Kit for obtaining an endoarterial biopsy sample

• US 20040031721A1
• Filed: 04/30/2003
• Published: 02/19/2004
• Est. Priority Date: 11/01/2000
• Status: Active Grant

• Current Assignee: Vascular Science Limited
• Original Assignee: David Marshall Mann
• Inventors: Mann, David Marshall
• Granted Patent: US 7,491,176 B2
• Time in Patent Office: Days
• US Class Current: 206/570
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2017/00362 Packages or dispensers for MIS instruments A61B2017/0479 takes precedence

Abstract

A kit for obtaining an endoarterial biopsy sample from a patient comprising: (i) packaging material enclosing one or more kit components; (ii) wherein the kit components comprise one or more of the following: a) an endoarterial biopsy catheter; b) Percutaneous Access Needle; c) Short Introducer Sheath with Dilator & Guidewire; d) Floppy Guidewire; e) Endhole Catheter with inflation syringe; f) Stiff Guidewire; g) Flushing Syringes; h) Long Introducer Sheath with Dilator; i) Biopsy specimen removal tool; j) Biopsy Cassettes; k) Specimen Containers; l) Connective Tubing; m) Vacuum Gauges & Canisters; and, n) Vacuum pump.

Claims

1. A kit for obtaining an endoarterial biopsy sample from a patient in a sequence of phases, the kit comprising:

a packaging-enclosing one or more kit components;

wherein the kit components comprise an endoarterial biopsy catheter;

2. A kit according to claim 1 characterized in that the packaging comprising a number of separate packaging parts at least one of which comprises a number of kit components, wherein the number of kit components which are packaged in a said packaging part are necessary for the same phase of the procedure.

34. ). A kit according to one of the claims 1 or 21 3 wherein the kit components are one or more components selected from the group consisting of:

a) Percutaneous Access Needle;

b) Short Introducer Sheath with Dilator &

Guidewire;

c) Floppy Guidewire;

d) Endhole Catheter with inflation syringe;

e) Stiff Guidewire;

f) Flushing Syringes;

g) Long Introducer Sheath with Dilator;

h) Biopsy specimen removal tool;

i) Biopsy Cassettes;

j) Specimen Containers;

k) Connective Tubing;

l) Vacuum Gauges &

Canisters; and

, m) Vacuum pump.

45. ). A kit according to claim 34 wherein the kit components include:

a) Percutaneous Access Needle;

b) Short Introducer Sheath with Dilator &

Guidewire;

c) Floppy Guidewire;

d) Endhole Catheter with inflation syringe;

e) Stiff Guidewire;

f) Flushing Syringes;

g) Long Introducer Sheath with Dilator;

h) Biopsy specimen removal tool;

i) Biopsy Cassettes;

j) Specimen Containers;

k) Connective Tubing;

l) Vacuum Gauges &

Canisters; and

, m) Vacuum pump.

56. ). A kit according to claim 1 wherein the kit components are packed in a vacuum formed tray.

67. ). A kit according to claim 56 wherein the kit is enclosed within a gas permeable polymer material.

78. ). A kit according to claim 1 wherein the kit is gas sterilized.

910. ). A kit according to one of claims 1-89, wherein the biopsy catheter is intended for obtaining a biopsy sample of the vascular tissue for monitoring e.g. organ transplant rejection, pulmonary hypertension, and/or a pulmonary vascular disease by evaluating the biopsy sample in a diagnostic laboratory.

101. ). A kit according to one of claims 1-89, wherein the biopsy catheter is intended for obtaining a biopsy sample of the vascular tissue for ex-vivo gene therapy, making autologous vascular grafts, and/or for culturing cells.

23. ). A kit according to claim 12, characterized in that the kit comprises:

a first packaging part containing the percutaneous access components comprising e.g. the percutaneous access needle, an introducer sheath with dilator and guidewire;

a second packaging part containing components to get access to the desired area of a vasculature and to provide a sterile connection to a vacuum pump, comprising e.g. connective tubing to vacuum pump, a floppy guidewire, an endhole catheter and a stiff guidewire;

a third packaging part containing e.g. an endoarterial biopsy catheter, a long introducer sheath with dilator and syringes;

a fourth packaging part containing e.g. various specimen containers, biopsy cassettes and a needle; and

a fifth packaging part containing e.g. a vacuum pump, vacuum gauges and canisters.

89. ). A kit according to claim 7 wherein the gas permeable membrane is TYVEK.

112. ). A business method for diagnosing a medical condition affecting a patient'"'"'s vascular tissue comprising the steps of:

a) employing a kit for obtaining an endoarterial biopsy sample to harvest an endoarterial biopsy sample at a health care facility;

b) placing the harvested biopsy sample in a specimen container suitable for preserving and safely mailing said sample for end use;

c) packaging the biopsy containing sample container in return mail material;

d) sending the return mail material to a remote diagnostic laboratory.

123. ). A business method according to claim 112 wherein the biopsy sample is evaluated at the remote diagnostic laboratory.

134. ). A business method according to claim 123 wherein the results of the evaluation of the biopsy sample is conveyed to a health care facility or physician desiring such information.

145. ). A methods according to claim 112 wherein the medical condition affecting vascular tissue involves organ transplant rejection.

156. ). A method according to claim 112 wherein the medical condition affecting vascular tissue involves autologous graft status.

167. ). A method according to claim 112 wherein the medical condition affecting vascular tissue involves ex vivo genetic manipulation.

178. ). A business method for procuring a tissue sample from a patient'"'"'s vascular system comprising the steps of:

a) employing a kit for obtaining an endoarterial biopsy sample to harvest an endoarterial biopsy sample at a health care facility;

b) placing the harvested biopsy sample in a specimen container suitable for conveying and preserving said sample in a condition for end use;

c) packaging the biopsy containing sample container in return mail material;

d) sending the return mail material to a remote biopsy processing facility.

189. ). A business method according to claim 178 wherein the harvested biopsy sample is used for ex-vivo gene therapy.

1920. ). A business method according to claim 189 wherein the harvested biopsy sample that is used for ex-vivo gene therapy is subsequently returned to the patient'"'"'s body.

201. ). A business method according to claim 178 wherein the harvested biopsy sample is used to make autologous vascular grafts.

212. ). A business method according to claim 201 wherein the autologous vascular graft made from the harvested biopsy sample is subsequently returned to the patient'"'"'s body.

223. ). A business method according to claim 178 wherein the harvested biopsy sample is used to culture cells.

234. ). A business method according to claim 223 wherein the cells cultured from the harvested biopsy sample are subsequently returned to the patient'"'"'s body.