuator 150 between its first position and its second position relative to thehandle 110. With thesecond catheter 170 physically and fluidically coupled to the second set of ports 143 (as described above), the movement of theactuator 150 can move thesecond catheter 170 relative to thehandle 110. More specifically, theproximal end portion 171 of thesecond catheter 170 can be movably disposed within the handle 110 (as described above) such that when theactuator 150 is moved from its first position to its second position, theproximal end portion 171 of thesecond catheter 170 is moved from a first position relative to the handle 110 (e.g.,FIG. 2 ) to a second position relative to the handle 110 (e.g.,FIG. 3 ). - With the
second catheter 170 movably disposed about thefirst catheter 160, the movement of theactuator 150 moves thesecond catheter 170 relative to thefirst catheter 160. For example, when thedevice 100 is in the first configuration, a first distance D1 is defined between theocclusion member 168 of thefirst catheter 160 and theocclusion member 178 of thesecond catheter 170. Therefore, with thefirst catheter 160 fixedly disposed within thehandle 110, the movement of thesecond catheter 170 in the proximal direction (e.g., the AA direction) increases the distance between theocclusion member 168 of thefirst catheter 160 and theocclusion member 178 of thesecond catheter 170 to a second distance D2, as shown inFIG. 3 . - In use, a guidewire (not shown) can be inserted into the
second port 125 and through a lumen defined by thefirst catheter 160. In this manner, the guidewire can be advanced through a bodily lumen and thedevice 100 can be manipulated to advance thefirst catheter 160 along the guidewire to place thedistal end portion 162 of thefirst catheter 160 and thedistal end portion 172 of thesecond catheter 170 at a target location within the bodily lumen. Once at the target location, theactuator 150 can be moved in the AA direction (e.g., the proximal direction) to define a desired distance between theocclusion member 168 of thefirst catheter 160 and theocclusion member 178 of thesecond catheter 170, thereby placing thedevice 100 in the second configuration (FIG. 3 ). As described above, an inflation source can be coupled to thesecond port 125 of thefirst catheter 160 and the same inflation source or a second inflation source can be coupled to thethird port 130 and/or thefourth port 135 of thesecond catheter 170. With the desired distance defined between theocclusion members occlusion members occlusion members occlusion members fourth port 135. For example, the biological or therapeutic agent can be delivered through thefourth port 135 into a lumen of the second catheter that is in fluid communication with the opening (see, e.g., opening 479 inFIG. 20 ) defined by thedistal end portion 172 of thesecond catheter 170. In some instances, the substantially isolated segment can be irrigated by coupling an irrigation source to thefifth port 140. Thus, the irrigation is delivered to the substantially isolated segment via the opening (described above) defined by thedistal end portion 172 of thesecond catheter 170. -
FIGS. 4-11 illustrate adilation catheter 200 according to an embodiment.FIG. 4 is a side view of the dilation catheter device 200 (also referred to herein as “catheter device”). In this embodiment, dilatation of two balloons is used to occlude a desired length of an artery such as, for example, the splenic artery 40 (see, e.g.,FIG. 2 ). Specifically, thecatheter device 200 includes a first catheter 260 (also referred to herein as “inner catheter”) and a second catheter 270 (also referred to herein as “outer catheter”), a first Y-adaptor 228 (also referred to herein as “first set of ports”) and a second Y-adaptor 243 (also referred to herein as “second set of ports”), a first occlusion element 268 (also referred to herein as “dilation element”, “occluder,” or “distal occlusion element”), and a second occlusion element 278 (also referred to herein as “dilation element”, “occluder,” or “proximal occlusion element”) each configured to occlude a portion of an artery. Thefirst occlusion element 268 is coupled to thefirst catheter 260 and thesecond occlusion element 278 is coupled to thesecond catheter 270. - The
occlusion elements catheter device 200 into a body of a patient (e.g., into an artery) and an expanded configuration (also referred to as “dilated configuration” or “inflated configuration”) for occluding a portion of an artery. Theocclusion elements - The
catheter device 200 includes adistal end portion 212 and aproximal end portion 211. In this embodiment, theocclusion elements first catheter 260 and an outer surface of thesecond catheter 270, respectively, and are disposed at thedistal end portion 212 of thecatheter device 200. Thecatheter device 200 is shown in a dilated configuration inFIG. 4 with theocclusion elements 268 and 278 (i.e., balloons) in their expanded configuration (i.e., inflated, dilated). -
FIG. 5 is a side view of thedistal end portion 212 of the catheter device 200 (e.g., a distal end portion of thefirst catheter 260 and the second catheter 270) andFIGS. 6-11 illustrate cross-sections at various locations along thedistal end portion 212 of thecatheter device 200 to illustrate the various lumens of thecatheter device 200. As shown inFIGS. 6-11 , thefirst catheter 260 defines afirst lumen 265 and asecond lumen 263 that each can extend a length of thefirst catheter 260. Thefirst lumen 265 can be configured to receive a guidewire 280 (shown, for example, inFIG. 4 ). Thesecond lumen 263 can be used to communicate an inflation medium to and from thefirst occlusion element 268 via anaperture 264 in fluid communication with the first occlusion element 268 (see, e.g.,FIG. 10 ). - As shown, for example, in
FIGS. 6 and 7 , thesecond catheter 270 defines afirst lumen 274, asecond lumen 273, and athird lumen 276. Thefirst lumen 274 can be used to communicate an inflation medium to and from thesecond occlusion element 278 via anaperture 275 in fluid communication with the second occlusion element 278 (see, e.g.,FIG. 7 ). Thesecond lumen 273 is configured to slidably receive at least a portion of thefirst catheter 260 therethrough, as shown inFIGS. 6-9 . Thethird lumen 276 can terminate and be in fluid communication with aninfusion aperture 279 near adistal end 272 of the second catheter 270 (see, e.g.,FIG. 8 ). Theinfusion aperture 279 can be used to communicate a cell/biological/therapeutic material to a desired location within a body/artery of a patient. - The first Y-
adaptor 228 is coupled to thefirst catheter 260 and includes twoports FIG. 4 . Theport 220 defines a lumen (not shown) that is in fluid communication with thefirst lumen 263 of thecatheter 260 and can be used to communicate an inflation medium to thefirst occlusion element 268 through thesecond lumen 263. For example, a source of an inflation medium (not shown) can be coupled to thecatheter device 200 via theport 220 of the first Y-adaptor 228. Theport 225 defines a lumen (not shown) that is in fluid communication with thesecond lumen 265 of the first catheter 260 (see, e.g.,FIGS. 6-11 ) and can be used for introduction of theguidewire 280 into thesecond lumen 265. - The second Y-
adapter 243 is coupled to thesecond catheter 270 and includes threeports FIG. 4 . Theport 230 defines a lumen (not shown) that is in fluid communication with thesecond lumen 273 of the second catheter 270 (see, e.g.,FIGS. 6-11 ) and can receive thefirst catheter 260 therethrough. Theport 235 defines a lumen (not shown) that is in fluid communication with thefirst lumen 274 of thesecond catheter 270 and can be used to communicate an inflation medium to and from thesecond occlusion element 278 in a similar manner as described above forport 225 andlumen 263. Theport 240 defines a lumen (not shown) that is in fluid communication with thethird lumen 276 of the second catheter 270 (see e.g.,FIG. 6-11 ) and can be used to introduce cells/biological/therapeutic materials into and through thethird lumen 276 and out through theinfusion aperture 279. - The
catheter device 200 can also include a seal element 285 (see, e.g.,FIG. 9 ) (also referred to a as a “seal”, “sealing element”, “selective sealing element”, or “filter-ring”) disposed at or near adistal end 272 of thesecond catheter 270. Theseal element 285 can prevent the entry of cells and or biologics that have been injected into an artery from flowing back into thelumen 273. By doing so, a maximum number of cells can be delivered to the treatment area, and improve engraftment efficiency. Theseal element 285 can be for example, a ring, a membrane or other known sealing elements used in medical devices. - The slidable coupling of the
first catheter 260 within thesecond lumen 273 of thesecond catheter 270 allows a collective length of thefirst catheter 260 and thesecond catheter 270 to be adjusted by slidably moving thefirst catheter 260 and thesecond catheter 270 relative to each other. Because thefirst occlusion element 268 is coupled to thefirst catheter 260 and thesecond occlusion element 278 is coupled to thesecond catheter 270, the slidable adjustment of thefirst catheter 260 and thesecond catheter 270 can thus allow adjustment of a distance between thesecond occlusion element 278 and thefirst occlusion element 268. Thesecond lumen 273 of thesecond catheter 270 can be sized to receive thefirst catheter 260 with sufficient clearance to allow for ease of sliding/adjustment. - In use, the
catheter device 200 can be placed at a desired location within an artery, such as for example, within a splenic artery 40 (see e.g.,FIG. 1 ) and used to infuse a cell/biological material to apancreas 30. A length of thefirst catheter 260 and thesecond catheter 270 can be adjusted such that a selected portion (e.g., a pancreatic portion) of thesplenic artery 40 is isolated between thefirst occlusion element 268 and thesecond occlusion element 278. A cell/biologic material can be injected through thecatheter device 200 and into the isolated region of thesplenic artery 40. - The infusion of a cell/biological agent can occur in the localized region surrounding the isolated region or segment of
vessel 40. In some instances, however, the presence of one or more additional, side-branching vessels forming a flow-restricting configuration in the isolated region ofvessel 40 can allow infusion to occur in a larger semi-localized region. - To allow the operator to accommodate the location of these side branches to fall within the isolated region, the
first catheter 260 can be configured such that it is slidably associated with thesecond catheter 270 and the space between (e.g., distance between)occlusion elements distal occlusion element 268 within an artery can be individualized based on the specific anatomy to allow an enclosed or isolated area between the twoocclusion elements - The cells targeted to the pancreas 30 (see e.g.,
FIG. 1 ) can be infused throughinfusion port 240, traverse through thethird lumen 276, and exit through theinfusion aperture 279 into the area isolated between the twoocclusion elements catheter device 200 can be configured to enable delivery of target cells, such as insulin producing beta cells, and autologous stem cells (mesenchymal, bone marrow, and others) to blood vessels in communication with the pancreas in situ. The infusion pressure in the isolated blood vessel region can be measured with pressure monitoring through the infusion lumen of the catheter (with a monometer (not shown) in line with infusion port 279). The pressure in thethird lumen 276 can be based on the size of the cells being delivered, on the flow rate, the viscosity of the solution, and/or flow resistance of thethird lumen 276 ofsecond catheter 270. The flow resistance of thecatheter device 200 can in turn be determined based on, for example, the inner coating material, the size and the length of thethird lumen 276, the size of thethird port 240, and/or the size of thedistal infusion aperture 279. Thecatheter device 200 can allow for rapid infusion of cells (e.g., up to 2 milliliter per second (ml/sec)). In some applications, the rapid infusion of cells can enhance uptake and eventual engraftment. Smaller aperture size (e.g., the infusion aperture 279), lumen size (e.g., the third lumen 276), and increased flow resistance may cause “sludging” of cells, leading to poor intra-arterial flow and diminished uptake. Lastly, theinfusion aperture 279 and luminal design of thecatheter device 200 can be configured to minimize risk of mechanical cell damage during the infusion process. -
FIG. 12 illustrates an embodiment of acatheter device 300 that uses two filter elements, instead of expandable balloons to occlude and isolate the area of interest for infusion of cells or chemotherapeutic agents, without inhibiting the flow of plasma through the isolated area. The filter elements can be formed with, for example, a medical mesh material. The size of the pores of the filter elements can be, for example, about 2 microns (μm) or less in length, which can inhibit cells from passing through the filter element, but not impede serum/plasma and other components from passing through the filter element. Thecatheter device 300 can be used for the same or similar functions as described above forcatheter device 200. For example, thecatheter device 300 can be used for introduction of cells or other biologic or therapeutic material into a desired location within a patient's body, such as within a splenic artery. - The
catheter device 300 includes afirst catheter 360 and asecond catheter 370 that can be slidably coupled together as described above forcatheter device 200, a first Y-adaptor 328 (also referred to herein as “first set of ports”) coupled to thefirst catheter 360, a second Y-adaptor 343 (also referred to herein as “second set of ports”) coupled to thesecond catheter 370, a first occlusion element 368 (also referred to herein as “dilation element”, “occluder”, “distal occlusion element”) and a second occlusion element 378 (also referred to herein as “dilation element”, “occluder”, “proximal occlusion element”) to occlude a portion of an artery. Thefirst occlusion element 368 is coupled to thefirst catheter 360 and thesecond occlusion element 378 is coupled to thesecond catheter 370. - In this embodiment, the
occlusion elements catheter device 300 into a body of a patient (e.g., into an artery) and an expanded configuration (also referred to as “dilated configuration” or “open configuration”), as shown inFIG. 12 , for occluding a portion of an artery. Theocclusion elements - The
catheter device 300 includes adistal end portion 312 and aproximal end portion 311.FIG. 13 is a side view of thedistal end portion 312 of thecatheter device 300 andFIGS. 14-19 illustrate cross-sections at various locations along thedistal end portion 312 of thecatheter device 300. As shown inFIGS. 14-19 , thefirst catheter 360 defines afirst lumen 363 and asecond lumen 365 that each can extend a length of thefirst catheter 360. Thefirst lumen 363 can be configured to receive awire deployment device 382 that can be coupled to thefilter element 368 and configured to move thefilter element 368 from its expanded or open configuration and its collapsed or closed configuration. Thesecond lumen 365 can be configured to receive a guidewire 380 (shown inFIG. 12 ). - The
second catheter 370 defines afirst lumen 373, asecond lumen 374, and athird lumen 376. Thefirst lumen 373 is configured to slidably receive at least a portion of thefirst catheter 360 therethrough. Thesecond lumen 374 can be configured to receive awire deployment device 381. Thewire deployment device 381 can be coupled to thefilter element 378 and used to move thefilter element 378 between its expanded or open configuration and its collapsed or closed configuration. Thethird lumen 376 can terminate and be in fluid communication with an infusion aperture 379 (see, e.g.,FIG. 16 ) near adistal end 372 of thesecond catheter 370. Theinfusion aperture 379 can be used to communicate, for example, a cell or cells (or other therapeutic or biologic material) to a desired location within a body of a patient. - The first Y-
adaptor 328 includes aport 320 and aport 325 as shown inFIG. 12 . Theport 320 defines a lumen (not shown) that is in fluid communication with thefirst lumen 363 of thecatheter 360. Theport 325 defines a lumen (not shown) that is in fluid communication with thesecond lumen 365 of thecatheter 360, and can be used for introduction of theguidewire 380 into thesecond lumen 365. The second Y-adapter 343 includes threeports FIG. 12 . Theport 330 defines a lumen (not shown) that is in fluid communication with thefirst lumen 373 of thesecond catheter 370 and can receive thefirst catheter 360 therethrough. Theport 335 defines a lumen (not shown) that is in fluid communication with thesecond lumen 374 of thesecond catheter 370, and theport 335 defines a lumen (not shown) that is in fluid communication with thethird lumen 376 of thesecond catheter 370. - The
filter elements FIGS. 12 and 13 . Thefilter elements catheter device 300 is to be deployed. After infusion of cells or a therapeutic/biologic material through thecatheter device 300, thefilter elements catheter device 300 from the patient. - In some embodiments, a diameter of the occlusion elements (e.g., 268, 278, 368, and 378) when expanded within an artery, such as, for example, the
splenic artery 40, can be adjustable to meet anatomical variations including a) individual variability in the size of thesplenic artery 40 and b) end to end variation as the artery size can taper down between the two ends of the artery. As such, in some embodiments, to allow successful isolation of the area for treatment, the proximal occlusion element (e.g., theballoon 278 and/or the filter element 378) can be sized (e.g., have an outer diameter or outer perimeter) between, for example, 3-12 mm and the distal occlusion element (e.g., theballoon 268 and/or the filter element 368) between, for example, 3-12 mm. The proximal occlusion element can be larger than the distal occlusion element, smaller than the distal occlusion element, or the same size as the distal occlusion element. - Referring now to
FIGS. 20-29 , a multi-lumencatheter insertion device 400 is illustrated according to an embodiment. The multi-occlusion catheter insertion device 400 (also referred to herein as “catheter device” or “device”) includes ahandle 410, anactuator 450, a first catheter 460 (also referred to herein as “inner catheter”), and a second catheter 470 (also referred to herein as “outer catheter”) and can be movable between a first configuration and a second configuration. As described in further detail herein, thedevice 400 can be grasped by a user (e.g., a doctor, physician, surgeon, technician, etc.) and manipulated substantially single handedly to insert a portion of thefirst catheter 460 and a portion of thesecond catheter 470 into a bodily lumen of a patient and to move, inflate, deflate, adjust, and/or otherwise reconfigure the portion of thefirst catheter 460 and the portion of thesecond catheter 470 within the bodily lumen. For example, thesecond catheter 470 can be moved relative to thefirst catheter 460, and vice-versa, to adjust a distance between afirst occlusion element 468 coupled to a distal end portion of thefirst catheter 460 and asecond occlusion element 478 coupled to a distal end portion of thesecond catheter 470. Thedevice 400 can be used to isolate a segment of a bodily lumen within the space or region defined between thefirst occlusion element 468 and thesecond occlusion element 478. Thus, a procedure can then be performed within the isolated segment such as, for example, delivering a cell or a therapeutic/biological agent to the isolated segment. - The
handle 410 of thedevice 400 can be any suitable shape, size, or configuration. For example, in some embodiments, thehandle 410 can have a shape and size that can enhance the ergonomics of thedevice 400. More specifically, thehandle 410 has aproximal end portion 411, adistal end portion 412, and amedial portion 413 that can be shaped in such a manner as to be easily gripped by a user (e.g., a doctor, physician, surgeon, technician, etc.). In some embodiments, thehandle 410 can include a grip section 417 (see, e.g.,FIG. 21 ) or the like that can have, for example, a rough surface finish, detents, protrusions, or the like that can enhance the ergonomics of thehandle 410. In other embodiments, the grip section can be, for example, an insert, an over-mold, or the like that is formed from a relatively deformable material and that can have a relatively high coefficient of friction, thereby enhancing the ergonomics of thehandle 410. - The
proximal end portion 411 of thehandle 410 includes afirst port 420 and asecond port 425 collectively referred to herein as a first set of ports 428). Thefirst port 420 and thesecond port 425 can be any suitable size, shape, or configuration. In some embodiments, thefirst port 420 and thesecond port 425 can be coupled together via any suitable method (e.g., an adhesive, ultrasonic welding, mechanical fastener, and/or the like). In other embodiments, thefirst port 420 and thesecond port 425 can be monolithically formed. - The
first port 420 and thesecond port 425 can extend from theproximal end portion 411 of thehandle 410 such that at least a portion of thefirst port 420 and thesecond port 425 is accessible, as shown inFIGS. 20 and 21 . In some embodiments, the first set ofports 428 can be, for example, a first Y-adapter, substantially similar to the Y-adapter 228 and/or 328. In other embodiments, a first port and a second port can be, for example, substantially parallel in a stacked configuration. In yet other embodiments, a handle can include a first port and a second port that are substantially coaxial and arranged in a substantially concentric configuration such that at least a portion of the first port is disposed within the second port, or vice versa. - Although not shown in
FIGS. 14-29 , thefirst port 420 and thesecond port 425 can be physically and fluidically coupled to an exterior device, mechanism, and/or the like as described above, for example, with reference toinsertion device 100. For example, thefirst port 420 and thesecond port 425 can each define a lumen (described in more detail below) in fluid communication with such a device. Thefirst port 420 and thesecond port 425 can each include a Luer-Lok® and/or any other attachment mechanism that can physically and fluidically couple thefirst port 420 and/or thesecond port 425 to any suitable device either directly or indirectly (e.g., by an intervening structure such as a flexible tubing to the like). The first set ofports 428 can be physically and fluidically coupled to thefirst catheter 460 such that when an external device is coupled to thehandle 410 via thefirst port 420 and/or thesecond port 425, at least the portion of thefirst catheter 460 is placed in fluid communication with that external device via thefirst port 420 and/or thesecond port 425. For example, thefirst port 420 can be coupled to a device that can, for example, supply a pressurized fluid (e.g., an inert gas, air, saline, water, and/or any other suitable fluid in gaseous or liquid form) that can flow through thefirst port 420 to be delivered to a portion of thefirst catheter 460, as described in further detail herein. Furthermore, thesecond port 425 can be coupled to a device that can advance a guidewire or the like through thesecond port 425 and into a portion of thefirst catheter 460, as described in further detail herein. In some embodiments, a guidewire or the like can be manually inserted through thesecond port 425 without the use of an external device. - The
distal end portion 412 of thehandle 410 includes athird port 430, afourth port 435, and a fifth port 440 (collectively referred to as a second set of ports 443). In some embodiments, the second set ofports 443 includes thefifth port 440 and only one of thethird port 430 and thesecond port 435. The second set ofports 443 can be any suitable size, shape, or configuration as described above with reference to the first set ofports 428. For example, the second set ofports 443 can be, for example, monolithically and/or unitarily formed. In some embodiments, the second set ofports 443 can be monolithically formed with thecatheter 470. In some embodiments, the second set ofports 443 can be formed with and/or coupled to any suitable structure or component of thehandle 410 such that the second set ofports 443 can be moved relative to thehandle 410 as described in more detail below. - The
third port 430, thefourth port 435, and thefifth port 440 can each include a Luer-Lok® and/or any other attachment mechanism that can physically and fluidically couple thethird port 430, thefourth port 435, and/or thefifth port 440 to any suitable attachment, device, mechanism, and/or the like. The second set ofports 443 can be physically and fluidically coupled to thesecond catheter 470 such that when an external device is coupled to thehandle 410 via thethird port 430, thefourth port 435, and/or thefifth port 440, at least a portion of thesecond catheter 470 is placed in fluid communication with that external device. For example, in some embodiments, thethird port 430 and/or thefourth port 435 can be coupled to a device that can supply a pressurized fluid (as described above) that can flow through thethird port 430 and/or thefourth port 435, respectively, to be delivered to a portion of thesecond catheter 470, as described in further detail herein. In some embodiments, thefifth port 440 is coupled to, for example, an infusion device that is configured to deliver a biological or therapeutic agent and/or other suitable drug formulation to a target tissue via thefifth port 440 and a portion of thesecond catheter 470. In some embodiments, thefifth port 440 can be coupled to, for example, an irrigation device that can deliver an irrigation fluid to, for example, an isolated segment of a bodily lumen via thefifth port 440 and a portion of thesecond catheter 470. In some embodiments, thefifth port 440 can be coupled to, for example, the infusion device configured to deliver the biological agent and/or other suitable drug formulation, as described in further detail herein. - As shown in
FIGS. 20-22 , thehandle 410 defines afirst track 414 and asecond track 416. Thefirst track 414 slidably receives a portion of theactuator 450. More specifically, at least a portion of theactuator 450 can extend through thetrack 414, thereby allowing a user to engage theactuator 450. As such, thetrack 414 can define a path along which theactuator 450 can be moved between a first position relative to thehandle 410 and a second position relative to thehandle 410, as described in further detail herein. In a similar manner, thesecond track 416 slidably receives a portion of thefifth port 440. In this manner, thefifth port 440 can extend through thesecond track 416 to be accessed by a user. Moreover, thesecond track 416 can define a path along which thefifth port 440 can be moved, as described in further detail herein. - Although the
device 400 is particularly shown inFIGS. 20-29 , the arrangement of the first set ofports 428, the second set ofports 443, thefirst track 414 and thesecond track 416 can be arranged along a surface of thehandle 410 in various orientations. For example, although thefirst track 414 is shown as being defined by a top surface of the handle 410 (see, e.g.,FIG. 20 ) and thesecond track 416 as being defined by a side surface of the handle 410 (see, e.g.,FIG. 21 ), in other embodiments, a first track configured to receive an actuator can be defined by a side surface of a handle and a second track configured to receive a fifth port can be defined by a top surface of the handle. Similarly, while the first set ofports 428 and the second set ofports 443 are shown extending from thehandle 410 in a specific orientation, the first set ofports 428 and/or the second set ofports 443 can be oriented in any suitable manner relative to a surface of thehandle 410. - The
actuator 450 of thedevice 400 is operably coupled to the second set ofports 443. - For example, in some embodiments, the
actuator 450 is included in and/or coupled to thehandle 410 and arranged relative to the second set ofports 443 to be operably coupled thereto. In other embodiments, a handle can be arranged such that at least a portion of an actuator is monolithically formed with at least a portion of a second set of ports. In some embodiments, an actuator is operably coupled to a second set of ports via an intervening structure or the like. For example, in some embodiments, the second set ofports 443 can be coupled to a shuttle or the like, which in turn, is coupled to an actuator. Theactuator 450 can be any suitable device, mechanism, assembly, etc. that is movable between the first position relative to thehandle 410, associated with thedevice 400 in the first configuration (FIGS. 20-22 ), and a second position relative to thehandle 410, associated with thedevice 400 in the second configuration (FIG. 29 ). - In some embodiments, the
actuator 450 can be a mechanism that can be pushed or pulled to slide within thefirst track 414 defined by thehandle 410 between its first position and its second position. In some embodiments, theactuator 450 can be arranged to slide relatively smoothly within thetrack 414 when moved between its first position and its second position. In other embodiments, thehandle 410 and/or theactuator 450 can include a set of ribs, teeth, detents, protrusions, etc. that are sequentially engaged as theactuator 450 is moved between its first position relative to thehandle 410 and its second position relative to thehandle 410. In this manner, a user can move the actuator 450 a desired distance that can be quantified by theactuator 450 and/or thehandle 410 engaging a particular surface (e.g., a particular rib, tooth, detent, protrusion, etc.). In some embodiments, thehandle 410 and/or theactuator 450 can be arranged at a predetermined setting that can correspond to a predetermined distance (e.g., 2 cm, 3 cm, etc.) between an end portion of thefirst catheter 460 and an end portion of thesecond catheter 470. In some embodiments, the set of ribs, teeth, detents, protrusions, etc. included in thehandle 410 and/or theactuator 450 can be associated with pre-defined settings and/or adjustments. - Although not shown in
FIGS. 20-29 , in some embodiments, ahandle 410 can include a visual indicator such as a measuring scale or the like. For example, in some embodiments, thehandle 410 can include indicia (e.g., lines, markings, tic marks, etc.) that represents a gradation of a length of travel associated with moving theactuator 450 between its first position relative to thehandle 410 and its second position relative to thehandle 410. In some embodiments, the markings can represent distances of, for example, a centimeter, half a centimeter, a millimeter, and/or the like. In this manner, a user can view the indicia to determine a desired distance to move thatactuator 450 that would otherwise be challenging or indeterminate. In some embodiments, the visual indicator can substantially correspond with the ribs, teeth, detents, protrusions, etc. of thehandle 410 and/oractuator 450. - In some embodiments, the
actuator 450 can be operably coupled to one or more energy storage device (e.g., a spring or the like) that can facilitate the movement of theactuator 450. For example, theactuator 450 can include a push button that can rearrange or reconfigure at least a portion of theactuator 450 to allow a spring to transition from a compressed configuration towards an uncompressed configuration to move theactuator 450 relative to thehandle 410. - With the
actuator 450 coupled to or monolithically formed with a portion of the second set ofports 443, theactuator 450 can be operable in moving the second set ofports 443 between a first position relative to the handle 410 (e.g., a distal position) and a second position relative to the handle 410 (e.g., a proximal position). Moreover, with thesecond catheter 470 physically and fluidically coupled to the second set of ports 443 (as described above), the movement of theactuator 450 and the second set ofports 443 can move thesecond catheter 470 between a first position relative to thehandle 410 and a second position relative to thehandle 410, as described in further detail herein. - The
first catheter 460 and thesecond catheter 470 can be any suitable catheter device. For example, in some embodiments, thefirst catheter 460 and thesecond catheter 470 are multi-lumen catheters. Thefirst catheter 460 has a proximal end portion 461 (see, e.g.,FIGS. 21, 23 and 29 ) and a distal end portion 462 (see, e.g.,FIGS. 20 and 29 ), and defines afirst lumen 463 and a second lumen 465 (see, e.g.,FIGS. 24-28 ). Theproximal end portion 461 of thefirst catheter 460 is disposed within a portion of thehandle 410. More specifically, theproximal end portion 461 of thefirst catheter 460 can be fixedly disposed within the portion of thehandle 410 to place thefirst catheter 460 in fluid communication with the first set ofports 428. In some embodiments, thefirst catheter 460 can be physically and fluidically coupled to the first set ofports 428. In other embodiments, a device can include a first catheter that is monolithically formed with a first set of ports. In this manner, theproximal end portion 461 of thefirst catheter 460 is arranged such that thefirst lumen 463 of thefirst catheter 460 is in fluid communication with alumen 421 defined by thefirst port 420 and thesecond lumen 465 of thefirst catheter 460 is in fluid communication with alumen 426 of thesecond port 425, as shown inFIG. 23 . Therefore, an external device (e.g., a device that can supply a pressurized fluid, as described above) can be physically and fluidically coupled to thefirst port 420 to place the external device in fluid communication with thefirst lumen 463 of thefirst catheter 460. Similarly, an external device including at least a guidewire (not shown) can be coupled to thesecond port 425 and can be manipulated to advance the guidewire through thesecond port 425 and into thesecond lumen 465, as described in further detail herein. - Referring back to
FIG. 20 , thedistal end portion 462 of thefirst catheter 460 extends beyond a distal end portion of thehandle 410 and includes anocclusion member 468. Theocclusion member 468 can be any suitable device or mechanism that is configured to selectively limit, block, obstruct, or otherwise occlude a body lumen (e.g., artery) in which theocclusion member 468 is disposed. For example, in some embodiments, theocclusion member 468 can be an inflatable balloon or the like that can be transitioned between a collapsed (e.g., deflated) configuration and an expanded (e.g., inflated) configuration. - The arrangement of the
first catheter 460 can be such that thefirst lumen 463 is in fluid communication with theocclusion member 468. For example, as shown inFIG. 24 , thedistal end portion 462 of thefirst catheter 460 can define achannel 464 that places thefirst lumen 463 in fluid communication with theocclusion member 468. Thus, when thefirst port 420 is fluidically coupled to a device that supplies a pressurized fluid (e.g., air, inert gas, or liquid), the pressurized fluid can be delivered to theocclusion member 468 via thelumen 421 of thefirst port 420, thefirst lumen 463 of thefirst catheter 460, and thechannel 464 of thefirst catheter 460. In this manner, the pressurized fluid can transition theocclusion member 468 between a collapsed configuration (not shown) and an expanded configuration (see e.g.,FIG. 20 ), as described in further detail herein. - The
second catheter 470 of thedevice 400 has a proximal end portion 471 (see, e.g.,FIGS. 20-22 ) and a distal end portion 472 (see, e.g.,FIGS. 20 and 29 ), and defines afirst lumen 473, asecond lumen 474, athird lumen 476 and an opening 479 (also referred to herein as “infusion aperture”) (as shown, for example, inFIGS. 25-28 ). Thesecond catheter 470 is movably disposed about a portion of the first catheter 460 (see, e.g.,FIGS. 21-23 ). More specifically, thesecond catheter 470 can be arranged such that thefirst catheter 460 is movably disposed within thefirst lumen 473 defined by thesecond catheter 470, as shown, for example, inFIGS. 26-28 . - The
proximal end portion 471 of thesecond catheter 470 is movably disposed within thehandle 410 to place thesecond catheter 470 in fluid communication with the second set ofports 443. In some embodiments, thesecond catheter 470 can be physically and fluidically coupled to thethird port 430 and thefourth port 435, and/or thefifth port 440. In other embodiments, a catheter insertion device can include a second catheter that can be movably disposed within a handle and can be operably coupled to one or more ports via an intervening structure such as, for example, flexible tubing or the like. In yet other embodiments, a catheter insertion device can include a second catheter that is monolithically formed with a third port, a fourth port, and/or a fifth port. In this manner, thesecond catheter 470 is arranged such that thefirst lumen 473 of thesecond catheter 470 movably receives thefirst catheter 460, thesecond lumen 474 of thesecond catheter 470 is in fluid communication with alumen 431 defined by thethird port 430 and alumen 436 defined by thefourth port 435, and thethird lumen 476 of thesecond catheter 470 is in fluid communication with alumen 441 defined by thefifth port 440, as shown inFIG. 25 . - Referring back to
FIG. 20 , thedistal end portion 472 of thefirst catheter 470 extends beyond a distal end portion of thehandle 410 such that anocclusion member 478 of thesecond catheter 470 is disposed in a proximal position relative to theocclusion member 468 of thefirst catheter 478. Expanding further, thefirst catheter 460 extends within theproximal end portion 471 and thedistal end portion 472 when disposed in thefirst lumen 473. Thus, theocclusion member 468 of thefirst catheter 460 can be disposed in a distal position relative to theocclusion member 478 of thesecond catheter 470. Theocclusion member 478 can be any suitable device or mechanism that is configured to selectively limit, block, obstruct, or otherwise occlude a body lumen (e.g., artery) in which theocclusion member 478 is disposed. For example, in some embodiments, theocclusion member 478 can be substantially similar to theocclusion member 468 of thefirst catheter 468. - The arrangement of the
second catheter 470 can be such that thesecond lumen 474 is in fluid communication with theocclusion member 468. For example, as shown inFIG. 27 , thedistal end portion 472 of thesecond catheter 470 defines achannel 475 that places thesecond lumen 474 in fluid communication with theocclusion member 478. Thus, when the third port 430 (and/or the fourth port 435) is fluidically coupled to a device that supplies a pressurized fluid, the pressurized fluid can be delivered to theocclusion member 478 via thelumen 431 of the third port 430 (and/or thelumen 436 of the fourth port 435), thesecond lumen 474 of thesecond catheter 470, and thechannel 475 of thesecond catheter 470. In this manner, the pressurized fluid can transition theocclusion member 478 between a collapsed configuration (not shown) and an expanded configuration (as shown inFIGS. 20 and 29 ). In a similar manner, the arrangement of thesecond catheter 470 can be such that thethird lumen 476 is in fluid communication with the opening 479 (see, e.g.,FIG. 28 ). For example, thedistal end portion 472 of thesecond catheter 470 defines achannel 477 that places thethird lumen 476 in fluid communication with theopening 479, as shown inFIG. 28 . Thus, when thefifth port 440 is fluidically coupled to an external device that supplies irrigation or to a device that supplies a therapeutic agent, the irrigation fluid or therapeutic agent can be delivered to an isolated segment of a bodily lumen via thelumen 441 defined by thefifth port 440 and thethird lumen 476, thechannel 477, and theopening 479 defined by thesecond catheter 470. - The
device 400 can be moved from the first configuration to the second configuration by moving the actuator 450 from its first position (e.g., a distal position) relative to thehandle 410 to its second position (e.g., a proximal position) relative to thehandle 410, as indicated by the arrow BB inFIG. 29 . Expanding further, with thesecond catheter 470 movably disposed about thefirst catheter 460 and with theproximal end portion 471 of thesecond catheter 470 operably coupled to theactuator 450, the movement of the actuator 450 from its first position to its second position moves thesecond catheter 470 relative to thefirst catheter 460, as indicated by the arrow CC inFIG. 29 . For example, when thedevice 400 is in the first configuration, a first distance D7 (FIG. 20 ) can be defined between theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470. With thefirst catheter 460 fixedly disposed within thehandle 410, the movement of thesecond catheter 470 in the CC direction (e.g., the proximal direction) increases the distance between theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470 to a second distance D8, as shown inFIG. 29 . Thus, a segment or volume having a desired length can be defined between theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470. - In use, a guidewire can be inserted into the
lumen 426 of thesecond port 425 and through thesecond lumen 465 defined by thefirst catheter 460. In this manner, the guidewire can be advanced through a bodily lumen and thedevice 400 can be manipulated to advance thefirst catheter 460 and thesecond catheter 470 along the guidewire. Thus, thedistal end portion 462 of thefirst catheter 460 and thedistal end portion 472 of thesecond catheter 470 can be placed at a target location within the bodily lumen such as, for example, the haptic or splenic artery of the pancreas, as shown inFIG. 30 . At the target location, theactuator 450 can be moved between its first position and its second position relative to the handle 410 (e.g., the BB direction inFIG. 29 ) to define a desired distance (e.g., the distance D8 inFIG. 29 ) between theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470. With the desired distance defined between theocclusion members first port 420 and the same or a different inflation source coupled to the third port 430 (and/or the fourth port 435), theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470, respectively, can be transitioned from a collapsed or deflated configuration to an expanded or inflated configuration to substantially isolate a segment of the bodily lumen disposed therebetween (e.g., the pancreatic segment or portion of thesplenic artery 40 associated with, for example, the dorsalpancreatic artery 42 and/or the pancreatic magnum artery 44), as shown inFIG. 30 .FIG. 30 is an illustration of thecatheter device 400 disposed in situ within the splenic branch of the celiac artery. As shown inFIG. 30 , theocclusion elements occlusion elements occlusion elements pancreatic artery 42 and thepancreatic magnum artery 44. - With the
occlusion members fifth port 440, thethird lumen 476, and the opening 479 (i.e., the infusion aperture), into the area substantially isolated between theocclusion elements fifth port 440. Thus, the irrigation can be delivered to the substantially isolated segment via thelumen 441 of thefifth port 440 and thethird lumen 476, thechannel 477, and theopening 479 of thesecond catheter 470. In some instances, such irrigation can be delivered prior to the delivery of the biological/therapeutic agent, after the delivery of the biological/therapeutic agent, or substantially concurrently with the biological/therapeutic agent. -
FIG. 31 is a flowchart illustrating a method of accessing and treating a pancreas. The method can be used, for example, to occlude a portion of the splenic branch of the celiac artery supplying the pancreatic tail. The method includes introducing a catheter (e.g., thecatheter device first catheter second catheter distal occlusion element FIG. 30 ). The distal occlusion element and a proximal occlusion element (e.g., theproximal occlusion element pancreatic artery 42 if the origin is within thesplenic artery 40, and (c) bothpancreatic magnum artery 44 and dorsalpancreatic artery 42 arteries are isolated in one contiguous area (if other extra-pancreatic arteries do not arise between the origin of the two within the splenic artery 40). - After the first takeoff of the
pancreatic magnum artery 44 is identified (or the dorsal pancreatic artery), the placement of the outer catheter of the catheter device can allow the edge of the distal occlusion element to be placed beyond this artery. At this point, the inner catheter can be secured in place, and the outer catheter can be moved relative to the inner catheter to allow the maximum perfusion area to the body and tail of the pancreas. Frequent injection of contrast through the infusion port can be made to ensure no extra-pancreatic vessels are included in the isolated area. - After the desired area is isolated and the occlusion elements are positioned at a desired location, the therapeutic cells/biologics/agent is introduced to the isolated area of the splenic artery through the infusion port of the outer catheter, at 506. The infusion port design can allow rapid and atraumatic infusion of cells/biologics/agent into the isolated area. This allows the clinician to adjust rate of infusion of therapeutic cells/biologics/agents into the isolated area based on specific pharmacodynamics and or engraftment efficiency requirements. The infusion of the therapeutic material can be followed by heparinized blood to exclude any residual cells left behind in the dead space of the catheter device. During isolation of the artery described above, perfusion to the end organ to the artery spleen can be disrupted, but the redundancy in the arterial perfusion system to the spleen, and limited time during which the arterial supply is interrupted, should prevent any long-term sequela, or abnormal condition of the splenic cells. If needed and/or desired, the guidewire port can be used to perform perfusion of the splenic artery beyond the isolated area. For example, the guidewire can be removed from its port after the catheter device is in place, and the guidewire port can be connected to a source of arterial blood with suitable pressure (i.e. the side port of an arterial sheath or guide sheath). At the end of the infusion, both occlusion elements are moved to a collapsed configuration and the catheter device is removed from the body over the guidewire as one unit, followed by the guidewire and the guide catheter.
- In a variation of the method described above using balloons as the occlusion elements, the same catheter can be used to isolate arterial branches supplying the head of the pancreas via the hepatic artery or superior mesenteric artery. One such clinical possibility is treatment of pancreatic cancer with the tumor located in the head of the pancreas. After placement of the catheter device in the respective artery, the infusion of contrast through the infusion port can identify the branches most proximate to the tumor, and then after occluding the distal and proximal portion of the artery around the branch(es), the chemotherapeutic agent can be delivered selectively to the area of interest in the pancreas.
- In some embodiments, a method can include introducing a catheter device into a splenic artery. The catheter device can include an inner catheter, a first expandable occlusion element coupled to the inner catheter, an outer catheter defining a first lumen configured to introduce a therapeutic biologic/agent to one or more target pancreatic vessels, a second lumen configured to slidably receive at least a portion of the inner catheter, and a second expandable occlusion element coupled to the outer catheter and disposed proximally to the first occlusion element. The catheter is advanced to a target pancreatic portion of the splenic artery. A region of the target pancreatic portion of the splenic artery is selectively isolated and the therapeutic biologic/agent is injected into the isolated region. In some embodiments, the therapeutic biologic/agent includes stem cells. In some embodiments, the method further includes advancing at least a portion of the catheter device to an ostium of a celiac artery, its hepatic branch, or if necessary, the superior mesenteric artery (based on individual anatomy). In some embodiments, a contrast dye is injected into the isolated region and isolation of a pancreatic magnum artery and/or a dorsal pancreatic artery can be confirmed. In some embodiments, a guidewire can be disposed through the infusion lumen to focally perforate the vascular lumen in the isolated area to increase exogenous cell penetration into the pancreatic tissue. In some embodiments, the therapeutic biologic can be introduced into the isolated segment or region to enhance cellular transmigration across the endothelial cells prior to introduction of the therapeutic biologic.
- In some embodiments, a method can include introducing a catheter device into a bile duct. In use, the
catheter device 200 can be placed at a desired location within the bile duct and used to infuse a therapeutic agents into the bile duct which will diffuse through the bile duct into the pancreas. A length of thefirst catheter 260 and thesecond catheter 270 can be adjusted such that a selected portion of the bile duct is isolated between thefirst occlusion element 268 and thesecond occlusion element 278. A therapeutic agent can be injected through thecatheter device 200 and into the isolated region of the bile duct. - The infusion pressure in the isolated blood vessel region can be measured with pressure monitoring through the infusion lumen of the catheter (with a monometer (not shown) in line with infusion port 279). The pressure in the
third lumen 276 can be based on the size of the agents being delivered, on the flow rate, the viscosity of the solution, and/or flow resistance of thethird lumen 276 ofsecond catheter 270. The flow resistance of thecatheter device 200 can in turn be determined based on, for example, the inner coating material, the size and the length of thethird lumen 276, the size of thethird port 240, and/or the size of thedistal infusion aperture 279. Thecatheter device 200 can allow for rapid infusion of agents (e.g., up to 2 milliliter per second (ml/sec)). In some applications, the rapid infusion can enhance uptake and eventual engraftment. - Any catheter device described herein and/or any combination of the catheter devices described herein can allow the above goals to be achieved. For example, a catheter device can include two catheters slidably coupled where an inner catheter defines a guidewire housing port and a distal occlusion element, and an outer catheter forms an infusion port and a proximal occlusion element, along with an inner lumen allowing the insertion of the inner catheter. The two catheters can be assembled outside the body with a distance between the two occlusion elements set to a desired length. For example, in some embodiments, the minimum distance between the two occlusion elements can be 3 cm, and the length can be adjusted up to a distance between the two occlusion elements of 25 cm as needed.
- The devices described herein can also be provided in a kit. In some embodiments, a kit for use in the delivery of a biological agent to an area proximal to the pancreas can include, for example, one or more catheter devices (e.g., the
catheter devices - In some embodiments, a kit can further include one or more biologic/therapeutic agents for delivery to the pancreas, a stylet(s); one or more catheters adapted and configured for accessing the pancreatic vessels; a dilator; a guidewire; a guide catheter; capsules for direct connection of biological materials/cells to the infusion port of the delivery catheter; a manometer to monitor the pressure in the isolated area; and/or a pump to regulate the infusion rate of cells/biologics.
- In some embodiments, any of the components of a kit can be packaged together and collectively sold as a catheter device or can be packaged independently or in subgroups and sold together or separately. For example, in some embodiments, the
handle 410 can be packaged independently from thefirst catheter 460 and thesecond catheter 470. Moreover, thefirst catheter 460 and thesecond catheter 470 can be packaged independent from one another or packaged together. As such, thehandle 410 can be sold independent of thefirst catheter 460 and thesecond catheter 470. Thefirst catheter 460 and thesecond catheter 470 can be sold independent of one another or together. Thus, in some embodiments, thehandle 410 can be packaged independent of thefirst catheter 460 and thesecond catheter 470 and, prior to use, can be coupled to thefirst catheter 460 and thesecond catheter 470 such that the first set ofports 428 are in fluid communication with the corresponding lumen of thefirst catheter 460 and the second set ofports 443 are in fluid communication with the corresponding lumen of thesecond catheter 470. In some embodiments, thehandle 410 can be, for example, reusable, while thefirst catheter 460 and thesecond catheter 470 are disposable. In other embodiments, thehandle 410 can be coupled to thefirst catheter 460 and thesecond catheter 470 during, for example, a manufacturing process and packaged together to be sold as a complete catheter device. - In some embodiments, placement of the occlusion elements (e.g., the
distal occlusion elements proximal occlusion elements catheter devices guidewire 280 and/or 380). Furthermore, for thefirst catheters second catheters - The
first catheters second catheters - In some embodiments, regions of a first catheter (i.e., an inner catheter) such as those described herein can also be fabricated in any manner that allows the relative stiffness of each region to vary. In some embodiments, an outer layer in each region of an outer catheter and/or an inner catheter can include a material with a different durometer measurement of hardness. For example, the material used in an intermediate region can be relatively harder than that used in a distal region, and the material used in a proximal region can be relatively harder than that used in the intermediate region. Other manners of varying the stiffness of an inner catheter and/or an outer catheter (i.e., a first catheter and a second catheter, respectively, such as those described herein) can include varying the length of a reinforcement structure, varying the degree of reinforcement provided by the reinforcement structure along the length of the inner catheter and/or the outer catheter, changing a cross-sectional size and/or shape of the inner catheter and/or the outer catheter, introducing and/or forming one or more discontinuities along a length of the inner catheter and/or the outer catheter (e.g., one or more ribs, notches, grooves, protrusions, etc.), and/or any other suitable means for varying stiffness.
- In some embodiments, the catheter devices described herein can include one or more sensors that can provide relative information such as, for example, position of the occlusion members, movement of the actuator, flow rate of the biological agent, and/or any other suitable information. For example, in some embodiments, a sensor can be operably coupled to the
actuator 450 of thedevice 400 and can be configured to provide information associated with a distance that theactuator 450 has been moved. In such embodiments, a user and/or an electronic device can determine a distance between theocclusion member 468 of thefirst catheter 460 and theocclusion member 478 of thesecond catheter 470 based on the information from the sensor. In some embodiments, a sensor can be disposed within thethird lumen 476 of thesecond catheter 470 that can be configured to determine a flow rate of irrigation and/or a biological/therapeutic agent therethrough. - In some embodiments, radiopaque markers of gold or tantalum, for example, can also be provided on or in an inner catheter positioned, within or on an occlusion element(s) (e.g., the
occlusion elements catheter devices - In some embodiments, an outer diameter of an outer catheter (e.g., the
second catheters occlusion elements - In some embodiments, after a guidewire (e.g., the
guidewire 280 and/or 380) is removed, a corresponding lumen (e.g., thesecond lumen first catheter - In some embodiments, any suitable configuration of the catheter devices can be used to achieve the objectives described herein including, for example, employing one or
more catheter devices - In some embodiments, to allow endovascular isolation of the pancreatic portion of the splenic artery 40 (see e.g.,
FIG. 1 ) as a mechanism to achieve substantially exclusive delivery of a therapeutic agent/cells to the pancreatic parenchyma, a catheter device such as those described herein can include anatomical and mechanical features such as, for example, isolation of the two ends of the pancreatic portion of the artery using two occlusion elements; adjustment of the diameter of the occlusion elements to meet the specific anatomical needs; adjustment of the distance between the two occlusion elements (based on individual variation to selectively isolate for instance the portion of thesplenic artery 40 to thepancreas 30 on one hand and maximize the perfusion area on the other hand); an infusion port where injection of contrast can be used to visualize the area of the artery isolated; an infusion port, shaft, and/or aperture design to allow atraumatic and rapid delivery of cells/therapeutic agents; and/or recovery of the occlusion element along with the catheter at the end of the procedure, prior to which flushes through the infusion port can assure clearance of the cells from the isolated space. - In some instances, any portion of the
catheter devices infusion apertures pancreas 30, in some instances, thecatheter device second catheter 470 relative to thepancreas 30. Thus, theinfusion aperture second catheter infusion aperture catheter device infusion aperture infusion aperture - Any catheter device described herein and/or any combination of the catheter devices described herein can allow the above goals to be achieved. For example, a catheter device can include two catheters slidably coupled where an inner catheter defines a guidewire housing port and a distal occlusion element, and an outer catheter forms an infusion port and a proximal occlusion element, along with an inner lumen allowing the insertion of the inner catheter. The two catheters can be assembled outside the body with a distance between the two occlusion elements set to a desired length. For example, in some embodiments, the minimum distance between the two occlusion elements can be 3 cm, and the length can be adjusted up to a distance between the two occlusion elements of 25 cm as needed.
- In some embodiments, a catheter device such as those described herein, which is suitable for accessing the pancreas 30 (see e.g.,
FIG. 1 ) can include features and/or functions, such as, for example, selective isolation of the targeted portion of the pancreatic portion of the splenic artery 40 for targeted delivery of the therapeutic agent to the pancreas 30; an adjustable distance between the two ends of the perfusion/infusion area (e.g., an isolated region) to accommodate individual anatomy to allow isolation of the largest portion of the splenic artery 40 with branches only supplying the pancreatic tail 32 and body 34 (see e.g.,FIG. 1 ) and if clinically indicated, the same catheter can be used to isolate portions of the hepatic artery 54 and/or superior mesenteric artery 52 supplying the head of the pancreas 38; an infusion port allowing first, injection of contrast into the isolated segment to allow direct visualization of the origin of the branches of the splenic artery 40 supplying the pancreatic tissue, and second, introduction of therapeutic drugs/cells, the dimensions and design of the infusion port and catheter shaft allowing rapid and atraumatic delivery of cells; adjustable diameter of the proximal and/or distal occluders to allow both intravariable and intervariable sizes of the splenic artery 40; and/or a self-contained assembly unit with easy retrieval after completion of the procedure. - While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. Furthermore, each feature disclosed herein may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
- For example, although the
outer catheters catheter devices inner catheter inner catheter outer catheter catheter devices first catheter second catheter second catheter 270 and/or 370, the sealingelement 285 and/or 385 can alternatively be coupled to thefirst catheter 260 and/or 360. - Although the
catheter devices balloon elements 268 and/or 278) and one or more filter element occlusion elements (e.g., thefilter elements 368 and/or 378). - While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. Furthermore, each feature disclosed herein may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
- Where methods and/or events described above indicate certain events and/or procedures occurring in certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain events and/or procedures may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
Claims (21)
1. (canceled)
2. A method of treatment, the method comprising:
inserting a catheter into a bile duct;
occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder, to isolate a region of the bile duct;
delivering a therapeutic agent into the isolated region of the bile duct; and
maintaining a pressure in the isolated region of the bile duct to diffuse the therapeutic agent into a tissue around the bile duct.
3. The method of claim 2 , wherein maintaining the pressure of the isolated region of the bile duct comprises delivering the therapeutic agent into the isolated region of the bile duct under pressure.
4. The method of claim 2 , further comprising increasing or decreasing the pressure in the isolated region of the bile duct to change a penetration depth of the therapeutic agent into the tissue around the bile duct.
5. The method of claim 2 , wherein the tissue around the bile duct comprises a tumor.
6. The method of claim 2 , wherein the tissue around the bile duct comprises one or more of: a pancreatic tumor, a liver tumor and a cholangiocarcinoma.
7. The method of claim 2 , wherein inserting the catheter comprises advancing the catheter over a guidewire within the bile duct.
8. The method of claim 2 , wherein inserting the catheter comprises inserting the catheter into the bile duct to a region of the bile duct that adjacent to a tumor.
9. The method of claim 2 , wherein inserting the catheter comprises inserting the catheter through an endoscopic retrograde cholangiopancreatogram (ERCP) catheter.
10. The method of claim 2 , wherein inserting the catheter comprises inserting the catheter percutaneously.
11. The method of claim 2 , wherein inserting comprises adjusting the distance between the first occluder and the second occluder by advancing the first occluder distally, wherein the first occluder is on an inner catheter slidably disposed within a lumen of the catheter.
12. The method of claim 2 , wherein occluding the bile duct comprises inflating the first occluder and the second occluder.
13. The method of claim 2 , wherein the therapeutic agent is selected from the group of: (5-fluorouracil (5-FU), Aldesleukin, Axitinib, Bleomycin, Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, doxorubicin liposomal non-pegylated (un-coated), doxorubicin liposomal pegylated (PEG coated), Floxuridine, Gemcitabine Hydrochloride, Irinotecan Hydrochloride Liposome, Lanreotide Acetate, leucovorin (antidote to folic acid antagonist used with 5FU), Methotrexate, Mitomycin, Mitoxantrone, Nivolumab, Olaparib, Oxaliplatin, Sorafenib Tosylate, Temsirolimus, Thiotepa, Topotecan Hydrochloride, Vinblastine Sulfate, vincristine sulfate).
14. A method of treatment, the method comprising:
inserting a catheter into a bile duct to a region of the bile duct that adjacent to a tumor;
isolating a region of the bile duct adjacent to the tumor by occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder;
introducing a therapeutic agent into the isolated region of the bile duct from out of an opening in a side wall of the catheter between the first occluder and the second occluder; and
diffusing the therapeutic agent into a tissue around the bile duct by maintaining the pressure in the isolated region of the bile duct at greater than an interstitial tissue pressure in the tissue around the bile duct.
15. The method of claim 14 , further comprising increasing or decreasing the pressure in the isolated region of the bile duct to change a penetration depth of the therapeutic agent into the tissue around the bile duct.
16. The method of claim 14 , wherein the tumor comprises one or more of: a pancreatic tumor, a liver tumor and a cholangiocarcinoma.
17. The method of claim 14 , wherein inserting the catheter comprises advancing the catheter over a guidewire within the bile duct.
18. The method of claim 14 , wherein inserting the catheter comprises inserting the catheter through an endoscopic retrograde cholangiopancreatogram (ERCP) catheter.
19. The method of claim 14 , wherein inserting comprises adjusting the distance between the first occluder and the second occluder by advancing the first occluder distally, wherein the first occluder is on an inner catheter slidably disposed within a lumen of the catheter.
20. The method of claim 14 , wherein the therapeutic agent is selected from the group of: (5-fluorouracil (5-FU), Aldesleukin, Axitinib, Bleomycin, Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, doxorubicin liposomal non-pegylated (un-coated), doxorubicin liposomal pegylated (PEG coated), Floxuridine, Gemcitabine Hydrochloride, Irinotecan Hydrochloride Liposome, Lanreotide Acetate, leucovorin (antidote to folic acid antagonist used with 5FU), Methotrexate, Mitomycin, Mitoxantrone, Nivolumab, Olaparib, Oxaliplatin, Sorafenib Tosylate, Temsirolimus, Thiotepa, Topotecan Hydrochloride, Vinblastine Sulfate, vincristine sulfate).
21. A method of treatment, the method comprising:
inserting a catheter into a bile duct to a region of the bile duct that adjacent to a tumor;
isolating a region of the bile duct adjacent to the tumor by occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder;
injecting a therapeutic agent into the isolated region of the bile duct from out of an opening in a side wall of the catheter between the first occluder and the second occluder so that the pressure in the isolated region of the bile duct is greater than an interstitial tissue pressure in a tissue around the bile duct, whereby the therapeutic agent diffuses into the tissue around the bile duct.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/685,950 US20200206481A1 (en) | 2009-12-02 | 2019-11-15 | Methods for delivery of therapeutic materials to treat cancer |
US17/558,577 US11541211B2 (en) | 2009-12-02 | 2021-12-21 | Methods for delivery of therapeutic materials to treat cancer |
US18/149,649 US20230355934A1 (en) | 2009-12-02 | 2023-01-03 | Methods for delivery of therapeutic materials to treat cancer |
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US26584509P | 2009-12-02 | 2009-12-02 | |
US12/958,711 US8821476B2 (en) | 2009-12-02 | 2010-12-02 | Devices, methods and kits for delivery of therapeutic materials to a pancreas |
US201361830218P | 2013-06-03 | 2013-06-03 | |
US14/293,603 US9457171B2 (en) | 2009-12-02 | 2014-06-02 | Devices, methods and kits for delivery of therapeutic materials to a target artery |
US14/870,833 US9463304B2 (en) | 2009-12-02 | 2015-09-30 | Devices, methods and kits for delivery of therapeutic materials to a pancreas |
US14/958,415 US20160082178A1 (en) | 2009-12-02 | 2015-12-03 | Angiographic methods for identification of feeder vessels |
US15/351,922 US10512761B2 (en) | 2009-12-02 | 2016-11-15 | Methods for delivery of therapeutic materials to treat pancreatic cancer |
US16/685,950 US20200206481A1 (en) | 2009-12-02 | 2019-11-15 | Methods for delivery of therapeutic materials to treat cancer |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/351,922 Continuation US10512761B2 (en) | 2009-12-02 | 2016-11-15 | Methods for delivery of therapeutic materials to treat pancreatic cancer |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/558,577 Continuation US11541211B2 (en) | 2009-12-02 | 2021-12-21 | Methods for delivery of therapeutic materials to treat cancer |
Publications (1)
Publication Number | Publication Date |
---|---|
US20200206481A1 true US20200206481A1 (en) | 2020-07-02 |
Family
ID=58097373
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/351,922 Active 2032-04-01 US10512761B2 (en) | 2009-12-02 | 2016-11-15 | Methods for delivery of therapeutic materials to treat pancreatic cancer |
US16/685,950 Abandoned US20200206481A1 (en) | 2009-12-02 | 2019-11-15 | Methods for delivery of therapeutic materials to treat cancer |
US17/558,577 Active US11541211B2 (en) | 2009-12-02 | 2021-12-21 | Methods for delivery of therapeutic materials to treat cancer |
US18/149,649 Pending US20230355934A1 (en) | 2009-12-02 | 2023-01-03 | Methods for delivery of therapeutic materials to treat cancer |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/351,922 Active 2032-04-01 US10512761B2 (en) | 2009-12-02 | 2016-11-15 | Methods for delivery of therapeutic materials to treat pancreatic cancer |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/558,577 Active US11541211B2 (en) | 2009-12-02 | 2021-12-21 | Methods for delivery of therapeutic materials to treat cancer |
US18/149,649 Pending US20230355934A1 (en) | 2009-12-02 | 2023-01-03 | Methods for delivery of therapeutic materials to treat cancer |
Country Status (1)
Country | Link |
---|---|
US (4) | US10512761B2 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11541211B2 (en) | 2009-12-02 | 2023-01-03 | Renovorx, Inc. | Methods for delivery of therapeutic materials to treat cancer |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9539081B2 (en) | 2009-12-02 | 2017-01-10 | Surefire Medical, Inc. | Method of operating a microvalve protection device |
WO2014197362A1 (en) | 2013-06-03 | 2014-12-11 | Ramtin Agah | Devices, methods and kits for delivery of therapeutic materials to a pancreas |
US9968740B2 (en) | 2014-03-25 | 2018-05-15 | Surefire Medical, Inc. | Closed tip dynamic microvalve protection device |
US20160287839A1 (en) | 2015-03-31 | 2016-10-06 | Surefire Medical, Inc. | Apparatus and Method for Infusing an Immunotherapy Agent to a Solid Tumor for Treatment |
US11400263B1 (en) | 2016-09-19 | 2022-08-02 | Trisalus Life Sciences, Inc. | System and method for selective pressure-controlled therapeutic delivery |
US10780250B1 (en) | 2016-09-19 | 2020-09-22 | Surefire Medical, Inc. | System and method for selective pressure-controlled therapeutic delivery |
US10588636B2 (en) | 2017-03-20 | 2020-03-17 | Surefire Medical, Inc. | Dynamic reconfigurable microvalve protection device |
US10695543B2 (en) | 2017-05-18 | 2020-06-30 | Renovorx, Inc. | Methods for treating cancerous tumors |
US11052224B2 (en) | 2017-05-18 | 2021-07-06 | Renovorx, Inc. | Methods for treating cancerous tumors |
US11559673B2 (en) | 2018-06-22 | 2023-01-24 | Acclarent, Inc. | Multi-balloon instrument for dilating eustachian tube via middle ear |
CN112426617B (en) * | 2018-07-30 | 2023-09-01 | 郑州大学第一附属医院 | Cone-shaped expansion saccule for cardiovascular interventional therapy |
US11850398B2 (en) | 2018-08-01 | 2023-12-26 | Trisalus Life Sciences, Inc. | Systems and methods for pressure-facilitated therapeutic agent delivery |
CN109700494A (en) * | 2018-08-03 | 2019-05-03 | 东莞天天向上医疗科技有限公司 | A kind of intravascular quick-acting haemostatic powder foley's tube of multichannel and more sacculus |
US11338117B2 (en) | 2018-10-08 | 2022-05-24 | Trisalus Life Sciences, Inc. | Implantable dual pathway therapeutic agent delivery port |
US20200383688A1 (en) * | 2019-06-04 | 2020-12-10 | Surefire Medical, Inc. | Atraumatic Occlusive System with Compartment for Measurement of Vascular Pressure Change |
Family Cites Families (140)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4445892A (en) | 1982-05-06 | 1984-05-01 | Laserscope, Inc. | Dual balloon catheter device |
US4714460A (en) * | 1983-07-29 | 1987-12-22 | Reynaldo Calderon | Methods and systems for retrograde perfusion in the body for curing it of the disease or immume deficiency |
US4883459A (en) | 1983-07-29 | 1989-11-28 | Reynaldo Calderon | Retrograde perfusion |
US4696304A (en) * | 1984-09-10 | 1987-09-29 | Thomas J. Fogarty | Thermodilution flow-directed catheter assembly and method |
US4665746A (en) * | 1985-07-17 | 1987-05-19 | Sheppard William J | Liquid level measuring apparatus and method |
US4655746A (en) * | 1985-12-02 | 1987-04-07 | Target Therapeutics | Catheter device |
JPH01207078A (en) | 1988-02-15 | 1989-08-21 | Terumo Corp | Catheter tube and endoscope |
US4830003A (en) | 1988-06-17 | 1989-05-16 | Wolff Rodney G | Compressive stent and delivery system |
US5575815A (en) | 1988-08-24 | 1996-11-19 | Endoluminal Therapeutics, Inc. | Local polymeric gel therapy |
US5069662A (en) | 1988-10-21 | 1991-12-03 | Delcath Systems, Inc. | Cancer treatment |
DE69224187T2 (en) | 1991-04-05 | 1998-08-06 | Boston Scient Corp | CONVERTIBLE CATHETER UNIT |
US5281200A (en) | 1992-12-08 | 1994-01-25 | Cordis Corporation | Multiple component balloon catheter system and stenosis treatment procedure |
US5318535A (en) | 1993-06-21 | 1994-06-07 | Baxter International Inc. | Low-profile dual-lumen perfusion balloon catheter with axially movable inner guide sheath |
US6113576A (en) | 1993-08-04 | 2000-09-05 | Lake Region Manufacturing, Inc. | Thrombolysis catheter system with fixed length infusion zone |
US5338301A (en) | 1993-08-26 | 1994-08-16 | Cordis Corporation | Extendable balloon-on-a-wire catheter, system and treatment procedure |
US5462529A (en) | 1993-09-29 | 1995-10-31 | Technology Development Center | Adjustable treatment chamber catheter |
US5397307A (en) | 1993-12-07 | 1995-03-14 | Schneider (Usa) Inc. | Drug delivery PTCA catheter and method for drug delivery |
US5419763B1 (en) | 1994-01-04 | 1997-07-15 | Cor Trak Medical Inc | Prostatic drug-delivery catheter |
US5415636A (en) | 1994-04-13 | 1995-05-16 | Schneider (Usa) Inc | Dilation-drug delivery catheter |
US5484412A (en) | 1994-04-19 | 1996-01-16 | Pierpont; Brien E. | Angioplasty method and means for performing angioplasty |
US5478309A (en) | 1994-05-27 | 1995-12-26 | William P. Sweezer, Jr. | Catheter system and method for providing cardiopulmonary bypass pump support during heart surgery |
US5836905A (en) | 1994-06-20 | 1998-11-17 | Lemelson; Jerome H. | Apparatus and methods for gene therapy |
US5514092A (en) | 1994-08-08 | 1996-05-07 | Schneider (Usa) Inc. | Drug delivery and dilatation-drug delivery catheters in a rapid exchange configuration |
US5833672A (en) | 1994-12-12 | 1998-11-10 | Nippon Zeon Co., Ltd. | Double tube, balloon catheter produced by using double tube, and process for producing balloon catheter |
WO1996030073A1 (en) | 1995-03-30 | 1996-10-03 | Heartport, Inc. | Endovascular cardiac venting catheter and method |
US5833650A (en) | 1995-06-05 | 1998-11-10 | Percusurge, Inc. | Catheter apparatus and method for treating occluded vessels |
AU6501296A (en) | 1995-07-21 | 1997-02-18 | General Hospital Corporation, The | Method and apparatus of enhancing the delivery of a pharmaceutical formulation |
US5925016A (en) | 1995-09-27 | 1999-07-20 | Xrt Corp. | Systems and methods for drug delivery including treating thrombosis by driving a drug or lytic agent through the thrombus by pressure |
US6440097B1 (en) | 1995-10-06 | 2002-08-27 | Target Therapeutics, Inc. | Balloon catheter with delivery side holes |
JPH09117510A (en) * | 1995-10-26 | 1997-05-06 | Buaayu:Kk | Infusion catheter |
US5843050A (en) | 1995-11-13 | 1998-12-01 | Micro Therapeutics, Inc. | Microcatheter |
FR2748212B1 (en) | 1996-05-06 | 1998-07-31 | Nycomed Lab Sa | CATHETER FOR LOCAL DELIVERY OF A THERAPEUTICALLY ACTIVE SUBSTANCE |
CA2254831C (en) | 1996-05-14 | 2006-10-17 | Embol-X, Inc. | Aortic occluder with associated filter and methods of use during cardiac surgery |
US5833644A (en) | 1996-05-20 | 1998-11-10 | Percusurge, Inc. | Method for emboli containment |
US6270477B1 (en) | 1996-05-20 | 2001-08-07 | Percusurge, Inc. | Catheter for emboli containment |
US6022336A (en) | 1996-05-20 | 2000-02-08 | Percusurge, Inc. | Catheter system for emboli containment |
US6325826B1 (en) | 1998-01-14 | 2001-12-04 | Advanced Stent Technologies, Inc. | Extendible stent apparatus |
DE69839007T2 (en) | 1997-02-04 | 2009-01-22 | Cook Urological Inc., Spencer | DRAINAGE CATHETER TO BE INSERTED BY THE BELLOW CEILING |
US5919135A (en) | 1997-02-28 | 1999-07-06 | Lemelson; Jerome | System and method for treating cellular disorders in a living being |
US6176844B1 (en) | 1997-05-22 | 2001-01-23 | Peter Y. Lee | Catheter system for the isolation of a segment of blood vessel |
ATE267625T1 (en) | 1997-06-23 | 2004-06-15 | Schneider Europ Gmbh | CATHETER ARRANGEMENT |
US5919163A (en) | 1997-07-14 | 1999-07-06 | Delcath Systems, Inc. | Catheter with slidable balloon |
US5968012A (en) | 1997-08-22 | 1999-10-19 | Scimed Lifesystems, Inc. | Balloon catheter with adjustable shaft |
US20010041862A1 (en) | 1997-09-02 | 2001-11-15 | Morton G. Glickman | Novel apparatus and method of treating a tumor in the extremity of a patient |
US5961536A (en) | 1997-10-14 | 1999-10-05 | Scimed Life Systems, Inc. | Catheter having a variable length balloon and method of using the same |
US6375634B1 (en) | 1997-11-19 | 2002-04-23 | Oncology Innovations, Inc. | Apparatus and method to encapsulate, kill and remove malignancies, including selectively increasing absorption of x-rays and increasing free-radical damage to residual tumors targeted by ionizing and non-ionizing radiation therapy |
US6699231B1 (en) * | 1997-12-31 | 2004-03-02 | Heartport, Inc. | Methods and apparatus for perfusion of isolated tissue structure |
US6986788B2 (en) | 1998-01-30 | 2006-01-17 | Synthes (U.S.A.) | Intervertebral allograft spacer |
US6156053A (en) | 1998-05-01 | 2000-12-05 | Intella Interventional Systems, Inc. | Dual catheter assembly |
US6508777B1 (en) | 1998-05-08 | 2003-01-21 | Cardeon Corporation | Circulatory support system and method of use for isolated segmental perfusion |
US8177743B2 (en) | 1998-05-18 | 2012-05-15 | Boston Scientific Scimed, Inc. | Localized delivery of drug agents |
US6206283B1 (en) | 1998-12-23 | 2001-03-27 | At&T Corp. | Method and apparatus for transferring money via a telephone call |
ATE312641T1 (en) | 1998-05-21 | 2005-12-15 | Us Gov Health & Human Serv | CANNULA FOR SELECTIVE, PRESSURE-DEPENDENT ADMINISTRATION OF THERAPEUTIC SUBSTANCES |
JPH11342208A (en) | 1998-06-02 | 1999-12-14 | Buaayu:Kk | Balloon catheter |
US6083198A (en) | 1998-06-25 | 2000-07-04 | Cardiovention, Inc. | Perfusion catheter providing segmented flow regions and methods of use |
US6461327B1 (en) | 1998-08-07 | 2002-10-08 | Embol-X, Inc. | Atrial isolator and method of use |
US6165152A (en) | 1998-09-11 | 2000-12-26 | Advanced Cardiovascular Systems, Inc. | Catheter with a flexible tip and taper and method of manufacture |
US6051014A (en) | 1998-10-13 | 2000-04-18 | Embol-X, Inc. | Percutaneous filtration catheter for valve repair surgery and methods of use |
US7780628B1 (en) | 1999-01-11 | 2010-08-24 | Angiodynamics, Inc. | Apparatus and methods for treating congestive heart disease |
US6743196B2 (en) | 1999-03-01 | 2004-06-01 | Coaxia, Inc. | Partial aortic occlusion devices and methods for cerebral perfusion augmentation |
US6287290B1 (en) | 1999-07-02 | 2001-09-11 | Pulmonx | Methods, systems, and kits for lung volume reduction |
US6351663B1 (en) | 1999-09-10 | 2002-02-26 | Akorn, Inc. | Methods for diagnosing and treating conditions associated with abnormal vasculature using fluorescent dye angiography and dye-enhanced photocoagulation |
US6575932B1 (en) | 1999-12-02 | 2003-06-10 | Ottawa Heart Institute | Adjustable multi-balloon local delivery device |
US6929633B2 (en) | 2000-01-25 | 2005-08-16 | Bacchus Vascular, Inc. | Apparatus and methods for clot dissolution |
US6482172B1 (en) | 2000-02-09 | 2002-11-19 | Jeffrey J. Thramann | Flow-by channel catheter and method of use |
US6346098B1 (en) | 2000-03-07 | 2002-02-12 | The Board Of Trustees Of The Leland Stanford Junior University | Methods and kits for locally administering an active agent to an interstitial space of a host |
US6485500B1 (en) | 2000-03-21 | 2002-11-26 | Advanced Cardiovascular Systems, Inc. | Emboli protection system |
US6685672B1 (en) | 2000-07-13 | 2004-02-03 | Edwards Lifesciences Corporation | Multi-balloon drug delivery catheter for angiogenesis |
US6569146B1 (en) | 2000-08-18 | 2003-05-27 | Scimed Life Systems, Inc. | Method and apparatus for treating saphenous vein graft lesions |
US6692458B2 (en) | 2000-12-19 | 2004-02-17 | Edwards Lifesciences Corporation | Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis |
US6436090B1 (en) | 2000-12-21 | 2002-08-20 | Advanced Cardiovascular Systems, Inc. | Multi lumen catheter shaft |
US7357794B2 (en) | 2002-01-17 | 2008-04-15 | Medtronic Vascular, Inc. | Devices, systems and methods for acute or chronic delivery of substances or apparatus to extravascular treatment sites |
US6602241B2 (en) | 2001-01-17 | 2003-08-05 | Transvascular, Inc. | Methods and apparatus for acute or chronic delivery of substances or apparatus to extravascular treatment sites |
US7179251B2 (en) | 2001-01-17 | 2007-02-20 | Boston Scientific Scimed, Inc. | Therapeutic delivery balloon |
US8979801B2 (en) | 2001-01-17 | 2015-03-17 | Medtronic Vascular, Inc. | Microcatheter devices and methods for targeted substance delivery |
US6749581B2 (en) | 2001-02-02 | 2004-06-15 | Medtronic, Inc. | Variable infusion rate catheter |
US7766894B2 (en) | 2001-02-15 | 2010-08-03 | Hansen Medical, Inc. | Coaxial catheter system |
EP3097863A1 (en) | 2001-02-15 | 2016-11-30 | Hansen Medical, Inc. | Flexible instrument |
US6887227B1 (en) | 2001-02-23 | 2005-05-03 | Coaxia, Inc. | Devices and methods for preventing distal embolization from the vertebrobasilar artery using flow reversal |
US6520183B2 (en) | 2001-06-11 | 2003-02-18 | Memorial Sloan-Kettering Cancer Center | Double endobronchial catheter for one lung isolation anesthesia and surgery |
US6682499B2 (en) | 2001-06-28 | 2004-01-27 | Jay Alan Lenker | Method and apparatus for venous drainage and retrograde coronary perfusion |
US6706013B1 (en) | 2001-06-29 | 2004-03-16 | Advanced Cardiovascular Systems, Inc. | Variable length drug delivery catheter |
US6533800B1 (en) * | 2001-07-25 | 2003-03-18 | Coaxia, Inc. | Devices and methods for preventing distal embolization using flow reversal in arteries having collateral blood flow |
US7452532B2 (en) | 2001-09-30 | 2008-11-18 | Scicotec Gmbh | Transluminal application of adult stem cells for body organ tissue repair |
AU2003214945A1 (en) | 2002-02-01 | 2003-09-02 | Robert J. Goldman | Multi-function catheter and use thereof |
US8062251B2 (en) | 2002-02-01 | 2011-11-22 | Vascular Designs, Inc. | Multi-function catheter and use thereof |
US7503904B2 (en) | 2002-04-25 | 2009-03-17 | Cardiac Pacemakers, Inc. | Dual balloon telescoping guiding catheter |
US20050015048A1 (en) | 2003-03-12 | 2005-01-20 | Chiu Jessica G. | Infusion treatment agents, catheters, filter devices, and occlusion devices, and use thereof |
US7250041B2 (en) | 2003-03-12 | 2007-07-31 | Abbott Cardiovascular Systems Inc. | Retrograde pressure regulated infusion |
JP2004337400A (en) | 2003-05-16 | 2004-12-02 | Terumo Corp | Medication kit |
US20050059930A1 (en) | 2003-09-16 | 2005-03-17 | Michi Garrison | Method and apparatus for localized drug delivery |
US20050059931A1 (en) * | 2003-09-16 | 2005-03-17 | Venomatrix | Methods and apparatus for localized and semi-localized drug delivery |
JP3877075B2 (en) | 2004-01-28 | 2007-02-07 | 有限会社エスアールジェイ | Endoscope device |
US20060009798A1 (en) | 2004-02-02 | 2006-01-12 | Ams Research Corporation | Methods and devices for occluding body lumens and/or enhancing tissue ingrowth |
US8764729B2 (en) * | 2004-04-21 | 2014-07-01 | Acclarent, Inc. | Frontal sinus spacer |
US7815624B2 (en) | 2004-05-18 | 2010-10-19 | Boston Scientific Scimed, Inc. | Medical devices and methods of making the same |
JP2008519659A (en) | 2004-11-12 | 2008-06-12 | リージェンツ オブ ザ ユニバーシティ オブ ミネソタ | Vein occlusion device and method of use |
US7947030B2 (en) | 2004-12-30 | 2011-05-24 | Reynaldo Calderon | Retrograde perfusion of tumor sites |
US7789846B2 (en) | 2005-01-25 | 2010-09-07 | Thermopeutix, Inc. | System and methods for selective thermal treatment |
US8721592B2 (en) * | 2006-01-25 | 2014-05-13 | Thermopeutix, Inc. | Variable length catheter for drug delivery |
US7708715B2 (en) | 2005-03-21 | 2010-05-04 | Boston Scientific Scimed, Inc. | Tissue approximation device |
US20060253078A1 (en) * | 2005-04-25 | 2006-11-09 | Wu Jeffrey M | Method of treating skin disorders with stratum corneum piercing device |
US7515957B2 (en) * | 2005-06-23 | 2009-04-07 | Medtronic Vascular, Inc. | Catheter-based, dual balloon photopolymerization system |
AU2006284540A1 (en) | 2005-08-25 | 2007-03-01 | Osprey Medical Inc. | Devices and methods for perfusing an organ |
DE102005042338B4 (en) | 2005-09-06 | 2007-07-05 | Siemens Ag | catheter device |
US8172792B2 (en) | 2005-12-27 | 2012-05-08 | Tyco Healthcare Group Lp | Embolic protection systems for bifurcated conduits |
WO2007081842A2 (en) | 2006-01-09 | 2007-07-19 | University Of Virginia Patent Foundation | Multi-port catheter system with medium control and measurement systems for therapy and diagnosis delivery |
US8177829B2 (en) | 2006-08-23 | 2012-05-15 | Boston Scientific Scimed, Inc. | Auxiliary balloon catheter |
US20100106181A1 (en) | 2007-01-08 | 2010-04-29 | Yossi Gross | In-situ filter |
JP2009034462A (en) | 2007-07-31 | 2009-02-19 | Koosei Advance:Kk | Perfusion system for therapy of pancreas |
US8182446B2 (en) | 2007-09-12 | 2012-05-22 | Cook Medical Technologies | Balloon catheter for delivering a therapeutic agent |
EP2211936B1 (en) | 2007-11-07 | 2014-07-16 | LANE, Rodney James | Systems and devices for circulatory access |
US20090143759A1 (en) * | 2007-11-30 | 2009-06-04 | Jacques Van Dam | Methods, Devices, Kits and Systems for Defunctionalizing the Cystic Duct |
US8100860B2 (en) | 2007-12-06 | 2012-01-24 | Abbott Laboratories | Device and method for treating vulnerable plaque |
US20090198093A1 (en) | 2008-02-06 | 2009-08-06 | Oliver Meissner | System and method for combined embolization and ablation therapy |
EP2110151A1 (en) | 2008-04-16 | 2009-10-21 | Edward Diethrich | Double balloon occlusion device |
US20090275918A1 (en) | 2008-05-01 | 2009-11-05 | Stemcor Systems, Inc. | Pancreatic delivery catheter |
JP5584687B2 (en) | 2008-09-18 | 2014-09-03 | アクラレント インコーポレイテッド | Method and apparatus for treating ear, nose and throat disorders |
US8162879B2 (en) * | 2008-09-22 | 2012-04-24 | Tyco Healthcare Group Lp | Double balloon catheter and methods for homogeneous drug delivery using the same |
US8088103B2 (en) | 2008-11-03 | 2012-01-03 | Advanced Catheter Therapies, Inc. | Occlusion perfusion catheter |
US8540667B2 (en) | 2008-11-12 | 2013-09-24 | Sanovas, Inc. | Multi-balloon catheter for extravasated drug delivery |
US8444624B2 (en) | 2009-10-19 | 2013-05-21 | Vatrix Medical, Inc. | Vascular medical devices with sealing elements and procedures for the treatment of isolated vessel sections |
US20160082178A1 (en) | 2009-12-02 | 2016-03-24 | Renovorx, Inc. | Angiographic methods for identification of feeder vessels |
US10512761B2 (en) | 2009-12-02 | 2019-12-24 | Renovorx, Inc. | Methods for delivery of therapeutic materials to treat pancreatic cancer |
US9457171B2 (en) | 2009-12-02 | 2016-10-04 | Renovorx, Inc. | Devices, methods and kits for delivery of therapeutic materials to a target artery |
US8821476B2 (en) | 2009-12-02 | 2014-09-02 | Renovorx, Inc. | Devices, methods and kits for delivery of therapeutic materials to a pancreas |
EP2555824A4 (en) | 2010-04-08 | 2013-09-11 | Bio2Medical Inc | Catheter hub |
WO2012109382A2 (en) | 2011-02-08 | 2012-08-16 | Advanced Bifurcation Systems, Inc. | Multi-stent and multi-balloon apparatus for treating bifurcations and methods of use |
US8597239B2 (en) | 2011-03-01 | 2013-12-03 | Sanovas, Inc. | Abrading balloon catheter for extravasated drug delivery |
US9180281B2 (en) * | 2011-04-08 | 2015-11-10 | Sanovas, Inc. | Adjustable balloon catheter for extravasated drug delivery |
US8702678B2 (en) | 2011-08-03 | 2014-04-22 | Venous Therapy, Inc. | Assemblies, systems, and methods for infusing therapeutic agents into the body |
US20140214002A1 (en) | 2013-01-27 | 2014-07-31 | Thermopeutix, Inc. | Bifurcation catheter with variable length occlusion elements |
EP2994188A4 (en) | 2013-05-08 | 2017-03-29 | Embolx, Inc. | Device and methods for transvascular tumor embolization with integrated flow regulation |
WO2014197362A1 (en) | 2013-06-03 | 2014-12-11 | Ramtin Agah | Devices, methods and kits for delivery of therapeutic materials to a pancreas |
RU2704811C2 (en) | 2014-07-17 | 2019-10-31 | БайоКьюрити Фармасьютикалз Инк. | Treating cancer with combination of radiation therapy, cerium oxide nanoparticles and chemotherapeutic agent |
CN113040895A (en) | 2014-10-30 | 2021-06-29 | 纽敦力公司 | Chemical ablation and methods for treating various diseases |
US9889120B2 (en) | 2016-01-14 | 2018-02-13 | Vicus Therapeutics, Llc | Combination drug therapies for cancer and methods of making and using them |
US11052224B2 (en) | 2017-05-18 | 2021-07-06 | Renovorx, Inc. | Methods for treating cancerous tumors |
US10695543B2 (en) | 2017-05-18 | 2020-06-30 | Renovorx, Inc. | Methods for treating cancerous tumors |
US20210268107A1 (en) | 2017-05-18 | 2021-09-02 | Renovorx, Inc. | Methods and apparatuses for treating tumors |
-
2016
- 2016-11-15 US US15/351,922 patent/US10512761B2/en active Active
-
2019
- 2019-11-15 US US16/685,950 patent/US20200206481A1/en not_active Abandoned
-
2021
- 2021-12-21 US US17/558,577 patent/US11541211B2/en active Active
-
2023
- 2023-01-03 US US18/149,649 patent/US20230355934A1/en active Pending
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11541211B2 (en) | 2009-12-02 | 2023-01-03 | Renovorx, Inc. | Methods for delivery of therapeutic materials to treat cancer |
Also Published As
Publication number | Publication date |
---|---|
US20170056629A1 (en) | 2017-03-02 |
US20230355934A1 (en) | 2023-11-09 |
US20220111184A1 (en) | 2022-04-14 |
US11541211B2 (en) | 2023-01-03 |
US10512761B2 (en) | 2019-12-24 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11541211B2 (en) | Methods for delivery of therapeutic materials to treat cancer | |
US9463304B2 (en) | Devices, methods and kits for delivery of therapeutic materials to a pancreas | |
US10099040B2 (en) | Occlusion catheter system and methods of use | |
US20160082178A1 (en) | Angiographic methods for identification of feeder vessels | |
US11123482B2 (en) | Device and methods for transvascular tumor embolization | |
US8821476B2 (en) | Devices, methods and kits for delivery of therapeutic materials to a pancreas | |
US10667822B2 (en) | Devices and methods for low pressure tumor embolization | |
US20240050703A1 (en) | Augmented delivery catheter and method | |
US9126016B2 (en) | Augmented delivery catheter and method | |
EP2852357B1 (en) | Control catheters for pulmonary suffusion | |
US7678075B2 (en) | Infusion catheter and use thereof | |
US20150018762A1 (en) | Perfusion-occlusion device | |
CA2412288A1 (en) | Multi-balloon drug delivery catheter for angiogenesis | |
US11850398B2 (en) | Systems and methods for pressure-facilitated therapeutic agent delivery | |
US20230302262A1 (en) | Methods and apparatuses for delivery of therapeutic materials for the treatment of cancer |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: APPLICATION DISPATCHED FROM PREEXAM, NOT YET DOCKETED |
|
AS | Assignment |
Owner name: RENOVORX, INC., CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:AGAH, RAMTIN;QURESHI, IMTIAZ L.;NAJMABADI, KAMRAN;AND OTHERS;SIGNING DATES FROM 20161201 TO 20161207;REEL/FRAME:054938/0763 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |