WO2011079220A1

WO2011079220A1 - Brachytherapy kit

Info

Publication number: WO2011079220A1
Application number: PCT/US2010/061874
Authority: WO
Inventors: Kevin Helle; Jay Reed
Original assignee: Medi-Physics, Inc.
Priority date: 2009-12-23
Filing date: 2010-12-22
Publication date: 2011-06-30

Abstract

A brachytherapy kit and process for delivering brachytherapy seeds, pre-loaded into needles, pre-loaded into a prostate grid, sterile packed for delivery to the end-user.

Description

BRACHYTHERAPY KIT

Field of the Invention

The present invention is directed to the field of brachytherapy equipment. More specifically, the present invention relates to a brachytherapy kit for performing brachytherapy procedures.

Background of the Invention

When performing a brachytherapy procedure, a physician or technician often must design and assemble the load pattern of radioactive brachytherapy seeds to be implanted into the body. With reference to Figure 1, a grid body 1 (or template) is supported on a patient stabilizing fixture 2 adjacent to a patient 3 in a manner to minimize any relative displacement between the grid body 1 and the patient 3. The grid body 1 includes an array of through-passages, the passages arranged in a known grid pattern.

The physician, knowing the location and size of the target tissue to be treated, will design the dose plan, ie, the three-dimensional array of brachytherapy seeds which will be implanted within and about the target tissue. The physician or technician will either load the radioactive seeds into individual brachytherapy needles or select brachytherapy needles pre-loaded with a number of radioactive seeds and/or spacers to be implanted according to the dose plan. Each of these brachytherapy needles must be carefully identified and controlled so that it is placed through the appropriate through-aperture of the grid body for the loads within the needle. Additionally, when the physician or technician must take the time to load the needles with the seeds or even just load the individual needles into the matrix, there can be additional exposure for the physician to the activity of the seeds.

As noted, brachytherapy seeds are available in numerous product configurations. They can be provided sterile, non-sterile, loose, loaded in cartridges, loaded into a braided carrier, etc. There are numerous manufacturers offering brachytherapy seeds in all of these configurations to either end-users (physicians) or loading pharmacies to prepare to an implant plan for the end-users. The trend over the past few years has been to deliver a seed product that is as ready for patient use as possible. This had been accomplished by loading individual needles with the required seed and spacer configuration, sterilizing the entire order of needles (typically 20-30) and providing the entire order with verification radiographs of the needles. Once delivered, the numbered needles are individually inserted into the patient through the prostate template located in the stabilizing fixture. This is one commonality with brachytherapy seeds, they are all implanted via needles through a template supported on a patient stabilizing fixture.

The prior art provides for the pre-loading needles for sterile delivery to the end- user. With additional reference to Figure 2, the pre-loaded needles are flat-packed into a plastic card 5 which has a snap top to physically retain the needles 6. The flat plastic card is then inserted into an envelope 7 that contains lead sheets 8 to shield the radiation of the seeds within the needles 6. There are various bags to provide the required sterility assurance of the sterilized pre-loaded needles. The flat packed method requires a large shipping box, numerous single use components, and undesirable lead sheeting. Currently available pre-loaded needle packaging configurations can be found on the Internet. For example, Advanced Care Medical currently provides information on their pre-loaded needle packaging at http://www.advancedcaretech.com, while Anazao Health provides information on its card-style packaging configurations at

http://anazaohealth.com/home.cfm.

There is therefore a need in the art for a brachytherapy kit which provides preloaded brachytherapy needles within a spacing grid body, or template, which can be positioned adjacent the patient so as to minimize preparation time within the surgical suite. Summary of the Invention

In view of the needs of the prior art, the present invention provides a

brachytherapy kit which reduces preparation time within the surgical suite. The kit includes a kit container having a grid body loaded with brachytherapy needles which are pre-loaded according to a dispense plan. The kit further desirably includes a brace for minimizing needle deflection for when the needle is inserted into a patient. Additionally, the kit desirably includes a secondary device for holding the needles away from the grid body. It is contemplated that the secondary device could also perform the function of the brace. Optionally, the needles may be of a plug-less design.

The present invention thus provides a brachytherapy kit and process for delivering brachytherapy seeds, pre-loaded into needles, pre-loaded into a prostate grid, sterile packed for delivery to the end-user. This kit and process offers numerous advantages to the user of the product in terms of preparation time, implant time, accuracy of implant, and verification of dose delivery pre-implant.

A new packaging method has been developed to shield and ship pre-loaded needles directly to the implanting physician. This method involves a newly designed shield which is reusable and consistent with the look and feel of radio-chemical packaging. The pre-loaded needle shield is a patient specific package that contains a single implant worth of needles, built to the requirements of the dose plan, for a specific patient. The outside of the container is a cleanable, sterilizable, non-particle shedding plastic, and the inside is a high Z shielding material such as stainless steel. The needle hubs are held secure inside the container in numbered locations to aid in referencing to the implant plan.

The packaging provides the ability to deliver pre-loaded, sterile needles directly to the implanting physician without the use of a loading pharmacy. The packaging allows the use of re-usable components and a drastic reduction in waste materials. It is contemplated that the packaging can accommodate a single patient implant, up to 30 needles. Brief Description of the Drawings

Figure 1 depicts a brachytherapy procedure of the prior art. Figure 2 depicts a card delivery container and supporting documentation of the prior art.

Figure 3 depicts a brachytherapy kit of the present invention. Figure 4 depicts an exploded view of the brachytherapy kit of Figure 3.

Figure 5 is a top side cross-sectional view of the brachytherapy kit of Figure 3 taken through the lines 5-5. Figure 6 depicts a needle stabilizer of the present invention.

Figures 7A-C depicts the needle stabilizer of Figure 6 being inserted into position over a load of brachytherapy needles. Figure 8 depicts a brachytherapy strand being loaded into the second end of a brachytherapy needle .

Figure 9 depicts a train of brachytherapy seeds and spacers being loaded into the second end of a brachytherapy needle.

Figure 10 depicts an alternate needle stabilizer to be used by the kit of the present invention.

Figure 11 depicts a brachytherapy needle provided by the present invention having a brace thereon. Figure 12 depicts the first end of one type of brachytherapy needle provided by the kit of the present invention.

Figure 13 depicts a second type of brachytherapy needle provided by the kit of the present invention.

Figure 14 depicts a brace bar provided by a kit of the present invention.

Detailed Description of the Preferred Embodiment

With reference to Figures 3-5, the present invention provides a brachytherapy kit

10. Kit 10 provides a grid body pre-loaded with brachytherapy needles which have been individually loaded according to the dose plan. After opening the kit packaging, an operator may then simply lift the loaded grid body from the packaging for fastening to a patient stabilizing fixture, reducing the time and resources required for proper positioning of the grid body with respect to the patient. The physician may then proceed to perform the seed implantation procedure.

Kit 10 desirably provides a brachytherapy seed array configuration prepared to a specific dose plan per the patient or clinician requirements. As the grid/template is already loaded with pre-loaded brachytherapy needles, the template can be lifted from the packaging and secured to the patient stabilizing fixture. Kit 10 thereby provides value to the end user as it offers savings in operating room time and resources as well as a reduction in packaging costs and in the resulting waste materials. The pre-loaded grid allows for the accurate preparation and positive verification according to pre-implant dosimetry requirements as well as for a three-dimensional implant verification procedure.

Kit 10 includes a kit package 12 comprising a package body 14 and a removable cover 16. Package body 14 includes a planar backwall 18 and an upstanding perimetrical wall 20 supported thereon. Perimetrical wall 20 and backwall 18 define a package cavity 22. Cover 16 sealingly engages wall 20 so as to maintain the environment within cavity 22. Package body 14 and cover 16 are desirably formed from stainless steel or any high Z material for shielding. Alternatively, the present invention contemplates that package body 14 and cover 16 may be formed from any material suitable for contact with medical devices, such as propylene, and which withstand sterilization. Suitable materials are also found with reference to http://www.eldonjames.com/frames/sterilize.html.

Kit package 12 is adapted to hold a brachytherapy grid 30 within cavity 22. Grid 30 includes a grid body 34 defining a plurality of needle passages 36 therethrough. Needle passages 36 are desirably parallel to each other and arranged in a 2x2 array corresponding to the dose plan for a patient.

Kit 10 includes at least one pre-loaded elongate brachytherapy needle 40. With additional reference to Figures 8 and 9, needle 40 is contemplated to be a standard brachytherapy needle having diameter of a 16-gage needle or smaller, and more preferably the diameter of an 18-gage or 20-gage needle, although it is clear that the teachings of the present invention may be used for a brachytherapy needle of any size. Needle 40 includes an elongate needle body 42 having an elongate tubular wall 44 defining opposed first and second open ends, 46 and 48 respectively, and an elongate passageway 50 extending therebetween. Needle 40 is desirably preloaded with a brachytherapy member 52 positioned within passageway 50. Brachytherapy member 52 may take the form of a brachytherapy strand 54 or a train of brachytherapy seeds 56 and/or spacers 58. Brachytherapy strand 54 includes one or more brachytherapy seeds and/or spacers within a biocompatible carrier 60 material. Each needle 40, furthermore, desirably includes a luer hub 45 supported at second end 48, for each of handling. Desirably, kit 10 includes all of the brachytherapy needles 40 required for a dose plan for a patient. Each of the brachytherapy needles 40 are adapted to extend through a unique one of the plurality of needle passages 36 of grid body 34. It is further contemplated by the present invention that each needle 40 is loaded into grid 30 with its own stylet 32 for urging brachytherapy load 52 from passageway 50.

Package body 14 also includes first and second channel ridges, 24 and 26

respectively, defining an open channel 28 therebetween for receiving grid body and holding grid body therebetween. Kit package 12 is adapted to receive grid 34 loaded with the brachytherapy needles 40 within package cavity 22. Desirably, the needles 40 and grid 34 are provided sterilized within kit cavity 22 and cover 16 is attached to the free rim 17 of wall 18 so that kit package 12 protects the sterility the needles 40 and grid 34.

With additional reference to Figures 6 and 7A-C, kit 10 is adapted to include a needle stabilizer 70 having a needle stabilizer body 72. Each of the brachytherapy needles 40 extend through needle stabilizer body 72 for additional support of the needles. The present invention further contemplates that needle stabilizer 70 is provided sterilized within kit package 12 and maintained so within cavity 22. While stabilizer 70 is shown in the Figures as 3-5 being positioned between grid 30 and the first end of the needles 40, the present invention also contemplates that stabilizer 70 may be positioned between grid 30 and the hubs 45 of needles 40. Needle stabilizer 70 is desirably in the form of a planar body 72 having opposed first and second major faces 74 and 76, respectively, and at least one perimetrical edge 78. Body 72 desirably includes a number of elongate arms 80 which define a number of channels 82 extending between said first and second major surfaces 74 and 76, each of the channels 82 are sized to accommodate a needle 40 therein so as to be held between adjacent arms 80. Desirably, the channels 82 each open on perimetrical edge 78. As seen in Figures 7A-C, after each of the needles 40 are inserted through the appropriate passage 36 within grid 30, stabilizer 70 may then be brought down over the needle bodies, in the direction of arrow A, so that each of the needles aligned along a vertical row of passages 36 will be received and held within a single channel 82. The present invention also contemplates that stabilizer 70 may be positioned about the needles 40 while adjacent to grid 30, so as to minimize deflection of the needles 40, and thereafter slid along the needle bodies, e.g. in the direction of Arrow B, to provide support of the freely-extending needles at some distance away from grid 30. Stabilizer 70 thus will provide additional support to the freely extending needle bodies during storage, transportation and handling. It is further contemplated that stabilizer 70 may be made from a material which is sterilizable and which will be structured so as to provide the necessary support to the needles 40. Stabilizer 70 may be formed from any material suitable for contact with medical devices, such as propylene, and which withstand sterilization. Figure 10 depicts an alternate needle stabilizer 90 of the present invention.

Stabilizer 90 includes a planar body 92 defining a number of needle passages 94 therethrough. Needle passages are desirably positioned in an array matching that of the passages 36 of grid 30 so as to be positioned in respective registry therewith. Each of the needle passages 94 of stabilizer 90 may receive a needle therethrough in accordance with the dosing plan for a patient. It is further contemplated that stabilizer 90 may be made from a material which is sterilizable and which will be structured so as to provide the necessary support to the needles 40. Stabilizer 90 may be formed as a rigid or semi-rigid body which, when positioned between grid 30 and the second ends of the needles 40, can be manipulated to provide additional support to the needle during insertion into a patient. That is, as grid 30 is positioned adjacent to a patient, stabilizer 90 may be used as a brace by the physician by being positioned at a location some distance from grid 30 so as to minimize any bending of the needle 40 being inserted into the patient. As each needle is inserted into the patient, stabilizer 90 may be slid along the length of the needle to a location where it can provide the best support. Alternatively, once a particular needle has been inserted through the dermis, the physician may release stabilizer 90 as bending should not be an issue. Passages 94 may be sized to allow sliding contact between stabilizer 90 and the needle 40.

Alternatively still, each of the needles 40 may individually incorporate a brace thereon to minimize bending of the needle during insertion into a patient. Preferred braces are disclosed in the co-pending and commonly-assigned patent application having docket no. PM-0985P, entitled, Braced Brachytherapy Needle, and filed at even date with the present application, the entire disclosure of which is incorporated by reference herein. Figure 11 depicts a needle 40 having a brace 100 thereon. Brace 100 has an elongate cylindrical brace body 102 defining a through-passage 104. Brace 100 is positioned on needle 40 as to extend between grid 30 and the hub 45 of needle 40. Desirably, brace 100 is positioned about mid- way between the needle hub and grid 30. Brace 100 is sized to slidingly engage needle body 42 so that should needle 40 need to be inserted far enough into a patient, grid 30 will stop the travel of brace 100 as needle 40 continues to be inserted.

In yet another embodiment, kit 10 may include a single brace bar 110. Brace bar 110, shown in Figure 14, includes an elongate body defining a notch 112 therein. A physician would use brace bar 110 to hold each needle 40 at some distance away from grid 30 during its insertion into a patient to minimize bending of the needle due to the buckling force experienced during insertion.

It is yet further contemplated that each of the needles 40 provided with kit 10 have a plugless design. That is, the first ends 46 of needles 40 would not include a plug within passageway 50 which would be dispensed into the patient with the brachytherapy member 52. Preferred needles are disclosed in the co-pending and commonly-assigned patent application having docket no. PM-0984P, entitled Plugless Brachytherapy Needle, and filed at even date with the present application, the entire disclosure of which is incorporated by reference herein. In such needles, the first open end 46 is shaped to hold said brachytherapy member therein. In one such embodiment, shown in Figure 12, the tubular wall 44 of needle 40 defines a first and second transversely-spaced elongate channels, 120 and 122

respectively, so as to further define an elongate detent span 124 therebetween. The central portion 124a of detent span 124 is deflected towards the needle passageway 50 so as to prevent passage of brachytherapy member 52 therepast due to gravitational or inertial forces, but to allow passage under urging of a stylet. In an alternate embodiment, shown in Figure 13, tubular wall 44 defines a transversely-opening aperture 130 proximate first end 46.

Tubular wall includes a first and second opposed longitudinal elongate detents 132 and 124 respectively, extending into aperture 130. Additionally, first detent 132 extends towards first end 46 of needle 40 while second detent 134 extends towards second end 48 thereof. Desirably, first detent 132 is deflected to extend further into passageway 50 than second detent 134. Desirably, first detent 132 prevents passage of brachytherapy member 52 therepast due to gravitational or inertial forces, but allows passage under urging of a stylet, while second detent 134 provides no resistance to brachytherapy member 52 whatsoever.

While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.

Claims

What is Claimed Is:

1. A brachytherapy kit for delivering fluid comprising

A brachytherapy grid comprising a grid body defining a plurality of needle passages therethrough;

At least one pre-loaded elongate brachytherapy needle comprising a an elongate needle body having an elongate tubular wall defining opposed first and second open ends and defining an elongate passageway extending therebetween, and a brachytherapy member positioned within said passageway, each of said at least brachytherapy needles extending into a unique one of the plurality of needle passages of said grid body; and

A kit package comprising a package cavity, wherein said kit package is adapted to receive said grid loaded with said at least one brachytherapy needle within said package cavity; wherein said at least one needle and said grid are provided sterilized within said kit package and said kit package protects the sterility of said at least one needle and said grid.

2. A brachytherapy kit of claim 1, wherein each of said at least one brachytherapy needles is loaded according a dose plan for a patient.

3. A brachytherapy kit of claim 2, wherein said grid is loaded with a plurality of brachytherapy needles through particular passeges of said grid body, such that said grid is loaded with a plurality of brachytherapy members according to a dose plan for a patient.

4. A brachytherapy kit of claim 3, further comprising a needle brace, said kit package adapted to receive said needle brace within said kit cavity, wherein said brace is provided sterilized within said kit package.

5. A brachytherapy kit of claim 4, wherein said brace comprises a

6. A brachytherapy kit of claim 4, wherein said brace comprises a

7. A brachytherapy kit of claim 4, wherein said brace comprises a

8. A brachytherapy kit of claim 4, wherein said brace comprises a

9. A brachytherapy kit of claim 3, wherein said first open end of said at least one brachytherapy needle is shaped to hold said brachytherapy member therein.

10. A brachytherapy kit of claim 9, wherein said tubular wall of said at least one brachytherapy needle defining a first and second transversely-spaced elongate channels to define a an elongate detent span therebetween, the central portion of said detent span being deflected towards the needle passageway so as to restrict passage of an elongate brachytherapy member therepast.

11. A brachytherapy kit of claim 9, wherein said tubular wall of said at least one brachytherapy needle defining a transversely-opening aperture therethrough proximate said first end thereof, and wherein said tubular wall includes a first and second opposed longitudinal elongate detent extending into said aperture, wherein said first detent extends towards said first end of said needle body and wherein said first detent extends further into said passageway than said second detent.

12. A brachytherapy kit of claim 1, wherein said at least one brachytherapy needle has a cross-sectional dimension of less than or equal to a 16-gage needle.

13. A brachytherapy kit of claim 1, wherein said at least one brachytherapy needle has a cross-sectional dimension of less than or equal to a 20-gage needle.

14. A brachytherapy kit of claim 1, wherein said at least one brachytherapy needle supports a luer fitting at said second end.

15. A brachytherapy kit of claim 1, further comprising a needle stabilizer having a needle stabilizer body, wherein each said at least one brachytherapy needle extends through said needle stabilizer body and wherein said kit package is adapted to receive said needle stabilizer within said kit cavity, wherein said needle stabilizer is provided sterilized within said kit package.

16. A brachytherapy kit of claim 15, wherein said needle stabilizer is positioned between said grid and said first end of said at least one brachytherapy needle.

17. A brachytherapy kit of claim 15, wherein said needle stabilizer is positioned between said grid and said second end of said at least one brachytherapy needle.

18. A brachytherapy kit of claim 15, wherein said needle stabilizer comprises a planar body having opposed first and second major faces and at least one perimetrical edge.

19. A brachytherapy kit of claim 18, wherein said planar body defines an aperture therethrough for receiving each of said at least one brachytherapy needle.

20. A brachytherapy kit of claim 18, wherein said planar body defines at least one slit extending between said first and second major surfaces, each said at least one slit for accommodating a brachytherapy needle therethrough.

21. A brachytherapy kit of claim 19, wherein said at least one slit of said planar body opens on said at least one perimetrical edge.

22. A brachytherapy kit of claim 1, wherein said package body further comprises: a planar backwall and an upstanding perimetrical wall supported by said backwall, said perimetrical wall and said backwall defining said package cavity; and a planar package cover removably engaging said perimetrical wall so as to enclose said package cavity.

23. A brachytherapy kit of claim 22, wherein said package body further comprises a first and second channel ridge defining an open channel therebetween for receiving said grid body, said channel ridges holding said grid body therebetween.

24. A brachytherapy kit of claim 1, further comprising at least one stylet within said package cavity.

25. A brachytherapy kit of claim 24, wherein said stylet extends at least partially into the passageway of one of said at least one brachytherapy needles through the second end thereof.

26. A brachytherapy kit of claim 25, wherein each said at least one brachytherapy needle supports a stylet at least partially into the passageway thereof through the second end thereof.