Access and drainage devices and methods of use thereof
A medical device can be used to drain fluids from the body during a medical procedure that requires the insertion of a medical instrument into an anatomical lumen or cavity. The device generally allows the simultaneous introduction of the medical instrument into the body and drainage of fluid out of the body during a medical procedure.
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The invention relates to ureteral devices. More specifically, the invention relates to ureteral access devices and methods of their use.
BACKGROUND INFORMATIONMedical evaluation and treatment involving the urinary tract of a patient often require medical instruments, such as scopes or other instruments, to be inserted through the urinary tract. As a result, trauma to tissue and organs often results unless the urinary tract is protected. Furthermore, the insertion of a medical instrument into the kidney and bladder through the urethra and ureter can inhibit the flow of urine out of the kidney or the bladder. If the flow of urine is impeded for an extended period of time, the kidney and/or the bladder can be irreversibly damaged.
As a result, a medical practitioner must intermittently remove any medical instruments from the kidney, the urethra, and the ureter during a medical procedure. This, however, requires repeated reintroduction of the instrument, further increasing trauma to the tissue and organs. To avoid this problem, certain practitioners use an invasive kidney or bladder catheter that is inserted directly into the back of a patient to drain the respective organ. Such catheters, however, cause even more trauma and can lead to infection as well as leakage. In addition, such drainage devices also lengthen the recovery time for a patient who undergoes such a medical procedure.
SUMMARY OF THE INVENTIONA medical procedure involving the insertion of standard medical devices and instruments into the urinary system interrupts the flow of urine, which can cause irreversible damage to the organs in the urinary system. The present invention mitigates the risk of damage to organs and surrounding body tissue when evaluating and/or treating the urinary system. The present invention allows for drainage of urine from the kidney and/or the bladder, while simultaneously allowing for multiple insertions and/or prolonged maintenance of a medical instrument in the urinary tract.
Generally, a medical device according to the invention includes a tubular access member and a tubular drainage member. The tubular access member allows a medical practitioner to interrogate a target organ (such as the kidney or bladder) with a medical instrument, such as a scope. The tubular drainage member allows a medical practitioner to simultaneously drain fluid from the interrogated organ (or from any other organs in the urinary system) while maintaining the tubular access member inside a patient. For example, a medical device according to the invention allows for the interrogation of a kidney with a medical instrument, while at the same time allowing for drainage from the kidney and/or the bladder.
In general, in one aspect, the invention features a medical device for accessing a cavity in a body. The medical device includes a tubular access member for insertion into a urinary tract. The tubular access member includes an insertion end, a proximal end, and a lumen. The tubular access member is adapted to allow access for at least one medical instrument through the lumen. The medical device also includes a tubular drainage member for draining fluid from an organ of a urinary system, such as the bladder and/or the kidney. The tubular drainage member includes a first end, a proximal end, and a lumen.
Embodiments according to this aspect of the invention can include the following features. The tubular drainage member can surround at least a portion of the tubular access member to define a space therebetween. The tubular access member and the tubular drainage member can be substantially concentric. Furthermore, the ends of the tubular access member and the tubular drainage member can be open. The inner circumference of the tubular drainage member can be greater than the outer circumference of the tubular access member. Furthermore, the tubular access member and/or the tubular drainage member can be slideably moveable.
Embodiments according to this aspect of the invention also can include the following other features. The tubular access member can taper inward at the insertion end. The tubular access member and/or the tubular drainage member may include a plurality of apertures for migration of fluid. The tubular drainage member can be sized such that the plurality of apertures extends from a location in the bladder to the proximal end of the tubular drainage member. The tubular drainage member also can be sized to extend from a location in the bladder to a location beyond the urethra. The first end of the tubular drainage member can extend to form a coil or, alternatively, a balloon. The tubular drainage member and the tubular access member can be the same. The tubular drainage member can include a valve.
In general, in another aspect, the invention features a medical device including a tubular access member for insertion into a urinary tract, wherein the tubular access member includes an open insertion end, an open proximal end and a lumen. The tubular access member is adapted to allow access for at least one medical instrument through the lumen. The medical device also includes a tubular drainage member for draining fluid from an organ of a urinary system, such as the bladder and/or the kidney. The tubular drainage member includes a first end, a drainage end, and a lumen.
Embodiments according to this aspect of the invention can include the following features. A portion of the tubular access member and a portion of the tubular drainage member can be coupled. The tubular drainage member can extend substantially in parallel with a portion of the tubular access member. Also, the inner circumference of the tubular access member can be greater than the inner circumference of the tubular drainage member. The tubular drainage member can extend from a location in the bladder to a location beyond the urethra. Furthermore, the tubular access member and/or the tubular drainage member can be slideably moveable.
Embodiments according to this aspect of the invention also can include the following other features. The tubular access member and/or the tubular drainage member can include a plurality of apertures for migration of fluid. The tubular drainage member can be sized such that the plurality of apertures can extend from a location in the bladder to the proximal end of the tubular drainage member. The ends of the tubular drainage member can be open. The tubular access member can taper inward at the insertion end. The first end of the tubular drainage member can extend to form a coil or, alternatively, a balloon. The tubular drainage member can include a valve.
In general, in another aspect, the invention features a method of simultaneously draining fluid from the urinary tract of a patient while maintaining access to a target organ for a medical instrument. The method includes the steps of extending a medical device through a urethra to a target organ of the urinary system. The device includes a tubular access member and a tubular drainage member. The method also includes allowing drainage of fluid into a lumen of the tubular drainage member from an organ of the urinary system while allowing access for at least one medical instrument in a lumen of the tubular access member.
Embodiments according to this aspect of the invention can include the following features. A medical instrument can reside in the lumen of the tubular access member for a period of time, such as the period of time sufficient to perform more than a single medical procedure on a patient. Methods according to this aspect of the invention can also include inserting a medical instrument into the lumen of the tubular access member. Methods according to this aspect of the invention also can include removing the medical instrument from the lumen of the tubular access member. Furthermore, methods according to this aspect of the invention also include re-inserting the medical instrument into the lumen of the tubular access member.
These and other objects, along with the advantages and features of the present invention herein disclosed, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations.
BRIEF DESCRIPTION OF THE DRAWINGSIn the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. For example, the following figures show embodiments of medical devices according to the invention and the body in which the device is deployed that are not necessarily drawn to scale, but instead are intended to illustrate the principles of the invention.
As set forth herein, a medical device according to the invention allows a practitioner to simultaneously drain fluid from the urinary system of a patient while maintaining a medical device in the urinary tract. Generally, a medical device according to the invention includes a tubular access member and a tubular drainage member. The tubular access member allows a medical practitioner to interrogate a target organ (such as the kidney or bladder) with a medical instrument, such as a scope. The tubular drainage member allows a medical practitioner to simultaneously drain fluid from the interrogated organ (or from any other organs in the urinary system) while maintaining the tubular access member inside a patient. For example, a medical device according to the invention allows for the interrogation of a kidney with a medical instrument, while at the same time allowing for drainage from the kidney and/or the bladder. In addition, a medical practitioner can maintain the tubular access member in the patient during the whole medical procedure, and even, for a prolonged period of time after the medical procedure.
In general, all of the following embodiments of the medical device allow for drainage of fluids while simultaneously providing for the insertion and maintenance of a medical instrument through an anatomical lumen. As shown in
As shown in
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The channel cross section may feature any of a variety of shapes, for example, a channel may be curved, or have any of a variety of geometric cross sectional shapes (e.g., triangular, square, circular, and semi-circular). Similarly, the projection cross section may feature any of a variety of shapes, for example, a projection may be curved or have any of a variety of geometric cross sectional shapes (e.g., triangular, square, circular, and semi-circular). The shape and number of each channel and projection may be selected to fit a particular patient and/or medical application.
The tubular members as provided herein can be manufactured from any appropriate biocompatible or medical grade material including, but not limited to, polymers, polyurethane, plastics, latex, and polyethylene. Tubular members according to the invention are preferably flexible and kink resistant. For example, tubular members according to the invention can include a reinforced coil sheath to avoid kinking or bending when inserted into an anatomical lumen. In addition, tubular members can be coated to ease insertion and/or retraction, such as with a hydrophilic coating. However, one skilled in the art understands that the principles according to the invention can be embodied in a medical device having any appropriate material or materials that is biocompatible, for example, polyurethane and silicone. In fact, in some embodiments, a medical device according to the invention can be structured and arranged, at least in part, with a shape-memory material that enables tubular members to assume a pre-determined configuration, for example, nitinol, polyanhydride and polycaprolactone.
The dimensions of the medical device 1 will vary to suit a particular application and/or patient. In one example, the tubular drainage member has an outside diameter from about 4 Fr. to about 20 Fr., preferably, about 10 Fr. to about 16 Fr. The size and/or dimensions of the tubular access member can vary, for example, based upon size and/or dimension of the tubular drainage member. In one example, the inside diameter of the tubular access member ranges from about 4 Fr. to about 16 Fr., preferably about 10 Fr. to about 14 Fr. Also, generally, the outer diameter of the tubular access member depends, in part, on the inner dimension of the tubular drainage member. For example, the difference between the outer diameter of the tubular access member and the inner diameter of the tubular drainage member can be less than about 1 Fr., about 2 Fr., about 3 Fr., about 4 Fr., or about 5 Fr. or greater. A medical device according to the invention includes a tubular access member having an outer diameter of about 7 Fr. to about 18 Fr. These dimensions are given for illustrative purposes only and are not meant to be limiting.
The overall length of the medical device 1 of the present invention depends on the application for which the medical device 1 is intended. Generally, the overall length of the medical device 1 will range from about 20 cm to about 250 cm. In one embodiment and with respect to urinary applications, the total length of the device is about 10 cm to about 100 cm, and, preferably, from about 20 cm to about 55 cm. However, the length of a medical device 1 as contemplated herein can range from below about 25 cm, to about 25 cm to 55 cm, and greater than about 55 cm. As shown herein, a tubular drainage member can have substantially the same length as the tubular access member in certain embodiments. Also, a tubular drainage member can be shorter than the tubular access member, for example, in certain embodiments where the tubular drainage member drains directly from the bladder. However, one skilled in the art understands that the medical device of the present invention can be of any appropriate length based upon the dimensions required for a particular patient or group of patients, and also based upon the organs and/or anatomical lumens sought to be evaluated. For example, devices for use on children generally will be of lesser lengths as compared to those devices intended to be used on adults. Similarly, devices for use with animals are adapted for their particular anatomies.
Referring to
The tubular drainage member 40 may feature one or more cross sectional shapes as described above with reference to
Also, in some embodiments, a tubular access member 46 according to the invention can be slideably moveable. For example, the tubular access member 46 may be slideably moveable relative to a tubular drainage member 40. Similarly, a tubular drainage member 40 can be slideably moveable so that different portions of the tubular access member 46 can be surrounded. A handle can actuate movement of the tubular access member 46 and/or the tubular drainage member 40.
Referring to
Apertures 61, 63 according to the invention can assume any shape, such as, for example, circles, squares, ovals, and any other geometric or irregular shape. In fact, in some embodiments, apertures 61, 63 include slits, perforations, or any other miniature openings that allow for passage or seepage of fluids through a side of a tubular member. In a particular embodiment, the apertures 61, 63 are circles having diameters of about 1 mm to about 3 mm. The apertures 61, 63 can extend from a location in the bladder 16 to a second, or proximal end 64, 65 of the tubular drainage member 62, 60.
In other embodiments, the invention features a medical device 1 having a tubular drainage member 86 that extends substantially in parallel with a portion of the tubular access member 80. Referring to
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Referring to the cross-section illustrated in
Referring to the exemplary embodiment depicted in
Either or both of the tubular members also can include a plurality of apertures for migration of fluid. As discussed herein and referring, for example, to
The tubular members according to the present invention can have a variety of configurations. For example, a first end 94 of a tubular drainage member 92 can extend to form a coil 99 (see
Also, in some other embodiments having a parallel design, the tubular access member is slideably moveable relative to the tubular drainage member. However, in some embodiments, the tubular drainage member is slideably moveable relative to the tubular access member. A handle can actuate movement of the tubular access member and/or the tubular drainage member.
Medical devices according to the present invention can also accept guidewires. For example, guidewires ranging from about 0.035 inches to about 0.038 inches can be used with the tubular members of the invention. Some embodiments of the invention can also accept guidewires less than about 0.035 inches and greater than about 0.038 inches.
In general, in another aspect, the invention provides a method of simultaneously draining fluid from the urinary tract of a patient while maintaining a medical instrument, e.g., an imaging scope, a retrieval device, and the like, in the urinary system of a patient. Referring, for example, to
A medical device according to the present invention can include tubular members comprising a polymeric material made of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), ethylene tetrafloroethylene (ETFE) or other suitable material that exhibits laser resistant characteristics (e.g., light color) that prevents or minimizes damage to the tubular members or other elements of the medical device during a medical procedure. In one embodiment, the color of the tubular access member differs from the color of the tubular drainage member and from the color of other elements of the device (e.g., the tubular access member is a light color) in order to assist a medical practitioner in determining the location of the respective member during a medical procedure. In addition, a tubular member of the present invention can include radioopaque markers to facilitate the medical practitioner in determining the location of any of the elements of the present invention.
In practice, the tubular access member of the present invention is a type of ureteral access sheath adapted and improved to provide drainage capabilities heretofore unavailable. Thus, a practitioner can employ the tubular access member in any manner heretofore accommodated by a standard ureteral access sheath. It is understood that all the features and/or properties described herein below as characteristic of a ureteral access sheath can also be characteristic of the tubular access member of the present invention. In fact, in certain embodiments contemplated herein, the tubular access member is a ureteral access sheath and can be used accordingly.
Typically, a ureteral access sheath can be used by medical practitioners performing evaluations of a patient's urinary tract, such as performing a flexible ureteroscopy. In some embodiments of a ureteral sheath, the ureteral sheath 200 includes a lumen through which a tubular dilator 202 can pass if desired (see
In some embodiments, the ureteral sheath is kink-resistant. For example, the ureteral sheath 200 can include a reinforced coil sheath 200 to avoid kinking or bending when inserted into an anatomical lumen. Furthermore, the ureteral sheath 200 can be radioopaque and can include, for example, a highly radioopaque ring at the distal tip 204 of the ureteral sheath 200. Also, the ureteral sheath 200 can have a coating that reduces friction when inserted into an anatomical lumen, thereby reducing resistance and trauma to the affected area. A ureteral sheath 200 can also accept guidewires. For example, guidewires ranging from about 0.035 inches to about 0.038 inches can be used with a ureteral sheath 200 to place the sheath 200 at a target site in the urinary system.
Dimensions of a ureteral sheath 200 of the present invention vary based upon the components for which the sheath 200 is configured to pass therein. Generally, dimensions of a ureteral access sheath 200 include an inner diameter of preferably less than about 10 Fr., more preferably from about 10 Fr. to about 16 Fr., or in some embodiments preferably greater than about 16 Fr. Also, the length of a ureteral access sheath 200 can range from preferably below about 25 cm, more preferably to about 25 cm to about 55 cm, and in some embodiments preferably greater than about 55 cm.
A ureteral access sheath 200 also can be compatible with other components that a medical practitioner may desire to insert into an anatomical lumen or cavity. Referring now to
Referring to
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Upon completion of the access procedure, the medical practitioner can withdraw the medical device if desired. Such a ureteral access sheath having the characteristics and uses described above can be modified to include a configuration with an access tube member and drainage tube member such that access and drainage from the kidney and bladder can be accomplished simultaneously.
Having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive.
Claims
1. A medical device comprising:
- a tubular access member for insertion into a urinary system comprising an insertion end, a proximal end, and a lumen, wherein the tubular access member is adapted to allow access for at least one medical instrument through the lumen; and,
- a tubular drainage member for draining fluid from an organ of the urinary system comprising a first end, a proximal end, and a lumen.
2. The medical device of claim 1, wherein the tubular access member and the tubular drainage member are substantially concentric.
3. The medical device of claim 1, wherein the inner circumference of the tubular drainage member is greater than the outer circumference of the tubular access member.
4. The medical device of claim 1 wherein the tubular access member is slideably moveable relative to the tubular drainage member.
5. The medical device of claim 1, wherein the tubular drainage member is slideably moveable relative to the tubular access member.
6. The medical device of claim 1, wherein the first end of the tubular drainage member extends to form a coil.
7. The medical device of claim 1, wherein the first end of the tubular drainage member extends to form a balloon.
8. The medical device of claim 1, wherein at least one of the tubular access member and the tubular drainage member includes a plurality of apertures for migration of fluid.
9. The medical device of claim 8, wherein at least one of the tubular access member and the tubular drainage member is sized such that the plurality of apertures extends from a location in the organ to the proximal end of at least one of the tubular access member and the tubular drainage member.
10. The medical device of claim 1, wherein the tubular drainage member surrounds at least a portion of the tubular access member to define a space therebetween.
11. The medical device of claim 1, wherein the tubular access member tapers inward at the insertion end.
12. The medical device of claim 1, wherein the tubular drainage member is sized to extend from a location in the organ to a location beyond the urethra.
13. The medical device of claim 1, wherein the ends of at least one of the tubular access member and the tubular drainage member are open.
14. The medical device of claim 1, wherein the tubular drainage member and the tubular access member are the same.
15. The medical device of claim 1, wherein the tubular drainage member further comprises a valve.
16. A medical device comprising:
- a tubular access member for insertion into a urinary system comprising an open insertion end, an open proximal end, and a lumen, wherein the tubular access member is adapted to allow access for at least one medical instrument through the lumen; and,
- a tubular drainage member comprising a first end, a drainage end, and a lumen for draining fluid from the urinary system.
17. The medical device of claim 16, wherein a portion of the tubular access member and a portion of the tubular drainage member are coupled.
18. The medical device of claim 16, wherein the inner circumference of the tubular access member is greater than the inner circumference of the tubular drainage member.
19. The medical device of claim 16, wherein the tubular access member is slideably moveable relative to the tubular drainage member.
20. The medical device of claim 16, wherein the tubular drainage member is slideably moveable relative to the tubular access member.
21. The medical device of claim 16, wherein the first end of the tubular drainage member extends to form a coil.
22. The medical device of claim 16, wherein the first end of the tubular drainage member extends to form a balloon.
23. The medical device of claim 16, wherein at least one of the tubular access member and the tubular drainage member includes a plurality of apertures for migration of fluid.
24. The medical device of claim 23, wherein the tubular drainage member is sized such that the plurality of apertures extends from a location in the urinary system to the drainage end of the tubular drainage member.
25. The medical device of claim 16, wherein the tubular drainage member extends substantially in parallel with a portion of the tubular access member.
26. The medical device of claim 16, wherein the tubular access member tapers inward at the insertion end.
27. The medical device of claim 16, wherein the tubular drainage member is sized to extend from a location in the urinary system to a location beyond the urethra.
28. The medical device of claim 16, wherein the ends of the tubular drainage member are open.
29. The medical device of claim 16, wherein the tubular drainage member further comprises a valve.
30. A method of simultaneously draining fluid from the urinary system of a patient while maintaining access for a medical instrument in the urinary system, the method comprising the steps of:
- extending a medical device through a urethra to a target organ of the urinary system, wherein the device comprises a tubular access member and a tubular drainage member; and
- allowing drainage of fluid into a lumen of the tubular drainage member from an organ of the urinary system while allowing access for at least one medical instrument in a lumen of the tubular access member.
31. The method of claim 30, wherein the medical instrument resides in the lumen of the tubular access member for a period of time.
32. The method of claim 31, wherein the period of time is sufficient to perform more than a single medical procedure on a patient.
33. The method of claim 30, further comprising the step of inserting a medical instrument into the lumen of the tubular access member.
34. The method of claim 33, further comprising the step of removing the medical instrument from the lumen of the tubular access member.
35. The method of claim 34, further comprising the step of re-inserting the medical instrument into the lumen of the tubular access member.
Type: Application
Filed: Apr 20, 2005
Publication Date: Nov 9, 2006
Applicant: Boston Scientific Scimed, Inc. (Maple Grove, MN)
Inventors: Prabhakar Pandey (Cumberland, MD), David Robertson (Framingham, MA)
Application Number: 11/111,097
International Classification: A61M 1/00 (20060101);